Stryker Acquires Inari Medical for $4.9 Billion
Stryker Corporation (“Stryker”) recently announced that it has entered into a definitive agreement to acquire Inari Medical, Inc. (“Inari”) for approximately $4.9 billion. Inari develops technologies and products for treating pulmonary embolism, deep vein thrombosis, in-stent...
Edwards v. Meril at the Supreme Court: Testing the Scope of Hatch-Waxman’s Safe Harbor
On October 11, 2024, Edwards[1] filed a petition for a writ of certiorari with the U.S. Supreme Court.[2] The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe...
Medical Device Deal Activity Shows Signs of Life for Q3 2024
Market reports indicate the global medical device industry for Q3 2024 saw an increase in merger and acquisition (M&A) activity in terms of value year-over-year. Although deal value decreased compared to...
Teva v. Amneal Oral Arguments and Claim Construction Order: Recent Developments in the Ongoing Debate Over the Orange Book Listing of Device Patents
As the FTC continues to crack down on pharmaceutical manufacturers’ allegedly improper listing of patents in the FDA Orange Book, counsel for Teva and Amneal presented oral arguments in the Court of Appeals for the Federal Circuit on November 8,...
Novacure’s Wearable Lung Cancer Treatment Device, Optune Lua, Receives FDA Approval
The FDA has granted approval for Novocure‘s wearable medical device, Optune Lua, designed to treat advanced non-small cell lung cancer (NSCLC). The device utilizes portable transducer arrays placed on the skin to deliver alternating electrical fields, termed Tumor Treating Fields (TTFs), thereby disrupting malignant cell division while leaving healthy cells largely unaffected.
Women’s Health Medical Device Company Caldera Medical Acquires UVision 360
Caldera Medical, Inc. on October 8th, 2024, announced the acquisition of UVision 360, Inc. Caldera Medical develops medical devices for women’s health, including surgical products for the treatment of stress urinary incontinence, pelvic floor disorders, pelvic organ prolapse, and hysteroscopic removal of intrauterine tissue. UVision 360 is a developer of in-office hysteroscopy systems for evaluating and treating uterine conditions.
Vertos Medical Latest Acquistion in Stryker’s M&A Streak
Medical technologies giant Stryker announced on Tuesday, October 1st, that it completed the acquisition of Vertos Medical for an undisclosed amount. Vertos Medical is a privately held company specializing in interventional pain management solutions for chronic back pain caused by lumbar spinal stenosis.
Cook Medical Sells Lead Management Portfolio to Merit Medical
Cook Medical recently announced it is selling its lead management portfolio to Merit Medical. Cook Medical is a medical device manufacturer with a portfolio of products used in lead management procedures, including for patients who need a pacemaker or an implantable cardioverter-defibrillator lead removed or replaced. Merit Medical is a manufacturer of disposable medical devices and has products used in interventional, diagnostic, and therapeutic procedures, including in the fields of cardiology, critical care, endoscopy, oncology, and radiology.
Test Anxiety: FDA Issues Warning Letters to Test Laboratories
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise concerns with the quality and integrity of data generated.” The press release can be found here.
Getinge Acquires Paragonix Technologies
Getinge, a Swedish public limited company, announced on September 11, 2024 that it completed acquisition of Paragonix Technologies, Inc., a U.S. company specializing in organ transport products and services. According to Getinge’s press release, the total purchase price was $477 million.
ARPA-H Announces New Funding related to AI-Enabled Medical Tools
The U.S. Advanced Research Projects Agency for Health (ARPA-H) announced new funding for a “program to help AI-enabled medical tools maintain peak performance.” The new funding is through the Performance and Reliability Evaluation for Continuous Modifications and Usability of Artificial Intelligence (PRECISE-AI) program.
Parent (Un)Trap: Most Parent Patents Cannot Be Invalidated by Their Children Because of PTA
Medical device companies are often well versed in prosecuting multiple patents within a single “family.” Indeed, such families are often of significant value to early stage (and later stage) medical device companies. But a Federal Circuit decision from last year raised the possibility that the continued prosecution of patents within a family could invalidate those early, valuable patents. In a clarifying decision, the Federal Circuit recently explained that “a first-filed, first-issued, later-expiring claim (e.g., in a Parent Patent) cannot be invalidated (under the doctrine of obviousness-type double patenting – “ODP”) by a later-filed, later-issued, earlier-expiring reference claim (e.g., in a child patent) having a common priority date.” This may sound complicated, but it can be good news for patent owners who own a family of patents because it is now less likely that a later prosecution will invalidate an earlier issued patent.
GE Healthcare Announces Deals in AI
GE HealthCare on July 25th, 2024, announced a collaboration with Amazon Web Services (AWS) to develop purpose-built foundation models and generative artificial intelligence (AI) applications. According to the GE HealthCare press release, the company intends to utilize Amazon Bedrock to amplify the advantages of generative AI for their customers and build its own proprietary generative AI applications for healthcare use cases.
Dr. Jeff Shuren, FDA CDRH Director, to Retire
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 to Acquire Innovalve
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.
FTC’s Proposed Noncompete Ban in Doubt
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).
Boston Scientific Agrees to Acquire Silk Road Medical in $1.16B Deal
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.
Delaware Court Denies Preliminary Injunction Seeking to Block Liquidia’s YUTREPIA Launch
The United States District Court for the District of Delaware recently denied United Therapeutics Corporation‘s motion for a preliminary injunction. The motion sought to prevent Liquidia Technologies, Inc. from launching its YUTREPIA, which is used to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). YUTREPIA is an inhaled dry power formulation of treprostinil delivered through a palm-sized inhalation device.
Becton, Dickinson and Company (BD) Announces Acquisition of Edwards Lifesciences’ Critical Care
BD (Becton, Dickinson and Company) has announced the acquisition of Edwards Lifesciences’ Critical Care product group for $4.2 billion. The acquisition follows Edwards’ previously announced plans to spin off Critical Care by the end of 2024 to focus on transcatheter/surgical therapies. BD has announced that the acquisition aims to enhance BD’s smart connected care solutions portfolio and advance its position in the monitoring technology sector.
UK Proposes Approving Medical Devices Based on Approval in Other Countries
Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom. On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of intent for what could be a significant shift in policy: approval to market and sell medical devices based on prior approval from a comparable regulatory country (CRC). Medical devices approved under the new framework would be allowed into the UK market but would not receive the UK Conformity Assessed (UKCA) certification. Market availability would be determined based on the CRC approval.
Florida Man Makes Medical Device – A Survey of Medtech in the Sunshine State
Florida is more than just the home of alligators and presidential candidates. The state was recently ranked as the fourth largest “medical device state” in the U.S., after California, Minnesota, and Massachusetts. It was estimated to have the third largest “total medical technology employment, with nearly 24,000 jobs, and No. 7 in total revenue generated in the sector, with $6.09 billion.” Florida has also recently been recognized as having the nation’s “second-largest pharmaceuticals manufacturing industry” and “the fourth-largest biotech R&D industry.”