India: CRISPR Case

Last Updated: 11 June 2019
Article by Dias Michelle Jerry

Regents of the University of California, University of Vienna, Emmanuelle Charpentier, (Appellants) (UC)v. Broad Institute, Inc., Massachusetts Institute of Technology, President and Fellows of Harvard College, (Respondents) (Broad)

This case was decided on 10th September 2018 in the United States Court of Appeal for the Federal Circuit ("FC"). It is an Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board.

Facts: CRISPR is an acronym for "Clustered Regularly Interspaced Short Palindromic Repeats." CRISPR is a family of DNA sequences that are used in genetic engineering to edit or alter gene functions of prokaryotes and eukaryotes. There are three components to a CRISPR-Cas9 system. 1. crRNA, 2. tracrRNA and 3. Cas9 protein.

In August 2012, an article ("Jinek 2012") was published by UC researchers which demonstrated the use of isolated elements of the CRISPR-Cas9 system in vitro non-cellular experimental environment. Within a year in February 2013, Broad researchers published an article describing the use of CRISPR-Cas9 in a human cell line. Both parties sought patent protection for their work. Jinek 2012 article did not report the results of experiments using CRISPR-Cas9 in a eukaryotic cell nor did theyrefer to a particular cell type or environment. They used naked nuclear material and Cas9 protein for their experiment. The Broad article on the other hand specifically mentiond the use of eukaryotic cell in their claims.

The UC instituted a suit against Broad for obviousness, and Broad moved to terminate the suit, arguing its claims are patentably distinct from UC's claims.There is no reasonable expectation that the CRISPR-Cas9 system would work successfully in a eukaryotic cell by a person of ordinary skill in the art. The Board (PTAB) determined there was no interference-in-fact because, given the differences between eukaryotic and prokaryotic systems, a person of ordinary skill in the art would not have had a reasonable expectation of success in applying the CRISPR-Cas9 system in eukaryotes. PTAB determined, therefore, that UC's claims to the use of CRISPR-Cas9 did not render obvious Broad's claims to its use in eukaryotes. UC appeals.

Issue: Whether there was interference-in-fact (obviousness) between UC's patent, and the claims of patent owned by the Broad.

Held: There is no interference-in-fact.

Explanation: US follows the first to invent system if there arises a dispute between two patents having similar subject matter. To determine obviousness, the Supreme Court has laid own four tests in the case ofGraham v. John Deere Co., 383 U.S. 1, 17–18 (1966)(1) the scope and content of the prior art; (2) the differences between the claims and the prior art;(3) the level of ordinary skill in the art; and(4) objective considerations of non-obviousness—are questions of fact to be reviewed for substantial evidence.To determine obviousness, it is required that a person of ordinary skill in the art would been couraged to combine or modify the instructions in the prior art and would have had a reasonable expectation of success in doing so. This case had to be decided on substantial evidence standard.

  1. Reasonable Expectation of Success: For obviousness,a rigid test was adopted by the Board that looked for specific instructions in the prior art while ignoring that a person of ordinary skill in the art would use his creativity and inferences to come to a conclusion.
    Response by FC: Only specific instructions in the art would have given one of ordinary skill in the art a reasonable expectation of success.There were failures demonstrated in using Cas9 which indicated the lack of a reasonable expectation of success.
  2. Simultaneous invention: It can be compelling and strong objective of evidence for obviousness because CRISPR-Cas9 was applied within months of UC's publication.
    Response by FC: Evidence of simultaneous invention cannot alone show obviousness, otherwise any claims involved in a conflict would be unpatentable for obviousness.

In addition to this there was also a testimony given by UC's expert Dr Dana Carroll recognizing issues that could arise in attempting to apply the CRISPR-Cas9 system in eukaryotic cells. That CRISPR-Cas9 might be degraded by nucleases in eukaryotic cells. The DNA of eukaryotes is in the form of chromatin coiled around proteins called histones. Targeting the site becomes difficult and even after it does recognise, DNA-RNA hybrid stability is seen as foreign in a normal cell.The efficacy of gene editing through base pairing remains unpromisingly low. Only attempts to apply the system in eukaryotes by conducting experiments will address these concerns.

FC thus decided that, PTAB had performed a thorough analysis of the factual evidence,considered statements by experts for both parties, past failures and successes of using CRISPR-Cas9 in the field, evidence of simultaneous invention, and the extent to which the claims provided specific instructions for applying the CRISPR-Cas9 technology in a new environment. It was concluded that there was no reasonable expectation of success and substantial evidence supports the Board's finding. The Board made no default in its determination that there is no interference-in-fact. The decision of the Board was affirmed by FC.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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