Judgment made by the grand panel of the Intellectual Property High Court concerning the effects of a patent right whose term has been extended

Japan Patent Information Committee
NAKAHAMA, AKIKO(Ms.) Patent Attorney

Heisei 28 (2016), “Ne” No. 10046,
An appeal case seeking an injunction against infringement of a patent right
(Original instance: Heisei 27 (2015), “Wa” No. 12414 by the Tokyo District Court)
-Oxaliplatin Case-, the judgment rendered on: January 20, 2017

In the subject case, a grand panel of the Intellectual Property High Court rendered a judgment about the scope of the effects of a patent right after the term of the patent right is extended (Article 68-2 of the Japanese patent law) in an infringement suit.

1. Summary

Debiopharm International S.A. (the appellant, the first trial plaintiff) is the holder of Patent No. 3547755 titled “Pharmaceutically Stable Oxaliplatinum Preparation” (the subject patent), and the extension of the term of the subject patent right was registered by reason of dispositions based on the approval for “Elplat^® Drip Infusion,” an oxaliplatin (synonymous with oxaliplatinum) preparation, in accordance with Article 14 of the Pharmaceutical Affairs Act (which dispositions are hereinafter referred to as “the subject dispositions”). Towa Pharmaceutical Co., Ltd. (the appellee, the first trial defendant) manufactures and sells “Oxaliplatin Intravenous Infusion,” a generic medicine of Elplat^® Drip Infusion, which contains concentrated glycerin added as a stabilizer. The indications as well as dosage and administration of the generic medicine are the same as those of “Elplat^® Drip Infusion.”

Asserting that the formulations of “Oxaliplatin Intravenous Infusion” (the products of the first trial defendant) belong to the technical scope of the invention according to Claim 1 in the Claims of the subject patent (the subject invention) and that the effects of the subject patent right for which the extension of the term is registered should extend to the manufacture, etc. of the products of the first trial defendant as carried out by the first trial defendant, the first trial plaintiff filed the injunction demanding cessation of the manufacture, etc. and the destruction of the products of the first trial defendant.

In the first trial, the scope of the effects of the subject patent right whose term had been extended, i.e. whether or not the effects of the subject patent right extend to the manufacture, etc. of the products of the first trial defendant, was disputed. The original judgment dismissed the first trial plaintiff’s claim, holding that such effects should not extend to the products of the first trial defendant, and, being dissatisfied with this judgment, the first trial plaintiff filed an appeal in the Intellectual Property High Court.

Based on the original judgment, the Intellectual Property High Court Judgment in the subject case provided a more detailed explanation of the interpretation of “substantially identical” with regard to the effects of an extended patent right (Article 68-2 of the Japanese patent law) and held that the products of the first trial defendant are not regarded as being substantially identical to the product that was subjected to the subject dispositions. Furthermore, the technical scope of the subject invention was determined from the Claims and the specification as well as the prosecution history, and it was also held that the products of the first trial defendant do not belong to the technical scope of the subject invention. Consequently, the Intellectual Property High Court dismissed the subject appeal.

The Intellectual Property High Court judgment included an additional remark, stating to the effect that although the judgment regarding the effects of the extended patent right preceded those regarding the other issues in the subject case, this occurred simply as a result of taking into account the condition and contents of the subject case, and “normally, a court should also consider making a judgment first as to whether or not a product of an opposing party belongs to the technical scope of the patented invention.”

2. The subject invention

Claim 1 of the subject patent reads as follows:
“A pharmaceutically stable preparation of oxaliplatinum for administration by the parenteral route, consisting of a 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.”

3. Judgment made by the Court

Based on the explanations made about the scope of the effects of an extended patent right, the Court held that the effects of the subject patent right for which an extension of the term had been registered do not extend to the products of the first trial defendant of the subject case.

(1) The scope of the effects of an extended patent right based on Article 68-2 of the Japanese patent law

Article 68-2 of the Japanese patent law stipulates that “the effects of the patent right whose term has been extended (including cases in which the term is deemed to be extended under Article 67-2, item 5) shall not extend to acts other than the working of the patented invention concerned in respect of the product (where, in the disposition concerned, any specific use of such product to be used was specified, the product used for such specific use) which was the subject of the disposition as provided for in Cabinet Order referred to in Article 67, Par. 2 and as being the ground for the registration of the extension.”

First, with regard to the effects of an extended patent right based on Article 68-2 of the Japanese patent law, the subject judgment contained the following explanations.

–   In the case of a patented invention of a product which is directed to an ingredient of a pharmaceutical product, the patent right whose term has been extended shall only extend its effects to the scope of “the working of the patented invention” as regards “the product” that is specified by “ingredient (not limited to an active ingredient), quantity, dosage, administration, and indications” as stipulated by a specific disposition under Cabinet Order.
–   However, from the viewpoint of the spirit of the system of registration of extension of term as well as the principle of equity, the effects of interest should extend to a product that is substantially identical as a pharmaceutical product to the product specified by the above-noted elements.
–   Therefore, even in the case where the constitution stipulated by the disposition under Cabinet Order involves a part that provides a difference from the product manufactured by the opposing party (the allegedly infringing product), if the part provides no more than a slight difference or a pro forma difference in view of the product in its entirety, the allegedly infringing product is encompassed by a product that is substantially identical as a pharmaceutical product to the product that was the subject of the disposition under Cabinet Order and it belongs to the scope of the effects of the patent right whose term has been extended.

Further, regarding the judgment as to whether or not the difference is “a slight difference or a pro forma difference in view of the product in its entirety,” the following explanation was provided.

–   In a patented invention of a product that is directed to an ingredient of a pharmaceutical product, and considering a limited case in which there is one difference or more concerning “ingredient” stipulated by the disposition under Cabinet Order, concerning a quantitative difference in “quantity” stipulated by the disposition under Cabinet Order and concerning a quantitative difference in “dosage and administration” stipulated by the disposition under Cabinet Order, with no other differences existing, a judgment as to whether or not the difference is a slight difference or a pro forma difference in view of the product in its entirety should be made on the basis of the contents of the patented invention by making a comparative review, in relation to those contents, of the identity in terms of technical features and advantageous actions/effects between the “product” specified by “ingredient, quantity, dosage, administration, and indications” as stipulated by the disposition under Cabinet Order and the allegedly infringing product, and by also taking into account the common technical knowledge of those skilled in the art.
–   Regarding the foregoing limited case, typical examples in which the allegedly infringing product is encompassed by a product that is substantially identical as a pharmaceutical product to “the product” specified by “ingredient, quantity, dosage, administration, and indications” as stipulated by the disposition under Cabinet Order include the following.

(i) In comparison with a patented invention that has been registered for term extension and that relates to a patented invention characterized solely by an active ingredient of a pharmaceutical product, the allegedly infringing product is such that, regarding an “ingredient” other than the active ingredient, an ingredient that provides partial difference is added, converted, or otherwise dealt with on the basis of well-known or commonly used techniques at the time of requesting the disposition under Cabinet Order;
(ii) In comparison with a patented invention that relates to the stability, dosage form, etc. of a pharmaceutical product comprising a known active ingredient, the allegedly infringing product is such that an ingredient that provides partial difference is added, converted or otherwise dealt with on the basis of well-known and commonly used techniques at the time of requesting the disposition designated by the Cabinet Order, provided that, in view of the contents of the patented invention, identity is recognized to exist between the two entities in terms of their technical features and advantageous actions/effects;
(iii) Regarding “quantity” or “dosage and administration” that are specified by the disposition under Cabinet Order, any difference is quantitatively insignificant; and
(iv) The “quantity” specified by the disposition under Cabinet Order is different, but taken together with “dosage” and “administration,” is recognized to be identical;
these differences fall under the category of “a slight difference or a pro forma difference in view of the product in its entirety” as set forth above and the allegedly infringing product is encompassed by a product that is substantially identical as a pharmaceutical product to the product that was the subject of the disposition under Cabinet Order:

Furthermore, the following criterion for judgment was provided: in the case of determining the scope of “substantially identical” with regard to Article 68-2 of the Japanese patent law, it is impossible to apply or apply by analogy the doctrine of equivalents (the Supreme Court’s Judgment concerning Ball Spline Case). However, based on the general concept of estoppel, the allegedly infringing product is not recognized to be “substantially identical” with regard to Article 68-2 of the Japanese patent law if there is a special circumstance, such as intentional exclusion from the scope of the effects of a patent right registered for term extension in the examination procedure of application for the registration of term extension.

According to another explanation provided by the Intellectual Property High Court, to confirm an infringement of a patent right whose term has been extended, it is required as a matter of course to assert and verify the fact that the allegedly infringing product belongs to the technical scope of the patented invention.

(2) Review of the subject case

A. Whether or not the products of the first trial defendant are identical to the product that was subjected to the subject dispositions

The “ingredient” of “Elplat^® Drip Infusion” which was subjected to the subject dispositions comprises only oxaliplatin and water for injection and does not contain any other ingredients.

On the other hand, the “ingredient” of the products of the first trial defendant comprisesot only oxaliplatin and water for injection but also concentrated glycerine as an additive in an amount equivalent to that of oxaliplatin, and the intended use of the concentrated glycerine is as a stabilizer.

It then follows that the product that was subjected to the subject dispositions and the products of the first trial defendant are at least literally different in terms of their “ingredient.”

B. Whether or not the products of the first trial defendant are encompassed by a product that is substantially identical to the product that was subjected to the subject dispositions

In view of the technical features of the subject invention (which falls under the category of a patented invention of the above-noted typical example (ii)), the aforementioned difference in “ingredient” between the product that was subjected to the subject dispositions and the products of the first trial defendant can be regarded neither as a slight difference nor as a pro forma difference in view of the product in its entirety, so it cannot be argued that the products of the first trial defendant are encompassed by a product that is substantially identical to the product that was the subjected to the subject dispositions.

Consequently, even without the need to review the identity in advantageous actions/effects and other points, it cannot be argued that the products of the first trial defendant belong to the scope of the effects of the subject patent right registered for term extension, as something that is substantially identical to the working of the subject invention of “the product” that was specified by “ingredient, quantity, dosage, administration, and indications” and was subjected to the subject dispositions.

C. Whether or not the products of the first trial defendant belong in technical scope

If the description of the subject specification and the description in the Written Argument that was submitted during the examination procedure of the application are taken into account as a whole, the wording of “consists of the aqueous solution of oxaliplatinum” in the Claims of the subject invention can only be interpreted to mean that the present invention is an aqueous solution consisting of oxaliplatinum and water only, containing no other ingredients such as additives.

On the other hand, the products of the first trial defendant contain not only oxaliplatin and water for injection but also concentrated glycerin in an amount equivalent to that of oxaliplatin as an ingredient other than the active ingredient and, hence, do not belong to the technical scope of the subject invention.

It should be noted here that regarding the effects of a patent right after an extension of the term, there are at least three judgments made by a district court, including the original decision of the subject case. Each of these judgments concerns an infringement lawsuit based on the same patent right as that of the subject case, in which the patentee of the subject case is the plaintiff.

The original decision of the subject case (defendant: Towa Pharmaceutical Co., Ltd.)

Heisei 27 (2015) (Wa) No. 12415 by the Tokyo District Court (defendant: Hosipira Japan Co., Ltd.)

Heisei 27 (2015) (Wa) No. 12412 by the Tokyo District Court (defendant: Teva Takeda Pharma Ltd.)