The United States Patent and Trademark Office (USPTO) is set to reexamine the Patent Trial and Appeal Board’s (PTAB) approval of Sanofi’s patent application, which had previously been rejected on the grounds of obviousness-type double patenting. This review underscores the ongoing complexities surrounding double patenting in the pharmaceutical sector.
Obviousness-type double patenting is a judicially created doctrine aimed at preventing the unjustified extension of patent exclusivity by prohibiting multiple patents on the same invention or obvious modifications thereof. In the United States, this doctrine is particularly contentious due to practices such as restriction requirements, where patent examiners may require applicants to divide a single application into multiple divisional applications. These divisionals can lead to varying expiration dates, complicating the patent landscape and potentially delaying generic competition. ([en.wikipedia.org](https://en.wikipedia.org/wiki/Double_patenting?utm_source=openai))
Sanofi has been involved in several high-profile patent disputes. Notably, in the case of Amgen Inc. v. Sanofi, the U.S. Supreme Court held that Amgen’s patents on cholesterol-lowering drugs failed to meet the enablement requirement of the Patent Act, as they did not sufficiently teach those skilled in the art how to make and use the claimed antibodies. ([pattersonsheridan.com](https://www.pattersonsheridan.com/publications/special-report-supreme-court-decision-in-amgen-inc-v-sanofi/?utm_source=openai))
In another significant case, Apotex Inc. v. Sanofi-Synthelabo Canada Inc., the Supreme Court of Canada addressed the validity of selection patents. The court concluded that selection patents are not invalid per se and can be valid if they meet the requirements of novelty and non-obviousness. ([en.wikipedia.org](https://en.wikipedia.org/wiki/Apotex_Inc_v_Sanofi-Synthelabo_Canada_Inc?utm_source=openai))
The USPTO’s forthcoming review of Sanofi’s patent application will likely focus on whether the PTAB correctly applied the principles of obviousness-type double patenting. This review is part of a broader effort to ensure that patent grants do not unjustly extend market exclusivity, thereby maintaining a balance between innovation incentives and public access to affordable medications.
As the USPTO revisits this case, stakeholders in the pharmaceutical industry will be closely monitoring the outcome, which could have significant implications for patent prosecution strategies and the management of patent portfolios.