Düsseldorf, November 15, 2024 – The revocation of two CRISPR patents, EP 3 138 911 B1 and EP 3 360 964 B1, from the Sigma-Aldrich patent portfolio, has become final following oral proceedings before the EPO Board of Appeal 3.3.08 (chair: Theresa Sommerfeld, rapporteur: Renate Morawetz) this week. Cohausz & Florack (C&F) represented Bayer as one of the opponents. These appeal cases are significant, as they mark the first time an EPO Board of Appeal has substantively addressed and ruled on the issue of inventive step within the broader CRISPR patent dispute.
The CRISPR/Cas9 genome-editing method enables precise and straightforward modifications to DNA, with the potential to cure hereditary diseases such as cystic fibrosis and sickle cell anemia, as well as chronic infections like hepatitis C and HIV. This technology is viewed as a key innovation not only in medicine but also in agriculture and microbiology. Emmanuelle Charpentier and Jennifer A. Doudna, the key inventors behind CRISPR/Cas9, were awarded the 2020 Nobel Prize in Chemistry for their groundbreaking work in genome editing.
Charpentier and Doudna first published their development of the CRISPR/Cas9 method in June 2012 (Jinek et al., Science, 2012, 337:816-821) and subsequently secured patent rights for the technology. In the wake of this publication, several companies and research groups successfully applied CRISPR/Cas9 to human cells, leading to a series of patent filings to protect its use in this context. The two revoked patents, EP'911 and EP'964, are representative members of this set of successor patents.
After hearing the parties for 1.5-days on inventive step of EP'911, the EPO Board of Appeal determined that the patent's claims, as presented in the Patentee’s main request, lacked inventive step in view of the Doudna/Charpentier publication. The inclusion of additional features, such as the use of a Pol III promoter or a nuclear localization signal (NLS), was not sufficient to overcome this deficiency. The Board also indicated, by way of preliminary opinion, that the auxiliary claim requests could be expected to face the same issue. In response, the patentee withdrew both the EP'911 and EP'964 appeals, thereby making the first-instance revocations final and avoiding a formal written decision on the matter.
Dr. Natalie Kirchhofer, patent attorney and partner at Cohausz & Florack, who represented Bayer as one of the opponents comments: "While it is regrettable that we will not receive a fully reasoned decision from the Board of Appeal due to the Patentee’s procedural maneuver, the Board’s finding that EP'911 lacks inventive step in light of the Doudna/Charpentier prior art is a significant precedent. This decision is likely to have wider implications for other broadly worded CRISPR platform patents facing similar inventive step challenges."
Picture credits: Feeney_AdobeStock.com
