The case between Novartis and Govt. of India

    The case between Novartis India and the Indian Government being heard in Chennai High Court highlights the importance of the law with respect to patented drugs. The entire world is watching this case. I am giving the facts of the case as given by update of Lawyers collective HIV/AIDS Unit consisting of four lawyers.     The case between Novartis India and the Indian Government being heard in Chennai High Court highlights the importance of the law with respect to patented drugs. The entire world is watching this case. I am giving the facts of the case as given by update of Lawyers collective HIV/AIDS Unit consisting of four lawyers.

            In 1997 Novartis AG, the Swiss company filed a patent application in the Chennai patent controller's office for the β- crystalline form of Imatinib Mesylate, brand name Glivec, on the ground that they invented the beta crystalline salt form of the free base, imatinib. The patent application was kept in the mail-box and not opened until 2005 as the TRIPS Agreement permitted developing countries from 1^st January 2005. In March 2005, with retrospective effect from 1^st January 2005, the Indian parliament enacted the patent law to protect product patents. Section 3d of this amendment is a significant provision meant to prevent ever greening and section 3 itself defines various forms of non patentable subject matter.

            In the meantime Novartis had got the Exclusive Marketing Rights (EMR) for marketing Gleevec in the Indian Market and on that basis got orders (from Chennai High Court) preventing some of the generic manufacturers from manufacturing generic equivalents of Gleevec. The earlier scene was, since 1993 Novartis held a product patent over Imatinib. But since, in India product patent was not respected till January 2005, many generic companies such as Natco, Cipla, Hetero, Ranbaxy etc. were producing the equivalent of Glivec and supplying it to the world at a very low price. Novarties was selling Glivec at US dollars 2666 per patient per month. Generic Companies were selling their generic versions at US dollars 177 to 266 per patient per month.

            Then, after obtaining EMR and preventing generic manufacturers from producing Glivec (as the price of Glivec climbed high) went on and awaited the consideration of its patent application. As the patent office in Chennai took up the patent application, the CPAA (Caner Patients Aid Association) filed a pre-grant opposition (which the amended IPA 1970 provided for) against Novartis application. This pre-grant opposition claimed among other things, that

1. Novartis' alleged "invention" lacked novelty.
2. It was "obvious" to a person skilled in the art
3. It was "merely" a "new form" of a "known substance"
4. It did not enhance the substance's efficacy
5. And so was not patentable under section 3(d) IPA 1970.

In January 2006, the Patent Controller in Chennai, in a landmark decision, refused to grant Novartis a patent agreeing with the contentions of CPAA and the generic companies that the subject application lacked novelty, was obvious and was unpatentable under section 3(d) of the Act.

      The patent rejection implied that Cipla, Ranbaxy etc. companies could manufacture and market their drug, both in India and abroad which they promptly started doing again. They started supplying imatinib to the world at one-tenth of the price chanrged by Novarties.

      However in May 2006, Novartis filed writ petitions before the Chennai High Court, claiming that the patent controller erred in rejecting its patent application and further claiming that section 3(d) was, among other things, vague, ambiguous and contrary to the requirement of TRIPS.

Novartis argued that

1. Imatinib mesylate was granted patent in 35 other countries
2. The Patent controller disregarded the case law placed before him
3. An in-house laboratory test performed by Novartis scientists on rates showed a 30% increase in bioavailability [thus there is enhanced efficacy]
4. Section 3(d) was not in compliance with the TRIPS agreement
5. 3(d) is in violation with the government's (non-enforceable) constitutional duty to harmonize its domestic laws with its international obligations.

The term "efficacy" in section 3(d) is vague and ambiguous and hence 3(d) is unconstitutional.

            It is open for Indian Parliament to repudiate its international obligations altogether, but it is invalid and unconstitutional for parliament to otherwise comply with TRIPS except for one particular provisions.

            The CPAA and the generic companies argued that

            It is not open to private companies or the Indian courts to decide whether the Indian Patent Law is TRIPS compliant or not.

            The Patent amendment was not in violation of any of the fundamental rights of the Indian Constitution.

            It was passed by a competent legislative.

            So this cannot be challenged.

            So this is the case going on even now in the Chennai High Court. Many voluntary organizations, many governments of sovereign countries are watching this case and they are fervently praying for a win for the government of India.

            This is because India today is a crucial source of affordable generic medicines, and 84% of the AIDS drugs used by poor countries to treat over 60,000 patients are generics from India.

            So the question today is : should India, which is producing quality drugs at low prices - to be used by the poor and needy of the world - be allowed to go on like this?