15) Request that India elaborates on what consists "efficacy trials" and how these function for obtaining patents for patent pharmaceuticals and agrochemicals. Are these requirements for compliance with the requirement of 'inventive step' or an additional requirement? Does this require scientific proof of the functioning and efficacy of the medicine?
Reply: As per section 3(d) of the Patents Act, efficacy requirement is invoked when the subject matter involves "mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance". The efficacy requirement has been further elaborated in the explanation provided under section 3(d). Unless the requirement of the efficacy is met with, a new form of a known substance is not an invention meaning thereby that the criteria of patentability is not fulfilled. Thus, the efficacy requirement for a new form of a known substance is to substantiate the inventive step provided novelty of the substance is already established.
Peru 16:
16) Request further explanation of the limitations that citizens and residents in India face while filing patents applications in foreign countries, in particular the need to get a "prior permission" of the Patent Office in certain cases (paragraph 251 of document).
Reply: Yes. The residents and citizens of India must take prior permission for filing patent application abroad. Such permission is required to enable the Patent Office to scrutinize the subject matter of the invention and to check whether the said invention falls under section 35 which relates to defence and atomic energy so as to invoke the secrecy provisions as required under the said section. Permissions are otherwise routinely granted.
However, these provisions are not applicable in relation to an invention for which application for patent protection has been first filed in a country outside India by a person resident outside India.
Peru 17:
17) Request clarification on the general doubt about the validity of the patent rights granted in India: period of 20 years is counted from the publication (as seems to be pointed out in paragraph 254 of document) or from the filing of the application (paragraph 255).
Reply: It may be noted that the term of patent starts from the date of filing of the application. In case of application filed under Patent Cooperation Treaty, the term of patent shall be reckoned from International filing date accorded under PCT.
However, Section 11A(7) provides provisional protection of the invention from the date of publication of the application. Accordingly, the patent right accrue from the date of publication of a patent application under section 11(A). However, as per Section 11A(7), the patent right can be enforced only when patent is granted i.e. the patentee can claim the damages from said date of publication only after the patent is granted and, also, the Applicant is not entitled to institute any infringement proceeding until grant of patent.
