Practice Areas & Industries: Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.

Practice/Industry Group Overview

Breakthrough discoveries and innovations require strong protection
Millions of people rely on the pharmaceutical industry for life-saving drugs and treatments that improve the quality of life. Even with billions of dollars invested in research and development, few drugs actually make it through the clinical trials and stringent regulatory clearances necessary to get to market. When they do, it is crucial for companies to protect the intellectual property underlying new drugs and treatments. The revenues from these products support the cycle of research and development for new generations of drugs and treatments. Finnegan has a long history of working with innovative pharmaceutical companies to protect and maximize their valuable IP rights and assets.

Legal strength, experience, and insight
As scientific discoveries advance in areas such as genetics, neuroscience, immunology, and stem cells, pharmaceutical companies are developing drugs and procedures that more effectively target and treat diseases. Many are partnering with biotechnology and diagnostic firms to develop groundbreaking methods of identifying, preventing, and treating disease. Finnegan’s lawyers understand the complex technological and legal implications presented by these arrangements and how they affect the parties’ strategic goals. The fast pace of new discoveries and their commercial applications requires a law firm that has a comprehensive grasp of the IP legal issues and the experience and industry expertise to understand the science and strategic implications of the advancements.  Our pharmaceutical practice  includes more than 85 attorneys and professionals dedicated to serving the IP needs of pharmaceutical companies. More than half of our attorneys in our pharmaceutical practice hold doctorate degrees in relevant sciences such as molecular biology, biochemistry, immunology, and pharmacology. Thirty-four members of this group joined Finnegan after holding positions in industry or at universities, and seven served as examiners with the U.S. Patent and Trademark Office.

Services Available

We have addressed virtually every type of IP issue for our pharmaceutical clients. Our experience includes:

• Representing clients in complex Hatch-Waxman litigation.
• Developing and executing prosecution strategies—to both protect a client’s products and analyze those of its competitors—to help ensure that the client realizes value from its IP assets.
• Preparing and negotiating licenses, assessing the licensing value of competitors’ patents, and guiding our clients in decisions to license.
• Providing due diligence for merger and acquisition and partnership targets.
• Providing counsel on business-related matters, including antitrust and competition issues.
• Determining priority in complex interferences.
• Providing trademark prosecution and counseling services.
• Advising on potential litigation strategies, and asserting and defending patents in court.

Multinational companies need a firm with a global focus
Our clients’ business and IP assets are global, and protection of these assets is increasingly challenging. Strong growth in the European Union will help boost European sales over the next five years. And changes in Asia are affecting the industry—continued double-digit market growth in China will make it the seventh largest drug market in sales in the next few years.  With offices around the world and experience with multinational companies, Finnegan has the resources and expertise to formulate and execute global strategies for pharmaceutical companies. With an expanding presence in Asia, a well-established base in Europe, and offices across the U.S., we work with our clients in real time and regularly appear on their behalf in the International Trade Commission, courts throughout the U.S., and the U.S. Patent and Trademark Office.

Far-reaching experience
Our experience in the pharmaceutical industry is broad. We work with clients on the cutting edge of scientific advancement:

• AIDS antibody test kits
• Antibiotics isolated from natural products
• Antibody therapy
• Anticancer drugs
• Atypical antipsychotic drugs
• Sustained release formulations
• Gene therapy
• Genetic engineering
• Nucleic acid sequence based amplification (NASBA) kits
• Recombinant growth factors
• Recombinant human insulin
• Vaccines

Leading pharmaceutical companies count on Finnegan
We work with innovative pharmaceutical clients of all sizes, including Fortune 100, Global 1000, start-ups, and public and private companies:

• Akros Pharma, Inc.
• AstraZeneca
• Cubist Pharmaceuticals
• Dyax Corp.
• Elan Corporation, PLC
• Eli Lilly and Company
• Ferring Pharmaceuticals
• Forest Laboratories
• Otsuka Pharmaceuticals
• sanofi-aventis
• Solvay Pharmaceuticals
• Vertex Pharmaceuticals
• Wyeth

Representative Engagements

A high-impact result for R&D licensing programs in the pharmaceutical industry
In this ANDA case, our client, Elan Corporation PLC, filed suit to prevent infringement of its patent directed to naproxen formulations for once-daily oral administration. The district court held Elan’s patent claims invalid in view of Elan’s offer to license technology directed generally to the joint R&D of such pharmaceutical products. The Federal Circuit vacated the district court’s holding and remanded the case so that Elan could pursue its claims on the merits.

Award of priority granted in case of treatment of PMS
We represented Novagen Research of Australia against Tufts College in successfully obtaining an award of priority against the patentee. The case involved a method for treating or ameliorating the symptoms of menopause or PMS by administering extracted isoflavones.

Pharmaceutical company wins judgment based on filing date
We assisted our client Elan Pharmaceuticals in obtaining a judgment against Paradissis based on the benefit of the earlier filing date of Elan’s foreign priority application. The subject involved controlled-release pharmaceutical formulation for once-per-day administration.

Securing rights for hemophilia treatment
We represented Wyeth against Genentech in an interference that related to the treatment of hemophilia. The successful result we achieved allowed Wyeth to secure patent rights to a protein, known as B-domain deleted Factor VIII, which is used to treat hemophilia.

Strategic alliance in medical diagnostics
Our client had the technology and the IP but not the market presence. A major pharmaceutical company needed a portfolio of diagnostic products. We assisted our client in a lengthy negotiation over a partnership arrangement that allowed both companies to prosper. While IP was an important part of the transaction, we assisted in creating contractual protection of the client’s business interests, particularly in the event of a separation.

Victory at the ITC and Federal Circuit keeps the U.S. market open for Hoechst AG
Finnegan successfully defended Hoechst against patent infringement claims by Kaken Pharmaceuticals in the ITC. Kaken sought to exclude Hoechst’s agricultural feed products containing salinomycin, an antibiotic, from U.S. markets. We persuaded the ITC that the Kaken patents were invalid and unenforceable on the grounds of inequitable conduct.

When the patent for Zyprexa® and $2 billion in annual revenue were on the line, Eli Lilly turned to Finnegan
This ANDA case involved Zenith and two other generic drug manufacturers that attempted to invalidate Lilly’s patent and thereby open the market for generic sales. The lengthy trial involved complex technical and legal issues—calling upon our deep experience in both areas. Lilly prevailed in the district court on all issues, protecting its exclusive marketing rights and a large revenue stream. The Federal Circuit later affirmed the lower court’s decision, which upheld Lilly’s patent on its blockbuster drug.

With hundreds of millions of dollars at stake in revolutionary technology involving genetic engineering, Finnegan prevails for Eli Lilly
Finnegan represented Eli Lilly in a landmark case brought by The Regents of University of California (UC). Two patents were at stake and both involved recombinant human insulin. UC claimed that its patents directed to DNA sequences that encode human proinsulin (a precursor to human insulin) covered Lilly's recombinant human insulin product. They argued that Lilly owed them hundreds of millions of dollars for infringing two of its patents. Finnegan succeeded in establishing that one patent was not valid and that the other patent was not infringed.