October 5, 2020

Patent News

The Intellectual Property High Court decides on the patentability of CRISPR-Cas9 related patents.

In regard to two decisions by the JPO Trial Board refusing to grant patents related to CRISPR-Cas9 by the Broad Institute, part of the Massachusetts Institute of Technology and the Harvard University, the IP High Court on February 25, 2020 rescinded one of the decisions and upheld the decision of the other case.
(IP High Court Case No. 2019 (Gyo-Ke) Nos. 10010 and 10011, Judgement issued on February 25, 2020)

Background

Generally speaking, CRISPR-Cas9 system includes Cas9 (cleavage enzymes) and guide RNAs (namely, crRNA and tracrRNA) that guide Cas9 to a target site. CRISPR-Cas9 system is a breakthrough genetic modification technology that allows for deletions, replacements, or insertions in the genome sequence at the target site. In this field, The Broad Institute, University of California Berkeley, Sigma-Aldrich, Vilnius University, University of Vienna, and Turgen have filed patent applications around the world.

Case No. 1 (2019 (Gyo-ke) 10010: the JPO decision was upheld)

The JPO Trial Board rejected the patent application made by the Broad Institute and others ("Plaintiffs") entitled "Engineering of systems, methods and optimized guide compositions for sequence manipulation" (Patent Application 2016-117740, Priority date: December 12, 2012), citing existing CRISPR technology, namely Citation 1 (Chen, PCT/US2013/073307, as a "prior application", priority date: December 6, 2012, publication date: June 12, 2014) and Citation 2 (Jinek 2012, as a basis of lack of inventive step, published online on June 28, 2012).
The Plaintiffs brought a lawsuit presenting the following grounds for rescission of the trial decision:

• Errors in decision under Article 29-2 (Prior Application) of the Patent Act based on Citation 1
• Errors in decision under Article 29 (2) (Inventive Step) of the Patent Act, based on Citation 2.

The Court upheld the trial decision as follows.

• One of the main issues here in this case was whether Citation 1 discloses the claimed configuration of "wherein the guide RNA directs the type II Cas9 protein to a targeted site in the chromosomal sequence in the eukaryotic cell where the type II Cas9 protein introduces a break of double-strand of chromosomal DNA in the targeted site, and the break of double-strand is repaired by a DNA repair process such that the chromosomal sequence is modified".
• Plaintiffs argued that Example 4 (FACS testing) of Citation 1 can only be used for screening and Example 5 (PCR testing) of Citation 1 is the more sensitive and accurate test, and that based on the results of Example 5 (PCR) which did not show results of integration, a person skilled in the art should have concluded that there was no integration into the target site in Citation 1, and therefore, Citation 1 shall not be qualified as a "prior application".
• The Decision took the position that "the degree of disclosure of technical contents is sufficient if the prior invention is described to the extent that a person skilled in the art can understand that the prior invention is described therein and that the invention is practicable" in recognizing the "invention" described in the prior application under Article 29-2 of the Patent Act.
• Further, the Decision stated that "Example 4 (FACS) describes a specific test method for confirming that a donor sequence (GFP gene) is integrated into the target sequence. Moreover, from the results of Example 4 (FACS), it can be understood that ... double-strand breaks and repair occur at the target site. Example 5 (PCR) cannot be interpreted as an obstacle to the above understanding."

Considering precedents regarding chemical substance patents, pharmaceutical patents, and so on, the above criteria that "the degree of disclosure of technical contents is sufficient if the prior invention is described to the extent that a person skilled in the art can understand that the prior invention is described therein and that the invention is practicable" is questionable. The case is on appeal to the Supreme Court.

Case No. 2 (2019 (Gyo-ke) 10011: the JPO decision was rescinded)

The JPO Trial Board rejected Plaintiffs' patent application entitled "CRISPR-Cas systems and methods for altering expression of gene products" (Patent Application 2016-128599) and then Plaintiffs sought recession of the decision. Unlike the application discussed above, this application had a limitation that the "tracr sequence is 30 or more nucleotides in length".

In this case, the Court found that a claimed element with regard to the length of the tracr RNA has patentability and reversed the trial decision:

• The Present Invention is not identical with Citation 1 (Chen), because the invention of the present application is characterized in that an efficiency of genome modification increases by focusing on "a length of a tracr sequence" and adopting a configuration that the "tracr sequence is 30 or more nucleotides in length".
• The Present Invention is characterized in that an efficiency of genome modification in eukaryotic cells increases by adopting the configuration that a "tracr sequence is 30 or more nucleotides in length", and this would not have been easily conceivable to a person skilled in the art on the basis of Citation 2 (Jinek) which is at an in vitro level.

Written by: Mr. Yuichiro Suzuki (Attorney at Law and Patent Attorney)