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
MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L.
Before Moore, Lourie, and Dyk. Appeal from the Patent Trial and Appeal Board
Summary: Federal Circuit confirms low bar for evidence corroborating prior inventorship pre-AIA.
As predictions of an economic recession in the United States loom, 2023 has started with extensive layoffs throughout the tech industry. Though not to an equal degree, the biotechnology, pharmaceutical, and life science industries have not been excluded from employment cuts. In January, Verily, the healthcare and life sciences subsidiary of Alphabet, Inc., announced a restructuring that would cut about 15% of its workforce. [1] Likewise, several other biotech giants, including Thermo Fisher Scientific and Grifols, have disclosed plans to decrease workforce in the coming quarters. [2]
DuPont announced on May 2, 2023 its acquisition of Spectrum Plastics Group (“Spectrum”), a specialty plastics manufacturer, from the private equity firm AEA Investors for $1.75 billion.
On April 26, 2023, the European Commission proposed a pharmaceutical law reform directed to replacing the existing pharmaceutical legislation. The reform aims to increase innovation and competition in the pharmaceutical industry, while reducing the cost of drugs for consumers.
SANOFI-AVENTIS DEUTSCHLAND GMBH V. MYLAN PHARMACEUTICALS INC.
Before Reyna, Mayer, and Cunningham. Appeal from Patent Trial and Appeal Board.
Summary: When arguing that a reference is analogous prior art, a petitioner must show that the reference is analogous to the challenged patent, and not other prior art references.
