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Client Alerts 37 results
Client Alert | 7 min read | 05.18.26
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.
Client Alert | 3 min read | 05.18.26
“To IPR or Not to IPR?” — Director Squires Offers Clarity, With Data and History
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.
Client Alert | 6 min read | 05.12.26
EU Pharma Package: Advertising Compromise Proposal
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.
Client Alert | 6 min read | 05.11.26
FDA’s AI in Early Phase Clinical Trials RFI: An Opportunity to Help Set the Rules of the Road
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.
Client Alert | 13 min read | 05.06.26
EU Pharma Package: Interplay with the Critical Medicines Act – Status Update
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.
Client Alert | 4 min read | 05.05.26
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?
Client Alert | 4 min read | 05.04.26
Decentralized Clinical Trials: Key Sponsor Considerations Under FDA and EMA Guidance
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.
Client Alert | 11 min read | 04.27.26
The New EU "Pharma Package": Access Conditionalities and Shortage Measures Compromise Proposal
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.
Client Alert | 5 min read | 04.13.26
The New EU "Pharma Package": Global (Orphan) Marketing Authorization Compromise Proposal
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.
Client Alert | 3 min read | 04.07.26
The New EU "Pharma Package": Fiscal Imports in the Supply Chain Compromise Proposal
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.
Client Alert | 5 min read | 04.07.26
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.
Client Alert | 5 min read | 03.30.26
The New EU "Pharma Package": The Transferable Exclusivity Voucher Compromise Proposal
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.
Client Alert | 5 min read | 03.22.26
The New EU "Pharma Package": Regulatory Data Protection Compromise Proposal
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.
Client Alert | 3 min read | 03.02.26
Clinical trial sponsors and all other stakeholders involved in conducting commercial clinical trials of investigational medicinal products (IMP) in the UK.
Client Alert | 3 min read | 01.07.26
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.
Client Alert | 13 min read | 12.22.25
European Commission Proposes Biotech Act to Boost Health Biotechnology in the EU
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.
Client Alert | 10 min read | 12.22.25
European Commission Proposes Simplifying the Rules on EU Medical and In-Vitro Diagnostic Devices
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.
Client Alert | 6 min read | 12.15.25
The New EU “Pharma Package:” EU Reaches Landmark Deal on Pharma Package
On December 11, 2025, the Council of the European Union and the European Parliament reached provisional agreement on the long-awaited “Pharma Package,” (see the announcement here). The Pharma Package is a comprehensive and major overhaul of the EU legislative framework for pharmaceuticals, which replaces the more than 20-year-old Directive 2001/83 and Regulation 726/2004 and incorporates (and updates) the separate regulations on orphan and pediatric medicines (Regulations 141/2000 and 1901/2006 respectively).
Client Alert | 3 min read | 12.09.25
In an effort to boost its clinical research industry, Germany has enacted the Medical Research Act or “MRA” (Medizinforschungsgesetz). The MRA introduces significant changes to various German healthcare laws and procedures.
Client Alert | 3 min read | 11.20.25
Implications of CRISPR Dispute on Licensees
A decision in May from the Federal Circuit Court of Appeals has extended the long-standing and well-publicized dispute over inventorship of use of CRISPR-Cas9 technology in eukaryotic cells. When final resolution comes, it will have important implications for users of this technology. Companies currently licensing CRISPR-Cas9 from one of the two groups claiming ownership rights to the fundamental patents covering this technology and those considering licenses or investment in users of the technology should review existing or proposed licenses to better prepare for the potential outcomes of the dispute.
