EPO upholds Berkeley divisional CRISPR patent

EP 34 01 400, is owned by the collaboration between the University of California (Berkeley), University of Vienna, and Emmanuelle Charpentier (known as CVC, or Berkeley). It specifically covers the Cas9 aspect, thus the human-gene editing aspect, of the CRISPR family. According to attendees, the proceedings took 15 hours to complete.

CRISPR in opposition

Initially, in a hearing held from 29 November to 1 December 2022, the Opposition Division determined that EP 400 lacked novelty. The Opposition Division then upheld EP 400 in amended form, pending a final decision in proceedings in February 2022. Now the EPO has upheld the patent in suit, taking on board the previous amendments. It decided these changes overcame the opponents’ further objections over novelty.

Amendments included adding New Auxiliary Request 9 (AR9) specifying a “two-molecule DNA-targeting RNA, with two separate RNA molecules.” Each RNA molecule thus has complementary stretches. But in November, the board also determined that even with amendments, the initial application contained non-patentable subject matter related to reproductive cells in humans.

Valid based on changes

On 21 February 2022, the panel reconvened to decide that EP 400 is valid based on a new auxiliary request (AR10) put forward by Berkeley. This disclaimed previous cell-related subject matter, which had been the basis for opposition. The four opponents objected to the amendments on the grounds of violating added matter through the original application containing an inadmissible combination of features.

The panel also rejected claims pertaining to a lack of valid priority date, lack of novelty and lack of inventive step. Parties can appeal the claims, although the EPO has warned this may take two to four years.

CRISPR in Europe

In February 2020, the EPO’s Opposition Division also dismissed objections to the CRISPR/Cas9 parent patent EP 2 800 811 B1, upholding the patent in its original form in May 2020. While EP 400 and EP 902 are divisional patents, EP 811 provides an umbrella protection for CRISPR in Europe more generally. This meant that the Berkeley/CVC faction could provisionally enforce their claim for broader European protection for CRISPR/Cas9.

Sigma-Aldrich, the Broad Institute, and South Korean company Toolgen are three high-profile companies also concerned with filing CRISPR successor patents. All parties have taken the original CRISPR/Cas technology and transferred it to human cells

However, the EPO revoked Sigma-Aldrich’s EP 910 for lack of inventive step over the original Doudna/Charpentier published work. Then, in April 2021, the EPO also revoked a patent belonging to the University of California, EP 32 41 902, on the grounds that it found claims enabled but no disclosure for the claim wording.

But with the EPO upholding EP 400 and EP 811, this could provide further security in patent protection for the Berkeley faction in Europe.

Dirk Bühler

Many straw men involved

Munich IP firm Maiwald acts for the Berkeley/CVC collaboration, with partners Dirk Bühler and Martin Huenges leading the team. The firm has worked with Berkeley for four years. It recently assumed responsibility for its patent prosecution proceedings, alongside its contentious actions.

CRISPR proceedings at the EPO often involve multiple straw men. Here, three commercial companies opposed the EP 400 patent, although all are acting as straw men in the proceedings. However, non-governmental organisation Testbiotech also opposed the patent on moral grounds, given the potentially complex area of gene editing in the human germline.

Christoph Then, who appeared for Testbiotech, is formerly of Greenpeace and works for coalition pressure group, No Patents on Seeds. From 1992 until 1998, Then also coordinated Germany’s No Patent On Life! campaign.

UK patent attorney firm Greaves Brewster regularly files biotech patents for Sigma-Aldrich. The firm has handled proceedings around EP 910 patent from the very beginning.

Martin Huenges

For the University of California (Berkeley)/University of Vienna/Emmanuelle Charpentier
Maiwald (Munich): Dirk Bühler, Martin Huenges (partners); senior associate: Kerstin Wolff

For first opponent (strawman)
df-mp Dörries Frank-Molnia & Pohlman (Munich): Sandra Pohlman, Annette Hilgendorf (partners, patent attorneys)

For second opponent (strawman)
Greaves Brewster (London): Rachel Wallis (partner, patent attorney)

For third opponent (strawman)
HGF (Glasgow): Douglas Drysdale (partner, patent attorney)

For fourth opponent (Testbiotech)
Testbiotech (Munich): Christoph Then (executive and scientific director)

European Patent Office, Opposition Division, Munich
Henrik Knudsen (chair); Matthias Ulbrecht, Suzanna Weinberg (members)