Double Patenting, Double Trouble: Continuations, Terminal Disclaimers, and Interplay with PTA and PTE

Double Patenting, Double Trouble: Continuations, Terminal Disclaimers, and Interplay with PTA and PTE

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The judicially created doctrine of obviousness-type double patenting (OTDP) is a complex body of law with very high stakes for the life sciences industry. A negative decision on OTDP can cost the patentee years of patent term on clinical assets, severely limit the ability of the patentee to monetize their patent portfolio, and even invalidate patents if careful control of ownership is not maintained across related patent families.

There have been some recent positive developments in OTDP case law.  In Novartis v. Erza the CAFC ruled that OTDP could not be used to cut off patent term associated with a Patent Term Extension (PTE). And district courts have also recently begun to wrestle with this very question and in Mitsubishi v. Sandoz the district court of New Jersey held that PTA was also safe from OTDP. This very question has also been raised in a recent petition for certiorari to the U.S. Supreme Court in Sawstop v. USPTO. SawStop Holding LLC v. USPTO, No. 22-11. Meanwhile, a recent letter from Senator Patrick Leahy (D-VT) and others to the USPTO urges the expansion of OTDP and asks “should the filing of a terminal disclaimer  be an admission of obviousness?”

This panel will tackle the recent changes in OTDP and discuss the future of this complex body of law.

CLE Materials

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