PhRMA files amicus brief with USPTO providing guidance on non-statutory double patenting
Client(s) Pharmaceutical Research and Manufacturers of America ("PhRMA")
On behalf of the Pharmaceutical Research and Manufacturers of America ("PhRMA"), Jones Day submitted an amicus brief responding to USPTO Director Squires's order presenting three questions on non-statutory double patenting ("NSDP"), also known as obviousness-type double patenting (OTDP). The Director's order granted rehearing sua sponte and invited amicus input regarding the Patent Trial and Appeal Board (PTAB) reversal of the examiner's NSDP rejection of a patent application.
To encourage a fair patent system that adequately protects the wide array of inventions relating to a new medicine or treatment, and in light of PhRMA's broad membership of innovators developing life-saving and life-enhancing medicines with a direct stake in how NSDP doctrine is applied, PhRMA's amicus brief provides an important voice on the Director's questions, including contextualizing them within the limited scope and purpose of NSDP, a judicially created doctrine. Taking each question in turn, PhRMA's brief first explains that Allergan USA, Inc. v. MSN Laboratories Private Ltd., 111 F.4th 1358 (Fed. Cir. 2024), is not confined to its facts, but instead reiterates NSDP's narrow, equitable purpose, limited to only those cases where there is an unjustified timewise extension of patent exclusivity. Consistent with that principle and with Allergan's teachings, PhRMA's brief further explains that "first-filed" means the earlier effective filing date between the pending patent application and the asserted NSDP reference, regardless of whether the two are from a common patent family. Second, PhRMA's brief submits that, in considering whether NSDP applies, examiners during prosecution may calculate expiration dates based on available information, such as the 20-year patent term or terminal disclaimers that would control, but they should not speculate about patent term adjustment (PTA), which remains a moving target during prosecution. Third, PhRMA's brief explains that hypothetical risk of potential separate ownership someday, such that a defendant in the future might face separate infringement suits from separate owners on obvious variants, cannot be an independent basis for an NSDP rejection. While risk of separate ownership is referenced in NSDP case law, the case law does not support it as an independent basis, particularly because the doctrine's fundamental animating purpose is focused on avoiding unjustified timewise extension. Moreover, it would be improper to rest on hypotheticals. Given these principles, where the first-filed application at issue in the case involves no unjustified timewise extension, NSDP does not apply.
Ex Parte Baurin (Appeal 2024-002920) (PTAB)
