Insights

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.

On April 30, 2026, USPTO Director John A. Squires issued an updated memorandum superseding the December 4, 2025, guidance on Best Practices for Submission of Rule 132 Subject Matter Eligibility Declarations (SMEDs). The USPTO has also created a new position — Deputy Commissioner for Patents focusing on AI Policy, Practice, and Operations — and has welcomed longtime practitioner and private-sector AI expert Barry Schindler to this role. This alert summarizes the key updates and actionable guidance for patent applicants and practitioners.

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?

In Constellation Designs, LLC v. LG Electronics Inc., No. 2024-1822 (Fed. Cir. Apr. 28, 2026), the U.S. Court of Appeals for the Federal Circuit distinguished between two sets of claims under a Section 101 analysis, invalidating one set as result-oriented “optimization” claims that did not recite how to achieve such optimization, but upholding the other set as patent-eligible for reciting specific configurations with defined parameters. The court also confirmed that patentees may prove infringement by combining standards-based and product-specific evidence on a limitation-by-limitation basis.

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 Fortress Iron, LP v. Digger Specialties, Inc., No. 24-2313 (Fed. Cir. Apr. 2, 2026), the U.S. Court of Appeals for the Federal Circuit reaffirmed what happens when a patent incorrectly lists the true inventors, and that error cannot be corrected under 35 U.S.C. § 256(b), which requires notice and a hearing for all “parties concerned.” In Fortress, the patent owner sought judicial correction to add an inventor under § 256(b), but that inventor could not be located. Because the missing inventor qualified as a “concerned” party under the statute, the lack of notice and a hearing for that inventor made correction under § 256(b) impossible, and the patents could not be saved from invalidity.

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.

At the European Patent Office (EPO), a recent referral of case T 873/24 from the Technical Board to the Enlarged Board of Appeal may clarify whether last summer’s decision in case G 1/24 on claim interpretation may be extended to the analysis of Added Subject-Matter. Already G 1/24 is impacting the assessment of patentability at the EPO, but should this referral be allowed, G 1/24’s effect on the assessment of added matter could result in a real shake up of the EPO’s notoriously strict assessment of support. Nonetheless, a review of how we got here highlights the value of late arguments during the EPO appeal process.

The U.S. Court of Appeals for the Federal Circuit recently decided in Bd. of Trs. of Columbia Univ. v. Gen Digital Inc., No. 2024-1243 (Fed. Cir. 2026) that the district court erred in its denial of judgment as a matter of law as to damages resulting from foreign sales of downloadable software. At Columbia University's request, the jury had been instructed that “Columbia [was] entitled to damages based on sales to customers located outside of the United States if . . . the infringing product sold to those customers was made in or distributed from the United States, even if the infringing product [was] delivered to and used by the customer outside the United States.” The court concluded as a matter of law that the software sold to Gen Digital‘s (Norton) foreign customers was made outside the United States, and therefore the $94 million in foreign sales damages could not stand.

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 March 25, 2026, in Cox Communications, Inc. v. Sony Music Entertainment, the U.S. Supreme Court reversed a $1 billion verdict against Cox. The judgment was the result of a jury trial in which Sony claimed that Cox was liable for contributory copyright infringement because it knew that its customers were using its service to infringe yet did not respond with sufficient diligence to prevent that infringement.

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.