March, 2016｜News Letter

How should Remarkable Effect be Demonstrated for Acknowledging Inventive Step?

Towa Pharmaceutical Co., Ltd. v. Merck Sharp & Dohme Corp., Case No. 2015 (Gyo-Ke) 10054 (Decision rendered on March 2, 2016)

The former Patentee, Schering Corp., obtained a patent relating to a medicament comprising an aqueous suspension of mometasone furoate in 2003, and the patent was transferred to Merck Sharp & Dohme (MSD). Against the MSD's patent, Towa filed an invalidation trial with the JPO in 2014. The JPO dismissed the Towa's demand in 2015, followed by Towa's appeal against the JPO's decision to the IPHC in 2015.

Claim 1 of the MSD's patent at issue claims as follows:
A medicament for the treatment of allergic or seasonal allergic rhinitis, the medicament comprising an aqueous suspension of mometasone furoate and being intranasally administered once-a-day.

The main issue in this case lied in how a remarkable effect should be demonstrated for acknowledging an inventive step. The IPHC answered to the issue as follows:

In the JPO's decision, although the JPO found that all the three differences between the invention of Claim 1 of the patent at issue and that disclosed in prior art references (p.a.r.) 1 and 2, i.e. (i) that the former specified "an aqueous suspension", while the latter did not, (ii) that the former specified "once-a-day" administration, while the latter did not, and (iii) that the former defined the subject matter of the claimed invention as "a medicament for the treatment", while the latter was a candidate for such a medicament, were easily conceivable for those skilled in the art, the JPO acknowledged inventive step on the grounds that two effects of the claimed medicament of Claim 1 of the patent at issue, i.e. (i) that allergic rhinitis was able to be effectively treated by administering mometasone furoate once-a-day, and (ii) that undesired systemic side effect was able to be prevented due to substantial non-existence of systemic absorption of mometasone furoate into bloodstream, were not disclosed in p.a.r.s 1 and 2 and could not be expected for those skilled in the art from p.a.r.s 1 and 2.

However, having reviewed the disclosures of the specification of the patent at issue as well as p.a.r.s 1 and 2 in detail, the IPHC found that the specification of the patent at issue demonstrated a treatment effect for allergic rhinitis without side effect in comparison with placebo only, and did not specifically demonstrate the comparison between the administration in the form of an aqueous suspension and the administration in other forms, such as a solution, or the comparison between the intranasal administration once-a-day and the cases wherein the number of administration or the form was changed. On the basis of the above findings, the IPHC decided that it was difficult to understand from the disclosures of the specification of the patent at issue (i) how much the treatment effect or the side effect was in the cases wherein the number of administration or the form was changed, and (ii) whether the claimed medicament of Claim 1 of the patent at issue was more advantageous than the inventions disclosed in p.a.r.s 1 and 2 in the treatment effect or the systemic side effect, thus any remarkable effect beyond the expectation of those skilled in the art was not acknowledged.

Conclusively, the IPHC upheld the Towa'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 CommentsUnder the Japanese practice, a remarkable effect brought about by the claimed invention is generally considered as an important positive factor for acknowledging an inventive step. However, such an effect is required to be disclosed in the specification of the patent as filed. The above decision teaches that it is important to adequately understand closely relevant prior art inventions and demonstrate the remarkable effect over them in the specification as filed.

In March 2016, the IPHC handed down 28 decisions including the above case on patent, and overturned the previous decisions in 11 cases.

In March 2016, the IPHC handed down 7 decisions on trademark, and overturned the previous decisions in 2 cases.