James Matthew Gould

Jim Gould specializes in the pharmaceutical and biotech sectors and previously held high level positions for almost 20 years with Merck & Co./Schering-Plough, most recently serving as a Legal Director at Merck, where he was responsible for patent portfolio strategy, IP due diligence, validity and infringement opinions, M&A, tech transfer, licensing, Hatch-Waxman cases, global patent litigation, and issues at the interface of FDA and patent laws. Jim continues to specialize in these areas, recently serving as an expert on patent issues on behalf of Pfizer and EMD Serono in major federal court litigation in the biopharma sector. 

How Jim Helps Clients

Having handled complex pharmaceutical and biotech patent cases for corporate clients throughout his career, Jim brings a strong business background and has substantial litigation and transactional experience both domestically and internationally. In addition, Jim was stationed at Schering-Plough’s European headquarters in Switzerland for several years as Director of European Patent Operations, where he had the chance to further develop his ability to counsel clients on a global basis. He also has substantial experience as a trial attorney at the United States International Trade Commission and frequently speaks on pharmaceutical and biotech patent law and litigation matters at major legal conferences (see under Experience tab for selected listing).

What Clients Can Expect

Regarding technical subject matter, Jim focuses on cases involving pharmaceuticals, biologics, therapeutic and diagnostic methods, pharmaceutical formulations, biosimilars, stem cells, medical devices, vaccines, and chemical and biotech process technology. Jim also has substantial expertise regarding the complex issues at the interface of patent law and FDA regulatory law and has handled major pharmaceutical cases involving subject matter such as chemotherapeutics, antivirals, antibiotics, statins, antihistamines such as Claritin^® and Clarinex^®, monoclonal antibodies, liposomal formulations, phosphodiesterase inhibitors, recombinant erythropoietin, pegylated interferon, vaccines, gene therapy, and inhaled steroids such as Nasonex^® and Asmanex^®. 

Outside the Office

Jim is an Adjunct Professor of Law at Penn State’s Dickinson Law School teaching Biotech, Pharmaceuticals & the Law. 

In his spare time, Jim enjoys skiing, tennis, scuba diving, and traveling with his wife and two daughters. One of his leisure-time goals is to ski as many of the World Cup skiing venues as possible before his knees give out.

Awards

• Peer review rated “AV^® – Preeminent” in the Martindale-Hubbell Lawyer lndex (the highest rating for legal ability and ethics in Martindale-Hubbell’s lawyer rating system).