India: Indian Patent Office Issues The Much Awaited Examination Guidelines For Pharmaceuticals

Last Updated: 6 January 2015
Article by Krishna & Saurastri Associates

Impetus

When we foray into the world of pharmaceutical patents, many contentions raise their heads. Once the product patent regime came into force in India, the road ahead seemed fraught with difficulties. Time and again the doors of the courts have been knocked for explanation, for intervention and for redressal. In view of the same, the endeavor of the Government to bring out pharmaceutical guidelines is worth applause. A copy of the guidelines published by the Indian Patent Office on October, 29, 2014 can be found here

We would like to bring out the highlights of the pharmaceutical guidelines.

Novelty

As regards Assessment of Novelty, it has been stated that while assessing novelty, it is generally not permitted to combine separate items of prior art together, unless such combination has specifically been suggested or essentially linked to one another. If a Markush formula covers innumerable compound and if some of the compound fall within one prior art and certain other compounds fall within another prior art, in such cases all these prior art documents are to be cited. A generic disclosure in the prior art may not necessarily take away the novelty of the specific disclosure. A specific disclosure in the prior art takes away the novelty of generic disclosure.

Markush Claims

While examining Markush claims, the complete specification should be critically examined whether:

(i) it discloses best representatives, as known to the applicant, of the possible embodiments ;

(ii) such embodiments share a common use or property;

(iii) such possible embodiments share common structure;

(iv) physical and/ or chemical properties of best representatives of such embodiments known to the applicant are disclosed;

(v) test conducted for the representatives of such embodiments known to the applicant is provided;

(vi) in case of product claims at least one process for preparing the compounds has been disclosed enabling the whole scope of the invention.

Moreover, if any one of (i) to (vi) are not met such a Markush claims may be objected under 'Unity of invention' and "Insufficiency of Disclosure" depending on the circumstances.

Furthermore, the report also says that while assessing the sufficiency of disclosure, it must be ensured that the best method for performing the invention known to the applicant is described so that the whole subject- matter that is claimed in the claims, and not only a part of it, must be capable of being carried out by skilled person in the relevant art.

Inventive Step

Inventive step is determined vis-à-vis any matter published in any document anywhere in the world or any use before the priority date of the claim. Mosaicing of prior art documents is permissible in the context of inventive step.

Industrial Applicability

With regard to industrial applicability, the report states that as per Section 2(1)(ac) of the Act, the expression ''capable of industrial application'', in relation to an invention, means that the invention is capable of being made or used in an industry. The specification should disclose the usefulness of industrial applicability of an invention in a distinct and credible manner unless the usefulness and industrial applicability of the invention is already established, either in explicit or in implicit manner. Mere speculative use or vague and speculative indication of possible objective will not suffice.

Section 3(d)

The stand taken by the Patent Office with respect to Section 3(d) is the same as that of the Hon'ble Madras High Court in Paragraph 180 of the order, it was held: What is "efficacy"? Efficacy means "the ability to produce a desired or intended result". Hence, the test of efficacy in the context of Section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, the test of efficacy would depend upon the function, utility or the purpose of the product under consideration. Therefore, in the case of a medicine that claims to cure disease, the test of efficacy can only be "therapeutic efficacy" .It may be noted that the text added to Section 3(d) by the 2005 amendment lays down the condition of "enhancement of the known efficacy". Further, the explanation requires the derivative of "differ significantly in properties with regards to efficacy". What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, as seen above, is its therapeutic efficacy. While dealing with the explanation as provided in Section 3(d), it must also be kept in mind that each of the different forms mentioned in the explanation have some properties inherent to that form, e.g., solubility to a salt and hygroscopicity to a polymorph. These forms, unless they differ significantly in property with regard to "therapeutic efficacy", are expressly excluded from patentability. Hence, the mere change of form with properties inherent to that form would not qualify as "enhancement of efficacy" of a known substance. In other words, the explanation is meant to indicate what is not to be considered as therapeutic efficacy.

Composition Claims

Claims related to compositions obtained by mere admixture resulting in aggregation of the properties of the individual components are not patentable under section 3(e) of Act. However, in a composition if the functional interaction between the features achieves a combined technical effect which is greater than the sum of the technical effects of the individual features, it indicates that such a composition is more than a mere aggregation of the features.

INN Names

It is to be noted that quite often the claims of the pharmaceutical compound involve derivation of known compound having established pharmaceutical activities. Also, it has been observed that such pharmaceutical substance have already been assigned generic names (International Non- proprietary Names, INN). When the patent specification under examination disclose such INNs, the report states that the examiner should search the prior art on the basis of such INNs as well

Intermediates

The report stresses on the following points with respect to intermediates –

  • To satisfy unity of invention between intermediate and final products when any one or both the structure are not known, there should be sufficient evidence to conclude that the intermediate and final product are technically closely interrelated such that the intermediates contain the same essential element as the final product or incorporate as essential element into the product.
  • Different intermediate products used in different processes for the preparation of the final product, satisfy unity of invention provided that they have the same essential structural element.
  • To satisfy unity of invention the intermediate and final products should not be separated, in the process by an intermediate which is not new.
  • Different intermediates for different structural parts of the final product, do not satisfy unity of invention.
  • To satisfy unity of invention where the intermediate and final products are families of compound, each intermediate compound should correspond to a compound claimed in the family of the final products.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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