Knobbe/Martens: Intellectual Property Law



Hatch-Waxman Litigation

Ranbaxy Labs. Ltd. v. Vertex Pharmaceuticals, Inc.
In one of the first inter partes review (“IPR”) petitions to challenge the validity of a patent protecting a branded pharmaceutical, Knobbe Martens achieved a positive settlement for Ranbaxy. In 2012, another generic producer challenged the validity of patent claims protecting Vertex's Lexiva product for treatment of HIV-1 and was later sued by Vertex for patent infringement. Ranbaxy filed an IPR petition  challenging the same patent claims as obvious over the prior art. The PTAB granted Ranbaxy’s petition and instituted the IPR. The PTAB’s institution of the IPR, as well as the ensuing proceedings, resulted in a favorable settlement.

Pfizer, Inc. v. Ranbaxy Labs., Ltd.
The firm successfully represented Ranbaxy in trial and before the U.S. Court of Appeals for the Federal Circuit in Ranbaxy's efforts to be the first company to seek approval to market a generic version of the world's best-selling drug, Pfizer's cholesterol-reducing drug Lipitor®. On appeal, the Federal Circuit invalidated one of the patents protecting Lipitor, shortening Pfizer's patent protection by fifteen months. Through our representation, Ranbaxy ultimately obtained a favorable settlement, and was able to successfully launch its generic product with six months of market exclusivity.

Glaxo Group Ltd. v. Ranbaxy Pharmaceuticals, Inc.
The firm successfully defended Ranbaxy in a patent infringement lawsuit brought by GlaxoSmithKline (“GSK”). Ranbaxy prevailed in its appeal to the Federal Circuit and overturned a preliminary injunction that had prevented Ranbaxy from marketing a generic version of GSK's anti-infective drug Ceftin®. Post appeal and after a six-week bench trial, the district court determined that Ranbaxy’s product does not infringe and Ranbaxy was not required to pay any monetary damages to GSK.

AstraZeneca v. Handa Pharmaceuticals
The firm successfully represented Handa Pharamceuticals, the first-to-file on Seroquel® XR, one of AstraZeneca's largest products. The firm obtained a favorable settlement on the courthouse steps prior to trial.

In re Metoprolol Succinate Patent Litigation
The firm represented Watson Pharmaceuticals in obtaining summary judgment of both invalidity and inequitable conduct against AstraZeneca with respect to Toprol® XL. The Federal Circuit affirmed the invalidity judgment and remanded for further proceedings with respect to inequitable conduct and potential exceptional case attorney fee issues. AstraZeneca subsequently settled the remaining exposure with Watson Pharmaceuticals. 


Alios BioPharma
The firm handled the intellectual property aspects of Alios Biopharma’s recent collaboration deal with Vertex Pharmaceuticals. Alios is a biopharmaceutical company that employs molecular modeling and replicon assays for drug screening. Vertex obtained rights to two hepatitis C drugs from Alios in a transaction worth up to $1.5 billion, said to be the largest preclinical licensing deal in history. Knobbe Martens developed an IP strategy for Alios, filed Alios’ patent applications, analyzed potential third party risks and strategies for market clearance, and assisted Alios in the due diligence aspects of the deal with Vertex.

Trius Therapeutics
Hospital-acquired infections are one of the leading causes of death in the US. These infections, many of which are caused by bacteria, have become increasingly resistant to antibiotic treatment. With the continuous increase in bacterial resistance to currently marketed drugs, serious infections are becoming more difficult, if not impossible, to treat, and this has led to a clear need for novel therapeutics to treat multi-drug resistant bacterial infections. Our client Trius Therapeutics has developed a next-generation oxazolidinone antibiotic (torezolid). This antibiotic is chemically differentiated from and designed for improved potency, resistance and spectrum of activity over Pfizer’s first generation oxazolidinone, Zyvox®, which sells over $1 billion annually. Torezolid is also effective against the serious infectious strains that are resistant to Zyvox. Torezolid is currently in Phase 3 clinical trials -- the last stage of development before seeking FDA approval to market the drug in the US -- for the treatment of serious gram-positive bacterial infections, including those caused by methicillin-resistant Staphylococcus aureus, or MRSA. Torezolid has shown in previous clinical studies to be safe, efficacious, rapid acting, cost effective and convenient. Knobbe Martens serves as IP counsel to Trius for matters related to the US patent portfolio and also manages the licensed worldwide patent portfolio covering torezolid.

Avanir Pharmaceuticals
The firm successfully prosecuted a world-wide patent portfolio for Avanir covering Docosanol and related long-chain fatty alcohols and their uses in topical and systemic antiviral therapies. The topical antiviral uses of docosanol received marketing approval from the FDA, under the name Abreva®, for treating cold sores caused by the herpes simplex virus. The firm was further successful in obtaining five years of Patent Term Extension for the key Abreva patent for regulatory delays under 35 U.S.C. 156, and in representing Avanir in negotiating a deal with GlaxoSmithKline for marketing Abreva.

The firm developed a large patent portfolio surrounding danoprevir, an HCV protease inhibitor, for our client InterMune, Inc. In addition to obtaining several key patents, the firm filed suit against the U.S. Patent Office on behalf of InterMune to maximize the patent term adjustment awarded to the U.S. patent. After successfully prosecuting the danoprevir portfolio world-wide, the firm handled the intellectual property aspects of the negotiations and ultimate $175 million cash deal with Hoffman-La Roche giving them the development and commercialization rights to danoprevir.

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