… a major change to the Regulation is needed to prevent shortages of life-saving medical devices… Background On Friday 9 December 2022, the European Commission proposed to extend the transition deadline in the Medical Device Regulation (EU) 2017/745 (MDR). According to the European Commissioner for Health and Food Safety, Stella Kyriakides, a major change to the Regulation is needed to prevent shortages of life-saving medical devices, from implants and prosthetics to ventilators and pacemakers. Medical devices in the EU are regulated under the MDR, and the MDR replaced the previous Medical Dev ..read more

The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 (“PIE Act”) was passed as part of Congress’s December 23, 2022 omnibus spending bill. Once signed into law, this legislation will amend the Federal Food, Drug, and Cosmetic Act’s (FDCA’s) provisions on misbranded drugs and devices to formally allow drug and medical device manufacturers to proactively share investigational drug and device information, including health care economic information, with payors, health plans, formulary committees, and other similar entities prior to the cl ..read more

The Unified Patent Court (“UPC”) is set to begin on June 1, 2023. Under the UPC framework, a single court proceeding could result in simultaneous revocation of European Patents across multiple European Union (“EU”) countries, including France and Germany. A three-month “Sunrise Period” is set to begin March 1, 2023. If a request is filed during the Sunrise Period, patent owners can “opt-out” specific patents from the UPC, such that they never become subject to the UPC unless the patent owner decides to withdraw the opt-out. However, the opt-out procedure is not necessarily straightforward. Imp ..read more

The U.S. Patent and Trademark Office (“USPTO”) published a Notice in the Federal Register announcing a new pilot program entitled, “Cancer Moonshot Expedited Examination Pilot Program” (the “Cancer Moonshot Program”) (87 Fed. Reg. 75608 (December 9, 2022)) (the “Notice”) to attempt to further accelerate innovation in the health and medical fields.  Beginning on February 1, 2023, this new program will replace the Cancer Immunotherapy Pilot Program and expedite examination for a broader scope of technologies to prevent cancer and advance smoking cessation.  The Cancer Moonshot Program ..read more

After a recent reminder from the U.S. Patent and Trademark Office (USPTO) regarding the duties of disclosure and reasonable inquiry during examination of a patent application and a Request for Comments (RFC) on the USPTO initiatives to ensure “robustness and reliability” of patent rights,[1] the Director of the U.S. Patent and Trademark Office published a third notice in less than four months.  The latest notice is in conjunction with the Food and Drug Administration (FDA) to further the discussion surrounding the patent practices of the pharmaceutical industry (87 Fed. Reg. 67019 (Novemb ..read more

The off-label use of ketamine to treat anxiety, depression, and other behavioral health disorders —coupled with the COVID-19 telehealth era—has spurred the opening of virtual ketamine clinics nationwide. Some clinics offer a full suite of health care services, including telehealth visits, prescribing, pharmacy dispensing, and counseling services, while others are focused on more niche areas like group coaching sessions. In the wake of public reports detailing investigations into a number of digital health companies prescribing controlled substances, it is more important than ever to ensure you ..read more

The third quarter in the life sciences space showed that business is generally proceeding as usual, with large pharma players successfully acquiring or licensing in clinical stage assets without running into antitrust delays. That said, even these inherently procompetitive deals appear to be receiving at least some attention from the agencies. As such, being ready for scrutiny should help avoid extensive and costly reviews. Indeed, a recent trio of mergers within the sickle cell disease space shows the importance of adequate preparation and engagement. Antitrust agency activity in other sector ..read more

The U.S. Food and Drug Administration’s (“FDA” or “the Agency”) Center for Devices and Radiological Health (“CDRH”) recently announced the launch of its Total Product Life Cycle Advisory Program (“TAP”) Pilot. The first phase of this voluntary initiative, called TAP Pilot Soft Launch, will be conducted during fiscal year (“FY”) 2023 with enrollment beginning on January 1, 2023. The Agency committed to establishing the TAP Pilot as part of the MDUFA V reauthorization, and the Agency’s long-term vision for TAP is “to help spur more rapid development and more rapid and widespread patient access t ..read more

Recent merger enforcement in the pharmaceutical space continues to follow traditional principles and modes of analysis. However, with a new 3-to-2 Democratic majority, it is increasingly likely that the Federal Trade Commission’s enforcement actions will reflect more aggressive theories that were previously advocated only in dissenting statements. Recent behavioural enforcement has largely consisted of pay-for-delay litigation and continuing prosecution of price-fixing charges against generic manufacturers. However, the FTC seems poised to open a new front of enforcement as it has given strong ..read more

On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022,[1] which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement and Modernization Act of 2003. The legislation is expected to pass without modification by the House of Representatives and to be signed by President Biden shortly thereafter. The healthcare-related portions of the bill introduce many important changes, most notably allowing the Medicare program to negotiate with pharmaceutical companies for reduced prescription drug prices ..read more