Patent Docs

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Medicis Pharmaceutical Corp. v. Ranbaxy Inc. et al.
1:09-cv-00435; filed June 11, 2009 in the District Court of Delaware

Infringement of U.S. Patent No. 5,908,838 ("Method for the Treatment of Acne," issued June 1, 1999) following a Paragraph IV certification as part of Ranbaxy's filing of an ANDA to manufacture a generic version of Medics' Solodyn® (minocycline hydrochloride extended release tablets, used to treat acne).  View the complaint here.

Reckitt Benckiser Inc. v. Watson Laboratories, Inc. - Florida et al.
0:09-cv-60852; field June 5, 2009 in the Southern District of Florida

Infringement of U.S. Patent Nos. 6,372,252 ("Guaifenesin Sustained Release Formulation and Tablets," issued April 16, 2002) and 6,955,821 ("Sustained Release Formulations of Guaifenesin and Additional Drug Ingredients," issued October 18, 2005) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of plaintiff's Mucinex® D (guaifenesin/pseudoephedrine hydrochloride, respectively, used to treat chest congestion).  View the complaint here.

Allergan, Inc. v. Hi-Tech Pharmacal Co., Inc.
2:09-cv-00182; filed June 5, 2009 in the Eastern District of Texas

Infringement of U.S. Patent Nos. 7,030,149 ("Combination of Brimonidine Timolol For Topical Ophthalmic Use," issued April 18, 2006) and 7,320,976 (same title, issued January 22, 2008) following a Paragraph IV certification as part of Hi-Tech's filing of an ANDA to manufacture a generic version of Allergan's Combigan® (brimonidine tartrate/timolol maleate ophthalmic solution, used to treat glaucoma).  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Takeda Pharmaceutical Co. et al. v. Sandoz, Inc.
1:09-cv-05210; filed June 3, 2009 in the Southern District of New York

Infringement of U.S. Patent Nos. 5,965,584 ("Pharmaceutical Composition," issued October 12, 1999), 6,329,404 (same title, issued December 11, 2001), 6,166,043 (same title, issued December 26, 2000), and 6,172,090 (same title, issued January 9, 2001) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Takeda's Actoplus MET® (pioglitazone hydrochloride and metformin, used to treat type II diabetes).  View the complaint here.

BASF Plant Science GmbH et al. v. Pioneer Hi-Bred International Inc. et al.
1:09-cv-00392; filed June 1, 2009 in the District Court of Delaware

Infringement of U.S. Patent No. 5,750,866 ("AHAS Promoter Useful for Expression of Introduced Genes In Plants," issued May 12, 1998) based on Pioneer's impending sale of its Optimum® GAT® corn.  Also, declaratory judgment of non-infringement, invalidity, and unenforceability of U.S. Patent Nos. 5,141,870 ("Nucleic Acid Fragment Encoding Herbicide Resistant Plant Acetolactate Synthase," issued August 25, 1992) and 5,605,011 (same title, issued February 25, 1997).  View the complaint here.

Pioneer Hi-Bred International Inc. et al. v. BASF Corp. et al.
1:09-cv-00393; filed June 1, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,013,659 ("Nucleic Acid Fragment Encoding Herbicide Resistant Plant Acetolactate Synthase," issued May 7, 1991), 5,141,870 (same title, issued August 25, 1992), 5,378,824 (same title, issued January 3, 1995), and 5,605,011 (same title, issued February 25, 1997).  Also, declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 5,750,866 ("AHAS Promoter Useful for Expression of Introduced Genes In Plants," issued May 12, 1998) and 6,025,541 ("Method of Using as a Selectable Marker a Nucleic Acid Containing AHAS Promoter Useful for Expression of Introduced Genes in Plants," issued February 15, 2000).  View the complaint here.

Human Genome Sciences Inc. v. Immunex Corp. et al.
1:09-cv-00389; filed May 29, 2009 in the District Court of Delaware

Review of the decision of the Board of Patent Appeals and Interferences awarding priority of invention to Immunex (now Amgen) in the interference between U.S. Patent No. 6,569,642 ("Receptor That Binds TRAIL," issued May 27, 2003), assigned to Immunex and U.S. Patent Application No. 09/042,583 ("Death Domain Containing Receptor 5," filed March 17, 1998), assigned to Human Genome Sciences.  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Stiefel Laboratories Inc. v. KV Pharmaceutical Co.
1:09-cv-00376; filed May 28, 2009 in the District Court of Delaware

Infringement of U.S. Patent No. 5,466,445 ("Topical Compositions Containing Bensoyl Peroxide and Clindamycin and Method of Use Thereof," issued November 14, 1995) following a Paragraph IV certification as part of KV's filing of an ANDA to manufacture a generic version of Stiefel's Duac® Topical Gel (clindamycin phosphate/benzoyl peroxide topical gel, used to treat acne).  View the complaint here.

Apotex, Inc. v. Cephalon, Inc.
2:09-cv-02416; filed May 27, 2009 in the Eastern District of Pennsylvania

Declaratory judgment of invalidity and non-infringement of U.S. Patent No. 7,297,346 ("Pharmaceutical Formulations of Modafinil," issued November 20, 2007) so the FDA can provide Apotex with approval to market a generic version of Cephalon's Provigil® (modafinil, used to improve wakefulness in adults who experience excessive sleepiness due to one of the following diagnosed sleep disorders:  obstructive sleep apnea, shift work sleep disorder, or narcolepsy).  View the complaint here.

Novo Nordisk Inc. et al v. Mylan Pharmaceuticals Inc.
3:09-cv-02445; filed May 20, 2009 in the District Court of New Jersey

Infringement of U.S. Patent No. 6,677,358 ("NIDDM Regimen," issued January 13, 2004) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novo Nordisk's Prandin® (repaglinide, used to treat non-insulin dependent diabetes mellitus in combination with metformin).  View the complaint here.

E8 Pharmaceuticals LLC v. Navigenics, Inc.
1:09-cv-10832; filed May 19, 2009 in the District Court of Massachusetts

Infringement of U.S. Patent No. 6,703,228 ("Methods and Products Related to Genotyping and DNA Analysis," issued March 9, 2004) based on Navigenics' providing and selling genetic counseling services that use certain GeneChip® products manufactured by Affymetrix, Inc.  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Teva Pharmaceutical Industries Ltd. et al. v. Amgen Inc.
2:09-cv-02256; filed May 20, 2009 in the Eastern District of Pennsylvania

Infringement of U.S. Patent No. 7,449,603 ("Process for the Preparation of Cinacalcet Base," issued November 11, 2008) based on Amgen's manufacture and sale of its Sensipar® (cinacalcet hydrochloride, used to treat secondary hyperparathyroidism in patients on dialysis, and hypercalcemia in patients with parathyroid carcinoma).  View the complaint here.

Takeda Pharmaceutical Co. et al. v. Teva Pharmaceutical Industries, Ltd. et al.
1:09-cv-04665; filed May 18, 2009 in the Southern District of New York

Infringement of U.S. Patent Nos. 5,965,584 ("Pharmaceutical Composition," issued October 12, 1999), 6,329,404 (same title, issued December 11, 2001), 6,166,043 (same title, issued December 26, 2000), 6,172,090 (same title, issued January 9, 2001), 6,211,205 (same title, issued April 3, 2001), 6,271,243 (same title, issued August 7, 2001), and 6,303,640 (same title, issued October 16, 2001) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Takeda's Actoplus MET® (pioglitazone hydrochloride and metformin, used to treat type II diabetes).  View the complaint here.

CIMA Labs Inc. et al. v. Barr Laboratories Inc. et al.
1:09-cv-00349; filed May 15, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,024,981 ("Rapidly Dissolving Robust Damage Form," issued February 15, 2000) and 6,221,392 (same title, issued April 24, 2001), licensed to Azur Pharma, following a Paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Azur's FazaClo® (clozapine, used to treat schizophrenia).  View the compliant here.

TET Systems Holding GmBH & Co. KG v. Pharmasset, Inc.
3:09-cv-02230; filed May 11, 2009 in the District Court of New Jersey

Infringement of U.S. Patent No. 5,464,758 ("Tight Control of Gene Expression in Eucaryotic Cells by Tetracycline-Responsive Promoters," issued November 7, 1995) based on Pharmasset's development of pharmaceutical compositions through the use of the plaintiff's TET System.  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Genzyme Corp. v. Lupin Ltd. et al.
1:09-cv-01258; filed May 14, 2009 in the District Court of Maryland

Infringement of U.S. Patent Nos. 5,496,545 ("Phosphate-Binding Polymers for Oral Administration," issued March 5, 1996), 5,667,775 (same title, issued on September 16, 1997), 6,509,013 ("Method of Making Phosphate-Binding Polymers for Oral Administration," issued January 21, 2003), 6,858,203 (same title, issued February 22, 2009), 7,014,846 ("Phosphate-Binding Polymers For Oral Administration," issued on March 21, 2006), and 7,459,151 (same title, issued December 2, 2008) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Genzyme's Renvela® (sevelamer carbonate, used for the control of serum phosphorus in patients with chronic kidney disease on dialysis).  View the complaint here.

Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al.
1:09-cv-04515; filed May 12, 2009 in the Southern District of New York

Declaratory judgment of invalidity and/or unenforceability of certain claims of U.S. Patent Nos. 5,747,282 ("17Q-Linked Breast and Ovarian Cancer Susceptibility Gene," issued May 5, 1998), 5,837,492 ("Chromosome 13-Linked Breast Cancer Susceptibility Gene," issued November 17, 1998), 5,693,473 ("Linked Breast and Ovarian Cancer Susceptibility Gene," issued December 2, 1997), 5,709,999 (same title, issued January 20, 1998), 5,710,001 ("17Q-Linked Breast and Ovarian Cancer Susceptibility Gene," issued January 20, 1998), 5,753,441 ("170-Linked Breast and Ovarian Cancer Susceptibility Gene," issued May 19, 1998), and 6,033,857 ("Chromosome 13-Linked Breast Cancer Susceptibility Gene," issued March 7, 2000) on the basis that the claims are invalid under 35 U.S.C. § 101 and are in violation of the First Amendment and Article I, section 8, clause 8 of the United States Constitution.  View the compliant here.

Reckitt Benckiser Inc. v. Watson Laboratories, Inc. Florida et al.
1:09-cv-04455; filed May 8, 2009 in the Southern District of New York

Infringement of U.S. Patent Nos. 6,372,252 ("Guaifenesin Sustained Release Formulation and Tablets," issued April 16, 2002) and 6,955,821 ("Sustained Release Formulations of Guaifenesin and Additional Drug Ingredients," issued October 18, 2005) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of plaintiff's Mucinex® D (guaifenesin/pseudoephedrine hydrochloride, respectively, used to treat chest congestion).  View the complaint here.

Allergan Inc. v. Barr Laboratories Inc.
1:09-cv-00333; filed May 7, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,688,819 ("Cyclopentane Heptanoic Acid, 2-Cycloalkyl or Arylalkyl Derivatives as Therapeutic Agents," issued November 18, 1997) and 6,403,649 ("Non-acidic Cyclopentane Heptanoic Acid, 2-Cycloalkyl or Arylalkyl Derivatives as Therapeutic Agents," issued June 11, 2002) following a Paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Allergan's Lumigan® (0.03% bimatoprost ophthalmic solution, used to treat lower intraocular eye pressure in people with open-angle glaucoma or ocular hypertension).  View the complaint here.

Public Patent Foundation, Inc v. Iovate Health Science Research Inc. et al.
1:09-cv-04361; filed May 6, 2009 in the Southern District of New York

False marking based on Iovate's marking of its Xenadrine® and Hyroxycut® products indicating that these products are covered by certain of U.S. Patent Nos. 6,814,986 ("Composition for Treating Obesity and Esthetic Treatment Process," issued November 9, 2004), 6,830,765 ("Green Tea Extract for Treating Obesity," issued December 14,2004), 4,923,855 ("Synthetic GTF Chromium Material and Process Therefor," issued May 8, 1990), 4,954,492 ("Synthetic GTF Chromium Material for Decreasing Blood Lipid Levels and Process Therefor," issued September 4, 1990), and 6,395,296 ("Soluble Double Metal Salt of Group IA and IIA of Hydroxycitric Acid, Process of Preparing the Same and its Use in Beverages and Other Food Products Without Effecting Their Flavor and Properties," issued May 28, 2002), two of which are expired.  View the complaint here.

Illumina, Inc. v. Affymetrix, Inc.
3:09-cv-00277; filed May 4, 2009 in the Western District of Wisconsin

Infringement of U.S. Patent No. 7,510,841 ("Methods of Making and Using Composite Arrays for the Detection of a Plurality of Target Analytes," issued March 31, 2009) based on based on Affymetix's manufacture and sale of certain products, including its GeneChip® HT RG-230 PM Array Plate, GeneChip® HT Array Plate Scanner, GeneChip® HT 3' IVT Express Kit, GeneChip® Array Station, and GeneTitan® Instrument.  View the complaint here.

Court Report: Special Edition

    By Kevin E. Noonan --

Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office, Myriad Genetics et al.
09-cv-04515-RWS; filed May 12, 2009 in the District Court for the Southern District of New York

Earlier today, a group of patients, physicians, academic researchers and medical societies filed suit in the Southern District of New York against the U.S. Patent and Trademark Office and Myriad Genetics, among others, over several patents claiming human BRCA1 and BRC2 genes and methods for detecting mutations in these genes to diagnose a predisposition to breast and ovarian cancer.  The causes of action asserted in the complaint are that patent claims directed to isolated nucleic acids are not patentable subject matter as being products of nature contrary to 35 U.S.C. § 101 and Article 1, Section 8, Clause 8 of the Constitution, and violations of free speech under the 1st Amendment and due process violations of the 14th Amendment.  The lawsuit was filed by American Civil Liberties Union (ACLU) lawyers and that perennial antipatent litigant, Daniel Ravitcher from the Public Patent Foundation (PubPat).  (In homage to Donald Chisum, it would be more accurate to call it the Public No-Patent Foundation.)  Details of the complaint, the parties, the patents, the politics, and the prospects for the suit will be presented in future Patent Docs posts -- in particular, we will be addressing "issues" with the complaint in a future post.  We wish to thank a Patent Docs reader for bringing this case to our attention.  The complaint can be viewed here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Yeda Research and Development Co., Ltd., v. Doll
1:09-cv-00820; filed May 4, 2009 in the District Court of the District of Columbia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,445,802 ("Site-Specific In Situ Generation of Allicin Using a Targeted Alliinase Delivery System for the Treatment of Cancers, Tumors, Infectious Diseases and Other Allicin-Sensitive Diseases," issued November 4, 2008).  View the complaint here.

Monsanto Co. et al. v. E.I. Dupont De Nemours and Co. et al.
4:09-cv-00686; filed May 4, 2009 in the Eastern District of Missouri

Infringement of U.S. Patent No. RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on defendants' development of a stacked soybean product incorporating Monsanto's Roundup Ready® technology.  View the complaint here.

Abbott Biotechnology Ltd. v. Centocor Ortho Biotech, Inc.
4:09-cv-40089; filed May 1, 2009 in the District Court of Massachusetts

Infringement of U.S. Patent No. 7,223,394 ("Human Antibodies that Bind Human TNF alpha," issued May 29, 2007) based on Centocor's imminent launch of it's Simponi product (golimumab, used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis).  View the complaint here.

Warner Chilcott Laboratories Ireland Ltd. et al. v. Mylan Pharmaceuticals Inc. et al.
2:09-cv-02073; filed May 1, 2009 in the District Court of New Jersey

Infringement of U.S. Patent No. 6,958,161 ("Modified Release Coated Drug Preparation," issued October 25, 2005) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Warner Chilcott's Doryx® (modified release doxycycline hyclate, used for adjunctive treatment of severe acne).  View the complaint here.

Alcon Research Ltd. v. Barr Laboratories Inc.
1:09-cv-00318; filed April 30, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,510,383 ("Use of Cloprostenol, Fluprostenol and Their Salts and Esters to Treat Glaucoma and Ocular Hypertension," issued April 23, 1996), 5,631,287 ("Storage-Stable Prostaglandin Compositions," issued May 20, 1997), 5,849,792 (same title, issued December 15, 1998), 5,889,052 ("Use of Cloprostenol and Fluprostenol Analogues to Treat Glaucoma and Ocular Hypertension," issued March 30, 1999) and 6,011,062 ("Storage-Stable Prostaglandin Compositions," issued January 4, 2000) following a Paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Alcon's Travatan® (travoprost ophthalmic solution, used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertention).  View the complaint here.

Pfizer Inc. et al. v. Lupin Ltd. et al.
1:09-cv-01113; filed April 30, 2009 in the District Court of Maryland

Pfizer Inc. et al. v. Sandoz Inc.
3:09-cv-02052; filed April 30, 2009 in the District Court of New Jersey

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,001,876 ("Isobutylgaba and Its Derivatives for the Treatment of Pain," issued December 14, 1999), 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001), and 5,563,175 ("GABA and L-glutamic Acid Analogs for Antiseizure Treatment," issued October 8, 1996) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia).  View the Lupin complaint here.

Pfizer Inc. et al. v. Wockhardt Ltd. et al.
3:09-cv-02069; filed April 30, 2009 in the District Court of New Jersey

Pfizer Inc. et al. v. Sun Pharma Global Inc. et al.
3:09-cv-02070; filed April 30, 2009 in the District Court of New Jersey

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia).  View the Wockhardt complaint here.

Novartis AG v. Doll
1:09-cv-00804; filed April 20, 2009 in the District Court of the District of Columbia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,446,175 ("Antibodies to human IL-1β," issued November 4, 2008).  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Warner Chilcott Co. et al. v. Midlothian Laboratories L.L.C.
2:09-cv-02026; filed April 30, 2009 in the District Court of New Jersey

Warner Chilcott Co. et al. v. Mission Pharmacal Co.
2:09-cv-02025; filed April 30, 2009 in the District Court of New Jersey

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,521,247 ("Dual Iron Containing Nutritional Supplement," issued February 18, 2003) based on Midlothian's manufacture and sale of its Foltabs and Foltabs DHA prenatal supplements and Misson's manufacture and sale of its CitraNatal DHA, CitraNatal90 DHA, and CitraNatal Rx prenatal supplements.  View the Midlothian Laboratories complaint here.

Biogen Idec Ma Inc. v. Doll
1:09-cv-00792; filed April 30, 2009 in the District Court of the District of Columbia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,446,173 ("Polymer Conjugates of Interferon Beta-1A and Uses," issued November 4, 2008).  View the complaint here.

Pfizer Inc. et al. v. Alphapharm Pty. Ltd. et al.
1:09-cv-00056; filed April 30, 2009 in the Northern District of West Virginia

Pfizer Inc. et al. v. Teva Pharmaceuticals USA Inc. et al.
1:09-cv-00307; filed April 29, 2009 in the District Court of Delaware

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,001,876 ("Isobutylgaba and Its Derivatives for the Treatment of Pain," issued December 14, 1999) and 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia).  View the Teva Pharmaceuticals complaint here.

Pfizer Inc. et al. v. Lupin Ltd. et al.
1:09-cv-00309; filed April 29, 2009 in the District Court of Delaware

Pfizer Inc. et al. v. Actavis Elizabeth LLC et al.
1:09-cv-00311; filed April 29, 2009 in the District Court of Delaware

Pfizer Inc. et al. v. Sandoz Inc.
1:09-cv-00310; filed April 29, 2009 in the District Court of Delaware

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,001,876 ("Isobutylgaba and Its Derivatives for the Treatment of Pain," issued December 14, 1999), 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001), and 5,563,175 ("GABA and L-glutamic Acid Analogs for Antiseizure Treatment," issued October 8, 1996) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia).  View the Lupin complaint here.

Pfizer Inc. et al. v. Cobalt Laboratories Inc. et al.
1:09-cv-00315; filed April 29, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,563,175 ("GABA and L-glutamic Acid Analogs for Antiseizure Treatment," issued October 8, 1996) and 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia).  View the complaint here.

Pfizer Inc. et al. v. Sun Pharma Global Inc. et al.
1:09-cv-00313; filed April 29, 2009 in the District Court of Delaware

Pfizer Inc. et al. v. Wockhardt Ltd. et al.
1:09-cv-00312; filed April 29, 2009 in the District Court of Delaware

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia).  View the Sun Pharma complaint here.

Pfizer Inc. et al. v. Alphapharm Pty Ltd. et al.
1:09-cv-00308; filed April 29, 2009 in the District Court of Delaware

Infringement of U.S. Patent No. 6,001,876 ("Isobutylgaba and Its Derivatives for the Treatment of Pain," issued December 14, 1999) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia).  View the complaint here.

Pronova BioPharma Norge AS v. Par Pharmaceutical Inc. et al.
1:09-cv-00305; filed April 29, 2009 in the District Court of Delaware

Pronova BioPharma Norge AS v. Apotex Corp. et al.
1:09-cv-00304; filed April 29, 2009 in the District Court of Delaware

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,502,077 ("Fatty Acid Composition," issued March 26, 1996) and 5,656,667 (same title, issued August 12, 1997) following a Paragraph IV certification as part of Eagle's filing of an ANDA to manufacture a generic version of Pronova's Lovaza® (omega-3-acid ethyl esters, used to reduce triglyceride levels in adult patients with very high triglyceride levels).  View the Par Pharmaceutical complaint here.

Novartis Pharmaceuticals Corp. et al. v. Anchen Pharmaceuticals, Inc.
2:09-cv-02929; filed April 27, 2009 in the Central District of California

Novartis Pharmaceuticals Corp. et al. v. Anchen Pharmaceuticals Inc.
1:09-cv-00294; filed April 24, 2009 in the District Court of New Jersey

Novartis Pharmaceuticals Corp. et al. v. Watson Pharmaceuticals Inc. et al.
0:09-cv-60622; filed April 27, 2009 in the Southern District of Florida

Novartis Pharmaceuticals Corp. et al. v. Watson Pharmaceuticals Inc. et al.
1:09-cv-00292; filed April 24, 2009 in the District Court of New Jersey

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,106,864 ("Pharmaceutical Formulations Containing Darifenacin," issued August 22, 2000) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Novartis' Enablex® (darifenacin, used to treat symptoms of overactive bladder).  View the California Anchen Pharmaceuticals complaint here.

Novartis Pharmaceuticals Corp. et al. v. Teva Pharmaceuticals USA Inc.
1:09-cv-00291; filed April 24, 2009 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 5,096,890 ("Pyrrolidine Derivatives," issued March 17, 1992) and 6,106,864 ("Pharmaceutical Formulations Containing Darifenacin," issued August 22, 2000) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Novartis' Enablex® (darifenacin, used to treat symptoms of overactive bladder).  View the complaint here.

Reckitt Benckiser Inc. v. Watson Laboratories, Inc. - Florida et al.
0:09-cv-60609; filed April 24, 2009 in the Southern District of Florida

Infringement of U.S. Patent Nos. 6,372,252 ("Guaifenesin Sustained Release Formulation and Tablets," issued April 16, 2002) and 6,955,821 ("Sustained Release Formulations of Guaifenesin and Additional Drug Ingredients," issued October 18, 2005) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of plaintiff's Mucinex® and Mucinex® DM (guaifenesin, and guaifenesin/dextromethorphan, respectively, used to treat chest congestion).  View the complaint here.

Pozen Inc. v. Teva Pharmaceuticals USA Inc.
6:09-cv-00182; filed April 24, 2009 in the Eastern District of Texas

Infringement of U.S. Patent Nos. 6,060,499 ("Anti-migraine Methods and Compositions Using 5-HT Agonists with Long-Acting NSAIDS," issued May 9, 2000) and 6,586,458 ("Methods of Treating Headaches Using 5-HT Agonists in Combination with Long-Acting NSAIDS," issued July 1, 2003), licensed to GlaxoSmithKline, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of GSK's Treximet® (sumatriptan and naproxen sodium, used to treat migrane attacks).  View the complaint here.

Hoffmann-La Roche Inc. v. Doll
1:09-cv-00760; filed April 24, 2009 in the District Court of the District of Columbia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,442,776 ("Cancerous Disease Modifying Antibodies," issued October 28, 2008).  View the complaint here.

Biogen Idec Ma Inc v. Doll
1:09-cv-00754; filed April 23, 2009 in the District Court of the District of Columbia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,442,370 ("Polymer Conjugates of Mutated Neublastin," issued October 28, 2008).  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Bone Care International LLC et al. v. Eagle Pharmaceuticals Inc.
1:09-cv-00285; filed April 23, 2009 in the District Court of Delaware

Infringement of U.S. Patent No. 5,602,116 ("Method for Treating and Preventing Secondary Hyperparathyroidism," issued February 11, 1997) following a Paragraph IV certification as part of Eagle's filing of an ANDA to manufacture a generic version of plaintiffs' Hectorol® (doxercalciferol, used to treat secondary hyperparathyroidism in patients with chronic kidney disease).  View the complaint here.

Pronova BioPharma Norge AS v. Teva Pharamceuticals USA, Inc. et al.
1:09-cv-00286; filed April 23, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,502,077 ("Fatty Acid Composition," issued March 26, 1996) and 5,656,667 (same title, issued August 12, 1997) following a Paragraph IV certification as part of Eagle's filing of an ANDA to manufacture a generic version of Pronova's Lovaza® (omega-3-acid ethyl esters, used to reduce triglyceride levels in adult patients with very high triglyceride levels).  View the complaint here.

Eli Lilly and Company et al. v. Barr Laboratories Inc.
1:09-cv-00272; filed April 22, 2009 in the District Court of Delaware

Infringement of U.S. Patent No. 5,344,932 ("N-(pyrrolo(2,3-d)pyrimidin-3-ylacyl)-Glutamic Acid Derivatives," issued September 6, 1994), licensed to Eli Lilly, following a Paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer).  View the complaint here.

Sepracor Inc. v. Alphapharm Pty. Ltd et al.
1:09-cv-03987; filed April 22, 2009 in the Southern District of New York

Infringement of U.S. Patent Nos. 6,864,257 ("Optically Active 5H-Pyrrolo[3,4-B] Pyrazine Derivative, Its Preparation and Pharmaceutical Compositions Containing It," issued March 8, 2005), 6,319,926 (same title, issued September 23, 2002), 6,444,673 (same title, issued November 20, 2001), and 7,381,724 (same title, issued June 3, 2008) following a Paragraph IV certification as part of Alphapharm's filing of an ANDA to manufacture a generic version of Sepracor's Lunesta® (eszopiclone, used to treat insomnia).  View the complaint here.

Pfizer, Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al.
1:09-cv-03965; filed April 21, 2009 in the Southern District of New York

Infringement of U.S. Patent No. 5,601,843 ("Pharmaceutical Tablet Composition," issued February 11, 1997) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Pfizer's Arthrotech® (diclofenac sodium/misoprostol, used for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications).  View the complaint here.

Reckitt Benckiser Inc. v. Watson Laboratories, Inc. - Florida et al.
1:09-cv-03933; filed April 20, 2009 in the Southern District of New York

Infringement of U.S. Patent Nos. 6,372,252 ("Guaifenesin Sustained Release Formulation and Tablets," issued April 16, 2002) and 6,955,821 ("Sustained Release Formulations of Guaifenesin and Additional Drug Ingredients," issued October 18, 2005) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of plaintiff's Mucinex® and Mucinex® DM (guaifenesin, and guaifenesin/dextromethorphan, respectively, used to treat chest congestion).  View the complaint here.

OptiGen, LLC v. Texas A&M University System et al.
5:09-cv-00457; filed April 17, 2009 in the Northern District of New York

Infringement of U.S. Patent Nos. 7,285,388 ("Methods for Identification of Alport Syndrome," issued October 23, 2007), 6,210,897 ("Identification of Canine Leukocyte Adhesion Deficiency In Dogs," issued April 3, 2001), 6,201,114 ("Identification of Congenital Stationary Night Blindness In Dogs," issued March 13, 2001), and 6,428,958 (same title, issued August 6, 2002), all licensed to OptiGen, based on defendants' sale of its Pawsitive I.D. kit to test for Progressive Rod-Cone Disease in dogs.  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Par Pharmaceutical, Inc. v. Novartis Pharmaceuticals Corp. et al.
2:09-cv-01592; filed April 16, 2009 in the Eastern District of Pennsylvania

Declaratory judgment of invalidity and non-infringement of U.S. Patent Nos. 5,463,116 ("Crystals of N- (trans-4-isopropylcyclohexlycarbonyl)-D-phenylalanine and Methods for Preparing Them," issued October 31, 1995), 5,488,150 (same title, issued January 30, 1996), 6,559,188 ("Method of Treating Metabolic Disorders Especially Diabetes, or a Disease or Condition Associated with Diabetes," issued May 6, 2003), 6,641,841 ("Tablet Composition," issued November 4, 2003), 6,844,008 (same title, issued January 18, 2005), and 6,878,749 ("Method of Treating Metabolic Disorders, Especially Diabetes, or a Disease or Condition Associated with Diabetes," issued April 12, 2005) based on Par's filing of an ANDA to manufacture a generic version of Novartis' Starlix® (nateglinide, used to treat type 2 diabetes mellitus).  View the complaint here.

Meda Pharmaceuticals Inc. v. Sun Pharmaceutical Industries Ltd.
1:09-cv-00241; filed April 9, 2008 in the District Court of Delaware

Infringement of U.S. Patent No. 5,164,194 ("Azelastine Containing Medicaments," issued November 17, 1992) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Meda's Optivar® (azelastine hydrochloride ophthalmic solution, used to treat seasonal allergic rhinitis).  View the complaint here.

Hoffmann-La Roche Inc. v. Mylan Inc. et al.
2:09-cv-01692; filed April 8, 2009 in the District Court of Delaware

Infringement of U.S. Patent No. 5,472,949 ("N4-(Substituted-Oxycarbonyl)-5'-
Deoxy-5-Fluorocytidine Compounds, Compositions and Methods of Using Same," issued December 5, 1995) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Roche's Xeloda® (capecitabine, used to treat breast and colorectal cancer and Dukes' C Stage III colon cancer).  View the complaint here.

AsymmetRx, Inc. et al. v. Dako Denmark A/S et al.
1:09-cv-10396; filed March 13, 2009 in the District Court of Massachusetts

Infringement of U.S. Patent Nos. 6,946,256 ("Cell Regulatory Genes, Encoded Products, and Uses Related Thereto," issued September 20, 2005) and 7,030,227 (same title, issued April 18, 2006) by selling products utilizing p63 antibodies in the U.S.  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Wyeth v. Cadila Healthcare Ltd. et al.
1:09-cv-00239; filed April 9, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,274,171 ("Extended release formulation of venlafaxine hydrochloride," issued August 14, 2001), 6,403,120 (same title, issued June 11, 2002), and 6,419,958 (same title, issued July 16, 2002) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Wyeth's EFFEXOR XR® (venlafaxine hydrochloride, extended release, used to treat depression).  View the complaint here.

Allergan, Inc. v. Sandoz Inc
2:09-cv-00097; filed April 7, 2009 in the Eastern District of Texas

Infringement of U.S. Patent Nos. 7,030,149 ("Combination of Brimonidine Timolol For Topical Ophthalmic Use," issued April 18, 2006) and 7,320,976 (same title, issued January 22, 2008) following a Paragraph IV certification as part of Sanoz's filing of an ANDA to manufacture a generic version of Allergan's Combigan® (brimonidine tartrate/timolol maleate ophthalmic solution, used to treat glaucoma).  View the complaint here.


Abbott Laboratories et al. v. Sandoz, Inc. et al.
3:09-cv-01587; filed April 2, 2009 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 5,246,925 ("19-nor-Vitamin D Compounds for Use in Treating Hyperparathyroidism," issued September 21, 1993), 5,587,497 ("19-nor-Vitamin D Compounds," issued December 24, 1996), 6,136,799 ("Cosolvent Formulations," issued October 24, 2000), and 6,361,758 (same title, issued March 26, 2002) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Abbott's Zemplar® (paricalcitol, used to treat secondary hyperparathyroidism in patients with kidney failure).  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Genzyme Corp. v. Impax Laboratories, Inc.
1:09-cv-00846; filed April 3, 2009 in the District Court of Maryland

Infringement of U.S. Patent No. 5,667,775 ("Phosphate-Binding Polymers for Oral Administration," issued on September 16, 1997) following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of Genzyme's Renvela® (sevelamer carbonate, used for the control of serum phosphorus in patients with chronic kidney disease on dialysis).  View the complaint here.

Abbott Laboratories et al. v. Sandoz Inc. et al.
1:09-cv-00215; filed April 1, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,246,925 ("19-nor-Vitamin D Compounds for Use in Treating Hyperparathyroidism," issued September 21, 1993), 5,587,497 ("19-nor-Vitamin D Compounds," issued December 24, 1996), 6,136,799 ("Cosolvent Formulations," issued October 24, 2000), and 6,361,758 (same title, issued March 26, 2002) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Abbott's Zemplar® (paricalcitol, used to treat secondary hyperparathyroidism in patients with kidney failure).  View the complaint here.

Shire Canada Inc. et al. v. Natco Pharma Ltd.
1:09-cv-03165; filed April 1, 2009 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 5,968,976 ("Pharmaceutical Composition Containing Selected Lanthanum Carbonate Hydrates," issued October 19, 1999) and 7,381,428 ("Stabilized Lanthanum Carbonate Compositions," issued June 3, 2008) following a Paragraph IV certification as part of Natco's filing of an ANDA to manufacture a generic version of Shire's Fosrenol® (lanthanum carbonate chewable tablets, used for the reduction of serum phosphate in patients with end stage renal disease).  View the complaint here.

Millennium Pharmaceuticals Inc. et al. v. Teva Parenteral Medicines Inc. et al.
1:09-cv-00204; filed March 27, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,747,447 ("Stable Polypeptide Composition," issued May 5, 1998) and 5,968,902 ("Platelet Aggregation Inhibitors," issued October 19, 1999), licensed to Schering Corp., following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Schering-Plough's Integrilin® (eptifibatide injection, used to treat acute coronary syndrome).  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Monsanto Co. et al. v. Dart et al.
4:09-cv-00474; filed March 25, 2009 in the Eastern District of Missouri

Infringement of U.S. Patent Nos. 5,352,605 ("Chimeric Genes for Transforming Plant Cells Using Viral Promoters," issued October 4, 1994) and RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on defendants' use of soybean seed produced from earlier planted Roundup Ready® soybean seed.  View the complaint here.

Cubist Pharmaceuticals Inc. v. Teva Parenteral Medicines Inc. et al.
1:09-cv-00189; filed March 23. 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,468,967 ("Methods for Administration of Antibiotics," issued October 22, 2002), 6,852,689 (same title, issued February 8, 2009), and RE39,071 ("Anhydro-and Isomer-A-21978C Cyclic Peptides, issued April 18, 2006) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Cubist's Cubicin® (daptomycin for injection, used for the treatment of skin infections caused by certain Gram-positive microorganisms).  View the complaint here.

Sepracor Inc. v. Teva Pharmaceuticals USA, Inc. et al.
2:09-cv-01302; filed March 20, 2009 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,864,257 ("Optically Active 5H-Pyrrolo[3,4-B] Pyrazine Derivative, Its Preparation and Pharmaceutical Compositions Containing It," issued March 8, 2005), 6,319,926 (same title, issued September 23, 2002), 6,444,673 (same title, issued November 20, 2001), and 7,381,724 (same title, issued June 3, 2008) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Sepracor's Lunesta® (eszopiclone, used to treat insomnia).  View the complaint here.

OSI Pharmaceuticals Inc. et al. v. Mylan Pharmaceuticals Inc.
1:09-cv-00186; filed March 19, 2009 in the District Court of Delaware

OSI Pharmaceuticals Inc. et al. v. Teva Pharmaceuticals USA Inc.
1:09-cv-00185; filed March 19, 2009 in the District Court of Delaware

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,747,498 ("Alkynyl and Azido-Substituted 4-Anilinoquinazoline," issued May 5, 1998), 6,900,221 ("Stable Polymorph on N-(3-Ethynylpheny1)-6, 7-Bis(2MethoxyEthoxy)-4-Quinazolinamine Hydrochloride, Methods of Production, and Pharmaceutical Uses Thereof," issued May 31, 2005), and 7,087,613 ("Treating Abnormal Cell Growth With A Stable Polymorph on N-(3-Ethynylpheny1)-6,7-Bis(2MethoxyEthoxy)-4-Quinazolinamine Hydrochloride," issued August 8, 2006) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of OSI's Tarceva® (erlotinib, used to treat non-small cell lung cancer and advanced pancreatic cancer).  View the Mylan complaint here.

Research Foundation of State University of New York et al. v. Mylan Pharmaceuticals Inc.
1:09-cv-00184; filed March 19, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 7,232,572 ("Methods of Treating Rosacea," issued June 19, 2007), 7,211,267 ("Methods of Treating Acne" issued May 1, 2007), 5,789,395 ("Method of Using Tetracycline Compounds for Inhibition of Endogenous Nitric Oxide Production" issued Augst 4, 1998), and 5,919,775 ("Method for Inhibiting Expression of Inducible Nitric Oxide Synthase with Tetracycline," issued April 16, 1998), all either assigned or licensed to Galderma, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Galderma's Oracea® (doxycyline delayed release capsules, used to treat inflammatory lesions of rosacea).  View the complaint here.

Shire Canada Inc. et al. v. Mylan Inc. et al.
1:09-cv-02555; filed March 19, 2009 in the Southern District of New York

Infringement of U.S. Patent No. 5,968,976 ("Pharmaceutical Composition Containing Selected Lanthanum Carbonate Hydrates," issued October 19, 1999) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Shire's Fosrenol® (lanthanum carbonate chewable tablets, used for the reduction of serum phosphate in patients with end stage renal disease).  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Warner Chilcott Laboratories Ireland Ltd. et al. v. Impax Laboratories, Inc.
2:09-cv-01233; filed March 18, 2009 in the District Court of New Jersey

Infringement of U.S. Patent No. 6,958,161 ("Modified Release Coated Drug Preparation," issued October 25, 2005) following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of Warner Chilcott's Doryx® (modified release doxycycline hyclate, used for adjunctive treatment of severe acne).  View the complaint here.

Allergan Inc et al. v. Athena Cosmetics Inc et al.
8:09-cv-00328; filed March 16, 2009 in the Central District of California

Infringement of U.S. Patent Nos. 6,262,105 ("Method of Enhancing Hair Growth," issued July 17, 2001), 7,351,404 (same title, issued April 1, 2008), and 7,388,029 ("Compositions and Methods for Treating Hair Loss Using Non-Naturally Occurring Prostaglandins," issued June 17, 2008) based on defendants manufacture and sale of hair and/or eyelash growth products with prostamides.  View the complaint here.

Stiefel Laboratories Inc. et al. v. Cobrek Pharmaceuticals Inc. et al.
1:09-cv-00167; filed March 13, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 7,141,237 ("Pharmaceutical Foam," issued November 28, 2006) and 7,374,747 (same title, issued May 20, 2008) following a Paragraph IV certification as part of Cobrek's filing of an ANDA to manufacture a generic version of Stiefel's Evoclin® (clindamycin phosphate foam, used to treat acne).  View the complaint here.

Abbott Laboratories v. Matrix Laboratories Inc. et al.
1:09-cv-00174; filed March 13, 2009 in the District Court of Delaware

Abbott Laboratories v. Matrix Laboratories, Inc. et al.
1:09-cv-01586; filed March 13, 2009 in the Northern District of Illinois

The complaints in these cares are substantially identical.  Infringement of U.S. Patent Nos. 7,148,359 ("Polymorph of a Pharmaceutical," issued December 12, 2006) and 7,364,752 ("Solid Dispersion Pharamaceutical Formulations," issued April 29, 2008) following a Paragraph IV certification as part of Matrix's filing of an ANDA to manufacture a generic version of Abbott's Kaletra® (lopinavir and ritonavir, used to treat HIV infections).  View the Delaware complaint here.

Genzyme Corp. v. Impax Laboratories, Inc.
1:09-cv-00653; filed March 13, 2009 in the District Court of Maryland

Infringement of U.S. Patent No. 5,667,775 ("Phosphate-Binding Polymers for Oral Administration," issued on September 16, 1997) following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of Genzyme's Renagel® (sevelamer hydrochloride, used for the control of serum phosphorus in patients with chronic kidney disease on dialysis).  View the complaint here.

Wyeth v. Intervet Inc. et al.
1:09-cv-00161; filed March 12, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,703,023 ("Circovirus Sequences Associated with Piglet Weight Loss Disease," issued March 9, 2004), 7,223,407 (same title, issued May 29, 2007), 7,223,594 (same title, issued May 29, 2007), and 7,407,803 (same title, issued August 5, 2008) based on defendants' manufacture and sale of their Circumvent® PCV, Porcilis® PCV, and CircoFLEX® vaccines (porcine circovirus vaccines).  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Sanofi-Aventis U.S. LLC et al. v. Ebewe Pharma Ges.M.B.H. NFG.KG
3:09-cv-01116; filed March 11, 2009 in the District Court of New Jersey

Infringement of U.S. Patent No. 5,338,874 ("Cis oxalato (trans 1-1,2-cyclohexanediamine) PT(II) Having Optically High Purity," issued August 16, 1994) following a Paragraph IV certification as part of defendants' supplementation of its ANDA to manufacture a generic version of plaintiffs' Eloxatin® (oxaliplatin for injection, used to treat colorectal cancer).  View the complaint here.

Abbott Laboratories et al. v. Lupin Ltd. et al.
1:09-cv-00152; filed March 6, 2009 in the District Court of Delaware

Abbott Laboratories et al. v Lupin Ltd. et al.
1:09-cv-00564; filed March 6, 2009 in the District Court of Maryland

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,129,930 ("Methods and Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia at Night," issued October 10, 2000), 6,406,715 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Urinary Metabolite Profiles," issued June 18, 2002), 6,676,967 ("Methods for Reducing Flushing in Individuals Being Treated with Nicotinic Acid for Hyperlipidemia," issued January 13, 2004), 6,746,691 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Biopharmaceutical Characteristics," issued June 8, 2004), 7,011,848 ("Hydrophobic Component Free Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued March 14, 2006), 6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia," issued November 16, 2004), and 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Abbott's Niaspan® (niacin extended-release tablets, used to treat hypercholesterolemia).  View the Delaware complaint here.

Genzyme Corp. v. Lupin Ltd. et al.
1:09-cv-00563; filed March 6, 2009 in the District Court of Maryland

Infringement of U.S. Patent Nos. 5,496,545 ("Phosphate-Binding Polymers for Oral Administration," issued March 5, 1996), 5,667,775 ("Phosphate-Binding Polymers for Oral Administration," issued on September 16, 1997), 6,509,013 ("Method of Making Phosphate-Binding Polymers for Oral Administration," issued January 21, 2003), and 7,014,846 ("Phosphate-Binding Polymers For Oral Administration," issued on March 21, 2006) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Genzyme's Renagel® (sevelamer hydrochloride, used for the control of serum phosphorus in patients with chronic kidney disease on dialysis).  View the complaint here.  [NB:  As reported previously in Court Report, Genzyme recently filed a comparable suit against Lupin in the District Court of Delaware.]

Abbott Laboratories et al. v. Lupin Ltd. et al.
2:09-cv-01007; filed March 6, 2009 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,277,405 ("Fenofibrate Pharmaceutical Composition Having High Bioavailability and Method for Preparing It," issued August 21, 2001), 7,037,529 (same title, issued May 2, 2006), and 7,041,319 ("Fenofibrate Pharmaceutical Composition Having High Bioavailabilty," issued May 9, 2006) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Abbott's Tricor® (fenofibrate, used in the treatment of increased triglyceride levels).  View the complaint here.

Elan Pharma International Ltd. et al. v. Lupin Ltd. et al.
2:09-cv-01008; filed March 6, 2009 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 7,276,249 ("Nanoparticulate Fibrate Formulations," issued October 2, 2007), and 7,320,802 ("Methods of Treatment Using Nanoparticulate Fenofibrate Compositions," issued January 22, 2008), all licensed to Abbott, following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Abbott's Tricor® (fenofibrate, used in the treatment of increased triglyceride levels).  View the complaint here.

Procter & Gamble Co. et al. v. Apotex Inc. et al.
1:09-cv-00281; filed March 5, 2009 in the Southern District of Indiana

Infringement of U.S. Patent No. 7,192,938 ("Method of Treatment Using Bisphosphonic Acid," issued March 20, 2007) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of P&G's Actonel® (risedronate sodium, used to treat and prevent postmenopausal osteoporosis).  View the complaint here.  [NB:  As reported previously in Court Report, P&G recently filed a comparable suit against Apotex in the District Court of Delaware.]

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Genzyme Corp. v. Lupin Ltd. et al.
1:09-cv-00147; filed March 5, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,496,545 ("Phosphate-Binding Polymers for Oral Administration," issued March 5, 1996), 5,667,775 ("Phosphate-Binding Polymers for Oral Administration," issued on September 16, 1997), 6,509,013 ("Method of Making Phosphate-Binding Polymers for Oral Administration," issued January 21, 2003), and 7,014,846 ("Phosphate-Binding Polymers For Oral Administration," issued on March 21, 2006) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Genzyme's Renagel® (sevelamer hydrochloride, used for the control of serum phosphorus in patients with chronic kidney disease on dialysis).  View the complaint here.

Procter & Gamble Co. et al. v. Apotex Inc. et al.
1:09-cv-00143; filed March 4, 2009 in the District Court of Delaware

Infringement of U.S. Patent No. 7,192,938 ("Method of Treatment Using Bisphosphonic Acid," issued March 20, 2007) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of P&G's Actonel® (risedronate sodium, used to treat and prevent postmenopausal osteoporosis).  View the complaint here.

Galderma Laboratories LP et al. v. Tolmar Inc.
3:09-cv-00400; filed March 3, 2009 in the Northern District of Texas

Infringement of U.S. Patent Nos. 6,881,726 ("Aqueous Compositions Containing Metronidazole," issued April 19, 2005) and 7,348,317 (same title, issued March 25, 2008), both licensed exclusively to Galderma, following a Paragraph IV certification as part of Tolmar's filing of an ANDA to manufacture a generic version of Galderman's MetroGel® (metronidazole gel, used to treat rosacea).  View the complaint here.

Duramed Pharmaceuticals, Inc. v. Paddock Laboratories, Inc.
1:09-cv-01905, filed March 2, 2009 in the Southern District of New York

Infringement of U.S. Patent No. 5,908,638 ("Pharmaceutical Compositions of Conjugated Estrogens and Methods for Their Use," issued June 1, 1999) following a Paragraph IV certification as part of Paddock's filing of an ANDA to manufacture a generic version of Duramed's Cenestin® (synthetic conjugated estrogens, used to peri-menopausal, menopausal, and post-menopausal disorders).  View the complaint here.

Millennium Pharmaceuticals Inc. v. Teva Parenteral Medicines Inc. et al.
1:09-cv-00127; filed February 27, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed exclusively to Millennium, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiply myeloma).  View the complaint here.

Merck & Co., Inc. v. Sandoz Inc.
3:09-cv-00890; filed February 27, 2009 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 5,719,147 ("Morpholine and Thiomorpholine Tachykinin Receptor Antagonists," issued February 17, 1998), 6,048,859 (same title, issued April 11, 2000), 6,096,742 ("Polymorphic Form of a Tachykinin Receptor Antagonist," issued August 1, 2000), and 6,235,735 ("Morpholine and Thiomorpholine Tachykinin Receptor Antagonists, issued May 22, 2001) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Merck's Emend® (aprepitant, used to prevent nausea and vomiting caused by chemotherapy).  View the complaint here.

Schering Corp. v. Mylan Pharmaceuticals Inc.
3:09-cv-00874; filed February 26, 2009 in the District Court of New Jersey

Infringement of U.S. Patent No. 7,405,223 ("Treating Allergic and Inflammatory Conditions," issued July 29, 2008) following a Paragraph IV certification as part of Mylan's amendment of its ANDA to manufacture a generic version of Schering-Plough's Clarinex® (desloratidine, used to treat allergies).  View the complaint here.

AstraZeneca Pharmaceuticals LP et al. v. Sandoz Inc.
3:09-cv-00870; filed February 26, 2009 in the District Court of New Jersey

Infringement of U.S. Patent No. 4,879,288 ("Novel Dibenzothiazepine Antipsychotic," issued November 7, 1989) following a Paragraph IV certification as part of Sandoz's filing of an amendment to its ANDA (adding additional dosage forms) to manufacture a generic version of AstraZeneca's Seroquel® XR (quetiapine fumarate, used to treat schizophrenia and bipolar disorder).  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

MedImmune, LLC v. Sun Pharmaceutical Industries Ltd. et al.
1:09-cv-00452; filed February 24, 2009 in the District Court of Maryland

Infringement of U.S. Patent Nos. 5,424,471 ("Crystalline Amifostine Compositions and Methods of the Preparation and Use of Same," issued June 13, 1995) and 5,591,731 ("Crystalline Amifostine Compositions," issued January 7, 1997) based on defendants' manufacture and sale of a generic version of MedImmune's Ethyol® (amifostine, used to treat xerostomia in patients receiving radiation therapy for head and neck cancer).  View the complaint here.

Anticancer, Inc. v. Cambridge Research & Instrumentation, Inc. et al.
3:09-cv-00351; filed February 23, 2009 in the Southern District of California

Infringement of U.S. Patent Nos. 6,251,384 ("Metastasis Models Using Green Fluorescent Protein (GFP) As a Marker, issued June 26, 2001), 6,759,038 (same title, issued July 6, 2004), and 6,649,159 ("Whole-body Optical Imaging of Gene Expression and Uses Thereof," issued November 18, 2003) based on CRI's manufacture and sale of its Maestro and Nuance imaging products.  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Millennium Pharmaceuticals Inc. et al. v. Teva Parenteral Medicines Inc. et al.
1:09-cv-00105; filed February 18, 2009 in the District Court of Delaware

Infringement of U.S. Patent No. 5,807,825 ("Platelet Aggregation Inhibitors," issued September 15, 1998), licensed to Schering Corp., following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Schering-Plough's Integrilin® (eptifibatide injection, used to treat acute coronary syndrome).  View the complaint here.

Kabushiki Kaisha Hayashibara Seibutsu Kaguku Kenkyujo v. Doll
1:09-cv-00308; filed February 17, 2009 in the District Court of the District of Columbia

Review and correction of the patent term adjustment calculation made by the USPTO for U.S. Patent No. 7,414,038 ("Embolic Materials," issued August 19, 2008).  View the complaint here.

Phylonix Pharmaceuticals, Inc. v. Zygogen, LLC
1:09-cv-10220; filed February 13, 2009 in the District Court of Massachusetts

Infringement of U.S. Patent Nos. 6,656,449 ("Methods of Screening Agents For Activity Using Teleosts," issued December 2, 2003), 7,041,276 (same title, issued May 9, 2006), and 7,482,507 (same title, issued January 27, 2009) based on Zygogen's manufacture and sale of its Z-Tag Angiogenesis Assay and related compound screening services.  View the complaint here.

Intema Ltd. v. NTD Laboratories, Inc. et al.
2:09-cv-00633; filed February 13, 2009 in the Eastern District of New York

Infringement of U.S. Patent No. 6,573,103 ("Antenatal Screening for Down's Syndrome," issued June 3, 2003) based on Perkin Elmer's marketing of its Modified Sequential Screening protocol.  View the complaint here.

Astrazeneca Pharmaceuticals LP et al. v. Accord Healthcare, Inc. et al.
3:09-cv-00619; filed February 10, 2009 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 4,879,288 ("Novel Dibenzothiazepine Antipsychotic," issued November 7, 1989) and 5,948,437 ("Pharmaceutical Compositions Using Thiazepine," issued September 7, 1999) following a Paragraph IV certification as part of Accord's filing of an amendment to its ANDA (adding additional dosage forms) to manufacture a generic version of AstraZeneca's Seroquel® XR (quetiapine fumarate, used to treat schizophrenia and bipolar disorder).  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Monsanto Co. et al. v. Schroeder et al.
2:09-cv-10460; filed February 6, 2009 in the Eastern District of Michigan

Infringement of U.S. Patent Nos. 5,352,605 ("Chimeric Genes for Transforming Plant Cells Using Viral Promoters," issued October 4, 1994) and RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on defendants' use of soybean seed produced from earlier planted Roundup Ready® soybean seed.  View the complaint here.

PerkinElmer, Inc. et al. v. Intema Ltd.
1:09-cv-10176; filed February 5, 2009 in the District Court of Massachusetts

Declaratory judgment of invalidity and non-infringement of U.S. Patent No. 6,573,103 ("Antenatal Screening for Down's Syndrome," issued June 3, 2003) based on Perkin Elmer's marketing of its Modified Sequential Screening protocol.  View the complaint here.

Court Report

    By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring.

Boehringer Ingelheim Vetmedica Inc. v. Merial Ltd. et al.
3:09-cv-00212; filed February 4, 2009 in the District Court of Connecticut

Declaratory judgment of license to practice, non-infringement and invalidity of U.S. Patent No. 6,224,882 ("Insect Cells or Fraction as Adjuvant for Antigens," issued May 1, 2001) based on Boehringer's manufacture and sale of its CircoFLEX® products (porcine circovirus vaccines).  View the complaint here.

Monsanto Co. et al. v. Jones
3:09-cv-00093; filed February 3, 2009 in the Southern District of Illinois

Monsanto Co. et al. v. Collins
4:09-cv-00195; filed February 3, 2009 in the Eastern District of Missouri

Monsanto Co. et al. v. Pool
4:09-cv-00185; filed February 2, 2009 in the Eastern District of Missouri

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,352,605 ("Chimeric Genes for Transforming Plant Cells Using Viral Promoters," issued October 4, 1994) and RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on defendants' use of soybean seed produced from earlier planted Roundup Ready® soybean seed.  View the Jones complaint here.

Alcon Research, Ltd. et al. v. Apotex Inc. et al.
1:09-cv-00102; filed February 2, 2009 in the Southern District of Indiana

Infringement of U.S. Patent Nos. 5,641,805 ("Topical Ophthalmic Formulations for Treating Allergic Eye Diseases," issued June 24, 1997), 6,995,186 ("Olopatadine Formulations for Topical Administration," issued on February 7, 2006), and 7,402,609 (same title, issued July 22, 2008) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Alcon's Pataday® (olopatadine hydrochloride ophthalmic solution, used to treat ocular itching associated with allergic conjunctivitis).  View the complaint here.

Alcon Research, Ltd. et al. v. Sandoz Inc.
1:09-cv-00103; filed February 2, 2009 in the Southern District of Indiana

Infringement of U.S. Patent Nos. 5,641,805 ("Topical Ophthalmic Formulations for Treating Allergic Eye Diseases," issued June 24, 1997) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Alcon's Patanol® (olopatadine hydrochloride ophthalmic solution, used to treat ocular itching associated with allergic conjunctivitis).  View the complaint here.

Cephalon Inc. et al. v. Barr Pharmaceuticals Inc. et al.
1:09-cv-00074; filed January 30, 2009 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,200,604 ("Sublingual Buccal Effervescent," issued March 13, 2001) and 6,974,590 (same title, issued December 13, 2005) following a Paragraph IV certification as part of Barr's filing of an amendment to its ANDA (adding additional dosage forms) to manufacture a generic version of Cephalon's Fentora® (fentanyl citrate buccal tablets, used to treat breakthrough pain in adult patients with cancer).  View the complaint here.

Warner Chilcott Laboratories Ireland Ltd. et al. v. Actavis Elizabeth LLC et al.
2:09-cv-00469; filed January 30, 2009 in the District Court of New Jersey

Infringement of U.S. Patent No. 6,958,161 ("Modified Release Coated Drug Preparation," issued October 25, 2005) following a Paragraph IV certification as part of Actavis Elizabeths' filing of an ANDA to manufacture a generic version of Warner Chilcott's Doryx® (modified release doxycycline hyclate, used for adjunctive treatment of severe acne).  View the complaint here.

Eli Lilly & Co. v. Invagen Pharmaceuticals, Inc.
2:09-cv-00392; filed January 29, 2009 in the Eastern District of New York

Infringement of U.S. Patent Nos. 6,458,811 ("Benzothiophenes Formulations Containing Same and Methods," issued October 1, 2002), 6,797,719 (same title, issued September 28, 2004), and 6,894,064 (same title, issued May 17, 2005) following a Paragraph IV certification as part of Invagen's filing of an ANDA to manufacture a generic version of Lilly's Evista® (raloxifene, used for the prevention and treatment of osteoporosis in postmenopausal women and for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk of invasive breast cancer).  View the complaint here.

Boehringer Ingelheim International GmBH et al. v. Mylan Pharmeceuticals Inc. et al.
2:09-cv-00366; filed January 26, 2009 in the District Court of New Jersey

Infringement of U.S. Patent No. 4,886,812 ("Tetrahydro-Benzthiazoles, the Preparation Thereof and Their Use as Intermediate Products or as Pharmaceuticals," issued December 12, 1989) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Boehringer's Mirapex® (pramipexole dihydrochloride, used for the treatment of the signs and symptoms of idiopathic Parkinson's disease).  View the complaint here.