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SUPREME COURT DECISION: Heisei-21-(Gyo-Hi)-326
summary:
Supreme Court ruled that the JPO should not reject a patent term extension application of a patent to a new formulation just because a marketing approval to a different formulation containing the same active ingredient has already been issued.
* Full translation of Takeda Case

Decision of Supreme Court of Japan,
Heisei-21-(Gyo-Hi)-326

Decided on April 28, 2011 by Supreme Court of Japan, The First Petty Bench
(Final Appeal against the decision of IP High Court, Heisei-20-(Gyo-Ke)-10460, decided on May 29, 2009)

Appellant: Commissioner, Japan Patent Office

Respondent: Takeda Chemical Industries, Ltd.

Principle Text of Judgment:
 The appeal is dismissed.  The costs of appeal procedure shall be borne by the appellant.

Reasons:
 The attorneys of the appellant, Noriaki SUDOU et al. show the following reasons for appealing.

1.  This is a case of the request by the patentee (the respondent in the final appeal) of Japanese Patent 3,134,187 (hereinafter referred to as “the present patent”) to revoke the decision of the Trial Board, JPO that the application for a patent term extension of the present patent shall be rejected.

2.  The facts etc. confirmed in the original decision are in brief as follows.
  (1)  The present patent application (number of claims: 22), title of the invention: Sustained Release Preparation, was filed on March 6, 1997 and was granted on December 1, 2000.
 The patented invention is concerned with a sustained release preparation which comprises coating a drug-containing core with a coating agent comprising a water-insoluble substance, a certain hydrophilic substance and a certain crosslinkable acrylic polymer.
  (2)  The respondent in this final appeal has obtained on September 30, 2005 an approval for manufacturing and selling of a drug in the tradename “Pacif Capsule 30 mg” (hereinafter referred to as “the present drug”) under the Pharmaceutical Affairs Law, Article 14, Item 1 (hereinafter referred to as “the present disposition”).  The present drug comprises as an active ingredient morphine hydrochloride and has efficacies/effects of analgesic activity for various cancers accompanying with meddle to high degrees of pain.
  (3)  Before the present disposition, an approval of a drug had been granted for a drug in the tradename “Opso Internal Medicine 5 mg・10 mg” (hereinafter referred to as “the preceding drug”) comprising the same active ingredient and having the same efficacies/effects as those of the present drug under the Pharmaceutical Affairs Law, Article 14, Item 1 (hereinafter referred to as “the preceding disposition”). The preceding drug is not inclusive within the scope of any of the claims of the patented invention.   
  (4)  The respondent of the final appeal has filed on December 16, 2005 an application for a patent term extension of the present patent because there was a period of time during which the patented invention could not be worked in view of necessity of obtaining the present disposition, but since the application was rejected, he appealed to the Trial Board, JPO against the decision of rejection.    
  (5)  On October 21, 2008, the Trial Board, JPO has decided to reject the appeal of the applicant because the preceding disposition has been obtained as to the preceding drug which comprised the same active ingredient and had the same efficacies・effects as those of the present drug and hence there was no necessity of obtaining the present disposition in order to practice the patented invention. (hereinafter, referred to as “the trial decision of the JPO”)

3.  Even where an approval for manufacturing and selling under the Pharmaceutical Affairs Law, Article 14 (hereinafter, referred to as “the preceding disposition) has previously been obtained with respect to a drug (hereinafter, referred to as “the preceding drug”) comprising the same active ingredient and having the same efficacies/effects as those of the drug (hereinafter, referred to as “the later drug”), of which the approval of manufacturing and selling under said law, Article 14 (hereinafter, referred to as “the later disposition) was obtained, when the preceding drug is not inclusive within the scope of any of the claims of the patented invention of the present patent for which an application for a patent term extension was filed, it can not be said that there was no necessity of obtaining the later disposition in order to work the patented invention.

 The reason is that the patent term extension system is provided for the purpose of recovering the period of time during which the patented invention can not be worked because of necessity of obtaining the disposition under Patent Law, Article 67, Item 2.  However, in the instant case, even though the preceding drug comprising the same active ingredient and having the same efficacies/effects as those of the later drug has been granted, it could not be said that it would be able to work the patented invention as to the later drug, any invention as claimed in any one of claims of said patent, because the preceding drug is not inclusive within the scope of any one of claims of said patent, for which an application for a patent term extension was filed.  Besides, this conclusion shall not be changed by how to interpret the effects of the patent right of which the term has been extended (as defined in Patent Law, Article 68bis), where the preceding drug is not inclusive within the scope of any one of claims of the patent for which an application for a patent term extension is filed.

 Since the preceding drug is not inclusive within the scope of any one of claims of the patent in question, it would not be said that the present disposition was not necessary to obtain in order to work the patented invention because of the existence of the preceding disposition.

4.  Thus, it is judged to affirm the original decision of IP High Court deciding that the trial decision of the JPO is illegal, wherein it is mentioned in said decision of IP High Court that it could not be denied the necessity of approval for manufacturing and selling the later drug under Pharmaceutical Affairs Law, Article 14, Item 1 merely by the reason of existing the preceding disposition.  Though the gist of the reasons to decide in the original decision is not acceptable.

 Accordingly, it is judged as mentioned in “Principle Text of Judgment” as above, as a unanimous decision of all of the judges.

(Chief Judge Tomoyuki YOKOTA; Judge Mitsuharu MIYAGWA; Judge Ryuko SAKURAI; Judge Seishi KANETSUKI; and Judge Isamu SHIRAKI)

By Yasuo Tamura
AOYAMA & PARTNERS