Skip to content

News & Insights

WTO Agrees to Partial Patent Waiver for COVID-19 Vaccines
On June 16, 2022, the World Trade Organization (WTO) agreed to a partial waiver of intellectual property rights related to COVID-19 vaccines.  The agreement came on the heels of an...
BD and Mayo Clinic Collaborate to Share De-Identified Patient Data
Becton, Dickinson and Company (BD) has partnered with Mayo Clinic to gain access to de-identified patient data from Mayo Clinic Platform_Discover, as reported by a press release dated June 13, 2022. The...
Medtronic and DaVita Join Forces for Kidney Health
Medtronic plc and DaVita Inc. are joining forces to form a new, independent medical device company to provide enhanced kidney health care. The new company will focus on making different...
U.S. FDA Approves Monkeypox Treatment Formulation
By Mark Rubinshtein (May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of...
Medtronic acquires Intersect ENT, sells Fiagon to Hemostasis LLC as required by FTC
On May 13, 2022, Medtronic, Inc. announced that it completed the acquisition of Intersect ENT, Inc.  The transaction was only able to gain approval of the Federal Trade Commission (FTC)...
FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program
On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement:...
FDA Publishes Draft Medical Device Cybersecurity Guidance Amidst Continued Cybersecurity Concerns
On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices, titled Cybersecurity in Medical Devices: Quality System Considerations and Content of...
Pfizer Australia Announces Deal to Acquire ResApp Health
ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc.  Pfizer agrees it would acquire 100% of the shares for AUD $0.115 /...
Medical Device Cybersecurity Survey Report Released
Cybellum released a medical device survey report on April 20, 2022 entitled “Medical Device Cybersecurity: Trends and Predictions.”  The company’s website states that their “mission is to enable manufacturers and...
Niazi’s Patent Survives on Appeal: Federal Circuit Reverses In Part Lower Court’s Decision
On April 11, 2022, Niazi Licensing Corporation (“Niazi”) succeeded in part in its appeal at the Federal Circuit in Niazi Licensing Corporation v. St. Jude Medical S.C. Inc. Niazi’s lawsuit...
Becton Dickinson’s PureWick Wins Patent Infringement Suit Against Stryker’s Sage Products Related To Female External Catheters
PureWick Corp., a Becton Dickinson company, succeeded in its infringement lawsuit PureWick Corp. v. Sage Products LLC. PureWick’s lawsuit alleged that Sage Products infringed U.S. Patent Nos. 10,226,376; 10,390,989; 10,376,407,...
Cancer Drug Patent Not Dead Yet
By Alistair J. McIntyre (Mar. 31, 2022) Last Friday, ImmunoGen won an appeal at the Federal Circuit in ImmunoGen, Inc. v. Hirshfeld. The lawsuit is a civil action to order...
close modal