[Ip-health] MADRAS HIGH COURT DISMISSES NOVARTIS' CHALLENGE TO THE INDIAN PATENT LAW

[chan park]

--
[ Picked text/plain from multipart/alternative ]

  6 August 2007

  A division bench of the Madras High Court today dismissed a challenge to =
section 3(d) of the Indian Patents Act, 1970 filed by Swiss pharmaceutical =
multinational Novartis AG and its Indian subsidiary, Novartis India . These=
 petitions challenged the validity of a key provision in the Indian law, wh=
ich seeks to prevent ever greening and which provided one of several ground=
s on which the Patent Controller rejected Novartis AG's patent application =
for the beta-crystalline of Imatinib Mesylate, brand name Glivec (Gleevec).

  In March 2005, with retrospective effect from 1 January 2005, the Indian =
Parliament amended its patent law to protect product patent protection. A s=
ignificant and important provision was introduced to prevent every greening=
 and granting of frivolous patents, section 3(d).

  In May 2006, Novartis filed writ petitions before the Madras High Court, =
claiming that the Patent Controller erred in rejecting its patent applicati=
on, and further claiming that section 3(d) was, among other things, vague, =
ambiguous, and contrary to the requirements of the TRIPS Agreement.

  In the challenge to section 3(d), Novartis argued that this provision is =
not in compliance with the TRIPS Agreement and that it is in violation with=
 the government's (non-enforceable) constitutional duty to harmonise its do=
mestic laws with its international obligations. Recognising the fact that t=
he TRIPS agreement is non-self executing and provides no private right of e=
nforcement (unlike the rights created under Chapter 11 of NAFTA and many su=
bsequent FTAs), Novartis advanced a somewhat novel claim that while it is o=
pen for the Indian Parliament to repudiate its international obligations al=
together, it is somehow invalid and unconstitutional for Parliament to othe=
rwise comply with TRIPS except for one particular provision.   The Governme=
nt of India, CPAA and the generic companies argued that neither could priva=
te companies such as Novartis challenge a law as being TRIPS non-compliant =
nor could an Indian court decide whether the Indian patent law is TRIPS com=
pliant or
 not. The appropriate forum, they argued, is the WTO Disputes Settlement Bo=
dy.   Upholding this argument, the Madras High Court held that it was not t=
he proper forum to decide whether the Indian patent law was TRIPS compliant=
 or not.

  The other ground of challenge raised by Novartis was that the use of the =
term "efficacy" in section 3(d) is vague and ambiguous, and therefore viola=
tes the equality provision (Article 14) of the Indian Constitution. During =
the arguments, while conceding that the meaning of the term "efficacy" is k=
nown, Novartis contended that because there was no clarity as to what const=
ituted "enhancement of efficacy" and "significant enhancement of efficacy" =
as required by section 3(d), the law was vague and lent itself to arbitrary=
 decisions by the Patent Controller.   The Government of India, CPAA and ge=
neric companies argued that section 3(d) is not in violation the equality p=
rovision of the Indian Constitution as the concept of efficacy is well-know=
n to persons in the pharmaceutical industry and it is impossible to lay dow=
n a "one size fits all" standard to determine what constitutes a significan=
t enhancement of efficacy.   Dismissing the petition, the Madras High Court=
 held that
 section 3(d) was not vague or arbitrary and therefore did not violate the =
Indian Constitution.

  The full text of the judgment will be made available shortly on our websi=
te ( www.lawyerscollective.org) as soon as it becomes available from the Co=
urt.

  Novartis' challenge to the Patent Controller's decision, which was filed =
before the Madras High Court, has been subsequently transferred to and is p=
ending before the Intellectual Property Appellate Board.

  Brief background of the Gleevec case

  In 1997, Novartis AG filed a patent application in the Chennai ( Madras) =
Patent Controller's office for the beta-crystalline of Imatinib Mesylate, b=
rand name Glivec (Gleevec) on the ground that they invented the beta crysta=
lline salt form (imatinib mesylate) of the free base, imatinib.   In 2003, =
it was granted Exclusive Marketing Rights (EMR) for marketing Gleevec in th=
e Indian market. On the basis of the EMR, Novartis AG obtained orders preve=
nting some of the generic manufacturers from generic equivalents of Gleevec=
. Novartis was selling Gleevec at USD 2666 per patient per year. Generic co=
mpanies were selling their generic versions at USD 177 to 266 per patient p=
er month.

  In 2005, the CPAA and the other generic companies filed a pre-grant oppos=
ition against Novartis' patent application for imatinib mesylate, claiming,=
 among other things, that Novartis' alleged "invention" lacked novelty, was=
 obvious to a person skilled in the art, and that it was merely a "new form=
" of a "known substance" that did not enhance the substance's efficacy, and=
 was thus not patentable under section 3(d) of the Patents Act. These argum=
ents were based on the fact that Novartis had already been granted a patent=
 in 1993 for the active molecule, imatinib, and that the present applicatio=
n only concerned a specific crystalline form of the salt form of that compo=
und.

  The CPAA and the generic companies contended that the 1993 patent effecti=
vely disclosed both the free base, imatinib, and the acid-addition salt, im=
atinib mesylate. Further, the CPAA and generic companies argued that differ=
ent crystalline forms of imatinib mesylate did not differ in properties wit=
h respect to efficacy, and thus the various forms of imatinib mesylate must=
 be considered the "same substance" under section 3(d) of the Patents Act.

  In January 2006, the Patent Controller in Chennai, in a landmark decision=
, refused to grant Novartis a patent, agreeing with the contentions of the =
CPAA and generic companies that the subject application lacked novelty, was=
 obvious, and was unpatentable under section 3(d) of the Act.

  The patent rejection meant that generic companies could manufacture and m=
arket their drug, both in India and abroad, who make available the generic =
imatinib mesylate priced at less than one-tenth the price that Novartis was=
 charging (USD 166 to 266 instead of 2666 per person per month).