[Ip-health] CII questionnaire on amending Section 3(d)

Malini Aisola malini.aisola at gmail.com
Tue Jul 31 02:04:24 PDT 2012


Dear all,

Please see below a questionnaire being circulated by the the Confederation
of Indian Industry (CII) in an attempt to muster support for the amending
Section 3(d) of the Indian Patent Act. See also the section on 'some
suggestions' after the questionnaire.

For those concerned about the questionnaire, the relevant ministry handling
is the Department of Industrial Policy and Promotion, Ministry of Commerce
& Industry (contact details at end of the message).

Kind regards,
Malini


******************
Questions

If disallow patents on incremental innovation (according Sec 3(d)) will
this discourage firms from doing fresh research?
How we make a solution which can keep the pharmaceutical industry motivated
without having to deny poor people medicines?
What should happen if only lifesaving drugs should be allowed to be made?
What should happen if only lifesaving drugs should be allowed for extended
period of protection?
What should happen if rest of the drugs in India will continue to have
higher patent standards like section 3(d)?
Should Incremental innovations be granted?
Is the said Section 3 (d) to be removed as beyond the scope of modified
older molecules and commercialize them?
What if the regimes in other countries change to approximate a section 3(d)
like position, where section 3(d) is interpreted in a restrictive manner?
Are Indian pharmaceutical companies willing to risk this “collective
action” problem?
Does the Indian patent regime matter for the R&D incentives of Indian
pharmaceutical companies?
What would constitute a “significant enhancement in efficacy” under the
Explanation to section 3(d)? Would a increase in the property such as
bio-availability/heat stability suffice?
What would constitute a “significant enhancement in efficacy” under the
Explanation to section 3(d) for other fields such as agro-chemicals?
To what extent will a narrow interpretation of efficacy affect R&D
incentives in relation to diseases of specific concern to India, such as
malaria, tuberculosis and other neglected diseases?
To what extent will a narrow interpretation of efficacy affect R&D
incentives in relation to traditional/herbal medicines?
To what extent will a narrow interpretation of efficacy impact foreign
direct investment (FDI) by multinational corporations?
To what extent will a narrow interpretation of efficacy impact the
introduction of new drugs into the Indian market by MNCs?
To what extent will a wide interpretation of efficacy impact the smaller
Indian pharmaceutical companies and their markets, both domestic and
international?
To what extent will a wide interpretation of efficacy affect public health
imperatives, such as access to affordable medicines?


Some suggestions

The main section of 3 (d) and the explanation are inconsistent,
particularly when it comes to the patentability of a “new form” that has a
“new use”.

New use for a new form is certainly more inventive than a mere showing of
an increase in known efficacy. Therefore, section 3(d) needs to be amended
to provide expressly for the patentability of new uses of new forms of
existing pharmaceutical substances.

Definition of “efficacy” will necessarily involve a more detailed
empirical/policy investigation.

The term “efficacy” should not be restricted to just therapeutic efficacy,
narrowly defined. Rather it should include all kinds of advantageous
properties exhibited by the new form including heat stability, enhanced
bioavailability, humidity resistance, new drug delivery mechanisms etc.

The creases in section 3(d) needs to be ironed out to make it work more
“efficaciously” and to help lend more certainty to the law.

Minor incremental innovations in the pharmaceutical sector do not require
patent protection and that section 3(d) of the Patents Act is not a bar for
patenting of significant incremental innovations.

Since an examination under section 3(d) is likely to call into question
some of the very same issues used in a non-obviousness determination, it
may help to explicitly state section 3(d) as a “patentability” criterion
rather than a patent eligibility criterion.

Section 3(d) ought to be amended to remove references to “discovery.”

Significantly enhanced efficacy is a factual determination to be assessed
with reference to the views of a person skilled in the art. This
proposition ought to be expressly introduced into the text of section 3(d)
or provided through government rules/patent office guidelines.

The optimal way to effectuate the above change in section 3(d) is through a
statutory amendment by the Parliament.

Another option is to effectuate the change through government rules

A third option is to effectuate the above change via patent office
guidelines in the patent manual.

What is required is more genuine innovations leading to development of
drugs for diseases which still pose a challenge to humanity and not minor
cosmetic modifications on existing drugs.

It is necessary to provide attractive incentives to Indian pharma industry
to get into genuine R&D. While having a conductive intellectual property
regime is one of the components of such an incentive package, removal of
section 3(d) thereby paving way for ever greening of existing patents in
pharmaceuticals will be counter productive.

The recommendations of CIPR (The United Kingdom Commission on Intellectual
Property Rights)
• limiting the scope of subject matter that can be patented
• applying standards such that only patents which meet strict requirements
for patentability are granted and that the breadth of each patent is
commensurate
with the inventive contribution and the disclosure made
• facilitating competition by restricting the ability of the patentee to
prohibit others from building on or designing around patented inventions
• providing extensive safeguards to ensure that patent rights are not
exploited inappropriately

*******************

Contact information for DIPP:

Saurabh Chandra
Secretary, Department of Industrial Policy and Promotion (DIPP)
Ministry of Commerce & Industry
Room No. 157, Udyog Bhavan
Tel: +91 11-23061815, 11-23061667
Email: chandras at nic.in

D.V. Prasad
Joint Secretary, Department of Industrial Policy and Promotion (DIPP)
Room No. 236, Udyog Bhavan
New Delhi – 110 001
Tel: +91 11-23063571
Email: dv.prasad at nic.in

Ms. Chandni Raina
Director, Department of Industrial Policy & Promotion (DIPP)
Room No. 260, Udyog Bhawan
New Delhi – 110 011
Tel: +91 11-23063596
Email: chandni.raina at nic.in



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