In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Supreme Court interpreted the “on sale bar” of the America Invents Act (AIA) version of 35 U.S.C. § 102 as unchanged from the pre-AIA version. In so doing, the Court put to rest suggestions that the AIA eliminated “secret sales” as prior art, and expressly held to the contrary.
In a long-awaited decision in Supernus Pharmaceuticals, Inc. v. Iancu (argued December 2017), the Federal Circuit held that the USPTO improperly imposed a Patent Term Adjustment (PTA) deduction for “applicant delay” during a period when the applicant “could have done nothing to advance prosecution.” The PTA deduction at issue was charged under 37 CFR § 1.703(c)(8) for an Information Disclosure Statement (IDS) filed after a Request for Continued Examination (RCE) had been filed, but the decision could have broader implications.
I previously wrote about the standing issue addressed in Amerigen Pharmaceuticals v. UCB Pharma GMBH. In this article, I look at the lead compound analysis that led the USPTO Patent Trial and Appeal Board (PTAB) to uphold the claims against an obviousness challenge, including a factor that doesn’t always get much attention.
Although “any person” except the owner can challenge a patent in an Inter Partes Review (IPR) proceeding, only those who satisfy the constitutional requirements for standing can appeal a decision of the USPTO Patent Trial and Appeal Board (PTAB) in a IPR proceeding. In Amerigen Pharmaceuticals v. UCB Pharma GMBH, the Federal Circuit held that a would-be generic competitor whose ANDA was tentatively approved but subject to a Paragraph III certification against the challenged patent had standing to appeal the PTAB decision upholding the patent. While Amerigen prevailed on that issue, the court affirmed the PTAB decision on the merits.
Although the Department of Commerce is impacted by the partial Federal government shutdown, the USPTO has been able to continue normal operations because it has access to prior-year fee collections. Underscoring its active status, the USPTO released revised patent subject matter eligibility guidance, effective January 7, 2019. This guidance implements the changes Director Iancu announced in his keynote address at the Intellectual Property Owners Association Annual Meeting, and may lead examiners to determine that more inventions satisfy § 101 at an early stage of a Mayo/Alice analysis. The guidance is effective immediately, but the USPTO will accept written comments through March 8, 2019.