[Ip-health] FDA admits Sun's appeal

[Joana Ramos]

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http://www.livemint.com/2007/11/22235614/FDA-admits-Sun8217s-appeal.html

FDA admits Sun's appeal

                            The challenge weakens Novartis' petition against an Indian ruling denying patent for the Swiss firm's cancer drug

                        C.H. Unnikrishnan

22 November 2007

                   Mumbai:
US drugs regulator food and drug administration (FDA) has accepted a
generic challenge by India's Sun Pharmaceuticals Industries Ltd against
Glivec, a controversial mega-earner cancer drug of Novartis AG,
potentially weakening the Swiss drug maker's petition against an Indian
ruling denying the drug a patent.The challenge in the US, if
it invalidates Novartis' patent, will not only significantly
stre-ngthen the plea of local drug makers here, but also open up a huge
generics market for them in the US for this drug, which, last year,
grossed some $2.5 billion (Rs11,605 crore then), equivalent to more
than one-10th?of?Novartis'?revenues.Novartis' patent on
Glivec was challenged by Sun Pharma through what is called a Para IV
filing with FDA. The filing initiates a process with which a generics
firm can seek marketing approval for an already patented product either
by invalidating the patent, by proving there is fundamentally nothing
novel in the product or by proposing to introduce a variant without
infringing the patent. The appeal was listed early this month by FDA
after a six-month surveillance by the regulator. Under the rules,
Novartis is expected to respond to this challenge within 45 days of the
date of listing.At least two drug industry insiders
confirmed the Sun Pharma challenge and the FDA listing. The filing is
likely aimed at invalidating the existing patent as the Mumbai drug
maker has found gaps in Novartis' patent.An email sent to
Novartis' media relations office at Basel on Wednesday did not elicit
any response and an India spokesperson said she was not authorized to
comment.In 2006, the Chennai patent office refused Novartis' claim on the ground that it is not an innovationAn
invalidation of the Glivec patent, if it happens through Sun Pharma's
Para IV filing, will help strengthen local drug makers' claims against
Novartis in India. "This very disclosure in the US will make Novartis'
appeal against the Chennai patent office's decision to reject its
patent application unacceptable," said Gopakumar Nair, a patent expert
in Mumbai.Shamnad Basheer, an associate at Oxford IP
Research Center, UK, echoed this view. "If the US, which is
comparatively liberal in granting patents, invalidates the Glivec
patent, it will look ridiculous for any (of the) patent court(s) in the
world, which are (usually) more cautious, to grant a patent for this
drug," he said in a telephone interview.Novartis has
challenged the Indian patent office's decision to turn down its patent
application through an appeal filed early in 2006 in the Madras high
court. The case has since shifted to the Intellectual Property
Appellate Board, or IPAB, which hears such disputes in the country.In
2006, the Chennai patent office refused Novartis' patent claim for
Glivec-which is a beta crystal or polymorphic form of the known cancer
drug Imatinib Mesylate-on the ground that it is not an innovation and
the Indian patent law does not identify this as patentable. One of the
newly amended provisions in the Indian patent law, Section 3D,
specifies that no derivatives or modified forms of known drug
substances are patentable unless it enhances the therapeutic efficacy
substantially.Following the refusal of its patent
application in India on this ground, Novartis challenged this provision
of the Indian law, saying the rule is not compliant to World Trade
Organization's globally accepted patent law. This challenge was
rejected by the Madras high court early this year.Rajeev
Nannapaneni, chief executive of Hyderabad-based Natco Pharma Ltd, which
is one of the corporate opponents in Novartis' patent dispute at IPAB,
said: "The US patent challenge gives us a most important message that
the Glivec patent has been questioned not only in India, but elsewhere
also."Meanwhile, Sun Pharma and Natco Pharma have also filed
drug master files or DMFs with FDA for off-patent or generic versions
of Glivec. Filing a DMF sets off the process for generic drug firms to
get their products registered in the US pharmaceuticals market.A
Sun Pharma spokesman confirmed that the company has filed DMFs for six
drugs in the US in April-June 2006, and one of them is the polymorph of
imatinib, but declined further details on the Para IV filings.(C.R. Sukumar in Hyderabad contributed to this story.)

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Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle WA USA
+1-206-229-2420
http://ramoslink.info/
www.healthyskepticism.org

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