Double Patenting: Constitutionality, In re Cellect and the fate of PTA & PTE

Double Patenting: Constitutionality, In re Cellect and the fate of PTA & PTE

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Patent Term Adjustment (PTA) was designed to serve an important purpose – to compensate patentees for time lost during examination due to U.S. Patent and Trademark Office (USPTO) delays.  But what is the effect of obviousness type double patenting (OTDP) on PTA and patent term extension (PTE)? In Novartis v. Breckenridge, the Federal Circuit upheld the validity of a patent having a five-year PTE. The court made explicit in Novartis v. Ezra what it implied in Breckenridge, affirming the lower court’s ruling that OTDP did not invalidate said challenged patent’s PTE. Subsequently, in Mitsubishi Tanabe Pharma v. Sandoz, Judge Wolfson of the U.S. Federal District Court for New Jersey, held that “[a] judge-made doctrine cannot cut off a statutorily authorized time extension.” Thus, the Federal Circuit’s ruling relating to PTE was extended to PTA, at least in New Jersey.

In December 2021, the Patent Trial and Appeal Board (PTAB) took the opposite view, disagreeing with Judge Woflson, in determing whether PTA and PTE should be treated alike under OTDP. In Ex Parte Cellect, the PTAB distinguished PTA from PTE, opining that the statutory language of §154(b), unlike §156, was limited where terminal disclaimers are filed. Cellect appealed to the Federal Circuit, with a decision about whether OTDP can truncate a legislative grant of PTA imminent.

This panel will discuss the Federal Circuit’s ruling in In re Cellect, as well as the intricacies of OTDP, PTA and PTE, and whether a judge-made doctrine should cut off a statutorily authorized extension or adjustment of patent term, and whether the doctrine of double patenting is even constitutional.

Materials

CAFC Issues Precedential Ruling on Proper Analysis for Patent Term Adjustment in Double Patenting Cases

The Unauthorized Doctrine of Non-Statutory Judicially Created Obviousness-Type Double Patenting

Damage to Our Patent System by Failure to Honor the U.S. Legal Framework: Double Patenting

Double Patenting Slide