Ipr Case Study | Novartis







On 17th May 2006 the Swiss pharmaceutical company Novartis Ltd. filed two cases,challenging both the Indian patent office’s rejection of its patent application for thecancer drug imatinib mesylate (brand name Gleevec or Glivec), and the section of thenew Indian patent law which formed the basis of the patent office decision.Imatinib mesylate (Gleevec) is a cancer drug used in the treatment of MyeloidLeukemia (cancer of the blood). It is produced and marketed internationally by theSwiss pharmaceutical company Novartis and various Indian pharmaceuticalcompanies, such as Cipla, Hetero, Natco and Ranbaxy. Novartis sells Gleevec at Rs.120,000 ($ 2500) per patient per month in India. Generic versions of the drug are priced at about Rs. 8,000 ($175) per patient per month on the Indian market.



Filing of patent by NovartisIn 1998, Novartis filed an application in the Chennai Patent Office for a patent onimatinib mesylate (Gleevec). At that time, India did not yet grant patents on medicines but in November 2003, Novartis was still able to obtain exclusive marketing rights(EMR) for a period of five years, based on a temporary provision of the previousIndian Patents Act. The granting of EMR was a TRIPS obligation for countries likeIndia, which did not grant patents for pharmaceutical products before 2005 (subject toa number of conditions). After 2005, when the Indian patent office began examining pharmaceutical product patent applications, EMRs would either be replaced by patents(if granted) or cancelled (if patents were rejected). The latter scenario applies to theGleevec patent application.The EMR operated like a patent monopoly, preventing Indian pharmaceuticalcompanies from producing affordable generic versions of imatinib mesylate.



Producers of generics were forced to withdraw the production and sale of genericversions of the drug in India and other developing countries.Cancer Patient Group files Patent

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OppositionIn 2005, India changed its patent law to become fully TRIPS compliant and Novartis’ patent application on Gleevec came up for examination by the Indian patent office of Chennai. The Indian Patents Act allows for any person or group to oppose a patentapplication before it is granted and the

Cancer Patients Aid Association filed anopposition on behalf of cancer patients in the Chennai patent office

 Chennai Patent Office rejects Gleevec patent applicationIn January 2006, the Chennai Patent office rejected Novartis’ patent application on thegrounds that the application claimed 'only a new form of a known substance.’ Thisorder of the Chennai patent office brought relief to thousands of cancer patients as itnot only prevented a patent monopoly until 2018, but also automatically cancelled theEMR . The Gleevec patent order rejecting a 'new form of a known substance' also setan important precedent for the examination of other patent applications claiming onlyimprovements of known molecules, including antiretroviral medicines to treat AIDS. Novartis challenges Patent Order and Indian Patent LawOn 17 May 2006, Novartis filed two sets of cases in the Chennai High Court.The first case challenges the

order of the Chennai Patent office

, which rejected theGleevec patent application of Novartis, following a pre-grant opposition by theCancer Patients Aid Association. Legal representatives of the Cancer Patients AidAssociation will appear on their behalf before the Chennai High Court. Novartis'constant litigation renews fears about the future availability of drugs if the patent caseof Gleevec is reopened. Further, it has raised serious concerns among other patientgroups, as the Gleevec patent order set an important precedent for the examination of crucial drug patent applications including those for AIDS treatment.The second case filed by Novartis challenges the constitutionality of 

section 3(d) of the 2005 Indian Patents Act

, which was specifically introduced by the Indian parliament as a safeguard against the misuse of the product patent regime. Novartis in


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