The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations, known as the ‘Orange Book.’” The FTC’s stated goal was to notify market participants of the FTC’s intent to scrutinize improper Orange Book listings to determine whether they constitute unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act. On November 7, 2023, the FTC followed through on its warning by sending notice letters to more than 10 companies challenging the Orange Book listing of more than 100 patents covering products including specific asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors.
On October 5, 2023, the World Intellectual Property Organization published Cast21’s PCT application related to its alternative cast device – a 3D-printed exoskeleton created from a medical-grade resin. Cast21’s device seeks to address limitations in one of orthopedic care’s fundamental treatment methods: the cast. A soggy cast can lead to infections, reduced support, skin infections, and more. But as discussed in Cast21’s white paper, Cast321’s FDA-approved product touts a waterproof and breathable design, allowing patients to shower, swim, or wash their limbs.
On November 21, 2023, the FDA published its final rule changing how prescriptions medicines are advertised to consumers.1 The FDA first issued its proposed rule in 2010, which subsequently went through three public comment periods between 2010 and 2012.2 Interestingly, the FDA provided no opportunities for the public to comment on the rule since 2012. The FDA addressed the over 10-year gap between the last comment opportunity and the issuance of the final rule, explaining that it was due in large part to competing demands for limited Agency resources, including repeated natural disasters, the opioid epidemic, and infectious disease outbreaks including Ebola, Zika, and COVID-19.3 The FDA concluded that no material changes have occurred in the fundamental concepts, scientific research, or literature underlying the proposed rule since 2012.4
On October 27th, 2023, the U.S. Food and Drug Administration (FDA) approved LOQTORZITM (toripalimab-tpzi), developed by Coherus BioSciences, Inc., and Shanghai Junshi Biosciences Co., Ltd., for two indications: 1) in…
CooperCompanies announced on November 1, 2023, the purchase of Cook Medical’s doppler monitoring, gynecology surgery, and obstetrics products for $300 million.
CooperCompanies is a global medical device company that is based in San Ramon, CA. CooperCompanies focuses on two areas within the medical device space, vision and women’s health and fertility. In it’s announcement, Al White, President and CEO of CooperCompanies stated:
In a recent precedential opinion, the Court of Appeals for the Federal Circuit vacated an infringement judgement against Mylan (Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 2022-1889, Fed. Cir. Nov. 6, 2023). This Abbreviated New Drug Application (ANDA) litigation involved Actelion’s patents related to epoprostenol formulations, which cover Actelion’s brand name product, Veletri®, an injectable drug for treatment of severe pulmonary arterial hypertension.
Neurovalens successfully secured 510(k) clearance from the FDA on October 27, 2023 for its Modius Sleep device with relation to treatment of insomnia and/or anxiety. The clearance was supported by data collected from a Phase III/pivotal clinical trial carried out in the UK and Ireland by Ulster University and in Hong Kong by PolyU University, Medical Device Network reports.
Cleerly, a digital healthcare company offering artificial-intelligence-based software to identify and measure atherosclerosis from Coronary Computed Tomography Angiography (CCTA) imaging tests, was awarded Best in Class for the Best Use of AI in Health Tech at the 2023 Digital Health Hub Foundation Awards.
IP rights can be vital to the success of medical device companies. Significant legislative changes governing some of these rights may be on the horizon. Senators Coons (Delaware), Durbin (Illinois), Hirono (Hawaii), and Tillis (North Carolina), along with Congressman Ken Buck (Colorado) and Representative Deborah Ross (North Carolina) have introduced the bipartisan, bicameral PREVAIL Act to Congress. The bill is awaiting committee consideration. And like all bills, the PREVAIL Act is subject to amendment prior to passing either chamber of Congress. The bill purports to remedy “[u]nintended consequences of the comprehensive 2011 reform of patent laws [such as] the strategic filing of post-grant review proceedings to depress stock prices and extort settlements, the filing of repetitive petitions for inter partes and post grant review . . . and the unnecessary duplication of work by the district courts” and PTAB. The bill has attracted high profile support, including former Federal Circuit Chief Judge Radar and former Director of the USPTO Andrei Iancu. The PREVAIL Act proposes several significant changes to PTAB proceedings that medical device companies should be aware of.
The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s Automated Impella Controller (AIC), which is part of a medical device system that provides temporary ventricular support to help a patient’s heart to pump blood in a critical care setting.