By Sherri Oslick —

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

Pfizer Inc. et al. v. Apotex
Inc. et al.
1:13-cv-01613; filed September
25, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.;
Wyeth LLC; Pfizer Pharmaceuticals LLC; PF Prism C.V.; Pfizer Manufacturing
Holdings LLC
• Defendants:  Apotex Inc.; Apotex
Corp.

Infringement of U.S. Patent
No. 8,372,995 ("Crystalline Solid Forms of Trigecycline and Methods of
Preparing Same," issued February 12, 2013), licensed to Pfizer, following
a Paragraph IV certification as part of Apotex's filing of an ANDA to
manufacture a generic version of Pfizer's Tygacil® (tigecycline injectible,
used for the treatment of complicated skin and skin structure infections,
complicated intra-abdominal infections, and community-acquired bacterial
pneumonia).  View the complaint here.

Merck Sharp & Dohme Corp. et
al. v. Ben Venue Laboratories Inc.
1:13-cv-01611; filed September
25, 2013 in the District Court of Delaware

• Plaintiffs:  Merck Sharp
& Dohme Corp.; Millennium Pharmaceuticals Inc.
• Defendant:  Ben Venue
Laboratories Inc.

Infringement of U.S. Patent
Nos. 5,807,825 ("Platelet Aggregation Inhibitors," issued September
15, 1998), 5,747,447 ("Stable Polypeptide Composition," issued May 5,
1998) and 5,968,902 ("Platelet Aggregation Inhibitors," issued
October 19, 1999), licensed to Merck, following a Paragraph IV certification as
part of Ben Venue's filing of an ANDA to manufacture a generic version of Merck's
Integrilin® (eptifibatide injection, used to treat acute coronary
syndrome).  View the complaint here.

Helsinn Healthcare SA et al.
v. Ben Venue Laboratories Inc.
1:13-cv-01612; filed September
25, 2013 in the District Court of Delaware

• Plaintiffs:  Helsinn
Healthcare SA; Roche Palo Alto LLC
• Defendant:  Ben Venue
Laboratories Inc.

Infringement of U.S. Patent
Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron,"
issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), and
7,960,424 (same title, issued June 14, 2011) following a Paragraph IV
certification as part of Ben Venue's 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.

Cornerstone Therapeutics, Inc.
et al. v. Sandoz Inc.
1:13-cv-05723; filed September
25, 2013 in the District Court of New Jersey

• Plaintiffs:  Cornerstone
Therapeutics, Inc.; Cornerstone Biopharma, Inc.; EKR Therapeutics, LLC
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent
Nos. 7,612,102 ("Pre-mixed, Ready-to-Use Pharmaceutical Compositions,"
issued November 3, 2009), 7,659,291 ("Methods of Treatment with Pre-Mixed,
Ready-to-Use Pharmaceutical Compositions," issued February 9, 2010),
8,455,524 (same title, issued June 4, 2013), and 7,659,290 ("Methods of
Preparing Pre-Mixed, Ready-to-Use Pharmaceutical Compositions," issued
February 9, 2010) following a Paragraph IV certification as part of Sandoz's
filing of an ANDA to manufacture a generic version of EKR's Cardene® I.V.
Premixed Injection (nicardipine hydrochloride premixed injection for
intravenous administration, used for the short-term treatment of hypertension
when oral therapy is not feasible or not desirable).  View the complaint here.

Forest Laboratories Inc. et
al. v. Apotex Corp. et al.
1:13-cv-01602; filed September
23, 2013 in the District Court of Delaware

• Plaintiffs:  Forest
Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection
Trust
• Defendants:  Apotex Corp.;
Apotex Inc.

Forest Laboratories Inc. et
al. v. Hetero USA Inc. et al.
1:13-cv-01603; filed September
23, 2013 in the District Court of Delaware

• Plaintiffs:  Forest
Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection
Trust
• Defendants:  Hetero USA Inc.;
Hetero Labs Ltd. Unit V; Hetero Labs Ltd.

Forest Laboratories Inc. et
al. v. Lupin Limited et al.
1:13-cv-01604; filed September
23, 2013 in the District Court of Delaware

• Plaintiffs:  Forest
Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection
Trust
• Defendants:  Lupin Ltd.;
Lupin Pharmaceuticals Inc.

Forest Laboratories Inc. et
al. v. Mylan Inc. et al.
1:13-cv-01605; filed September
23, 2013 in the District Court of Delaware

• Plaintiffs:  Forest
Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection
Trust
• Defendants:  Mylan Inc.;
Mylan Pharmaceuticals Inc.

Forest Laboratories Inc. et
al. v. Par Pharmaceutical Inc.
1:13-cv-01606; filed September
23, 2013 in the District Court of Delaware

• Plaintiffs:  Forest
Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection
Trust
• Defendant:  Par
Pharmaceutical Inc.

Forest Laboratories Inc. et
al. v Ranbaxy Inc. et al.
1:13-cv-01607; filed September
23, 2013 in the District Court of Delaware

• Plaintiffs:  Forest
Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection
Trust
• Defendants:  Ranbaxy Inc.;
Ranbaxy Laboratories Ltd.

The complaints in these cases
are substantially identical.  Infringement
of U.S. Patent Nos. 6,602,911 ("Methods of Treating Fibromyalgia,"
issued August 5, 2003), 7,888,342 ("Methods of Treating Fibromyalgia
Syndrome, Chronic Fatigue Syndrome and Pain," issued February 15, 2011),
and 7,994,220 ("Milnacipran for the Long-Term Treatment of Fibromyalgia
Syndrome," issued August 9, 2011), all licensed to Forest, following a
Paragraph IV certification as part of defendants' filing of an ANDA to
manufacture a generic version of Forest's Savella® (milnacipran hydrochloride,
used in the management of fibromyalgia). 
View the Apotex complaint here.

Counsyl, Inc v. Myriad
Genetics, Inc.
3:13-cv-04391; filed September
20, 2013 in the Northern District of California

Declaratory judgment of
noninfringement and invalidity of U.S. Patent Nos. 5,709,999 ("Linked
Breast and Ovarian Cancer Susceptibility Gene," issued January 20, 1998),
5,747,282 ("17-Q-Linked Breast and Ovarian Cancer Susceptibility Gene,"
issued May 5, 1998), 5,753,441 (same title, issued May 19, 1998), 6,951,721 ("Method
for Determining the Haplotype of a Human BRCA1 Gene," issued October 4,
2005), 7,250,497 ("Large Deletions in Human BRCA1 Gene and Use Thereof,"
issued July 31, 2007), 5,837,492 ("Chromosome 13-Linked Breast Cancer
Susceptibility Gene," issued November 17, 1998), 6,033,857 (same title,
issued March 7, 2000), and 6,051,379 ("Cancer Susceptibility Mutations of
BRCA2," issued April 18, 2000) based on Counsyl's development and
anticipated launch of genetic tests and related services related to sequencing
and analysis of BRCAI and BRCA2 genes. 
View the complaint here.

Senju Pharmaceutical Co. et
al. v. Sandoz Inc.
1:13-cv-06608; filed September
18, 2013 in the Southern District of New York

• Plaintiffs:  Senju
Pharmaceutical Co.; Bausch & Lomb, Inc.; Bausch & Lomb Pharma
Holdings Corp.
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent
Nos. 6,335,335 ("Prolonged-Action Eye Drop," issued January 1, 2002)
and 6,645,963 (same title, issued November 11, 2003) following a Paragraph IV
certification as part of Sandoz's filing of an ANDA to manufacture a generic
version of Senju's Istalol® (timolol maleate ophthalmic solution, 0.5%, used
treat elevated intraocular pressure in patients with ocular hypertension or
open-angle glaucoma).  View the complaint here.

AbbVie Inc. et al. v. Hikma
Pharmaceutical Co Ltd. et al.
1:13-cv-01557; filed September
13, 2013 in the District Court of Delaware

• Plaintiffs:  AbbVie Inc.;
Wisconsin Alumni Research Foundation
• Defendants:  Hikma
Pharmaceutical Co Ltd.; West-Ward Pharmaceuticals Corp.; Exela Pharma Sciences
LLC

Infringement of U.S. Patent
No. 5,597,815 ("Prevention of Hyperphosphatemia in Kidney Disorder
Patients," issued January 28, 1997) following a Paragraph IV certification
as part of defendants' filing of an NDA (under § 505(b)(2) of the Food, Drug
and Cosmetic Act) to manufacture a generic version of AbbVie's Zemplar®
(paricalcitol, used to treat secondary hyperparathyroidism in patients with
kidney failure).  View the complaint here.

Eli Lilly and Co. v. Sun
Pharmaceutical Industries Ltd. et al.
1:13-cv-01469; filed September
13, 2013 in the Southern District of Indiana

• Plaintiff:  Eli Lilly and
Co.
• Defendants:  Sun
Pharmaceutical Industries Ltd.; Sun Pharma Global FZE

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 Sun'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.

Jazz Pharmaceuticals, Inc. v. Amneal
Pharmaceuticals, LLC
2:13-cv-05450; filed September
12, 2013 in the District Court of New Jersey

Infringement of U.S. Patent
Nos. 8,457,988 ("Sensitive Drug
Distribution System and and Method," issued June 4, 0213) and 8,461,203 ("Microbiologically
Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of
Narcolepsy," issued June 11, 2013) following
a Paragraph IV certification as part of Amneal's filing of an ANDA to
manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat
narcolepsy).  View the complaint here.

Merck, Sharp & Dohme Corp.
et al. v. Aurobindo Pharma Ltd. et al.
1:13-cv-05442; filed September
11, 2013 in the District Court of New Jersey

• Plaintiffs:  Merck, Sharp
& Dohme Corp.; Bristol-Myers Squibb Co.; Bristol-Myers Squibb Pharma
Co.
• Defendants:  Aurobindo Pharma
Ltd.; Aurobindo Pharma USA, Inc.

Infringement of U.S. Patent
Nos. 6,639,071 ("Crystal Forms of
(-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one,"
issued October 28, 2003), 6,939,964 (same title, issued September 6, 2005), and
6,673,372 ("Crystalline Efavirenz," issued January 6, 2004) following
a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture
a generic version of BMS' Sustiva® (efavirenz, used to treat HIV
infection).  View the complaint here.