Lana A. Gladstein is a partner with Pepper Hamilton LLP, resident in the Boston office. Ms. Gladstein has 15 years of experience handling all phases of complex litigation, including appeals, in a range of technical specialties including pharmaceuticals, biotechnology, medical devices and software. She represents clients in patent infringement, licensing, and contract disputes, appeals to the Court of Appeals for the Federal Circuit, and in interferences and contested proceedings before the USPTO. Ms. Gladstein is currently involved in more than 30 inter partes review proceedings, which took effect with the new America Invents Act. She also is a co-editor of Pepper’s blog, www.PostGrant-Counsel.com, devoted to commentary and analysis of the America Invents Act’s new administrative proceedings for challenging patents.
In addition to her trial and contested matters practice, Ms. Gladstein provides life sciences clients with strategic patent portfolio assessments, opinion services, patent due diligence, and counseling in the Food and Drug Administration’s laws and regulations pertinent to drugs and medical devices. She is a frequent speaker and commentator on legislative and FDA regulatory developments in the areas of biologics and medical devices.
Selected Speaking Engagements and Webinars
Ms. Gladstein is a co-chair of Legal & Regulatory Working Group at MassBIO, a mentor on the MIT Enterprise Forum’s Mentor Smart program, a member of the Boston Bar Association, the American Intellectual Property Law Association, Boston Intellectual Property American Inn of Court, North Shore Technology Council, MassMEDIC, and New England Women In Science Executives Club. Ms. Gladstein also is an avid supporter of the arts and artists, and provides pro bono legal services to artists.
- “Regulatory and Reimbursement Strategy” panel moderator, MassBio Biotechnology Entrepreneurship Boot Camp, Cambridge, MA (December 6, 2013)
- “Biosimilars” panel presentation with MassBio’s President Robert Coughlin and Bio’s Fritz Bittenbender to Massachusetts lawmakers (September 12, 2013)
- “Clinical, Regulatory and Reimbursement Strategy” panel moderator, MassBio Biotechnology Entrepreneurship Boot Camp, Cambridge, MA (November 30, 2012)
- “What Medical Device Companies Need to Know,” keynote speaker, Massachusetts Medical Society Annual FDA Update: 510(k) Program, Waltham, MA (December 9, 2011)
- “Biosimilars in the New Health Care Legislation - Prepare Now for the New Approval Framework,” Pepper Hamilton LLP Webinar (August 18, 2010).
Ms. Gladstein received her undergraduate degree from Brandeis University, with a concentration in biology, and her law degree from Northeastern University School of Law, where she was founder and president of the Intellectual Property Society. During law school, she served as a law clerk to the Honorable Margaret H. Marshall, Chief Justice of the Supreme Judicial Court of Massachusetts.
Ms. Gladstein is admitted to practice in Massachusetts, as well as before the U.S. Patent and Trademark Office, the U.S. District Court for the District of Massachusetts, and the U.S. Courts of Appeals for the First and Federal Circuits.