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CRISPR/Cas9 – High Stakes and Lessons for Patenting

Date: 24 February 2020

 

The renowned journal Science declared the CRISPR method to be the Breakthrough of the Year 2015. The abbreviation CRISPR/Cas stands for clustered regularly interspaced short palindromic repeats and is a pioneering invention that allows DNA to be cut in a tailored and targeted way to perform “Genome Editing”. Genes or other important DNA sequences can be inserted, removed or “knocked-out” in an unprecedentedly fast and simple way. 

 

More than one group of inventors made the fundamental discovery underlying this invention. This has resulted in patent applications and patents which interfere in various ways, leading to patent office and court conflicts e.g. in the US or in Europe. A lot of money can be made for anyone who is able to monopolize the method, with regard to the general principle and specific variants. In a nutshell, the two most important patent families were filed by the University of California in Berkeley and the University of Vienna, based on work of the inventors Jennifer Doudna and Emmanuelle Charpentier, and by the Broad Institute of the Massachusetts Institute of Technology and Harvard University, including Feng Zhang as main inventor.

 

In September 2018 the US Court of Appeals for the Federal Circuit held that these two most important patents can co-exist. However, in June 2019, the US Patent and Trademark Office announced a new examination of the CRISPR patents in a new interference process.

 

In Europe, EP 2 800 811, which is owned by the University of California and University of Vienna, was held to be valid in an opposition proceedings after several amendments were introduced into the claims. An appeal is possible.

 

In January, the European Patent Office in T 844/18 revoked EP 2 771 468 owned by Broad, as the relevant priorities were not acknowledged.

 

Article 87 of the European Patent Conventions requires that any person who has filed a patent in a state party to the Paris Convention, or his successor in title, shall enjoy the priority right as effective date to the same invention as a later filed patent right claiming the priority. If there is more than one applicant, under the prevailing EP case law the earlier application can only serve as basis for claiming priority of the subsequent application that designates all of the applicants of the earlier priority application.

 

As the priority could not be acknowledged, there was intervening prior art with an effective date between the priority filings and the final PCT application forming the basis for EP 2 771 468. This affected the validity of the granted claims. Here the Appeal confirmed the revocation by an opposition Division. No referral to the Enlarged Board of Appeal was allowed. See here for the Statement and Background of the CRISPR case  and here for the Decision in case T 844/18 

 

A further issue was a dissent regarding the inclusion of an inventor not named originally had to be resolved in parallel.

 

See here a press release from the Broad Centre to announce an update to the CRISPR/Cas9 Portfolio 

 

What can be learned from CRISPR?

 

First, it is important to have an early priority date for an application in order to avoid interference with rights from other parties – first come, first served!

 

Second, it is important to determine inventorship as best as possible and to name all inventors.

 

And third, in order to claim priority correctly, there must be a clear succession in title – be it the same applicants or a clear and duly timed assignment or agreement on succession in the right to claim priority.

 

For example, where US provisional applications form the basis for priority claims, it is often the case that inventors are named as applicants. In later filed (e.g. PCT) applications claiming the priority, all of a sudden a company or university may appear as applicant. The succession in right for claiming the priority must be identified in advance of the filing of the final application claiming priority from one or more former priority applications!

 

Maucher Jenkins can provide support in accelerating the filing of a patent application, in determining the inventors and in ensuring proper priority is claimed. Please read more information here on our work in Patents & Inventions 

 

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