Return to site

Priority Entitlement and the Presumption of Validity in CRISPR-Cas Patent Disputes

T2689/19

· EPO,EPOCaseLaw,PriorityEntitlement,G122,CRISPRCas9

Introduction

The decision T 2689/19 from the Board of Appeal of the European Patent Office (EPO), deals with key legal issues related to priority entitlement under the European Patent Convention (EPC). This case involves the well-known CRISPR-Cas9 technology, with the patent holders, The Broad Institute and Massachusetts Institute of Technology, appealing a decision revoking their patent based on an invalid priority claim. The legal points include the application of the presumption of priority entitlement established in decision G 1/22 and the burden of proof required to rebut this presumption. The case sheds light on how the EPO deals with complex inventorship disputes and priority rights.

Summary of the Invention

The patent in question, EP 2764103, relates to CRISPR-Cas systems and methods for altering the expression of gene products in eukaryotic cells. The invention provides a novel method of using CRISPR-Cas9 for precise genome editing, making it a foundational technology for biotechnology and medical research. The CRISPR-Cas9 system, composed of a guide RNA and a Cas9 protein, allows scientists to target specific genes and modify them.

Summary of the Board of Appeal Decision

The patent was initially revoked because the Opposition Division found that the priority claims from four US provisional applications (P1, P2, P5, and P11) were invalid. The crux of the issue was that one of the inventors listed in the US priority applications, Luciano Marraffini, and his employer, Rockefeller University, were not named in the subsequent international (PCT) application. Under the "all applicants approach" applied by the EPO before decision G 1/22, this discrepancy invalidated the priority claim.

During the appeal proceedings, the Enlarged Board of Appeal’s decision G 1/22, issued in October 2023, significantly changed the legal landscape. G 1/22 established a presumption of priority entitlement, meaning that priority is presumed valid unless compelling evidence proves otherwise. This presumption applies even when there is no explicit transfer of rights from all applicants of the priority application, so long as there is no evidence contradicting an implied agreement between the parties.

The opponents in this case argued that there was no valid transfer of priority rights from Marraffini or Rockefeller University. However, the Board found that the settlement of an inventorship dispute in the United States in 2018 between the parties implied an agreement to transfer the priority rights. The Board concluded that the opponents had not provided sufficient evidence to rebut the presumption of valid priority, as established in G 1/22.

As a result, the Board set aside the decision of the Opposition Division and remitted the case for further prosecution.

Lessons to be Learned

This case reinforces the importance of the presumption of valid priority entitlement in European patent law, particularly following G 1/22. The Board highlighted that the burden of proof to rebut this presumption lies with the opponents. Merely raising doubts about the existence of a transfer agreement is insufficient; solid evidence is required. Furthermore, the case underlines the significance of inventorship and ownership disputes and how their resolution can impact patent rights.

Legal Basis and Case Law

  • EPC Articles: 87, 88, 111(1), 113(1)
  • Enlarged Board Decisions: G 1/22
  • Relevant Board of Appeal Decisions: T 577/11, T 1242/04, T 844/18

 

Contact

If you have any questions concerning intellectual property issuesor need assistance with patent applications, oppositions, or appeals, please do not hesitate to contact us at Novitech IP. Our team of experienced professionals is here to provide you with expert guidance and support. Reach out to us today to discuss how we can help protect your innovations and navigate the complexities of IP law.

To stay informed about the latest reviewsand updates in IP law, subscribe to our blog. Join our community and receive notifications whenever we publish new reviews and insights on important case law and developments in the field of intellectual property.

Legal Disclaimer

The information provided in this blog post is for generalinformational purposes only and does not constitute legal advice. The summary and analysis of the EPO case are based on publicly available information and are intended to offer insights into the decision and its implications. This content should not be used as a substitute for professional legal advice tailored to your specific circumstances. For advice related to any specific legal matters, you should consult a qualified attorney.