Transcript COMMENTS ON DRAFT BIOTECH GUIDELINES

Issues on General Matters
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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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Issues on General Matters
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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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Issues on General Matters
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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
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Issues on General Matters
INN
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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
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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
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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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Issues on Claims of Pharmaceutical Inventions
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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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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
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Issues related to Assessment of Novelty
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"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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Issues related to Assessment of Novelty
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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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Issues related to Assessment of Novelty
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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
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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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Issues related to Assessment of Novelty
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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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Issues related to 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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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
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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 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
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Issues related to Assessment of Inventive Step
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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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Issues related to Assessment of Inventive Step
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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 nonobviousness criteria so as to have balanced and all-inclusive
guidelines
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Issues related to Industrial Applicability
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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”
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Issues related to Industrial Applicability
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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
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Issues of Section 3(c)
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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 relevant
Guidelines
should not impose “therapeutic efficacy” as the sole
standard for examining “enhanced efficacy” in all section 3(d)
evaluations
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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
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Issues of Section 3(d)
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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)
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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”
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Issues on Section 3 (e)
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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)
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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)
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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
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Issues on Section 3 (j)
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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 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
vires of 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
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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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Issues on Sufficiency of Description, Clarity & Support of Claims
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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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Issues on Sufficiency of Description, Clarity & Support of Claims
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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
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Issues on Unity of Invention
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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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