The inventor of a "first medical indication" can obtain purposelimited product protection

Print this page 05-12-1984
IPPT19841205, EBA-EPO, EISAI - Second medical indication

PATENT LAW

 

Vienna Convention applies to interpretation of European Patent Convention:there are convincing precedents for applying the rules for interpretation of treaties incorporated in the Vienna Convention to a treaty to which in terms they do not apply.

 

"4. Nevertheless, there are convincing precedents for applying the rules for interpretation of treaties incorpo-rated in the Vienna Convention to a treaty to which in terms they do not apply. The International Court of Jus-tice has already applied principles expressed in the Vienna Convention to situations to which the Conven-tion strictly did not apply, whilst the European Court of Human Rights, the Federal German Constitutional Court and the House of Lords (England) have applied the principles of interpretation in Articles 31 and 32 of the Convention also to treaties to which strictly they do not apply (cf. Wetzel, Rausching "Die Wiener Ver-tragsrechtskonvention", Metzner, Frankfurt 1978 and Fothergill v. Monarch Airlines [1981] A.C. 251 (House of Lords (England)). After a careful study of the whole subject, the Enlarged Board of Appeal concludes that the European Patent Office should do the same."

 

No therapeutic use claims permitted: A European patent with claims directed to the use may not be granted for the use of a substance or composition for the treatment of the human or animal body by therapy.

 

"12. Whilst, therefore, there can be no objection to "use claims" in general, the obvious objection to a patent "with claims directed to the use" being granted for "the use of a substance or composition for the treatment of the human or animal body by therapy" is that it seems to be in direct conflict with the provisions of Article 52 (4) EPC, in accordance with which "methods for treat-ment of the human or animal body by therapy ... shall not be regarded as inventions which are susceptible of industrial application" within the meaning of Article 52 (1) EPC.
13. For the reasons already given, in the considered opinion of the Enlarged Board, a claim directed to the "use of a substance or composition for the treatment of the human or animal body by therapy" is in no way dif-ferent in essential content from a claim directed to "a method of treatment of the human or animal body by therapy with the substance or composition". The differ-ence between the two claims is one of form only and the second form of claim is plainly in conflict with Ar-ticle 52 (4) EPC. Since this is so, no patent can be granted including any such claims: Article 97 (1) EPC."

 

Therapeutic substances or compositions – medical indication: A European patent may be granted with claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application.

 

"14. Claims directed to substances or compositions for use in any methods for treatment of the human or ani-mal body, on the other hand, are unquestionably directed to inventions which are susceptible of indus-trial application within the meaning of Article 52 (1) EPC. This is not only expressly made clear in Article 52 (4) EPC, last sentence, but also to be deduced from the definition of "susceptible of industrial application" in Article 57 EPC, namely, that the invention "can be made or used in any kind of industry, including agricul-ture". The last sentence of Article 52 (4) EPC, indeed, appears to be a statement of the self-evident, made out of an abundance of caution."

 

Second medical indication – novelty – Swiss type claim: the inventor of a "first medical indication" can obtain purposelimited product protection for a known substance or composition, without having to restrict himself to the substance or composition when in a form technically adapted to a specified therapeutic purpose.

 

"15. Furthermore, Article 54 (5) EPC provides that the general rules of law relating to novelty (Article 54 (1) to (4) EPC) shall not exclude the patentability of any substance or compositions, comprised in the state of the art for use in a method referred to in Article 52 (4) EPC, provided that its use for any such method is not comprised in the state of the art. Thus the inventor of a "first medical indication" can obtain purposelimited product protection for a known substance or composi-tion, without having to restrict himself to the substance or composition when in a form technically adapted to a specified therapeutic purpose. The appropriate protec-tion for him is, therefore, in its broadest form, a purpose-limited product claim. No problem arises over its susceptibility of industrial application, within the meaning of Article 57 EPC.
16. Claims directed to the use of a substance or compo-sition for the preparation of a pharmaceutical product are equally clearly directed to inventions which are susceptible of industrial application, within the mean-ing of Article 57 EPC."

 

IPPT19841205, EBA-EPO, EISAI – Second medical indication

 

Gr 05/83