The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more
1/20/2025
/ Biotechnology ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Life Sciences ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Regulatory Requirements ,
Safe Harbors
In Kyocera Senco Industrial Tools Inc. v. International Trade Commission, the Federal Circuit held that an expert must meet the definition of a “person of ordinary skill in the art” of the asserted patents in order to opine...more
In a highly anticipated decision, the en banc Federal Circuit overruled the longstanding Rosen-Durling test for assessing obviousness of design patents. The challenged framework, derived from two cases, In re Rosen, 673 F.2d...more
A district court recently precluded a patent attorney from testifying as an expert in a patent infringement lawsuit where the proposed expert lacked the requisite technical expertise to assist the trier of fact in...more
The Patent Trial and Appeal Board denied institution of a petition for IPR after determining that the petitioner failed to show a reasonable likelihood that its primary asserted reference, which was available through the...more
The Western District of Texas recently denied a defendant’s motion to stay pending inter partes review based in part on the defendant’s status as a non-party in the IPR proceedings. In doing so, the district court focused on...more
The District Court of Delaware dismissed a generic drug company’s declaratory judgment counterclaims of non-infringement and invalidity, finding that the court no longer had subject matter jurisdiction after the generic...more
In an IPR institution decision issued shortly after the USPTO issued interim guidance on discretionary denials, the PTAB held that the petition presented “compelling evidence of unpatentability,” foreclosing a Fintiv...more
Key Points -
On August 5, 2022, the Federal Circuit held in Thaler v. Vidal that the term “inventor” under the United States Patent Act must be a human being.
This ruling precludes patent protection for inventions...more
The USPTO recently issued new guidance on how the Patent Trial and Appeal Board (PTAB) will apply Apple Inc. v. Fintiv Inc., a 2020 precedential decision which laid out considerations for denying institution of a post-grant...more
Key Points -
On June 21, 2022, USPTO Director Katherine K. Vidal issued a memorandum titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings With Parallel District Court Litigation.”
Under...more
In the weeks preceding a recent Hatch-Waxman bench trial, a district court excluded portions of an expert’s opinion on obviousness that addressed internal documents and inventor testimony concerning the “inventors’ path” to...more
A district court recently denied a motion for attorney’s fees under 35 U.S.C. § 285 where the defendant successfully invalidated each claim of the patent at issue during an inter partes review proceeding. The district court...more