PharmaPatents

Timely Insights On Emerging Developments

In Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, the Federal Circuit once again held diagnostic method claims invalid under 35 USC § 101. Footnote 4 of the majority decision blames the Supreme Court for this outcome, but Judge Newman’s dissent outlines her views on how the court could have followed all relevant Supreme Court precedent and reached a different conclusion by heeding Supreme Court guidance that patent claims must be considered as a…
The Federal Circuit decision in Mylan Pharmaceuticals, Inc. v. Research Corporation Technologies, Inc., highlights the difficulty of challenging a patent directed to a new chemical entity. The court affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that upheld the validity of RCT’s Vimpat lacosamide patent, which is approved for the treatment of epilepsy. The court considered the arguments that had been made for and against patentability under the “lead compound…
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…
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…
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…
The USPTO has announced that it will not be extending the Extended Missing Parts Pilot program, so it will end on January 2, 2019. While many USPTO pilot programs are renewed time after time–the Pre-Appeal Brief Review pilot program was launched in 2005–the willingness to terminate less successful pilot programs gives the USPTO flexibility to test different initiatives designed to advance and support the examination process.…
In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., Novartis scored another obviousness-type double patenting (OTDP) win when the Federal Circuit held that a post-URAA child patent could not be cited as an OTDP reference against a pre-URAA parent patent having the same priority date, and upheld the validity of an Orange Book-listed patent for Novartis’s Zortress® and Afinitor® products. This decision was issued the same day the Federal Circuit held that a patent term extension award…
In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the Novartis Gilenya patent, the court confirmed that the statute permits an extended product patent to “effectively” block the practice of an earlier-expiring method patent, and refused to elevate the judicially-created doctrine of obviousness-type double patenting over the statutory grant of PTE. Pharmaceutical…