Taking into account the various relevant legal provisions in the Patents Act, 1970 and the various court decisions on the legal provisions, the Indian Patent office has issued Guidelines to Patent Examiners examining pharmaceutical patent applications so as to standardise and bring about uniformity in the examination of pharmaceutical patent applications. According to the Guidelines:
- while examining Markush Claims, the specification should be critically examined for disclosures related to :
- (a) best representative compounds and tests related thereto, (b) physical and / or chemical properties of the claimed compounds, and (c) at least one process for preparing the representative compounds; and
- while conducting prior art or novelty search, comprehensive search strategy to be adopted utilising:
- molecular and structural formula of the compounds;
- IUPAC nomenclature, CAS Registry Numbers, generic name searching (INN); and
- International Patent Classification (IPC).
- while assessing novelty, inter alia, the following pointers should be considered:
- a generic disclosure in the prior art may not necessarily take away the novelty of a specific disclosure; and
- implicit disclosures should be scrutinised.
- while assessing the product-by-process claims, the product must qualify for novelty and inventive step irrespective of the novelty or inventive step of the process.
- while assessing the inventive step, emphasis to be given to identify the person skilled in the art and his common general knowledge on the priority date, and the difference between the inventive concept and state of the art.
- while assessing the usefulness and industrial applicability of an invention, it should be checked whether the specification discloses the same in a distinct and credible manner.
- while assessing efficacy of a product, in the case of Section 3(d) inventions, it should be assessed from the point of therapeutic efficacy. The substance should demonstrate significantly improved therapeutic efficacy.
While the Guidelines on one hand will help to streamline the examination of the pharmaceutical patent applications, on the other hand they will also help stakeholders to ensure that the disclosures in the specifications are sufficient and adequate to address the legal requirements.
Incidentally, with regard to biological material disclosed in a specification which is not available to the public, there is an obligation on the Applicant to disclose the full details of the material including the source and geographical origin of the material in the specification (Section 10(4)(d)(ii)).