The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023 following the White House’s announcement of initiatives to lower health care and prescription drug costs via competition.
On December 27, 2023, Judge Thomas S. Kleeh of the United States District Court for the Northern District of West Virginia issued an order finding that Mylan (Viatris) infringed claims 4, 7, 9, 11, and 14-17 of Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”) after a nine-day bench trial held in June 2023.
A recent paper published by market.us projects that the Deep Brain Stimulation (DBS) devices market is expected to reach around $3.5 Billion by 2033, compared to the projected $1.5 Billion for 2024.
A recent paper published by market.us projects that the Deep Brain Stimulation (DBS) devices market is expected to reach around $3.5 Billion by 2033, compared to the projected $1.5 Billion for 2024.
In recent years, Congress has considered potential new laws for patent reform, typically changes to the system supported by patent owners. Two main areas of focus are “Section 101” and the “PTAB.” Below is a summary of two such efforts currently being considered by Congress.
On January 9, 2024, the USPTO published guidelines for its patent examiners when evaluating compliance with the enablement requirement in light of the U.S. Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023). In Amgen, the Supreme Court unanimously held that claims drawn to a genus of monoclonal antibodies, which were functionally claimed, were invalid due to a lack of enablement. Notably, the Supreme Court did not expressly cite the Wands factors in analyzing whether the specification at issue in Amgen enabled the claims, but the recently published USPTO guidelines underscore that “USPTO personnel will continue to use the In re Wands factors to ascertain whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable.”
In this inaugural episode of the Knobbe IP+ podcast, Knobbe Martens partner Greg Phillips speaks with Joe Wheatley, Senior Counsel, Amazon Counterfeit Crimes Unit, about how the Counterfeit Crimes Unit…
(December 27, 2023) Natera Inc. succeeded in obtaining a preliminary injunction against NeoGenomics Laboratories, Inc.’s medical assay test. Natera’s ongoing federal lawsuit alleges that NeoGenomics’ product “RaDaR,” a tumor informed molecular residual disease (“MRD”) assay, infringes two of Natera’s patents, U.S. Patent No. 11,519,035, entitled “Methods for Simultaneous Amplification of Target Loci,” and U.S. Patent No. 11,530,454, entitled “Detecting Mutations and Ploidy in Chromosomal Segments.”
Boston Scientific Corporation (“Boston Scientific”) announced on January 8 that it has entered into a definitive agreement to acquire Axonics, Inc. (“Axonics”) for an equity value of approximately $3.7 billion. The timing of the announcement coincided with the start of the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, which also saw the announcement of major acquisitions by large players in the pharmaceutical space.
CardioMech AS (“CardioMech”) announced that the company successfully raised $13 Million in capital in addition to the $18.5 Million Series A financing in 2020 bringing total funding to $42 Million.
