Zachary B. Messick

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.

SALIX PHARMACEUTICALS, LTD. v. NORWICH PHARMACEUTICALS., INC. Before Lourie, Chen, and Cunningham. Appeal from the District of Delaware Summary: The Federal Circuit ruled that an ANDA listing an infringing indication cannot be approved during the pendency of the infringed patent even if the ANDA also lists a non-infringing indication.

The World Health Organization (WHO) recently released guidelines for the ethics and governance of large multi-modal models (LMMs). In the past year, LMMs like Chat GPT have come to the forefront of the news, and people have begun using them in different fields with varying success. Within the healthcare space, LMMs have the potential to respond to patients’ inquiries, identify research topics, and maintain electronic health records. However, the use of LMMs in healthcare raises many legal and ethical questions, such as how they can be used effectively without jeopardizing patient safety and privacy.

USPTO Announces New, Limited-Time Program for Expedited Semiconductor Patent Applications On December 1, 2023, the United States Patent and Trademark Office (“USPTO”) began accepting petitions for the Semiconductor Technology Pilot...

The FDA implemented the breakthrough device program in 2015. The program was designed to expedite review of premarket approval (PMA), 510(k) clearance, and De Novo marketing authorizations. Applicants can seek a breakthrough device designation prior to requesting market approval regardless of the classification of the device. In order to qualify as a breakthrough device, the device must (1) provide for a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition and (2) meet at least one of: (a) represents a breakthrough technology; (b) no approved or cleared alternatives exist, (c) offers significant advantages over existing approved or cleared alternatives, or (d) device availability is in the best interest of patients.

As retailers or distributors that are not manufacturers of a product, companies may believe they cannot infringe a patent claiming how the product is made. After all, the retailers or distributors are not performing any steps of the patented manufacturing process. The companies may have no say in, or even be aware of how the product is manufactured. The companies may conclude they are insulated from liability based simply on being downstream from the manufacturing process.