2017 <Special News Flash>｜News Letter

IPHC Rules Scope of Extended Patent Right Covers Only Same or Substantially Same Drug as Approved One

Debiopharm International S.A. v. Towa Pharmaceutical Co., Ltd., Case No. 2016 (Ne) 10046 (Decision rendered on January 20, 2017)

The Grand Panel¹⁾ of the IPHC (Chief Judge, Ryuichi Shitara) decided that the Debiopharm’s extended patent right relating to a pharmaceutically stable preparation containing a solution of oxaliplatinum in water did not cover the accused generic drug prepared and sold by Towa, one of the biggest generic drug manufactures in Japan, on the grounds that the scope of the extended patent right covered only the same or substantially the same drug as the approved drug, while the Towa’s accused drug was not substantially the same drug since it additionally contained concentrated glycerin, which was not contained in the approved drug. This is the first case where the IPHC construed the scope of an extended patent right.

Claim 1 of the Debiopharm’s patent at issue claims as follows:
A pharmaceutically stable preparation of oxaliplatinum for parenteral administration, said preparation being composed 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.

Regarding the scope of the extended patent right, the Japanese Patent Law stipulates a provision in Article 68^bis as below:
Where the duration of a patent right is extended (…), 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).

In this infringement case, the IPHC first reviewed Article 68^bis in detail and generally ruled that the “product” and the “usage” in Article 68^bis should be specified by “ingredient, quantity, dosage, administration, indication and effect” defined in the disposition on the basis of the leading Supreme Court Decision on an examination of an application for patent term extension (PTE) [Case No. 2014 (Gyo-Hi) 356 (Decision rendered on November 17, 2015)], thus the scope of the extended patent right covered the working of the product specified by the “ingredient, quantity, dosage, administration, indication and effect” defined in the disposition.
Further, the IPHC ruled that, if it was possible to escape from an enforcement by the patentee when the accused drug did not formally match up precisely with all of the “ingredient, quantity, dosage, administration, indication and effect” defined in the disposition, it would be against the spirit of the PTE system and the principle of equity, thus the scope of the extended patent right covered not only the drug specified by the “ingredient, quantity, dosage, administration, indication and effect” defined in the disposition, but also substantially the same drug including the drug having only a slight difference or a formal difference on the whole, and third parties should expect it.

Regarding “a slight difference or a formal difference on the whole”, the IPHC construed that whether the difference between the product specified by the “ingredient, quantity, dosage, administration, indication and effect” defined in the disposition and the accused drug fell into “a slight difference or a formal difference on the whole” should be judged by comparing the technical feature(s) and the operation and effect of the drug specified by the “ingredient, quantity, dosage, administration, indication and effect” defined in the disposition with those of the accused drug on the basis of the content of the patented invention in light of common technical knowledge of those skilled in the art.

The IPHC provides 4 types of cases regarding “a slight difference or a formal difference on the whole” as below:
(1) In a patented invention of a drug characterized only by its specific active ingredient(s), a case where any ingredient other than the active ingredient(s) is added to or changed in the accused drug on the basis of well-known technique at the filing of the approval for the accused drug;
(2) In a patented invention relating to stability or dosage form of a drug containing publicly-known active ingredient, a case where any different ingredient is added to or changed in the accused drug on the basis of well-known technique at the filing of the approval for the accused drug, and when it is possible to recognize that technical feature(s) and the operation and effect are the same between both drugs in view of the content of the patented invention;
(3) A case where there is only a meaningless difference in numerical quantity in “quantity” or “dosage, administration” defined in the disposition; and
(4) Although “quantity” defined in the disposition is different, a case where it is possible to recognize that both drugs are the same, when taking into consideration “dosage, administration”, as well.

On the basis of the above rulings and construction, the Grand Panel decided (i) that the approved drug contained only oxaliplatin and water for injection, while the accused drug contained concentrated glycerin as an additive for a stabilizer in the same amount of oxaliplatin, thus (ii) that they were literally different from each other, and (iii) that, according to the description of the specification of the patented invention, the object of the patented invention was to obtain a solution of oxaliplatinum in water having a chemical purity and a treatment activity similar to freeze-dried oxaliplatinum, which corresponded to the above type (2), and the specification disclosed that “this preparation does not contain other ingredients, and impurities beyond about 2% must not be contained, in principle”, thus (iv) that it was one of the technical features that no additive was contained, and accordingly (v) that the above difference did not fall into “substantially the same” drug.

Conclusively, the IPHC dismissed the Debiopharm’s appeal and upheld the decision rendered by the 1st instance, i.e. the Tokyo District Court.

The lost party, Debiopharm is entitled to bring the case to the Supreme Court within 44 days (including 30 days as an additional period for foreign entities) after the mailing date of the decision, and thus the decision is NOT final and binding to date.

1) Grand Panel: Grand Panel is convened to hear cases where it is necessary to virtually unify court decisions, or cases involving important issues, which is somewhat similar to en banc in CAFC of the U.S.A. Since the founding of the IPHC in 2005, 11 cases including the above case have been heard.

K&P’s CommentsAs shown above, the Grand Panel construes the scope of the extended patent right very narrowly. Accordingly, it is quite advisable for patentees of pharmaceutical or agrochemical companies to consider filing applications for PTE every time they or their licensee obtain a market approval from the authority in Japan.