agosto 31 2023

Federal Circuit Invalidates Patent Term Adjustments for Obviousness-Type Double Patenting


The Federal Circuit has issued a unanimous precedential decision holding that a patent whose term was extended through Patent Term Adjustment (“PTA”) can be invalidated for obviousness-type double patenting (“ODP”), affirming the PTAB’s Ex Parte Cellect decision that we discussed in a previous post. The Court agreed with the PTAB that ODP should be assessed after PTA is applied to a patent, meaning that PTA does not protect a patent from ODP.

In the holding, the Court rejected Cellect’s and amici’s argument that statutorily mandated extensions like PTA “cannot be cut short by a judge-made doctrine like ODP,” refusing to extend to PTA the Court’s holding in Novartis v. Ezra Ventures that PTE is immune from ODP. The Court called that argument “an unjustified attempt to force disparate statutes into one.” The Court approved of the USPTO’s different interpretations of the PTA and PTE statutes (35 U.S.C. §§ 154, 156) as setting forth different frameworks, based on their different treatment of disclaimers, stating that there was “nothing in the PTA statute to suggest that application of ODP to the PTA-extended patent term would be contrary to the congressional design.” The Court therefore held that invalidating PTA for ODP “does not allow a judge-made doctrine to restrict the scope of the PTA statute.” The Judges even found a “statutory acknowledgement” of the judge-made doctrine of ODP in the PTA statute. The Court also found irrelevant Cellect’s arguments that ODP requires an applicant to engage in gamesmanship—some purposeful manipulation of the system to delay patent issuance to improperly extend the term—or that PTA lacks gamesmanship as it is accrued by USPTO delay. “[T]he mere presence of an unjustified extension is sufficient . . . to find that claims are unpatentable under ODP,” and “[t]he ability of the applicant to show good faith during prosecution does not entitle it to a patent term to which it otherwise is not entitled.”

The decision, if not altered en banc, could jeopardize a common occurrence in patent prosecution, where continuation applications can accrue PTA and expire later than a family member. This is particularly acute for patents to biologics, such as antibody immunotherapies and pharmaceuticals, because Patent Office “A” delays in Technology Center 1600 (Biotechnology and Organic Chemistry) are among the longest at the USPTO. Unless the patent’s claims can be shown to be patentably distinct, after this decision patentees should consider preemptively filing terminal disclaimers to preserve validity in such a situation. Fortunately, the Court did not find that no PTA could apply to a terminally-disclaimed patent as some briefs argued. Consistent with the statute, PTA appears to be allowed on a patent up to the date a terminal disclaimer would end its term. Also noteworthy is the Federal Circuit’s rejection of the assumption that a Patent Examiner considers all grounds of patentability during prosecution in its finding that a substantial new question of patentability existed. To preclude a new question, the Judges appear to have expected the patentee to show that the Examiner “affirmatively” and “explicitly” considered the issue during prosecution. In rejecting Cellect’s argument that the Examiner necessarily considered ODP, the Court stated that Cellect did not “indicate a single portion of the prosecution history explicitly showing that the examiner considered ODP.” The Judges refused to credit Cellect’s argument that the Examiner must have considered ODP because he prosecuted the family applications, calling it “attempting to prove a negative.” The Judges therefore appear to have implicitly rejected the idea that an Examiner considers all grounds of patentability during prosecution. This holding is worth noting for practitioners who may have thought that an Examiner will be assumed to have considered all potential rejections during prosecution.

The post Federal Circuit Invalidates Patent Term Adjustments for Obviousness-Type Double Patenting appeared first on Immuno-Innovation.

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