Experience

Pharmaceutical

About

Pharmaceutical is part of our work in Life Sciences.

Breakthrough discoveries and innovations require strong protection

People rely on the pharmaceutical industry for life-saving drugs and treatments, as well as those that improve the quality of life. Even with billions of dollars invested in research and development, few drugs make it through clinical trials and stringent regulatory clearances necessary to get to market. For those that do, it is crucial that the companies have protected the intellectual property (IP) underlying new drugs and treatments. Finnegan has a long history of working with innovative pharmaceutical companies to protect and maximize their valuable IP rights and assets, strategizing prosecution pathways and portfolio planning.

Understanding the law, science, and technology

Our clients’ business and IP assets are global; protecting these assets across jurisdictions is increasingly challenging. With offices around the world and experience with multinational companies, Finnegan has the resources and experience to formulate and execute global strategies for pharmaceutical companies. The fast pace of new discoveries and their commercial applications require a comprehensive grasp of the IP legal issues and the industry insight to understand the scientific and strategic implications of the advancements.

With experience addressing virtually every type of IP issue for our pharmaceutical clients, we help by:

Representing clients in complex pharmaceutical patent infringement and trade secret cases, including Hatch-Waxman litigation
Litigating high value products in district and appellate courts with experienced trial and appellate teams
Developing and executing prosecution strategies to both protect a client’s products and analyze those of its competitors, thus helping ensure that the client realizes value from its IP assets
Preparing and negotiating licenses, assessing the licensing value of competitors’ patents, and guiding 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
Advising on potential litigation strategies, and asserting and defending patents in court
Providing trademark prosecution and counseling services

We work with clients innovating and advancing science in myriad fields, including:

Antibody therapies—small and large molecules
Atypical antipsychotic drugs
Sustained-release formulations
Vaccines

Contacts

Justin J. Hasford: Partner; Washington, D.C.; +1 202 408 4175; Email

Howard W. Levine: Partner; Washington, D.C.; +1 202 408 4259; Email

Charles E. Lipsey: Partner; Reston, VA; +1 571 203 2755; Email

Jill K. MacAlpine, Ph.D.: Partner; Washington, D.C.; +1 202 408 4105; Email

Leslie A. McDonell: Partner; Boston, MA; +1 617 646 1650; Email

James B. Monroe: Partner; Washington, D.C.; +1 202 408 4159; Email

Barbara R. Rudolph, Ph.D.: Partner; Washington, D.C.; +1 202 408 4346; Email

Erin M. Sommers, Ph.D.: Partner; Washington, D.C.; +1 202 408 4292; Email

Linda A. Wadler: Partner; Washington, D.C.; +1 202 408 4037; Email

Everyone in this industry

Experience

Represents Bausch Health Companies (f/k/a Valeant), Salix, and Progenics in Hatch-Waxman patent infringement litigation concerning an ANDA for generic oral versions of Relistor® tablets. The District of New Jersey granted judgment in favor of Valeant following trial on U.S. Patent No. 8,524,276 covering Relistor® tablets through 2030.

2:16-cv-09038, D.N.J., Judges Chesler, Waldor

Representing AstraZeneca in Abbreviated New Drug Application (ANDA) litigation against Zydus on its Farxiga^® pharmaceutical drug product.

1:18-cv-00664, D. Del., Judge Andrews

Representing Vifor and American Regent in two Hatch-Waxman Act cases against Mylan and Sandoz regarding their attempts to obtain FDA approval for their respective ANDAs directed to generic copies of Injectafer®. The cases are currently pending in the District of New Jersey.

3:19-cv-13955, 3:19-cv-16305, D.N.J., Judges Wolfson, Arpert

Representing Bial in district court Hatch-Waxman litigation involving the anti-epileptic drug Aptiom®.

1:18-cv-00304; 1:18-cv-00382; 1:18-cv-00341; 1:18-cv-00342; 1:18-cv-00336; 1:18-cv-00312; 1:18-cv-00775; 1:18-cv-00279, D. Del., Judges Connolly, Thynge

Appellate counsel for Valeant and Salix, successfully argued motion to disqualify opposing counsel at Federal Circuit.

18-2097, Fed. Cir., Judges Lourie, O'Malley, Reyna

Finnegan prepared and prosecuted patents for startup Hutchison Medipharma in the United States for the treatment of metastatic colorectal cancer. Those patents cover a small molecule, fruquintinib, which received approval in China.

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