ニュース

Case Law with regard to the extension of patent term

Published on: 29 August 2014
by Kazuya SEKIGUCHI, Patent Attorney at Dennemeyer & Associates, Germany

Summary

The proprietor has a Japanese patent the terms of which have been extended on the grounds that there was a period during which the patented invention was unable to be implemented. This occurred due to difficulties in obtaining an approval for implementing a pharmaceutical product (first product) under the Pharmaceutical Affairs Law (first approval). The proprietor has obtained another approval under the Pharmaceutical Affairs Law (second approval) for a pharmaceutical product (second product) having the same active ingredient and efficacy as the first approved pharmaceutical product but with different dosage and administration.

Based on the second approval, the proprietor requested the second extension of the term to the Japanese Patent Office (JPO). Although the JPO rejected the request because of the existence of the first extension of the term, the Grand Panel of the Intellectual Property High Court (IPHC) accepted the request of the proprietor to extend the patent term based on the second approval (Grand Panel decision of 30 May 2014: 2013(Gyo-ke)10195, 2013(Gyo-ke)10196, 2013(Gyo-ke)10197, 2013(Gyo-ke)10198).

Extension of the patent term under the Japanese Patent Law

According to Article 67, paragraph 2 of Japanese Patent Law, when there is a period during which a patented invention is unable to be implemented, the term of the patent right may be extended, upon filing of an application to register a patent term extension, by a period not exceeding five years. The inability for implementation may occur in cases when it is necessary to obtain approvals or any other dispositions designated by the Cabinet Order1 under a law intended to ensure safety.

Factual Background

- Patent No: JP 3398382B, filed on 28 Oct. 1992, and granted on 14 Feb. 2003

- Proprietor: Genentech Inc.

- Title of the Invention: Vascular Endothelial Cell Growth Factor Antagonists

- Claims:

1. A composition for the treatment of cancer, comprising a therapeutically effective amount of a hVEGF antagonist which is an anti-VEGF antibody.

2-11. omitted (note: none of claims 2-11 defines the dosage of anti-VEGF antibody to be administered.)

The proprietor obtained an approval and certification in 2007, for manufacturing and selling the pharmaceutical products, under the Pharmaceutical Affairs Law with the following condition (first approval):

Drug (active ingredients): Bevacizumab (“Avastin” as product name)

Efficacy of the drug: Treatment for cancer of colon and rectum (which curative resection is impossible)

Dosage and administration of the drug: 5 mg/kg (weight) or 10 mg/kg (weight) per administration (intravenous administration). The administration interval is more than two weeks.

With regard to the first approval, the proprietor requested the extension of the patent term, and the term has been extended by about 4 years.

In addition to the first approval, the proprietor also obtained another approval and certification in 2009, for manufacturing and selling the pharmaceutical products, under the Pharmaceutical Affairs Law with the following condition (second approval):

Drug (active ingredients): Bevacizumab (“Avastin” as product name)

Efficacy of the drug: Treatment for cancer of colon and rectum (which curative resection is impossible)

Dosage and administration of the drug: 7.5 mg/kg (weight) per administration (intravenous administration). The administration interval is more than three weeks.

As can be seen, only the dosage of the active ingredient and its administration intervals of the second approval differ from those of the first approval.

There was a period during which a patented invention (whose dosage is 7.5 mg/kg (weight) per administration and whose administration interval is more than three weeks) was unable to be implemented because of obtaining the second approval. Therefore, the proprietor requested another extension of the patent term based on the second approval.

The Examining Board of the JPO rejected the request. The proprietor appealed against the Examining Board’s decision to the Board of Appeal (BoA) of the JPO. The BoA also rejected the request based on Article 67-3, paragraph (1), item (i)2.

Decision by the Board of Appeal

In the Appeal Decision, the BoA stated that:

  1. Although the pharmaceutical composition which has been approved under the Pharmaceutical Affairs Law is restricted to exactly the compositions described in the approval/certification (defined by active ingredients, efficacy, dosage and intervals, etc.), the patented invention is a technical idea defined by matters specifying the invention (technical features in claims). Therefore, the scopes defined by the approval/certificate and patented claims are different;
  2. Thus, “to implement the patent invention” in Article 67-3, paragraph 1, item (i) should not be restricted to the manufacture and/or sale of the exact pharmaceutical product which is approved/certified under the Pharmaceutical Affairs Law. It should be regarded as the manufacture and/or sale of a pharmaceutical product defined by the matters specifying the invention which overlap the features of the pharmaceutical product approved/certified;
  3. Consequently, the scope of the invention which is to be implemented by the first approval should be considered to the range defined by the matters specifying the claimed invention which overlap the features of the approved/certified pharmaceutical product.

Based on the above mentioned criteria, the BoA analysed the subject case.

The claims of the subject patent do not include the limitation of dosage and administration interval. Therefore, the matters specifying the invention which overlap the features of the approved/certified pharmaceutical product are: the composition comprising Bevacizumab which is used for the treatment of cancer of colon and rectum.

With regard to the second approval, the matters specifying the invention which overlap the features of the approved/certified pharmaceutical product are also the composition comprising Bevacizumab which is used for the treatment of cancer of colon and rectum. Therefore, the invention which was unbanned to be implemented by the second approval is regarded as the “the composition comprising Bevacizumab which is used for the treatment of cancer of colon and rectum”, without limitation of dosage and administration interval.

As a result, the scope of the pharmaceutical product which was unbanned to be implemented by the second approval is the same as that of the first product. That is, “the composition comprising Bevacizumab which is used for the treatment of cancer of colon and rectum” had already been permitted to be implemented by the first approval, and thus the BoA concluded that the second approval (the disposition designated by Cabinet Order under Article 67(2)) is not deemed to have been necessary to implement the patented invention, and the request for the second extension of the term should be rejected under Art. 67-3(1)(i).

The proprietor filed a lawsuit before the IPHC against the decision of the BoA, and the IPHC decided to review this case in Grand Panel (collegial body of five judges including four chief judges of each division of IPHC).

Decision by the Grand Panel of the IPHC

The purpose of the system to extend patent terms is to compensate for the disadvantage to the proprietor who was not able to implement the patented invention because there was a need to obtain approvals under a certain law.

Considering Article 67-3, paragraph 1, item (i), in light of mentioned purpose, it can be said that “the disposition designated by Cabinet Order under Art. 67(2) is deemed to have been necessary”, when:

  1. the implementation of the invention was unbanned by the disposition of Cabinet Order (it is impossible to judge that the first approval unbans the pharmaceutical product relating to the second approval); and
  2. the unbanned implementation of the invention includes the implementation of claimed inventions.

When obtaining an approval under the Pharmaceutical Affairs Law, “the name of the pharmaceutical, active ingredient and its structure, dosage, usage, efficacy, side effects, quality and safeness, etc.” must be examined (Art. 14(2)(iii) of Pharmaceutical Affairs Law). With the approval, only the examined pharmaceutical product (limited by its active ingredient and its structure, dosage, usage, efficacy, side effects, quality and safeness, etc.) is unbanned for its implementation, and the implementation of a broader scope (but within the scope of patented claims) cannot be unbanned. Therefore, considering the purpose of the system of extension of the patent term, the scope of the invention whose implementation is unbanned by the approval should be the same as the pharmaceutical product examined under the Pharmaceutical Affairs Law (the product defined by, in particular, active ingredient and its structure, dosage, usage, efficacy).

Therefore, the invention which could be implemented by the first approval should be regarded as:

Bevacizumab (“Avastin” as product name), having an efficacy for treating cancer of colon and rectum (which curative resection is impossible), for 5 mg/kg (weight) or 10 mg/kg (weight) per administration (intravenous administration), with administration interval of more than two weeks.

The implementation of

Bevacizumab (“Avastin” as product name), having the same efficacy for 7.5 mg/kg (weight) per administration (intravenous administration), with administration interval of more than three weeks

cannot be regarded to have been unbanned for its implementation by the first approval.

Consequently, the second product has not been unbanned for its implementation by the first approval, and thus the second approval was necessary to implement the second product. The decision by the BoA, which concluded that the second approval was not necessary to implement the second product, could not be justified and thus it was overturned.

 


1 The following dispositions are designated by the Cabinet Order:
- The registration of agricultural chemicals under the Agricultural Chemicals Regulation Law
- The approval and certification of drug products under the Pharmaceutical Affairs Law

2 Article 67-3, paragraph 1, item (i) of Japanese Patent Law:
“(1) Where an application for the registration of extension of the duration of a patent right falls under any of the following items, the examiner shall reject the application:
(i) where the disposition designated by Cabinet Order under Article 67(2) is not deemed to have been necessary to implement the patented invention;
”.