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Intellectual Property High Court (IPHC) expresses its interpretation of “invention described in the written description of prior application” set forth in Japanese Patent Act Article 29bis, upholding judgment of Board of Appeal.

1. Background
Plaintiffs (Broad Institute, MIT, and Harvard University) filed a patent application for “Engineering of systems,
methods and optimized guide compositions for sequence manipulation” on June 14, 2016 (Japanese Patent
Application No. 2016-117740) claiming a convention priority of December 12, 2012 (US).  The examiner
rejected the claimed invention under Article 29bis on the ground that the claimed invention was described  in a
prior application filed previously but published after the present application, and that decision was upheld by the
board of appeal (along with finding the claims obvious).  The plaintiffs filed a lawsuit before the Intellectual
Property High Court (IPHC) on January 29, 2017, challenging the board’s decision.  What is at issue in this suit is
whether the rejection under Article 29bis is appropriate.

2. Claim at issue
Claim 1 at issue (present invention) reads as follows: 
　　　An engineered, non-naturally occurring Clustered Regularly Interspersed Short Palindromic Repeats
(CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) vector-system comprising one or more vectors comprising:
(a)  　a first regulatory element operably linked to a nucleotide sequence encoding a CRISPR-Cas system
 polynucleotide sequence including a guide sequence, tracr RNA and a tracr mate sequence, wherein the
guide sequence is capable of hybridizing to a target sequence in a locus in a eukaryotic cell;
(b)  　a second regulatory element operably linked to a nucleotide sequence encoding a Type II Cas9 protein; and
(c) a recombinant template,
 　　　wherein components (a), (b) and (c) are located on the same or different vectors of the system, and
the vector system comprises nucleotide sequence(s) coding for one or more nuclear localization signals (NLSs)
expressed with the nucleotide sequence encoding for the Cas9 protein,
 　　　by which the guide sequence targets one or more polynucleotide loci in a eukaryotic cell, and Cas9 protein 
cleaves one or more polynucleotide loci,
 　　　by which one or more polynucleotide loci are modified.

3. Decision by Board of Appeal
The board of appeal held, among other things, that the present invention is unpatentable under Article 29bis as it
is the same as an invention described in PCT/US2013/073307, filed on December 5, 2013 with a priority date of
December 6, 2012 and published as WO 2014/089290 (‘290 publication) on June 12, 2014.  The board of appeal
found that the ‘290 publication discloses an invention (cited invention) which is directed to a vector system,
comprising:
　　　 vector including a promoter control sequence, operably linked to a nucleic acid encoding for at least one 
Type II Cas9 protein comprising at least one nuclear localization signal;
 　　　vector including promoter control sequence operably linked to DNA coding for at least one guide RNA
comprising the first region at 5′ terminal that is complementary to a target site in the chromosomal sequence in a 
eukaryotic cell, the second internal region in stem-loop structure and the third region which is essentially single
chain, and
　　　 vector including at least one donor polynucleotide, wherein the guide RNA derives Type II Cas9 protein into
the target site in the chromosomal sequence in a eukaryotic cell, Type II Cas9 protein derives the cleavage of the
double strand DNA of the chromosomal sequence at the target site and the cleavage of the double strand DNA is
restored in the restoration process as the chromosomal sequence is restored.

4. Arguments by Plaintiffs
Plaintiffs argued that the ‘290 publication fails to show any support such as experimental data for the modifications of sequence at the target site and the board of appeal erred by failing to provide any rationale for its finding that
the CRISPR-Cas9 system could be applied to a eukaryote.

The plaintiffs further argued that 
　　　The ‘290 publication fails to disclose a functional limitation of the present invention “the guide RNA derives
 Type II Cas9 protein into the target site in the chromosomal sequence in a eukaryotic cell, Type II Cas9 protein
derives the cleavage of the double strand DNA of the chromosomal sequence at the target site and the cleavage
of the double strand DNA is restored in the restoration process as the chromosomal sequence is restored” and,
therefore, the present invention is not substantially the same as the cited Invention (plaintiff’s argument 1); and
 　　　the system disclosed in the ‘290 publication is unable to solve the problem that the present invention
intends to overcome and, therefore, the cited invention does not have an effect that excludes later filed
applications from being patented, set forth in Article 29bis (plaintiff’s argument 2).

5.  Decision by IPHC
a. Substantial disclosures
The IPHC found that, in light of the description of the ‘290 publication and in comparison with the present
invention, the ‘290 publication substantially discloses that “the guide RNA derives Type II Cas9 protein into the
target site in the chromosomal sequence in a eukaryotic cell, Type II Cas9 protein derives the cleavage of the
double strand DNA of the chromosomal sequence at the target site and the cleavage of the double strand DNA is
restored in the restoration process as the chromosomal sequence is restored”, and concluded that the vector
system can be read from the ‘290 publication so that it is disclosed as it performs the same function and, on the
basis of this understanding, rejected Plaintiff’s argument 1.

b. Interpretation of Article 29bis
The IPHC found that ‘”an invention described in the prior application” set forth in Article 29bis covers an invention
that is derived from not only what is explicitly described but also what is considered to be described, in the
prior application.  What is considered to be described should be interpreted as that derived from the description
of the prior application in light of technical common knowledge at the time of filing the application.  Accordingly,
an invention described in the prior application can be determined to include what is considered to be described
in understanding the invention of prior application.  In contrast, an invention that is abstract or an invention
that is considered not to be described even in light of technical common knowledge of those skilled in the art is
qualified as an “invention described in the prior application” and, therefore, does not have an effect to exclude
later applications from being patented.  Therefore, the level of disclosure required in this Article is satisfied if
the invention is described to such an extent that those skilled in the art consider that the prior invention is
explicitly disclosed in the description or the invention can be carried out in light of the description of the prior
application.’

c. Applicability of Article 29bis
Considering the disclosures of the cited reference 1, the IPHC found that the cited reference 1 describes a prior
invention to such an extent that those skilled in the art would understand the prior invention from the reference
and make the prior invention in light of the descriptions of the reference.  Also, the IPHC found that the cited
reference 1 should be interpreted to disclose technologies that are qualified to exclude later applications from
being patented, including “the guide RNA derives Type II Cas9 protein into the target site in the chromosomal
sequence in a eukaryotic cell, Type II Cas9 protein derives the cleavage of the double strand DNA of the
chromosomal sequence at the target site and the cleavage of the double strand DNA is restored in the restoration
process as the chromosomal sequence is restored”, and rejected Plaintiff’s argument 2.

6. Comments
The present invention relates to a hot genomic editing technology.  In this judgement, the IPHC expressed
its interpretation of “an invention described in the written description of prior application” set forth Article 29bis,
and upheld the decision of the board of appeal and rejected the application.  Also, the level of technical disclosure
required in this Article should be determined from a viewpoint that “the invention is described to such an extent
that those skilled in the art consider that the prior invention is explicitly disclosed in the description or the 
invention can be carried out based on the description of the prior application.”

The Examination Guideline states that “an invention described in prior publication should be an invention that
is derived not only from what is explicitly described in the prior publication but also from what is considered to
be described by those skilled in the art in light of technical common knowledge at the time filing the application. 
The Examination Guideline also states that this standard is also applied to “an invention described in the written
description of prior application (Part III, Chapter 3: Enlarged Prior Application “4.2 Determination of Prior Art
Invention”), so the standard of “an invention described in prior application” defined in this decision matches that
described in the Examination Guideline.

An accumulation of court decisions is expected to enhance predictability of the rejection under Article 29bis.

In another decision issued from the IPHC on the same day in connection with a patent application claiming
genomic editing technology (JP 2016-128599 A), the IPHC found that the claims should not be rejected under
Article 29bis and reversed the board’s decision.

https://www.ip.courts.go.jp/app/files/hanrei_jp/260/089260_hanrei.pdf