Patent Docs

Court Report

By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Purdue Pharma L.P. et al. v. Sandoz Inc.
1:12-cv-00897; filed February 3, 2012 in the Southern District of New York

• Plaintiffs:  Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P., Rhodes Technologies, Board of Regents of the University of Texas Systems, Grunenthal GMBH
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent Nos. 6,488,963 ("Hot-Melt Extrudable Pharmaceutical Formulation," issued December 3, 2002), 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), 7,683,072 (same title, issued March 23, 2010), and 7,776,314 ("Abuse-Proofed Dosage System," issued August 17, 2010) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.

Shire LLC et al. v. Mylan Pharmaceuticals, Inc. et al.
2:12-cv-00638; filed February 2, 2012 in the District Court of New Jersey

• Plaintiffs:  Shire LLC; Shire Development Inc.
• Defendants:  Mylan Pharmaceuticals, Inc.; Mylan Inc.; Johnson Matthey Pharmaceutical Materials; Johnson Matthey Inc.

Infringement of U.S. Patent Nos. Nos. 7,105,486 ("Abuse-resistant Amphetamine Compounds," issued September 12, 2006), 7,223,735 ("Abuse Resistant Lysine Amphetamine Compounds," issued  May 29, 2007), 7,655,630 ("Abuse-Resistant Amphetamine Prodrugs," issued February 2, 2010), 7,659,253 (same title, issued February 9, 2010), 7,659,254 (same title, issued February 9, 2010), 7,662,787 ("Abuse Resistant Lysine Amphetamine Compounds," issued February 16, 2010), 7,671,030 ("Abuse-Resistant Amphetamine Prodrugs," issued on March 2, 2010), 7,671,031 (same title, issued on March 2, 2010), 7,674,774 (same title, issued on March 9, 2010), 7,678,770 (same title, issued on March 16, 2010), 7,678,771 (same title, issued on March 16, 2010), 7,687,466 (same title, issued on March 30, 2010), 7,687,467 (same title, issued on March 30, 2010), 7,718,619 (same title, issued on May 18, 2010), and 7,723,305 (same title, issued on May 25, 2010) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Shire's Vyvanse® (lisdexamfetamine dimesylate, used to treat Attention Deficit Hyperactivty 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.

Abbott Laboratories et al. v. Sandoz Inc.
1:12-cv-00103; filed January 30, 2012 in the District Court of Delaware

• Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent Nos. 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000) and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Sandoz's filing of an amended ANDA to manufacture a generic version of Abbott's Simcor® (niacin extended release / simvastatin tablets, used to treat hypercholesterolemia).  View the complaint here.

Enzo Life Sciences Inc. v. Gen-Probe Inc.
1:12-cv-00104; filed January 30, 2012 in the District Court of Delaware

Enzo Life Sciences Inc. v. Life Technologies Corp.
1:12-cv-00105; filed January 30, 2012 in the District Court of Delaware

Enzo Life Sciences Inc. v. Roche Molecular Systems Inc. et al.
1:12-cv-00106; filed January 30, 2012 in the District Court of Delaware

• Plaintiff:  Enzo Life Sciences Inc.
• Defendants:  Roche Molecular Systems Inc.; Roche Diagnostics Corp.; Roche Diagnostics Operations Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,922,180 ("Oligo- Or Polynucleotides Comprising Phosphate-Moiety Labeled Nucleotides," issued January 31, 2006) based on defendants' manufacture and sale of certain nucleic acid probe products.  View the Gen-Probe complaint here.

Bayer Healthcare LLC v. Pfizer Inc.
1:12-cv-00630; filed January 30, 2012 in the Northern District of Illinois

Infringement of U.S. Patent No. 5,756,506 ("Single High Dose Fluoroquinolone Treatment" issued May 26, 1998) based on Pfizer's planned launch of ADVOCIN™ (single high dose fluoroquinolone, used to treat bovine respiratory disease).  View the complaint here.

Takeda Pharmaceutical Co., Ltd. et al v. Sandoz, Inc.
5:12-cv-00446; filed January 27, 2012 in the Northern District of California

• Plaintiffs:  Takeda Pharmaceutical Co., Ltd.; Takeda Pharmaceuticals U.S.A., Inc.; Takeda Pharmaceuticals LLC; Takeda Pharmaceuticals America, Inc.
• Defendant:  Sandoz, Inc.

Infringement of U.S. Patent Nos. 6,462,058 ("Benzimidazole Compound Crystal," issued October 8, 2002), 6,664,276 (same title, issued December 16, 2003), 6,939,971 (same title, issued September 6, 2005), 7,285,668 ("Process for the Crystallization of (R)- or (S)-Lansoprazole," issued October 23, 2007), and 7,790,755 ("Controlled Release Preparation," issued September 7, 2010) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Takeda's Dexilant® (dexlansoprazole, used for the treatment of all grades of erosive esophagitis, maintaining healing of esophagitis, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease).  View the complaint here.

Allergan, Inc. v. Hi-Tech Pharmacal Co.
6:12-cv-00043; filed January 27, 2012 in the Eastern District of Texas

Infringement of U.S. Patent No. 7,851,504 ("Enhanced Bimatoprost Ophthalmic Solution," issued December 14, 2010) following a Paragraph IV certification as part of Hi-Tech's filing of an ANDA to manufacture a generic version of Allergan's Lumigan® (0.01% bimatoprost ophthalmic solution, used to treat lower intraocular eye pressure in people with open-angle glaucoma or ocular hypertension).  View the complaint here.

Exelixis, Inc. v. Kappos
1:12-cv-00096; filed January 27, 2012 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,989,622 ("Phosphatidylinositol 3-kinase Inhibitors and Methods of Their Use," issued August 2, 2011).  View the complaint here.

Valeant International (Barbados) SRL et al. v. Spear Pharmaceuticals, Inc.
2:12-cv-00043; filed January 26, 2012 in the Middle District of Florida

• Plaintiffs:  Valeant International (Barbados) SRL; A.P. Pharma, Inc.
• Defendant:  Spear Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 6,670,335 ("Fluorouracil-Containing Formulation," issued December 30, 2003) following a Paragraph IV certification as part of Spear's filing of an ANDA to manufacture a generic version of Valeant's Carac® (fluorouracil 0.5% cream, used to treat multiple actinic or solar keratoses of the face and anterior scalp).  View the complaint here.

Astrazeneca AB et al. v. Torrent Pharmaceuticals Ltd. et al.
3:12-cv-00506; filed January 26, 2012 in the District Court of New Jersey

• Plaintiffs:  Astrazeneca AB; Aktiebolaget Hassle; Astrazeneca LP; KBI Inc.; KBI-E Inc.
• Defendants:  Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.

Infringement of U.S. Patent Nos. 5,714,504 ("Compositions," issued February 3, 1988), 5,877,192 ("Method for the Treatment of Gastric Acid-Related Diseases and Production of Medication Using (-)Enantiomer of Omeprazole," issued March 2, 1999), and 6,875,872 ("Compounds," issued April 5, 2005), following a Paragraph IV certification as part of Torrent's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux 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.

Cephalon Inc. v. Mylan Pharmaceuticals Inc. et al.
1:12-cv-00073; filed January 24, 2012 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

Cephalon Inc. v. Sandoz Inc.
1:12-cv-00074; filed January 24, 2012 in the District Court of Delaware

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,092,832 ("Generally Linear Effervescent Oral Fentanyl Dosage Form and Methods of Administering," issued January 10, 2012) in conjunction with Mylan's prior filing of an ANDA 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 Mylan complaint here.

Abbott Laboratories et al. v. Cadila Healthcare Ltd. et al.
1:12-cv-00065; filed January 20, 2012 in the District Court of Delaware

• Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
• Defendants:  Cadila Healthcare Ltd. d/b/a Zydus Cadila; Zydus Pharmaceuticals (USA) Inc.

Infringement of U.S. Patent No. 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 Zydus' filing of an ANDA to manufacture a generic version of Abbott's Niaspan® (niacin extended-release tablets, used to treat hypercholesterolemia).  View the complaint here.

Eli Lilly and Company v. Accord Healthcare, Inc., USA
1:12-cv-00086; filed January 20, 2012 in the Southern District of Indiana

Infringement of U.S. Patent No. 7,772,209 ("Novel Antifolate Combination Therapies," issued August 10, 2010) following a Paragraph IV certification as part of Accord'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.

Spectrum Pharmaceuticals, Inc. et al v. Sandoz Inc.
2:12-cv-00111; filed January 20, 2012 in the District Court of Nevada

• Plaintiffs:  Spectrum Pharmaceuticals, Inc.; University of Strathclyde
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent No. 6,500,829 ("Substantially Pure Diastereoisomers of Tetrahydrofolate Derivatives," issued December 31, 2002) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Spectrum's Fusilev® (levoleucovorin, used to treat advanced metastatic colorectal cancer).  View the complaint here.

Meda Pharmaceuticals Inc. v. Apotex Inc. et al.
3:12-cv-00361; filed January 19, 2012 in the District Court of New Jersey

• Plaintiff:  Meda Pharmaceuticals Inc.
• Defendants:  Apotex Inc.; Apotex Corp.; Perrigo Co.; L. Perrigo Co.; Perrigo Israel Pharmaceutical Ltd.

Infringement of U.S. Patent No. 8,071,073 ("Compositions Comprising Azelastine and Methods of Use Thereof," issued December 6, 2011) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Meda's Astepro® (azelastine hydrochloride nasal spray, used to treat hay fever and allergy symptoms).  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.

Alnylam Pharmaceuticals, Inc. et al. V. Tekmira Pharmaceuticals Corp.
1:12-cv-10087; filed January 17, 2012 in the District Court of Massachusetts

• Plaintiffs:  Alnylam Pharmaceuticals, Inc.; Isis Pharmaceuticals Inc.
• Defendant:  Tekmira Pharmaceuticals Corp.

Infringement of U.S. Patent Nos. 7,695,902 ("Oligoribonucleotides and Ribonucleases for Cleaving RNA," issued April 13, 2010), 6,858,225 ("Lipid-Encapsulated Polyanionic Nucleic Acid," issued February 22, 2005), 6,815,432 ("Methods for Encapsulating Plasmids in Lipid Bilayers," issued November 9, 2004), 6,534,484 (same title, issued March 18, 2003), 6,586,410 ("Lipid-Nucleic Acid Particles Prepared Via Hydrophobic Lipid-Nucleic Acid Complex Intermediate and Use for Gene Transfer," issued July 1, 2003), and 6,858,224 ("Method of Preventing Aggregation of a Lipid: Nucleic Acid Complex," issued February 22, 2005) based on Tekmira's sale and offer to sell in, and importation into, the United States dsRNA formulations comprising SNALP (stable nucleic acid-lipid particles) for use by Bristol-Myers Squibb to use for target validation purposes.  View the complaint here.

Pamlab, L.L.C. et al. v. Viva Pharmaceutical, Inc.
2:12-cv-00098; filed January 17, 2012 in the Western District of Washington

• Plaintiffs:  Pamlab, L.L.C.; Metabolite Laboratories, Inc.; Breckenridge Pharmaceutical, Inc.
• Defendant:  Viva Pharmaceutical, Inc.

Infringement of U.S. Patent No. 6,528,496 ("Compositions Treating, Preventing, or Reducing Elevated Metabolic Levels," issued March 4, 2003) based on Viva's manufacture for sale in the U.S. by Macoven Pharmaceuticals, L.L.C. folic acid products allegedly represented to be substitutable for plaintiffs' Foltx® and/or Folbic® products (vitamin B12, vitamin B6, and folic acid, used to treat hyperhomocysteinemia).  View the complaint here.

Fresenius Medical Care Holdings, Inc. v. Nostrum Laboratories, Inc.
1:12-cv-10083; filed January 13, 2012 in the District Court of Massachusetts

Infringement of U.S. Patent No. 6,576,665 ("Encapsulated Calcium Acetate Caplet and a Method for Inhibiting Gastrointestinal Phosphorous Absorption," issued June 10, 2003) following a Paragraph IV certification as part of Nostrum's filing of an ANDA to manufacture a generic version of Fresenius' PhosLo® GelCaps (calcium acetate, used to treat renal failure).  View the complaint here.

Merck Frosst Canada & Co. et al. v. Teva Pharmaceuticals USA, Inc.
3:12-cv-00210; filed January 11, 2012 in the District Court of New Jersey

• Plaintiffs:  Merck Frosst Canada & Co.; Merck Canada Inc.; Merck Sharp & Dohme Pharmaceuticals
• Defendant:  Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent No. 8,007,830 ("Granule Formation," issued August 30, 2011) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Merck's Singulair® (montelukast sodium, used to treat asthma and allergic rhinitis).  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.

Shire LLC et al. v. Sandoz Inc.
1:12-cv-00040; filed January 6, 2012 in the District Court of Colorado

• Plaintiffs:  Shire LLC; Supernus Pharmaceuticals, Inc.; Shire Development Inc.; Shire International Licensing B.V.; Amy F.T. Arnsten; Pasko Rakic; Robert D. Hunt
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent Nos. 5,854,290 ("Use of Guanfacine in the Treatment of Behavioral Disorders," issued December 19, 1998), 6,287,599 ("Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles," issued September 11, 2001), and 6,811,794 (same title, issued November 2, 2004) based on Sandoz's amendment of its ANDA (adding additional dosage forms) to manufacture a generic version of Shire's Intuniv® (guanfacine, used to treat attention-deficit hyperactivity disorder).  View the complaint here.

Takeda Pharmaceutical Co. et al v. Mylan, Inc. et al.
2:12-cv-00026; filed January 6, 2012 in the Western District of Pennsylvania

• Plaintiffs:  Takeda Pharmaceutical Co.; Takeda Pharmaceuticals North America, Inc.; Takeda Global Research and Development Center, Inc.; Watson Pharmaceuticals, Inc.; Andrx Labs, LLC
• Defendants:  Mylan, Inc.; Mylan Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 5,965,584 ("Pharmaceutical Composition," issued October 12, 1999), 6,166,043 (same title, issued December 26, 2000), 6,172,090 (same title, issued January 9, 2001), 6,099,859 ("Controlled Release Oral Tablet Having a Unitary Core," issued August 8, 2000), 6,495,162 (same title, issued December 17, 2002), 6,790,459 ("Methods for Treating Diabetes Via Administration of Controlled Release Metformin," issued September 14, 2004), 6,866,866 ("Controlled Release Metformin Compositions," issued March 15, 2005), 7,785,627 ("Pharmaceutical Formulation Containing a Biguanide and a Thiazolidinedione Derivative," issued August 31, 2010), 7,919,116 ("Controlled Release Metformin Composition," issued April 5, 2011), and 7,959,946 ("Pharmaceutical Formulation Containing a Biguanide and a Thiazolidinedione Derivative," issued June 14, 2011) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Takeda's ACTOplus met® XR (pioglitazone and metformin, used an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes).  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.

Takeda Pharmaceutical Co. et al. v. Mylan, Inc. et al.
1:12-cv-00024; filed January 3, 2011 in the Southern District of New York

• Plaintiffs:  Takeda Pharmaceutical Co.; Takeda Pharmaceuticals North America, Inc.; Takeda Global Research and Development Center, Inc.; Watson Pharmaceuticals, Inc.; Andrx Labs, LLC
• Defendants:  Mylan, Inc.; Mylan Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 5,965,584 ("Pharmaceutical Composition," issued October 12, 1999), 6,166,043 (same title, issued December 26, 2000), 6,172,090 (same title, issued January 9, 2001), 6,099,859 ("Controlled Release Oral Tablet Having a Unitary Core," issued August 8, 2000), 6,495,162 (same title, issued December 17, 2002), 6,790,459 ("Methods for Treating Diabetes Via Administration of Controlled Release Metformin," issued September 14, 2004), 6,866,866 ("Controlled Release Metformin Compositions," issued March 15, 2005), 7,785,627 ("Pharmaceutical Formulation Containing a Biguanide and a Thiazolidinedione Derivative," issued August 31, 2010), 7,919,116 ("Controlled Release Metformin Composition," issued April 5, 2011), and 7,959,946 ("Pharmaceutical Formulation Containing a Biguanide and a Thiazolidinedione Derivative," issued June 14, 2011) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Takeda's ACTOplus met® (pioglitazone and metformin, used an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes).  View the complaint here.

Allergan, Inc. v. Lupin Ltd. et al.
2:11-cv-00530; filed December 30, 2011 in the Eastern District of Texas

• Plaintiff:  Allergan, Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 8,008,338 (""Ketorolac Tromethamine Compositions for Treating or Preventing Ocular Pain," issued August 30, 2011) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Allergan's Acular LS® (ketorolac tromethamine ophthalmic solution, 0.4%, used for the reduction of ocular pain and burning/stinging following corneal refractive surgery).   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.

Synbias Pharma v. Solux Corp.
3:11-cv-03035; filed December 29, 2011 in the Southern District of California

Declaratory judgment of non-infringement, invalidity, and unenforceability of U.S. Patent Nos. 7,485,707 ("Thermally Stable Crystalline Epirubicin Hydrochloride and Method of Making The Same," issued February 3, 2009), 7,388,083 ("Epimerization of 4'-C Bond and Modification of 14-CH3-(CO)-Fragment in Anthracyclin Antibiotics," issued June 17, 2008) and 7,053,191 ("Method of Preparing 4-R-Substituted 4-Demethoxydaunorubicin," issued May 30, 2006) relating to Synbias' manufacture and sale of epirubicin hydrochloride and idarubicin hydrochloride (anthracycline antibiotics, used in cancer chemotherapy).  View the complaint here.

Merck Frosst Canada & Co. et al. v. Mylan Pharmaceuticals Inc.
3:11-cv-07569; filed December 29, 2011 in the District Court of New Jersey

• Plaintiffs:  Merck Frosst Canada & Co.; Merck Canada Inc.; Merck Sharp & Dohme Pharmaceuticals
• Defendant:  Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent No. 8,007,830 ("Granule Formation," issued August 30, 2011) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Merck's Singulair® (montelukast sodium, used to treat asthma and allergic rhinitis).  View the complaint here.

Fidopharm Inc. v. Merial Ltd.
1:11-cv-01285; filed December 27, 2011 in the District Court of Delaware

Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 6,096,329 ("Insecticidal Combination to Control Mammal Fleas, in Particular Fleas on Cats and Dogs," issued August 1, 2000) based on Plaintiffs' anticipated sale of its new fipronil-based animal health products.  View the complaint here.

GlaxoSmithKline Intellectual Property Management Ltd. et al. v. Sandoz Inc.
1:11-cv-01284; filed December 23, 2011 in the District Court of Delaware

• Plaintiffs:  GlaxoSmithKline LLC; GlaxoSmithKline Intellectual Property Management Ltd.
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent Nos. 6,858,596 ("Formulation Containing Anti-Inflammatory Androstane Derivative," issued February 22, 2005), 7,101,866 ("Anti-Inflammatory Androstane Derivative," issued September 5, 2006), and 7,541,350 (("Formulation Containing Anti-Inflammatory Androstane Derivative," issued June 2, 2009) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of GSK's Veramyst® (fluticasone furoate nasal spray, used to treat allergic rhinitis and perennial nonallergic rhinitis).  View the complaint here.

Genentech, Inc. v. Regeneron Pharmaceuticals, Inc. et al.
7:11-cv-09463; filed December 23, 2011 in the Southern District of New York

• Plaintiff:  Genentech, Inc.
• Defendants:  Regeneron Pharmaceuticals, Inc.; Sanofi-Aventis U.S. LLC; Sanofi-Aventis U.S. Inc.; Sanofi-Aventis Amerique Du Nord S.N.C.; Sanofi

Infringement of U.S. Patent Nos. 6,100,071 ("Receptors as Novel Inhibitors of Vascular Endothelial Growth Factor Activity and Processes for Their Production," issued August 8, 2000), 6,383,486 ("Inhibitors of Vascular Endothelial Growth Factor Activity, Their Uses and Processes for Their Production," issued May 7, 2002), 6,897,294 (same title, issued May 24, 2005), and 7,771,721 ("Methods for Using Chimeric Vascular Endothelial Growth Factor Receptor Proteins," issued August 10, 2010) based on Regeneron's manufacture, use, and intended sale of, and filing of a Biologics License Application for, its Zaltrap® product (aflibercept, used to treat cancer).  View the complaint here.

Santarus, Inc. et al. v. Zydus Pharmaceuticals (USA) Inc.
3:11-cv-07441; filed December 21, 2011 in the District Court of New Jersey

• Plaintiffs:  Santarus, Inc.; The Curators of the University of Missouri
• Defendant:  Zydus Pharmaceuticals (USA) Inc.

Infringement of U.S. Patent Nos. 6,699,885 ("Substituted Benzimidazole Dosage Forms and Methods of Using Same," issued March 2, 2004), 6,489,346 (same title, issued December 3, 2002), 6,645,988 (same title, issue November 11, 2003), and 7,399,772 (same title, issued July 15, 2008) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Santarus' Zegerid® (omeprazole/sodium bicarbonate, used to treat heartburn and other symptoms associated with gastroesophageal reflux 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.

Allergan Inc. v. Akorn Inc. et al.
1:11-cv-01270; filed December 21, 2011 in the District Court of Delaware

• Plaintiff:  Allergan Inc.
• Defendants:  Akorn Inc.; Akorn Ophthalmics Inc.

Infringement of U.S. Patent No. 7,842,714 ("Ketorolac Tromethamine Compositions for Treating Ocular Pain," issued November 30, 2010) following a Paragraph IV certification as part of Akorn's filing of an ANDA to manufacture a generic version of Allergan's Acuvail® (ketorolac tromethamine ophthalmic solution, used to treat pain and inflammation following cataract surgery).  View the complaint here.

MSD Consumer Products, Inc. et al. v. Zydus Pharmaceuticals (USA) Inc.
3:11-cv-07437; filed December 21, 2011 in the District Court of New Jersey

• Plaintiffs:  MSD Consumer Products, Inc.; Santarus, Inc.; Curators of the University of Missouri
• Defendants:  Zydus Pharmaceuticals (USA) Inc.

Infringement of U.S. Patent Nos. 6,699,885 ("Substituted Benzimidazole Dosage Forms and Methods of Using Same," issued March 2, 2004), 6,489,346 (same title, issued December 3, 2002), 6,645,988 (same title, issue November 11, 2003), and 7,399,772 (same title, issued July 15, 2008) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of MSD's Zegerid® OTC (omeprazole/sodium bicarbonate, used to treat heartburn and other symptoms associated with gastroesophageal reflux disease).  View the complaint here.

Roche Palo Alto LLC et al. v. Dr. Reddy's Laboratories Ltd. et al.
1:11-cv-01264; filed December 20, 2011 in the District Court of Delaware

• Plaintiffs:  Roche Palo Alto LLC; Genentech Inc.
• Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

Infringement of U.S. Patent No. 6,083,953 ("2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-1,3-propanediol Derivative," issued July 4, 2000) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Roche's Valcyte® (valganciclovir hydrochloride, used to treat cytomegalovirus retinitis and cytomegalovirus disease).  View the complaint here.

Pfizer Inc. et al. v. Sandoz Inc.
1:11-cv-01252; filed December 15, 2011 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.
• Defendant:  Sandoz Inc.

Pfizer Inc. et al. v. Intas Pharmaceuticals Ltd. et al.
1:11-cv-01253; filed December 15, 2011 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.
• Defendants:  Intas Pharmaceuticals Ltd.; Astron Research Ltd.; Accord Healthcare Ltd.; Accord Healthcare Inc. USA

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,362,718 ("Rapamycin Hydroxyesters," issued November 8, 1994) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Pfizer's Torisel® (temsirolimus injection, used to treat advanced renal cell carcinoma).  View the Sandoz complaint here.

Court Report

By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Shire LLC et al. v. Mylan Pharmaceuticals Inc. et al.
1:11-cv-00201; filed December 15, 2011 in the Northern District of West Virginia

• Plaintiffs:  Shire LLC; Supernus Pharmaceuticals, Inc.; Shire Development Inc.; Shire International Licensing B. V.; Amy F. T. Arnsten, Ph.D.; Robert D. Hunt, M.D.; Pasko Rakic, M.D.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan, Inc.

Infringement of U.S. Patent Nos. 5,854,290 ("Use of Guanfacine in the Treatment of Behavioral Disorders," issued December 19, 1998), 6,287,599 ("Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles," issued September 11, 2001), and 6,811,794 (same title, issued November 2, 2004) based on Mylan's filing of an ANDA to manufacture a generic version of Shire's Intuniv® (guanfacine, used to treat attention-deficit hyperactivity disorder).  View the complaint here.

Cephalon, Inc. et al. v. Celgene Corp. et al.
1:11-cv-12226; filed December 14, 2011 in the District Court of Massachusetts

• Plaintiffs:  Cephalon, Inc.; Acusphere, Inc.
• Defendants:  Celgene Corp.; Abraxis Bioscience, Inc.; Abraxis Bioscience, LLC

Infringement of U.S. Patent No. RE40,493 (""Porous Paclitaxel Matrices and Methods of Manufacture Thereof," reissued September 9, 2008) based on Celgene's manufacture and sale of its Abraxane® product (paclitaxel protein-bound particles for injectable suspension; used for the treatment of breast cancer).  View the complaint here.

Janssen Pharmaceuticals, Inc. et al. v. Sandoz, Inc.
3:11-cv-07247; filed December 13, 2011 in the District Court of New Jersey

• Plaintiffs:  Janssen Pharmaceuticals, Inc.; Peninsula Pharmaceuticals, Inc.; Shionogi & Co. Ltd.
• Defendant:  Sandoz, Inc.

Infringement of U.S. Patent No. 5,317,016 ("Pyrrolidylthiocarbapenem Derivative," issued May 31, 1994) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Janssen's Doribax® (doripenem injecction, used to treat complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis).  View the complaint here.

Warner Chilcott Co., LLC v. Lupin Ltd. et al.
3:11-cv-07228; filed December 12, 2011 in the District Court of New Jersey

• Plaintiff:  Warner Chilcott Co., LLC
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 6,667,050 ("Chewable Oral Contraceptive, " issued December 23, 2003) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Warner Chilcott's Generess^TM Fe (norethindrone and ethinyl estradiol, used for oral contraception).  View the complaint here.

Alza Corp. v. Mylan Pharmaceuticals Inc. et al.
2:11-cv-07158; filed December 9, 2011 in the District Court of New Jersey

• Plaintiff:  Alza Corp.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

Infringement of U.S. Patent No. 5,591,454 ("Method For Lowering Blood Glucose," issued January 7, 1997), licensed to Pfizer, following a Paragraph IV certification as part of Mylan's filing of an amendment to its ANDA  (adding additional dosage forms) to manufacture a generic version of Pfizer's Glucotrol XL® (glipizide extended release tablets, used to improve glycemic control in adults with type 2 diabetes mellitus).  View the complaint here.

PAMLAB, L.L.C. et al. v. Macoven Pharmaceuticals, L.L.C.
1:11-cv-09022; filed December 9, 2011 in the Southern District of New York

• Plaintiffs:  PAMLAB, L.L.C.; Metabolite Laboratories, Inc.; Breckenridge Pharmaceutical, Inc.
• Defendant:  Macoven Pharmaceuticals, L.L.C.

Infringement of U.S. Patent No. 6,528,496 ("Compositions Treating, Preventing, or Reducing Elevated Metabolic Levels," issued March 4, 2003) based on Macoven's manufacture, sale, and offer for sale of folic acid products allegedly represented to be substitutable for plaintiffs' Foltx® and/or Folbic® products (vitamin B12, vitamin B6, and folic acid, used to treat hyperhomocysteinemia).  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.

Pfizer Inc. et al. v. Alembic Ltd. et al.
1:11-cv-01213; filed December 7, 2011 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Warner-Lambert Co. LLC; C P Pharmaceuticals International CV; Northwestern University
• Defendants:  Alembic Ltd.; Alembic Pharmaceuticals Ltd.

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 Alembic's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia).  View the complaint here.

Abbott Laboratories et al. v. Sun Pharmaceutical Industries Ltd. et al.
1:11-cv-01190; filed December 2, 2011 in the District Court of Delaware

• Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
• Defendants:  Sun Pharmaceutical Industries Ltd.; Sun Pharma Global FZE

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), 6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia," issued November 16, 2004), and 7,011,848 ("Hydrophobic Component Free Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued March 14, 2006) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Abbott's Niaspan® (niacin extended-release tablets, used to treat hypercholesterolemia).  View the complaint here.

Alkermes Pharma Ireland Ltd. et al. v. Wockhardt, Ltd. et al.
2:11-cv-07047; filed December 2, 2011 in the District Court of New Jersey

• Plaintiffs:  Alkermes Pharma Ireland Ltd.; Fournier Laboratories Ireland Ltd.
• Defendants:  Wockhardt, Ltd.; Wockhardt USA, LLC

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 Wockhardt'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.

Abbott Laboratories et al. v. Wockhardt, Ltd. et al.
2:11-cv-07046; filed December 2, 2011 in the District Court of New Jersey

• Plaintiffs:  Abbott Laboratories; Laboratories Fournier S.A.
• Defendants:  Wockhardt, Ltd.; Wockhardt USA, LLC

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 Wockhardt'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.

Celgene Corp. et al. v. Teva Pharmaceuticals USA, Inc.
2:11-cv-07064; filed December 2, 2011 in the District Court of New Jersey

• Plaintiffs:  Celgene Corp.; Novartis Pharmaceuticals Corp.; Novartis Pharma AG
• Defendants:  Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), 6,635,284 (same title, issued October 21, 2003), and 7,431,944 ("Delivery of Multiple Doses of Medications," issued October 7, 2008) all licensed exclusively to Novartis in certain fields of use, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Alkermes Pharma Ireland Ltd. v. Teva Pharmaceuticals USA Inc.
1:11-cv-01186; filed December 1, 2011 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Senju Pharmaceutical Co. Ltd. et al. v. Apotex Inc. et al.
1:11-cv-01171; filed November 28, 2011 in the District Court of Delaware

• Plaintiffs:  Senju Pharmaceutical Co. Ltd.; Kyorin Pharmaceutical Co. Ltd.; Allergan Inc.
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent No. 6,333,045 ("Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin," issued December 25, 2001), licensed to Allergan, in relation to Apotex's ANDA to manufacture a generic version of Allergan's Zymaxid® (gatifloxacin ophthalmic solution, used to treat bacterial conjunctivitis).  View the complaint here.

Warner Chilcott Co., LLC et al. v. Teva Pharmaceuticals USA, Inc. et al.
2:11-cv-06936; filed November 22, 2011 in the District Court of New Jersey

• Plaintiffs:  Warner Chilcott Co., LLC; Warner Chilcott(US), LLC
• Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. 7,645,459 ("Dosage Forms of Bisphosphonates," issued January 12, 2010) and 7,645,460 ("Dosage Forms of Risedronate" issued January 12, 2010) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Warner Chilcott's Atelvia^TM (risedronate sodium delayed-release, used to treat osteoporosis in women after menopause).  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.

Ferring B.V. v. Watson Pharmaceuticals, Inc. et al.
3:11-cv-00853; filed November 25, 2011 in the District Court of Nevada

• Plaintiff:  Ferring B.V.
• Defendants:  Watson Pharmaceuticals, Inc.; Watson Laboratories, Inc.; Watson Laboratories, Inc. – Florida; Watson Pharma, Inc.

Ferring B.V. v. Apotex, Inc. et al.
3:11-cv-00854; filed November 25, 2011 in the District Court of Nevada

• Plaintiff:  Ferring B.V.
• Defendants:  Apotex, Inc.; Apotex Corp.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,022,106 ("Tranexamic Acid Formulations," issued September 20, 2011) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Ferring's Lysteda® (tranexamic acid, used to treat heavy menstrual bleeding).  View the Watson complaint here.

AntiCancer, Inc. v. Leica Microsystems, Inc. et al.
3:11-cv-02756; filed November 23, 2011 in the Southern District of California

• Plaintiff:  AntiCancer, Inc.
• Defendants:  Leica Microsystems, Inc.; DOES 1-10, inclusive

Infringement of U.S. Patent No. 6,649,159 ("Whole-body Optical Imaging of Gene Expression and Uses Thereof," issued November 18, 2003) based on Leica's use, manufacture and sale of its FCM1000 device.  View the complaint here.

Bristol-Myers Squibb Co. v. Apotex, Inc. et al.
3:11-cv-06918; filed November 23, 2011 in the District Court of New Jersey

• Plaintiff:  Bristol-Myers Squibb Co.
• Defendants:  Apotex, Inc.; Apotex Corp.

Infringement of U.S. Patent Nos. 6,596,746 ("Cyclic Protein Tyrosine Kinase Inhibitors," issued July 22, 2003), 7,125,875 (same title, issued October 24, 2006), 7,153,856 (same title, issued December 26, 2006), and 7,491,725 ("Process For Preparing 2-Aminothiazole-5-Aromatic Carboxamides As Kinase Inhibitors" duly and legally issued on February 17, 2009) following a Paragraph IV certification as part of Apotex's filing of a second ANDA to manufacture additional dosage forms of a generic version of Bristol-Myers' Sprycel® (dasatinib, used to treat adults chronic myeloid leukemia).  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.

Medicines Co. v. Sun Pharma Global FZE et al.
2:11-cv-15175; filed November 23, 2011 in the Eastern District of Michigan

• Plaintiff:  Medicines Co.
• Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.; Sun Pharmaceutical Industries Inc.; Caraco Pharmaceutical Laboratories, Ltd.

Medicines Co. v. Sun Pharma Global FZE et al.
3:11-cv-06819; filed November 19, 2011 in the District Court of New Jersey

• Plaintiff:  Medicines Co.
• Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries Ltd.; Sun Pharmaceutical Industries Inc.; Caraco Pharmaceutical Laboratories, Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 7,582,727 ("Pharmaceutical Formulations of Bivalirudin and Process of Making the Same," issued September 1, 2009) and 7,598,343 (same title, issued October 6, 2009) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of The Medicines Company's Angiomax® (bivalirudin, used as an anticoagulant in patients with unstable angina undergoing percutaneous translurninal coronary angioplasty).  View the New Jersey complaint here.

Warner Chilcott Co. LLC v. Mylan Inc. et al.
3:11-cv-06844; filed November 22, 2011 in the District Court of New Jersey

• Plaintiff:  Warner Chilcott Co.
• Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.; Famy Care Ltd.

Infringement of U.S. Patent No. 6,667,050 ("Chewable Oral Contraceptive, " issued December 23, 2003) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Warner Chilcott's Generess^TM Fe (norethindrone and ethinyl estradiol, used for oral contraception).  View the complaint here.

Cephalon Inc. et al. v. Impax Laboratories Inc.
1:11-cv-01152; filed November 18, 2011 in the District Court of Delaware

• Plaintiffs:  Cephalon Inc.; CIMA Labs Inc.
• Defendant:  Impax Laboratories Inc.

Infringement of U.S. Patent Nos. 6,200,604 ("Sublingual Buccal Effervescent," issued March 13, 2001), 6,974,590 (same title, issued December 13, 2005), 7,862,832 ("Generally Linear Effervescent Oral Fentanyl Dosage Form and Methods of Administering," issued January 4, 2011) and 7,862,833 ("Effervescent Oral Opiate Dosage Forms and Methods of Administering Opioids," issued January 4, 2011) following a Paragraph IV certification as part of Impax's filing of an ANDA 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.

Yeda Research and Development Co., Ltd. v. Kappos
1:11-cv-01272; filed November 18, 2011 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,947,672 ("Water-Soluble Anionic Bacteriochlorophyll Derivatives and Their Uses," issued May 24, 2011).  View the complaint here.

Takeda Pharmaceutical Co. et al. v. Hetero Drugs Ltd. et al.
1:11-cv-08302; filed November 16, 2011 in the Southern District of New York

• Plaintiffs:  Takeda Pharmaceutical Co.; Takeda Pharmaceuticals North America, Inc.
• Defendants:  Hetero Drugs Ltd.; Hetero Labs Ltd. Unit V; Hetero USA Inc.; Camber Pharmaceuticals Inc.; Invagen Pharmaceuticals Inc.

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 Hetero's filing of an ANDA to manufacture a generic version of Takeda's Actos® (pioglitazone hydrochloride, used to treat type II diabetes).  View the complaint here.

Aventis Pharma S.A. et al. v. Strides Inc. et al.
1:11-cv-01121; filed November 14, 2011 in the District Court of Delaware

• Plaintiffs:  Aventis Pharma S.A.; Sanofi-Aventis US LLC
• Defendants:  Strides Inc.; Onco Therapies Ltd.

Infringement of U.S. Patent Nos. 5,714,512 ("Compositions Containing Taxane Derivatives," issued February 3, 1998) and 5,750,561 (same title, issued May 12, 1998) following a Paragraph IV certification as part of Strides' filing of an ANDA to manufacture a generic version of Aventis' Taxotere® (docetaxel, used to treat breast, lung, prostate, gastric, and head and neck cancers).  View the complaint here.

Alkermes Pharma Ireland Ltd. v. Par Pharmaceutical Inc.
1:11-cv-01119; filed November 11, 2011 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Allergan, Inc. v. Lupin Ltd. et al.
6:11-cv-00611; filed November 11, 2011 in the Eastern District of Texas

• Plaintiff:  Allergan, Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 7,851,504 ("Enhanced Bimatoprost Ophthalmic Solution," issued December 14, 2010) following a Paragraph IV certification as part of Lupin'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.

Celgene Corp. et al. v. Par Pharmaceutical, Inc.
2:11-cv-06640; filed November 10, 2011 in the District Court of New Jersey

• Plaintiffs:  Celgene Corp.; Novartis Pharmaceuticals Corp.; Novartis Pharma AG
• Defendant:  Par Pharmaceutical, Inc.

Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), 6,635,284 (same title, issued October 21, 2003), and 7,431,944 ("Delivery of Multiple Doses of Medications," issued October 7, 2008) all licensed exclusively to Novartis in certain fields of use, following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Novartis Pharmaceuticals Corp. et al. v. Watson Laboratories, Inc. et al.
1:11-cv-08130; filed November 10, 2011 in the Southern District of New York

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; Novartis International Pharmaceutical Ltd.; LTS Lohmann Therapie-Systeme AG
• Defendants:  Watson Laboratories, Inc.; Watson Pharma, Inc.; Watson Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 5,602,176 ("Phenyl Carbamate," issued February 11, 1997), 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001), and 6,335,031 (same title, issued January 1, 2002) following a Paragraph IV certification as part of Waton's filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease).  View the complaint here.

Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals, LLC
1:11-cv-08153; filed November 10, 2011 in the Southern District of New York

• Plaintiffs:  Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies; Grunenthal GMBH
• Defendant:  Amneal Pharmaceuticals, LLC

Infringement of U.S. Patent Nos. 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), 7,683,072 (same title, issued March 23, 2010), and 7,776,314 ("Abuse-Proofed Dosage System," issued August 17, 2010) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  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.

Cephalon Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:11-cv-01111; filed November 9, 2011 in the District Court of Delaware

• Plaintiffs:  Cephalon Inc.; CIMA Labs Inc.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

Infringement of U.S. Patent Nos. 6,200,604 ("Sublingual Buccal Effervescent," issued March 13, 2001), 6,974,590 (same title, issued December 13, 2005), 7,862,832 ("Generally Linear Effervescent Oral Fentanyl Dosage Form and Methods of Administering," issued January 4, 2011), and 7,862,833 ("Effervescent Oral Opiate Dosage Forms and Methods of Administering Opioids," issued January 4, 2011) following a Paragraph IV certification as part of Mylan's filing of an ANDA 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.

Novartis Pharmaceuticals Corp. et al.v. Watson Laboratories Inc. et al.
1:11-cv-01112; filed November 9, 2011 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; Novartis International Pharmaceutical Ltd.; LTS Lohmann Therapie-Systeme AG
• Defendants:  Watson Laboratories Inc.; Watson Pharma Inc.; Watson Pharmaceuticals Inc.

Novartis Pharmaceuticals Corp. et al.v. Actavis South Atlantic LLC et al.
0:11-cv-62371; filed November 4, 2011 in the Southern District of Florida

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; Novartis International Pharmaceutical Ltd; LTS Lohmann Therapie-Systeme AG
• Defendants:  Actavis South Atlantic LLC; Actavis, Inc.

Novartis Pharmaceuticals Corp. et al.v. Actavis South Atlantic LLC et al.
1:11-cv-01077; filed November 3, 2011 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; Novartis International Pharmaceutical Ltd.  LTS Lohmann Therapie-Systeme AG
• Defendants:  Actavis South Atlantic LLC; Actavis Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,602,176 ("Phenyl Carbamate," issued February 11, 1997), 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001), and 6,335,031 (same title, issued January 1, 2002) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease).  View the Actavis Delaware complaint here.

Abbott Laboratories et al.v. Sandoz Inc.
1:11-cv-01113; filed November 9, 2011 in the District Court of Delaware

• Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent Nos. 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000) and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Abbott's Simcor® (niacin extended release / simvastatin tablets, used to treat hypercholesterolemia).  View the complaint here.

Reckitt Benckiser LLC et al.v. Amneal Pharmaceuticals, LLC
3:11-cv-06609; filed November 9, 2011 in the District Court of New Jersey

• Plaintiffs:  Reckitt Benckiser LLC; UCB Manufacturing, Inc.
• Defendant:  Amneal Pharmaceuticals, LLC

Infringement of U.S. Patent No. 5,980,882 ("Drug-resin Complexes Stabilized by Chelating Agents," issued November 9, 1999) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Reckitt Benckiser's Delsym® extended release liquid suspension (dextromethorphan polistirex, used to temporarily relieve cough due to minor throat and bronchial irritation).  View the complaint here.

Warner Chilcott Co. LLC v. Zydus Pharmaceuticals (USA) Inc. et al.
1:11-cv-01105; filed November 8, 2011 in the District Court of Delaware

• Plaintiff:  Warner Chilcott Co. LLC
• Defendants:  Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

Infringement of U.S. Patent No. 6,893,662 ("Pharmaceutical Dosage Form with Multiple Coatings for Reduced Impact of Coating Fractures," issued May 17, 2005) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of plaintiffs' Asacol® HD (mesalamine, used to treat ulcerative colitis).  View the complaint here.

Galderma Laboratories Inc. et al.v. Amneal Pharmaceuticals LLC et al.
1:11-cv-01106; filed November 8, 2011 in the District Court of Delaware

• Plaintiffs:  Galderma Laboratories Inc.; Galderma Laboratories LP; Supernus Pharmaceuticals Inc.
• Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals Co (I) Pvt Ltd.

Infringement of U.S. Patent Nos. 7,749,532 ("Once Daily Formulation of Tetracyclines," issued July 6, 2010), 7,232,572 ("Methods of Treating Rosacea," issued June 19, 2007), and 7,211,267 ("Methods of Treating Acne" issued May 1, 2007) following a Paragraph IV certification as part of Amneal'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.

Alkermes Pharma Ireland Ltd. v. Actavis Inc. et al.
1:11-cv-01098; filed November 4, 2011 in the District Court of Delaware

• Plaintiff:  Alkermes Pharma Ireland Ltd.
• Defendants:  Actavis Inc.; Actavis South Atlantic LLC

Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Celgene Corp. et al.v. Actavis South Atlantic LLC
2:11-cv-06519; filed November 4, 2011 in the District Court of New Jersey

• Plaintiffs:  Celgene Corp.; Novartis Pharmaceuticals Corp.; Novartis Pharma AG
• Defendant:  Actavis South Atlantic LLC

Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), 6,635,284 (same title, issued October 21, 2003), and 7,431,944 ("Delivery of Multiple Doses of Medications," issued October 7, 2008) all licensed exclusively to Novartis in certain fields of use, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity 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.

Cephalon Inc. et al. v. Breckenridge Pharmaceutical Inc. et al.
1:11-cv-01070; filed November 2, 2011 in the District Court of Delaware

• Plaintiffs:  Cephalon Inc.; Cephalon France
• Defendants:  Breckenridge Pharmaceutical Inc.; Natco Pharma Ltd.

Infringement of U.S. Patent No. 7,132,570 ("Method for the Production of Crystalline Forms of Optical Enantiomers of Modafinil," issued November 7, 2006) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Cephalon's Nuvigil® (armodafinil, used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep disorder).  View the complaint here.

Senju Pharmaceutical Co. et al. v. Hi-Tech Pharmacal Co. Inc.
1:11-cv-01059; filed October 31, 2011 in the District Court of Delaware

• Plaintiffs:  Senju Pharmaceutical Co.; Kyorin Pharmaceutical Co.; Allergan Inc.
• Defendant:  Hi-Tech Pharmacal Co. Inc.

Infringement of U.S. Patent Nos. 6,333,045 ("Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin," issued on December 25, 2001) and 5,880,283 ("8-Alkoxyquinolonecarboxylic Acid Hydrate With Excellent Stability And Process For Producing The Same," issued March 9, 1999), licensed to Allergan, following a Paragraph IV certification as part of Hi-Tech's filing of an ANDA to manufacture a generic version of Allergan's Zymar® (gatifloxacin ophthalmic solution, used for the treatment of bacterial conjunctivitis).  View the complaint here.

Abbott Products, Inc. et al. v. Perrigo Co. et al.
3:11-cv-06357; filed October 31, 2011 in the District Court of New Jersey

• Plaintiffs:  Abbott Products, Inc.; Unimed Pharmaceuticals, LLC; Besins Healthcare Inc.
• Defendants:  Perrigo Co.; Perrigo Israel Pharmaceuticals Ltd.

Infringement of U.S. Patent No. 6,503,894 ("Pharmaceutical Composition and Method for Treating Hypogonadism," issued January 7, 2003) following a Paragraph IV certification as part of Perrigo's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Abbott's AndroGel® (testosterone gel, used to treat conditions associated with a deficiency or absence of endogenous testosterone).  View the complaint here.

Astrazeneca AB et al. v. Anchen Pharmaceuticals, Inc. et al.
3:11-cv-06348; filed October 28, 2011 in the District Court of New Jersey

• Plaintiffs:  Astrazeneca AB; Astrazeneca LP; KBI-E Inc.; Pozen Inc.
• Defendants:  Anchen Pharmaceuticals, Inc.; Anchen, Inc.

Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002), 7,411,070 ("same title," issued August 12 ,2008), 7,745,466 (same title, issued June 29, 2010), and 6,926,907 ("Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs," issued August 9, 2005) following a Paragraph IV certification as part of Anchen's filing of an ANDA to manufacture a generic version of AstraZeneca's Vimovo® (naproxen and esomeprazole magnesium, used to relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment with non-steroidal anti-inflammatory drugs (NSAIDs)).  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.

Alkermes Pharma Ireland Ltd. et al. v. Torrent Pharmaceuticals Ltd. et al.
1:11-cv-01009; filed October 21, 2011 in the District Court of Delaware

• Plaintiffs:  Alkermes Pharma Ireland Ltd.; Jazz Pharmaceuticals Inc.
• Defendants:  Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.

Infringement of U.S. Patent No. 7,456,462 ("Multiparticulate Controlled Release Selective Serotonin Reuptake Inhibitor Formulations," issued December 16, 2008), licensed to Jazz Pharmaceuticals, following a Paragraph IV certification as part of Torrent's filing of an ANDA to manufacture a generic version of Jazz's Luvox® CR (fluvoxamine maleate, used to treat social anxiety disorder and obsessive compulsive disorder).  View the complaint here.

Fred Hutchinson Cancer Research Center et al. v. Branhaven, LLC
3:11-cv-00710; filed October 21, 2011 in the Eastern District of Virginia

• Plaintiffs:  Fred Hutchinson Cancer Research Center; Argus Genetics, LLC; Mars, Inc.
• Defendant:  Branhaven, LLC; Scidera, INC.; Scidera Canine, LLC

Infringement of U.S. Patent No. 7,729,863 ("Methods and Materials for Canine Breed Identification," issued June 1, 2010) based on defendants' use, sale, and offers to sell its dog breed identification services (Canine Heritage XL Breed Test).  View the complaint here.

Janssen Pharmaceuticals, Inc. v. Sun Pharma Global FZE et al.
2:11-cv-06089; filed October 17, 2011 in the District Court of New Jersey

• Plaintiff:  Janssen Pharmaceuticals, Inc.
• Defendants:  Sun Pharma Global FZE; Sun Pharmaceutical Industries, Inc.

Infringement of U.S. Patent No. 6,214,815 ("Triphasic Oral Contraceptive," issued April 10, 2001) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Ortho-McNeil's Ortho Tri-Cyclen® Lo (norgestimate and ethinyl estradiol, used for oral contraception).  View the complaint here.

Novo Nordisk Inc. et al. v. Sandoz Inc.
3:11-cv-06106; filed October 14, 2011 in the District Court of New Jersey

• Plaintiffs:  Novo Nordisk Inc.; Novo Nordisk A/S
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent No. 6,677,358 ("NIDDM Regimen," issued January 13, 2004) following a Paragraph IV certification as part of Sandoz'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.

Alcon Pharmaceuticals, Ltd. vs. Perrigo Co.
4:11-cv-00732; filed October 14, 2011 in the Northern District of Texas

• Plaintiff:  Alcon Pharmaceuticals, Ltd.
• Defendants:  Perrigo Co; Perrigo Israel Pharmaceuticals Ltd.

Infringement of U.S. Patent No. 7,977,376 ("Olopatadine Formulations for Topical Nasal Administration," issued July 12, 2011) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Alcon's Patanase® (olopatadine hydrochloride, used to treat seasonal allergic rhinitis).  View the complaint here.

Noven Pharmaceuticals, Inc. v. Watson Laboratories, Inc. et al.
2:11-cv-05997; filed October 13, 2011 in the District Court of New Jersey

• Plaintiff:  Noven Pharmaceuticals, Inc.
• Defendants:  Watson Laboratories, Inc.; Watson Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 6,210,705 ("Compositions and Methods For Treatment of Attention Deficit Disorder and Attention Deficit/Hyperactivity Disorder With Methylphenidate," issued April 3, 2001) and 6,348,211 (same title, issued February 19, 2002) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Noven's Daytrana® (transdermal methylphenidate delivery system, used to treat attention deficit disorder and attention deficit/hyperactivity disorder).  View the complaint here.

Schering Corp. et al. v. Actavis Inc. et al.
2:11-cv-06067; filed October 13, 2011 in the District Court of New Jersey

• Plaintiffs:  Schering Corp.; MSP Singapore Company LLC
• Defendants:  Actavis Inc.; Actavis Group HF

Infringement of U.S. Patent Nos. RE42,461 ("Hydroxy-Substituted Azetidinone Compounds Useful as Hypocholesterolemic Agents," issued June 14, 2011) and 5,846,966 ("Combinations of Hydroxy-Aubstituted Azetidinone Compounds and HMG CoA Reductase Inhibitors," issued December 8, 1998), both licensed to MSP, following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of MSP's Vytorin® (ezetimibe and simvastatin, used to treat hyperlipidemia).  View the complaint here.

Warner Chilcott Co., LLC et al. v. Watson Pharmaceuticals, Inc. et al.
2:11-cv-05989; filed October 12, 2011 in the District Court of New Jersey

• Plaintiffs:  Warner Chilcott Co., LLC; Warner Chilcott (US), LLC
• Defendants:  Watson Pharmaceuticals, Inc.; Watson Laboratories, Inc. – Florida; Watson Pharma, Inc.

Infringement of U.S. Patent Nos. 7,645,459 ("Dosage Forms of Bisphosphonates," issued January 12, 2010) and 7,645,460 ("Dosage Forms of Risedronate" issued January 12, 2010) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Warner Chilcott's Atelvia (risedronate sodium delayed-release, used to treat osteoporosis in women after menopause).  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.

Senju Pharmaceutical Co. et al. v. Hi-Tech Pharmacal Co. Inc.
1:11-cv-00926; filed October 11, 2011 in the District Court of Delaware

• Plaintiffs:  Senju Pharmaceutical Co.; Kyorin Pharmaceutical Co.; Allergan Inc.
• Defendant:  Hi-Tech Pharmacal Co. Inc.

Infringement of U.S. Patent Nos. 6,333,045 ("Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin," issued December 25, 2001) and 5,880,283 ("8-Alkoxyquinolonecarboxylic Acid Hydrate With Excellent Stability and Process for Producing the Same," issued March 9, 1999), licensed to Allergan, following a Paragraph IV certification as part of Hi-Tech's filing of an ANDA to manufacture a generic version of Allergan's Zymaxid® (gatifloxacin ophthalmic solution, used to treat bacterial conjunctivitis).  View the complaint here.

Pfizer Inc. et al.v. Watson Pharmaceuticals, Inc. et al.
2:11-cv-05860; filed October 7, 2011 in the District Court of New Jersey

• Plaintiffs:  Pfizer Inc.; Alpha Pharmaceuticals LLC; King Pharmaceuticals, Inc.
• Defendants:  Watson Pharmaceuticals, Inc.; Watson Laboratories Inc.; Watson Pharma, Inc.; Watson Laboratories, Inc. - Florida

Infringement of U.S. Patent Nos. 7,682,633 ("Pharmaceutical Composition," issued March 23, 2010), 7,682,634 ("Pharmaceutical Compositions," issued March 23, 2010), and 7,815,934 ("Sequestering Subunit and Related Compositions and Methods," issued October 19, 2010) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Pfizer subsidiary King Pharmaceutical's EMBEDA® (morphine sulfate and naltrexone hydrochloride extended release capsules, used in the management of moderate to severe pain).  View the complaint here.

Purdue Pharma L.P. et al.v. Ranbaxy Inc. et al.
1:11-cv-07104; filed October 7, 2011 in the Southern District of New York

• Plaintiffs:  Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies
• Defendants:  Ranbaxy Inc.; Ranbaxy Pharmaceuticals Inc.; Ranbaxy Laboratories Ltd.

Infringement of U.S. Patent Nos. 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), and 7,683,072 (same title, issued March 23, 2010) following a Paragraph IV certification as part of Ranbaxy's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.

Novartis Pharmaceuticals Corp. et al.v. Alembic Pharmaceuticals Ltd. et al.
1:11-cv-07092; filed October 7, 2011 in the Southern District of New York

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; Novartis International Pharmaceutical Ltd.
• Defendants:  Alembic Pharmaceuticals Ltd.; Alembic Pharma Ltd.; Alembic Ltd.; Breckenridge Pharmaceutical, Inc.

Infringement of U.S. Patent No. 5,602,176 ("Phenyl Carbamate," issued February 11, 1997) following a Paragraph IV certification as part of Alembic's filing of an ANDA to manufacture a generic version of Novartis' Exelon® (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's 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.

Pfizer Inc. et al. v. Watson Pharmaceuticals Inc. et al.
1:11-cv-00914; filed October 6, 2011 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Alpharma Pharmaceuticals LLC; King Pharmaceuticals Inc.
• Defendants:  Watson Pharmaceuticals Inc.; Watson Laboratories Inc.; Watson Pharma Inc.; Watson Laboratories Inc. - Florida

Infringement of U.S. Patent Nos. 7,682,633 ("Pharmaceutical Composition," issued March 23, 2010), 7,682,634 ("Pharmaceutical Compositions," issued March 23, 2010), and 7,815,934 ("Sequestering Subunit and Related Compositions and Methods," issued October 19, 2010) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Pfizer subsidiary King Pharmaceutical's EMBEDA® (morphine sulfate and naltrexone hydrochloride extended release capsules, used in the management of moderate to severe pain).  View the complaint here.

Eisai Inc. v. Banner Pharmacaps Inc.
1:11-cv-00901; filed October 4, 2011 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,780,676 ("Compounds Having Selective Activity for Retinoid X Receptors, and Means for Modulation of Processes Mediated by Retinoid X Receptors," issued July 14, 1998) and 5,962,731 (same title, issued October 5, 1999) following a Paragraph IV certification as part of Banner's filing of an ANDA to manufacture a generic version of Eisai's Targretin® (bexarotene, used to treat cutaneous T-cell lymphoma).  View the complaint here.

Cellectis S.A. v. Precision Biosciences Inc.
1:11-cv-00890; filed September 30, 2011 in the District Court of Delaware

Declaratory judgment of invalidity and non-infringement of U.S. Patent No. 8,021,867 ("Rationally Designed Meganucleases with Altered Sequence Specificity and DNA-Binding Affinity," issued September 20, 2011) based on Cellectis' manufacture and sale of its engineered I-Crel meganucleases.  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.

Precision BioSciences, Inc. v. Cellectis SA et al.
5:11-cv-00513; filed September 26, 2011 in the Eastern District of North Carolina

• Plaintiff:  Precision BioSciences, Inc.
• Defendants:  Cellectis SA; Cellectis Bioresearch; Cellectis Bioresearch, Inc.

Infringement of U.S. Patent No. 8,021,867 ("Rationally Designed Meganucleases with Altered Sequence Specificity and DNA-Binding Affinity," issued September 20, 2011") based on Cellectis' manufacture and sale of certain products, including meganucleases targeting the human RAG1 gene, meganucleases targeting the HIV1 genome, and meganucleases targeting the GS gene in Chinese Hamster Ovary cells.  View the complaint here.

Helsinn Healthcare S.A. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
3:11-cv-05579; filed September 23, 2011 in the District Court of New Jersey

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants:  Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, Inc.; Sandoz Inc.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.

Infringement of U.S. Patent No. 7,960,424 ("Liquid Pharmaceutical Formulations of Palonosetron," issued June 14, 2011 following a Paragraph IV certification as part of defendants filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting).  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.

ISIS Pharmaceuticals, Inc. v. Santaris Pharma A/S Corp. et al.
3:11-cv-02214; filed September 22, 2011 in the Southern District of California

• Plaintiff:  ISIS Pharmaceuticals, Inc.
• Defendants:  Santaris Pharma A/S Corp.; Santaris A/S

Infringement of U.S. Patent Nos. 6,326,199 ("Gapped 2' Modified Oligonucleotides," issued December 4, 2011) and 6,066,500 ("Antisense Modulation of Beta Catenin Expression" issued May 23, 2000) based on Santaris' sale and offers for sale of certain drug discovery services and drug candidates, including antisense compounds that inhibit beta-catenin production.  View the complaint here.

Cephalon, Inc. v. Sun Pharmaceutical Industries, Inc. et al.
2:11-cv-14181; filed September 22, 2011 in the Eastern District of Michigan

• Plaintiff:  Cephalon, Inc.
• Defendants:  Sun Pharmaceutical Industries, Inc.; Sun Pharmaceutical Industries Ltd.

Cephalon, Inc. v. Sun Pharmaceutical Industries, Inc. et al.
3:11-cv-05474; filed September 21, 2011 in the District Court of New Jersey

• Plaintiff:  Cephalon, Inc.
• Defendants:  Sun Pharmaceutical Industries, Inc.; Sun Pharmaceutical Industries Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,958,951 ("Modified Form Of The R(-)-N-(4,4-Di(3-Methylthien-2-yl)But-3-enyl)-Nipecotic Acid Hydrochloride," issued September 28, 1999) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Cephalon's Gabitril® (tiagabine hydrochloride, used to treat epilepsy).  View the Michigan complaint here.

Momenta Pharmaceuticals, Inc. et al. v. Amphastar Pharmaceuticals, Inc. et al.
1:11-cv-11681; filed September 21, 2011 in the District Court of Massachusetts

• Plaintiffs:  Momenta Pharmaceuticals, Inc.; Sandoz Inc.
• Defendants:  Amphastar Pharmaceuticals, Inc.; International Medication Systems, Ltd.; Watson Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 7,575,886 ("Analysis of Sulfated Polysaccharides," issued August 18, 2009) and 7,790,466 ("Evaluating Mixtures of Low Molecular Weight Heparins by Chain Profiles or Chain Mapping," issued September 7, 2010) in conjunction with the manufacture and planned launch of Watson's generic Lovenox® (enoxaparin sodium injection, used for the prophylaxis and treatment of thromboembolic disease).  View the complaint here.

Fresenius Medical Care Holdings, Inc. v. Invagen Pharmaceuticals, Inc.
2:11-cv-04505; filed September 16, 2011 in the Eastern District of New York

Fresenius Medical Care Holdings, Inc. v. Invagen Pharmaceuticals, Inc.
1:11-cv-11645; filed September 16, 2011 in the District Court of Massachusetts

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,576,665 ("Encapsulated Calcium Acetate Caplet and a Method for Inhibiting Gastrointestinal Phosphorous Absorption," issued June 10, 2003) following a Paragraph IV certification as part of Invagen's filing of an ANDA to manufacture a generic version of Fresenius' PhosLo® GelCaps (calcium acetate, used to treat renal failure).  View the New York complaint here.

Cephalon Inc. et al. v. Sandoz Inc.
1:11-cv-00821; filed September 15, 2011 in the District Court of Delaware

• Plaintiffs:  Cephalon Inc.; CIMA Labs Inc.
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent Nos. 7,862,832 ("Generally Linear Effervescent Oral Fentanyl Dosage Form and Methods of Administering," issued January 4, 2011) and 7,862,833 ("Effervescent Oral Opiate Dosage Forms and Methods of Administering Opioids," issued January 4, 2011) following a Paragraph IV certification as part of Sandoz's filing of an ANDA 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.

Court Report

By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Takeda Pharmaceutical Co. et al. v. Accord Healthcare, Inc.
1:11-cv-06360; filed September 12, 2011 in the Southern District of New York

• Plaintiffs:  Takeda Pharmaceutical Co.; Takeda Pharmaceuticals North America, Inc.
• Defendant:  Accord Healthcare, Inc.

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 Accord's filing of an ANDA to manufacture a generic version of Takeda's Actos® (pioglitazone hydrochloride, used to treat type II diabetes).  View the complaint here.

Novartis AG et al. v. Accord Healthcare, Inc. USA et al.
1:11-cv-01631; filed September 9, 2011 in the District Court of the District of Columbia

• Plaintiffs:  Novartis AG; Novartis Pharmaceuticals Corp.
• Defendants:  Accord Healthcare, Inc. USA; Intas Pharmaceutical Ltd.

Infringement of U.S. Patent Nos. 6,025,391 ("Enteric-Coated Pharmaceutical Compositions of Mycophenolate," issued February 15, 2000), 6,172,107 ("Entric-Coated Pharmaceutical Compositions," issued January 9, 2001), and 6,306,900 (same title, issued October 23, 2001) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Novartis' Myfortic® (mycophenolate sodium, used for the prophylaxis or prevention of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids).  View the complaint here.

Abbott Laboratories et al. v. Hospira Inc.
1:11-cv-00795; filed September 9, 2011 in the District Court of Delaware

• Plaintiffs:  Abbott Laboratories; Wisconsin Alumni Research Foundation
• Defendant:  Hospira Inc.

Infringement of U.S. Patent No. 5,587,497 ("19-nor-Vitamin D Compounds," issued December 24, 1996) following a Paragraph IV certification as part of Hospira's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Abbott's Zemplar® (paricalcitol, used to treat secondary hyperparathyroidism in patients with kidney failure).  View the complaint here.

Flamel Technologies S.A. v. Anchen Pharmaceuticals, Inc.
1:11-cv-02570; filed September 9, 2011 in the District Court of Maryland

Infringement of U.S. Patent No. 6,022,562 ("Medicinal and/or Nutritional Microcapsules for Oral Administration," issued February 8, 2000) following a Paragraph IV certification as part of Anchen's filing of an ANDA to manufacture a generic version of GSK's Coreg® CR (carvedilol, used to treat congestive heart failure).  View the complaint here.

GlaxoSmithKline LLC v. Mylan Inc. et al.
1:11-cv-00789; filed September 8, 2011 in the District Court of Delaware

• Plaintiff:  GlaxoSmithKline LLC
• Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.; Impax Laboratories Inc.

Infringement of U.S. Patent Nos. 5,565,467 ("Androstenone Derivative," issued October 15, 1996), 5,846,976 (same title, issued December 8, 1998), and 5,998,427 ("Androstenones," issued December 7, 1999) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of GSK's Avodart® (dutasteride, used to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate) and GSK's Jalyn® (dutasteride and tamsulosin hydrochloride, used to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate).  View the complaint here.

Cephalon Inc. et al. v. Sandoz Inc.
1:11-cv-00782; filed September 6, 2011 in the District Court of Delaware

• Plaintiffs:  Cephalon Inc.; Cephalon France
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent No. 7,132,570 ("Method for the Production of Crystalline Forms of Optical Enantiomers of Modafinil," issued November 7, 2006) following a Paragraph IV certification as part of Sandoz's amendment of its ANDA to manufacture a generic version of Cephalon's Nuvigil® (armodafinil, used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep disorder).  View the complaint here.