PharmaPatents

Timely Insights On Emerging Developments

Provisional applications tempt stakeholders with the possibility of securing a filing date on an expedited basis and limited budget, but the value of that filing date will depend on its ability to serve as a valid priority date for the invention claimed in the non-provisional application. The non-precedential Federal Circuit decision in Purdue Pharma L.. v. Iancu shows that even a robust provisional application may not suffice if it does not include “blaze marks” that…
In a non-precedential decision, a three-judge panel of the Federal Circuit made clear that it would not give deference to USPTO patent eligibility guidance that it finds inconsistent with Supreme Court and Federal Circuit decisions. In the case before it, the patent owner (The Cleveland Clinic Foundation) argued that its claims should be found to satisfy 35 USC § 101 by analogy to Julitis Claim 1 of the USPTO guidance, but the panel found that example…
In Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit distinguished method of treatment claims that involve personalized dosing from the claims invalidated in Mayo v. Prometheus, and found them to satisfy 35 USC 101 by analogy to Vanda. The district court had invalidated the method of treatment claims at the motion to dismiss stage of ANDA litigation.…
In Natural Alternatives Internat’l v. Creative Compounds, LLC, the Federal Circuit vacated the district court decision that held the asserted claims invalid under 35 USC § 101 at the pleadings stage. I previously wrote about the court’s treatment of the product claims. Now, I consider the method of treatment claims, and the distinction the majority draws between Vanda and Mayo. This analysis may be significant now that the Supreme Court has issued a CVSG in…
In Natural Alternatives Internat’l v. Creative Compounds, LLC, the Federal Circuit vacated the district court decision that held the asserted claims invalid under 35 USC § 101 at the pleadings stage. The claims at issue included method of treatment, product, and manufacturing claims. Here, I focus on the product claims. While the decision provides a welcome discussion of Chakrabarty and Funk Brothers, my enthusiasm is tempered by the narrow holding and Judge Reyna’s dissent.…
In Ni-Q, LLC v. Prolacta Bioscience, Inc., the United States District Court for the District of Oregon invalidated under 35 USC § 101 Prolacta’s patent on testing milk to establish or confirm the identity of the donor. The decision was made on Ni-Q’s motion for summary judgement, and illustrates the reach of recent Federal Circuit jurisprudence on “diagnostic” methods.…
In Momenta Pharmaceuticals, Inc. v. Bristol-Meyers Squibb Co., the Federal Circuit issued another decision analyzing the contours of a petitioner’s Article III standing to appeal PTAB decisions upholding a patent. In contrast to Amerigen, where the court found standing for a would-be generic competitor whose ANDA was subject to a Paragraph III certification against the challenged patent, in Momenta the court found that the challenger’s termination of product development precluded standing.…
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.…