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

In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available FDA and NIH databases for prior art searches. The goal of the training is to ensure that all relevant prior art is considered by examiners when assessing patentability. As with disclosures on clinicaltrials.gov, drug labels and drug approval information are publicly available and thus may qualify as prior art. This training is related to initiatives outlined in President Bid ..read more

On March 1, 2024, the Office of Information and Regulatory Affairs (“OIRA”), Office of Management and Budget (“OMB”), Executive Office of the President received the final version of FDA’s rule on regulation of laboratory developed tests (“LDTs”) for administrative review.  Having swiftly moved to OIRA review in under 5-months from the publication of the proposed rule and under 3-months from the end of its comment period, the rule has undoubtedly been a top priority for the FDA.  Further, as of the date of this post, OIRA has scheduled four back-to-back meetings with interested stakeh ..read more

This is the first of two articles focused on 2023 life sciences deals in China. The second article, which is coming soon, looks at trends in M&A.  In 2023, there were 240 reported life sciences licensing deals in China, an increase of almost 50% compared to 2021. That includes 70 out-license deals involving Chinese companies licensing drugs and technologies to foreign companies, with a disclosed aggregate deal value surpassing US$35 billion. It also includes 170 in-license deals involving Chinese companies licensing drugs and technologies from other Chinese companies or from fore ..read more

On February 12, 2024, the US Patent Office and Trademark Office (USPTO) released the Inventorship Guidance for AI-assisted Inventions (the Guidance). We previously discussed the Guidance here. Following up on the Guidance, the USPTO released two examples illustrating what the USPTO considers proper inventorship analyses for AI-assisted inventions. Each example sets forth different fact patterns and walks through an analysis of whether one or more human individuals qualify as inventors. Acknowledging that life sciences companies are increasingly employing AI systems to help identify molecu ..read more

Goodwin’s Life Sciences team will be hosting an upcoming event in our Boston office on March 13, 2024 to spotlight the critical work being done to address the 7,000+ rare diseases that impact more than 300 million people globally. Join us in person in our Boston office or attend virtually for our Annual Rare Disease Symposium on March 13, 2024. Look forward to an afternoon of engaging fireside chats, inspirational presentations, and networking with your peers in the rare disease community. This year’s program will include speakers covering the patient, advocacy, policy, research, and CEO’s pe ..read more

Despite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as “business as usual” in the antitrust world. In contrast, 2023 featured a significant step up in enforcement activity, including multiple challenged transactions and lengthy investigations in the life sciences space. As notable, many of these enforcement activities involved more “novel” theories of harm — such as bundling, potential competition, and harm to research, development, and innovation — displaying a willingness by the Federal Trade Commission (FTC) to put its rhetoric into action. At the same ..read more

Life sciences companies continue to make up a small portion of the companies registering for Unitary Patents. Per the European Patent Office’s statistics portal, as of January 30, 2024 there have been 18,721 registered Unitary Patents. The Uptake Rate is 17.5%. Of this, Medical Technology companies account for 2,266 (or, 11.8%) of the registrations. This is the largest of the 35 technology fields that the portal is tracking. Pharmaceuticals account for 717 (or, 3.7%) of the registrations. Biotechnology accounts for 444 (or, 2.3%) of the registrations. Notably, Johnson & Johnson has the lar ..read more

On January 10, 2024, the USPTO published guidelines for assessing enablement in view of Amgen v. Sanofi and other recent court cases (“the Guidelines”). The Guidelines state that they are not intended to “announce any major changes to USPTO practice or procedure” but instead “incorporat[e] guidance from the Amgen decision and several post-Amgen enablement court decisions that are consistent with current USPTO policy.” “The enablement requirement refers to the requirement of 35 U.S.C. § 112(a) that the specification must describe the invention in such terms t ..read more