Finnegan Victory for BioDelivery Sciences International in ANDA Case Affirmed

FOR IMMEDIATE RELEASE
December 29, 2022

WASHINGTON, DC—The Federal Circuit affirmed a victory for Finnegan on behalf of client BioDelivery Sciences International (BDSI) in a Hatch-Waxman Abbreviated New Drug Application (ANDA) patent infringement case against Alvogen. The case was on appeal from the U.S. District Court for the District of Delaware before Chief Judge Colm Connolly. The case involved Alvogen’s attempt to market generic copies of BDSI’s highly successful Belbuca© buprenorphine buccal film product, a unique opioid that is used to manage severe pain. Belbuca© is BDSI’s backbone product with sales of over $100 million per year.

Following a three-day bench trial in March 2021, Judge Connolly ruled that Alvogen failed to prove by clear and convincing evidence that claims 4 and 5 of U.S. Patent No. 8,147,866 and claims 9 and 20 of U.S. Patent 9,901,539—to which Alvogen stipulated to infringement—were invalid for obviousness or anticipation.

The ruling, which prohibited the sale of Alvogen’s generic buprenorphine buccal film product until after the ’539 patent expires, in 2032, was favorable to BDSI. On appeal, the Federal Circuit affirmed Judge Connolly’s ruling on the ’866 and ’539 patents, thereby preserving this expressive win.

Contacts: 

Erika H. Arner, Managing Partner
erika.arner@finnegan.com

Anand K. Sharma, Chair
anand.sharma@finnegan.com

About Finnegan

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP is one of the largest IP law firms in the world. From offices in Atlanta, Boston, London, Munich, Palo Alto, Reston, Seoul, Shanghai, Taipei, Tokyo, and Washington, DC, the firm practices all aspects of patent, trademark, and copyright law, including counseling, prosecution, licensing, and litigation. Finnegan also represents clients on IP issues related to advertising, trade secret law, European patents and trade marks, international trade, portfolio management, the Internet, e-commerce, government contracts, antitrust, and unfair competition. For additional information on the firm, please visit www.finnegan.com and follow us on LinkedIn.