Legal Lens on the Unified Patent Court | August 2024

Overview


The Unified Patent Court (UPC) is revolutionizing the way patents are enforced in Europe, and McDermott’s intellectual property team is here to help you navigate this dynamic landscape. Our Legal Lens on the Unified Patent Court newsletter is designed to keep patent holders and legal departments well-informed. And with an on-the-ground team in Germany, France, the United Kingdom and the United States, we offer a unique cross-border perspective.


 

NOTABLE CASE & POTENTIAL IMPACT


REGENERON PHARMACEUTICALS, INC. V. AMGEN INC.

Topics: inventive step; obviousness; genus claims in the life sciences sector

On July 16, 2024, the UPC issued its first-ever revocation judgment, invalidating a key patent owned by Amgen Inc. Back in June 2023, Amgen filed an infringement action against Regeneron Pharmaceuticals, Inc. and its partner company, Sanofi, in the Local Division Munich. Regeneron counterclaimed for revocation of the patent in the infringement action and the Sanofi parties brought a separate revocation action against the patent in the Central Division Munich. Thereafter, Regeneron’s counterclaim was referred to the Central Division and combined with the revocation action.

The Amgen patent at issue relates to a monoclonal antibody or fragment that binds to and blocks a protein (PCSK9) to lower low-density lipoprotein cholesterol. The Central Division Munich invalidated the patent because it lacked an inventive step over a prior art reference by Lagace et al. that directed researchers to develop antibodies that target PCSK9. The Court reasoned that it would have been “the next obvious step” from the Lagace reference for researchers to develop antibodies against PCSK9 and doing so “would not amount to more than routine experimentation for the skilled person.”

This latter assertion that making PCSK9 antibodies requires only routine experimentation marks an important point of disagreement between the UPC and the Supreme Court of the United States, which in 2023 invalidated two related Amgen patents directed at PCSK9 antibodies for lack of enablement. In the 2023 decision, the Supreme Court said that Amgen’s patents would require a skilled person to engage in not routine but “painstaking” experimentation amounting to a “hunting license” and a “research assignment.”

TAKEAWAYS:

  • The Amgen patents at issue claimed a genus of antibodies. European and US courts invalidated related patents but for entirely different reasons: While US courts found the patent claims invalid because the full scope of the genus is not enabled, the UPC held that a skilled person would have known how to proceed based on the prior art alone because methods for finding antibodies were well known in the art.
  • The UPC’s decision in this case potentially shows that US courts and the UPC have different standards for enablement and inventive step that may collide across the Atlantic.

RECENT FILINGS


This section reflects updated data regarding UPC usage, taken from the UPC’s register as of August 19, 2024.

NUMBER OF CASES ON UPC REGISTER BY TYPE

*The number of counterclaims for revocation cases does not necessarily reflect the UPC’s true case load because the UPC’s Case Management System required several defendants in infringement proceedings to launch their own counterclaim for revocation, even if the substance of the counterclaims was fully identical across the parties. This inflates the number.

NUMBER OF CASES ON UPC REGISTER PER DIVISION

LANGUAGE OF UPC PROCEEDINGS

FIRST INSTANCES OF INFRINGEMENT AND REVOCATION CASES PER MONTH IN 2023 AND 2024

*July 2024 values are potentially incomplete.

INFRINGEMENT AND REVOCATION CASE VALUES


LATEST INSIGHTS


We provide real-time insights on UPC filings, decisions, and other related developments. Check out our latest insights below.

Legal Lens on the Unified Patent Court, July 2024

1 Year at the UPC: Implications for Transatlantic Disputes, July 17, 2024

Legal Lens on the Unified Patent Court, June 2024


UPC TEAM


Have questions or want to discuss your UPC strategy? Contact Hon.-Prof. Dr. Henrik HolzapfelChuck Larsen or Diana Pisani.