Background
The plaintiff (patent owner) in the lower court requested an injunction against infringement by the defendant, who was selling a generic pharmaceutical product. The original decision (Tokyo District Court, 2015 (Wa) No. 12414) denied the plaintiff's request, on the basis that the effective scope of the extended patent right did not encompass the defendant's product. The plaintiff did not accept the decision and filed an appeal.
 

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Invention of the Patent at Issue
Patent No. 3547755
Title of Invention: Pharmaceutically Stable Preparation of Oxaliplatinum
Claim 1: A pharmaceutically stable preparation of oxaliplatinum for administration by the parenteral route, consisting of an aqueous solution of oxaliplatinum at a concentration of 1 to 5 mg/ml and having a pH of 4.5 to 6, and after storage for a pharmaceutically acceptable duration of time, with the oxaliplatinum content in the preparation being at least 95% of the initial content and the solution remaining clear, colorless and free of any precipitate.

The JPO had granted the patent owner an extension of the term of the patent right in the patent at issue.
 

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Main Points of Conflict
The parties disagreed as to whether the effective scope of the extended patent right encompassed the manufacture, marketing and sale of the defendant's product. The efficacy and effect, usage, and dosage of the plaintiff's original product (Elplat® intravenous drip solution) were identical to those of the defendant's generic product. However, the defendant's product included concentrated glycerin as an additive (stabilizer), whereas the plaintiff's product did not.

Given this difference, the primary dispute was whether the defendant's product could be deemed substantially identical to the effective scope of the extended patent right, and whether the defendant's actions of manufacturing and the like constituted infringement, as a result.

Article 68bis of the Patent Law stipulates:

The effects of the patent right of which the term has been extended ... 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 ... .

Accordingly, "the effective scope of the extended patent right" here refers to the scope, determined by the "product" and "use" subject to the disposition designated by Cabinet Order (regulatory allowance), that was the reason for the registration of an extension of term.
 
 

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Decision of the Grand Panel
The IP High Court Grand Panel upheld the lower court decision, ruling that the effects of the extended patent right did not extend to the defendant's product. The following aspects of the court's decision were particularly important.

(1) Basic principles regarding the effects of an extended patent right
The decision of the Supreme Court of Japan in Case No. 2014 (Gyo-Hi) 356 (the "Avastin Case") held that matters to be examined, which would directly affect the substantial identity of relevant products as pharmaceutical products, are "ingredients, quantity, administration, dosage, efficacy and effect". In view of this, the Grand Panel ruled that, in the case of a patent pertaining to the ingredients of a pharmaceutical product, the effective scope extends to the working of the patented invention as regards the "product" defined by the specific "ingredients, quantity, administration and dosage, and efficacy and effect" stipulated by the disposition designated by Cabinet Order.

In addition, the Grand Panel also stated that the above-noted "ingredients" are not limited to active ingredients of a pharmaceutical product, since ingredients subject to examination and necessary for approval are not limited to active ingredients.

(2) Cases in which it can be said that there is substantial identity with a product that is the subject of a disposition designated by Cabinet Order as a pharmaceutical product
The decision stated that substantial identity would be recognized in the following cases.

1. For a patent having an extended patent term, which is only characterized by an active ingredient of a pharmaceutical product, a target (allegedly infringing) product will be considered substantially identical if it includes some different ingredients that are not the active ingredient and that are added or substituted based on techniques that were well known or commonly practiced at the time of application for the disposition.

2. For a patent related to the stability, formulation or the like of a pharmaceutical product having a known active ingredient, a target product will be considered substantially identical if it includes some different ingredients that are added or substituted based on techniques that were well known or commonly practiced at the time of application for the disposition, and, in view of the content of the patented invention, both products are deemed identical in terms of technical characteristics and functions and effects.

3. For cases in which the "quantity" or the "administration and dosage" specified by the disposition merely differ in quantitative terms to an insignificant degree, the target product will be considered substantially identical.

4. For cases in which the "quantity" specified by the disposition is different, but the products can be deemed identical in consideration of the "administration and dosage", the target product will be considered substantially identical.

(3) Are the five conditions for equivalence applied to the scope of the effects of the patent right that is based on the registration of extension of term?
Analogous application of the Doctrine of Equivalents is denied on the basis that if the five conditions for equivalence were to be applied "as is", the effective scope would be disproportionately broad.

In consideration of the patent specification and the prosecution history, and the fact that one of the means for solving the problem addressed by the patented invention was the feature whereby "the aqueous solution does not include acidic or alkaline pharmaceuticals, buffering agents or other additives", the court construed the phrase "consisting of an aqueous solution of oxaliplatinum" in claim 1 to mean "an aqueous solution consisting only of oxaliplatinum and water and not including other ingredients such as additives". On this basis, the Grand Panel ruled that the defendant's product, which includes concentrated glycerin, was not substantially identical to the claimed invention and was not within the effective scope of the extended patent right. In fact, the Grand Panel found that the defendant's product did not fall within the technical scope of the patented invention to begin with.
 

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Comments
In the earlier Avastin Case that ruled on the conditions for extension and registration, the IP Grand Panel deliberated the issue of the effects of a patent right that had been granted registration of extension of term, but the Supreme Court made no ruling in this regard. (The Grand Panel for the Avastin Case stated that "in the case of a patented invention of an ingredient of a medicine, it is reasonable to conclude that the patent right whose duration was extended pursuant to Article 68-2 of the Patent Act is effective for the scope of the working of the patented invention that is identified by 'ingredient (not limited to active ingredient)' as an invention pertaining to a 'product' and is also identified by 'effectiveness and efficacy' and 'dosage and administration' as an invention pertaining to a 'usage'".)

In the present decision, we believe it is significant that certain criteria were provided for the effective scope of an extended patent right, including criteria for the scope of substantial identity.

Further, while the present decision specifies "quantity" as a factor limiting the effective scope of an extended patent right, we believe this will be judged in relation to the above-described third case in which substantial identity is recognized.

The plaintiff asserted that the criteria for determining the scope of substantial identity depend on whether or not the generic product has obtained approval, having done so by relying wholly on the accomplishments according to the disposition granted to the original pharmaceutical product and without performing the experimentation and the like stipulated by law, and that it is a mistake to consider the matter in view of a normal understanding of technical scope. However, the decision clearly repudiates the plaintiff's assertions, stating that substantial identity is a concept that demarcates the effective scope of the patent right. It is not a concept that directly extends the effective scope of the patent right to a generic product that has an equivalent quality to, and relies on, the original drug, since the concept is not based on the drug approval system. In other words, what is protected by the Patent Law is the technical concept of an invention, and this technical concept does not depend on efficacy or similar factors that are pertinent to a pharmaceutical product approval examination. Thus, we believe the decision to be significant in terms of the ruling that the effective scope should be determined by assessing the technical characteristics and actions/effects based on the content of the patented invention, rather than by relying on the active ingredients or therapeutic effects of the pharmaceutical product.

Text of the Decision (Japanese)
　http://www.ip.courts.go.jp/hanrei/g_panel/index.html

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Summary prepared by International Information Group
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