Issues on General Matters

1. COMMENTS RECEIVED ON REVISED DRAFT GUIDELINES FOR EXAMINATION OF PATENT APPLICATIONS IN THE FIELD OF PHARMACEUTICALS

2. Issues on General Matters • The title may be amended to “GUIDELINES FOR EXAMINERS FOR EXAMINATION OF PATENTAPPLICATIONS IN THE FIELD OF PHARMACEUTICALS” • “Scope of the present guidelines” should be introduced right at the beginning, before the “Development of pharmaceutical patent in India” section • Wording of the Sections to be reproduced verbatim as prescribed in the Indian Patent Act • Unnecessary comments give an impression that the procedure before the patent office for innovators is unfair and titled towards generics

3. Issues on 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 • Making guidelines are against the established norms of proper legislative process, is unconstitutional and should be discontinued • Many of the issues raised in the guidelines do not have any legal sanction and are not supported by any judicial precedents • The illustrative examples are not based on any case laws • The provisions of Indian Patent Act are strong enough to check patent abuse, putting negative toned guidelines is giving a feel of discouragement and hence should be reconsidered

4. Issues on General Matters • The guidelines creates unnecessary bias against pharmaceutical patent applications • Some provisions relating to tests, claim terms, source and location of biological materials impose unnecessary burdens on pharmaceutical patents, driving up the costs and risks of innovation

5. Issues on General Matters 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

6. Issues on 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

7. Issues on Claims of Pharmaceutical Inventions • It could be a prudent approach not to focus too much on the issue of alleged over-broad nature of the scope of the Markushclaims and the negative impression created toward Markush claiming should be eliminated • Disclosure of best representatives is not clear and it should be modified accordingly to require the representative disclosure of the embodiments only • The assessment for unity of claims in paragraph 4 contradicts the assessment of unity made under paragraph 12.9 • Qualifying parameters for satisfying the requirement of sufficiency are dogmatic and unrealistic

8. Issues on Claims of Pharmaceutical Inventions • Further clarification and guidance for Applicants and Examiners alike should be provided regarding the extent of disclosure of embodiments and the types of test results required to provide support to markush claims • 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 wrtmarkush claims is confusing • There is no requirement in the Act to exemplify each and every genus of the claimed subject matter and the Act does not even necessitate providing examples in the specification.

9. Issues on Claims of Pharmaceutical Inventions Markush claims should be critically examined under Unity of invention 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 Generally the claims related to kits characterized by a set of instructions to carry out the treatment will not be patentable since the contribution to the art is merely a presentation of written information Section 3(f) has not been covered

10. Issues related to Assessment of Novelty • "Use of compound" claims are PROCESS claims. It is illogical and wrong to say that use claims are not directed to a process or a product • 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 • WRT “Second uses of known compounds”- “Necessary care may be exercised to examine these cases in the light of Section 2(1)(j)” to be replaced with “"Necessary care may be exercised to examine in the light of Section 3(d)” as second use of a known compound is a patentable matter in many developed countries

11. Issues related to Assessment of Novelty • Para 7.6 example 3 to be evaluated also in terms of inventive step • The term ‘new invention’ is not used in the Act, Rules nor in the Patents Manual • Public Use of an invention is detrimental to novelty (viz. the invention is anticipated) only if such use is within India • Wrt"Documents" suggested statement is "a single reference may be relied upon, and it is generally not permitted to rely on two or more references of prior art and combine them together” • Wrtto 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.

12. Issues related to Assessment of Novelty • Implicit disclosure has not been recognized by any Indian court • An objection of anticipation by implicit disclosure, should be set aside if the applicant demonstrates that the said prior art does not have a clear teaching to arrive at the invention • The definition on inherent anticipation is incorrect • For anticipation enabling disclosure is necessary as Indian Patents Act permit improvement and selection inventions also • The concept of Accidental anticipation and allowability of disclaimers in claims to be incorporated

13. Issues related to Assessment of Novelty • Implicit disclosure /Inherent anticipation- confusion created by using different terminology for the same concept should be eliminated • Implicit disclosure would tend to raise of an issue of inventive step only and not novelty per se • Examiner making a finding of “inherent anticipation‟ must provide detailed reasoning • Implicit disclosure of prior art anticipates the novelty of claimed subject-matter • Implicit disclosure is not a criterion for assessment of Novelty • Quality of the examination may not be secured if examiners freely judge implicit description of the prior art. It should be the one that a standard artisan can derive directly from the description of the prior art based on their common technical knowledge • Doctrine of inherency should not be raised at the time of prosecution at the Patent office

14. Issues related to Assessment of Novelty • There should be a uniform principle in assessing novelty which should be consistent across all technology domains • 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 • Paragraph 7.6 - Illustrative Examples 2 and 3, reflect a certain prejudice against selection inventions • 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

15. Issues related to Assessment of Novelty • “An explanation to “selection inventions” commonly observed in the pharmaceutical field to be given • The doctrine of selection patents is not applicable in India • 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 • Illustrative examples where novelty is recognized for compound, combination and composition claims to be added • 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) • Illustrative Example 2 for determination of novelty for combination/composition claims should identify the decision of the Technical Board of Appeal issued in FISONS plc v. Dr. Gerhard Mann Chem.- pharm. FabrikGmbh (Case Number: T 0081/98 – 3.3.2)

16. Issues related to Assessment of Novelty For prior claiming under Section 13(1)(b), a claim has to be claimed in an application filed in India prior to the application for the invention Anticipation by prior claiming require clarification where the prior application is not published and therefore does not form a part of the prior art as of the priority date of the subsequent application Document cited for anticipation due to prior claiming should not be applicable for inventive step or section 3d 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 The expression “existing knowledge” to be reworded as “state of knowledge existing before the priority date of the application” The validity of the IPAB decisions in Enercon (India)/Wobben revocation matters cited in the footnotes in the Guidelines do not appear unambiguous

17. Issues related to Assessment of Inventive Step • The teaching of the document as a whole has to be considered for assessment of inventive step • Prior art teaching away that does not motivate a person skilled in the art to arrive at the invention, cannot make it obvious • Hindsight is clearly not permissible when assessing inventive step • The mere existence in the prior arts, of each of the elements in the invention, will not ipso facto mean obviousness • 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

18. Issues related to Assessment of Inventive Step • 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 • Inventive step has to be analyzed on the basis of (1) A “feature” of an invention that involves • (a) technical advance as compared to the existing knowledge • (b) economic significance or • (c) both, and (2) such a feature should make the invention not obvious to a person skilled in the art • If the solution is from a limited set of alternatives, the demonstration of surprising effect indeed imparts non obviousness

19. Issues related to Assessment of Inventive Step • It should be clarified that “obvious to try” does not mean varying all parameters, where the prior art provides no direction as to which of parameter provides a reasonable expectation of success • 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 • Clear guidelines must be in place to identify ‘what is obvious’ and ‘what is non-obvious’ • Clarity wrt closest prior art in assessment of inventive step requires • There should be positive examples based on non-obviousness criteria so as to have balanced and all-inclusive guidelines

20. Issues related to Industrial Applicability • Where the invention gives the result promised, utility must be accepted • The standards prescribed for establishing Industrial applicability / utility is extremely rigid and impractical as correlation of workability with industrial applicability/utility is improper and misleading • Example 1 is not sufficiently clear to provide necessary guidance on industrial applicability • There is no case law provided to adjudge whether the use mentioned in claims is “merely speculative”

21. Issues related to Industrial Applicability • Act only requires the invention to have an “industrial application” and does not require it to be commercially viable • “capable of industrial application” means “that the invention is capable of being made or used in an industry”, it is incorrect to interpret that the specification should disclose the usefulness and industrial applicability of the invention in a distinct and credible manner • Specification must disclose concrete benefit to satisfy industrial application requirement

22. Issues of Section 3(c) • Section 3(c) must not be used as a blanket provision to prohibit the grant to discovery of living or nonliving substance occurring in nature and a clear distinction between discovery and invention be made • Section 3(c) prohibits “discovery” but discovery involving human ingenuity and intervention should be patentable • The isolation of the compound and various human efforts made on the compound to obtain the same in the form which is claimed will make the compound patentable per se • It may not be appropriate to apply the Guidelines fitted for biotechnological inventions as such to pharmaceutical inventions

23. Issues of Section 3(d) • “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 • In pharmaceutical field, safety and stability are as equally important as therapeutic efficacy, therefore, should be evaluated as ‘efficacy’ • Clarity on “therapeutic efficacy‟ under Section 3(d) is required • Guidance as to what parameters/kind of research data would suffice to meet the requirement of enhancement of therapeutic efficacy be provided • More positive examples, complying with Section 3(d) to be provided • Statistically significant data required under section 3(d) can be arrived through in-vitro tests/studies

24. Issues of Section 3(d) • Section 3(d) not to be applied to pharmaceutical patents in discriminative manner • 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 • Patent Office decisions should be cited as examples for Section 3(d) to bring clarity amongst Examiners • Objection under Section 3(d), should clearly identify the known substance(s), so that data for enhancement of efficacy could be provided • Claim to derivatives of known compounds can not be rejected either under section 2(1) (j) or on the ground of lacking in novelty

25. Issues of Section 3(d) • 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 • The expression “other derivatives of known substance” as mentioned in the Explanation part of Section 3(d) is to be construed as derivatives (chemical or physical) which are similar in nature to the known substances but may not be covered under the definition of the terms “salts”, “esters”, “ethers”, etc. • Genuine advancements and developments should be worthy of patent protection which is hampered by Section 3(d) requiring “enhancement of the known efficacy”

26. Issues on Section 3 (e) • 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 • Kind of data required for demonstrating the surprising/unexpected effect in composition claims to be clarified • Irrelevant wording in the analysis of Section 3(e) should be deleted • Positive and specific illustrations for examination of compositions under section 3(e) are to be provided

27. Issues on Section 3 (i) • A diagnostic method is excluded from patentability only if the following method steps are cumulatively included in one claim: a. examination phase involving collection of relevant data i.e, blood pressure, sugar level etc. b. comparison of examination data obtained in step 1 with the standard values c. finding if any significant deviation (a symptom) during comparison; d. attribution of the deviation to a particular disease • 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)

28. Issues on Section 3 (i) • Clarity with respect to inventions that do not pertain to a method of treatment to render humans or animals free of disease or to increase their economic value or that of their products to be provided • 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

29. Issues on Section 3 (j) • 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 • The phrase “from the conjoined reading of Section 3(c) and 3(j), the micro-organisms, which occur in nature are not patentable subject matter” provides incorrect and misleading interpretation • Prohibition against patenting plants and animals is overbroad

30. Issues on Section 3(p) • TKDL documents to be made available to the public • Guidelines should be amended to safeguard both traditional knowledge and the rights of applicants filing applications based on of ingredients already known for treating a given disease • Human intervention is required in isolating, selecting and characterizing the novel compounds form a plant extract, it is not clear if such compounds would qualify for patenting • Guidelines have gone beyond the scope of Section 3(p) and thus prove to be detrimental to the Applicants especially the Guiding Principle 3 • Guiding Principle 3 of Guidelines on Traditional knowledge is ultra viresof the Patents Act • Traditional knowledge should be treated like other kinds of prior art in assessing novelty and inventive step • Reference to other guidelines such as Biotech and Traditional Knowledge should be removed

31. Issues on 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 • In case of product patent, there is no requirement to give at least one example of process, because ‘product’ is distinct from the ‘process’ • 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 • "best" should be deleted from the clause "it must be ensured that the best method for performing the invention is ...” • The term "insecticidal" in the claim (in Example 3 of 11.17) to be deleted because the claim directs to a compound not to an use of the compound

32. Issues on Sufficiency of Description, Clarity & Support of Claims • For the purpose of sufficiency of description the claim need to be as clear enough and the patentee need not simplify his claim to make it easy for infringers to evade (F&H, the Bombay High Court) • It is not clear why use type claims lacks clarity and support requirements • Illustrative examples to describe how support can be met in the description when claims contain “comprising” and/or ”including” • 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

33. Issues on Sufficiency of Description, Clarity & Support of Claims • 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) • Clarity of claim language must be analyzed in light of the content disclosure, the teachings of the prior art and the claim interpretation that would be given by the person skilled in the art at the time the invention was made • 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 whole concept of patent is “first to file” thus full clinical trials can not be provided at the time of filling • The term “tests conducted” is very vague • No reference in the Guidelines is provided related to NBA approvals • Under Section 6 of the BDA, approvals from NBA are necessary only if the biological resource is from India and not otherwise

34. Issues on 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 • Assessment of unity without explicit representation of structure(s) of formula (I), formula (A) and formula (X) is misleading in Illustration 12.5 (Example 1) • Questioning the validity of a divisional application once objection regarding unity of invention is raised is the first examination report of the parent application