Supreme Court decision regarding the 5th Requirement of the Doctrine of

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1 Asamura NEWS Vol. 26 July 2018 Kenji Wada Attorney at Law Asamura Law Offices Mari Yuge Patent Attorney Chemical Department Hisashi Kanamori Patent Attorney Chemical Department Supreme Court decision regarding the 5th Requirement of the Doctrine of Equivalents ( Special Circumstance ) Is a flexible bar approach introduced into the doctrine of equivalents in Japan? Intellectual Property High Court decision on the support requirement A problem to be solved by the invention should be determined in principle based on the descriptions in the specification Intellectual Property High Court Grand Panel decision on prior-art eligibility A general formula having a huge number of options for substituents does not work as prior art. 1

2 1. Heisei 28 [Ju] 1242 Supreme Court decision: Is a flexible bar approach introduced into the doctrine of equivalents in Japan? Summary of facts The plaintiff was the owner of Japanese Patent No entitled Intermediates for the synthesis of vitamin D and steroid derivatives and processes for preparation thereof, and the patented invention relates to a process for producing chemical compounds including Maxacalcitol, which is an active pharmaceutical ingredient of drugs for Keratoma ( the patented process ). The defendants imported and sold drugs which contained Maxacalcitol ( the accused products ) in Japan. The process of producing Maxacalcitol contained in the Accused Products ( the accused process ) met all the constituent features recited in the claims of the patent except the isomer type of the Vitamin D structure in the starting material and intermediate material. The starting material and intermediate material in the patented process was cis-type while the same of the accused process was trans-type (see below), and the accused process includes an additional step of conversion from trans to cis. Patented Process: Accused Process: The specification of the patent provides no description of the starting material or intermediate materials with the trans-type vitamin D structure. The plaintiff demanded the defendants to cease importing, selling and offering for sale the accused products 2

3 and to discard the stocks of accused products. The plaintiff asserted on the basis of the doctrine of equivalents that the accused process was equivalent to the patented process and thus fell within the technical scope of the patented process. The Tokyo District Court granted the plaintiff's demand, and the Intellectual Property High Court upheld the district court decision. The first trial defendants (the appellants) made a final appeal to the Supreme Court. The appellants asserted that the accused process was not equivalent to the patented process because there is a special circumstance, for example, the fact that the accused process was excluded intentionally from the patented process in the patent prosecution (5 th requirement of doctrine of equivalents is not satisfied). The appellants argued that the patentee (the first trial plaintiff) could easily recognize the accused process at the time of filing the patent application of the patented process and thus a special circumstance should be affirmed. Main Issue Whether or not there is a special circumstance, for example, the fact that the accused process was excluded intentionally from the claim of the patented process in the patent prosecution. Outline of court decision The Supreme Court dismissed the final appeal, and the decision of the Tokyo District Court in favor of the patentee (first trial plaintiff) which was upheld by the Intellectual Property High Court became final. The reason is as follows: It is prohibited to argue infringement based on the doctrine of equivalents in the event that there is a special circumstance, for example, the fact that the accused process was excluded intentionally from the patented process in the patent prosecution. This is because the estoppel principle prohibits the patentee from making assertion contradictory to the acts previously taken by the patentee. Even if a patent applicant could easily recognize the difference between the claimed product/process of the patent and accused products/processes at the time of filing the patent application but did not make a claim covering the different feature of the accused products/processes, such a fact alone does not let the third parties trust that the applicant excluded the accused products/processes from the technical scope of the invention of the patent. Further, under the first-to-file system, it is unfair to force patent applicants to cover any and all of the features which can be recognized at the time of the applications into the claims. Accordingly, even if the applicant could easily recognize the difference between the claimed product/process of the patent application and accused products/processes at the time of the application but did not make a claim covering such constitution, it is not enough to affirm the special circumstance. On the other hand, in addition to the facts above, when it is further found that the applicant objectively and seemingly showed (or represented) that the applicant was aware that the difference could replace the claimed element but 3

4 intentionally did not make a claim covering it, for example, by describing the difference and replaceability in the specification, then a special circumstance is found. In the present case, there is no proof that the appellee (the patentee) objectively and seemingly showed (or represented) that the appellee (the patentee) was aware that the difference in the accused process can replace the claimed element of the patented process. Thus, no special circumstance is found. Comments In 1998, the Supreme Court established the requirements of the doctrine of equivalents infringement (Ball Spline Case, Heisei 6 [O] 1083 Supreme Court decision) as follows: Under the doctrine of equivalents, even if there is a difference between the claim elements and the accused product/process, infringement can be found under the following five requirements. Requirement 1: The difference is not an essential part of the patented invention. Requirement 2: Even if the difference exists, the purpose of the invention can be achieved, and the same function and effect can be obtained. Requirement 3: A person of ordinary skill in the art could easily recognize such replacement at the time of producing accused product/ practicing accused process. Requirement 4: Accused product/process did not belong to public domain at the time of the patent application, and a person of ordinary skill in the art could not easily conceive the accused product/process by the public domain at the time of the patent application. Requirement 5: There is no special circumstance, for example, the fact that the accused product/process was excluded intentionally from the claim of the patent in the patent prosecution. This Maxacalcitol Supreme Court decision is related to Requirement 5 above, and it upholds the Intellectual Property High Court decision based on the almost same reasoning. However, as stated above, this Supreme Court decision uses the wording the applicant objectively and seemingly showed (or represented) that the applicant was aware that the difference can replace the claimed element but intentionally did not include it in the claims, while the Intellectual Property High Court decision used slightly different wording. It seems that the Supreme Court decision implicitly clarifies that appearance is important, not just a subjective awareness of the patentee, by using the wording above. In the present case, there was no description in the specification of the Patented Process regarding the transtype Vitamin D structure in the starting material. Thus, a special circumstance was not to be found. On the other hand, this Supreme Court decision does not teach us regarding the cases other than either the case there is no description in the specification regarding the difference like this case; or the case such as that there is an explicit description in the specification that the difference is replaceable. 4

5 For example, with regard to the case that there is only an ambiguous/generic description regarding the difference in the specification, we need to await further court judgments. This case is different from that in which the accused product/process had been once recited in the claims at the time of application but was excluded after the filing by the amendment. In this regard, the Research law clerks of the Supreme Court, a judge who conducted the research necessary for the proceedings and drafting the decision of this case, expressed his personal opinion as follows: Although exclusion after the filing by claim amendment is out of the scope of this Supreme Court decision, this Supreme Court decision would be compatible with such potential decision that, even if accused product/process is excluded by amendments from the claims, such a fact alone does not constitute a special circumstance. 2. Heisei 29 [Gyo-ke] Intellectual Property High Court decision: A problem to be solved by the invention should be determined in principle based on the descriptions in the specification. Summary of facts The plaintiff is the owner of Japanese Patent No ( the patent ) entitled Food product containing rice-saccharified material and rice oil and/or inositol. The claims of the patent are as follows: Claim 1: Rice milk comprising a rice-saccharified product and rice oil containing 1 to 40 mass% of γ- oryzanol, wherein the rice milk comprises 0.1 to 10 mass% of the rice oil. Claim 2: The rice milk according to claim 1, further comprising inositol. Claim 3: The rice milk according to claim 2, which comprises 0.01 to 0.5 mass% of inositol. Claim 4: A food comprising rice milk according to any one of claims 1 to 3. The Japan Patent Office (JPO) rendered a decision for grant for the patent, and the patent was once registered. However, the opposition was filed against the patent, and the JPO decided to revoke the patent by reasoning that none of Claims 1 to 4 is supported nor meets the support requirement set forth in the Article 36 (6) (i) of the Patent Act. The patentee filed suit requesting cancellation of the decision in the opposition to the Intellectual Property High Court. Main Issue Whether or not the claims of the patent meet the support requirement. 5

6 Outline of court decision The Intellectual Property High Court dismissed the JPO s decision on the opposition for the following reason: Whether or not the claim of the patent meets the support requirement should be determined by comparing the claims with the descriptions in the specification in order to investigate whether a person of ordinary skill in the art can understand that a problem to be addressed by the invention can be solved by the descriptions of the specification, teaching given thereby and/or the general technical knowledge at the time of filing the patent application. The plaintiff asserted that this criterion should be only used with regard to limited cases 1, but this criterion can be used in a general way. The problem to be solved by the invention, which is the premise of the criterion of the support requirement above, should be found in principle on the basis of the descriptions in the specification while referring to the general technical knowledge. In this case, the specification explicitly states that it is an object of the invention to provide foods containing a rice saccharified product which have richness, sweetness, flavor and the like. On the other hand, the decision on opposition by the JPO alleged the problem to be solved of claim 1 of the patent as to provide products which have a significant difference in richness (creaminess), sweetness and flavor from the rice-milk of embodiment 1-1 in the specification. The defendant (JPO) asserts that the problem to be solved should be found as the problem which has not been solved yet, and the problem described in the speciation ( to provide foods containing a rice-saccharified product which have richness, sweetness, flavor and the like ) should correctly be interpreted as to provide products which have significant difference with regard to richness (creaminess), sweetness and flavor from the rice-milk of embodiment 1-1 in the specification. However, the problem to be solved by the invention should be found in principle on the basis of descriptions in the specification unless there is no description regarding the problem to be solved in the specification. The general technical knowledge can be used only supplementarily in order to understand the details of the descriptions in the specification, and cannot be used in order to find the problem to be solved which is different from the problem described in the specification. As such, the way how the decision on opposition by the JPO finds the problem to be solved is inappropriate. Thus, the problem to be solved by the invention is found to be to provide foods containing a rice-saccharified 1 The criterion comes from the Intellectual Property High Court Grand Panel Decision (Case Number: Heisei 17 [Gyo-ke] No ), which addressed a specific parameter patent. The plaintiff therefore asserted that this criterion should be only applied to such a specific case. Please see our corresponding comments. 6

7 product which have richness, sweetness, flavor and the like. The descriptions in the specification sufficiently support and show how to solve this problem. The decision on opposition by the JPO made an unreasonable decision regarding the support requirement, and it is thus illegal. Comments The criterion of the support requirement referred to in the decision above has been established by the Intellectual Property High Court (Grand Panel) decision (Case Number: Heisei 17 [Gyo-ke] No ) ( the Grand Panel decision ). This criterion has been cited in many Intellectual Property High Court decisions rendered since the Grand Panel decision. However, the scope of applicability of this criterion has been still under discussion partly because the patent at issue in the case of the Grand Panel decision was so-called Parameter Patent with special claim form including inequality using parameters such as Y > X and X 65. In fact, there was an Intellectual Property High Court decision which pointed out this particularity of the Grand Panel decision and used different criterion regarding the support requirement. Under these circumstances, this Intellectual Property High Court decision provided a guide in relation to the support requirement issue by confirming that the criterion given in the Grand Panel case can be used in a general way. The Grand Panel decision did not specifically rule how to determine a problem to be solved by the invention. However, as this Intellectual Property High Court decision states, what is a problem to be solved by the invention is the premise of the criterion to assess the support requirement. This Intellectual Property High Court decision has clearly ruled that a problem to be solved by the invention should be determined in principle based on the descriptions in the specification. From the perspective of the support requirement, it is very important to include explicit description regarding the problem in the specification. If not, there is a risk that unintended problem would be decided to be found based on the general technical knowledge (and maybe public domain at the time of application). In addition, it is also important to describe a problem to be addressed by the claimed invention in as general a way as possible, at least from the perspective of the support requirement. 3. Heisei 28 [Gyo-ke] Intellectual Property High Court Grand Panel decision: A general formula having a huge number of options for substituents does not constitute prior art. Summary of facts Nippon Chemipha (generic company) filed suit with the Intellectual Property High Court to cancel a decision to dismiss a demand for invalidation against Japanese Patent No ( the patent ) entitled Pyrimidine Derivative, the patentee being Shionogi & Co., Ltd. Claim 1 of the patent is as follows: Claim 1: A compound represented by the formula (I), 7

8 wherein R¹ is lower alkyl, R 2 is phenyl substituted with halogen, R 3 is lower alkyl, R 4 is hydrogen or calcium ion which forms hemicalcium salt, X is imino having a substituent of alkylsulfonyl, and the dotted line represents the presence or absence of a double bond; or a corresponding ring-closed lactone thereof. This compound covers a product under the tradename Crestor, HMG-CoA reductase inhibitor. The plaintiff asserted that the compound of the patent lacks inventive step over D1 (JPH , primary prior art) in combination with D2 (JPH , secondary prior art). D1 (JPH ) discloses in Example 1 the following compound: (M=Na) D2 (JPH ) describes a compound represented by formula (I). wherein R 1 is... alkyl; R 2,... aryl; and R 3,... -NR 4 R 5, wherein R 4 is... alkyl; R 5,... alkylsulfonyl; X,... -CH=CH-; and A,..., wherein R 6 is hydrogen... ; and R 7,... cation. 8

9 D2 also lists, as a more preferable compound, isopropyl as R 1, phenyl monosubstituted with fluorine, - NR 4 R 5 wherein R 4 is methyl and R 5 is methylsulfonyl as R 3, and calcium cation as R 7. On the other hand, R 3 list includes more than 20 million combinations in the more preferable compounds. Moreover, -NR 4 R 5 as R 3 is not listed in most preferable compounds and there is no Example which exemplifies a compound having the specific combination of -NR 4 R 5 as R 3. Main Issue Whether or not the present invention has an inventive step over D1 and D2. Outline of court decision The Intellectual Property High Court upheld the decision rendered by the JPO in the Invalidation trial. The reason is as follows: 1. Criterion When a prior-art compound is represented by a general formula having a huge number of options for substituents (Markush claim), unless there is a reasonable circumstance to positively or preferentially select a technical idea directed to a specific combination, a technical idea regarding the specific combination cannot be identified and such a prior-art compound is not eligible as an invention in sense of Article 29 of the Patent Act, which is used for novelty and inventive-step assessment. Whether the prior art is primary or secondary, the same idea applies. Re. Relevant case The Intellectual Property High Court first found that the compound of the present patent differs from the compound in D1 in the following aspect. - Difference 1: The former has imino substituted with alkylsulfonyl (i.e. (-N(CH 3 )(SO 2 R ) ) as X, while the latter has imino substituted with methyl (i.e. (-N(CH 3 ) 2 ) ) as X. - Difference 2: The former has H or Ca 2+ as R 4, while the latter has Na + as R 4. Regarding Difference 1, the Intellectual Property High Court found imino substituted with methylsulfonyl to be one of more than 20 million in R3, and ruled that there are no reasonable circumstances to positively or preferentially select (-N(CH 3 )(SO 2 R ) as R 3 and hence D2 is not eligible for the cited invention. The Intellectual Property High Court then concluded that the Difference 1 could not have been easily conceived of by combining the invention of D1 with the invention of D2. Comments If there is an example of a compound having the specific combination of (-N(CH 3 )(SO 2 R ) as R 3, 9

10 Pharmacological data on HMG-CoA reductase inhibitory activity for the compound with (-N(CH 3 )(SO 2 R ) as R 3 are provided, and/or the compound with the specific combination of (-N(CH 3 )(SO 2 R ) as R 3 is listed as one of most preferable compounds in D2, the Intellectual Property High Court would consider that there were reasonable circumstances to positively or preferentially select (-N(CH 3 )(SO 2 R ) as R 3 and thus D2 is eligible for the cited invention. In this view, when it appears that a prior-art compound represented by a general formula may encompass a certain compound which is being considered for a new patent application, it is recommendable to check if there are reasonable circumstances, for example as stated above. If there are no reasonable circumstances, such prior-art compound would not destroy novelty and inventive step of an invention directed to the certain compound which is being considered for the new patent application. From the perspective of challenging a patent, it should be noted that mere listing of options would not have prior-art effects. ********************************************************* Disclaimer The information, material and opinions in this newsletter do not constitute legal or professional advice, and Asamura Patent Office, p.c., is not responsible for any direct or indirect losses resulting from their use. Copyright ASAMURA PATENT OFFICE, p.c. All Rights Reserved. 10