Stakeholders meet to discuss the “Draft guidelines for examination of patent application in the field of pharmaceuticals

October 14, 2014

Controller General of Patents, Design and Trademarks (CGPDTM) conducted a stakeholder’s meet on October 7, 2014 at Indian Patent Office (IPO), Mumbai to discuss “REVISED DRAFT GUIDELINES FOR EXAMINATION OF PATENT APPLICATION IN THE FIELD OF PHARMACEUTICALS”. The Patent Office invited the comments of its stakeholders on revised draft guidelines which were hosted on IPO website on August 12, 2014. The meeting was attended by patent agents and Indian as well as international representatives of pharmaceutical companies.

At the meet various important comments received from the stakeholders were discussed and final comments/suggestions are requested to be sent to the CGPDTM office by October 16, 2014 via e-mail at

Below is the summarization of the comments and suggestions received from stakeholders on revised draft guidelines which were discussed in the meet.

A. General Matters

  • Objective of the guidelines is to ensure consistency, quality and uniformity of examination between all the four patent offices, irrespective of the technology field.
  • The illustrative examples are not based on any case laws.
  • Making guidelines are against the established norms of proper legislative process, is unconstitutional and should be discontinued.

B. International Non Proprietary Names (INN)

  • INN disclosure requirement is a debatable issue, it may open the flood gates to abusive patent oppositions and may be burdensome for the pharmaceutical entities banking on incremental innovation.
  • Guidelines unreasonably focus solely on INN searching.
  • INN is not the correct tool for prior art search.
  • The Guidelines should clarify that failure to disclose the INN will never lead to refusal of a patent application.

C. Claims of Pharmaceutical Inventions

  • In ‘Markush Claims’ following explanations/clarifications are requested:
    • Elaboration of the meaning of the terms ‘common structure’ and “recognized class of chemical compounds”.
    • criterion (iii) to be read as: such possible embodiments either share a common structure or belong to a recognized class of chemical compounds in the art to which the invention pertains.
    • In criterion (vi) “in case of product claims…” should be replaced with “in case of process claims…”.
    • Since the criteria (ii) and (iii) are only for determining the Unity of Invention and criteria (i), (iv), (v) and (vi) are for determining the sufficiency of disclosure, it should be split and revised.
  • Disclosure of best representatives is not clear and it should be modified accordingly to require the representative disclosure of the embodiments only.
  • There should not be any requirement of disclosing physical and/or chemical properties of all possible compounds covered by such Markush structure.
  • If skilled person is able to understand the claimed compounds with reference to the existing examples, test for each embodiment of the claimed compound is not needed.
  • The criteria for determining “Insufficiency” and “Unity of invention” are different and the last Para of page 8 wrt markush claims is confusing.
  • Markush claims should be adequately represented through working examples.
  • Illustrative examples to clarify whether or not kit claims are allowed and in what format should the “kit” claims be filed.
  • Section 3(f) has not been covered.

D. Assessment of Novelty

  • Claim should not be rejected out-rightly, merely on the basis of the expression “use”.
  • Use claims and Swiss type claims should be allowed to be reworded.
  • Clarification is required whether amendment of use claims to product claims would be allowed u/s 57 to 59.
  • The term ‘new invention’ is not used in the Act, Rules nor in the Patents Manual.
  • Wrt to assessment of novelty it is stated different embodiments of same document cannot be combined. More clarity is required as to why different embodiments in same document cannot be combined.
  • The concept of Accidental anticipation and allowability of disclaimers in claims to be incorporated.
  • Implicit disclosure would tend to raise of an issue of inventive step only and not novelty per se.
  • The guidelines should reflect widely accepted practice that a generic disclosure does not take away the novelty of a specific disclosure unless specific additional disclosure criteria are met.
  • Clear guidelines for assessing the novelty of the selection patents should be incorporated.
  • No positive illustration or Example is provided in connection with the assessment of novelty.
  • “An explanation to “selection inventions” commonly observed in the pharmaceutical field to be given.
  • The expression “novelty” should be essentially removed from the paragraph regarding ‘person skilled in the art’ as it is not applicable for the determination of novelty.
  • If ” A product of known substance for the treatment of new disease” does not pertain to “a new product” it should be considered under Section 2 (1)(l) and not Section 2 (1)(j).
  • If ” A product of known substance for the treatment of new disease” does not pertain to “a new product” it should be considered under Section 2 (1)(l) and not Section 2 (1)(j).
  • The product-by-process would be better understood if the same would have been discussed with three different possibilities wherein the product is novel, the process is novel and both product and process are novel.

E. Assessment of Inventive Step

  • Hindsight is clearly not permissible when assessing inventive step.
  • Inclusion of the judgment dated September 7, 2012 passed by the Learned Single Judge of the Hon’ble Delhi High Court in

F. Hoffmann-La Roche Ltd. v. Cipla Ltd. MANU/DE/4182/2012, in Hindsight analysis.

  • Para relating to reasonable expectation of success should be altered/deleted as enhanced efficacy and unexpected /surprising property would impart inventiveness to the product.
  • The statement “when the solution is from a limited set of alternatives which is obvious to try, even the demonstration of surprising effect does not provide any answer to the obviousness” is incorrect because the surprising effect is evidence of the non-obviousness of the invention.
  • The standard of the person skilled in the art (the obviousness person) is too high, thus global standard, i.e. the person who has average skill (enablement man) is appropriate.

F. Industrial Applicability

  • There is no case law provided to adjudge whether the use mentioned in claims is “merely speculative”.
  • Act only requires the invention to have an “industrial application” and does not require it to be commercially viable.

G. Section 3(c) of the Indian Patents Act, 1970

  • Section 3(c) prohibits “discovery” but discovery involving human ingenuity and intervention should be patentable.

H. Section 3(d) of the Indian Patents Act, 1970

  • “differ significantly in properties with regard to efficacy” does not mean that all advantageous or beneficial properties are relevant, only properties directly relate to efficacy (in case of medicine, therapeutic efficacy) are relevant.
  • Guidelines should not impose “therapeutic efficacy” as the sole standard for examining “enhanced efficacy” in all section 3(d) evaluations.
  • Interpretation of 3(d) in context of new compounds derived from known compounds by High Court in Roche v. Cipla (Erlotinib hydrochloride) case [CS (OS) No.89/2008 and C.C. 52/2008] should be included
  • The concepts of “mere”, “derivatives” and “efficacy” in the context of section 3(d) should be clarified.
  • Clarification on “other derivatives” of known compounds to be given..

I. Section 3 (e) of the Indian Patents Act, 1970

  • Section 3(e) does not apply to cases where claims recite a pharmaceutical composition comprising a novel active pharmaceutical ingredient and inert carriers.
  • Section 3(e) applies only in situations where there are two or more active ingredients.
  • Allowability of “kit” claims wrt Section 3(e) to be clarified.

J. Section 3 (i) of the Indian Patents Act, 1970

  • Method of diagnosis performed on tissues or fluids, which have been permanently removed from the body, are not excluded from patentability.
  • Diagnostic methods, drug screening methods and in vitro methods should be the outside scope of Section 3(i).
  • There is a thin line between the term “cosmetics” and “cosmetic purposes”. The term used in paragraph 10.19 that is “cosmetics” and “purely cosmetic purposes” may create confusion for the Applicant as well as Examiner.

K. Section 3 (j) of the Indian Patents Act, 1970

  • Section 3(j) does not bar the grant of patents to cell as a cell is not be considered as a part of a plant or animal.
  • Distinction between “essential biological process” and “essentially biological process” to be considered.
  • Micro-organism isolated, classified, named, characterized, deposited in international depository authority (if needed) and utility identified becomes a patentable subject matter essentially because of human efforts involved.L. Section 3(p) of the Indian Patents Act, 1970
  • TKDL documents to be made available to the public.
  • Guidelines have gone beyond the scope of Section 3(p) and thus prove to be detrimental to the Applicants especially the Guiding Principle 3.

M. Sufficiency of Description, Clarity & Support of Claims

  • Section 10(4) of the Indian Patents Act does not require examples to be present in the specification.
  • Guidelines places a significant burden on patent applicants by setting a higher standard of disclosure for Markush claims than for other claim types.
  • Submission of further test results to prove efficacy/synergism by way of explanation, under provision of Section 59 of the Indian Patents Act to be allowed.
  • It is not clear why use type claims lacks clarity and support requirements.
  • Use of terms such as “near to”, “approximately”, “comprising”, “including” and the like should be allowed as these expressions are needed to protect certain kinds of inventions which cannot be defined with specific integers or numbers..
  • It is to be indicated that supplementary data to further corroborate the claims would be allowed, during the prosecution.
  • Guidelines is silent about the situation, wherein the disclosure of invention is complete but additional data is required in order to meet requirements of objections under section 3(e) and 3(d).
  • If the person skilled in the art can determine the boundaries of the claimed invention with a reasonable degree of certainty, the claim complies with the requirement for clarity.
  • The term “tests conducted” is very vague.
  • No reference in the Guidelines is provided related to NBA approvals.

N. Unity of Invention

  • Cases where the common structure cannot be the unifying criteria to be provided.
  • Example(s) to be provided where a single process claim comprises alternative embodiments for the preparation of novel compounds.
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