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Novartis patent claim - case study - Patent law

Written by: Vidya Sunderam - 5th Year, Amity Law school, New Delhi
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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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