[pp.int.general] Fwd: [SPICY IP] Section 3(d) equivalent in the offing for Thailand...

[Amelia Andersdotter]

recap: Thailand has been deeply criticized for a compulsory license issued
on the influenza medicine "tamiflu" in the US (although somewhat unfairly,
as has been pointed out by James Love at KEI for instance).

apparently they are now planning to introduce an exception similar to that
of indianpatent act section 3(d) in the thai patent law.



---------- Forwarded message ----------
From: Shan Kohli <shankohli at gmail.com>
Date: 2 November 2011 00:08
Subject: [SPICY IP] Section 3(d) equivalent in the offing for Thailand...
To: spicyip at googlegroups.com


A slightly dated piece reported on IP
Komodo<http://ipkomododragon.blogspot.com/2011/09/patent-evergreening-in-thailand.html>(a
wonderful blog dealing with IP issues from East Asia) caught Spicy
IP’s
attention. It states that The Thailand Health Systems Research Institute is
planning to introduce an Indian Section 3(d) equivalent provision in its
Patent Act. This is aimed at curbing the practice of ever greening in
Thailand, since out of 2,000 patents granted over the last 10 years over
1,900 consist only of mere changed formulations, alternate medical uses or
chemical selections.

For example, the Bristol Myers AIDS drug Atazanavir originally patented in
1997 was further patented in 2005 in respect of further medical uses and
again in 2008 on the formulation itself. It is
believed<http://www.bangkokpost.com/news/local/255143/medicine-patent-laws-drive-up-drug-prices-says-institute>that
if the evergreening patent is granted, it could extend the validity of
the Atazanavir patent to 2028 from 2017, and in the process block attempts
by others to manufacture generic versions.

*Fallacies *
*
*
This argument however fails to make a distinction between incremental
innovation and ever greening. It assumes that alternate medical uses and
pharmaceutical derivatives amount to ever greening of patents. As explained
over here<http://www.cptech.org/ip/health/c/india/feb07/ipi_report_on_india_patent_act_2006.pdf>,
it is important to distinguish between incremental innovation and ever
greening. Ever greening refers to an improper extension of patent monopoly
in relation to a specific pharmaceutical product, while incremental
innovation refers to sequential developments of existing products and
technologies that can help bring in improved products to the market. It
would therefore be incorrect to classify all incremental innovations as
tantamount to ever greening.

*Incremental Innovation v. Ever Greening- Indian Section 3(d)*
*
*
Some commentators have stated that such a provision would prevent the
incentive for incremental innovation known to be a highly successful method
of producing drugs. However, as pointed out
here<http://www.atrip.org/.../Shamnad%20Basheer%20Glivec%20Patent%20Saga.doc>and
here<http://www.cptech.org/ip/health/c/india/feb07/ipi_report_on_india_patent_act_2006.pdf>,
the Indian Section 3(d) does not seek to prohibit incremental innovation.

In fact it draws a distinction between ever greening and incremental
innovation.

Section 3(d) reads as below: - The following are not inventions within the
meaning of this Act:-

*the mere discovery of a new form of a known substance which does not
result in increased efficacy of that substance* or the mere discovery of
any new property or new use for a known substance or of the mere use of a
known process, machine or apparatus unless such process results in a new
product or employs at least one new reactant.

Explanation: For the purposes of this clause, salts, esters, ethers,
polymorphs, metabolites, pure form, particle size, isomers, mixtures of
isomers, complexes, combinations and other derivatives of known substance
shall be considered to be the same substance, *unless they differ
significantly in properties with regard to efficacy.”*

Section 3(d) aims to prevent “ever-greening”. It states that only those
pharmaceutical derivatives that demonstrate significantly enhanced efficacy
are patentable. This may occur either when a manufacturer supposedly
‘stockpiles’ patent protection by obtaining separate 20-year patents on
multiple attributes to a single product or when drug manufacturers try to
patent wide range of inventions connected with modifications of their
products, including minor features such as inert ingredients and the form,
colour and scoring of tablets.

By making derivatives with added efficacy patentable, Section 3(d)
encourages sequential developments of existing products or technologies
that help bring in improved products to the market, capable of addressing
unmet public health needs.

Therefore, it does not seek to prohibit incremental innovations from being
patented at all. It is based on the premise that incentives are just as
necessary for sequential pharmaceutical developments as they are for new
chemical entities.

Therefore if the aim is to prevent ever greening in Thailand, introducing
an Indian Section 3(d) type provision would adequately prevent it and at
the same time would not prove to be detrimental to innovation.

*Next Steps*

As reported here<http://www.bangkokpost.com/news/local/255143/medicine-patent-laws-drive-up-drug-prices-says-institute>,
the next phase of research in Thailand would look into the impact of ever
greening patents on people of various economic means by studying the top
100 kinds of pharmaceuticals, such as cholesterol blockers, glucosamine,
diabetes, heart disease and Aids drugs. The study is expected to be
completed by January 2012 at the end of which the results will be submitted
to the Department of Intellectual Property to seek ways of protecting
Thailand from ever greening of patents.

****


--
Posted By Shan Kohli to SPICY
IP<http://spicyipindia.blogspot.com/2011/11/section-3d-equivalent-in-offing-for.html>at
11/02/2011 04:21:00 AM

-- 
You received this message because you are subscribed to the Google Groups
"SPICY IP" group.
To post to this group, send email to spicyip at googlegroups.com.
To unsubscribe from this group, send email to
spicyip+unsubscribe at googlegroups.com.
For more options, visit this group at
http://groups.google.com/group/spicyip?hl=en.
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://lists.pirateweb.net/pipermail/pp.international.general/attachments/20111102/9498c19d/attachment.html>