Issues on General Matters

COMMENTS RECEIVED ON

REVISED DRAFT GUIDELINES FOR EXAMINATION OF PATENT

APPLICATIONS IN THE FIELD OF PHARMACEUTICALS

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

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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

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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

Issues on General MattersINN

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

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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

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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 Markush claims 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

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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 wrt markush 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.

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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

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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

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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”

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.

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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

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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

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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

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“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. Fabrik Gmbh (Case Number: T 0081/98 – 3.3.2)

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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

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Issues related to Assessment of Inventive Step

The teaching of the document as a whole has to be considered for assessment of inventive stepPrior art teaching away that does not motivate a person

skilled in the art to arrive at the invention, cannot make it obviousHindsight is clearly not permissible when assessing inventive

stepThe mere existence in the prior arts, of each of the elements

in the invention, will not ipso facto mean obviousnessInclusion 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

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

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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

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Issues related to Industrial Applicability

Where the invention gives the result promised, utility must be acceptedThe standards prescribed for establishing Industrial applicability / utility is extremely rigid and impractical as correlation of workability with industrial applicability/utility is improper and misleadingExample 1 is not sufficiently clear to provide necessary guidance on industrial applicabilityThere is no case law provided to adjudge whether the use mentioned in claims is “merely speculative”

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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 mannerSpecification must disclose concrete benefit to satisfy industrial application requirement

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

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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 relevantGuidelines should not impose “therapeutic efficacy” as the sole standard for examining “enhanced efficacy” in all section 3(d) evaluationsIn 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 requiredGuidance as to what parameters/kind of research data would suffice to meet the requirement of enhancement of therapeutic efficacy be providedMore positive examples, complying with Section 3(d) to be providedStatistically significant data required under section 3(d) can be arrived through in-vitro tests/studies

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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

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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”

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

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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)

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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

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

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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 diseaseHuman 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 vires of the Patents ActTraditional knowledge should be treated like other kinds of prior art in assessing novelty and inventive stepReference to other guidelines such as Biotech and Traditional Knowledge should be removed

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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

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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

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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

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

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