K&P's Intellectual Property High Court Decision Report in March, 2013

Merial S.A.S. v. Fujita Pharmaceutical Co., Ltd., Case No. 2012 (Gyo-Ke) 10037 (Decision rendered on March 19, 2013)

The Patentee, Merial, obtained a patent relating to an antiparasitic composition in 2006, against which Fujita filed an invalidation trial before the JPO in 2010. The JPO accepted Fujita's demand and made a decision of invalidation in 2011, followed by Merial's appeal against the JPO's decision to the IPHC in 2012.

Claim 1 of the patent at issue claims as follows:
"A composition for the treatment or prevention of a pet against parasite ... (omitted), the composition comprising the following (a) to (d):
(a) an insecticidal active substance of the formula (I): <formula (I) is omitted>;
(b) a crystallization inhibitor selected from the group consisting of ... (omitted);
(c) an organic solvent selected from the group consisting of ... (omitted); and
(d) an organic co-solvent selected from the group consisting of ... (omitted);
wherein the compound of formula (I) is present in a proportion from 1 to 20% (w/v); the crystallization inhibitor is present in a proportion from 1 to 20% (w/v), and meets the following test: a 0.3 ml solution comprising 10% (w/v) of the compound of formula (I) in the organic solvent defined in (c), and 10% of said crystallization inhibitor, placed on a glass slide at 20°C for 24 hours results in fewer than 10 crystals observed on the glass slide with the naked eye; and ... (omitted)".

The main issue in this case was whether or not the industrial applicability and the enablement requirement could be satisfied even when key measurement conditions for the test defined in a claim were not specified in the specification. The IPHC answered to the issue as follows.

First, the IPHC found that the specification of the patent at issue did not specifically disclose the range of the relative humidity (RH) and the degree of airflow as measurement conditions of the test defined in the claim. In this connection, during the court proceedings, Merial submitted some additional results of tests carried out under the RH of 25 to 75% in a desiccator so as to prevent the effect of airflow, and showed that the number of crystals was below 10, while Fujita also submitted different results of tests carried out under the RH of over 80% in a box, and showed that the number was over 10.

On the basis of the above, the IPHC decided that those skilled in the art could have easily understood on the basis of the description of the specification of the patent at issue (i) that unnecessary air ventilation should have been generally prevented and (ii) that it would have not been necessary to specify the RH insofar as the conditions had been within the standard test environments, and found that Merial's test results of about 50 to 70% of the RH was the standard, while Fujita's results of over 80% was beyond the standard.

Conclusively, the IPHC determined that the claimed composition had an industrial applicability and the specification of the patent at issue satisfied the enablement requirement, and cancelled the JPO's decision.

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

Generally speaking, the enablement requirement is much more strictly applied in Japan than in the EP and the U.S.A., and the measurement conditions of the parameters defined in a claim are also required to be disclosed in greater detail in the specification. Nevertheless, this decision teaches that some insufficient disclosure of the conditions can be complemented by submitting supplemental data showing that the claimed parameter is satisfied in a wide range within the "standard" conditions.

Honshu Chemical Industry Co., Ltd. v. Commissioner of JPO, Case No. 2012 (Gyo-Ke) 10245 (Decision rendered on March 25, 2013)

The Applicant, Honshu Chemical, filed a patent application relating to a process for production of 1,1-bis(4-hydroxyphenyl)-3,3,5-trimethylcyclohexane (BHTC) in 2000, but the application was finally rejected on the grounds of lacking inventive step by the Appeal Board of JPO in 2012. Against the JPO's decision, Honshu filed a cancellation action before the IPHC in 2012.

Claim 1 of the patent application at issue claims as follows:
"A process for production of 1,1-bis(4-hydroxyphenyl)-3,3,5-trimethylcyclohexane (BHTC) which comprises:
(a) a reaction step of reacting phenol with 3,3,5-trimethylcyclohexanone in the presence of an acid catalyst in a slurry containing phenol adduct crystals of BHTC;
(b) a neutralization step of neutralizing the resulting slurry reaction mixture with an alkali in a pH range of 5 to 8 with heating the mixture to bring it into a solution after the reaction;
(c) a first filtration step of cooling the solution to obtain phenol adduct crystals of BHTC, followed by filtering the obtained crystals;
(d) a second filtration step of heating and dissolving the adduct crystals obtained in the first filtration step in a crystallization solvent, followed by cooling and filtering a crystal of BHTC; and
(e) a circulation step of circulating at least a part of the filtrate containing BHTC obtained in the second filtration step to the reaction step (a)".

One of the main issues in this case was how much general common technical knowledge can be relied on in determining inventive step. The IPHC answered to the issue as follows.

First, the IPHC found (i) that it was generally well known to recycle a fraction which was not the main fraction principally containing the desired product but still contained the desired product and/or useful materials in a preparation process of chemical compounds with reference to well-known prior art references (w.p.a.r.) 4 to 6 and the like, and (ii) that some recycling steps were actually carried out in various preparation processes of bisphenols from a phenol and a carbonyl compound.

However, the IPHC decided that it depended on the preparation process and the type of fraction to which step the fraction containing useful materials were recycled, but the JPO's decision did not state the reason why those skilled in the art could easily reach the claimed feature that the circulation should be made to the claimed reaction step, despite that several specific steps could be recognized as the steps to which the useful materials could be recycled in the cited invention.

In this connection, during the court proceedings, the JPO asserted that the desired product and the useful materials were the same in w.p.a.r. 4 to 6 and in the cited invention, and thus those skilled in the art could have easily conceived of circulating the fraction containing BHTC to the reaction step. However, the IPHC rejected the JPO's assertion by pointing out that the fraction to be recycled and the recycling method varied depending on the specific preparation processes, which required undue consideration depending on each process even though the desired product and the useful materials were the same.

Conclusively, the IPHC upheld the Honshu's appeal, and cancelled the JPO's decision.

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

This decision teaches that even though a claimed element itself is a well-known technique in general, you may argue, against the lack of inventive step, that undue consideration or experimentation is required to specifically apply the well-known technique to a cited invention to reach a claimed invention.

Daicho Kikaku Incorporated Company v. Commissioner of JPO, Case No. 2012 (Gyo-Ke) 10284 (Decision rendered on March 27, 2013)

The Applicant, Daicho Kikaku, filed a patent application relating to a muscle-strengthening agent and the like in 2002, but the application was finally rejected on the grounds of lacking inventive step by the Appeal Board of JPO in 2012. Against the JPO's decision, Daicho filed a cancellation action before the IPHC in 2012.

Claim 1 of the patent application at issue claims as follows:
"A muscle-strengthening agent, an anti-cerebral infarction sequelae agent, an anti-motor paralysis agent, an anti-asthmatic agent, an anti-diminution of vision agent, an anti-functional cardiopathy agent, or an anti-dementia agent comprising the following ingredients A, B and C:
A. scymnol or scymnol sulfates;
B. soybean isoflavones or soybean isoflavone glycosides; and
C. curcumin".

The main issue in this case was whether or not two prior art references might be combined in examining inventive step when the problems to be solved in the prior art references were different from each other. The IPHC answered to the issue as follows.

First, the IPHC found (i) that prior art reference (p.a.r.) 1 disclosed a health food containing a scymnol sulfate and daidzin, which was a soybean isoflavone glycoside, and (ii) that the problem to be solved by the health food was to provide a method for improving the body's activity by enhancing egestion of harmful endocrine disrupters and the like, but (iii) that p.a.r. 1 did not suggest that the health food was effective for dementia, asthmatic, cardiac affection, and the like. Meanwhile, the IPHC found that p.a.r.s 2 to 4 and 6 disclosed that soybean isofavones were effective for dementia, asthmatic, cardiac affection, and the like.

On the basis of the above findings, the IPHC decided that none of p.a.r.s 2 to 4 and 6 had a common problem to be solved with p.a.r. 1, i.e. enhancing egestion of harmful endocrine disrupters and the like, and thus those skilled in the art could not easily conceive from the p.a.r. 1 that daidzin had a bioactivity which did not relate to enhancing egestion of harmful endocrine disrupters.
In this connection, during the court proceedings, the JPO asserted that it was well known that soybeans which contained daidzin as an active ingredient were effective for motility disorder after cerebral infarction, motor paralysis and the like, and thus those skilled in the art could have easily specified the use of the health food containing daidzin disclosed in p.a.r. 1 as the claimed use. However, the IPHC rejected the JPO's assertion by pointing out that the health food disclosed in p.a.r. 1 was intended to solve the problem by combining some crude drug extracts and thus those skilled in the art could not have been motivated to focus attention particular on daidzin since daidzin had been merely one component among the extracts.

Conclusively, the IPHC upheld Daicho'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.

This decision teaches that the IPHC recently tends to place more emphasis on the commonality of the problem to be solved among the prior art references when examining inventive step on the basis of two or more prior art references.

In March 2013, the IPHC handed down 47 decisions including the above 3 cases on patents, and overturned the previous decisions in 12 cases.
In March 2013, the IPHC handed down 11 decisions on trademarks, and overturned the previous decisions in 7 cases.