On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™. GE HealthCare reports that Sonic DL™ is a deep learning-based technology intended to capture cardiac MRI images within a single heartbeat.
PARUS HOLDINGS, INC. V. GOOGLE LLC
Before Lourie, Bryson, and Reyna. Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board.
Summary: PTAB did not err in declining to consider evidence in IPR that was incorporated by reference without adequate explanation.
In Sanofi-Aventis Deutschland GmbH v. Mylan Pharm. Inc., Case No. 2021-1981, the Federal Circuit reversed an obviousness determination by the PTAB. At issue was Sanofi’s reissued U.S. Patent No. RE47,614 (the ’614 patent), directed to a drug delivery device. The PTAB had found Sanofi’s drug delivery patent to be obvious in view of three prior art references: Burren, Venezia, and de Gennes.
YITA LLC V. MACNEIL IP LLC
Before Taranto, Chen, and Stoll. Appeal from the Patent Trial and Appeal Board.
Summary: Evidence of commercial success that relates entirely to an individual claim element that was disclosed in the prior art cannot support a finding of non-obviousness.
On June 6, 2023, Merck & Co. filed a lawsuit against the U.S. government in federal court over the Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices with drugmakers. The suit is the first attempt by a pharmaceutical company to challenge the IRA’s Medicare drug price negotiation program.
MEDTRONIC, INC. v. TELEFLEX INNOVATIONS
Before Moore, Lourie, and Dyk. Appeal from the Patent Trial and Appeal Board.
Summary: A close prima facie case of obviousness can be overcome by strong evidence of objective indicia of non-obviousness.
Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by adding Section 524B to the Federal Food, Drug, and Cosmetic Act (FD&C Act) at the end of 2022, addressing concerns over the cybersecurity of medical devices. Risks from cybersecurity incidents involving medical devices may include “Health Insurance Portability and Accountability Act (HIPAA) violations, improper patient health assessments, miscalculated medication dosages, and other potentially fatal outcomes,” according to Lifesciences Intelligence.
On April 25th, 2023, the U.S. Food and Drug Administration (FDA) approved QalsodyTM (tofersen) for the treatment of amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). The accelerated approval for QalsodyTM was based on a reduction in levels of plasma neurofilament light (NfL), a biomarker associated with neuronal injury and neurodegeneration. QalsodyTM was developed in a partnership between Ionis Pharmaceuticals, Inc. and Biogen Inc.
Brain computer interface developer Paradromics on May 18, 2023, announced a $33 million Series A funding round as well as a “Breakthrough Device Designation” from the FDA.
OneSubsea IP UK Limited v. FMC Technologies, Inc.
Before Clevenger, Moore, and Dyk. Appeal from the United States District Court for the Southern District of Texas.
Summary: Ordering additional discovery before ultimately grating summary judgment suggests that suit was not objectively baseless
