Patent Docs

Bilski and Aventis Petition for Certiorari from the Supreme Court

    By Kevin E. Noonan --

The Supreme Court was petitioned today to grant certiorari in two cases important to biotechnology patenting:  In re Bilski, involving the standard for determining that method claims are patentable subject matter; and Aventis Pharma S.A. v. Amphastar Pharmaceuticals, regarding the standard for finding inequitable conduct.  And in each case, dissents by Judge Rader are an important part of petitioner's arguments.

There were two questions presented by petitioners in the Bilski petition:

Whether the Federal Circuit erred by holding that a "process" must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing ("machine-or-transformation" test), to be eligible for patenting under 35 U.S.C. § 101, despite this Court's precedent declining to limit the broad statutory grant of patent eligibility for "any" new and useful process beyond excluding patents for "laws of nature, physical phenomena, and abstract ideas."

Whether the Federal Circuit's "machine-or-transformation" test for patent eligibility, which effectively forecloses meaningful patent protection to many business methods, contradicts the clear Congressional intent that patents protect "method[s] of doing or conducting business."  35 U.S.C. § 273.

Bilski argues that the "machine or transformation" test is a misreading of the Court's precedent, which has been expansive in determining the outer boundaries of patentable subject matter (citing the famous "anything under the sun made by man" language from Diamond v. Chakrabarty).  Recognizing that the Chakrabarty case concerned "compositions of matter" or "manufacture" claims, the petition also cites Diamond v. Diehr to find the Court's precedent for permissible method or process claims.  Here, the Court's reading is decidedly different from the Federal Circuit, where the majority believed its tests, based on the Supreme Court's decision in Gottschalk v. Benson, 409 U.S. 63 (1972), was supported by Diamond v. Diehr.  Petitioners stress that while the Court precluded natural phenomena and laws of nature from patentability, the Diehr case held that a process is patentable if, "'taken as a whole', [it] represents 'an application of a law of nature or mathematical formula'."  Petitioners suggest that this distinction provides a "bright line" for the Court to draw in deciding what is a patentable method and what is not.

Petitioners also maintain that the Supreme Court itself has deigned not to adopt the Federal Circuit's "machine or transformation" test, ironically in Gottschalk v. Benson, but also in Parker v. Flook.  And they are also quick to point out that the Federal Circuit's reliance on the "machine or transformation" test is contrary to the positions the CAFC itself took in State Street Bank & Trust Co. v. Signature Financial Group, 149 F.3d 1368 (Fed. Cir. 1998), and AT&T Corp. v. Excel Communications, Inc., 172 F.3d 1352 (Fed. Cir. 1999).

Petitioners also urge the Court to grant certiorari and reverse the Federal Circuit because the "machine or transformation" test is too restrictive, adopting Judge Rader's position that the test is an outdated relic of the age of mechanical patents in an era where the "bleeding edge" of innovation is "subatomic particles and terabytes."  They cite recent examples of the application of the restrictions on process patent claims (arguing that these claims are not "second class" claims under the statute), including In re Comisky and Classen Immunotherapies, Inc. v. Biogen Idec, and also warn that these cases mark a trend.  In the Federal Circuit, petitioners cited Comisky and Prometheus Labs., Inc. v. May Collaborative Srvs. as cases where the Federal Circuit had stayed consideration (or reconsideration) in favor of deciding the Bilski case to establish its precedent.  The Bilski decision was also affecting how the U.S. Patent and Trademark Office was deciding questions of patent eligibility for process claims, the petitioners argue, citing Ex parte Roberts, 2008 WL 2754746 (B.P.A.I. July 15, 2008), as well as claims to other statutory categories, citing Ex parte Godwin, 2008 WL 4898213 (B.P.A.I. Nov. 13, 2008)  (claims directed to a "portal server system" and a "portal server") and Ex parte Noguchi, 2008 WL 4968270 (B.P.A.I. Nov. 20, 2008) (claims directed to a "program for causing a computer connected to an external network to perform the functions of . . .").  These trends rendered certiorari urgent, to avoid continued application of the Federal Circuit's over-limiting test, according to petitioners.

In the Aventis case, this question was presented:

Whether a court may refuse to enforce an otherwise valid patent on the basis of an inequitable conduct determination premised on a sliding scale between intent and materiality, effectively permitting a finding of fraudulent intent to be predicated on gross negligence,

based on the following succinct statement of what is wrong with the Federal Circuit's inequitable conduct jurisprudence:

Under the judge-made doctrine of "inequitable conduct," a federal court may decline to enforce an otherwise valid patent that was procured through fraud or deceit.  Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806 (1945).  As befits the punitive nature of the doctrine, this Court has invoked it only in extreme circumstances involving "deliberate," "corrupt," "sordid" and "highly reprehensible" misconduct.  Some panels of the Federal Circuit have similarly limited the inequitable conduct doctrine to deliberately planned and carefully executed schemes to defraud, but other Federal Circuit panels -- including the majority in this case -- have adopted a "sliding scale" under which "less intent" is required as the materiality of an omission or misrepresentation increases.

In framing the factual and legal background of the case, the petition relies heavily on Judge Rader's dissent, regarding "the improper '[m]erging [of] intent and materiality' under the majority's sliding-scale standard, and highlighting several previous cases in which the Federal Circuit had 'emphasized materiality almost to the exclusion of intent'."  Perhaps befitting the presence of Supreme Court advocate Theodore Olsen on the brief, petitioner's prayer for relief is based not only on the law of inequitable conduct but also on the application of equitable principles under federal common law.  In addition, the petition cites dissension at the appellate level not only among the judges of the Federal Circuit, but in the several regional circuit courts of appeal and the district courts, citing cases that predate the creation of the Federal Circuit but that implicate differences in the circuits relevant to more general questions of equity.  In support of these notions, the petition cites Microsoft Corp. v. AT&T Corp., 550 U.S. 437 (2007); MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007); and eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006), for the principle that patent law (and the Federal Circuit) are bound by more than just its own specific doctrines (like inequitable conduct) but needs to fit properly within the federal judicial scheme for deciding on the bases for equitable relief.  And here, the petitioners argue, the Federal Circuit's "sliding scale" of proof, where the amount of intent required to be shown by a party alleging inequitable conduct varies inversely with the materiality of the reference, is outside the bounds of appropriate federal judicial standards.

In making this argument, petitioners remind the Court that it has held a patent unenforceable in just three cases:  Keystone Driller Co. v. General Excavator Co., 290 U.S. 240 (1933); Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238 (1944); and Precision Instrument Mfg. Co. v. Automotive Maintenance Machinery Co., 324 U.S. 806 (1945).  In all those cases, petitioners argue that the Court found overwhelming evidence of affirmative, culpable behavior, involving "'deliberate,' 'corrupt,' 'sordid,' and 'highly reprehensible' fraudulent conduct intentionally committed by the patent holder during prosecution or enforcement of the patent."  Such conduct included "false affidavit and false deposition testimony 'to keep secret the details of [a] prior use' which would have been 'sufficient to cast doubt upon the validity of the patent'" (Keystone Driller); "fabrication of an 'ostensibly disinterested' publication describing the claimed invention as a 'remarkable advance in the art,' which was submitted to the PTO and relied on by the patentee in the Court of Appeals" (Hazel-Atlas Glass); and "false testimony by Larson (the patentee) in an interference proceeding, and the discovery of Larson's perjury by Automotive, which used that information to blackmail Larson into assigning his patent rights to Automotive and agreeing never to contest the resulting patent" (Precision Instrument). 

Notwithstanding this precedent, the Federal Circuit erred almost from its inception, by adopting a "sliding scale" or "balancing" test in American Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350, 1363 (Fed. Cir. 1984).  In that case, petitioners argue:

A knowing deception is thus presumed from the mere fact that highly material information was omitted, under the justification that "he who failed to supply highly material information should have known about the information's materiality."

According to petitioners, this standard is erroneous and inconsistent with Supreme Court precedent, wherein "[t]he non-disclosure of material information is a necessary but not sufficient element of fraud or inequitable conduct.  The complainant must also prove that the material information was intentionally withheld" (emphasis in original).  The petitioners characterize the Federal Circuit's standard as one of "strict liability" under circumstances where the materiality of the undisclosed information is high.  Such a standard is inconsistent with "almost two centuries" of Supreme Court precedent on the requirements of showing fraud, all of which require some element of knowing intention, according to petitioners, citing Lord v. Goddard, 54 U.S. 198, 211 (1851); Wiscart v. Dauchy, 3 U.S. 321, 330 (1796); Moss v. Riddle & Co., 9 U.S. 351, 357 (1809); Magee v. Manhattan Life Ins. Co., 92 U.S. 93, 98-99 (1875); Reilly v. Pinkus, 338 U.S. 269, 275 (1949); and Madigan v. Telemarketing Assocs., 538 U.S. 600, 621 (2003).

Petitioners also assert that the Federal Circuit's "extraordinary" remedy -- unenforceability -- is contrary to equitable principles, since it is a "one-size-fits-all" remedy imposed without regard to whether there are other legal remedies available nor with regard to the effect of the remedy on the public interest.  "''The essence of equity jurisdiction has been the power of the Chancellor to do equity and to mould each decree to the necessities of the particular case.  Flexibility rather than rigidity has distinguished it,'" citing Hecht Co. v. Bowles, 321 U.S. 321, 329 (1944).

Finally, petitioners argue that the consequences of the chaotic application of inequitable conduct by the Federal Circuit affects innovation by excessive litigation costs, imposing excessive citations of references of dubious relevance to the Patent Office, and creating business uncertainty.  This situation is particularly appropriate for Supreme Court review:

The inequitable conduct doctrine in patent cases is judge-made in every sense, and can (and should) be shaped by the Judiciary to conform to the broader policies of the Progress Clause and the Patent Act, as well as the general run of federal law.  This issue will not benefit from further percolation in the circuits.  The split in the lower courts and within the Federal Circuit itself is deep and mature, and the Federal Circuit has exhibited a steadfast unwillingness to revisit the issue en banc.  Four decades of confusion are enough.  The question presented is ripe -- indeed overdue -- for this Court's review.

The Court can be expected to decide whether to grant these petitions by the end of this term.

For additional information regarding this and other related topics, please see:
• "The Relevance of In re Bilski to the Patentability of the Metabolite Claim," November 17, 2008
• "Aventis Pharma S.A. v. Amphastar Pharmaceuticals (Fed. Cir. 2008)," May 26, 2008

Abbott Laboratories v. Sandoz, Inc. (Fed. Cir. 2008) - Part II

Opposing Federal Circuit Preliminary Injunction Standards in Abbott Laboratories v. Sandoz

    By Kevin E. Noonan --

The decision of the Court of Appeals for the Federal Circuit in Abbott Laboratories v. Sandoz, affirming the District Court's grant of a preliminary injunction, nicely illustrates the way the Federal Circuit exercises its prerogatives in applying the abuse of discretion standard.  In our previous post, we discussed the portion of the decision relating to how the CAFC reviewed the District Court's determination of the first prong of the preliminary injunction standard, establishing a reasonable expectation of success on the merits, with regard to invalidity.  This post will discuss how the Federal Circuit conducted its review of how the District Court evaluated Sandoz's contentions that the patents-in-suit, U.S. Patent Nos. 6,010,718 and 6,551,616, were unenforceable due to inequitable conduct during patent prosecution.

Sandoz made three assertions of inequitable conduct against the '718 patent and an additional two inequitable conduct assertions against the '616 patent.  For the '718 patent, the first assertion involved a statement by one of the inventors, Dr. Linda Gustavson, in a declaration submitted during prosecution.  In her declaration, Dr. Gustavson stated that there was a statistically-significant difference in the Cmax of clarithromycin API in the extended release (ER) formulations claimed in the '718 patent when compared with immediate release (IR) formulations in the prior art.  However, during litigation, Dr. Gustavson admitted that she never performed statistical analyses on the differences reported between ER and IR formulations.  Abbott countered that the experimental evidence was submitted to the Patent Office and that the statistical significance of the difference was not material to patentability, despite the prosecuting attorney's use of Dr. Gustavson's declaration as support in overcoming an obviousness rejection asserted by the Examiner.  The District Court, using the "reasonable examiner" test for materiality, decided that although it was "obviously troublesome that Gustavson made her assertion without having actually performed the statistical test," her statement was not material to patentability.  The Federal Circuit supported this conclusion by stating:

Since 1) no claim of the '718 patent requires the extended release formulation to have a statistically significant lower Cmax than the immediate release formulation; 2) the data in fact shows the Cmax of the extended release formulation to be lower (albeit not statistically significantly lower) than the Cmax of the immediate release formulation; and 3) the extended release formulation was in fact pharmacokinetically different from the immediate release suspension formulation, it is more likely than not that the PTO would not have found the "statistically significantly lower" statement to be important.

The District Court also found no evidence of an intent to deceive under these circumstances, rejecting Sandoz's contention that the combination of the false statement and the materiality of the information was sufficient to infer intent.  The Federal Circuit's majority opinion, written by Judge Newman and joined by Judge Archer, found no abuse of discretion in the District Court's weighing of the evidence of materiality and intent and refusing to find inequitable conduct.

Sandoz's second assertion related to clinical trial evidence obtained after the filing date of the application that was granted as the '718 patent, concerning the results of "taste perversion" experiments, i.e., the tendency of different formulations to have an unpleasant metallic taste.  These test results were submitted to the FDA and included on Abbott's Biaxin® XL product label but were not disclosed to the examiner during prosecution.  Sandoz contended that these test results showed a higher incidence of taste perversion for ER formulations compared with prior art IR formulations, contrary to the disclosure in the '718 patent specification.  Abbott opposed this contention (supported by an expert declaration) on the grounds that the taste tests were done at different API concentrations in the formulation and were thus not directly comparable.  The District Court found that this information was material under Rule 56, but that a reasonable examiner would not have considered the information "important" in deciding whether to grant the '718 patent because the dosages were not comparable (and the reasonable examiner would have required a comparison at equivalent dosages in order for the information to be "important" to making a patentability determination).  Moreover, the District Court found no intent to deceive, because there was no evidence of deliberate withholding of information from the examiner, once again refusing to infer intent from the degree of materiality of the undisclosed information.  The Federal Circuit agreed with the District Court that under its precedent (including Kingsdown Medical Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988) and Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995)), materiality and intent to deceive must be independently established, and that there was no abuse of discretion in the District Court's refusal to find inequitable conduct on this basis asserted by Sandoz.

Sandoz's last inequitable conduct contention regarding the '718 patent was based on Abbott's failure to disclose another set of clinical trial results obtained after the '718 patent was filed, relating to pharmacokinetics of clarithromycin administered under different conditions.  These test results concerned comparisons between IR formulations and "modified release" (MR) formulations in the prior art for mean DFL (degree of fluctuation) values.  The District Court did not find these studies material because, inter alia, the MR formulations were different from the claimed ER formulations.  The majority opinion did not find clear error in this determination by the District Court.

Turning to the '616 patent, the District Court rejected Sandoz's first inequitable conduct contention because it was directed to taste perversion claims cancelled before examination in the application that resulted in the granted '616 patent.  The majority opinion cited Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir. 1991), for the proposition that "[a] reference that is material only to withdrawn claims can not be the basis of a holding of inequitable conduct" and agreed with the District Court's conclusion that the "withheld" information was not material to patentability of any claims in the '616 patent.

Sandoz's second inequitable conduct contention was based on another undisclosed set of clinical trial results, which Sandoz's expert testified did not support formulations useful in claimed methods for reducing gastrointestinal side effects.  Again in this instance, these clinical trial results were submitted to the FDA but not to the PTO.  The District Court determined that there was sufficient evidence in the '616 patent specification to support claimed to methods for reducing gastrointestinal side effects of clarithromycin administration and that the clinical trial data did not contradict this disclosure.  Thus, the clinical trial results were not material according to the District Court, and in the absence of any affirmative evidence of an intent deceive, the '616 patent claims were not unenforceable for inequitable conduct on this evidence.

The majority opinion agreed, and further stated:

This is not a case of new information that affects the fundamental invention; this is a case of challenging every action or inaction of the "conduct" of patent solicitation, although patentability is unaffected.  The purpose of Kingsdown was to bring patent practice into the mainstream of the law and administrative practice.  The law severely punishes fraudulent practices, and the patent practice includes recognition that the inventor usually knows more about the field than does the "expert" patent examiner.  However, routine actions that do not affect patentability and that are devoid of fraudulent intent are not subject to a different standard than other inquiries into fraudulent procurement.  The Administrative Procedure Act governs patent examination, see Dickinson v. Zurko, 527 US 150 (1999), and actions of patent examiners are reviewed with recognition of examiner expertise so well as recognition of the occasionally imperfect examination process.  "It was to mitigate the 'plague' whereby every patentee's imperfections were promoted to 'inequitable conduct' that this court reaffirmed that both materiality and culpable intent must be established."  Allied Colloids, Inc. v. American Cyanamid Co., 64 F.3d 1570, 1578 (Fed. Cir. 1995).

This succinctly states the majority opinion's philosophical view, shared by other members of the Court (most notably, Judge Rader) that a finding of inequitable conduct results in such a draconian remedy (patent unenforceability) that it should be found only on those rare occasions where a defendant can bear the heavy burden of establishing both prongs, materiality and intent to deceive, by clear and convincing evidence.

The dissent illustrates the opposite philosophical stance, wherein a court is justified in using circumstantial evidence to support a determination of an intent to deceive, said circumstantial evidence including the materiality of the withheld information.  In this regard, Judge Gajarsa (at right) points to two of Sandoz's inequitable conduct contentions that were persuasive to him that granting a preliminary injunction was an abuse of discretion.  The first, was Dr. Gustavson's admission that she did not perform any statistical analyses of her experimental data but nonetheless asserted in her declaration that the differences in Cmax between ER and (prior art) IR formulations were statistically significant.  Here, the affirmative nature of the misrepresentation was sufficient, because according to Judge Gajarsa the District Court "created such a high bar for materiality that in essence no statement or withholding of information would be material if it would not change the ultimate outcome of allowing the patent."  This, according to the dissent, was inconsistent with such precedent as Hoffmann-La Roche, Inc. v. Promega Corp., 323 F.3d 1354 (Fed. Cir. 2003), where "[t]he fact that the examiner did not have to rely on the purity representations in issuing the patent is not inconsistent with a finding of materiality.  Although the inventors' statements regarding purity were not the principal focus of the office action response, they were clearly an important aspect of it.  Under the circumstances, a reasonable examiner would have wanted to know that the patentability argument based on purity was unsupported by the experimental results cited by the inventors."

Judge Gajarsa also took issue with the District Court's finding that Abbott's withholding clinical trial evidence on DFL values was not material, since (according to the dissent) "the extent the PK parameters of the ER formulation differed from the clarithromycin formulations in the prior art was the primary focus of the examiner's concerns regarding patentability, and Abbott's ability to establish sufficient differences was the basis for allowing the claims."  Judge Gajarsa objected to a materiality standard the would permit a patentee to selectively disclose "one set of studies that supported patentability and therefore could ignore studies reaching the opposite result," citing Paragon Podiatry Lab., Inc. v. KLM Labs., Inc., 984 F.2d 1182 (Fed. Cir. 1993).  Thus, in Judge Gajarsa's estimation, Sandoz had raised sufficient doubts about the enforceability of the patents in suit that its grant of a preliminary injunction was an abuse of discretion.

While it may appear that Judge Gajarsa's criticisms of the District Court's consideration of the evidence regarding inequitable conduct has logical force (particularly in view of the Federal Circuit's recent decision, in Aventis Pharma S.A. v. Amphastar Pharma, Inc., that misstatements in a declaration evinced an intent to deceive sufficient to support an inequitable conduct determination), the issue here is the same as that raised by the differing views on the standard for establishing vel non a likelihood of success on the merits based on invalidity.  The Federal Circuit clearly views its mandate to include plenary review of a district court's decisions for which the lower court is entitled to a deferential, abuse of discretion standard of review.  As was seen in our earlier post, this has led to conflicting decisions from different appellate panels on whether the likelihood of success prong of the preliminary injunction analysis can be defeated by a defendant raising a substantial question of unpatentability.  Here, the Federal Circuit appears committed to reviewing the evidence presented in support of the twin requirements of materiality and intent, and then further reviewing the subtle balancing by a district court in determining whether a defendant has established (or a likelihood of establishing) inequitable conduct sufficient to preclude grant of a preliminary injunction.  In addition to seemingly squandering significant judicial resources in performing this review, the CAFC's behavior raises questions about whether it is giving appropriate deference to areas properly within the sound discretion of the district court.

For additional information regarding this case, please see:

• "Abbott Laboratories v. Sandoz, Inc. (Fed. Cir. 2008) - Part I," October 28, 2008

Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. (Fed. Cir. 2008)

    By Kevin E. Noonan --

We may have reached the high-water mark on the expansion of the inequitable conduct doctrine.  Recent decisions from the Federal Circuit seem to signal a retrenchment in the Court's treatment of the doctrine, and its willingness to affirm district court judgments finding inequitable conduct, particularly in the context of summary judgment decisions.  One of the first indications of this new direction came in the Eisai Co. v. Dr. Reddy's Laboratories, Inc. decision last month, where Judge Rader forcefully reminded us that finding inequitable conduct should be "a high bar," citing the Court's en banc decision in Kingsdown Medical Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 876 (Fed. Cir. 1988).  In doing so, the Court cast some doubt on the wisdom of recent decisions that expanded the inequitable conduct doctrine to encompass improperly claiming small entity status (Nilssen v. Osram Sylvania, Inc.), improperly filing a petition to make special (General Electro Music Corp. v. Samick Music Corp.), failing to disclose that a declarant had been a paid consultant prior to filing an expert declaration under 37 C.F.R. § 1.132 (Ferring B.V. v. Barr Laboratories, Inc.), misjoinder of inventorship (PerSeptive Biosystems, Inc. v. Pharmacia Biotech, Inc.), and inaccuracies in an expert declaration (Aventis Pharma S.A. v. Amphastar Pharma, Inc.).  Indeed, the beginnings of the trend may have started with Judge Rader's spirited dissent in Aventis Pharma.  A determination of inequitable conduct, according to Judge Rader (at right) in the Eisai decision, should include evidence of affirmative instances of "culpable conduct" rather that mere omissions, citing the greater evidentiary difficulties that should attach when intent must be discerned from negligent conduct.  His opinion also emphasized that a defendant must establish intent by clear and convincing evidence.

This trend continues today in the Federal Circuit's decision reversing summary judgment of inequitable conduct against the patentee in Star Scientific, Inc. v. R.J. Reynolds Tobacco Co.  The patents-in-suit, U.S. Patent Nos. 6,202,649 and 6,425,401 (filed as a continuation of the '649 patent), were directed to methods for curing tobacco in a way that reduced the amount of a carcinogen, tobacco-specific nitrosamines (TSNAs), in the cured product used in cigarettes and other tobacco-containing products.  The undisclosed information was a letter from one of Star Scientific's consultants, Dr. Harold Burton, relating to curing methods used in China that resulted in low levels of TSNAs.  The attorney who prosecuted the '649 patent was aware of this letter, but "ultimately concluded that neither [the letter itself] nor its content was material to the contemplated patent application," after speaking with Dr. Burton.  Also undisclosed was experimental data generated by Dr. Burton relating to reduced TSNA levels in cured tobacco.

During prosecution of these patents, Star Scientific transferred responsibility from its first set of prosecuting attorneys at Sughrue, Mion, Zin, Macpeak & Seas to a second set at Banner and Witcoff.  The Banner attorneys also became aware of the Burton letter, from litigation counsel (Crowell & Moring) in Star Scientific's patent litigation in the District Court against R.J. Reynolds; litigation counsel opined that this information should be disclosed to the U.S. Patent and Trademark Office during prosecution of the '401 patent.  The Banner attorneys considered the Burton letter, and the experimental data, decided neither was material and did not need to be disclosed, and neither was disclosed during prosecution of the '401 patent.  The file transfer formed the basis for R.J. Reynolds' inequitable conduct theory, which posited that Star Scientific did not want the Banner attorneys to be aware of the Burton letter or experimental data so it could be concealed from the Patent Office during prosecution of the '401 patent.  The District Court agreed and granted summary judgment in favor of R.J. Reynolds that neither patent was enforceable due to inequitable conduct.

The Federal Circuit disagreed, in a unanimous decision by Chief Judge Michel joined by Judges Schall and Dyk.  The Court began its analysis by setting up the analytical framework:

To successfully prove inequitable conduct, the accused infringer must present "evidence that the applicant (1) made an affirmative misrepresentation of material fact, failed to disclose material information, or submitted false material information, and (2) intended to deceive the [PTO]."  Further, at least a threshold level of each element -- i.e., both materiality and intent to deceive -- must be proven by clear and convincing evidence.  And even if this elevated evidentiary burden is met as to both elements, the district court must still balance the equities to determine whether the applicant's conduct before the PTO was egregious enough to warrant holding the entire patent unenforceable.  Thus, even if a threshold level of both materiality and intent to deceive are proven by clear and convincing evidence, the court may still decline to render the patent unenforceable [citations omitted].

The CAFC goes on to say that the "need to strictly enforce the burden of proof and elevated standard of proof in the inequitable conduct context is paramount," because the penalty, unenforceability, is "so severe."  The Court, ever mindful of the heightened levels of oversight scrutiny the Supreme Court is wont to exercise lately over its decisions, supported this sentiment by reminding us of Supreme Court precedent (specifically, Hazel-Atlas Glass Co. v. Hartford-Empire Co. and Precision Instrument Mfg. Co. v. Automotive Maintenance Machinery Co.).  Courts must be "vigilant in not permitting the defense to be applied too lightly."  "Just as it is inequitable to permit a patentee who obtained his patent through deliberate misrepresentations or omissions of material information to enforce the patent against others, it is also inequitable to strike down an entire patent where the patentee only committed minor missteps or acted with minimal culpability or in good faith."

Specifically with regard to the deceptive intent prong, the Court noted that "materiality does not presume intent" (they are separate prongs of the analysis), and then cited Molins PLC v. Textron, Inc.:

[T]he alleged conduct must not amount merely to the improper performance of, or omission of, an act one ought to have performed.  Rather, clear and convincing evidence must prove that an applicant had the specific intent to . . . mislead[] or deceiv[e] the PTO.  In a case involving nondisclosure of information, clear and convincing evidence must show that the applicant made a deliberate decision to withhold a known material reference.

What is required, said the Court, is a "specific intent to deceive the PTO."

Since the CAFC recognizes that "direct evidence of deceptive intent is rarely available," the required intent can be inferred from conduct and other "indirect and circumstantial evidence," citing Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359, 1364 (Fed. Cir. 2007).  But this doesn't lower the evidentiary requirements; indeed, it appears the Court believes that it raises them.  If a court must deal with inferences, such inferences "must not only be based on sufficient evidence and be reasonable in light of that evidence, but it must also be the single most reasonable inference able to be drawn from the evidence to meet the clear and convincing standard," citing Scanner Technologies Corp. v. ICOS Vision Systems Corp., 528 F.3d 1365 (Fed. Cir. 2008) (emphasis added).

With regard to the exercise of a court's equitable discretion in finding inequitable conduct, in the absence of clear and convincing evidence of both materiality and intent a court has no discretion -- it cannot find inequitable conduct, according to the Federal Circuit.  Even if a defendant establishes both intent and materiality by clear and convincing evidence, a finding of unenforceability on inequitable conduct grounds is not inevitable.  A court should "look to the equities" and balance all of these equities with the substance of the facts underlying the "clear and convincing" evidence of materiality and intent, "to determine whether the severe penalty of unenforceability should be imposed."  This determination is left to a court's sound discretion.

In this case, the Federal Circuit disagreed that Defendants had shown clear and convincing evidence of intent as to patentee's conduct in prosecuting the '649 patent, and also disagreed that the withheld information was material to the patentability of the '401 patent claims.  The Court found that R.J. Reynolds' "quarantine" theory (of preventing the Banner attorneys from knowing what the Sughrue attorneys knew about the Burton letter and experimental data) was not established by clear and convincing evidence.  The Court found that Star Scientific had proffered other, plausible explanations for changing counsel.  While acknowledging that credibility determinations were properly within the province of the district court and should not be second-guessed by an appellate court, the Federal Circuit also cautioned against shifting the burden from R.J. Reynolds to Star Scientific:  Star Scientific did not bear the burden of rebutting R.J. Reynolds' evidence unless and until Reynolds had established an intent to deceive by clear and convincing evidence.  "[A] patentee need not offer any good faith explanation unless the accused infringer first carried his burden to prove a threshold level of intent to deceive by clear and convincing evidence."  Here, the Federal Circuit found "major gaps" in the evidentiary bases for R.J. Reynolds' theory, and accordingly found that the Defendants had not established intent by clear and convincing evidence.

With regard to the '401 patent, the issue was materiality and here the CAFC found that Star Scientific had provided additional information and evidence, including evidence from the litigation, that rendered the Burton letter and experimental data cumulative.  Ironically, key evidence provided by Star Scientific that rendered the undisclosed Burton letter and data cumulative was R.J. Reynolds' response to one of Star Scientific's interrogatories, outlining that changing curing conditions to reduce TSNA concentrations in cured tobacco was known in the prior art.

So far, it has been the Court's veteran judges, like Judge Rader and Chef Judge Michel (at right), who have hewed more closely to the limitations on inequitable conduct set forth in Kingsdown and Molins.  The Court has shown a willingness in other areas, such as claim construction, to revisit and reaffirm its jurisprudence en banc when panels of the Court have significant drifted from those principles.  Perhaps the time is approaching when the Court will decide to revisit and reaffirm its Kingsdown and Molins principles for determining whether a patent should be deemed unenforceable for being improperly procured through inequitable conduct.

Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. (Fed. Cir. 2008)
Panel: Chief Judge Michel and Circuit Judges Schall and Dyk
Opinion by Chief Judge Michel

Eisai Co. v. Dr. Reddy's Laboratories, Inc. (Fed. Cir. 2008)

    By Kevin E. Noonan --

Sanity may be returning to the Federal Circuit's treatment of two issues, obviousness and inequitable conduct.  In Eisai Co. v. Dr. Reddy's Laboratories, Inc., the Court (in an opinion by Judge Rader joined by Judges Linn and Prost) affirmed the District Court's determination that the patent-in-suit, U.S. Patent No. 5,045,552 was not obvious and was not obtained through inequitable conduct.  In doing so, the Court illustrated how its approach to chemical obviousness has developed after KSR Int'l Co. v. Teleflex Inc. and suggested that its inequitable conduct analysis may be returning to the principles enunciated in Kingsdown Medical Consultants, Ltd. v. Hollister, Inc., 863 F.2d 867 (Fed. Cir. 1988) (en banc).

The '552 patent discloses and claims rabeprazole, a proton pump inhibitor that suppress gastric acid production by inhibiting action of the enzyme H+, K+ ATPase.  Eisai sells the sodium salt of rabeprazole as Aciphex® for duodenal ulcers, heartburn, and related disorders.  It has worldwide sales of more than $1 billion.  Eisai filed suit pursuant to notification from Defendants Dr. Reddy's Laboratories and Teva Pharmaceuticals that each company had filed an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification that the '552 patent was invalid and/or unenforceable.  (Mylan Laboratories, Inc. and Mylan Pharmaceuticals also filed ANDAs, but Eisai's lawsuit against those companies was stayed pending resolution of this action; Mylan agreed to be bound by the final judgments and any appeals in Eisai's lawsuit against Dr. Reddy's and Teva.)

Neither Defendant contested that filing an ANDA constituted infringement under the Hatch-Waxman Act, and both asserted the affirmative defense that the '552 patent was unenforceable for being obtained by Eisai through inequitable conduct.  In addition, Teva asserted that the '552 patent claims were invalid as being obvious over three prior art references.  The District Court granted summary judgment in Eisai's favor on infringement, invalidity, and inequitable conduct.  Infringement was not appealed by either Defendant.

Teva based its allegations that the '552 patent was obvious over three prior art references: 1) European Patent No. 0 174 726, claiming lansoprazole (see below); 2) U. S. Patent No. 4,255,431, claiming omeprazole; and 3) an article by Brändström et al., entitled "Structure Activity Relationships of Substituted Benzimidazoles."  Lansoprazole was disclosed in the '726 EP for treating ulcers, and differs from rabeprazole in having a trifluoroethoxy at the 4-position on the pyridine ring instead of a methoxypropoxy substituent:

Omeprazole differs more significantly in chemical structure, having a methoxy substituent at the equivalent 4-position:

The Brändström reference discloses a generic structure for anti-ulcerative compounds having a benzimidazole-sulfinylmethyl-pyridine core structure that encompasses lansoprazole, omeprazole, and rabeprazole:

The Federal Circuit adopted for the purposes of the appeal two properties of lansoprazole:  that it was twenty-fold more active than omeprazole in its anti-ulcer action, and that the trifluoroethoxy group improved lipophilicity "that would have made it desirable to the skilled artisan."

The Court took this as evidence that lansoprazole would have been considered a "lead compound" for the skilled artisan in the search for alternative anti-ulcer compounds.  Contrary evidence considered by the Court was testimony by Teva's expert that the data set forth in the '726 EP application would not permit the level of acid secretion to be determined.  Moreover, the District Court, and the Federal Circuit, considered the teachings of the '726 EP application that the trifluoroethoxy substituent provided "a special path to achieving lipophilicity," a desirable property for an anti-ulcer medication, something Teva's expert testified was supported by a separate prior art reference.  Another of Teva's experts refused to testify as to the relevance of the '726 EP application to the patentability of the '552 patent claims, and the Federal Circuit further noted that there was "no discernible reason for a skilled artisan to begin with lansoprazole only to drop the very feature, the fluorinated substituent, that gave this advantageous property."

The Federal Circuit articulated the following principles for applying the Supreme Court's KSR teachings to the question of chemical obviousness:

First, KSR assumes a starting reference point or points in the art, prior to the time of invention, from which a skilled artisan might identify a problem and pursue potential solutions.  Second, KSR presupposes that the record up to the time of invention would give some reasons, available within the knowledge of one of skill in the art, to make particular modifications to achieve the claimed compound.  See Takeda Chem. Indus. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1356 (Fed. Cir. 2007).  ("Thus, in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound.").  Third, the Supreme Court's analysis in KSR presumes that the record before the time of invention would supply some reasons for narrowing the prior art universe to a "finite number of identified, predictable solutions," 127 S. Ct. at 1742.  In Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008), this court further explained that this "easily traversed, small and finite number of alternatives . . . might support an inference of obviousness."  To the extent an art is unpredictable, as the chemical arts often are, KSR's focus on these "identified, predictable solutions" may present a difficult hurdle because potential solutions are less likely to be genuinely predictable.  (Emphasis added)

The Federal Circuit stated that the record showed no reasons why the skilled artisan would have identified modifying lansoprazole to substitute the lipophilicity-conferring trifluoroethoxy group as a predictable solution to the problem of providing an alternative anti-ulcer compound.  The Court characterized Teva's argument as relying on "unsupported assertions" that compounds other than lansoprazole, such as rabeprazole, would have been identified by the skilled artisan as an alternative anti-ulcer compound.  Thus, finding no genuine issue of material fact and no evidence that the District Court committed clear error, the Federal Circuit affirmed the finding that the '552 patent claims were non-obvious.

Turning to the question of inequitable conduct, the defendants raised five bases for their allegations:  first, that Eisai did not disclose a related, co-pending application that disclosed the "ethyl homolog" of rabeprazole; second, failing to disclose rejections in the related application alleged to be material to patentability; third, failing to disclose a prior art reference (WO 86/02646); fourth, by submitting a misleading declaration; and finally, concealing the existence of lansoprazole in the prior art.  The District Court found the materiality of the ethyl homolog application to be low, even in the face of Teva's allegation that its existence could have provoked an obviousness-type double patenting rejection.  Although the Federal Circuit stated that disclosure of the co-pending application would have been "prudent," Eisai's failure to do so was not inequitable conduct, according to the Federal Circuit because the low materiality of the application was coupled with a record "devoid of any real suggestion of intent to deceive."  Similarly, the District Court found, and the Federal Circuit agreed, that there was "no compelling evidence" of an intent to deceive relating to Eisai's failure to disclose the rejections asserted by the Examiner in the co-pending application.  This determination was based in part on the District Court's appreciation that filing separate applications on sufficiently-related subject matter in an effort to "hide" the existence of each of them from the Patent Examiner was "implausibly risky" in view of the likelihood that the same examiner would be assigned to both.  The District Court found the undisclosed reference to be merely cumulative to art of record during prosecution of the '552 patent.  Although the Court found the declaration at issue "highly material," it was unconvinced by the Defendants that the failure to disclose the relationship between the anti-ulcerative properties of rabeprazole and the "ethyl homolog" was material, characterizing the undisclosed information as "additional" and "unnecessary."  Moreover, there was a sufficient lack of any evidence of an intent to deceive to render "stillborn" the inequitable conduct allegation.  Finally, the lansoprazole allegation, which the District Court had dismissed on summary judgment, was supported by evidence of neither materiality nor an intent to deceive.

More important than the decision in this case regarding inequitable conduct was the Federal Circuit's discussion of the guiding principles of law it applied:

Inequitable conduct in prosecuting a patent application before the United States Patent & Trademark Office may take the form of an affirmative misrepresentation of material fact, a failure to disclose material information, or the submission of false material information, but in every case this false or misleading material communication or failure to communicate must be coupled with an intent to deceive.  Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1378 (Fed. Cir. 2008).  Materiality, defined as "what a reasonable examiner would have considered important in deciding whether to allow a patent application," and intent are both questions of fact, and require proof by clear and convincing evidence.  Id.  To satisfy the "intent" prong for unenforceability, "the involved conduct, viewed in light of all the evidence, including evidence indicative of good faith, must indicate sufficient culpability to require a finding of intent to deceive."  Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 876 (Fed. Cir. 1988) (en banc) (citing Norton v. Curtiss, 433 F.2d 779 (CCPA 1970)).  Gross negligence is not sufficient.  Id.  This is a high bar.

Lately, it hasn't been a high bar.  Indeed, since Kingsdown, the Court has expanded the limits of the behavior it has considered amounts to inequitable conduct.  Examples of this expansion include improperly claiming small entity status (Nilssen v. Osram Sylvania, Inc.), improperly filing a petition to make special (General Electro Music Corp. v. Samick Music Corp.), failing to disclose that a declarant had been a paid consultant prior to filing an expert declaration under 37 C.F.R. § 1.132 (Ferring B.V. v. Barr Laboratories, Inc.), misjoinder of inventorship (PerSeptive Biosystems, Inc. v. Pharmacia Biotech, Inc.), and inaccuracies in an expert declaration (Aventis Pharma S.A. v. Amphastar Pharma, Inc.).  Judge Rader, who dissented in Aventis Pharma, here emphasized the need, in his opinion, for affirmative instances of "culpable conduct" rather that mere omissions, with the concomitantly more difficult need to discern evidence of intent from such conduct.  And Judge Rader is more clearly focused, in Aventis and in this opinion, on a defendant carrying the extraordinary burden of establishing inequitable conduct by clear and convincing evidence.

It remains to be seen whether Judge Rader's formulation of the proper boundaries of what constitutes inequitable conduct for the Federal Circuit will prevail.

Eisai Co. v. Dr. Reddy's Laboratories, Inc. (Fed. Cir. 2008)
Panel: Circuit Judges Rader, Linn, and Prost
Opinion by Circuit Judge Rader

AstraZeneca Prevails in Seroquel® Paragraph IV Litigation

    By Sherri Oslick --

Late last week, Judge Pisano of the District Court of New Jersey granted summary judgment of no inequitable conduct in favor of AstraZeneca in its consolidated Paragraph IV litigation against Teva Pharmaceuticals and Sandoz, Inc. over AstraZeneca's antipsychotic drug Seroquel®.  Because the Defendants previously abandoned their other defenses, no issues remain for trial; AstraZeneca has petitioned for entry of final judgment.

The patent-in-suit, U.S. Patent No. 4,879,288 ("Novel Dibenzothiazepine Antipsychotic," issued November 7, 1989), covers quetiapine fumarate, the active ingredient in Seroquel®, used to treat schizophrenia and bipolar disorder.  The original case, 05-cv-05333 (JAP) was consolidated with later filed cases, including one against Sandoz as reported here, and one against Teva, as reported here.

AstraZeneca moved for summary judgment of no inequitable conduct on March 18, 2008.  The Defendants had alleged multiple bases for their charge of inequitable conduct, however, Judge Pisano found the alleged omissions to lack sufficient materiality to constitute inequitable conduct.  Additionally, the Court found that the Defendants had failed to present evidence of intent.  AstraZeneca's motion was granted on July 1, 2008.

For additional information, please see:

• Judge Pisano's opinion
• AstraZeneca's press release
• "Court Report," July 1, 2007
• "Court Report," April 15, 2007

University of Pittsburgh v. Hedrick (C.D. Cal. 2008)

    By Kevin E. Noonan --

On June 9, 2008, the University of Pittsburgh obtained a judgment correcting inventorship of U.S. Patent No. 6,777,231 under 35 U.S.C. § 256.  The U.S. District Court for the Central District of California determined that several of the inventors, who had assigned their rights to the Regents of the University of California, were not properly named as inventors, thus extinguishing the Regents' rights and nullifying a license from the University of California to Cytori Therapeutics, Inc.  As a consequence, the Pittsburgh licensee, Artecel Inc., became the sole licensee of the '231 patent.

The '231 patent is directed to adipose-derived stem cells.  Claim 1 of the '231 patent reads as follows:

1.  An isolated adipose-derived stem cell that can differentiate into two or more of the group consisting of a bone cell, a cartilage cell, a nerve cell, or a muscle cell.

As granted, the '231 patent named Adam J. Katz, Ramon Llull, William J. Futrell, Marc H. Hedrick, Prosper Benhaim, Hermann Peter Lorenz, and Min Zhu as inventors, and the patent is assigned to both the University of Pittsburgh and the Regents of the University of California.  The District Court determined in its findings of fact that Katz, Llull, and Futrell worked only at the University of Pittsburgh; Benhaim, Lorenz, and Zhu worked only at UCLA; and Hedrick worked first at Pittsburgh and later at UCLA.

The University of Pittsburgh filed suit to remove the UCLA inventors from the '231 patent under 35 U.S.C. § 256, and the UCLA inventors counterclaimed to remove the University of Pittsburgh inventors.  (Curiously UCLA does not seem to be a party to the suit even though a determination that the Defendants were not inventors would destroy any rights UCLA has in the '231 patent.)

On June 9th, Judge Consuelo B. Marshall issued the District Court's Findings of Fact and Conclusions of Law; the Court had earlier granted summary judgment that Drs. Katz and Llull were properly named as inventors.  The Court found that Dr. Katz had isolated adipose-derived stem cells, and that Drs. Katz and Llull conceived that these cells could be induced to differentiate into cells from multiple mesodermal lineages, "including bone, cartilage, fat and muscle."  The Court credited evidence from laboratory notebooks that Drs. Katz and Llull showed their adipose-derived stem cells could differentiate into several different cell types, including adipose cells, nerve cells, and muscle cells.  Dr. Katz also "appreciated" the capacity of these adipose-derived stem cells for self-renewal, according to the Court.  The Court found that the earliest date of conception for the invention claimed in the '231 patent was several years before work began at UCLA.

Based on these factual findings, the District Court concluded that the University of Pittsburgh had carried its burden of showing by clear and convincing evidence that the UCLA inventors (Benhaim, Hedrick, Lorenz, and Zhu) were not inventors of the invention claimed in the '231 patent.  According to the Court, the evidence established that Dr. Hedrick's work regarding differentiation of adipose-derived stem cells into nerve cells occurred after Drs. Katz and Llull conceived of the claimed invention, i.e., adipose-derived stem cells that could be induced to differentiate into multiple cell types (adipose and muscle cells).  The Court concluded that the UCLA inventors' work merely "confirmed the operability of the invention."  Thus, only Drs. Katz and Llul are properly named as inventors of the '231 patent.

The UCLA inventors had previously attempted to correct inventorship during prosecution of the corresponding application, asserting that the inventors were properly named upon filing but that claim amendments had changed inventorship.  The first petition, filed before the '231 patent issued, was never acknowledged by the Office, while the second (accompanied by a Certificate of Correction) was denied.  Also denied was another petition supported by a copy of Pittsburgh's complaint.  The Court did not rule on the question of whether filing any of these petitions constituted inequitable conduct; this question should be mooted as to the UCLA scientists by the inventorship determination (since if the inventors were not inventors, Rule 56 should not apply).  The question of the culpability of Defendants' patent counsel is another matter, including an allegation on Arcetel's website that the last filed petition was filed during the litigation and without notice to Pittsburgh or its named inventors.  These activities could provide one avenue for an accused infringer to challenge the enforceability of the '231 patent.

Cytori Therapeutics, the University of California's licensee, had this to say on its website regarding the District Court's decision:

Cytori believes the recent decision on the '231 patent is in error and that work completed at the University of California was critical to obtaining this patent.  Cytori recognizes that [the] '231 [patent] may have value in the long term in areas unrelated to the Company's existing product pipeline, and consequently Cytori and the UC Regents are reviewing their legal alternatives to this ruling, including that of appealing this decision to the Federal Circuit.  It is Cytori's intention to aggressively protect its business, its intellectual property and its investors.

However, the company also asserts that losing its rights to the technology claimed in the '231 patent is not critical to its business:

The Court's decision [in the '231 inventorship lawsuit] does not impact Cytori's primary ongoing business activities or product development pipeline because Cytori's products do not practice the '231 patent.  Cytori's Celution® System yields an output comprising a diverse mixture of cells found in adipose tissue whereas the '231 patent covers a narrowly defined population of adipose derived adult stem cells in an environment substantially free of other cellular materials found in adipose tissue.  The output that is covered by the '231 patent requires different isolation or processing techniques, which are unnecessary for therapeutic efficacy, and which the Celution System, by design, does not perform.

Cytori's Celution® System device is protected, according to the company, by U.S. Patent No. 7,390,484.

Evolution of Inequitable Conduct

    By Kevin E. Noonan --

Among the many things "wrong" with U.S. patent law, few outside the profession (meaning few among the cadre of gadflies, pundits, careerists, and those grinding their different shades of political and rhetorical axes against current patent law) focus on one of the real problems:  the varying and inconsistent standards governing inequitable conduct.  These variations, and inconsistent application of what standards exist by the Federal Circuit, create more problems and drive more inefficient behavior in the patent system (both in procuring patents before the U.S. Patent and Trademark Office and in litigation) than any of the other several foci of common complaint.

Like other provisions in patent law, inequitable conduct arose from a Supreme Court decision, which established:

A patent by its very nature is affected by a public interest.  As recognized by the Constitution, it is a special privilege designed to serve the public purpose of promoting the "Progress of Science and useful Arts."  At the same time, a patent is an exception to the general rule against monopolies and to the right to access a free and open market.  The far-reaching social and economic consequences of a patent, therefore, give the public a paramount interest in seeing that patent monopolies spring from backgrounds free from fraud or other inequitable conduct and that such monopolies are kept within their legitimate scope.

Precision Instrument Mfg. Co. v. Automotive Maintenance Machinery Co., 324 U.S. 806, 816 (1945).  What an applicant must do to comply with these requirements was first established by the PTO in 1977, with the promulgation of Rule 56, imposing on applicants for the first time the need to comply with a duty of good faith and candor in their dealings with the Office.  37 C.F.R. § 1.56.  Rule 56 was revised in 1992 with regard to how the standard must be measured.

It is not the Patent Office standard that creates the issues with the doctrine, however, it has been the way the Federal Circuit has applied the doctrine.  Twenty years ago, the CAFC bemoaned the trend for the inequitable conduct defense to be asserted in almost every patent case, becoming according to the Court a "plague on the patent system."  Burlington Industries Inc. v. Dayco Corp., 849 F.2d 1418 (Fed. Cir. 1988).  Judge Nichols rightly identified the pernicious effects of how the doctrine was being used:

Reputable lawyers seem to feel compelled to make the charge against other reputable lawyers on the slenderest grounds, to represent their client's interests adequately, perhaps.  They get anywhere with the accusation in but a small percentage of the cases, but such charges are not inconsequential on that account.  They destroy the respect for one another's integrity, for being fellow members of an honorable profession, that used to make the bar a valuable help to the courts in making a sound disposition of their cases, and to sustain the good name of the bar itself.  A patent litigant should be made to feel, therefore, that an unsupported charge of "inequitable conduct in the Patent Office" is a negative contribution to the rightful administration of justice.  The charge was formerly known as "fraud on the Patent Office," a more pejorative term, but the change of name does not make the thing itself smell any sweeter.  Even after complete testimony the court should find inequitable conduct only if shown by clear and convincing evidence.  A summary judgment that a reputable attorney has been guilty of inequitable conduct, over his denials, ought to be, and can properly be, rare indeed.

The Federal Circuit appeared determined to follow this philosophy, as illustrated by its decisions in Kingsdown Medical Consultants, Ltd. v. Hollister, Inc. and Molins PLC v. Textron, Inc.  In Kingsdown, the Federal Circuit refused to affirm a District Court finding of inequitable conduct in a case where a rejected claim was later introduced in unamended form in a continuation application.  The CAFC did not countenance mere mistake, even a mistake that inarguably affected the integrity of the patenting system.  Rather, the Federal Circuit required some evidence of "culpable conduct" established by clear and convincing evidence.  The CAFC's failure, on en banc consideration, to find inequitable conduct in Kingsdown, signaled its agreement with Judge Nichols that a finding of inequitable conduct should be rare.

In contrast, in Molins the Federal Circuit affirmed a finding of inequitable conduct on evidence that an experienced patent prosecutor failed to disclose material prior art to the Office during prosecution.  Important to this determination was evidence that the prosecutor had argued in foreign prosecution that the reference not disclosed to the PTO was the "closest prior art."  In this instance, the patentee's argument that this was an inadvertent failure to disclose was not credible and the Federal Circuit affirmed.

Since Kingsdown and Molins, however, the Federal Circuit has found increasingly less stringent reasons for finding inequitable conduct.  These include improperly claiming small entity status (Nilssen v. Osram Sylvania, Inc.), improperly filing a petition to make special (General Electro Music Corp. v. Samick Music Corp.), failing to disclose that a declarant had been a paid consultant prior to filing an expert declaration under 37 C.F.R. § 1.132 (Ferring B.V. v. Barr Laboratories, Inc.), and misjoinder of inventorship (PerSeptive Biosystems, Inc. v. Pharmacia Biotech, Inc.).

This trend continues in Aventis Pharma S.A. v. Amphastar Pharma, Inc., decided earlier this month (see Patent Docs post on case).  The Federal Circuit affirmed a District Court finding of inequitable conduct based on the content of an expert declaration by a non-inventor employee of the patent assignee, Aventis.  This expert, Dr. Uzan, provided experimental evidence and affidavit testimony regarding comparisons between the prior art and compounds of the claimed invention, low molecular weight heparin formulations used as blood thinners (sold by Aventis under the brand name Lovenox®).  Importantly, Dr. Uzan testified repeatedly that the inventive compounds had a longer half-life in vivo than the prior art formulations.  This testimony was important because the claimed heparin formulations were "identical or nearly identical" (according to the Examiner) with the formulations disclosed in the cited art.  Included with his testimony, Dr. Uzan submitted tables of his experimental data establishing the differences in half-life of the formulations in vivo.

At trial and before the Federal Circuit, the inequitable conduct finding was based on the fact that the inventive formulations were administered at a different (and higher) dosage than the prior art compounds, a fact the CAFC found was not disclosed to the Examiner.  Nor did Dr. Uzan point out that the half-lives of the inventive and prior art formulations were significantly closer when the comparison was performed using the same administered dose.  The Federal Circuit found it incredible that a scientist of Dr. Uzan's caliber would be so negligent as to unintentionally fail to perform the proper comparisons.

Judge Rader in dissent raised the issue of how far the majority had strayed from the principles enunciated in Kingsdown.  Citing Nilssen and General Electro Music, he decried the trend for the CAFC to find inequitable conduct in evidence of omissions rather than affirmative instances of "culpable conduct."  Judge Rader also found Dr. Uzan's credentials to be evidence of his intent; however, Judge Rader thought it unlikely that a scientist of Dr. Uzan's caliber would sully his reputation by intentionally withholding evidence, particularly for an application for which he was not a named inventor.

Part of the reason that the majority (an opinion by Judge Prost, joined by Judge Moore) differed with Judge Rader bespeaks Judge Rader's point:  they approached the issue with a greater propensity to find inequitable conduct than Judge Rader did (and according to Judge Rader, with a greater propensity than Kingsdown contemplated).  The majority, and the District Court, judged the evidence in a more neutral way, not predisposed against the inequitable conduct defense.  Judge Rader believes that Kingsdown mandates that courts turn a gelid eye towards the defense, and require a much higher quantum of proof to satisfy the clear and convincing evidence standard.

These issues bring to mind the Senate Judiciary Committee's Report in the stalled Senate "patent reform" bill (S. 1145).  Section 12 of S. 1145 amends Title 35 to add new Section 298, as follows:

§ 298. Inequitable conduct

A party advancing the proposition that a patent should be cancelled or held unenforceable due to inequitable conduct shall prove independently, by clear and convincing evidence, that material information was misrepresented, or omitted, from the patent application with the intention of deceiving the USPTO.  Information is material if a reasonable examiner would consider such information important in deciding whether to allow the patent application; any such information is not cumulative.  Although intent to deceive the USPTO may be inferred, it may not be done so based solely on the gross negligence of the patent owner or its representative, or on the materiality of the information misrepresented or not disclosed.  The party asserting the defense or claim shall comply with the pleading requirements set forth under Federal Rules of Civil Procedure 9(b).  If the court finds inequitable conduct, the court has discretion to (1) hold the entire patent unenforceable, (2) hold 1 or more claims unenforceable, or (3) hold that patentee is not entitled an injunction.

The draft report advises that the intent of this new section is to codify (for the first time) the inequitable conduct defense and the consequence of unenforceability to a finding that a patent (or any claim thereof) was obtained through inequitable conduct.  The need, at least in part, for this legislation included the inconsistent definitions of what constitutes a reference "material to patentability" under the Federal Circuit's jurisprudence.  The Report identifies five different definitions used by the Federal Circuit in defining materiality:

(1) the objective "but for" standard, where the misrepresentation was so material that the patent should not have issued;

(2) the subjective "but for" test, where the misrepresentation actually caused the examiner to approve the patent application when he would not otherwise have done so;

(3) the "but it may have" standard, where the misrepresentation may have influenced the patent examiner in the course of prosecution;

(4) the old Rule 56 standard where it is likely a reasonable examiner would have considered the information important in deciding whether to issue of the patent; and

(5) the new Rule 56 standard where the information is not cumulative and (i) establishes a prima facie case of unpatentability (either alone or in combination with other references), or (ii) refutes or is inconsistent with a position the applicant has taken.

See Digital Control Inc. v. Charles Machine Works , 437 F.3d 1309, 1314-16 (Fed. Cir. 2006); see also American Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350, 1362 (Fed. Cir. 1984).  The Federal Circuit justifies these different tests on the grounds that there is "no reason to be bound by any single standard."

There are a number of other, perhaps better and certainly more direct ways to address the problem of inequitable conduct.  First is the remedy:  unenforceability is a "nuclear" option that has the greatest influence on behavior.  In prosecution, it motivates applicants to disclose any prior art reference that could have any plausible (and sometimes implausible) relation to the claimed invention.  Indeed, the only art that can safely be "undisclosed" are general reference works (the Maniatis cloning manual, for example) whose general content should be known to anyone with skill in the art.  In litigation, the possibility of establishing inequitable conduct motivates pleading it as an affirmative defense.  If there were good reason to believe that inequitable conduct was rampant, this remedy might be justified.  However, even in cases where the Federal Circuit has found inequitable conduct, the number involving withholding material information with clear evidence of an intent to deceive are few.

As an alternative, a finding of inequitable conduct might be sufficient to destroy the presumption of validity.  This would be a boon to defendants who found undisclosed art, because a judge or jury could more easily find claims substantively invalid (which would also ensure the materiality of the references at issue).  Another alternative would be for inequitable conduct to be applied claim-by-claim.  Raising the standard of intent, akin to how the CAFC has addressed the question of willfulness in the In re Seagate case, would also reduce inequitable conduct claims, and would be in accord with the facts in cases where a defendant's explanation of non-disclosing behavior was incredible.

Beyond these remedies, the defense can be curtailed in litigation by stringent application of Federal Rule of Civil Procedure 8(a).  This rule requires a pleading to contain assertions of fact supporting any allegations contained therein, including affirmative defenses.  Inequitable conduct allegations are usually contained in a defendant's answer to the patentee's complaint, at a time prior to discovery when the defendant has not yet obtained evidence to support the claim.  Preventing this automatic allegation of inequitable conduct, coupled with liberal application of the Rules regarding amended pleadings (Fed. R. Civ. Proc. 15), would at a minimum permit the inequitable conduct defense to be plead only after there was some evidence to support it.

Inequitable conduct is an issue in dire need for resolution to promote efficiency in both patent prosecution and litigation.  With any luck, it is an issue the Federal Circuit will address before either Congress or the Supreme Court is compelled to act.

Aventis Pharma S.A. v. Amphastar Pharmaceuticals (Fed. Cir. 2008)

    By Donald Zuhn --

Earlier this month, the Federal Circuit in a 2-1 decision affirmed the determination by the District Court for the Central District of California that U.S. Patent Nos. RE 38,743 and 5,389,618, which are owned by Plaintiffs-Appellees Aventis Pharma S.A. and Aventis Pharmaceuticals, Inc. (Aventis), are unenforceable for inequitable conduct.  In affirming the District Court's determination of unenforceability, the Federal Circuit concluded that the lower court did not abuse its discretion in finding that Aventis intended to deceive the U.S. Patent and Trademark Office while procuring the '743 and '618 patents.

The '743 and '618 patents are directed to a composition comprising low molecular weight heparins (LMWHs), which Aventis markets as Lovenox® in the U.S. and as Clexane® in Europe, and which is used to prevent blood clotting while minimizing the possibility of hemorrhaging, especially during high-risk surgery.  The '743 patent is a reissue of the '618 patent.

During prosecution of the '618 patent, the examiner rejected the claims as being anticipated and/or obvious in view of European Patent No. 0 040 144, asserting that the '144 patent teaches a LMWH composition that falls within the molecular weight range recited in the claims and which is considered to be inherently the same as the claimed LMWH composition.  In attempting to overcome the rejection, Aventis pointed to Example 6 of the specification, which states that a 40 mg dose of the claimed composition has a half-life of more than 4.5 hours in 45% of cases and an unspecified dose of the composition of the '144 patent has a half-life of more than 4.5 hours in only 17% of cases.  Aventis argued that because compounds are inseparable from their properties, the evidence of a difference in a property (i.e., half-life) is evidence of a difference in structure, and thus the compositions were not inherently the same.

In a second Office action, the examiner maintained the 102 and 103 rejections for reasons of record, and noted again that the Patent Office did not have facilities for testing and comparing products that appear to be identical or nearly identical, such as the claimed and prior art LMWH compositions.  Aventis responded by amending the claims and submitting a declaration from Dr. Andre Uzan, an Aventis chemist (but non-inventor) who had helped with the preparation of Example 6.  The Uzan Declaration reiterated the results of Example 6, described the specific composition of claimed heparin admixture (in support of the claim amendments), and concluded that the LMWH composition of the '144 patent was "clearly outside the scope of the present invention."

In a third Office action, the examiner withdrew the 102 rejection but maintained the 103 rejection, stating that Aventis had failed to show a statistically significant difference between the half-life of the claimed LMWH composition and the half-life of the prior art ('144 patent) LMWH composition.  Aventis responded by submitting a second declaration from Dr. Uzan, which provided results showing a statistically significant difference between a 40 mg dose of the claimed composition and an unspecified dose of the prior art composition.  In response to Aventis' submission, the examiner allowed the '618 patent.

Seeking approval to market a generic version of Aventis' LMWH composition, Defendants-Appellees Amphastar Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. each filed an Abbreviated New Drug Application (ANDA) with the FDA.  Aventis responded by filing an infringement suit against each ANDA filer in the District Court for the Central District of California.

In Aventis I, Amphastar filed a motion for summary judgment of unenforceability, asserting that Dr. Uzan had engaged in inequitable conduct for failing to disclose that different doses of the claimed and prior art compositions had been used to generate the results disclosed in Example 6 and the second Uzan Declaration (Dr. Uzan had used a 60 mg dose of the prior art composition).  The District Court granted Amphastar's motion, finding that Aventis' representation that the claimed composition had a better half-life than the prior art composition was material to patentability, and further, that there was a strong inference of intent to deceive since there was "no credible explanation for comparing half-lives at different doses and because comparisons at the same dose showed little difference in half-life."

On appeal, the Federal Circuit affirmed the finding of materiality, but remanded on the issue of intent to deceive.  In particular, the Federal Circuit determined that the reasonableness of using different doses to compare the compositions was relevant to determining whether there was an intent to deceive (Aventis had argued that those of ordinary skill in the art frequently compare half-lives at different doses).

In Aventis III, the District Court rejected Aventis' arguments for failing to disclose the dose of the prior art composition.  In particular, Aventis had asserted that it was customary to compare the half-lives of different drugs at their clinically relevant doses, the comparison of drugs at different doses was reasonable because half-lives are dose independent, and the failure to disclose the dose of the prior art composition was the result of inadvertence.  The District Court rejected each of these arguments, and with respect to the inadvertence argument, specifically determined that "it was not credible that a scientist with Dr. Uzan’s qualifications could have committed, and failed to correct during a lengthy prosecution, such an egregious error."

In the instant appeal, Aventis first argued that the failure to disclose the dose of the prior art composition was permissible since the half-life compositions were intended to show a difference in properties (to overcome the 103 rejection) and not a difference in composition (to overcome the 102 rejection).  This new argument was premised on the fact that the latter situation requires equivalent doses and the former permits different doses.  The Federal Circuit, however, rejected Aventis' argument, finding that the District Court did not clearly err in determining that the half-life comparisons were intended to show compositional differences to address the 102 rejection.

Aventis next renewed its argument that it was customary to compare the half-lives of different drugs at their clinically relevant (and thus, different) doses.  The Federal Circuit also rejected this argument, finding that evidence of the industry practice of using clinically-relevant doses would only be relevant if the half-life comparisons were being used to address an obviousness rejection, and not an anticipation rejection.  The Federal Circuit also rejected Aventis' remaining arguments (including inadvertence), affirming the District Court's finding of inequitable conduct and holding of unenforceability of the '743 and '618 patents.

Judge Rader, writing in dissent, noted that "my reading of our case law restricts a finding of inequitable conduct to only the most extreme cases of fraud and deception," and stated that "[t]o my eyes, this record does not show clear and convincing evidence of intent to deceive the United States Patent and Trademark Office."  Judge Rader (at left) found the instant case to be distinguishable from Nilssen v. Osram Sylvania, Inc., 504 F.3d 1223 (Fed. Cir. 2007) – where an improper claim of small entity status led to a finding of inequitable conduct – or General Electro. Music Corp. v. Samick Music Corp., 19 F.3d 1405 (Fed. Cir. 1994) – where the patentee filed a petition to make special with a declaration that falsely stated that a thorough search of the prior art had been conducted.

Despite acknowledging that "[w]ithout question, Dr. Uzan should have disclosed the dosage of the ['144 patent] LMWH in example 6," and further, that "Dr. Uzan ought to have disclosed to the USPTO that he compared the 60 mg dose of the prior art ['144 patent] LMWH to the 40 mg dose of the [claimed] LMWH in the declaration he submitted on March 29, 1993 [i.e., the first Uzan Declaration]," Judge Rader found that Dr. Uzan's argument for not disclosing the dose "has merit."  In particular, Dr. Uzan had testified that the different dose "did not come to his mind."

In support of Dr. Uzan's testimony, Judge Rader noted that:

the absence of a dosage in [Example 6] is blatantly obvious.  Surely if Dr. Uzan had intended to deceive the USPTO, he would not have made this omission so conspicuous.  Moreover, I find it difficult to fathom that a scientist of Dr. Uzan's caliber and reputation would engage in such deception.  . . .  This world-class scientist would hardly risk his reputation and tarnish his brilliant career for a single example in the prosecution of a patent for an invention in which he was not even involved.

Judge Rader also noted that Dr. Uzan had revealed and corrected the error himself by submitting all of the underlying data to the Patent Office with his second declaration before the '618 patent had issued, and that "[t]his candor is inconsistent with deceptive intent."  Moreover, because the '743 patent issued with all of the original independent claims, but without Example 6 (which was deleted during reissue proceedings), Judge Rader observed that "[t]he half-life data were apparently not even necessary for patentability."

Aventis Pharma S.A. v. Amphastar Pharmaceuticals (Fed. Cir. 2008)
Panel: Circuit Judges Rader, Prost, and Moore
Opinion by Circuit Judge Prost; dissenting opinion by Circuit Judge Rader

Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2008)

    By Kevin E. Noonan --

On Friday, the Court of Appeals for the Federal Circuit handed Pfizer a mixed decision on defendant Teva's appeal of a District Court judgment that Teva was liable for infringing a trio of Pfizer patents (U.S. Patent Nos. 5,466,823; 5,563,165; and 5,760,068) relating to the pain medication Celebrex® (celocoxib).  While keeping Teva's generic celocoxib off the market for now, the Federal Circuit's ruling advances the date when the generic version of Celebrex® will become available by about 12 months.

Pfizer initiated its lawsuit upon notification by Teva of its Paragraph IV certification filed in Teva's Abbreviated New Drug Application (ANDA) with the FDA.  Although Pfizer asserted a number of claims against Teva, the claims relevant to the issues on appeal were claim 9 of the '823 patent:

Compound of claim 8 where the compound is [celocoxib], or a pharmaceutically-acceptable salt thereof.

Claim 17 (dependent on claim 15) of the '165 patent:

A pharmaceutical composition comprising a therapeutically-effective amount of a compound and a pharmaceutically-acceptable carrier or diluent, said compound selected from a family of compounds . . . where the compound is [celocoxib], or a pharmaceutically-acceptable salt thereof.

And claim 4 (dependent on claim 1) of the '068 patent:

A method of treating inflammation or an inflammation-associated disorder in a subject, said method comprising administering to the subject having or susceptible to such inflammation or inflammation-associated disorder, a therapeutically-effective amount of a compound . . . where the compound is [celocoxib], or a pharmaceutically-acceptable salt thereof.

(Where "celocoxib" is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-
yl]benzenesulfonamide.)

The District Court found the asserted claims infringed, the claims of the '068 patent not invalid for obviousness-type double patenting, claim 9 of the '823 patent and claim 17 of the '165 patent not invalid for violation of the best mode, and the asserted claims not unenforceable due to alleged inequitable conduct.

The Federal Circuit, in a unanimous opinion by Judge Dyk (joined by Chief Judge Michel and District Judge Matthew Kennelly of the Northern District of Illinois, sitting by designation) reversed the District Court's determination that the claims of the '068 patent were not invalid for obviousness-type double patenting but affirmed Teva's failure to carry its burden of a best mode violation or inequitable conduct on the other asserted patents.  The basis for the Federal Circuit's decision that the '068 patent was invalid for obviousness-type double patenting was that the designation of this patent as a "continuation-in-part" was not merely semantic but had substantive repercussions regarding whether the '068 claims were entitled to the "safe harbor" provisions of 35 U.S.C. § 121.  These provisions entitle a divisional application filed as the result of a restriction requirement (a Patent Office determination that an applicant has filed claims directed to more than one invention) to be exempt from obviousness-type double patenting.  These provisions illustrate a Congressional intention, from the legislative history of the 1952 Patent Act, to prevent the unfairness of forcing an applicant to be required to file a divisional application based on claiming "independent inventions" through restriction while permitting the original application to be used as "prior art" in a obviousness-type double patenting rejection.  The Federal Circuit noted, however, that Congress also evinced the intention to restrict the safe harbor to divisional applications (which have an identical specification to the originally-filed application) and keep any claims in such a divisional application strictly within the bounds of what had been determined to be a separate invention.  This intention meant, for example, that an applicant would not be able to include claims in a divisional that were within the scope of any claims previously elected for examination.  In this way applicants would be precluded from inequitably increasing patent term while not being penalized for electing one invention and pursuing additional inventions in divisional applications.

The Federal Circuit found that the '068 application did not fall within the safe harbor because it was a continuation-in-part application, not a divisional.  Such a "CIP" application by definition contains some of the disclosure of an earlier-filed application in addition to new disclosure.  Because of this distinction, the Federal Circuit found that CIP applications could not fall within the safe harbor because they could encompass additional information (and patentable inventions) that were not a part of the original, restricted claims.

In this case, however, the CAFC has applied the rubric to the application rather than to the claims.  A review of the claims of the '165 patent, as originally filed, shows that the application contains a claim (claim 29) that recites the same method as the '068 patent and a list of species of the generic formula, expressly reciting celecoxib.  This claim was subjected to a restriction requirement and the applicants elected to forego prosecution of these method claims until filing the CIP application that resulted in the '068 patent.  However, the specification of the '068 patent is much more extensive than the earlier-filed '823 and '165 patents; in particular, the '068 patent specifically discloses celecoxib synthesis, and contains biological data relating to the specificity of celecoxib for COX2 over COX1 (the biological basis for its advantages as an anti-inflammatory agent).  Without specifying any rationale other than the noted distinction between divisional and CIP applications, it appears that these differences in the specification may provide additional support for the Federal Circuit's determination.

The CAFC upheld the District Court's determination that claim 9 of the '823 patent and claim 17 of the '165 patent (directed specifically to celecoxib) were not invalid for failure to satisfy the best mode requirement of 35 U.S.C. § 112, first paragraph.  Teva contended that Pfizer's failure to disclose the COX2 specificity of the claimed compounds was a violation because it prevented the skilled worker from appreciating which of the disclosed compounds exhibited the specificity for COX2.  In Teva's view, this failure of disclosure was significant, because the capacity to block the action of COX2, related to pain, while not inhibiting COX1, related to normal processes such as gastrointestinal integrity, was an important feature of the claimed invention.  The Federal Circuit adopted the view of the District Court that Pfizer was under no obligation to disclose this distinction.  (Presumably, this would not have been the case if the claim was to a method or included the COX enzyme specific limitations.)  Disclosing how to make and use the compounds of the invention was enough to satisfy the best mode requirement.  Interestingly, the CAFC noted that while Teva had raised the defense of invalidity against Pfizer's claims, it had not counterclaimed for a declaratory judgment of invalidity; thus, since claim 9 of the '823 patent and claim 17 of the '165 patent satisfied the best mode requirement and were infringed, it did not need to reach the "difficult issue" raised by the generic claims.  This dicta from the Federal Circuit would seem to raise a caution for similar instances where generic claims are asserted.

Finally, the Federal Circuit found that while the references cited by Teva in its inequitable conduct allegation were material (despite the fact that they would not have constituted invalidating prior art), the CAFC found that Pfizer had rebutted any evidence of intent proffered by Teva.  This rebuttal was evidence that the structure of the core heterocyclic ring in the two prior art references was different from the core heterocyclic ring of Pfizer's patented compounds, and that Pfizer consistently used such distinctions in determining whether prior art was relevant "in hundreds of its other patent applications."  The Federal Circuit also credited testimony on this point by a Pfizer witness, that Pfizer had considered these references and had come to a good-faith determination that they were not material to patentability.  The CAFC cited its own three-prong test for inequitable conduct enunciated in Ferring B.V. v. Barr Labs., Inc. (Fed. Cir. 2006):

(1) the applicant knew of the information;
(2) the applicant knew or should have known of the materiality of the information; and
(3) the applicant has not provided a credible explanation for the withholding.

Here, Teva's failure to establish or rebut the third prong was fatal to its inequitable conduct allegation.

As a consequence of the Federal Circuit's holding the '068 patent invalid, the expiration date for the remaining Orange Book listed patents is now May 30, 2014 (when pediatric exclusivity for the '165 patent expires) rather than June 2, 2015.  Undoubtedly this means millions of dollars in revenue lost, especially since the '823 patent was deemed ineligible for patent term extension under 35 U.S.C. § 156.

Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2008)
Panel: Chief Judge Michel, Circuit Judge Dyk, and District Judge Kennelly
Opinion by Circuit Judge Dyk

Additional information regarding this case can be found at Patently-O and the Orange Book Blog.

Monsanto Co. v. Bayer Bioscience N.V. (Fed. Cir. 2008)

    By Kevin E. Noonan --

Even as the Senate may be preparing to vote on a patent "reform" bill that contains (for the first time) provisions codifying a standard for inequitable conduct, the Federal Circuit continues to develop its own inequitable conduct jurisprudence.  The draft Senate report on the proposed bill, S. 1145, rejects the Federal Circuit's approach on determining materiality of a reference, but consideration of the circumstances under which the courts must apply current law (which approach is unlikely to change) at least suggests that such criticism misses many relevant issues.

The most recent case illustrating these principles is Monsanto Co. v. Bayer Bioscience N.V.  In response to Monsanto's declaratory judgment action, Bayer asserted infringement of four patents (U.S. Patent Nos. 5,545,565 ("the '565 patent"), 5,767,372 ("the '372 patent"), 6,107,546 ("the '546 patent"), and 5,254,799 ("the '799 patent")) which were found on summary judgment to be invalid, not infringed (specifically, the asserted '565 patent claims), and unenforceable because Bayer was guilty of inequitable conduct during prosecution.  The Federal Circuit reversed the original claim construction of the District Court and vacated the invalidity and inequitable conduct judgment, in part because there were genuine issues of material fact inappropriate for summary determination.  On remand, Bayer dismissed its claims with regard to the '799, '372, and '546 patents, filing a Statement of Non-liability as to those patents, so the claims based on the '565 patent alone went to trial.

The claims at issue relate to genetically-engineered corn plants transformed with an expression construct that expressed a protein encompassing the amino terminal portion of an insecticidal toxin from Bacillus thuringiensis.  Monsanto produces a genetically-modified corn product that expresses a Bt toxin having the same amino acid sequence as the claimed toxin.  On remand, a jury found the asserted claims of the '565 patent to be not infringed and invalid for obviousness and anticipated by Monsanto's own prior invention.  The District Court then found the '565 patent to be unenforceable due to inequitable conduct, a judgment affirmed by the Federal Circuit, which did not reach Bayer's appeal on the invalidity and non-infringement judgments.

The basis for the District Court's inequitable conduct decision was Bayer's failure during prosecution to disclose its full knowledge of the subject matter of an abstract ("the Barnes Abstract") from a poster presentation made at a scientific conference.  The subject matter of the presentation was production of a chimeric gene comprising an amino terminal portion of Bt toxin fused to a selectable marker protein (conferring kanamycin resistance) that could be used to select recombinant cells.  In prosecution of the '565 patent, the Examiner rejected Bayer's claims (directed to a genus of Bt toxin-encoding constructs) for obviousness over several prior art references including the Barnes Abstract.  In particular, the Examiner asserted that Barnes provided motivation to produce genetically-engineered plant cells comprising a truncated Bt toxin gene, since the art recognized that this portion was sufficient for the insecticidal activity of the toxin.  In response, Bayer argued that the Barnes reference failed to show that the fusion protein was biologically active, or that the amino terminal fragment of the protein was toxic.  In addition, Bayer argued that the Barnes Abstract was not enabling, since while it asserted that the fusion gene "may" be inserted into a plant vector and that the resulting protein "should" express the insecticidal and kanamycin-resistant phenotype, "no concrete evidence [of function] was provided."

However, the Barnes Abstract was not the only information regarding Dr. Barnes' work known to Bayer.  One of its employees, Dr. Celestina Mariani, attended the conference and took extensive notes.  These notes reflected the poster contents, specifically that Barnes had in fact determined that his amino terminal fragment retained insecticidal activity and had produced a vector encoding the fusion protein.  Moreover, the poster showed that the construct conferred kanamycin resistance in a bacterial system, and when the protein was applied to plants showed insecticidal activity.  The poster also showed that Barnes had made a recombinant construct in an Agrobacterium T-DNA plant expression vector where expression of the fusion protein was controlled by a plant-specific promoter.  At her deposition, Dr. Mariani testified that the Barnes laboratory "surely w[as] busy with introducing in plants this cassette" since there was no other reason to insert the fusion protein sequence into the Agrobacterium construct.

In addition to this testimony, the District Court heard undisputed evidence that these notes were "widely distributed" to the scientists working on the Bt project at Bayer.  Most significantly, the notes were also known to Dr. Wouter Meulemanns, who was responsible for prosecuting the four Bayer patents in suit.  Although Dr. Meulemanns testified that he spoke with Dr. Mariani about the Barnes poster, he asserted that she did not remember "anything" about the presentation.  In view of the clear recollection of the notes and poster Dr. Mariani exhibited during her deposition testimony, the District Court did not find Dr. Meulemanns' testimony to be credible.  The District Court found the notes to be material to patentability, both under the "reasonable examiner" test and because they would have established a "prima facie case of unpatentability."  Coupled with the District Court's skepticism regarding Dr. Meulemanns' testimony, it found the requisite intent to deceive the Patent Office, and that Bayer had committed inequitable conduct in obtaining the '565 patent.  In addition, the District Court found that the other three patents originally asserted were also unenforceable for inequitable conduct.

The Federal Circuit affirmed, in a unanimous decision written by Judge Gajarsa, based on finding no clear error in the District Court's analysis.  The Federal Circuit held that the information on the Barnes Abstract was material because it "refutes, or is inconsistent with, a position the applicant takes in . . . an argument of unpatentability relied on by the Office" under 37 C.F.R. § 1.56(2)(i).  Although the amino terminal fragment of the Bt toxin disclosed by Barnes was different from the fragment in Bayer's '565 patent claims, the scope of those claims pending when Bayer made its argument was broader and encompassed a genus of fragments that would include the one disclosed by Barnes.  The Federal Circuit found that Bayer knew that Barnes' recombinant fusion protein showed insecticidal properties when applied to a plant leaf, and yet argued that the unpredictability of plant recombinant genetics precluded the skilled worker from having a reasonable expectation of success in producing a functional recombinant Bt toxin fragment.  In addition, the Federal Circuit noted Bayer's argument that there was "no concrete evidence" that the Barnes construct had been made, when Dr. Mariani's notes clearly showed that the poster contained positive information that Barnes had made the construct.  The CAFC was careful to circumscribe the rubric in enunciated in making its materiality finding:

We do not suggest that all internal documents of potential relevance must be submitted to the PTO as a matter of course.  Rather, it is the particular circumstances that render the internal documents material in this case.

The Federal Circuit easily dismissed Bayer's challenges to the District Court's findings with regard to its intent to deceive, stating:

Intent is easily inferred when, as here, an applicant makes arguments to the PTO that it knows, or obviously should have known, are false in light of information not before the examiner, and the applicant knowingly withholds that additional information.

The Federal Circuit also affirmed the District Court's holding that the '799, '372, and '546 patents were also unenforceable due to inequitable conduct.  Here, Bayer had asserted a jurisdictional challenge to the judgment, based on it having dismissed the infringement claims as to these patents.  But the Federal Circuit held that Monsanto's motion for attorneys' fees under 35 U.S.C. § 285 was sufficient to bring these patents within the scope of the District Court's jurisdiction, and that the Statement of Non-liability was not sufficient to exempt these patents from the lower court's scrutiny.  The CAFC noted that its decision in Nilssen v. Osram Sylvania, Inc. (Fed. Cir. 2007) would also support the District Court's jurisdiction on a theory of infectious unenforceability, but that here "the outcome is even clearer as there is no dispute that the court had an independent grant of jurisdiction under § 285 to consider inequitable conduct relating to the withdrawn patents."

 Monsanto Co. v. Bayer Bioscience N.V. (Fed. Cir. 2008)
Panel: Circuit Judges Bryson, Gajarsa, and Dyk
Opinion by Circuit Judge Gajarsa

Additional information regarding this case can be found at Patently-O.

Federal Circuit Issues Patent Law Malpractice Decisions

    By Kevin E. Noonan --

Malpractice is an ugly word.  But patent practitioners may take some comfort in two precedential decisions today from the Federal Circuit, holding that allegations of malpractice in patent prosecution "arise under" patent law and thus provide subject matter jurisdiction in Federal Court under 28 U.S.C. § 1338.

The first of these cases, Air Measurement Tech., Inc. v. Akin Gump Strauss Hauer & Feld, L.L.P., was an appeal from the interlocutory decision of the U.S. District Court for the Western District of Texas denying plaintiffs' motion to remand the case to state court, on the grounds that the court did not have subject matter jurisdiction on the malpractice cause of action for non-diverse parties.  The malpractice claim alleged that counsel "(1) failed to file the initial patent application within the one year 'on sale bar' of 35 U.S.C. § 102(b); (2) failed to disclose two prior patents and other facts during the prosecution of the patent applications; (3) failed to file in a timely fashion the application that resulted in the '771 patent, which contains the broadest claims to the invention; (4) miscalculated the settlement damages in [a] . . . prior litigation; (5) failed to inform AMT of his mistakes despite his fiduciary duty to do so; (6) failed to inform AMT adequately of the existence of the prior litigant's defenses of on sale bar and inequitable conduct; and (7) made misrepresentations to AMT."  As a consequence, AMT claimed it was forced to settle several malpractice lawsuits for much less than the patents would have been worth "but for" counsel's malpractice.  The claim was originally filed in Texas state court, and had been transferred to federal court on defendants' motion, and the court earlier denied plaintiff's motion to remand on the grounds that "in order to prevail, AMT 'must establish that their infringement claims were otherwise valid, but that Hamilton's negligence afforded the patent defendants certain defenses under patent law.'"  Now, the parties had changed their positions, and the court's denial of defendants' motion for remand to state court was the subject of this appeal.

The Federal Circuit affirmed the District Court's denial of defendants' remand motion in an opinion written by Chief Judge Michel and joined by Judges Lourie and Rader; in doing so, the CAFC asserted that this was a question of first impression.  In his analysis, Judge Michel applied the two-part test recited by the Supreme Court in Christianson v. Colt Indus. Operating Corp., 486 U.S. 800 (1988).  According to the Federal Circuit, "Section 1338 jurisdiction extends to any case 'in which a well-pleaded complaint establishes either that federal patent law creates the cause of action or that the plaintiff's right to relief necessarily depends on resolution of a substantial question of federal patent law, in that patent law is a necessary element of one of the well-pleaded claims.'"  Under the Federal Circuit's analysis, the question is whether patent law is a "necessary element" of the plaintiff's malpractice claim.  Reviewing the complaint, the CAFC found that seven allegations of error constituting malpractice concerned patent prosecution or litigation.  Moreover, in order to prevail, the plaintiffs would have to establish that they would have prevailed on the earlier infringement lawsuits "but for" counsel's malpractice.  Thus, the District Court would have to, "hypothetically," adjudicate the infringement claim on the merits.  Thus, patent law comprised a "necessary element" of the malpractice claim.  On this record, the Federal Circuit found that the malpractice claim "arose under" patent law, and thus provided federal question jurisdiction under 28 U.S.C. § 1338.  Accordingly, the CAFC affirmed denial of defendants' removal motion.

In the second of these cases, Immunocept, LLC v. Fulbright & Jaworski LLP, the plaintiff appealed a decision of the U.S. District Court for the Western District of Texas on summary judgment that the malpractice claim was barred by the statute of limitations and the claim for damages was too speculative to be recovered under state law.  The panel raised sua sponte the question of whether jurisdiction over the malpractice claim (which is clearly a state law matter) could be considered as "arising under" patent law when patent prosecution was basis of the claim.  The facts of the case are as follows.  The invention involved large pore hemofiltration ("LPHF") technology for treating a number of diseases and disorders, including sepsis, shock, acute renal failure, multiple organ system failure, and systemic inflammatory response syndrome-related diseases.  Fulbright and Jaworski was retained to prepare the patent application, which was granted as U.S. Patent No. 5,571,418 on November 5, 1996, Immunocept LLC being named assignee of this patent.  Claim 1 of the '418 patent reads as follows:

A method of treating a pathophysiological state caused by a toxic mediator-related disease consisting of hemofiltering blood with a filter, wherein said filter has a molecular weight exclusion limit of 100,000 to 150,000 Daltons and allows for passage of molecules with a molecular weight of about 70,000 Daltons in the presence of whole blood.

Importantly, the transitional phrase "consisting of" was added by amendment during prosecution.  Immunocept hired another attorney to pursue additional applications while Immunocept pursued licensing opportunities.  These efforts were fruitless, however, since the potential licensees assessed the '418 patent claims to provide insufficient protection based on the closed claim language "consisting of."  Immunocept's malpractice claim was based on this limitation of the '418's claims.  However, the District Court found that the claim was time-barred by the Texas statute of limitations and that Immunocept's damages claim was too speculative.

The Federal Circuit affirmed in an opinion written by Chief Judge Michel and joined by Judges Lourie and Rader.  More important to patent practitioners than the Federal Circuit's decision on the substantive question presented was its determination that the malpractice claim was one "arising under" U.S. patent law and thus within its (and federal District Courts') jurisdiction.  The Federal Circuit analyzed federal court jurisdiction under the two-part test enunciated by the Supreme Court in Grable & Sons Metal Prods., Inc. v. Darue Eng'g & Mfg., 545 U.S. 308 (2005).  As stated by the Federal Circuit, the test requires that "a state-law claim necessarily raise[s] a stated federal issue, actually disputed and substantial, which a federal forum may entertain without disturbing any congressionally approved balance of federal and state judicial responsibilities."  Id. at 314.  The malpractice claim, a tort, requires under Texas law proof of "proof of duty, breach, causation, and damages."  In this case, the basis for the malpractice claim was solely that the patent attorney improperly narrowed the scope of the '418 claims and thus that the patent was unable to be licensed for value.  Thus, according to the Federal Circuit, claim drafting and the question of claim scope were necessary elements of the cause of action.  Since claim scope defines the scope of patent protection, the court considered it to be "surely" a substantial question of patent law, citing Johnson & Johnston Assocs. v. R.E. Serv. Co., 285 F.3d 1046 (Fed. Cir. 2002) (en banc).  The panel also cited Air Measurement Techs. in support of their decision.  The Federal Circuit further justified this outcome on the grounds that "[l]itigants will benefit from federal judges who are used to handling these complicated rules [of claim construction]" and that jurisdiction was consistent with Congressional intent to harmonize U.S. patent law when it enacted the Federal Courts Improvement Act of 1982 (Pub. L. No. 97-164, 96 Stat. 25) that established the Federal Circuit.

Air Measurement Tech., Inc. v. Akin Gump Strauss Hauer & Feld, L.L.P. (Fed. Cir. 2007)
Panel: Chief Judge Michel and Circuit Judges Lourie and Rader
Opinion by Chief Judge Michel

Immunocept, LLC v. Fulbright & Jaworski LLP (Fed. Cir. 2007)
Panel: Chief Judge Michel and Circuit Judges Lourie and Rader
Opinion by Chief Judge Michel

Additional information regarding these cases can be found at Patently-O.

Synthon IP, Inc. v. Pfizer Inc. (E.D. Va. 2007)

Pfizer Earns One More Victory in Norvasc Litigation

    By Robert Dailey --

This week Pfizer won another courtroom battle against generic drug manufacturer Synthon in the companies' ongoing dispute over Pfizer's drug Norvasc.  The District Court held two Synthon patents, U.S. Patent Nos. 6,653,481 and 6,858,738 unenforceable due to inequitable conduct.  Pfizer had already prevailed over Synthon in a jury trial that addressed noninfringement and invalidity.

The Synthon patents disclose methods and intermediates useful for synthesizing Norvasc.  Pfizer, however, has been using these methods and intermediates since the late 1980s, and disclosed them in printed publications in 1989 and 1996.  Synthon's earliest alleged invention occurred in late 1999.  But since the facts demonstrated that Synthon scientists had based their work off of Pfizer publications, the Court concluded that Synthon scientists committed inequitable conduct.

Despite the difficulty of proving inequitable conduct, Synthon's actions left little doubt in this instance.  First, the project supervisor possessed a binder labeled "Maps" whose first page was a Pfizer document describing the method and intermediates that Synthon would later claim in its patents.  Second, the supervisor had faxed a copy of the Pfizer document to one of the named inventors.  Third, the literature file for the Norvasc project contained a copy of this same Pfizer document.  Yet Synthon never disclosed this Pfizer document to the Patent Office during the prosecution of either patent.

Synthon had also prepared two internal monographs that referred directly to the Pfizer document and described Pfizer's synthetic pathway.  Both monographs were prepared before Synthon's alleged date of conception, and one even listed one of the inventors as its author.  Meanwhile, another inventor had saved a document on his computer entitled "route according to Pfizer."

Yet throughout the prosecution of its patents, Synthon referred to its claimed intermediate as a "new" compound.  Synthon even submitted a Rule 131 affidavit by one of the "inventors" to swear behind the dates of two pieces of prior art.  Furthermore, Synthon mischaracterized the nature of the Pfizer method when the Examiner asserted Pfizer composition patent as prior art.

It seems that the scientists and project managers kept Synthon's in-house patent counsel in the dark on the whole matter.  And at trial, these scientists and managers could not recall having any knowledge of the Pfizer method.

To prove inequitable conduct, the defendant must prove that the plaintiff withheld material documents or information from the PTO and did so with deceptive intent.  First, the District Court held that the withheld Pfizer publication and Synthon's false statements to the PTO were material.  The withheld document would have anticipated claims in both patents, and the false statements were used to overcome prior art.  Next, the Court held that the facts demonstrated that the Synthon inventors had intended to deceive the PTO.  The Court acknowledged that a defendant cannot prove deceptive intent simply by showing an absence of good faith on the part of the inventors.  Yet a plaintiff cannot avoid inequitable conduct simply by asserting forgetfulness in the face of facts that tend to show bad faith.

Pfizer officials have announced that they will week attorney's fees against Synthon for its conduct in this litigation.

In a related case, Pfizer recently defeated Synthon's efforts to launch a generic version of Norvasc.  See Pfizer, Inc. v. Synthon Holdings BV, No. 1:05CV39 (M.D.N.C. 2006).

Synthon IP, Inc. v. Pfizer Inc., No. 1:05cv1267 (E.D. Va. 2007).

Additional information regarding this case can be found at the Orange Book Blog.

Robert Dailey, Ph.D., is a physical chemist and a third-year law student at the University of North Carolina at Chapel Hill.  Dr. Dailey was a member of MBHB's 2006 class of summer associates.

Impax Laboratories, Inc. v. Aventis Pharmaceuticals Inc. (Fed. Cir. 2006)

    By Donald Zuhn --

In an appeal from a District Court judgment holding claims 1-5 of U.S. Patent No. 5,527,814 (the '814 patent) enforceable, valid, and infringed, the Federal Circuit affirmed the District Court's finding of no inequitable conduct, vacated the District Court's finding that claims 1-5 of the '814 patent were not invalid as anticipated, and remanded the case for further proceedings on the issue of anticipation.

Defendant-Appellee Aventis Pharmaceuticals Inc. (Aventis) owns the '814 patent, which relates to methods for treating amyotrophic lateral sclerosis (ALS) using 2-amino-6-(trifluoromethoxy) benzothiazole, commonly referred to as riluzole.  Dr. Erik Louvel, the lone inventor on the '814 patent, had discovered in comparative testing of eight compounds on rat spinal cord cells, that only riluzole produced positive results for all three of the key parameters tested.

Seeking approval to market generic riluzole tablets for the treatment of ALS, Plaintiff-Appellant Impax Laboratories, Inc. (Impax) filed an Abbreviated New Drug Application (ANDA) with the FDA.  Impax became aware of the '814 patent in the course of preparing its ANDA, and thereafter filed a declaratory judgment action in the District of Delaware.  In its suit, Impax sought a declaration that it had not infringed the '814 patent by filing its ANDA, and that its proposed manufacture and sale of riluzole would not infringe the '814 patent.  In addition, Impax asserted that the '814 patent was invalid over the prior art, as well as unenforceable due to inequitable conduct.

Following a bench trial, the District Court determined that Impax's manufacture and sale of riluzole would infringe the '814 patent, and that Impax had not established that the '814 patent was unenforceable due to inequitable conduct or that claims 1-5 were invalid as anticipated by the prior art.  Impax appealed the District Court's determination that it failed to prove that the '814 patent was unenforceable due to inequitable conduct or invalid as anticipated.

On the issue of enforceability, the Federal Circuit found that the District Court had not erred in determining that some of Dr. Louvel's comparative testing results were not material.  Before the District Court, and again on appeal, Impax argued that Dr. Louvel had failed to disclose the testing results for all of the eight compounds he tested, and therefore, had withheld material information from the Patent Office.  In particular, Impax contended that Dr. Louvel had failed to disclose the results for a compound that yielded positive results for two of the three key parameters tested.  Aventis countered that the withheld data was not material because only riluzole had yielded positive results for all three parameters tested.  The Federal Circuit concluded that "the district court correctly recognized that the comparative test data did not produce results that indicated that any of [the compounds for which data was withheld] was effective in treating ALS," and therefore, found "no error in the ruling of the district court that the [withheld test results] were not material under either Rule 56 standard."  The Federal Circuit also concluded that the District Court had not erred in finding no intent to deceive, and affirmed the District Court's ruling that the '814 patent was not unenforceable due to inequitable conduct.

On the issue of validity, Impax asserted before the District Court that Aventis' U.S. Patent No. 5,236,940 (the '940 patent) and Aventis' French Application No. 2,640,624 (the '624 application), from which the '940 patent claims priority, anticipate claims 1-5 of the '814 patent.  In particular, Impax contended that the '940 patent and '624 application disclose a class of compounds that includes riluzole, and suggest that this class of compounds may be used to treat ALS.  Aventis countered that the prior art cited by Impax was not enabling because it did not provide specific instruction for using riluzole and, in fact, taught away from using riluzole.

Citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318 (Fed. Cir. 2005), as standing for the proposition that "proof of efficacy is not required for a prior art reference to be enabling," the Federal Circuit determined that the District Court had focused on whether the prior art disclosed that riluzole was effective for treating ALS rather than on whether the prior art enabled the use of riluzole for treating ALS.  In Rasmusson, the Federal Circuit had reversed a decision by the Board of Patent Appeals and Interferences that a prior art reference disclosing a method of treating prostrate cancer using finasteride was not enabling, and therefore, not anticipatory, because the reference failed to demonstrate that finasteride was effective in treating prostrate cancer.  The Federal Circuit determined that the instant case was similar to Rasmusson, since "the district court stopped its analysis after concluding that the [prior art] did not disclose the compounds of formula I [of the '814 patent] were effective in treating ALS," and failed to "determine whether the [prior art] enables a person of ordinary skill in the art to treat ALS with riluzole."

Finding that the District Court had stopped short of completing a proper enablement analysis, the Federal Circuit looked to the allegedly anticipatory references to determine whether either was enabling.  With respect to the '624 application, the Federal Circuit noted that "[w]hen a reference discloses a class of compounds, i.e., a genus, a person of ordinary skill in the art should be able to 'at once envisage each member of th[e] . . . class' for the individual compounds, i.e., species, to be enabled" (citing In re Petering, 301 F.2d 676, 681 (C.C.P.A. 1962).  The Federal Circuit concluded that because riluzole is just one of hundreds of compounds encompassed by the class of compounds disclosed in that application, and because the '624 application does not identify riluzole by name, the '624 application did not enable the use of the species riluzole for treating ALS.  Thus, the Federal Circuit affirmed the District Court's finding that the '264 application does not anticipate the '814 patent.

The Federal Circuit, however, reached a different conclusion with respect to the '940 patent.  Noting that the '940 patent, unlike the '264 application, identifies riluzole by name (by explicitly exempting riluzole from formula I), the Federal Circuit concluded that this reference could not be similarly dismissed as nonenabling.  Instead, the Federal Circuit vacated the District Court's finding with respect to the '940 patent, and remanded the case to allow the District Court to reach its own legal conclusion as to whether this reference is enabled.

Finally, in a separate opinion in which he joined the majority on all issues except the anticipation determination, Judge Rader concluded that "[w]hile the trial court referred to effectiveness, its findings go beyond that narrow ruling and suffice to uphold its judgment," and further, that "the majority opinion provides even more evidence that the '940 patent is not an enabling reference for purposes of anticipating the '814 patent."

Impax Laboratories, Inc. v. Aventis Pharmaceuticals Inc. (Fed. Cir. 2006)
Panel: Circuit Judges Rader, Schall, and Prost
Opinion by Circuit Judge Schall; concurring-in-part opinion by Circuit Judge Rader

Thanks to MBHB attorney Brad Crawford for providing the structure of riluzole.

Additional Disclaimer:  MBHB represented Aventis in the above appeal.  To the extent that this case summary contains any opinions, the opinions would be of Dr. Zuhn and not Aventis or MBHB.