Pharmaceuticals

The world’s leading generic pharmaceutical companies and a large number of pharmaceutical and drug development companies rely on us for the insight, innovation and expertise they need to succeed in an increasingly competitive marketplace.

We routinely represent pharmaceutical companies that specialize in the development of small molecule and biologic drugs—providing full-scale services that include everything from product conception to exit strategies. Our legal and technical expertise spans virtually all therapeutic areas and stages of the drug development process. Likewise, our clients cover the spectrum from venture-funded startups and university spin-offs to publically-traded companies. The majority of our lawyers and patent scientists hold advanced degrees in chemistry, biology, or a closely related field. A large number also have worked in the pharmaceutical industry, enabling them to deliver keen business insight on issues facing our clients.

Our services entail all aspects of the patent process, including but not limited to patentability, infringement, and validity searches and opinions (with extensive chemical structure search experience); preparation, filing and prosecution of patent applications both domestically and worldwide; appeals and interferences; and reexaminations and reissues. In addition, we offer broad-based strategic portfolio management – helping our clients to develop interlocking families of patents that cover the entire pharmaceutical life cycle and maximize the patent term.

We’re also adept at providing guidance, due diligence, and agreement drafting for investors and pharmaceutical companies regarding a number of business-critical issues, including research collaborations, in-licensing, out-licensing, asset divestiture, mergers and acquisitions, and public offerings. And, we foster opportunity by providing access to several venture capital and angel investing groups.

As the pharmaceutical industry has evolved, so have we. Today we represent some of the world’s largest and most successful generic pharmaceutical companies—helping them bring generic versions of many of the world’s best-selling and well-known drugs to market, while maximizing and monetizing their pharmaceutical opportunities. Our services span every aspect of pharmaceutical-related intellectual property, including strategic counseling, litigation under the Hatch-Waxman Act, settlement, pre-suit analysis and Paragraph IV letters, and opinion letters.

We have multiple litigators who have firstchaired trials and appeals for several key drugs. We also have represented companies holding first-to-file status on several of the world’s best-selling drugs. Our trial teams are supported by several attorneys who hold advanced degrees in chemical sciences. We also have attorneys who have served in key positions at leading pharmaceutical firms, giving us a solid understanding of critical business issues facing our pharmaceutical clients.

Representative Engagements

Hatch-Waxman Litigation

Anchen Pharmaceuticals, Inc.

Ebewe Pharma

Handa Pharmaceuticals

Impax Laboratories

Kremers Urban Pharmaceuticals

Lupin Ltd.

Mylan

Ranbaxy Pharmaceuticals

Teva Pharmaceuticals USA

Watson Pharmaceuticals

Wockhardt USA

Pharmaceuticals

Alios BioPharma

Avanir Pharmaceuticals

Burnham Institute

Cincinnati Children’s Hospital

InterMune

MannKind Corporation

Medicis Pharmaceutical Corporation

Mpex Pharmaceuticals

Nitto Denko

Orexigen Therapeutics

Pacira Pharmaceuticals

Rempex Pharmaceuticals

Somaxon Pharmaceuticals

Trius Therapeutics

University of California at San Diego

Representative Exits

Mpex Pharmaceuticals – Acquisition by Aptalis Pharma

Pacira Pharmaceuticals – Initial Public Offering

Somaxon Pharmaceuticals – Initial Public Offering

Trius Therapeutics – Initial Public Offering

Orexigen Therapeutics – Initial Public Offering

Successes

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. 

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.

InterMune

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.

Large Quantity of Routine Experimentation Can Be “Undue Experimentation”
Patent Claim Reciting a List “Consisting Essentially of” Is Indefinite Where the Basic and Novel Property of the Invention Is Indefinite
Completion of Phase I Safety Trials for FDA Approval May Not Be Sufficient to Show Reasonable Expectation of Success