Biopharma Patent Enforcement and Litigation Strategies 2016

March’s program was held at the Nippon Club. To download the event summary, click here.

The landscape of pharmaceutical and biotech patent litigation is constantly changing and challenging biopharma companies to come up with effective patent strategies. At this program, three patent experts will use non-technical language to discuss notable developments in key areas such as inter partes reviews (IPRs) and biosimilars, legal trends that all biopharma executives must know to protect their companies’ assets globally and understand the current business environment.

Kyle Bass, a hedge fund manager, and Erich Spangenberg, an intellectual-property expert, formed “The Coalition for Affordable Drugs,” and filed 34 separate IPRs aimed at pharma patents in 2015. This sparked a debate around the use of reviews as part of an investment strategy. That debate quickly spread to the U.S. Congress, with biopharma companies lobbying for protective provisions in new patent reform legislation. NYPF Associate Member Paul Hastings successfully defended Acorda Therapeutics’ patent estate in the first IPR proceedings brought by the Coalition for Affordable Drugs. Based on this case study, Gerald Flattmann of Paul Hastings will discuss the challenges posed by third party IPR petitions, and lessons learned from the trial for a branded company in a pharmaceutical patent IPR proceeding.

The Biologics Price Competition and Innovation Act heralded in an entire new set of procedures for resolving patent disputes before a biosimilar enters the market.  Courts are presently being asked to decide how much information the biosimilar must share with the originator before FDA approval, and the timing of such disclosures. Clark Sullivan of Troutman Sanders will address the status of these disputes in the courts.  His presentation will also address the ultimate question in these cases, which will most likely persist after all of the dust settles: should a biosimilar manufacturer share its technical product information with the originator voluntarily, or wait until it is sued in federal court?

Recent decisions by the United States Supreme Court and the United States Court of Appeals for the Federal Circuit have had chilling effects on personalized medicine.  Dr. Hassen Sayeed of Ropes & Gray will provide an overview of a recent major decision, Ariosa v. Sequenom, which established a far-reaching and deeply restrictive interpretation of what may be patented in the life sciences.  Dr. Sayeed will explore the history behind and the disturbing implications of Ariosa for pharmaceutical and biotechnology companies, capital investors, and the public.  In this new stark legal landscape, can genetic and diagnostic testing patents be obtained and enforced?

**Click Speaker Name for Bio
(An additional speaker will be announced.)

Gerald J. Flattmann, Jr., Partner, Paul Hastings LLP

Mr. Flattmann is a partner in the Intellectual Property practice of the Paul Hastings New York office. He has extensive experience in all aspects of patent litigation, licensing, and counseling. His primary focus is biotechnology and pharmaceutical patent litigation and his clients have included companies at the forefront of these technologies.

In addition to representing clients, Mr. Flattmann speaks regularly on topics relating to patent litigation and the protection of intellectual property. He has been recognized as a leading patent lawyer by countless publications, including Chambers USA; The Legal 500; New York Super Lawyers; International Who’s Who Legal, Life Sciences; International Asset Management 250: Life SciencesExpert’s Guide to the World’s Leading Patent Law Practitioners; and Managing Intellectual Property IP Stars (2013).

According to Chambers, clients recognize Mr. Flattmann for his “outstanding work” and call him one of the “most insightful hard-working litigators, with great instincts, who knows the business” and makes “accessible presentation of complex technical information.” Chambers also notes he “is singled out for his outstanding litigation skills.”

Professional and Community Involvement

-A member of the American Bar Association, the American Intellectual Property Law Association, the Federal Circuit Bar Association, and the New York Intellectual Property Law Association
-A member of the State Bar of New York, Court of Appeals for the Federal Circuit, and the United States Patent and Trademark Office.

-Harvard Law School, J.D. (cum laude, Editor-in-Chief of the Harvard Journal of Law and Technology)
-Yale University, B.S. in Biology (magna cum laude)

Clark G. Sullivan, Partner, Troutman Sanders LLP

Mr. Sullivan focuses his practice on patent litigation, patent prosecution, technology licensing and other intellectual property issues. He has handled numerous disputes for his clients over the years involving patent infringement, false advertising, appeals of administrative actions, and federal antitrust law. He has represented plaintiff and defendant drug companies, nutritional supplement companies, and chemical and beverage companies, on an array of different technologies, at the preliminary injunction stage and through trial and appeal.

Mr. Sullivan also has a significant practice in patent prosecution, counseling and transactional work. He is an active member of the Food and Drug Bar, and regularly advises clients on the Hatch-Waxman Act and FDA approval issues. He has negotiated numerous asset purchase and technology transfer agreements for pharmaceutical, medical device and diagnostics clients. His patent prosecution work is primarily in the pharmaceutical and diagnostic industries, and he has extensive experience defending client patent positions around the world, in countries including Europe, Japan, Australia, China and India.

Bar Admissions
-U.S. Patent and Trademark Office

Court Admissions
-U.S. District Court for the Northern District of Georgia
-U.S. District Court for the Southern District of New York
-U.S. Court of Appeals for the Eleventh Circuit
-U.S. Court of Appeals for the Federal Circuit

-Georgia State University, J.D., magna cum laude
-Georgia Institute of Technology, B. Ch. E.

Hassen A. Sayeed, M.D., Partner, Ropes & Gray LLP

Dr. Sayeed is an experienced patent litigator based in the firm’s New York City office. Recognized as a “Rising Star” by Super Lawyers in 2014 and 2015, Dr. Sayeed is one of the few patent litigators in the United States who holds a medical degree. He counsels life sciences clients in all aspects of complex patent litigation at the district court and appellate levels to help businesses achieve their strategic goals. Dr. Sayeed has litigated cases involving small-molecule pharmaceuticals, biotechnology and medical devices. He also has more than a decade of experience with cases arising under the Hatch-Waxman Act on behalf of pioneer pharmaceutical companies. Clients have included AstraZeneca, Bayer HealthCare Pharmaceuticals, Inc., Genzyme, Kissei Pharmaceuticals, Medac Pharma, Pfizer, Schering Corporation and Senju Pharmaceuticals.

Bar Admissions
-New York

Court Admissions
-Supreme Court of the United States
-Federal Circuit Court of Appeals
-U.S. District Court for the Eastern District of New York
-U.S. District Court for the Southern District of New York

-JD, Harvard Law School
-MD, The Warren Alpert Medical School of Brown University
-AB (Government), cum laude, Harvard College

Membership & Affiliations
-American Bar Association
-Association of the Bar of the City of New York
-New York Intellectual Property Association
-New Jersey Intellectual Property Association