On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” originally released in May 2005.
CELGENE CORP. v. MYLAN PHARM. ET AL.
Before Prost, Chen, and Hughes. Appeal from the District of New Jersey.
Summary: In Hatch-Waxman litigation: (1) infringement occurs where the ANDA is submitted and not where the patentee received notice of the ANDA submission; (2) the presence of an affiliated entity or employees in the district is insufficient to show a regular and established place of business; and (3) pleadings must explain how a defendant was involved in the ANDA submission to support a claim for infringement.
UNIVERSITY OF STRATHCLYDE v. CLEAR-VU LIGHTING LLC
Before Reyna, Clevenger, and Stoll. Appeal from the Patent Trial and Appeal Board.
Summary: The Federal Circuit reversed the PTAB’s obviousness decision because the inventors succeeded where the prior art failed and there could be no expectation of success based on the failed attempts of the prior art.
On October 5, 2021, the U.S. Federal Circuit reversed a finding of invalidity by the Patent Trial and Appeal Board (PTAB) for patent claims related to an “artificial valve for repairing a damaged heart valve.” St. Jude Medical LLC (“St. Jude”) filed for an inter partes review (IPR) at the PTAB for U.S. Patent No. 6,821,297, entitled “Artificial Heart Valve, Implantation Instrument and Method Therefor,” owned by Snyders Heart Valve LLC (“Snyders”).
Bioventus recently announced that its shareholders approved its agreement to acquire Misonix. Bioventus agrees to pay Misonix shareholders either 1.6839 shares of Bioventus class A common stock or $28.00 for each share of Misonix common stock held. The amount paid to Misonix shareholders results in an approximate valuation of $518 million for Misonix, based on share prices from around the time the acquisition agreement was reached. With the completion of this acquisition, Misonix will become a wholly-owned subsidiary of Bioventus.
BROOKLYN BREWERY CORPORATION V. BROOKLYN BREW SHOP, LLC Before Judges Dyk, O’Malley, and Hughes. Appeal from the Trademark Trial and Appeal Board. Summary: A challenger must demonstrate an injury in…
ENERGY HEATING, LLC v. HEAT ON-THE-FLY, LLC Before Moore, Prost, and Stoll. Appeal from the U.S. District Court for the District of North Dakota. Summary: Enforcing a patent with knowledge…
TRAXCELL TECHNOLOGIES, LLC V. NOKIA SOLUTIONS AND NETWORKS
Before Prost, O’Malley, and Stoll. Appeal from the Eastern District of Texas.
Summary: An applicant’s arguments distinguishing prior art during patent prosecution constituted a disclaimer of claim scope and estopped the patentee from relying on the doctrine of equivalents to show infringement.
Traxcell Techs., LLC v. Sprint Commn’s Co. et al
Before Prost, O’Malley, and Stoll. Appeal from the Eastern District of Texas.
Summary: A patentee’s extensive citations to evidence failed to avoid summary judgment of noninfringement because the patentee never explained the relevance of this evidence.
MOBILITY WORKX, LLC v. UNIFIED PATENTS, LLC
Before Newman, Schall, and Dyk. Appeal from the Patent Trial and Appeal Board.
Summary: Fee-funded structure of AIA review proceedings does not violate due process.
After inter partes review (“IPR”), the Board found Mobility’s patent claims invalid. Mobility appealed the decision to the Federal Circuit, arguing that the structure and funding of AIA review proceedings violates due process. Particularly, Mobility argued that the Board and the individual administrative patent judges (“APJs”) have impermissible financial incentives to institute IPRs.
