Drug Patent Prosecution before Indian Patent Office| Examination Guidelines for Pharmaceuticals Patents

“Where Technology, Law and Business Intersect”
TECH CORP LEGAL® LLP
PATENT ADVOCATES & INTERNATIONAL LEGAL CONSULTANTS
Comments on Draft Guidelines
for Examination of
Patent Applications in the Field of Pharmaceuticals
before the Indian Patent Office (IPO)
Indian Intellectual Property Law Firm– Tech Corp Legal | Business Consulting – Tech Corp
International Consultants, Singapore (www.techcorpgroup.com) Email: prity.k@techcorplegal.com

To:
Controller General of Patents, Designs and Trademarks,
Office of the Controller General of Patents, Designs & Trade Marks,
Bhoudhik Sampada Bhavan,
Antop Hill, S. M. Road,
Mumbai - 400037
Dear Sir,
RE: Comments on Draft Guidelines for Examination of Patent Applications in
the Field of Pharmaceuticals dated 20 March, 2014. Response to be submitted
to a.chakaraborti@nic.in
On 28 February, the Indian Patent Office (IPO) published Draft Guidelines for
Examination of Patent Applications in the Field of Pharmaceuticals. We highly
appreciate the steps undertaken by your office for issuance of above- mentioned
guidelines. However, we have certain apprehensions and the same have been
explained herein-below for your kind perusal.
Comments:

4. Claims of Pharmaceutical Inventions
Markush Claims:
With regards to various terms / definitions included in the referenced section, we
respectfully submit that the use of Markush claim structures can leave the
multinational pharmaceutical companies or the Indian drug companies unprotected
when structurally diverse compounds with the same activity for e.g. bioisosteres are
identified. Further, it should be noted that the currently available field-based
processes allow the routine detection of such bioisosteres and can be used to
evaluate patent positions, strengthen the process of new patent filings and select
innovative chemistry methods to get over existing chemical patents.
A simple example of a Markush formula is as follows:
R1 – R2
wherein R1 is phenyl or 1-naphthalene, and R2 is chlorine or bromine.
This patent claim would include chlorobenzene, bromobenzene, 1-
chloronaphthalene and 1-bromonaphthalene. However, for determining novelty of

the invention, a prior art disclosure of even just one of these compounds in the prior
art document would render the claim lacking in novelty.
Further, a typical Markush claim might be constructed using language such as “an
alcohol of the formula R-OH, wherein R is selected from the group consisting of
CH3-, CH3CH2- and (CH3)2CH-”. In practice, for the purposes of the patent claims,
each of the potential combinations of substituents is considered to be equivalent and
have ‘unity of invention’. For example, in the case of a pharmaceutical drug, all of
the potential structures are assumed to have the same efficacy, side effects and
other biological properties which are difficult to determine.
For a patent examiner to conduct prior art search for a markush claim claiming a
number of compounds is virtually impossible, the search of the patent office and the
corresponding patent claims granted should be limited to what has been actually
assessed and supported by the examples provided in the detailed description of
the patent specification.
Moreover, the patent examiner should make a note that patent claims covering a
large range of compounds should not be allowed. If the patent specification provide

sufficient disclosure, such as fusion point, Infrared Absorption Spectrum (IR) or
Nuclear Magnetic Resonance (NMR), and the like obtained through true testing
and experimentation results to enable the reproduction by the disclosed method of
every embodiment of the invention for which protection is sought by the patent
claims, the said patent claims covering a large range of compounds can be allowed.
However, patent claims of limited scope could be granted if evidence is provided at
least that, with the substitution of any member within the same family class, the
same disclosed result would be obtained. The scope of the patent claims should
be limited to what is actually enabled by the patent disclosure and the examples
cited in the patent specification.
If the members of the Markush group are sufficiently less in number or so closely
related in patent claims that a search and examination of the entire claim can be
made, the patent examiner must examine all the members of the Markush group
in the patent claim on the merits, even though they are directed to independent
and distinct inventions.

5. Prior Art Search
With regards to conducting a prior art search by the patent examiner included in
the referenced section, we respectfully submit that the patent examiner should also
take into account patent family status of corresponding foreign applications and
review the prior art patent applications and non-patent literature cited by
foreign patent examiners. Moreover, the examiner should design and frame a
comprehensive patent search strategy and analyse backward patent citations
and forward patent citations of the highly relevant prior art that impacts on the
patentability of the patent specification during the patent examination stage. The
first examination report (FER) issued by the patent examiner should not be limited
to the prior art cited in International Search Report (ISR) issued with the PCT
document and extensive additional search should be conducted.

7. Assessment of Novelty:
7.4 Implicit disclosure:
With regards to the point of implicit disclosure, we respectfully submit that the prior
art is read through the understanding of the person skilled in the art, and as a result
the implicit features of a specification may also be taken into account for
determining novelty of the invention. Subsequently, if the person skilled in the art
would read a specification as including a particular feature without it being
specifically mentioned it would be considered an implicit feature of that disclosure.
In particular, the operating conditions used in a process will need to be very
similar in order to sustain an argument that a reaction or process will inevitably give
the same product. For example, a claim defines an industrial process for preparing a
product comprising a particular ratio of compounds A and B wherein a set of
steps are carried out using specific reaction parameters for e.g. pH, temperature,
and the like. However, a prior art citation discloses a similar process for preparing a
mixture of A and B, but does not disclose the specific ratio of these components
claimed in the present application. In this particular case, it may be necessary to

consider the examples described in the prior art specification in order to determine
whether the one or more parameters are sufficiently similar that it could be
concluded that the prior art disclosure would inevitably provide the presently claimed
ratio.
7.9 Product-by-process claims:
With a view to understand product-by-process claim in detail the patent examiner
should take into consideration that product-by-process claim is one in which the
product is defined in whole or in part in terms of the process used to manufacture
the product, instead of solely by structure, composition, properties or characteristics.
We respectfully submit that product-by-process claims fall into either the statutory
category of article of manufacture or composition of matter claims. Moreover, when
the structure of a product is unknown, and the product cannot adequately be defined
in terms of composition, structure, properties or characteristics, a product-by-process
claim may be allowable. These patent claims are in particular relevant for
biological products or polymers that cannot be defined in terms of their structure or
composition.

8. ASSESSMENT OF INVENTIVE STEP:
8.7 Hindsight Analysis:
We respectfully submit that the patent examiner should attempt to place themselves
in the shoes of the person skilled in the art faced with the problem. This is difficult in
practice since the examiner approaches the consideration having both the problem
and the solution in hand. To assess the inventive step of the invention, the patent
examiner should identify the claimed inventive concept, by assuming the onus of the
normally skilled but unimaginative addressee in the art at the priority date and to
ascribe to him what was, at that date, common general knowledge of the art in
question. Subsequently, identify what, if any, differences exist between the matter
cited as being "known or used" and the alleged invention. The patent examiner
should determine the “inventive step” without any knowledge of the alleged
invention, whether these differences constitute steps which would have been
obvious to the person skilled in the art or whether they require any degree of
invention.

9. Industrial applicability
We respectfully submit that the word "Industry" should be understood in its broadest
sense and includes any functional and practical activity as distinct from intellectual or
aesthetic activity. In general there must be something in which a new and useful
effect, be it creation or alteration, may be observed. It need not be an article or
substance nor necessarily involve a manufacturing process, but it must be useful in
practical affairs.
10. Inventions not patentable:
10.12 Section 3(e): Mere Admixture Resulting Only In Aggregation Of The
Properties Or A Method Of Making Such Mere Admixture
10.17: Illustrative examples for section 3(e):
With respect to examples cited in the guidelines, we respectfully submit that the
following Intellectual Property Appellate Board(IPAB) order is of particular
importance as it is a classic case where IPAB revoked Indian Patent granted to
Kibow Biotech INC, titled “A process of making pharmaceutical composition”
bearing patent grant number IN205478 and the Intellectual Property Appellate

Board(IPAB) upheld Patent Revocation Petition filed by Gujarat based La Renon
Health Care for the product patent titled “Compositions for Augmenting Kidney
Function” for patent No.224100 granted to Kibow Biotech Inc.
On 13th November, 2013 Intellectual Property Appellate Board (IPAB) upheld
Patent Revocation Petition filed by Gujarat based La Renon Health Care Pvt.
Ltd for patent No.224100 granted to Kibow Biotech Inc., for the patent
invention “Compositions for Augmenting Kidney Function” under the provisions
of the Indian Patents Act, 1970. However, on the same day, Intellectual Property
Appellate Board (IPAB) revoked Indian Patent granted to Kibow Biotech INC,
titled “A process of making pharmaceutical composition” bearing patent grant
number IN205478 under the provisions of the Indian Patents Act, 1970.
The IPAB found that the granted patent No.224100 is not obvious in view of the prior
art documents cited by La Renon HealthCare. The inventive composition of the
patent comprises at least one probiotics bacteria of a certain kind, in a certain
composition and it is not a mere admixture and is patentable under the Indian
Patent Act, 1970. As stated by IPAB “the invention covers a new and inventive

composition comprising at least one probiotic bacteria of a certain kind, in a
certain composition and along with other additives (such as vitamins etc) that
confer synergistic impact, enabling the augmentation of kidney function. By
no stretch of imagination can this unique composition be labelled as mere
admixture.”
However, from time to time, India has been held responsible by foreign
pharmaceutical and biotech companies that India’s patent ecosystem is weak and
doesn’t encourage innovation nor provides adequate patent protection to research
and development activities. However, recent judgement of Intellectual Property
Appellate Board (IPAB) has been ruled in favour of US-based biotechnology
company Kibow, headed by Natarajan Ranganathan upholding its initial patent and
affirming that the company’s break through probiotic dietary supplement sold under
the brand name “Renadyl” capsules is patentable in India. Therefore, Kibow
Biotech’s win in patent battle for its probiotic dietary supplement, ‘Renadyl’ in Indian
court, has busted the myth that we completely lack ecosystem for patent protection.

Accordingly, we submit that such orders and / or judgements should be used as
reference.
Thank you for your time and consideration. We at Tech Corp Legal are grateful to
have the opportunity to comment on the guidelines and would be happy to answers
any questions related to above mentioned points, if any.
Best Regards,
Prity Khastgir
PARTNER, Tech Corp Legal LLP (India)
Patent & Trademark Attorney, International Business Lawyer
Director, Tech Corp International Consultants (Singapore)
Law Firm | Personal Site | LinkedIn | Quora | Google Group | APAC Consulting - Singapore
Prity Khastgir is a Patent Attorney, specializing in Medical Devices,
Biotech, Food Technology & Pharmaceuticals, and partner of
Tech Corp Legal LLP, an International Law Firm. Connect with me
on:

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