In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35 U.S.C. § 112. This decision establishes that it is more difficult to satisfy the enablement requirement for antibody claims that use functional language to describe the antibody. (The court granted Amgen’s motion to extend the deadline for filing a petition for panel rehearing and/or rehearing en banc until April 14, 2021. See id., Order (March 8, 2021).)
The regulation of drug prices has received significant recent bipartisan support in Congress. Democrats and Republicans in both houses have proposed approximately eighty bills relating to drug pricing over the past two years. The charts below summarize the key provisions of representative bills.[i]
Although the proposed price-regulating mechanisms differ from bill to bill, the bills do not indicate a clear difference in the parties’ goals when viewed at a high level. Many of the proposed bills focus on price transparency as well as reporting to the Department of Health and Human Services (HHS). Certain bills would require pharmaceutical manufacturers to provide data on, and justifications for, the pricing of certain drugs that would exceed specified price increase limits. These bills usually include penalties for reporting failures; however, they usually do not provide a procedure to lower a price that triggers the reporting provisions. Instead, they often establish or enhance public databases for the reported information, and some go as far as requiring pharmacists to communicate this information to the patient at the point of sale.