Life After Cellect: Potential Pitfalls and Arguments to Navigate Through the Invalidity/Unpatentability/Loss of PTA Minefields

Description

On Oct. 7, 2024, the Supreme Court declined to hear Cellect L.L.C. v. Vidal, in which the Federal Circuit had upheld PTAB's application of the judicially created doctrine of non-statutory obvious-type double patenting (ODP). The PTAB found, in a reexamination proceeding, that claims in four patents were unpatentable because they were not patentably distinct from claims in other patents in the same family. The decision clarified that in an ODP situation, patent term adjustments (PTA) are first calculated and then added to a normal patent expiration to obtain an expiration date for a challenged patent, after which ODP via an ODP reference is applied against the PTA-lengthened expiration date. In Cellect, all the challenged patents, under this methodology, were unpatentable over ODP reference patents.

Following Cellect, PTA may now result in a risk of invalidity/unpatentability giving defendants another option to achieve their objective of no liability for patent infringement. Furthermore, Cellect did not treat PTA the same as patent term extensions (PTE). In a patent with PTE, ODP is applied before PTE is added to the expiration date. Had Cellect applied PTA as it does PTE, none of the Cellect patents would have been declared unpatentable! Now that Cellect is final, patent counsel should take steps to mitigate the risk of ODP challenges.

The panel will discuss strategies designed to reduce the risk of Cellect's devastating result, such as drafting claims to elicit a restriction requirement, filing one or more divisionals to swim into the Safe Harbor of 35 U.S.C. § 121 and then staying there through consonance, and obtaining patents timely claiming the results of clinical trials, such as Phase 2B or Phase 3. Also, patent counsel should avoid the pitfall of admitting claims in different applications in a family are patentably indistinct (Cellect made such an admission, and it did not turn out well, as noted above), and making efforts to get the USPTO to consider other family patents that might be ODP reference (Cellect did not make any such efforts, and the Cellect court considered that to be a negative against Cellect).

Listen as our authoritative panel of patent attorneys reviews the Federal Circuit's decision in Cellect and what it means for PTA. The panel will offer guidance on how to navigate the fallout of the Cellect decision, understanding the potential pitfalls that may be encountered and the arguments that can be made to circumvent those pitfalls.