Federal Court Sides With Novartis And Protects Gilenya Patent From Obviousness-Type Double Patenting

This decision arose from ANDA litigation relating to Novartis’s Gilenya® product for treating multiple sclerosis.
In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the Novartis Gilenya patent, the court confirmed that the statute permits an extended product patent to “effectively” block the practice of an earlier-expiring method patent, and refused to elevate the judicially-created doctrine of obviousness-type double patenting over the statutory grant of PTE. Pharmaceutical patent owners will welcome this decision as reinforcing the validity of patents during their PTE term, and may consider how it might apply to similar circumstances raised by a patent term adjustment (PTA) award.

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LIPITOR Patent Litigation Settled, Ranbaxy Will Market Generic Atorvastatin In The U.S.A

Ranbaxy will Market Generic Atorvastatin in the U.S. with 180 Days Exclusivity from Nov. 30, 2011

Agreement Also Resolves Caduet, Accupril Litigation in the US

Gurgaon, Harayana, India; Princeton, NJ, USA – June 18 , 2008

Ranbaxy Laboratories Limited (Ranbaxy), announced today that it has entered into an agreement with Pfizer Inc. to settle most of the patent litigation worldwide involving Atorvastatin (Lipitor), the world’s most-prescribed cholesterol-lowering medicine. This decision will allow for an earlier introduction of a generic formulation that will benefit patients and many healthcare systems throughout the world. Lipitor is the world's largest selling drug with worldwide sales in 2007 of $12.7 billion .

The agreement pertains solely to Ranbaxy and its affiliates and does not cover legal challenges to the Lipitor patents involving other generic manufacturers. However, as Ranbaxy was the first generic challenger to the listed Lipitor patents, it retains the right to the marketing exclusivity of 180 days in the United States. Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of Atorvastatin and the fixed-dose combination of Atorvastatin-Amlodipine besylate in the United States effective Nov. 30, 2011.

Welcoming the development, Malvinder Mohan Singh, CEO and MD, Ranbaxy Laboratories Ltd., said, “This comprehensively settles outstanding issues between Ranbaxy and Pfizer bringing to closure a number of ongoing patent disputes. It also provides certainty and visibility to the launch of Ranbaxy’s Generic Atorvastatin, with180 day market exclusivity in the US and an early entry in other markets. This will make the worlds largest selling drug more accessible to patients who will gain from the timely availability of an affordable quality option.”

Ranbaxy will also have a license to sell Atorvastatin on varying dates in an additional 7 countries, including: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia, Brunei, Peru and Vietnam.

In addition, the lawsuits between Pfizer and Ranbaxy regarding Atorvastatin will be dismissed in select countries and the lawsuits between Pfizer and Ranbaxy regarding the fixed dose combination product containing Atorvastatin and amlodipine will be dismissed in the U.S. and Ranbaxy will no longer contest the validity of Pfizer’s patents in such countries. Such patent challenges by Ranbaxy regarding Lipitor have been underway in numerous markets since 2003.

The Atorvastatin patents involved in this agreement are the basic compound patent, which expires in the United States in 2010; the enantiomer patent, which expires in the United States in 2011; and various process and crystalline form patents, which expire in 2016 and 2017; and the combination patent for fixed-dose combination product which expires in 2018.

The agreement also covers the fixed-dose combination of Atorvastatin-Amlodipine besylate (presently marketed under the brand Caduet, which also contains crystalline Form I Atorvastatin), a fixed-dose combination product indicated for patients suffering from both high blood pressure and high levels of cholesterol. The patent for the fixed-dose combination expires in 2018. The settlement also resolves additional patent litigation between the companies involving the branded drugs Accupril (in the U.S.) and Viagra (in Ecuador) and all patent litigation with Ranbaxy relating to generic formulation of Quinapril hydrochloride in the United States and Sildenafil in Ecuador.

Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -- Finland, Spain, Portugal, Denmark and Romania.

Tags: Drug Patents, LIPITOR, Ranbaxy Laboratories Limited, Ranbaxy, Pfizer, Caduet, Accupril Litigation, Atorvastatin

Bayer Schering Pharma AG files a patent infringement lawsuit against Watson Pharmaceuticals, Inc., and Sandoz, Inc. Over Contraceptive Yasmin

Leverkusen, April 21, 2008 – Bayer confirmed that Bayer Schering Pharma AG and Bayer HealthCare Pharmaceuticals Inc. filed a patent infringement lawsuit in U.S. Federal Court in the Southern District of New York (New York) against Watson Pharmaceuticals, Inc., Watson Laboratories, Inc. and Sandoz, Inc. Bayer Schering Pharma’s suit concerns Watson’s and Sandoz’s respective applications to the FDA for approval to market a generic form of Bayer Schering Pharma’s oral contraceptive Yasmin®. The patent at issue in the suit is Bayer Schering Pharma’s U.S. Patent No. 5,569,652.
Health Law, Drug Patents, Bayer Schering Pharma,Watson Laboratories, Sandoz,Watson Pharmaceuticals,yasmin

Thailand By Passes Patents on Cancer Drugs to cut the cost of medicines for the Thai people.

Thailand's new health minister announced that he would urge the Thai government to continue to ignore patents on several cancer drugs, disappointing big pharmaceutical companies that had hoped Bangkok might roll back a policy of overriding patents in the name of public health.

The drugs' makers include Roche Holding AG and Novartis AG of Switzerland and Sanofi-Aventis of France.

Suphan Srithamma, a spokesman for the Thai health ministry, said that Minister Chaiya Sasomsup has decided to support the previous government's decision to ignore cancer-drug patents in a bid to cut the cost of medicines for the Thai people. The health ministry will make its recommendation to the Thai cabinet today, according to Dr. Suphan.

Thailand's previous health minister, Mongkol na Songkhla, decided in early January to issue compulsory licenses (a policy that permits lower-cost generics) for four drugs: Novartis's imatinib, also known as Gleevec; Novartis's breast-cancer drug letrozole, whose brand name is Femara; Sanofi-Aventis's docetaxel, marketed as Taxotere and used to fight lung and breast cancer; and Roche's erlotinib, whose trade name is Tarceva.

Continue to read at Wall Street Journal

tag: Drug Patents, Thailand, Roche Holding AG, Novartis AG, Sanofi-Aventis, cancer drugs, Thai health ministry, imatinib, Gleevec, letrozole, Femara, docetaxel, Taxotere, erlotinib, Tarceva, breast cancer