Introduction

The Novartis case can be traced to 1997 when a patent application was filed by Novartis AG for the -crystalline of imatinib mesylate (brand name Glivec) which was a slightly different version of their 1993 patent, a vital anti-leukaemia drug, filed in the Chennai (Madras) Patent Office. The petitioner claimed that they had invented the beta crystalline salt from the free base of imatinib. In 2003, Glivec was granted EMR in the Indian market. Novartis obtained orders preventing some of the generic manufacturers from producing the generic equivalents of Glivec in India. Soon, Novartis was selling Gleevec at USD 2666 per patient per year.15 Generic companies had been selling their generic versions at USD 177 to 266 per patient per month. Pre-grant oppositions were filed by Natco Pharma Ltd., M/s Cipla Ltd., M/s Hetro Drugs Ltd., M/s Cancer Patient Aid Association and M/s Ranbaxy Laboratories Ltd., India and in an order dated January 25, 2006, the Assistant Controller of Patents and Designs, Chennai Patent Office rejected the Novartis application.

History of Glivec in India

1993: The base compound of Glivec, imatinib, is invented and patented worldwide. There is no patent filed in India at this time, as India does not have patent laws for pharmaceutical products. 1995: India joins the World Trade Organization (WTO) and begins its mandated 10-year transition period to bring its patent laws into alignment with TRIPS. JULY 1998: Novartis files a mailbox application in India for imatinib mesylate in crystalline form, the active ingredient of Glivec, in accordance with Indias provisions for obtaining patents. DECEMBER 2001: Novartis obtains marketing approval for Glivec in India. APRIL 2002: Glivec is launched in India. SEPTEMBER 2002: Novartis launches the Glivec International Patient Assistance Program (GIPAP) in India. NOVEMBER 2003: Novartis is awarded Exclusive Marketing Rights (EMR) for Glivec, marking the first time a pharmaceutical firm is granted an EMR in India. The EMR protects the beta crystal form of the drug for five years, or until the review of the mailbox application. Prior to Novartis receiving the EMR, nine Indian companies obtain approval for commercializing copies of Glivec. Novartis asks that the EMR be enforced; three companies are allowed to continue.

APRIL 2005: The Indian Patents Amendment Act of 2005 is enacted, introducing product patents for pharmaceuticals to fulfil Indias obligation to WTO/TRIPS. JANUARY 2006: Novartis is denied a patent for Glivec under Section 3(d) of the Indian Patents Act 2005, which introduced a new improved efficacy hurdle for patentability of new forms of known compounds. The Indian Patent Office contends that Glivec does not satisfy the requirements of novelty and inventiveness. This rejection automatically terminates the EMR. AUGUST 2006: Novartis challenges the January 2006 ruling by the patent office denying its application for Glivec on the grounds that the ruling lacks legal or factual basis and justification. Novartis asks the High Court of Chennai to declare Section 3(d) unconstitutional and in breach of Indias obligation under TRIPS. DECEMBER 2006: The number of current GIPAP patients in India reaches 6700, representing 99% of Indian patients taking Glivec. FEBRUARY 23, 2007: The court agrees with the Novartis request to convert one part of its case the challenge to the patent offices decision to not grant a patent for Glivec from a writ petition to an appeal. This allows the court to review data and evidence about the effectiveness of Glivec. MARCH 5-6, 2007: The court hears matters relating to the conversion of the writ petition into an appeal, and the Chief Justice announces that the Glivec appeal will be heard by the existing bench. APRIL 2, 2007: The Intellectual Property Appellate Board (IPAB) becomes operational for patent review in India. The newly-appointed technical member of the appellate board is the former Controller General of the Indian Patent Office, who was responsible for the original decision on the Glivec patent in 2006 and is acting as a party in the current Court case. APRIL 3, 2007: The High Court in Chennai determined that Novartiss appeals matter on the Glivec patent should be heard by the newly-operational Intellectual Property Appellate Board (IPAB) in India. High Court / Section 3(d) Matter APRIL 2007: Arguments on the Section 3(d) matter have closed, and the writ petition is still under deliberation in the High Court in Chennai. AUGUST 6, 2007: The High Court dismisses challenge on constitutionality and defers to WTO to resolve question on compliance with TRIPS. APRIL 2007: Mr. Chandrasekaran the former Controller General of the patent office is appointed technical member of the IPAB.

JULY 2007: Novartis petitions the High Court for a new technical member. OCTOBER 2007: Government of India suggests a revised approach consisting of a twomember review panel. NOVEMBER 13, 2007: High Court accepts the approach put forward by the Government of India. DECEMBER 2007: Natco appeals against decision before the Supreme Court. NOVEMBER 2008: Glivec case comes for hearing before the IPAB. JUNE 2009: IPAB rejects application on grounds of price of the product. (affordability is an important concern). Acknowledges the fact that it is otherwise patentable under international law. JULY 2009: Novartis challenges the IPAB decision on patent as price is not a clause under patents act.

Actual Controversy
THE astronomical rise in the price of Glivec, the blood cancer drug, which has now become representative of the dangers of a product patents regime, began when the Indian Patent Office granted it exclusive marketing right (EMR) to Novartis A.G., a multinational based in Switzerland. 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. The anti-cancer drug is composed of the beta-crystalline form of the compound imatinib mesylate and is sold under the brand names Glivec, Imanib, Imalek, Temsab, Zoleta, and so on. The drug is used to treat people suffering from chronic myeloid leukaemia (CML), a lifethreatening form of cancer. Of the 24,000 people afflicted by CML every year, 18,000 succumb to the disease, mainly because they cannot afford to buy even the generic drugs. 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. Interestingly, the lawyer representing Novartis A.G. was P. Chidambaram, who is now the Finance Minister.

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. (The generic version of the drug cost about Rs.90 per 100 mg capsule, and if four capsules are taken a day it would cost Rs.360 a day. After Novartis obtained the injunction, the price of Glivec rose to Rs.1,000 per 100 mg capsule.)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. 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. It said that it had instituted a programme called Gipap to supply free Glivec, thus taking care of the element of `public interest'. The court refused to interfere with the single Judge's order. However, as an interim arrangement, it ordered foreign drug producers to arrange for the free supply of the betacrystalline form of imatinib mesylate. The Glivec case is seen widely as an example of what is to come after the product patents regime is put in place. It was cited repeatedly by the Left parties and health activists when the Patents Bill was discussed in and outside Parliament.

My take on Glivec case study: 1) Section 3d of Indian Patent Act does not clearly indicate the efficacy of the new version of already existing molecule. 2) Also 30% increase in the bioavailability of Imatinib mesylate was not taken into account for increased efficacy. 3) When the decision was taken by IPAB there was no technical person which was against the Section 84(2) - Trade Mark Act and Section 116(2) - Indian Patent law. 4) The revised decision in the presence of technical person on IPAB reject Patent for Gleevec on the ground of PRICE, but the fact is that no Patent rejection can be done on the basis of Price. 5) After launch of Gleevec in India in April 2002, NOVARTIS launch GIPAP (Gleevec International Patient Assistance Program), under this program Novartis gave free Medicine to patient who cannot afford Gleevec, till he is alive. 6) This program has covered 99% of the patient suffering from Chronic Myeloid Leukaemia in India. 7) Considering all facts we as a team feels that Novartis should grant with Gleevec patent or some modification should be done in Indian patent law to match up with the International Standards so there is clear understanding of the law and no in between lines remains.