Thursday, March 7, 2013

Pfizer Files Case against Generic Drug Makers

Plaintiffs: G.D Searle, Pfizer
Defendants: Lupin, Mylan, Teva, Watson, Apotex
Case Number: 2:13-cv-00121
Court: Virginia Eastern District Court
Date Filed: Mar 05, 2013
Patent-in-Suit: USRE44048
The patent involved in this suit is assigned to G.D Searle LLC as per face page. The patent entitled 4 [5 (4-methylphenyl) 3 (trifluoromethyl) 1H pyrazol 1 YL]benzenesulfonamide for the treatment of inflammation or an inflammation-associated disorder was issued on March 05, 2013 and expires[i] by Mar 05, 2030.
The Parties:
G. D. Searle, LLC is a research-based pharmaceutical company that manufactures and markets prescription pharmaceuticals and other healthcare solutions worldwide. G.D Searle is a wholly owned subsidiary of Pfizer.

Pfizer is a research-based, global biopharmaceutical company. The company's diversified global healthcare portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products.

Mylan Pharmaceuticals is a manufacturer of generic prescription and specialty drugs with facilities for large scale manufacture of active pharmaceutical ingredient (API). Mylan's medicine cabinet holds generic versions of antibiotics, antidepressants, anti-inflammatories, and respiratory agents in a range of delivery forms.

Teva Pharmaceutical Industries develops, manufactures, markets, and distributes pharmaceutical products worldwide. It offers generic pharmaceutical products; and basic chemical entities, as well as specialized product families, such as sterile products, hormones, narcotics, high-potency drugs, and cytotoxic substances.

Lupin is a manufacturer of the anti-TB drugs based in Mumbai, Maharashtra, India. The company production lines include the cardiovascular (prils and statins), diabetology, asthma, pediatrics, CNS, GI domains, apart from anti-infectives and NSAIDs.

Apotex is a pharmaceutical company engaged in the research and development, manufacture, and distribution of generic pharmaceuticals. It offers products in various dosage forms, such as liquids, ophthalmics, nasal sprays, and injectables. Apotex Inc. operates as a subsidiary of Apotex Pharmaceutical Holdings Inc.

Watson Pharmaceutical is engaged in the development, manufacture, marketing and distribution of generic pharmaceuticals in a number of therapeutic categories and specialized branded pharmaceutical products. Watson also distributes generic and branded pharmaceuticals through Anda, Inc.

As in Complaint:
Defendants with the Abbreviated New Drug Application (ANDA) No. 202240 (Lupin), 76-898 (Teva), 78-857 (Mylan), 200562 (Watson) and 204197 (Apotex) seeks approval of FDA to market a generic version of Pfizer’s pharmaceutical product Celebrex®, which is covered by the patent-in-suit.
G.D Searle is the current holder[ii] of the New Drug Application (NDA) no. 20-998 for Pfizer’s Celebrex, (source: Patent Marker) (see Fig. 1) for 50mg, 100mg, 200mg, and 400 mg dosage strengths that is approved by FDA on Dec 31, 1998.  Celebrex is used to treat pain or inflammation caused by many conditions such as arthritis and ankylosing spondylitis. It is also used in the treatment of hereditary polyps in the colon.

If you are interested in knowing about the other cases filed by plaintiffs, please contact us.To get alerts on cases filed, subscribe to our Litigation Alerts.

[i] Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents.
[ii] Patent Marker provides an online environment where patentees can virtually mark products and search for patent-related information.

No comments:

Post a Comment