[Ip-health] HC ruling to affect access to cheap drugs

[Joana Ramos]

http://economictimes.indiatimes.com/News/News_By_Industry/Healthcare__Biote=
ch/Pharmaceuticals/HC_ruling_to_affect_access_to_cheap_drugs/articleshow/20=
98307.cms

HC ruling to affect access to cheap drugs

NOEMIE BISSERBE

TIMES NEWS NETWORK[ TUESDAY, JUNE 05, 2007 02:12:42 AM]

MUMBAI: After months of hearings, the Madras High Court is expected to
rule next week on a case that could have a profound impact on patients=92
access to affordable generic medicines in India and in developing
countries all around the world. The case concerns Novartis. Following
the rejection of its patent application in India for anti-cancer drug
Glivec, Novartis had filed a petition with the Madras High Court,
challenging the constitutionality of the Indian patent law.

The argument is about the level of protection Indian patent law offers
to modifications of existing products of global pharmaceutical
companies. Indian law says that only those modifications that make the
drug more effective can be offered patent protection. Novartis disagrees
and says that any modification that has commercial utility should be
allowed. So once a drug, available in tablet form, is about to go off
patent then it could be converted into a syrup and this new form should
be patent protected. Even two drugs that are independently patent
protected, if combined to create a =91new=92 product, should receive furthe=
r
protection.

If Novartis wins, the Madras High Court will ask the Union government to
amend the Indian patent law. Hardest hit may be HIV patients as many
anti-HIV drugs are combinations of existing drugs, and Indian drugs will
therefore not be able to copy these drugs.

While the Swiss drug major is not challenging a basic provision of the
Patent Act, the legal clause at stake, Section 3(d), is significant as
it concerns incremental innovations =97 new versions or combinations of
existing drugs =97 which represent 90% of the 9,000-odd patent
applications in India, according to Doctors without borders (MSF)m, a
global charity organisation. The clause stipulates that modifications of
already-known medicines cannot be patented unless they make the drug
significantly more effective.

=93Section 3(d) fails to recognise that incremental inventions have
utility and value not just in improving therapeutic efficacy but also
provides significant benefits in terms of patient safety, patient
compliance, manufacturing efficacy and delivery,=94 argues Novartis=92
vice-chairman and managing director Ranjit Shahani.

This legal provision is designed to prevent a common practice in the
pharmaceutical industry known as =91evergreening=92, whereby the patent
holder patents trivial modifications of already existing drugs to extend
their monopolies beyond the 20-year period granted for the original patent.

=93If the High Court amends the Indian patent law, this would
significantly delay the entry of generic medicines in the market and
open the door to ever-greening,=94 said Indian Pharma Alliance (IPA)
secretary general Dilip G Shah. This could lead to a dramatic increase
in drug prices in India, barring access to treatment to many patients in
India as an innovative product is typically 30 to 50 times more
expensive than its generic version, according to IPA.

=93This would not only impact accessibility to generic drugs in India, but
also in other developing countries, which depend in a big way on India
for the supply of generic drugs. Indian companies provide over 25% of
the essential drugs and 84% of the anti-retroviral drugs that MSF gives
to patients world-wide,=94 said MSF campaign manager Leena Menghany.
Domestic companies also provide 50% of the essential drugs UNICEF
distributes to patients world-wide.

Above all, this case has opened a world-wide debate on the value of
incremental innovation, as pharma companies seek further clarity on the
definition of patentability in India. =93There is still a certain
ambiguity in the Indian Patent Act,=94 said Anoop Narayan, partner of
Majmudar & Co, a leading law firm in Mumbai.

This comes at a time too, when the definition of patentability is
becoming blurry in the US. Recent cases have shown that now even in the
US, pharma companies may not be unconditionally granted a patent for new
versions of existing drugs. Earlier this year for instance, domestic
pharma major Dr Reddy=92s Lab was refused a patent in the US for its new
version of Sanofi Aventis=92 blockbuster drug Allegra. The alarming
increase in the number of patent litigation in the US between innovators
and generic companies also goes to show that the requirements for the
grant of a patent are rapidly changing.

There is, however, fear that a ruling against the Swiss drug major might
undermine India=92s new patent law=92s credibility and deter MNC players
from investing in research in India. =93We prioritise investing in R&D in
countries, which respect intellectual property. Recently, the Chinese
government has made great progress in strengthening protection for
intellectual property, and Novartis has announced a significant R&D
centre in Shanghai, China,=94 said Mr Shahani. Other companies like
GlaxoSmithKline and Johnson & Johnson have also recently set up research
facilities in China.

In spite of Novartis=92 opposition, the case will now be heard by the
newly set up Intellectual Property Appellate Board in India. This will
create a paradoxical situation. The newly appointed head of the
appellate board, Chandrasekaran, had himself in January 2006, as India=92s
Controller General of Patents, Designs & Trade Marks, denied a patent to
Novartis=92 anti-cancer drug. While Glivec is not an incremental
innovation, Novartis is seeking patent protection in India on a salt =97 a
crystalline form of Imatinib mesylate, as Glivec=92s basic molecule=92s
invention is prior to 1995.


---

Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle WA USA
http://ramsolink.info/
www.cancersurvivorsproject.org
www.healthyskepticism.org
www.mavinfoundation.org