[Ip-health] Update on Novartis Hearing in Madras High Court

[chan park]

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[ Picked text/plain from multipart/alternative ]
Dear friends,

  Beginning today, a division bench in the Madras High Court will begin hea=
ring arguments on a series of writ petitions filed by Swiss pharmaceutical =
multinational Novartis AG and its Indian subsidiary, Novartis India against=
 the Indian government, the Cancer Patients Aid Association (CPAA), and fou=
r Indian generic manufacturers: Natco, Cipla, Hetero, and Ranbaxy. The writ=
 petitions challenge the decision of the Patent Controller to refuse to gra=
nt Novartis a patent relating to the anticancer drug, imatinib mesylate, as=
 well as the validity of a key provision in the Indian Patents Act that pro=
vided one of several grounds for rejecting the patent application.

  Due to the keen interest both domestically and internationally on this ca=
se, the Lawyers Collective HIV/AIDS Unit, representing the CPAA in these ma=
tters, will provide the general public with daily updates on the progress o=
f the case. The reports will be factual updates without any comments as tha=
t is not permissible under Indian law relating to contempt. This initial po=
sting will provide a brief factual and legal background leading up to the c=
ase.
  In 1997 Novartis AG, the Swiss Company filed a patent application in the =
Chennai (Madras) Patent Controller=92s office for the B-crystalline of Imat=
inib Mesylate, brand name Glivec (Gleevec) on the ground that they invented=
 the beta crystalline salt form (imatinib mesylate) of the free base, imati=
nib.

  The patent application was kept in the mail-box and not opened until 2005=
 as the TRIPS Agreement permitted developing countries to introduce product=
 patent protection from 1 January 2005. In March 2005, with retrospective e=
ffect from 1 January 2005, the Indian Parliament enacted the patent law to =
protect product patent protection. A significant and important provision wa=
s introduced to prevent every greening and granting of frivolous patents, s=
ection 3 (d).

  In the meantime Novartis had got the Exclusive Marketing Rights (EMR) for=
 marketing Gleevec in the Indian market and on that basis got orders preven=
ting some of the generic manufacturers from generic equivalents of Gleevec.=
 Novartis was selling Gleevec at USD 2666 per patient per year. Generic com=
panies were selling their generic versions at USD 177 to 266 per patient pe=
r month.

  In 2005, the CPAA and the other generic companies filed a pre-grant oppos=
ition against Novartis=92 patent application for imatinib mesylate, claimin=
g, among other things, that Novartis=92 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=92s efficac=
y, and was thus not patentable under section 3(d) of the Patents Act. These=
 arguments were based on the fact that Novartis had already been granted a =
patent in 1993 for the active molecule, imatinib, and that the present appl=
ication only concerned a specific crystalline form of the salt form of that=
 compound.

  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).

  However, in May 2006, Novartis filed the current writ petitions pending b=
efore the Madras High Court, claiming that the Patent Controller erred in r=
ejecting its patent application, and further claiming that section 3(d) was=
, among other things, vague, ambiguous, and contrary to the requirements of=
 TRIPS.

  In the challenge to the Patent Controller=92s order, Novartis has argued =
that the Patent Controller refused to give weight to the fact that the pate=
nt for imatinib mesylate had been granted in 35 other countries, that the P=
atent Controller disregarded the case law (from mostly foreign jurisdiction=
s) placed before him, and that an in-house laboratory test performed by Nov=
artis scientists on rats to show an alleged 30% increase in bioavailability=
 between imatinib and imatinib mesylate was sufficient to meet the "enhance=
d efficacy" standard under section 3(d).

  The CPAA and the generic companies responded by claiming that the determi=
nations of the other countries=92 patent offices had no bearing in India, b=
oth due to differing standards for patentability and the independence of pa=
tent validity under article 4bis of the Paris Convention. They further argu=
ed that India is not bound to follow the liberal patentability criteria in =
effect in many other countries, and is free to set more rigorous standards =
for patentability. They have argued that Novartis has failed to discharge i=
ts burden of showing that the beta-crystalline form of imatinib mesylate di=
ffers significantly in efficacy from other known forms of imatinib mesylate=
.

  In the challenge to section 3(d), Novartis has argued that this provision=
 is not in compliance with the TRIPS agreement and that it is in violation =
with the government=92s (non-enforceable) constitutional duty to harmonise =
its domestic laws with its international obligations. Further, Novartis has=
 argued that the use of the term "efficacy" in section 3(d) is vague and am=
biguous, and therefore unconstitutional. Recognising the fact that the TRIP=
S agreement is non-self executing and provides no private right of enforcem=
ent (unlike the rights created under Chapter 11 of NAFTA and many subsequen=
t FTAs), Novartis has advanced a somewhat novel claim that while it is open=
 for the Indian Parliament to repudiate its international obligations altog=
ether, it is somehow invalid and unconstitutional for Parliament to otherwi=
se comply with TRIPS except for one particular provision.

  The CPAA and the generic companies have argued that it is not open to pri=
vate companies or the Indian courts to decide whether the Indian Patent law=
 is TRIPS compliant or not. They have further argued that it is not violati=
on of any of the fundamental rights of the Indian Constitution and was pass=
ed by a competent legislature, the only two grounds for striking down a sta=
tute in India, and therefore not open to challenge. They have also argued t=
hat 3(d) is clear and not vague and in full compliance with TRIPS.


  Whether Novartis succeeds in these challenges is likely to be determined =
in the coming days. We will keep you posted.

  In solidarity,
  From Chennai
  Lawyers Collective HIV/AIDS Unit Team
  Anand Grover
  Chan Park
  Julie George
  Prafulla


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