Mr. Burns noted that one significant issue impacting the pharmaceutical industry at this time is how to structure settlements of pharmaceutical patent litigation without triggering antitrust liability. Notwithstanding the U.S. Supreme Court’s ruling in the 2013 Actavis case, it remains uncertain where the dividing line stands between lawful and unlawful conduct, and the recent ruling from a Boston federal district court in In re Nexium (Esomeprazole) Antitrust Litigation only adds to the uncertainty, said Mr. Burns.
Another issue affecting the pharmaceutical industry in 2015 is the growing reluctance of branded pharmaceutical companies to provide generics with product samples. Mr. Burns noted that steps have been taken by the FDA to help generic companies obtain samples of drugs from branded manufacturers, but that the issue remains unsettled. Commenting on the FDA’s guidance, Mr. Burns stated: “In issuing the guidance, the FDA signaled a hope that the branded manufacturer now would more willingly provide a sample to the generic manufacturer. While the FDA guidance, if finalized, will eliminate a potential cause for branded manufacturer unwillingness to provide generic companies with samples, it won’t likely lead to an end to the issue.”
To read more about these issues and what other legal issues are likely to lie ahead for the pharmaceutical industry in 2015, please click here. The article is reproduced with permission from Pharmaceutical Law & Industry Report, 13 PLIR 79 (Jan. 16, 2015). Copyright 2015 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>.