Teva Settles Generic Eloxatin Litigation

Patent infringement litigation pertaining to Teva's generic version of sanofi-aventis and Debiopharm's Eloxatin (oxaliplatin injection) has been dismissed by the United States District Court for the District of New Jersey pursuant to a settlement between the parties. The settlement, which provides for a full release of Teva, includes an injunction prohibiting Teva from selling its oxaliplatin injection product and a license to reenter the market at a later point in time. Teva anticipates continued sales of its oxaliplatin injection at least through June 30, 2010, and will resume shipping additional units August 9, 2012, subject to acceleration under certain contingencies.

Teva Pharmaceutical Settles Lawsuit With Novartis

Teva Pharmaceuticals USA, Inc., has signed an agreement with Novartis to settle patent litigation involving Teva’s U.S. generic version of Novartis’ Famvir(R) (famciclovir) 125 mg, 250 mg and 500 mg tablets including all claims for patent infringement and damages. Teva launched its generic famciclovir tablets in the U.S. in September 2007. The present agreement releases Teva for all past and future activities in connection with the U.S. marketing and sale of Teva’s generic famciclovir tablets. Under the terms of the agreement, Teva will make a one-time payment to Novartis in addition to an ongoing royalty on U.S. sales of the generic product.

Teva sends ANDA certificate notification to Gilead Sciences for Viread

Gilead Sciences announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an ANDA to the USFDA requesting permission to manufacture and market a generic version of Viread^® (tenofovir disoproxil fumarate). In the notice letter, Teva alleges that three patents associated with tenofovir disoproxil – US Patent Numbers 5,922,695; 5,977,089; and 6,043,230; and one patent associated with tenofovir disoproxil fumarate – US Patent Number 5,935,946 – owned by Gilead Sciences are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA submission. 

Gilead is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva. Such a lawsuit would restrict the FDA from approving Teva's ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first. Viread is currently protected by four patents, which are listed in the FDA's Approved Drug Products List, and all four patents would need to be invalidated or expired before a generic version of Viread could be marketed. The USPTO confirmed the patentability of these four Viread patents in 2008.

Gilead currently has a lawsuit pending against Teva in response to Teva's attempts to seek approval for generic versions of Truvada^® (emtricitabine and tenofovir disoproxil fumarate) and Atripla^® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on allegations that two emtricitabine patents are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of its generic product.

Watson files ANDA for generic LoSeasonique® [(levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg)]

Watson has filed an ANDA with the USFDA seeking approval to market its levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg) oral contraceptive product prior to the expiration of US Patent No. 7,615,545, which is owned by Duramed Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceutical Industries, Ltd.

On November 23, 2009, pursuant to the Hatch-Waxman Act, Watson notified Duramed that its ANDA requesting approval from the FDA for a generic version of LoSeasonique® contained a paragraph IV certification asserting that the LoSeasonique® patent is invalid, unenforceable and/or not infringed. Teva Women's Health, Inc. filed suit against Watson on January 6, 2010 in the U.S. District Court for the District of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 7,615,545. Based on available information, Watson believes it may be entitled to 180 days of generic market exclusivity or shared exclusivity should its product receive approval.

Medicines Company files additional Patent Infringement Lawsuits

The Medicines Company has filed lawsuits against Teva Parenteral Medicines, Inc., Pliva Hrvatska d.o.o. and related entities in the United States District Court for the District of Delaware alleging patent infringement based on ANDA seeking USFDA approval to market and sell generic versions of The Medicines Company's Angiomax(R) product prior to expiration of U.S. Patent No. 7,598,343 ("the '343 patent"). Each lawsuit alleges infringement of the '343 patent which was issued on October 6, 2009. As per an earlier announcement, The Medicines Company has patent infringement lawsuits pending against the same parties in the United States District Court for the District of Delaware for infringement of its U.S. Patent No. 7,502,727.

Teva entered into agreement with AstraZeneca regarding Prilosec® (omeprazole) and Nexium® (esomeprazole) generics

Teva Pharmaceuticals has entered into two definitive agreements with AstraZeneca to settle patent litigation regarding Teva's US generic versions of AstraZeneca's Prilosec® (omeprazole) and Nexium® (esomeprazole), including all claims for patent infringement and damages. Under the terms of the omeprazole agreement, Teva will obtain a release for all past sales of its generic omeprazole and will continue to market its product in the US and will make a one-time payment to AstraZeneca. As part of the esomeprazole agreement, AstraZeneca has granted Teva a license, subject to regulatory approval, to enter the US market with its generic esomeprazole delayed-release capsules on May 27, 2014, or earlier in certain circumstances. Additional details were not disclosed. Merck Sharp & Dohme Corp, through KBI Inc. and KBI-E, and under the terms of Merck's restructured partnership with AstraZeneca, announced in 1998, also entered into the settlement agreements.

Trial date set for CUBICIN® (daptomycin for injection) patent litigation

A trial date has been set for patent litigation in the U.S. District Court for the District of Delaware against Teva alleging infringement of Cubist's US Patent Nos. 6,468,967 and 6,852,689 (expiry September 24, 2019) and US Patent No. RE39,071 (expiry June 15, 2016). The Court has set a date for trial beginning on April 25, 2011. The court also scheduled a claim construction hearing (a.k.a. Markman hearing) for June 2, 2010. The court indicated that summary judgment motions will not be permitted in this lawsuit. Cubist filed the lawsuit in response to an ANDA filed by TPM seeking USFDA approval to market a generic version of daptomycin prior to the expiration of Cubist's patent rights. Daptomycin is marketed in the US and internationally under the brand name CUBICIN® (daptomycin for injection) as therapy for serious skin and bloodstream infections caused by certain Gram-positive bacteria.

Cephalon files an infringement suit on Teva for NUVIGIL® (armodafinil) Tablets

Cephalon, Inc. it has filed a lawsuit in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. for infringement of U.S. Patent Nos. 7,132,570 (the "'570 Patent"), 7,297,346 (the "'346 Patent") and RE37,516 (the "'516 Patent") for the Cephalon product NUVIGIL® (armodafinil) Tablets [C-IV]. Cephalon has a three-year period of marketing exclusivity for NUVIGIL that extends until June 15, 2010. In addition, including the six-month pediatric extension, the '516 Patent, the '346 Patent, and the '570 Patent expire on April 6, 2015, May 29, 2024, and June 18, 2024, respectively.

Teva did not challenge Orange Book-listed U.S. Patent No. 4,927,855 (the "'855 Patent"), which provides additional protection until October 22, 2010, the expiration date of the '855 Patent. The lawsuit is based upon an Abbreviated New Drug Application (ANDA) filed by Teva seeking FDA approval for a generic equivalent of armodafinil to be sold in the United States. Teva alleges that the above NUVIGIL patents are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA.