On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of laboratory developed tests (“LDTs”) under the Federal Food, Drug and Cosmetic Act (“FDCA”). As detailed in our prior analysis (here), the final rule amended the FDA’s existing regulations to make explicit the agency’s interpretation that LDTs are “devices” under the FDCA, and established a five-stage plan to phaseout the agency’s current general policy of “enforcement discretion” with resp ..read more

In newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development, the FDA addresses its new designation program for platform technologies, which is intended to bring efficiencies to drug development, manufacturing, and review processes for applications that incorporate designated platform technologies. Read the full alert here. The post Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance appeared first on Life Sciences Perspectives ..read more

On May 17, 2024, an Appeals Review Panel (ARP) of the United States Patent and Trademark Office (“USPTO”) released its decision in Ex parte Chamberlain (referred to in Federal Circuit proceedings as In re Xencor; “Chamberlain”). The Chamberlain decision provides some clarity on the USPTO’s position on written description requirements for Jepson and means-plus-function claims in the life sciences space. Importantly, it suggests that carefully drafted means-plus-function claims are a potential path for Applicants to claim antibodies broadly by use of functional lang ..read more

On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) published its final rule setting forth its framework for oversight of LDTs. The final rule and accompanying policy to phase out the agency’s general policy of “enforcement discretion” for LDTs comes roughly six months after FDA published its proposed rule that outlined the agency’s proposed approach to increasing oversight over LDTs. As detailed in our prior analyses of the p ..read more

Rapid advancement in life sciences technologies has made keeping up with the legal implications more important than ever. Join the Berkeley Center for Law and Technology for the 2nd BCLT Advanced Life Sciences Institute, where you will learn from the experts about cutting-edge issues impacting your life sciences practice. The programming will share key insights and best practices related to the rapid rise of AI in the life sciences and new trends for licensing, deals, and life sciences funding models. Expert will review key developments in the law (Section 112, obviousness-type double patentin ..read more

On April 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs). This final ruling amends the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs), including those manufactured by laboratories, are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Alongside the amendment, FDA issued its policy to phase in regulatory requirements for certain LDTs over the course of four years. The FDA will host a webinar to provide an overview of the final rule on May 14, 2024. A link to register can be found ..read more

In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines (including those for rare diseases and children). On April 10, 2024, the European Parliament adopted its position on the European Commission’s legislative proposals with respect to (i) Regulation 2023/0131 that can be found here and (ii) Directive 2023/0132 that can be found here. For certain key areas covered in the proposed EU legislation, we ..read more

Goodwin’s Rare Disease Initiative hosted its Annual Rare Disease Symposium in Boston on March 13, 2024. Participants were invited to join for an afternoon of engaging and inspirational conversations led by Julie Tibbets, Matt Wetzel, and Danielle Lauzon, in addition to networking with peers in the rare disease community. The program included speakers covering the patient, advocacy, policy, research, and CEO perspectives. For more event highlights and key takeaways from our speakers, please visit the Goodwin Rare Disease Symposium 2024 page. The post Recap: Goodwin Rare Disease Symposium 2024 a ..read more

On April 1, 2024 the Federal Circuit released its opinion in Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al., affirming the district court’s finding that certain claims were not indefinite and remanding to the district court to reevaluate its obviousness decision.  The Federal Circuit’s analysis provides important considerations for life sciences companies litigating method of treatment patents. Janssen sued Teva for patent infringement, asserting U.S. Patent No. 9,439,906 (“the ’906 patent”).  Teva stipulated to infringement but chall ..read more

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team has provided an overview of key developments. We update and publish a quarterly tracker detailing these developments. You can read about the Q2 2024 updates here. The post A Look Ahead in Life Scien ..read more