News & Topics

By Yasuo Tamura
AOYAMA & PARTNERS

I. Introduction
According to Japanese Patent Law, Article 36, it is required to disclose the invention in such a manner that any person skilled in the art can readily work the invention. It will be not necessarily clear what/how disclosure will satisfy the requirements. The requirements will vary in each technical field and will be depended on the practice in each technical field.
In a medical invention, particularly an invention concerning a new medical use of old substance, e.g. second medical indication, the JPO has required to include experimental/pharmacological data supporting the medical use in the originally filed description, that is, the JPO’s position is that it is essential to disclose the experimental data supporting the medical/pharmacological activity in the original description and that it is not permitted to supplement the experimental data after filing of the patent application. The JPO has taken this severe practice since the medical patent system has been adopted in 1976.
Against such severe practice taken by the JPO, many pharmaceutical companies in the world, particularly in the U.S.A. as well as the practitioners in this technical field have complained, and it has been contested in a court, as is explained hereinbelow.
We wonder whether it is surely correct to take such a severe practice of the JPO that it is essential to disclose the pharmacological data in the originally filed description for satisfying the description requirement under Japanese Patent Law, Article 36. We are sorry but has assumed that it is unlikely that the severe practice of the JPO will be changed in the near future, at least within several years.
However, we are pleased to see light in change of the severe practice in some recent decisions of IP High Court, wherein the court says that a medical invention shall not be rejected merely by the reason of absence of experimental data supporting the medical use, and further points out that it is not necessarily required to support the medical use by experimental data, when the activity (utility) can be assumed based on the original disclosure in view of the prior art by a person skilled in the art. Thus, we hope/expect that the JPO may change the severe practice in future, while we are still not sure whether the JPO change immediately the severe practice which has been taken for many years.

II. Court decisions holding the severe practice of the JPO
Although many pharmaceutical companies and practitioners have complained the severe practice of the JPO and have disputed in the court, the severe practice of the JPO has been held in the most court decisions. One of the court decisions is shown below.

A. Decision of Tokyo High Court, Heisei-8-(Gyo-Ke)-201
(Decided on October 30, 1998)
This is one of the most famous cases to hold the severe practice of the JPO that pharmacological data are required in original description for satisfying the enablement requirements for medical use invention, and hence, it is explained in detail below.
This is an appeal against trial decision in Trial No. Heisei-6-15405
(Title of Invention: Medicaments for treating nausea, vomiting or the like) and it was decided by the Tokyo High Court that the appeal shall be dismissed, that is, the rejection of application was affirmed.

In said decision of the Trial Board of the JPO, it was stated that the application does not disclose any pharmacological data or a concrete disclosure to be substituted therefor and hence does not comply with the requirements as defined in Patent Law, Article 36, Item 3 (Note: it corresponds to the present patent law, Article 36, Item 4, hereinafter the same).
Against the trial decision of final rejection of the patent application, the applicant/plaintiff appealed to Tokyo High Court and argued that in the present description, it is exactly disclosed that by combination of a medicinal root ginger (Rhizoma Zingiberis) and a special extract of dried leaves of Ginkgo biloba (extr. Ginkgo bilobae E fol. sicc), there is obtained a medicament useful for treating nausea or vomiting, especially effective for travel sickness (e.g. motion sickness), nausea in pregnancy, and migraine without undesirable side effects, and further that it is also disclosed with respect to the dosage, administration methods, and that accordingly, even if it will be required “to disclose the invention in the description in such a manner that the pharmacological effects shall be confirmed by pharmacological data or a concrete disclosure to be substituted therefor”, the present description includes the concrete disclosure to be substituted for the pharmacological data.
However, the court has affirmed the decision of the Trial Board of the JPO and maintained the rejection of the application because of lack of support of the medical use by pharmacological data in the original description.
Thus, the Judges of the Tokyo High Court stated in the court decision as follows:
a) Requirement of description in medical use invention:
In case of an invention concerning a medical use, it is usually difficult to assume the utility merely from the chemical name and chemical structure of the active substance, and even if the description includes the disclosure of effective amount, administration methods, and formulations, a person skilled in the art still can not understand whether the substance is exactly useful as a medicament for the utility mentioned. Accordingly, it is required to support the utility by the pharmacological data or comparable disclosure in the description. Otherwise, the application does not comply with the description/enablement requirements as defined in Patent Law, Article 36. From this viewpoint, the decision by the Trial Board of the JPO has no error in judgment.
The judges stated as “since an invention concerning a medical use is worked solely depending on the ascertained pharmacological effects of the active substance or pharmaceutical composition, it is required to disclose the pharmacological data or alternatively a certain concrete disclosure to be substituted therefor in the description so that the pharmacological effects of the product can be confirmed.
b) Failure of description as to the invention directing to medicaments for treating nausea, vomiting or the like
In the description of the present invention concerning “medicaments for treating nausea, vomiting or the like”, there is entirely not any disclosure in what degree the nausea and vomiting will be remedied at the dose and administration time disclosed, and to what extent the therapeutic effects are enhanced by administering both of a medicinal root ginger (Rhizoma Zingiberis) and a specific extract of dried leaves of Ginkgo biloba (extr. Ginkgo bilobae E fol. sicc) in comparison with each substance alone, and hence, a person skilled in the art will be not able to readily understand from such a description whether the medicament of the present invention can exactly be used for the utility mentioned in the description. Accordingly, there is no error in judgment in said trial decision stating that the present application does not disclose the invention so that it is readily carried out by a person skilled in the art.
(Note: the details of this court decision are shown in my separate article written in February 2006 in title of “Decision of Tokyo High Court, Heisei-8-(Guo-Ke)-201”)

III. Other court decisions holding the severe practice of the JPO
Even after the severe practice of the JPO was supported by the above decision of Tokyo High Court, Heisei-8-(Gyo-Ke)-201, many pharmaceutical companies are still complaining about the practice, and some cases have been brought before the court, e.g. the following cases:
B. Decision of Tokyo High Court, Heisei-13-(Gyo-Ke)-345, decided
on October 1, 2002 (“Pyrrolidine Derivatives-Containing
Pharmaceutical Composition” case)
C. Decision of Tokyo High Court, Heisei-15-(Gyo-Ke)-166, decided
on January 18, 2005 (“Metronidazole” case)
D. Decision of Tokyo High Court, Heisei-15-(Gyo-Ke)-104, decided
on December 26, 2005 (“NK1 Receptor Antagonist” case)
E. Decision of IP High Court, Heisei-17-(Gyo-Ke)-10042, decided
on November 11, 2005 (“Polarizing Film” case)
(Note: IP High Court was established on April 04, 2005 (converted from
Tokyo High Court. This case (E) is not concerned with a medical
use patent, but treats also the enablement requirements requiring
support of experimental data in the original description)

In all these cases, the JPO has rejected the patent application or made invalid the patents because of lack of support or less of support of the experimental (pharmacological) data in the original description, and against the decisions of the JPO, the patent applicants/patentees have appealed to the Tokyo High Court/IP High Court and argued against the JPO’s position that the experimental data are required for satisfying the description requirement under Japanese Patent Law, Article 36. These cases are briefly explained below.
(i) In the above “Pyrrolidine…”case (B), the patent applicant argued that Patent Law, Article 36 does not require to include pharmacological data in the original description for satisfying the description requirement and that the invention was sufficiently disclosed in the original description how to make/how to use. However, the judges of the court dismissed the applicant’s argument and upheld the position of the JPO.
(ii) In the “Metronidazole” case (C), although the JPO has recognized the patentability of the invention in the invalidation trial, it was shockingly decided in the appeal to the Tokyo High Court that the originally disclosed clinical data was incorrect and doubtful and hence the invention has never been completed, and as a result, the patent was made invalid because of incompliance with Japanese Patent Law, Article 29, Paragraph 1, First Sentence (in this case, it was not based on the Patent Law, Article 36 contrary to other cases).
(iii) In the “NK1 Receptor Antagonist” case (D), the JPO rejected the patent application because that the originally disclosed pharmacological data were merely a part of the compounds inclusive in the claim but it was unclear whether all compounds could exhibit the desired effects like the compound supported by the pharmacological data. In spite of argument of the patentee that any person skilled in the art would have readily understood that other compounds would also exhibit the desired effects like the compound with pharmacological data, the JPO dismissed the applicant’s argument and the Tokyo High Court upheld the decision of refusal by the JPO.
(iv) The “Polarizing Film” case (E) is an appeal to the decision of opposition to nullify a patent, and the IP High Court affirmed the decision of nullification by the Trial Board of the JPO, wherein it is stated that the patent does not comply with the supporting requirements. In this patented invention, the desired polarizing film having excellent properties is produced by subjecting the starting polyvinyl alcohol film to uniaxial orientation under the conditions satisfacting two equations with respect to the completely dissolving temperature (X) and the equiliburium swelling temperature (Y). However, the description includes only two working examples and two comparative examples. The Examiner pointed out that it is doubtful to lead the two equations as defined in claim 1 based on such too small number of examples and any person skilled in the art can not work the claimed invention, and that the patent does not comply with the disclosure requirements under Patent Law, Article 36, Item 4, and ibid. Item 5, Paragraph 1 (these correspond to the present Patent Law, Article 36, Item 4, and Item 6, Paragraph 1, respectively).
Against the decision of opposition by the Trial Board of the JPO, the patentee appealed to the IP High Court, but the court affirmed the decision of opposition by the JPO and pointed out that the claimed invention shall be supported by the description so that a person skilled in the art can work well the invention within the scope of the claimed invention based on the description in the light of the common knowledge, but the patent does not comply with the requirements under Patent Law, Article 36.

III. A gleam of hope of relaxing the severe practice for the requirement of support by experimental data in view of the recent court decisions
We are pleased to see light of relaxing the severe practice of the JPO in the recent decisions of IP High Court as mentioned below, wherein it is mentioned that it is not necessarily required to support the medical use by experimental data when the activity (utility) can be assumed in view of some prior art and the original disclosure by a person skilled in the art. It is further pointed out that a medical invention shall not be rejected merely by the reason of absence of experimental data supporting the medical use.

F. Decision of IP High Court, Heisei-21-(Gyo-Ke)-10033
(Decided on January 28, 2010)
This case is concerned with a second medical use invention in the form of Swiss type use claim for treating hypoactive sexual desire disorder comprising as an active ingredient “Flibanserin” (a product of the applicant: Boehringer Ingelheim). The experimental data was not disclosed in the original description but has been submitted in response to an Office Action. However, the Examiner in Examining Division did not accept the late-filed experimental data and then rejected the patent application by the reason that it does not comply with the requirements under Patent Law, Article 36, Item 6, Paragraph 1 because of lack of support for the medical use, wherein the Examiner has pointed out that the claimed invention shall be well supported by the pharmacological data or an equivalent thereto in the original description and it can not be supplemented after filing of the patent application, referring to two decisions of Tokyo/IP High Court, i.e. the above-mentioned Tokyo High Court, Heisei-15-(Gyo-Ke)-104 (Case D) and IP High Court, Heisei-17- (Gyo-Ke)-10042 (Case E). Against the decision of refusal, the applicant appealed to the Trial Board, but the Trial Board has maintained the rejection.
Then, the applicant has appealed against the trial decision to the IP High Court.
In the appeal, the IP High Court disaffirmed the decision of the Trial Board of the JPO and pointed out that the decision of the JPO which requires “pharmacological data or an equivalent thereto” in a medical invention in order to comply with the disclosure requirements (requirements of support) as defined in Patent Law, Article 36, Item 6, Paragraph 1 is wrong, because said Article 36, Item 6, Paragraph 1 requires that the invention as claimed in claim(s) shall be described so that a person skilled in the art can understand how to solve the problems and can work the invention, but does not necessarily require to disclose “the pharmacological data or an equivalent thereto”. The court further pointes out that in a medical invention, it will surely be necessary to disclose the utility, but it is not necessarily required to disclose “the pharmacological data or an equivalent thereto” for supporting the utility, and it will be sufficient to disclose the invention so that a person skilled in the art can recognize the utility, and the court further pointed out that the Examiner of the Trial Board of the JPO has mistaken in the interpretation of Patent Law, Article 36, Item 6 Paragraph 1 by confusing the provision of said Art. 6, Item 6, Paragraph 1 with the provision of Art. 36, Item 4, Paragraph 1 defining enablement requirements.
Thus, in this court decision, the judges of the IP High Court disaffirmed the trial decision by the reason that the Examiners of Trial Board have mistaken in the interpretation of the Article 36, Item 6, Paragraph 1 (confusing with the enablement requirements of Article 36, Item 4, Paragraph 1). From this view point, said court decision is somewhat different from the past court decisions affirming the JPO’s severe practice to disclose the experimental/pharma￢cological data in the original description for supporting the utility in medical use invention.
However, this court decision is important in that the judges also mentioned that even from the provision of Article 36, Item 4, Paragraph 1 (enablement requirements) it is not necessarily required to disclose the concrete data for supporting the utility (e.g. “the pharmacological data or an equivalent thereto”) in the original description but the requirements of Art. 36, Item 6, Para. 1 will be satisfied when a person skilled in the art can understand the technical characteristics of the invention such as problems to be solved by the invention, means for solving the problems and the like from the original description and can work the invention.

G. Decision of IP High Court, Heisei-21-(Gyo-Ke)-10238
(Decided on July 15, 2010)
This case is concerned with a composition suitable for use as sunscreen comprising a) a UVA-absorbing dibenzoylmethane sunscreen active, b) a stabilizing agent having the specific formula (omitted), c) 2-phenylbenzimidazol-5-sulfonic acid UVB sunscreen active, and d) a carrier.
The patent application was rejected by lack of inventive step over Citation A which discloses similar sunscreen composition only different from the instant invention in that the UVB sunscreen actives are mentioned generally as “optionally conventional UV-B filter” but does not specify the specific 2-phenylbenzimidazol-5-sulfonic acid UVB sunscreen active and by no experimental data supporting unexpectedly superior effects over Citation A.
The applicant has submitted some comparative experimental data for showing the unexpectedly superior effects in comparison with a composition of Citation A when appealed to the Trial Board of the JPO, but the Trial Board has denied to accept the supplemental data because it will be unfair for keeping the balance of rights between the patent applicant and a third party, and has decided to reject the application by lack of inventive step over Citation A under Patent Law, Article 29, Item 2 because there is no evidence to support the unexpectedly superior effects of the invention. Then, the patent applicant has appealed to the IP High Court.
The IP High Court disaffirmed the decision of the Trial Board of the JPO and mentioned that to deny or not to consider the late-filed comparative data is depended on whether it gives affect on the justice/unfair treatment in the right between the patent applicant and the third party, and there is no unfair treatment in the instant case because the patent application discloses that the composition using the specific 2-phenylbenzimidazol-5-sulfonic acid UVB sunscreen active can exhibit superior effects in comparison with the known sunscreen composition (while no concrete data being disclosed), and hence it will be acceptable to consider the late-filed comparative experimental data for understanding the inventive step over the citation.
Thus, in this case the IP High Court has admitted to consider the experimental data submitted after filing of a patent application when a person skilled in the art can understand that the invention exhibits the superior effects from the original description even if any concrete (experimental) data of the activity is not disclosed in the original description.

V. Postscript
The JPO has taken for many years severe practice of requiring support of a medical invention by experimental/pharmacological data in the original description and refusing to accept late-filed experimental data, and said severe practice of the JPO has been affirmed by Tokyo High Court/IP High Court like in the cases (A) to (E) as mentioned above.
However, we are beginning to see light of relaxing the severe practice of the JPO in the recent decisions of IP High Court such as cases (F) and (G).
Although these cases (F) and (G) are necessarily opposite judgement to that of the past court decisions affirming the JPO’s severe practice, because in the case (F) the Judges disaffirmed the trial decision by the reason of misinterpretation of Patent Law, Article 36, Item 6, Paragraph 1 (confusing with the provision of Article 36, Item 4, Paragraph 1) and in the case (E) it was accepted to take into consideration the late-filed experimental data for the purpose of proving the inventive step over the citation, these court decisions are meaningful in that the Judges in the case (F) also mentioned that even from the provision of Article 36, Item 4, Paragraph 1 (enablement requirements) it is not necessarily required to disclose the concrete data (e.g. “the pharmacological data or an equivalent thereto”) for supporting the utility in the original description but the requirement will be satisfied when a person skilled in the art can understand and work the invention based on the original description, and that the Judges in the case (G) mentioned that the late-filed experimental data shall be accepted to consider when a person skilled in the art can understand the effects of the invention from the original description.
Accordingly, we are not sure but hope/expect that the JPO may change/relax the severe practice as to the support of medical use by the concrete data (experimental data) disclosed in the original description in future in the light of the recent court decisions by the IP High Court. However, it is still recommendable, highly recommendable to disclose some pharmacological data for supporting the medical use in the original description, because it is not sure whether the JPO will change or relax the severe practice in the near future and further in view of the severe practice in other Asian countries such as China, Korea.