On July 23, 2024, Dr. Jeff Shuren, the director for the Center for Devices and Radiological Health (CDRH), announced that he will retire. Dr. Shuren became director of the CDRH in 2009. As director of the CDRH, Dr. Shuren oversaw the approval of medical devices and monitoring of radiation-emitting products.
Edwards Lifesciences recently announced that it would acquire Innovalve Bio Medical, an early-stage transcatheter mitral valve replacement (“TMVR”) company. Edwards had the option to acquire Innovalve following an initial investment in 2017. The acquisition is expected to close by the end of the year.
As we previously discussed, on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device patents in the Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book” or “OB”).
On April 23, 2024, the United States Federal Trade Commission (“FTC”), via a 3-2 vote, issued a final rule, which, according to the FTC’s rule summary, provides a comprehensive ban on new noncompetes nationwide and bans existing noncompetes with workers other than senior executives. The rule is scheduled to go into effect September 4, 2024. However, a federal judge in Texas temporarily halted the implementation and enforcement of the FTC rule and stayed the September 4 start date, at least with respect to the specific plaintiffs involved in a lawsuit that challenged the FTC rule, Ryan, LLC v. Federal Trade Commission Case (No. 3:24-cv-00986).
On May 24, 2024, member states of the World Intellectual Property Organization (WIPO) adopted a new treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge that was over 20 years in the making. Genetic resources, which can include medicinal plants, agriculture crops and animal breeds, cannot themselves be claimed as intellectual property. However, inventions developed using genetic resources can be protected, usually through patents. The stated goals of the treaty include enhancing the efficacy, transparency, and quality of the patent system and preventing patents from being granted erroneously for inventions that are not novel or inventive with regard to genetic resources and traditional knowledge.
On Friday, June 21, 2024, the FDA updated its Patent Listing Dispute List to indicate that the ten pharmaceutical companies who had received warning letters from the FTC in April did not make changes to their patent listings in the FDA’s catalog in view of the warning letters.
Press releases report that Boston Scientific (BSX) has entered an agreement to acquire medical device developer Silk Road Medical in a deal totaling $1.16 billion.
AMARIN PHARMA, INC. v. HIKMA PHARMACEUTICALS USA INC.
Before Moore, Lourie, and Albright. Appeal from the United States District Court for the District of Delaware.
Summary: The totality of the complaint’s allegations must be considered when assessing whether induced patent infringement was sufficiently pleaded.
BETEIRO, LLC v. DRAFTKINGS INC
Before Dyk, Prost, and Stark. Appeal from the United States District Court for the District of New Jersey.
Summary: Recitations of a computer-implemented method can be an abstract idea and non-eligible under 35 U.S.C. § 101 if the claims recite result-focused functional language that is analogous to longstanding “real-world” activities and do not improve technology.
In this episode of the Knobbe IP+ podcast, Knobbe Martens partner Jared Bunker speaks with guest David A. Gauntlett, principal of Gauntlett & Associates, on how businesses may use insurance policies…