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Life Sciences - Patent Litigation

“This firm is a heavyweight in patent litigation. Kaye Scholer has an exceptionally strong reputation for biotech work, and is known for its representation of branded pharmaceutical companies.”—Chambers USA 2012 (National: Intellectual Property).
“Kaye Scholer’s IP lawyers combine high trial and litigation standards with extensive knowledge of patent law, science and engineering.”—2012 Euromoney LMG Life Sciences Guide.

Our partners have strong track records when it comes to trying exceptionally complicated patent infringement cases, particularly in the life sciences and technology industries. As authors of Pharmaceutical and Biotech Patent Law (PLI, 2004, 2011), Kaye Scholer’s patent lawyers set the standard when it comes to advising on Hatch-Waxman suits against generic infringers; general patent infringement litigation for research-based pharma and biotech companies and universities; life cycle management; and the impact of the America Invents Act for life sciences companies.

Many of our intellectual property lawyers have degrees in chemistry, biochemistry, engineering or computer science, which allows us to quickly grasp the most sophisticated scientific concepts and make them understandable to judges and juries.

Viagra® patents
For more than 10 years we have been representing Pfizer in connection with IP litigation matters worldwide aimed at preserving Pfizer’s market exclusivity with respect to Viagra®. Recently, we defeated an attempt by Teva to market a generic version of Viagra® in the US. After a 12-day bench trial, the Eastern District of Virginia ruled that Teva’s proposed copy would infringe a Pfizer patent claiming the use of Viagra® to treat erectile dysfunction. The court rejected Teva’s invalidity and unenforceability arguments and ultimately awarded Pfizer a portion of its attorney fees relating to Teva’s assertion of an unfounded inequitable conduct claim.

Anti-Tumor Necrosis Factor Antibody Patents
We represented Rockefeller University and Chiron (now Novartis Vaccines & Diagnostics) in asserting patents directed to pharmaceutical compositions containing and methods of treatment using antibodies that neutralize Tumor Necrosis Factor against Centocor’s Remicade® product and against Abbott’s Humira® product, both of which are prescribed to treat inflammatory diseases such as rheumatoid arthritis. During litigation in the Eastern District of Texas, Novartis reached a favorable settlement with Centocor (J&J), which took a royalty-bearing license. By agreement, plaintiffs’ patent infringement claims against Abbott were shifted to arbitration and tried to an arbitration panel, resulting in an award to plaintiffs.

TOBI® inhalable antibiotic patent
We represented Seattle Children’s Hospital and Novartis in several Hatch-Waxman patent litigations regarding TOBI®, an inhalable antibiotic formulation for treatment of cystic fibrosis patients. The litigation against Roxane resulted in withdrawal of Roxane’s ANDA. We achieved a successful settlement of the litigation against Teva. A case against Akorn is pending in the Northern District of Illinois.

Allegra® patents
Since 1994 and continuing to date, Sanofi-Aventis and its predecessor companies have entrusted Kaye Scholer with protecting its non-sedating antihistamine products, Seldane® and Allegra®, in Hatch-Waxman litigations against numerous generic drug companies.

Human Genome patent cases
We are representing Complete Genomics in two lawsuits relating to Complete Genomics’ disruptive sequencing technology. This groundbreaking technology has driven the cost of sequencing of human genomes well below $5,000 per genome. The first suit relates to a patent for pair wise sequencing. Plaintiff accuses the Complete Genomics Analysis Platform, including its cPal technology, of infringing the patent-in-suit, and seeks an injunction. The second patent concerns sequencing by ligation. Plaintiff accused the client of infringing the patent-in-suit and sought an injunction that would shutter Complete Genomics’ business. On October 16, 2012, the court granted Complete Genomics’ motion for summary judgment that plaintiffs’ DNA sequencing patent was invalid – a huge victory for our client.

Tarceva® in ANDA case
We represented clients OSI Pharmaceuticals, Inc., Pfizer, Inc. and Genentech, Inc. in defeating a challenge by generic drug manufacturer Mylan Pharmaceuticals, Inc. (Mylan), which was seeking FDA approval to market a generic version of Tarceva®. Annual worldwide sales of Tarceva total approximately one billion dollars. After a 5-day bench trial, the U.S. District Court for the District of Delaware ruled that “Mylan did not meet its burden to demonstrate that the patents are invalid by clear and convincing evidence.” The district court decision is on appeal to the Federal Circuit.

Merial’s Frontline®
We are currently representing the plaintiff in Merial v. Fujita Pharmaceuticals, a patent infringement action before the Tokyo District Court regarding Merial’s blockbuster medication for cats and dogs, Frontline. We are also representing Merial in an ongoing case before the IP High Court in Japan, which is an appeal from an invalidation trial of the same patent.

Case Study: Hepatitis C patents
When Chiron (now Novartis Vaccines & Diagnostics) needed patent lawyers to preserve and assert the intellectual property rights protecting its landmark discovery of the Hepatitis C Virus (HCV), it turned to Kaye Scholer. We first represented Chiron in defeating a suit in the Northern District of California brought by a former Center for Disease Control scientist who alleged inventorship and ownership of the client’s patents on HCV. Subsequently we represented Chiron in patent litigation suits against Roche alleging infringement of Chiron’s patents directed to the detection of HCV. After winning summary judgment dismissing each of Roche’s various defenses and obtaining an outcome-determinative claim construction, Roche surrendered and entered into a consent judgment of patent validity and infringement. Roche ultimately took a license paying a very high running royalty which continues to date. We continue to represent Novartis in litigation and licensing of its HCV patents with respect to the latest HCV therapeutics, protease inhibitors.

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