Insights

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.

[1] In a recent development, the UK Supreme Court ruled that Artificial Neural Networks (ANNs) are not excluded from patentability due to being a computer program “as such.” In doing so, the Court set out the framework of a new test for the UK Intellectual Property Office (IPO) to use when evaluating the patentability of computer. The ruling breaks down barriers to the patenting of AI algorithms in the UK and paves the way for a wider change in the UK IPO’s approach to assessing excluded subject matter.

On March 11, 2026, U.S. Patent and Trademark Office (USPTO) Director Squires issued a memorandum (2026 memo) to all Patent Trial and Appeal Board (PTAB) users titled “Additional Discretionary Institution Considerations — U.S. Manufacturing and Small Business Use of AIA Proceedings.”[1] In the 2026 memo, the director adds three new factors in determining whether to institute inter partes review (IPR) and post-grant review (PGR) proceedings.[2] The factors focus on domestic manufacturing and the use of these proceedings by small businesses.[3] The memo applies immediately to all pending IPR and PGR proceedings in which the due date for the patent owner’s discretionary brief has not yet elapsed.[4] Patent owners, petitioners with domestic manufacturing ties, and small business petitioners should take note.

The EU Pharma Package represents the most significant reform of EU pharmaceutical legislation in over two decades, setting the stage for a new era in medicine regulation. Introduced by the European Commission back in April 2023, the proposals are designed to promote innovation, strengthen medicine availability and affordability, reduce regulatory burdens, ensure a fair and competitive European pharmaceutical market, and modernize the EU's pharmaceutical framework. The EU Pharma Package will replace the more than twenty-year-old Directive 2001/83/EC and Regulation 726/2004, and incorporates the separate regulations on orphan and pediatric medicines, thereby bringing the entire regulatory framework up to date.

Ex parte reexamination is seeing a resurgence in popularity as a cost-effective means to challenge a patent’s validity and should be part of your patent strategy. An ex parte reexamination is a proceeding in which any party — including a patent owner or an anonymous third party — may submit prior art to request that the United States Patent and Trademark Office (USPTO) reassess an issued patent's validity. Once overshadowed by the introduction of inter partes review (IPR) and post-grant review (PGR) following the enactment of the America Invents Act in 2012, ex parte reexamination is now experiencing a significant resurgence as a strategic alternative to both proceedings. This client alert explains what is driving ex parte reexamination’s resurgence and what it means for your patent strategy.

The Court of Justice of the European Union (CJEU) recently delivered its judgment in the CeramTec case (C-17/24).

The federal Defend Trade Secrets Act (“DTSA”) is celebrating its 10th anniversary.  After many years of consideration, in 2016, Congress passed and the President signed the DTSA.  Patterned on the Uniform Trade Secrets Act adopted in most states, the DTSA creates a federal cause of action for misappropriation of trade secrets and thereby gives litigants a direct avenue into federal court.  Since then, the federal courts have been grappling with how to manage DTSA cases.  One issue still to be resolved is the absence of model jury instructions in most jurisdictions.

New York Governor Kathy Hochul has signed into law the most significant update to New York’s consumer protection law in 45 years — the Fostering Affordability and Integrity through Reasonable Business Practices Act, or FAIR Business Practices Act — expanding the scope of the state’s authority to now challenge unfair and abusive business practices. The measure, backed by New York Attorney General (“AG”) Letitia James and signed on December 19, 2025, amends New York’s General Business Law § 349, giving regulators new tools to protect consumers and promote fair marketplace practices.

The United States Trademark Trial and Appeal Board (TTAB or Board) recently issued a refreshed opinion in the trademark dispute Naterra International, Inc. v. Samah Bensalem, where Naterra International, Inc. petitioned the TTAB to cancel Samah Bensalem’s registration for the mark BABIES' MAGIC TEA based on its own BABY MAGIC mark. On remand from the U.S. Court of Appeals for the Federal Circuit, the TTAB reconsidered an expert’s opinion about relatedness of goods based on the concept of “umbrella branding” and found that the goods are unrelated and therefore again denied the petition for cancellation.

On November 4, 2025, the USPTO in Ex parte Desjardins designated as precedential an earlier Appeals Review Panel (ARP) decision overruling the Patent Trial and Appeal Board (Board), instead holding that claims directed to training a machine learning model are patent-eligible under 35 U.S.C. § 101 when they integrate a mathematical concept into a practical application that improves how the model operates. That precedential designation represents a material shift in legal precedent in the § 101 arena post-Alice, and it has already driven updates to the MPEP and examiner practice. As a result, Desjardins signals an adjustment in practice in favor of AI and software eligibility at the USPTO.

On 4 December 2025, the Court of Justice of the EU (CJEU) issued a landmark judgment in the joined cases C-580/23 (Mio v. Asplund) and C-795/23 (USM v. Konektra) concerning copyright protection for “works of applied art” (i.e., utilitarian objects such as tables, furniture, lighting fixtures, sofas, chairs, kitchen appliances, vases, and fashion items).

On November 12, 2025, Judge King in the U.S. District Court for the Western District of Washington granted in part Haldiram India Ltd.’s (“Plaintiff” or “Haldiram”) motion for a preliminary injunction against Punjab Trading, Inc. (“Defendant” or “Punjab Trading”), a seller alleged to be importing and distributing gray market snack food products not authorized for sale in the United States. The court found that Haldiram was likely to succeed on the merits of its trademark infringement claim because the products at issue, which were intended for sale in India, were materially different from the versions intended for sale in the U.S., and for this reason were not genuine products when sold in the U.S. Although the court narrowed certain overbroad provisions in the requested order, it ultimately enjoined Punjab Trading from importing, selling, or assisting others in selling the non-genuine Haldiram products in the U.S. market.

On November 13, 2025, the president of the French-speaking Brussels Enterprise Court ruled in the long-running battle between Sandoz and Regeneron about the correct interpretation of the EU’s Supplementary Protection Certificate (SPC) Manufacturing Waiver Regulation regarding exports to a non-EU market. The Brussels Court dismissed Regeneron’s claim that Sandoz had provided a defective notification and agreed with Sandoz’s interpretation of the Regulation.

Claim construction is a key stage of most patent litigations, where the court must decide the meaning of any disputed terms in the patent claims.  Generally, claim terms are given their plain and ordinary meaning except under two circumstances: (1) when the patentee acts as its own lexicographer and sets out a definition for the term; and (2) when the patentee disavows the full scope of the term either in the specification or during prosecution.  Thorner v. Sony Comput. Ent. Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).  The Federal Circuit’s recent decision in Aortic Innovations LLC v. Edwards Lifesciences Corp. highlights that patentees can act as their own lexicographers through consistent, interchangeable usage of terms across the specification, effectively defining terms by implication.

The Court of Justice of the European Union (CJEU) recently issued a landmark judgment in the LEGO Group case (C-211/24) concerning the scope of EU design protection for modular systems. This recent judgment addresses fundamental questions regarding the protection and enforcement of Community designs for modular products, specifically the LEGO Group’s iconic toy building blocks and parts:

Although the Supreme Court’s 2014 decision in Alice v. CLS Bank and its progeny affected the issuance and enforcement of software patents and led to a major shift in U.S. patent policy, software patents still have value today and such protection therefore should be pursued.

Nearly a decade and a half after the passage of the Leahy-Smith America Invents Act (“AIA”), the Federal Circuit finally had its first occasion to review an appeal of a derivation proceeding that was litigated before the Patent Trial and Appeal Board (“Board”) in Global Health Solutions LLC v. Selner. This case provides helpful guidance for patent litigators regarding the proper legal framework in a derivation proceeding and serves as a reminder that patent applications should be filed as soon as possible. As the facts of this case show, it is important that inventors retain documents and other evidence of the conception of their invention, as well as its communication to others, should there be any challenge to their invention.

The Ninth Circuit ruled that NFTs are not just digital collectibles but legally recognized goods under the Lanham Act. Yuga Labs, Inc. v. Ryder Ripps and Jeremy Cahen, Case No. 24-879 (9th Cir. July 23, 2025). NFTs are intangible, fully virtual, authenticating software code that is associated with separate digital or physical content. Although the Ninth Circuit found that there were genuine issues of material fact that precluded summary judgment on the issue of likelihood of confusion, the court recognized that NFTs are commercial products with tangible value subject to trademark protection. This means that NFT creators and projects can now claim trademark rights in their collections’ names, logos, and associated marks.

In the last few months, both Washington State and Pennsylvania enacted significant legislation addressing the malicious use of deepfakes—artificial intelligence-generated or manipulated media. These new laws reflect a growing national and state-level trend to regulate AI-generated content, especially when used to harm individuals or mislead the public.