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. Hetero Drugs Ltd. et al.
1:11-cv-05135; filed July 26, 2011 in the Southern District of New York

• Plaintiffs:  Pfizer Inc.; Pfizer Ltd.; Pfizer Ireland Pharmaceuticals
• Defendants:  Hetero Drugs Ltd.; Hetero USA Inc.; Invagen Pharmaceuticals Inc.; Hetero Labs Ltd., Unit V

Infringement of U.S. Patent No. 6,469,012 ("Pyrazolopyrimidinones for the Treatment of Impotence," issued October 22, 2002) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of Pfizer's Viagra® (sildenafil citrate, used to treat erectile dysfunction).  View the complaint here.

Astrazeneca AB et al. v. Lupin Ltd. et al.
3:11-cv-04275; filed July 25, 2011 in the District Court of New Jersey

• Plaintiffs:  Astrazeneca AB; Astrazeneca LP; KBI-E Inc.; Pozen Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 5,714,504 ("Compositions," issued February 3, 1998), 6,875,872 ("Compounds," issued April 5, 2005), 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 Lupin'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.

Pellet Technologies, LLC et al. v. Martin Avenue Pharmacy, Inc. et al.
1:11-cv-04283; filed July 25, 2011 in the District Court of New Jersey

• Plaintiffs:  Pellet Technologies, LLC; Lance L. Gooberman
• Defendants:  Martin Avenue Pharmacy, Inc.; Thomas Marks

Infringement of U.S. Patent No. 6,203,813 ("Pharmaceutical Delivery Device and Method of Preparation Therefor," issued March 20, 2001) based on defendant's manufacture and sale of naltrexzone containing pellets.  View the complaint here.

Pfizer Inc. et al. v. Torrent Pharmaceuticals Ltd et al.
2:11-cv-04279; filed July 25, 2011 in the District Court of New Jersey

• Plaintiffs:  Pfizer, Inc.; Pharmacia & Upjohn Co., LLC; Pfizer Health AB
• Defendants:  Torrent Pharmaceuticals Ltd; Torrent Pharma Inc.

Infringement of U.S. Patent Nos. 6,630,162 ("Pharmaceutical Formulation and Its Use," issued October 7, 2003) and 6,770,295 ("Therapeutic Formulation for Administering Tolterodine with Controlled Release," issued August 3, 2004) following a Paragraph IV certification as part of Torrent's filing of an ANDA to manufacture a generic version of Pfizer's Detrol LA® (extended release tolterodine tartrate, used to treat overactive bladder).  View the complaint here.

Abbott Laboratories v. Hospira Inc.
1:11-cv-00648; filed July 21, 2011 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,136,799 ("Cosolvent Formulations," issued October 24, 2000) and 6,361,758 (same title, issued March 26, 2002) following a Paragraph IV certification as part of 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.

Nautilus Neurosciences, Inc. et al. v. Edict Pharmaceuticals PVT. Ltd.
2:11-cv-04183; filed July 20, 2011 in the District Court of New Jersey

• Plaintiffs:  Nautilus Neurosciences, Inc.; APR Applied Pharma Research SA
• Defendant:  Edict Pharmaceuticals PVT. Ltd.

Infringement of U.S. Patent Nos. 6,974,595 ("Pharmaceutical Compositions Based on Diclofenac," issued December 13, 2005), 7,482,377 ("Pharmaceutical Compositions and Methods of Treatment Based on Diclofenac," issued January 27, 2009), and 7,759,394 ("Diclofenac Formulations and Methods of Use," issued July 10, 2010) following a Paragraph IV certification as part of Edict's filing of an ANDA to manufacture a generic version of Nautilus' Cambia® (diclofenac potassium, used for the acute treatment of migraine attacks).  View the complaint here.

Comments

[Reddy B]

Dear Sir,
This is regarding Abbot & Hospira on Paricalcitol. as mentioned here, If Hospira filed NDA (505(b)(2) does it come under PIV filing?. What is the difference between Hopira's 505 (b)(2) application and Abbot's already aprroved NDA?

[Sherri]

Dear Reddy B:

NDAs under 505(b)(2) are similar to ANDA filings in many ways - they offer the option for a generic company to rely on data provided by the innovator to obtain FDA approval to market their product. And just like an ANDA filing, the generic filer must submit a certification - such as was done here, where Hospiral submitted a Para IV certification. The differences between an NDA under 505(b)(2) (also known as a "paper NDA") and an ANDA is that a 505(b)(2) NDA allows for certain differences between the generic product for which approval is sought and the approved innovator product - for example, changes in formulation, changes in dosage stregth, etc. So here, Abbott filed the original innovator NDA, and Hospira's NDA is one of a generic that will rely in part on Abbott's NDA to obtain FDA approval.

I hope this helps.

Sherri