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Tokyo District Court Case Summary:2015 (Wa) 12414:

Effect of the extended patent right was determined for the first time in the extended patent infringement case.

March 30, 2016, Tokyo District Court determined the scope of an extended patent right in a patent infringement case. Additionally, the court explained the practical criteria to determine the scope of the extended patent right.

<Outline of this case>
The plaintiff, Debiopharm International SA, has a patent of the invention titled “Pharmaceutically stable oxaliplatinum preparation”. The patent term was extended based on the approval of “ELPLAT intravenous infusion solution” (oxaliplatin, equal to oxaliplatinum) under the Pharmaceutical Affairs Law.

The defendant, Towa Pharmaceutical Co, Ltd, manufactured and sold generic medicines of ELPLAT. Debiopharm asserted that the scope of the extended patent right covers Towa’s products (generic medicines), and demanded the injunction of those products.

<Claimed invention and the generic medicines>
Claimed invention of this patent is “Pharmaceutically stable oxaliplatinum preparation for parenteral administration; comprising of an aqueous solution of oxaliplatinum, in a concentration of 1 to 5 mg/ml, with a pH in the range of 4.5 to 6, having the oxaliplatimum at the volume of at least 95% of the initial content after the preservation for the pharmaceutically available period, and still making the solution transparent, colorless and deposition-free.”

Towa’s products are identical to ELPLAT with regard to efficacy/effect and dosage/administration. However, the ingredients are different in that “concentrated glycerol” was included in Towa’s products as additives.

[Oxaliplatin] (source: PMDA website)

<Decision of Tokyo District Court>
1. The scope of the extended patent right
The scope of the extended patent right only covers the working of “the product [used for that usage]”, and it does not reach the working of the patented products other than “the product [used for that usage]” as a general rule.

However, it is not appropriate that the scope of the extended patent right does not reach the product which is only a little bit different from “the product [used for that usage]”.

Therefore, it is reasonable that the scope of the extended patent right covers the working of such a product as the equivalent or substantially identical product of “the product [used for that usage]” where the difference is addition, deletion, conversion, etc., of well-known arts or commonly used arts which does not cause any new effects.

2. The disposition of an approval for a medicine
The disposition of the approval for medicines based on the Pharmaceutical and Medical Device Act corresponds to “where the specific usage of the product is prescribed by the disposition” in the bracket of Article 68-2 in Patent Act (see attachment). Therefore, it is necessary to identify “product” and “usage” for determining the effect of the extended patent right of medicines.

In the case of a patented invention related to ingredients of a medicine, the scope of the extended patent right reaches the working of the patented invention identified by “ingredient (not limited to active ingredient) and quantity” as “product” and identified by “efficacy/effect” and “dosage/administration” as “usage”. (It also reaches the working of such a product as the equivalent or substantially identical product of “the product [used for that usage]”, as is mentioned before.)

[Note] In 2014 (November), the name of “Pharmaceutical Affairs Law” changed to “Pharmaceutical and Medical Device Act” which stipulates the disposition of the approval for medicines.

3. The equivalent or substantially identical product
If the characteristic part of the invention is only the active ingredient of the medicine such as an invention related to a novel compound or a medicinal use of a specific compound, the product that only differs in the ingredients other than the active ingredient and has bioequivalence, not infrequently, corresponds to the equivalent or substantially identical product of “the product used for that usage” because that difference of the ingredients tend to be addition, deletion, conversion, etc., of well-known arts or commonly used arts which does not cause any new effects.

On the other hand, if the characteristic part of the invention is the whole ingredient of the medicine such as an invention related to the preparation, the product which only differs in the ingredients other than the active ingredient and has bioequivalence does not often correspond to the equivalent or substantially identical product because that difference tend not to be addition, deletion, conversion, etc., of well-known arts or commonly used arts which causes new effects.

4. Application to this case
Towa’s products differ from “the product used for that usage” because Towa’s products includes “concentrated glycerin” other than “oxaliplatin” and “water”.

There is no evidence that adding “concentrated glycerin” is addition, deletion, conversion, etc., of well-known arts or commonly used arts. On the other hand, “Concentrated glycerin” causes a new effect to inhibit the natural degradation of oxaliplatin.

Consequently, Towa’s products do not correspond to the equivalent or substantially identical product of “the product used for that usage”. Then, the scope of the extended patent right (Debiopharm’s patent) cannot reach Towa’s products, and there is no infringement.

<Comments>
This is the first case which determined the scope of a patent during its extended patent term in a patent infringement case.

According to this judgement, the scope of the extended patent right reaches the equivalent or substantially identical product of “the product used for that usage”. Then, this judgement indicated “addition, deletion, conversion, etc., of well-known arts or commonly used arts which does not cause any new effects” as the equivalent or substantially identical product.

Moreover, this judgement indicated two different types. First type is that the characteristic part of the invention is only the active ingredient of the medicine, and the second type is that the characteristic part is the whole ingredient of the medicine. In this judgement, the equivalent or substantially identical product seems to be interpreted more widely in the first type than in the second type.

It is necessary for generic companies to interpret the scope of the extended patent right in consideration of this judgement, and then the infringement of the extended patent right will be avoided effectively. In addition, it is also necessary to watch the further discussion in the appeal hearing (IP High Court) of this case.

The accumulation of the precedents is necessary to foresee the future direction. The future cases related to the infringement based on the extended patent right should be carefully checked.

http://www.courts.go.jp/app/files/hanrei_jp/838/085838_hanrei.pdf

(Hiroshi KATO)

Note

Patent Act

Provisions related to the extension of the duration of patent rights

Article 67 (Duration of the patent rights)
(1) The duration of a patent right shall expire after a period of 20 years from the filing date of the patent application.
(2) Where there is a period during which the patented invention is unable to be worked because approvals prescribed by relevant Acts that are intended to ensure the safely, etc. or any other disposition designated by Cabinet Order as requiring considerable time for the proper execution of the disposition in light of the purpose, procedures, etc., of such a disposition is necessary to obtain for the working of the patented invention, the duration of the patent right may be extended, upon the filing of a request for the registration of extension of the duration, by a period not exceeding 5 years.
 

Article 68 (Effect of the patent rights)
A patentee shall have the exclusive right to work the patented invention as a business; provided, however, that where an exclusive license regarding the patent right is granted to a licensee, this shall not apply to the extent that the exclusive licensee is licensed to exclusively work the patented invention.

Article 68-2 (Effect of the extended patent rights)
Where the duration of a patent right is extended (including the case where the duration is deemed to have been extended under Article 67-2(5)), such patent right shall not be effective against any act other than the working of the patented invention for the product which was the subject of the disposition designated by Cabinet Order under Article 67(2) which constituted the reason for the registration of extension (where the specific usage of the product is prescribed by the disposition, the product used for that usage).