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Introduction
In November 2003, The Controller General of Patents & Trademarks
of India granted exclusive marketing right (EMR) of Glivec, the
blood cancer drug to Novartis A.G., a multinational based in
Switzerland. EMR was granted for a period of 5 years in
expectation of the product patent regime that was due to be
enacted in India by January 1, 2005. The EMR , which is the first
such granted in the country, gave Novartis the right to be the
only company that can produce and market the drug in India.
Novartis began enforcing the EMR for Glivec by asking for an
injunction against generic manufacturers of the drug in the Madras
High Court.
In January 2004, the court granted Novartis an injunction,
restraining companies such as Cipla, Ranbaxy and Sun from
manufacturing, selling, distributing or exporting the drug. The
injunction was later made absolute by a single Judge of the High
Court.
Once the generic manufacturers stopped producing Glivec, the price
of the drug jumped from approximately Rs.10, 000 for a month's
requirement to around Rs.1, 20,000.
Indian drug companies went in appeal, which was heard by a
Division Bench of the Madras High Court. They contended that
Novartis had obtained a patent in the U.S. and Canada in respect
of 'pyramadine derivatives and processes for preparation thereof'.
They argued that no patent was filed in India for imatinib
mesylate. The EMR has been fiercely challenged in courts by
generic producers of the drug on the grounds that the compound
being a derivative of a molecule known prior to 1995 did not
satisfy the novelty criterion in the Patents Act.
Novartis said that the EMR was conferred for a period of five
years, or until an order was passed on the patent claim in India,
whichever was earlier. Novartis in 1997 applied for grant of
patent for the drug glivec in the patent office in Chennai.
In 2005, the patent act was amended. The Amendment Act 2005
granting product patent, provides that EMRs would either be
replaced by patents (if granted) or cancelled (if patents were
rejected).
By way of opposition, Cipla Limited along with other generic
producers filed their representation under the Patents Act, 1970
sec. 25(1) as amended by Patents (Amendment) Act, 2005 and the
Patents Rules, 2003, r. 55 as amended by Patents (Amendment)
Rules, 2005. The following two issues will be argued.
Whether the product applied for patents qualified to be an
invention as the product was anticipated by prior publication and
obviousness
Whether the Patent Specification brought out any improvement
in the efficacy of the beta crystals over the known substance as
required by Sec.3(d) of the Patents Act, 1970 as amended by
Patents (Amendment) Act, 2005
The Assistant Controller held imatinib mesylate is already known
from prior publications because the claims 6 to 23 of the US
Patent claim a pharmaceutically acceptable salt of the base
compound and the patent term extension certificate, specifically
mentions imatinib mesylate as the product. Further the US Patent
discloses methanesulphonic acid as one of the salt forming groups
and the patent specification clearly states that the required acid
addition salts are obtained in a customary manner. Also that
imatinib mesylate normally exist in the beta crystals form, which
is thermodynamically most stable product and thus the invention is
obvious and anticipated by prior publication; hence not an
invention under the Patents Act.
The Controller agreed with the contention of the opponent that a
difference of 30% on comparing the relative bioavailability of the
freebase with that of the beta crystal form of imatinib mesylate
which could be due to difference in their solubility in water, did
not bring out any improvement in the efficacy of the beta crystals
over the known substance and thus could not be patnetable under
Sec. 3(d) of the Patents Act. Mr.V.Rengaswamy, Asst. Controller of
Patents & Designs, the learned judge in the present case refused
to proceed with the application for Patent.
Aggrieved by the decision of the Indian Patent Office in Chennai,
Novartis has filed a Writ Petition before the Chennai High Court
in Jan 2006 challenging the constitutional validity of Section 3
(d) of The Patents Act and also for quashing of the order of the
Patent Office for its refusal to grant product patent. It asked
the court to declare s3(d) as being non compliant with TRIPS and
arbitrary and in violation of Ar14 of the constitution.
On Aug 7 2007 the Madras HC dismissed the petition filed by the
Swiss pharma. The court held that s3 (d) of the Patents Act as
amended in 2005 along with its explanation is valid. This decision
has stymied Novartis move to challenge the rejection of patent
application by the patent office.
The appeal against the rejection of patent has to be decided by
the IPAB. The court transferred the case to IPAB after the
government announced the setting up of IPAB and declared the
transfer of all pending IP related appeals to it The IPAB has
appointed former Patent Controller General S Chandresekaran to
hear the appeal. Novartis filed a petition in the IPAB to appoint
new member in place of S Chandresekaran on the ground that he was
responsible for the patent application rejection. IPAN dismissed
the petition.
On Aug 1 2007 Novartis filed an appeal in the Madras HC
challenging IPAB s decision.
The appeal is pending for hearing in the HC. Also the appeal
against decision of patent office rejecting the patent for Glivec
is pending. The decision of the Madras HC is a landmark decision
after the amendment act of 2005. The decision makes the appeal for
rejection of patent weak; thus drugs being available at economic
rates throughout the county.
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author can be reached at: vidya.sunderam@legalserviceindia.com/
