Less than two months after CVC made the surprising move to revoke two of its seminal European CRISPR patents, Sigma-Aldrich has done it too. While the facts that led to Sigma’s “self” revocation may be different than CVC’s, this en vogue trend of avoiding final decisions is troubling because it denies the public of the certainty it deserves. 

The two Sigma patents involved are EP3138911 and EP3360964 (EP ’911 and EP ’964, respectively) directed to broad methods and compositions for modifying a chromosomal sequence in a eukaryotic cell by integrating a donor sequence using RNA-guided endonuclease, such as a CRISPR/Cas protein, with a nuclear localization signal.

Unlike CVC, Sigma’s patents were initially revoked by the Opposition Division for lack of inventive step over the June 2012 Science paper published by Nobel Laureates Emmanuelle Charpentier and Jennifer Doudna. On appeal, Sigma attempted to buttress its inventive arguments with additional submissions and auxiliary requests. The Boards of Appeal of the European Patent Office (the “Appeal Boards”) however refused to admit Sigma’s additional submissions and requests because of their late filing, affirming the lack of inventive step finding by the Opposition Division. Before the Appeal Boards had a chance to decide on other issues, Sigma moved to terminate the appeal proceedings, giving up its effort to overturn the Opposition Division’s revocation decisions of both EP ’911 and EP ’964 patents.

Like CVC, Sigma’s decision to withdraw the appeals was presumably to insulate other family members from a negative final decision and preserve its ability to get new patents in Europe. However, the fact Sigma’s patents were initially revoked by the Opposition Division would make it harder for this strategy to work for Sigma. Regardless, the back-to-back “self” revocation of dominant CRISPR patents in Europe by key IP holders is remarkable and concerning at the same time. This not only creates uncertainty in the CRISPR field but also an inefficient use of EPO resources. Some question whether the EPO should implement procedural changes to prevent this trend from continuing.

Print:
Email this postTweet this postLike this postShare this post on LinkedIn
Photo of Fangli Chen Fangli Chen

Dr. Fangli Chen is a partner in the Litigation Department and 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…

Dr. Fangli Chen is a partner in the Litigation Department and 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, nucleic acid based technologies including messenger RNA therapy, gene therapy, gene editing, antisense and oligonucleotides based therapies, 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.

Photo of Nicholas C. Prairie Nicholas C. Prairie

Nicholas Prairie is an associate in the Litigation Department, and a member of the Life Sciences Patent practice. He works with life science and pharmaceutical clients of all sizes in the preparation and prosecution of patent applications.

Prior to joining Proskauer, Nicholas was…

Nicholas Prairie is an associate in the Litigation Department, and a member of the Life Sciences Patent practice. He works with life science and pharmaceutical clients of all sizes in the preparation and prosecution of patent applications.

Prior to joining Proskauer, Nicholas was an associate at another Boston firm, where he worked with corporate clients of all sizes. He drafted and prosecuted U.S. and foreign patent applications, and assisted in district court litigation and Inter Parte Reviews. Nicholas’s technical expertise includes small molecules, peptides, and protein conjugates.

Before law school, he worked as a chemist at Ipsen (Biomeasure, Milford, MA) where he synthesized a variety of pharmaceutically interesting compounds including; small molecules, peptides, peptide-drug conjugates, proteins, and protein-polymer conjugates. As a graduate student his research focused on natural product synthesis.