Case Number:  2013 (Gyo-Ke) 10195-10198

Parties:  Genentech, Inc. [plaintiff] vs. Commissioner of Japanese Patent Office (JPO) [defendant]

Judgment:  IPHC Grand Panel

Judgment Date:  May 30, 2014

Background

The plaintiff, Genentech, Inc., is the patent holder of patents for inventions titled “Vascular endothelial cell growth factor antagonists” (Japanese Patent Number: 3398382) and “Anti VEGF antibodies” (Japanese Patent Number: 3957765).

The plaintiff filed requests for a five-year extension of patent term (Japanese Patent Application Nos. 2009-700156 to 2009-700159) since it was necessary to obtain dispositions designated by Cabinet Order for the working of the patented inventions (manufacturing and sales approval in accordance with the Pharmaceutical Affairs Law, hereinafter called “dispositions”).

However, Trial Decisions were issued by the JPO which rejected the applications for patent term extension (Trial Nos. 2011-8105 to 2011-8108).

Therefore, the plaintiff filed lawsuits requesting cancelation of the JPO’s Trial Decisions.

Although the plaintiff filed a total of four suits concerning two different patent rights, the points of issue and summaries of the judgments are common in both cases.

Japanese Patent Number: 3398382

Claim 1:

A composition for treating a cancer, comprising a therapeutically effective amount of hVEGF antagonist which is an anti-VEGF antibody.

Japanese Patent Number: 3957765

Claim 1:

A humanized anti-VEGF antibody having a heavy chain variable domain comprising the following hypervariable region amino acid sequences: CDRH1 (GYX1FTX2YGMN, wherein X1 is T or D and X2 is N or H; SEQ ID NO: 130), CDRH2 (WINTYTGEPTYAADFKR; SEQ ID NO: 2) and CDRH3 (YPX1YYGX2SHWYFDV, wherein X1 is Y or H and X2 is S or T; SEQ ID NO: 131), and having a light chain variable domain comprising the following hypervariable region amino acid sequences: CDRL1 (SASQDISNYLN; SEQ ID NO: 4), CDRL2 (FTSSLHS; SEQ ID NO: 5) and CDRL3 (QQYSTVPWT; SEQ ID NO: 6), wherein the antibody binds human vascular endothelial growth factor (VEGF) with a Kd value of no more than about 1 × 10-8 M.

Prior to the disposition, the drug products which were the subject of the disposition had been approved for manufacturing and sales of drug products (prior disposition) whose active ingredient was designated as “Bevacizumab (gene recombination)”, the efficacy or effects were designated as “advanced/recurring rectal/colorectal cancer of which curative resection is considered to be impossible”, and the usage and dosage were designated as “in combination with another anti-malignant tumor agent, it is normally administered to an adult through an intravenous drip infusion in an amount of 5 mg/kg (body weight) or 10 mg/kg (body weight), as Bevacizumab, per administration, wherein the administration duration is two weeks or more”.

Therefore, this disposition approved a partial change to the approved matters of manufacturing and sales of drug products, where the main change in content is the addition of the new usage and dosage of “in combination with another anti-malignant tumor agent, it is normally administered to an adult through an intravenous drip infusion in an amount of 7.5 mg/kg (body weight), as Bevacizumab, per administration, wherein the administration duration is three weeks or more”.

Summary of the Judgment

This judgment canceled the JPO’s Trial Decisions on the following grounds.

(1) Ground 1: Trial Decision of Rejection based upon Japanese Patent Law, Article 67-3(1)(i)

(A) When considering the validity of a judgment in a Trial Decision which rejected a patent term extension application, a conclusion must be reached by determining whether or not the requirement of Japanese Patent Law, Article 67-3(1)(i), which is the governing regulation stipulating the requirements for a decision to reject such an application, has been satisfied.

Proving the fact that “it was necessary to obtain the disposition designated by Cabinet Order for the working of the patented invention” provided by Japanese Patent Law, Article 67-3(1)(i) is premised on: (1) that a ban was lifted by the disposition designated by Cabinet Order, and (2) that the activity whose ban was lifted by “the disposition designated by Cabinet Order” is included among activities falling under the category of “working of the patented invention”, and it can be said that both of these must be established.

Since the above regulations are specified such that the examiner (or trial examiner) will reject a patent term extension application when “the disposition designated by Cabinet Order was not deemed to have been necessary in order to obtain a disposition for the working of the patented invention”, the examiner (or trial examiner) must selectively show that either: (1) the ban was not lifted by the disposition designated by Cabinet Order (first requirement), or (2) the activity whose ban was lifted by “the disposition designated by Cabinet Order” is not included among activities falling under the category of “working of the patented invention” (second requirement).

(B) Drug products, which are the subject of approval under the Pharmaceutical Affairs Law, Article 14(i) or (ix), are specified by their “name, ingredients, amounts, structure, usage, dosage, method of use, efficacy, effects, performance, side effects and other matters related to qualities, effectiveness and safety”.  Therefore, activities whose ban is to be lifted are activities such as manufacturing and sales of the drug products which are the subject of the approval and which are specified by the above matters.

When considering whether the requirement stipulated in Japanese Patent Law, Article 67-3(1)(i) is satisfied, it is necessary to make a judgment in a practical way in accordance with the purpose of the Japanese Patent Law which is to provide a system for registration of a patent term extension, but must not be judged by formally applying each element of the examination matters of drug products such as “name, ingredients, amounts, structure, usage, dosage, method of use, efficacy, effects, performance, side effects and other matters related to qualities, effectiveness and safety”.

In the case of a patent directed to an ingredient of a drug product (excluding process patents, patents related to product-by-process claims, and the like), the scope of “the working of the patented invention” whose ban is lifted by obtaining the approval based on Pharmaceutical Affairs Law, Article 14(i) or (ix) should be interpreted as activities such as manufacturing and sales specified by the matters (ingredients, amounts, usage, dosage, efficacy, and effects) excluding the “name”, “side effects and other matters related to qualities”, and “other matters related to effectiveness and safety” among the above-mentioned examination matters.

(C) The ban of the use of the drug products according to the method specified by the usage and dosage of “in combination with another anti-malignant tumor agent, it is normally administered to an adult through an intravenous drip infusion in an amount of 7.5 mg/kg (body weight), as Bevacizumab, per administration, wherein the administration duration is three weeks or more” and the ban of activities such as the manufacturing and sales of the drug products which are to be used in the above method were not lifted by the prior disposition.  These bans were lifted by the present disposition.  Therefore, it is apparent that the present disposition does not satisfy the requirement that “the ban was not lifted by the disposition designated by Cabinet Order (the above-mentioned first requirement)”.

It is also apparent that among the above-mentioned selective requirements to reject patent term extension applications, the requirement (above-mentioned second requirement) that “ ‘the activity whose ban was lifted by the disposition designated by Cabinet Order’ is not included among ‘activities falling under the category of working of the patented invention’ ” is not satisfied by the present disposition.

As explained above, this case does not satisfy the requirement for the rejection of an application for patent term extension provided by Japanese Patent Law, Article 67-3(1)(i) since “the ban was not lifted by the disposition designated by Cabinet Order”.

(2) Ground 2: Scope of Patent Right whose Patent Term was Extended under Japanese Patent Law, Article 68-2

The scope of a patent right whose patent term was extended under Japanese Patent Law, Article 68-2 was also examined in this case.  In accordance with the purpose of the system for registration of patent term extension and for patent infringement litigation, if a patented invention is directed to an ingredient of a drug product, the patent right whose term has been extended under Japanese Patent Law, Article 68-2 should be regarded as being effective over the scope of the working of the patented invention specified by the “ingredients (not limited to an active ingredient)” designated as a “product” and specified by the “efficacy and effects” and “usage and dosage” designated as a “use” (it is obvious that its equivalents and matters which are considered to be virtually identical are included therein in accordance with the purpose of the system for registration of patent term extension).

Our Comments

An application for patent term extension must satisfy the requirement that the ban of the working of the patented invention was lifted by a disposition designated by Cabinet Order in order to prove the fact that “the disposition designated by Cabinet Order was deemed to have been necessary in order to work the patented invention” as provided by Japanese Patent Law, Article 67-3(1)(i).

This judgment determined the scope of “the working of the patented invention” to be activities such as manufacturing and sales of drug products which are identified by ingredients, amounts, usage, dosage, efficacy, and effects.

Therefore, according to this judgment, when a ban on the working of a patented invention was lifted through a disposition of approval for manufacturing and sales of a modified drug product pertaining to the patent where the matters for defining the drug product that were modified are any of its ingredients, amounts, usage, dosage, efficacy, or effects, generally, it will be possible to obtain an opportunity to receive a patent term extension for the drug product for which the ban was lifted, for each disposition.