By Sherri
Oslick

Gavel_2About
Court
Report:  Each week we will report briefly on recently filed
biotech and pharma cases.


Biovail Laboratories International SRL v. Paddock Laboratories,
Inc.

0:10-cv-00687; filed March 9, 2010 in the District
Court of Minnesota

Biovail Laboratories International SRL v. Paddock Laboratories
Inc.

1:10-cv-00185; filed March 8, 2010 in the District
Court of Delaware

The complaints in these cases are substantially
identical.  Infringement of U.S.
Patent Nos. 7,569,610 ("Modified Release Formulations of a Bupropion Salt,"
issued August 4, 2009), 7,572,935 (same title, issued August 11, 2009),
7,649,019 (same title, issued January 19, 2010), 7,563,823 (same title, issued
June 21, 2009), 7,553,992 (same title, issued June 30, 2009), and 7,671,094 ("Bupropion
Hydrobromide and Therapeutic Applications," issued March 2, 2010)
following a Paragraph IV certification as part of Paddock's filing of an ANDA
to manufacture a generic version of Biovail's Aplenzin ER (bupropion, used to
treat depression).  View the
Delaware complaint
here.


Simonian v. Allergan, Inc.
1:10-cv-01544; filed March 9, 2010 in the Northern
District of Illinois

False marking based on Allergan's marking of its Avage®,
Tazorac® cream, and Tazorac® gel products indicating that these products are
covered by U.S. Patent No. 5,089,509 ("Disubstituted Acetylenes Bearing
Heteroaromatic and Heterobicyclic Groups Having Retinoid Like Activity,"
issued February 18, 1992), marking of its Restasis® product indicating that
this product is covered by U.S. Patent No. 4,839,342 ("Method of
Increasing Tear Production by Topical Administration of Cyclosporin,"
issued July 13, 1989), and marking of its Zymar® product indicating that this
product is covered by U.S. Patent No. 4,980,470 ("8-alkoxyquinolonecarboxylic
Acids and Salts Thereof," issued December 25, 1990), all of which are
expired.  View the complaint
here.


Simonian v. Abbott Laboratories
1:10-cv-01542; filed March 9, 2010 in the Northern
District of Illinois

False marking based on Abbott's marking of its
Ery-Tab® product indicating that this product is covered by U.S. Patent No.
4,340,582 ("Erythromycin Base Tablets," issued July 20, 1982) and
marking of its PCE® product indicating that this product is covered by U.S.
Patent No. 4,874,614 ("Pharmaceutical Tableting Method," issued
October 17, 1989), all of which are expired.  View the complaint
here.


Simonian v. Amgen, Inc.
1:10-cv-01540; filed March 9, 2010 in the Northern
District of Illinois

False marking based on Amgen's marking of its
Neupogen® product indicating that this product is covered by U.S. Patent Nos.
4,810,643 ("Production of Pluriptent Granulocyte Colony-stimulating
Factor," issued March 7, 1989) and 4,999,291 (same title, issued March 12,
1991), which are expired.  View the
complaint
here.


Simonian v. Baxter Healthcare Corp.

1:10-cv-01547; filed March 9, 2010 in the Northern
District of Illinois

False marking based on Baxter's marking of its
Advate® product indicating that this product is covered by U.S. Patent Nos. 4,757,006
("Human Factor VIII: C Gene and Recombinant Methods for Production,"
issued July 12, 1988) and  4,891,319
("Protection of Proteins and the Like," issued January 2, 1990),
marking of its Artiss®, Bebulin VH®, Feiba®, Floseal®, and Tisseel® products
indicating that these products are covered by U.S. Patent No. 4,640,834 ("Method
of Inactivating Reproducible Filterable Pathogens in Blood Products as Well as
a Method of Producing Blood Products," issued February 3, 1987) and
marking of its Bebulin VH® product indicating that this product is covered by
U.S. Patent No. 4,388,232 ("Method of Producing Plasma Fractions Free of
Side-effects Using Fast-reacting Antithrombin," issued June 14, 1983), all
of which are expired.  View the
complaint
here.


Simonian v. Astellas Pharma US, Inc.
1:10-cv-01539; filed March 9, 2010 in the Northern
District of Illinois

False marking based on Astellas' marking of its
Amevive® product indicating that this product is covered by U.S. Patent No. 4,956,281
("Antifungal Carbinols," issued September 11, 1990), which is
expired.  View the complaint
here.


Teva Women's Health, Inc. v. Mylan Pharmaceuticals, Inc. et al.
2:10-cv-01234; filed March 9, 2010 in the District
Court of New Jersey

• Plaintiff:  Teva Women's Health, Inc.
• Defendants:  Mylan Pharmaceuticals, Inc.; Mylan
Inc.; Famy Care Ltd.

Infringement of U.S. Patent No. 7,615,545 ("Oral
Contraceptives to Prevent Pregnancy and Diminish Premenstrual Symptomatology,"
issued November 10, 2009) following a Paragraph IV certification as part of
Mylan's filing of an ANDA to manufacture a generic version of Teva's
LoSeasonique® (ethinyl estradiol and levonorgestrel, used as oral
contraception).  View the complaint
here.


Teva Women's Health, Inc. v. Mylan Pharmaceuticals, Inc. et al.
2:10-cv-01235; filed March 9, 2010 in the District
Court of New Jersey

• Plaintiff:  Teva Women's Health, Inc.
• Defendants:  Mylan Pharmaceuticals, Inc.; Mylan
Inc.; Famy Care Ltd.

Infringement of U.S. Patent No. 7,320,969 ("Oral
Contraceptives to Prevent Pregnancy and Diminish Premenstrual Symptomatology,"
issued January 22, 2008) following a Paragraph IV certification as part of
Mylan's filing of an ANDA to manufacture a generic version of Teva Women's
Health's Seasonique® (levonorgestrel/ethinyl estradiol, used as oral
contraception).  View the complaint
here.


Merck, Sharp & Dohme Corp. et al. v. Teva Pharmaceuticals
USA, Inc. et al.
1:10-cv-01851; filed March 9, 2010 in the Southern
District of New York

• Plaintiffs:  Merck, Sharp & Dohme Corp.;
Bristol-Meyers Squibb Co.
• Defendants:  Teva Pharmaceuticals USA, Inc.; Teva
Pharmaceutical Industries, Ltd.

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) and 6,939,964 (same title, issued September 6, 2005)
following Paragraph IV certifications as part of Teva's filing of ANDAs to
manufacture generic versions of Gilead's Atripla® (efavirenz, emtricitabine,
and tenofovir disoproxil, used for the treatment of HIV-1 infection)
products.  View the complaint
here.


Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Kappos
1:10-cv-00370; filed March 5, 2010 in the District
Court of the District of Columbia

• Plaintiffs:  Boehringer Ingelheim Pharma GmbH
& Co. KG; Boehringer Ingelheim International GmbH; Boehringer Ingelheim
Pharmaceuticals, Inc.
• Defendant:  David Kappos

Review and correction of the patent term adjustment
calculation made by the U.S. Patent and Trademark Office for U.S. Patent No.
7,585,845 ("Hepatitis C Inhibitor Compound," issued September 8,
2009).  View the complaint
here.


Gilead Sciences, Inc., et al. v. Teva Pharmaceuticals
Industries Ltd. et al.

1:10-cv-01798; filed March 5, 2010 in the Southern
District of New York

• Plaintiffs:  Gilead Sciences, Inc.; Emory
University
• Defendants:  Teva Pharmaceuticals Industries
Ltd.; Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent Nos. 5,814,639 ("Method
for the Synthesis, Compositions, and Use of 2'-Deoxy-5-Fluoro-3'-Thiacytidine
and Related Compounds," issued September 29, 1998) and 5,914,331 ("Antiviral
Activity and Resolution of 2-Hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane,"
issued June 22, 1999) following Paragraph IV certifications as part of Teva's
filing of ANDAs to manufacture generic versions of Gilead's Truveda®
(emtricitabine and tenofovir disoproxil fumarate, used for the treatment of
HIV-1 infection) and Gilead's Atripla® (efavirenz, emtricitabine, and
tenofovir disoproxil, used for the treatment of HIV-1 infection) products.  View the complaint
here.


Gilead Sciences, Inc., v. Teva Pharmaceuticals USA, Inc. et al.
1:10-cv-01796; filed March 5, 2010 in the Southern
District of New York

• Plaintiffs:  Gilead Sciences, Inc.
• Defendants:  Teva Pharmaceuticals USA, Inc.; Teva
Pharmaceuticals Industries Ltd.

Infringement of U.S. Patent Nos. 5,922,695 ("Antiviral
Phosphonomethoxy Nucleotide Analogs Having Increased Oral Bioavailability,
issued July 13, 1999), 5,935,946 ("Nucleotide Analog Composition and
Synthesis Method," issued August 10, 1999), 5,977,089 ("Antiviral
Phosphonomethoxy Nucleotide Analogs Having Increased Oral Bioavailability,
issued November 2, 1999), and 6,043,230 (same title, issued March 28, 2000),
following Paragraph IV certifications as part of Teva's filing of ANDAs to
manufacture generic versions of Gilead's Viread® (tenofovir disoproxil
fumarate, used for the treatment of HIV-1 infection), Gilead's Truveda®
(emtricitabine and tenofovir disoproxil fumarate, used for the treatment of
HIV-1 infection), and Gilead's Atripla® (efavirenz, emtricitabine, and
tenofovir disoproxil, used for the treatment of HIV-1 infection) products.  View the complaint
here.


Endo Pharmaceuticals Inc. et al. v. Watson Pharmaceuticals, Inc.
et al.

2:10-cv-01242; filed March 4, 2010 in the District
Court of New Jersey

• Plaintiffs:  Endo Pharmaceuticals Inc.; Penwest
Pharmaceuticals Co.
• Defendants:  Watson Pharmaceuticals, Inc.; Watson
Laboratories, Inc.; Watson Pharma, Inc.

Infringement of U.S. Patent Nos. 5,662,933 ("Controlled
Release Formulation (Albuterol)," issued September 2, 1997) and 5,958,456
(same title, issued September 28, 1999) following a Paragraph IV certification
as part of Watson's filing of an ANDA to manufacture a generic version of Endo's
Opana® ER (oxymorphone hydrochloride, used to treat moderate to severe pain in
patients requiring continuous, around-the-clock opioid treatment for an
extended period of time).  View the
complaint
here.


Merck Serono S.A. v. Kappos
1:10-cv-00348; filed March 3, 2010 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.
7,585,840 ("Use of Osteoprotegerin for the Treatment and/or Prevention of
Fibrotic Disease," issued September 8, 2009).  View the complaint
here.

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