Insights

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. 

Enbrel (etanercept) is one of the best-selling biologic drugs in the United States, approved to treat rheumatoid arthritis and other serious inflammatory conditions. Etanercept was launched as Enbrel in 1998 as a treatment for moderate to severe rheumatoid arthritis, and was later approved to treat additional inflammatory diseases including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis.  

If a court finds that a patent applicant intentionally misrepresented or withheld material information from the USPTO with the intent to deceive, the consequences are severe, leading to unenforceability of the entire patent (and likely any later patents claiming priority to the unenforceable patent).

The first applications to lift an automatic suspension under the Procurement Act 2023 (the Act) have recently been decided. In Parkingeye Limited v Velindre University NHS Trust & Anor [2026] EWHC 1019 (TCC), handed down on 1 May 2026, HHJ Keyser KC dismissed applications by two NHS contracting authorities to lift the suspension preventing them from concluding a car park management services contract. This is the first judicial consideration of the new test under section 102(2) of the Act.

For 15 years, the question “Should we file an IPR?” was easy. The answer — almost invariably — was “yes.” High institution rates, a famously skeptical U.S. Patent Trial and Appeal Board (PTAB), and minimal downside made inter partes review (IPR) a nearly reflexive tool in the litigator’s arsenal. U.S. Patent and Trademark Office (USPTO) Director Squires’ precedential decision issued May 14, 2026, in Magnolia Medical Technologies, Inc. v. Kurin, Inc. (IPR2026-00097) provides clarity to that calculus.

In our ninth alert in this EU Pharma Package Series, we discussed the proposals of the Commission, Council, and Parliament with respect to advertising of medicinal products.

Consistent with recent FDA initiatives directed at leveraging AI technologies and improving early-phase clinical trial conduct, the FDA has issued a Request for Information (RFI) for input on a proposed AI-enabled optimization pilot program for early-phase clinical trials. The issues for which FDA is requesting information fall into two categories:  (A) Pilot program design and implementation and (B) Program evaluation metrics and success criteria.

In our eighth alert in this EU Pharma Package Series, we took a “detour” to discuss the interplay between the measures proposed in the Pharma Package and those contained in other important EU initiatives such as the proposed Critical Medicines Act (CMA), and the Medicinal Countermeasures and EU Stockpiling Strategies.

As prescription drug prices continue to soar in the United States, the Supreme Court recently heard the highly anticipated oral arguments in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., the first patent case at the Court since 2023. While the Justices did not seem motivated to make significant changes to the current standards for induced patent infringement, the stakes are high for brand and generic pharmaceutical companies, as each side continues to wrestle with the main dilemma that this case raises: What is the right balance between marketing skinny labels to engage in lawful generic competition and avoiding induced infringement liability?

The FDA and the European Medicines Agency (EMA) (jointly with the European Commission and Heads of Medicines Agencies) each have issued or updated their respective guidance addressing decentralized clinical trials (DCT), i.e., clinical trials that include trial-related activities conducted at locations other than the traditional investigative site.

In our seventh alert in this EU Pharma Package Series, we provided an analysis of the increasing focus on shortages of medicinal products in the EU and the prevention and mitigation measures as proposed by the EU institutions.

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product.

In our fourth alert in this EU Pharma Package Series, we provided an analysis of the long-standing but increasingly debated issue of fiscal imports in the pharmaceutical supply chain and the EU’s evolving approach to this issue.

On April 2, 2026, President Trump issued a Proclamation invoking Section 232 of the Trade Expansion Act of 1962, as amended (19 U.S.C. § 1862), to impose tariffs on imports of patented pharmaceuticals, biologics, and associated ingredients into the United States.  The action affects pharmaceutical manufacturers, importers, and supply chain participants.   

In our third alert in this EU Pharma Package Series, we provided a detailed overview of the diverging positions of the European Commission, the European Parliament , and the Council of the European Union on the transferable exclusivity voucher (TEV) for priority antimicrobials.

In our second alert in this EU Pharma Package Series, we provided a detailed overview of the diverging positions of the European Commission (Commission), the European Parliament (Parliament), and the Council of the European Union (Council) on one of the most debated and anxiously anticipated topics, the regulatory data protection (RDP). While all EU institutions proposed a modulation system, they differed significantly in terms of the baseline period and the structure of the possible extensions.

Clinical trial sponsors and all other stakeholders involved in conducting commercial clinical trials of investigational medicinal products (IMP) in the UK.

On December 17, 2025, the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) on a proposal designed to help the FDA engage more directly with innovative, venture-backed companies focused on biotechnology, medical devices, AI, and regulatory technology.[i]The RFI includes 19 questions, with responses due by 2:00 p.m. ET on January 18, 2026.

On December 16, 2025, the European Commission published its proposal for a regulation establishing a European Biotech Act to strengthen the EU's biotechnology and biomanufacturing sectors with a primary focus on health.

The European Commission has proposed targeted amendments to the Medical Devices Regulation 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). The amendments are intended to simplify the rules, reduce the administrative burden, and enhance the predictability and cost-efficiency of notified body certification, while maintaining high public health and patient safety standards.