Judgment concerning the scope of the effects of a patent right whose term has been extended – Oxaliplatin Case-

Japan Patent Information Committee
NAKAHAMA, Akiko  Patent Attorney

Judgment made by Tokyo District Court on March 30, Heisei 28 (2016) (Heisei 27(2015), “Wa” No. 12414)
Case to seek an injunction against infringement of a patent right

The subject case is the first case on which a judgment is made on the scope of the effects of a patent right after an extension of the term of the patent right has been registered (Article 68-2 of the Patent Law). The Judgment on the Avastin Case made by the Large Collegial Body of the Intellectual Property High Court (Heisei 25 (2013), “Gyo Ke” No. 10195, etc.), which concerns the interpretation of the requirement for rejecting an application for the registration of extension of the term of a patent, has also set out obiter dictum certain standards with regard to this point. Regarding a patented invention whose subject matter is an ingredient or ingredients of a pharmaceutical product, the subject judgment made by the Tokyo District Court generally adheres to the standards set forth in the judgment made by the Large Collegial Body of the IP High Court, and also presents a more detailed way of thinking about “an equivalent” of or “a product that is evaluated to be substantially identical” to “the product that was the subject of a disposition as provided for in Cabinet Order (in the case where a specific use of such product is prescribed in the disposition concerned, the product put to such specific use).”

1. Summary

Debiopharm S.A., the plaintiff, is the holder of Patent No. 3547755 titled “Pharmaceutically Stable Oxaliplatinum Preparation,” and the extension of the term of the subject patent right was registered by reason of the disposition based on the approval for “Elplat^® I.V. Infusion Solution,” an oxaliplatin (synonymous with oxaliplatinum) preparation, in accordance with Article 14 of the Pharmaceutical Affairs Act (which disposition is hereinafter referred to as “the subject disposition”). Towa Pharmaceutical Co., Ltd, the defendant, manufactures and sells “Oxaliplatin Intravenous Infusion,” a generic medicine of Elplat I.V. Infusion Solution, which has concentrated glycerin added as a stabilizer. The efficacy and effect, as well as dosage and administration of the defendant’s product, are the same as those of “Elplat^® I.V. Infusion Solution.” Debiopharm filed a suit with the Tokyo District Court to seek an injunction, etc. against the manufacture, sales, etc. of the defendant’s product, alleging that the subject patent right whose term had been extended was infringed by the acts of manufacturing and selling the defendant’s product.

Here, Claim 1 of the subject patent reads as follows:
“A pharmaceutically stable preparation of oxaliplatinum for the administration by the parenteral route, consisting of an aqueous solution of oxaliplatinum in water at a concentration of 1 to 5 mg/ml and having a pH of 4.5 to 6, the oxaliplatinum content in the preparation being at least 95% of the initial content and the solution remaining clear, colorless and free of precipitate after storage for a pharmaceutically acceptable duration of time” (the invention according to this claim is hereinafter referred to as “the subject invention”).

2. Judgment made by Court

Article 68-2 of the Patent Law stipulates that the effects of an extended patent right shall not extend to acts other than the working of the patented invention concerned in respect of the product that was the subject of the disposition that constitutes the reason for the registration of the extension of the term of the patent right (in the case where a specific use of such product is prescribed in the disposition concerned, the product put to such specific use) (hereinafter “the product that was the subject of the disposition” and “the product put to such specific use,” which are prescribed in Article 68-2, are collectively referred to as “the product (put to such specific use)”).

The Tokyo District Court rejected Debiopharm’s claim, by making the following decision on whether the defendant’s product falls under the category of “the product (put to such specific use)” that was the subject of the subject disposition.

In principle, the effect of an extended patent right extends only to acts of working on“the product (put to such specific use),” which product could not be worked because of the need to obtain the disposition.

There may be a case where a would-be infringing product has a difference from “the product (put to such specific use)” that was the subject of the disposition. However, even in such a case, if the would-be infringing product is an equivalent of “the product (put to such specific use)” that was the subject of the subject disposition or a product that is evaluated to be substantially identical to “the product (put to such specific use)”  (hereinafter referred to as “a substantially identical product”) for such reasons that at the point in time when preparation for the manufacture, sales, etc. of the would-be infringing product commenced (in the case where a disposition prescribed by Cabinet Order is required for the manufacture, sales, etc. of the would-be-infringing product, said point in time is interpreted to be when testing necessary for obtaining the disposition commenced), the difference was recognized to be the addition, deletion, conversion, etc. of a well-known technique or a commonly used technique and not to exert any new effects in light of the type or target of the patented invention under the patent right whose term has been extended, it is reasonable to maintain that the effects of the extended patent right extend to acts of working on such an equivalent or substantially identical product.

“Elplat^® I.V. Infusion Solution,” which was the subject of the subject disposition is a preparation containing only oxaliplatin and water for injection, and no other ingredients. The defendant’s product contains concentrated glycerin and differs from “the product (put to such specific use)” in terms of ingredients. Hence, the defendant’s product cannot be recognized as “the product (put to such specific use)” that was the subject of the subject disposition.

A review is made of the type or target of the subject invention. The subject invention relates to “pharmaceutically stable oxaliplatinum preparation,” and oxaliplatinum (oxaliplatin) was a known substance before the priority date of the subject invention, and using this substance as an active ingredient in anticancer drugs was also known; hence, the subject invention is not an invention whose characterizing part consists solely of the active ingredient of the pharmaceutical product, but an invention in which the entire ingredients of the pharmaceutical product make up the characterizing part. At the commencement of the testing of the defendant’s product necessary for obtaining the disposition as the approval for the pharmaceutical product, there was not sufficient evidence to establish that adding concentrated glycerin was merely the addition, etc. of a well-known or commonly used technique; and rather, it is more reasonable to consider that the glycerin added to the aqueous oxaliplatin solution exerts a new effect for inhibiting the natural decomposition of oxaliplatin. Thus, the defendant’s product does not correspond to an equivalent or substantially identical product with respect to “the product (put to such specific use)” that was the subject of the subject disposition.

In view of the foregoing, the defendant’s product is not “the product (put to such specific use)” that was the subject of the subject disposition, nor is it recognized to fall under the category of an equivalent or substantially identical product with respect to the product (put to such specific use) that was the subject of the subject disposition. Consequently, the effects of the subject patent right of which the term has been extended do not extend to the manufacture, etc. of the defendant’s product by the defendant.