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IP Court Case Summary:2014 (Gyo-Ke) 10202:

Support Requirement was unsatisfied because Crystalline Polymorphism is unpredictable from the Molecular Structures and etc.

January 27, 2016, the Intellectual Property High Court (IP High Court) reversed JPO board of appeal’s decision on the trial for invalidation of patents.

<Invention>

The title of the invention at issue is “Crystalline Polymorph of Fluorene derivative and Process thereof”. Claim-1 is “Manufacturing method for a Crystalline polymorphism of 9,9 -bis (4-(2-hydroxy ethoxy) phenyl) fluorine, by obtaining partially purified 9,9 -bis (4-(2-hydroxy ethoxy) phenyl) fluorine from the reaction mixture of fluorenone and 2-phenoxyethanol under the existence of heteropoly acid, by starting the deposition of 9,9 -bis (4-(2-hydroxy ethoxy) phenyl) fluorine at less than 50 °C; and then starting the deposition of 9,9 -bis (4-(2-hydroxy ethoxy) phenyl) fluorine at 50 °C or more after making it dissolve in one solvent chosen from a group which consists of an aromatic hydrocarbon solvent, a ketone solvent and an ester solvent at the purity of 85% or more.”

<JPO Board of Appeal’s Decision>

This is the trial for invalidation of patents. JPO Board of Appeal’s decided that the support requirement and other requirements (not explained here) are satisfied, and then this patent is maintained.

<IP High Court Decision>

 (1) Claim and Specification

Claim has “at 50 °C or more” as the temperature of the deposition, but the specification discloses only 65 °C and 70 °C in embodiments.

Claim has “an aromatic hydrocarbon solvent, a ketone solvent and an ester solvent” as the solvent for the deposition, but the specification discloses only “an aromatic hydrocarbon solvent”.

The plaintiff sued the defendant (patentee) for invalidation of patents by canceling JPO board of appeal’s decision.

(2) Discussion

It is difficult to predict crystalline polymorph, including crystalline structure, from the molecular structure of the compound. The condition for the deposition of desired crystalline polymorph can be found by attempting crystallization thoroughly in conditions as many as possible.

In addition, the deposition of the crystalline polymorph is influenced by the kind of the solvents and the crystalline start temperature. Particularly, the influence of the kind of the solvents is serious, and it was the common general technical knowledge at the time of this filing that “new crystalline polymorph” might be found by changing the kind of the solvents.

After the consideration above, even if a polymorph was able to be produced at a particular solvent and particular deposition start temperature selectively, in case chemical structure and property in the solvent is different, or in case the deposition starts at the temperature other than the deposition start temperature, it was difficult to predict whether a polymorph could be produced selectively without really confirming by experiments.

(3) Conclusion

Temperature from 50 °C to 65 °C is not supported by the specification, and “a ketone solvent and an ester solvent” is not supported by the specification because crystalline polymorph is unpredictable from the molecular structure and etc.

<Comments>

According to this precedent, Crystalline Polymorph is unpredictable, and can be influenced by some conditions such as temperatures and solvents for the deposition. This means that the embodiments are important to satisfy the support requirement. This precedent is useful for the practice of Crystalline Polymorph.

http://www.ip.courts.go.jp/app/files/hanrei_jp/721/085721_hanrei.pdf