CRISPR patents continue to face priority challenges in Europe. Following an earlier revocation of CRISPR patent EP2771468 based on a successful priority challenge, another foundational CRISPR patent EP3241902, co-owned by University of California Berkeley (UCB), was revoked in its entirety last month by the European Patent Office (EPO) based on an invalid priority claim. This is the first significant loss of UCB’s CRISPR patent rights in Europe.

UCB patent EP3241902 (“the ‘902 patent”) has been revoked following oral proceedings at the EPO on April 12 and 13, 2021. As is common for CRISPR patent challenges at the EPO, multiple opponents sought revocation of the patent on multiple grounds. While the written decision setting out the grounds for revocation by the EPO Opposition Division (OD) has not yet been published, preliminary non-binding opinions by the OD cite a pivotal June 28, 2012 UCB publication (“Jinek 2012”) as potentially relevant prior art to support revocation of the patent on the basis of lack of inventive step under Article 56 EPC.

Notably for the ‘902 patent, its earliest priority date of May 25, 2012 (US 61/652,086; “P1”), antedated the Jinek 2012 publication date, and a successful challenge of the priority claim would be required in order to make Jinek 2012 available as prior art and a basis for revocation. In contrast to the successful priority challenge of the Broad Institute’s revoked CRISPR patent EP2771468, which relied on a formal defect in ownership, the Opponents of the ‘902 patent instead argued that the priority claim was invalid because inter alia P1 failed to render the claimed invention plausible and that the skilled person faced an undue burden in carrying out the claimed invention.

In the first preliminary non-binding opinion rendered on February 13, 2020 (“the first opinion”) the OD initially considered that ‘902 patent was entitled to its earliest priority date, and therefore Jinek 2012 was not considered to be prior art for the assessment of inventiveness. In support of this preliminary determination, the OD placed considerable weight on UCB’s extensive reference to post-filing data that allegedly supported enablement (§8.1.10.7 of the first opinion, citing Section H.V of UCB’s June 29, 2019 submission). For example, UCB had argued that the sufficiency of the disclosure of P1 was evidenced by the fact that multiple groups independently were able to carry out aspects of the invention following UCB’s Jinek 2012 publication (e.g., ¶914 of UCB’s submission).

In view of further submissions by the Opponents and UCB in the run up to previously scheduled oral proceedings (that were cancelled due to COVID), the OD rendered a revised preliminary non-binding opinion on September 29, 2020 in which the OD reconsidered its position on the enablement in view of P1. This was primarily based on submissions by Opponents O1 and O2 (see, e.g., Section 6) focusing on the lack of disclosure provided in P1 vis-à-vis the claimed subject matter. Notably, the OD provisionally concluded that the invention as claimed in the ‘902 patent was not plausible in view of the content of P1, and therefore UCB’s post-filing evidence could not remedy the deficiency. The OD also agreed with additional arguments by O2 that there was critical knowledge in Jinek 2012 that was not included in P1. The OD elected to defer further discussions of novelty and inventiveness to the oral proceedings, at which the relevant prior art would be determined in view of its decision on entitlement to priority. Ultimately, at these proceedings entitlement to priority from P1 was denied, and the patent was revoked in view of Jinek 2012.

UCB has filed a notice of appeal against the revocation of the ‘902 patent.

This latest revocation of UCB’s patent indicates that priority challenges, whether based on formal defects or the substantive content of the priority document, continue to be useful lines of challenge at the EPO.

Following key technological advances in 2012-2013, CRISPR genome editing has been the subject of cutting edge research and development by biotech and pharmaceutical companies seeking to translate basic research into new therapeutic methods. Consequently, CRISPR technology also has been the subject of numerous patent office proceedings worldwide as companies seek to clear or clarify the patent landscape in view of potentially dominating patent filings that may impact freedom to operate.

The EPO has emerged as a particularly active arena for patent challenges via its post-grant opposition procedure in which a party can challenge the validity of an issued European Patent within nine months of grant. In addition to a relatively compact timeline (the EPO has targeted a 15-month pendency following a 2016 procedural streamlining), EPO opposition also serves as an early, centralized opportunity to seek revocation of a patent in lieu of lodging individual challenges in the nearly 40 EPO member states in which a European patent may be validated. Additionally, a party may choose to file an opposition via a third-party “straw man” in order to obscure their identity and interest in the proceeding.  Opposed European CRISPR patents include those owned by University of California Berkeley, University of Vienna, and Emmanuelle Charpentier; Broad Institute, MIT, and Harvard; and Sigma-Aldrich.

Photo of Christine G. Espino Christine G. Espino

Christine is a senior counsel in the Litigation Department, and a member of the Life Sciences Patent practice. She works with pharmaceutical and biotechnology clients at all stages of product development, from early-stage R&D through clinical trials and product commercialization. She brings the…

Christine is a senior counsel in the Litigation Department, and a member of the Life Sciences Patent practice. She works with pharmaceutical and biotechnology clients at all stages of product development, from early-stage R&D through clinical trials and product commercialization. She brings the dual perspectives of scientist and attorney to her role as counsel on US and foreign patent prosecution, post-grant proceedings, transactional due diligence, and freedom-to-operate and patentability analyses.

Prior to joining Proskauer Christine worked as an intellectual property associate at two leading Boston law firms, where she worked with large academic, institutional and corporate clients in all phases of product development and patent prosecution strategy. She drafted and prosecuted U.S. and foreign patent applications, assisted in due diligence for financing, and conducted freedom-to-operate and patentability analyses in the life sciences area.

Christine’s technical experience includes small molecules, pharmaceutical formulations, crystalline polymorphs, polymers for drug delivery, and protein-drug and antibody-drug conjugates. She performed her post-doctoral research in organic and polymer chemistry at M.I.T., where she developed transition-metal mediated strategies for preparing novel conjugated polymers and extended aromatic structures. As a graduate research fellow at Stanford University, Christine developed a new methodology for synthesizing highly functionalized amine derivatives, which culminated in a novel, commercially available catalyst, Rh2(esp)2. As an undergraduate research assistant at Harvard University, she delineated the substrate scope of the enantioselective aluminum-catalyzed addition of HCN to imines as a route to non-natural a-amino acids.

Photo of Fangli Chen Fangli Chen

Dr. Fangli Chen is a partner in the Litigation Department and vice chair of the Life Sciences Patent Practice. She represents all types of companies in the biotech and pharmaceutical industries, and has deep scientific expertise and a strong business sense. Fangli effectively…

Dr. Fangli Chen is a partner in the Litigation Department and vice chair of the Life Sciences Patent Practice. She represents all types of companies in the biotech and pharmaceutical industries, and has deep scientific expertise and a strong business sense. Fangli effectively identifies and transforms technological developments into valuable intellectual property assets for her clients and specializes in the strategic development of complex IP portfolios for companies that align with their business goals.

Fangli’s practice also focuses on post-grant review before the USPTO, oppositions, pre-litigation and litigation strategy, due diligence investigations, freedom-to-operate, non-infringement and invalidity analysis, licensing and other IP matters in connection with commercial transactions. She handles a variety of technology areas including biochemistry, molecular and cell biology, immunotherapy, enzyme replacement therapy, messenger RNA therapy, gene therapy, vaccines, bioinformatics, and small molecule compound drugs.

Fangli also has a wealth of experience in the following areas:

  • Post-grant challenges: representing clients in inter partes review interference and various foreign opposition proceedings.
  • Technology transactions & licensing: advising clients on matters relating to technology or material transfer, licensing and research collaborations.
  • Investment or acquisition counsel: assisting investors in assessing the technology and intellectual property assets and risks for potential target investments and counseling companies on intellectual property matters in connection with public offering or acquisition.

Fangli has been repeatedly noted for her top-tier work by industry publications, including being listed as a World’s Leading Patent Practitioner by IAM Patent 1000 and recognized as one of the Top 250 Women in IP nationwide by Managing Intellectual Property. In 2019, she was named Patent Strategy & Management Attorney of the Year in Massachusetts by LMG Life Sciences. She has also been recognized by Best Lawyers in AmericaClient Choice, Legal 500Massachusetts Lawyers Weekly and Massachusetts Super Lawyers. Prior to joining Proskauer, Fangli was a partner at a leading Boston law firm.