[Ip-health] Novartis's Second Bite at the Section 3(d) Apple

Baker, Brook b.baker at neu.edu
Tue Sep 6 07:53:30 PDT 2011

Access to medicines activists might still be confused about why Novartis
is getting a second chance to attack India's strict patenting standards
reflected in Section 3(d) of its 2005 Amended Patents Act.  After all,
Novartis lost a decisive lawsuit in 2007 when it unsuccessfully challenged
the constitutionality of Section 3(d) and its compliance with the WTO
TRIPS Agreement, which establishes global norms for minimum standards of
intellectual property rights and their enforcement.  The Madras High Court
basically threw Novartis's case out by the seat of its pants in August of
2007, holding that Section 3(d) was rational and a constitutional exercise
of legislative authority by the India Parliament.

However, in addition to firing a legal canon directly at Section 3(d),
Novartis has also pursued a second case arguing for two legal principles:
(1) that the "enhancement of efficacy" standard in Section 3(d) is a
light-weight provision that should do little rein in the practice of
evergreening a patent by making minor improvements to am existing
medicine, and (2) that Novartis's blockbuster cancer medicine, Glivec,
satisfies the light-weight standard because the beta-crystalline form of
imatinib mesylate (the active ingredient of Glivec) is 30% more
bioavailable than imatinib myselate which was patented in 1993 in the U.S.

Most credible experts in the field of pharmacology would argue that that
finding a more active specific crystalline form of a salt form of a known
compound is not high art, but rather a routine discovery.  It is on this
ground that the Patent Controller of Chennai issued a lucid decision
finding that the Glivec patent application lacked novelty, inventive step
(two general patentability criteria straight from TRIPS) and that it was
also excluded from patentability under Section 3(d) because there was no
significant enhancement of efficacy.

Unfortunately, this landmark decision was partially undermined in an
appeal before the Intellectual Property Appellate Board, which wrongly
concluded that novelty and inventive step were present, but which
fortunately also concluded that the "enhanced efficacy" standard was not
met.  The IPAB thereby upheld the construction of efficacy standard that
has emerged in Indian law that routine improvements to medicines, such as
increased bioavailability, improved stability, enhanced solubility, etc.,
do not meet the anti-evergreening standard embodied in Section 3(d).

Novartis and its contingent of high-priced lawyers is now taking a
second-bite at the Section 3(d) apple trying to eviscerate its efficacy in
ensuring that 20-year patent monopolies are granted to new versions of
existing medicines only under the most stringent conditions - when there
is a surprising and important therapeutical effect that significantly
enhances treatment of human illness.  By thus limiting unwarranted patent
monopolies, the India Patent Act is designed to rewards true innovations
but to simultaneously prevent the renewal and re-renewal of monopolies so
that robust competition among lawful generic producers can drive down the
costs of medicines both for Indian patients and for patients throughout
the developing world.

Let's hope that the judges hearing this appeal abide by the letter and
spirit and the Indian Patents Act and that they remain cognizant of the
human right to health.  But shame on Novartis for continuing its
relentless pursuit of monopoly protections so that it can - as its has
stated in the past - sell its medicines at high prices to rich and
middle-class Indians who can afford it hyper-profitable medicines.  To
maximize its profits, Novartis would undermine an entire edifice of public
interest protections designed to put a little more balance into the highly
imbalanced international intellectual property regime.

To put this case in a little perspective, if Novartis wins, generic
equivalents of Glivec will disappear from the market, and the price of
this life-saving medicine will rise ten-fold or more. Novartis's profits
will shoot up while cancer patients' survival rates shoot down.  This
second bite is not only outrageous, it is dangerous to health throughout
the developing world.

Professor Brook K. Baker

Health GAP (Global Access Project)
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
(w) 617-373-3217
(cell) 617-259-0760
(fax) 617-373-5056
b.baker at neu.edu

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