Global Patent Litigation Developments: US Supreme Court, Madras High Court, UPC, and EPO Updates

This edition of the Irides Weekly Update highlights significant patent litigation developments from the United States, India, the Unified Patent Court (UPC), and the European Patent Office (EPO).

In the United States, the Supreme Court issued a unanimous decision on June 4, 2026, reversing the Federal Circuit’s approach to induced infringement claims under 35 U.S.C. §271(b). The case, Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., clarified that liability for induced infringement requires affirmative steps by the manufacturer designed to encourage infringing use, rather than passive actions that merely facilitate off-label use.

The Court found that Hikma’s skinny label, which excluded Amarin’s patented cardiovascular indication, along with associated patient leaflets, website content, and press releases, did not meet the threshold for active inducement. Statements attributable to statutory labeling requirements, standard industry practices, omissions, or vague language were deemed insufficient to establish liability for inducement.

Turning to India, the Madras High Court delivered a significant judgment on June 3, 2026, in Novartis v. Venkata Narayana Active Ingredients, concerning Indian Patent No. 212815 related to vildagliptin. The ruling provides important guidance on the scope and application of the Bolar exemption under Section 107A of the Indian Patents Act.

The dispute arose after Venkata, which had previously undertaken in 2015 not to manufacture, sell, supply, export, import, or offer for sale vildagliptin, continued exporting substantial quantities of the active pharmaceutical ingredient (API) to generic manufacturers in Egypt. Novartis initiated a further infringement action in 2018.

Venkata’s defense centered on the Bolar exemption, arguing that all supplies to Egyptian generic companies were solely for research and development purposes permitted under Section 107A. However, the Madras High Court held that the burden of proof lies with the party asserting the exemption—in this case, Venkata.

The Court diverged from the Delhi High Court’s approach in Bayer v. Union of India by treating Section 107A as a strict exception. It established two prerequisites for an API supplier to rely on the exemption: (i) the sole purpose of making, using, selling, or importing the patented product must be to meet regulatory requirements; and (ii) the use must be reasonably related to those regulatory requirements. The Court clarified that “selling” includes sales intended to obtain regulatory approval in India or abroad.

Regarding evidentiary standards, the Court emphasized that defendants must provide documentary proof demonstrating a genuine regulatory nexus. This includes evidence that regulatory approval was actively sought and that the relevant authority requested product-related data such as pre-clinical or clinical trial information.

On the facts, Venkata’s evidence was insufficient. Invoices and purchase orders did not indicate regulatory purposes, and certificates stating the API was for “process validation trials” lacked corroboration from Egyptian regulatory authorities. The Court underscored that mere labeling of supplies as for “R&D purposes” is inadequate, imposing a “far heavier burden” on defendants to establish the exemption.

The judgment also offered non-exhaustive guidance on evidence categories necessary to invoke the Bolar exemption, including:

- Documentation of regulator requests for product-related data such as pre-clinical or clinical trial information;

- Where the applicant is not the manufacturer, evidence of supply requests supported by relevant regulatory documents.

Beyond these jurisdiction-specific rulings, the update references ongoing monitoring of key UPC decisions spanning preliminary injunctions, cross-border jurisdiction, and inventive step issues, as well as developments at the EPO.

This comprehensive overview underscores evolving standards in patent enforcement and defenses across major patent jurisdictions, offering valuable insights for practitioners navigating complex global patent litigation landscapes.