January, 2016｜News Letter

1. How should Support Requirement for Invention Relating to Process of Producing Crystal Polymorph be Examined?Osaka Gas Chemicals Co., Ltd. v. Taoka Chemical Co., Ltd., Case No. 2014 (Gyo-Ke) 10202 (Decision rendered on January 27, 2016)

The Patentee, Taoka Chemical, obtained a patent relating to a crystal polymorph of fluorine derivative and a method of production thereof in 2008, against which Osaka Gas filed an invalidation trial with the JPO in 2013. The JPO dismissed the Osaka Gas's demand in 2014, followed by Osaka Gas's appeal against the JPO's decision to the IPHC in 2014.

Claim 1 of the Taoka's patent at issue claims as follows:
A method of producing a crystal polymorph of 9,9-bis(4-(2-hydroxyethoxy)phenyl)fluorine (“BHPF”), comprising:
reacting fluorenone and 2-phenoxyethanol in the presence of a heteropolyacid,
initiating deposition of “BHPF” at lower than 50°C from the resultant reaction mixture to obtain a crude product of “BHPF”, then 
dissolving the crude product having a purity of 85% or more in at least one solvent selected from the group consisting of aromatic hydrocarbon solvents, ketone solvents and ester solvents, and
initiating deposition of “BHPF” at 50°C or higher.

One of the main issues in this case lied in how a support requirement for an invention relating to a process of producing a crystal polymorph should be examined.  The IPHC answered to the issue as follows:

First, having reviewed various publicly known literatures, the IPHC recognized that it had been common technical knowledge at the filing of the application of the patent at issue (i) that deposition conditions of crystal polymorphs were experimentally found by screening methods wherein crystallization was exhaustively tried under various conditions as much as possible, since it was quite difficult to expect deposition of a crystal polymorph from the molecular structure of the compound and to control deposition of a crystal polymorph, and (ii) that a crystal polymorph was greatly affected by the kind of solvent and the deposition-starting temperature.  Then, having reviewed the specification of the patent at issue, in particular examples 5 and 6, the IPHC found that example 5 demonstrated the deposition process in which toluene was used as the solvent for deposition at 65°C as the deposition-starting temperature and example 6 demonstrated the deposition process in which xylene was used at 70°C, and no examples demonstrated the deposition process in which a ketone solvent or an ester solvent was used below 65°C, although the specification of the patent at issue mentioned as general descriptions that ketone solvents, such as acetone and ester solvents, such as ethyl acetate might be used and 50°C or higher temperature might be applied as the deposition-starting temperature.
On the basis of the above recognition and finding, the IPHC decided that, taking into consideration the above common technical knowledge, it was quite difficult to expect whether or not a specific crystal polymorph could be selectively prepared when solvents different from the examples were used or temperatures different from the examples were applied with no actual confirmation by experimentations and the like, thus that those skilled in the art could have recognized that the problem of the patent at issue could be solved only when “aromatic hydrocarbon solvents” were used as the solvents for deposition and 65°C or higher temperature was applied as the deposition-starting temperature,  and accordingly that Claim 1 was beyond the above scope and did not satisfy the support requirement.

Conclusively, the IPHC upheld the Osaka Gas’s appeal and cancelled the JPO’s decision.

An appeal to the Supreme Court was filed against this decision, and thus the decision is NOT final and binding.

K&P’s CommentsPatent applications claiming a specific crystal polymorph of compounds are often filed in Japan for the purpose of substantially extending the patent term of the compounds. The above IPHC's approach of judging for support requirement, i.e. placing importance on the disclosure of examples and common technical knowledge, is generally and normally found in the IPHC's precedents. Nevertheless, we have an impression that it is somewhat too strict that no temperature range lower than the specific temperature applied in the examples is admitted at all.

In January 2016, the IPHC handed down 9 decisions including the above case on patent, and overturned the previous decisions in 2 cases.

In January 2016, the IPHC handed down 7 decisions on trademark, and overturned the previous decisions in 4 cases.