DateMay 30, 2014

Case number

2013 (Gyo-Ke) 10196

Court

Intellectual Property High Court,Special Division– A case in which, regarding a JPO decision dismissing a request for a trial against an
examiner's decision of refusal of an application for the registration of extension of theduration of a patent right on the grounds that the "working of a patented invention,"
which was made possible by the disposition in question, had already been madepossible by a prior disposition and that the disposition in question is thus not deemed
to have been necessary to obtain for the working of the Patented Invention, the court
ruled that said application is not regarded as falling under the requirement for refusal
provided for in Article 67-3, paragraph (1), item (i) of the Patent Act; based on thisruling, the court dismissed the JPO decision.
Reference: Article 67, paragraph (2), Article 67-3, paragraph (1), item (i) and Article
68-2 of the Patent Act
1. Background
The plaintiff is the patentee of a patent for an invention titled "vascular endothelial
cell growth factor antagonists" (the "Patent"). The plaintiff filed an application for theregistration of extension of the duration of a patent right (the "Application") in relation
to the Patent to seek the registration of extension of the duration of five years,
asserting that a disposition designated by Cabinet Order (approval under thePharmaceutical Affairs Act; the "Disposition") was necessary to obtain for the workingof the invention pertaining to the Patent. However, having received an examiner'sdecision of refusal, the plaintiff filed a request for a trial against the examiner'sdecision of refusal (Trial against Examiner’s Decision of Refusal No. 2011-8106).
However, the JPO rendered a decision dismissing the request.
This is an action instituted by the plaintiff to seek rescission of the JPO decision.
With regard to the medicine (the "Medicine") which was the subject of theDisposition, approval of manufacturing and sale of the medicine (the "PriorDisposition") had been given in advance of the Disposition. The details of the subjectof the Prior Disposition are as follows: the active ingredient is "bevacizumab(transgenic)"; effectiveness and efficacy are stated as "unresectable advanced orrecurrent colorectal cancer"; dosage and administration are stated as "In combination
with other anticancer drugs, adults are ordinarily intravenously infused withbevacizumab at a dose of 5 mg/kg (weight) or 10 mg/kg (weight) at administrationintervals of at least two weeks." The Disposition is approval of a partial change to thematters included in the approval of manufacturing and sale of the medicine. The1

content of the major change is the addition of the following dosage and administration:"In combination with other anticancer drugs, adults are ordinarily intravenouslyinfused with bevacizumab at a dose of 7.5 mg/kg (weight) at administration intervalsof at least three weeks."
2. Reason for the JPO decision
The reason for the JPO decision dismissing the request is as follows: In making adetermination concerning Article 67-3, paragraph (1), item (i) of the Patent Act, it isappropriate to consider the "working of a patented invention" not as the act ofmanufacturing, selling, etc. a medicine which was the subject of a disposition but as
the act of manufacturing, selling, etc. the medicine that is identified by all matters thatfall under the matters to identify the invention of the patented invention ("Matters thatFall under Matters to Identify the Invention") out of the matters stated in the written
approval of the medicine which was the subject of the disposition; the scope of thePatented Invention that is identified by the "Matters that Fall under Matters to Identify
the Invention" of the medicine which was the subject of the Disposition had become
workable by the Prior Disposition; therefore, the Disposition is not deemed to havebeen necessary to obtain for the working of the Patented Invention; consequently, theApplication falls under the cases prescribed in Article 67-3, paragraph (1), item (i) ofsaid Act, and the plaintiff cannot obtain the registration of extension of the duration ofthe patent right.
3. Summary of this judgment
In this judgment, the court determined as follows, and rescinded the JPO decision.
(1) Regarding an error in the determination concerning whether the Application falls
under the cases prescribed in Article 67-3, paragraph (1), item (i) of the Patent Act(Ground for Rescission 1)
A. In considering the propriety of the determination in the JPO decision to the effectthat the application for the registration of extension of the duration of the patent rightshould be refused, the conclusion should be drawn by determining whether therequirement set forth in Article 67-3, paragraph (1), item (i) of the Patent Act, which isa basic provision that provides for the requirement for rendering an examiner'sdecision of refusal (JPO decision), is fulfilled (the scope for which a patent rightwhose duration was extended on the grounds of a prior disposition is effective cannot
be necessarily regarded as a matter that always directly relates to the question ofwhether a disposition designated by Cabinet Order was necessary to obtain for theworking of the patented invention).
The following are the prerequisites for saying that there is the fact that " the2disposition designated by Cabinet Order was necessary to obtain for the working of thepatented invention" as set forth in Article 67-3, paragraph (1), item (i) of said Act: [i] A
ban was lifted through obtainment of the "disposition designated by Cabinet Order";[ii] The relevant act on which the ban was lifted by the "disposition designated byCabinet Order" is included in the acts that fall under the "working of the patentedinvention." The fulfillment of /these two prerequisites is considered to be necessary.
The aforementioned provision is set as a requirement for an examiner (trialexaminer) to refuse an application for the registration of extension as follows: "wherethe disposition designated by Cabinet Order … is not deemed to have been necessary
to obtain for the working of the patented invention." Therefore, in order to refuse theApplication, it is necessary for the examiner (trial examiner) to selectively demonstrateeither [i] "that it cannot be said that a ban was lifted through obtainment of thedisposition designated by Cabinet Order" (first requirement) or [ii] that "the 'act onwhich the ban was lifted through obtainment of the disposition designated by Cabinet
Order' is not included in the 'acts that fall under the working of the patented invention'"(second requirement).
B. A medicine which is the subject of approval under Article 14, paragraph (1) or (9)of the Pharmaceutical Affairs Act is a medicine that is identified by "name, ingredient,quantity, dosage, administration, effectiveness, efficacy, side effects and otherqualities, and matters relating to effectiveness and safety." Therefore, the form of theact on which the ban is lifted by the aforementioned approval is the act ofmanufacturing, selling, etc. the medicine that is identified by the aforementioned
matters which were the subjects of the approval.
It is necessary to substantially determine the fulfillment of the aforementioned firstrequirement provided for in Article 67-3, paragraph (1), item (i) of the Patent Act inlight of the purpose of the Patent Act, which established the system for the registrationof extension of the duration, instead of determining it by formally applying eachelement of "name, ingredient, quantity, dosage, administration, effectiveness, efficacy,side effects and other qualities, and matters relating to effectiveness and safety," which
are matters to be examined for a medicine.
With regard to a patent for an ingredient of a medicine (excluding process patents
and patents pertaining to product-by-process claims, etc.), it is reasonable tounderstand that the scope of the "working of a patented invention" on which the ban islifted through obtainment of approval under Article 14, paragraph (1) or (9) of thePharmaceutical Affairs Act covers the act of manufacturing, selling, etc. a medicine
that is identified by the aforementioned matters to be examined, excluding "name" and3

"side effects and other qualities" and "matters relating to effectiveness and safety"(ingredient, quantity, dosage, administration, effectiveness and efficacy).
C. The ban on the act of using the Medicine by the use method that is identified by thedosage and administration, "In combination with other anticancer drugs, adults areordinarily intravenously infused with bevacizumab at a dose of 7.5 mg/kg (weight) at
administration intervals of at least three weeks," and the act of manufacturing, selling,etc. the Medicine on the premise of its use by the aforementioned use method was notlifted by the Prior Disposition but was lifted by the Disposition for the first time.
Therefore, it is obvious that the Disposition does not fulfill the aforementioned firstrequirement, "it cannot be said that a ban was lifted through obtainment of thedisposition designated by Cabinet Order," out of the aforementioned selective
requirements for refusing an application for the registration of extension. It is also
obvious that the Disposition does not fulfill the aforementioned second requirement,"The 'act on which the ban was lifted through obtainment of the disposition designatedby Cabinet Order' is not included in the 'acts that fall under the working of the patented
invention,'" out of the aforementioned selective requirements for refusing anapplication for the registration of extension.
As mentioned above, in this case, it is impossible to say that "it cannot be said thatthe ban on the act of working of the Patented Invention was lifted through obtainmentof the Disposition." Therefore, it cannot be said that the requirement for refusal
provided for in Article 67-3, paragraph (1), item (i) of the Patent Act is fulfilled.
(2) Regarding the scope for which a patent right extended under Article 68-2 of thePatent Act is effective
In this judgment, the court considered, for confirmation, the scope for which apatent right extended under Article 68-2 of the Patent Act is effective, and determined
that, in light of the purpose of the system for the registration of extension of theduration of a patent right and that of a patent infringement action, it is reasonable tounderstand that in the case of a patented invention for an ingredient of a medicine, thepatent right whose duration was extended pursuant to Article 68-2 of said Act iseffective for the scope of the working of the patented invention that is identified by"the ingredients (not limited to active ingredient)" as an invention pertaining to a"product" and is identified by "effectiveness and efficacy" and "dosage andadministration" as an invention pertaining to "usage."4