In the case of Novartis AG vs Union of India & Others, the Supreme Court of India delivered a landmark judgment on April 1, 2013, that had far-reaching implications for the pharmaceutical industry, patent law, and public health. The case revolved around Novartis AG, a Swiss multinational pharmaceutical company, and its attempt to secure a patent for the beta crystalline form of a chemical compound called Imatinib Mesylate, a therapeutic drug used for chronic myeloid leukemia and certain kinds of tumors, marketed under the names “Glivec” or “Gleevec”.
Facts of the Case
Novartis AG filed an application for the grant of a patent for Imatinib Mesylate in beta crystalline form at the Chennai Patent Office on July 17, 1998. The company claimed that the beta crystalline form of Imatinib Mesylate had more beneficial flow properties, better thermodynamic stability, and lower hygroscopicity than the alpha crystalline form of Imatinib Mesylate. These properties, according to Novartis, made the beta crystalline form a new and superior product, as it stored better and was easier to process.
Issues Raised
The case raised several significant issues. The primary question was the interpretation of section 3(d) of the Patents Act, 1970, and its interplay with clauses (j) and (ja) of section 2(1). The court had to determine whether the beta crystalline form of Imatinib Mesylate qualified as a “new product” resulting from an invention that involved a technical advance over existing knowledge and was “not obvious” to a person skilled in the art. Even if the product satisfied these tests and qualified as an “invention” within the meaning of clauses (j) and (ja) of section 2(1), the court had to decide whether its patentability could still be denied on the grounds that section 3(d) excluded it from the category of “invention”.
Court’s Observations
The court was urged to strike a balance between promoting research and development in science and technology and minimizing private monopoly. Arguments were made about India’s obligation to comply with its commitments under international treaties, and counter-arguments were made to protect India’s status as “the pharmacy of the world”. The court was reminded of its duty to uphold the rights granted by the statute, and also that an error of judgment by it could put life-saving drugs beyond the reach of the multitude of ailing humanity not only in this country but in many developing and under-developed countries, dependent on generic drugs from India.
The court noted that the comparison of the properties of the beta crystal form of Imatinib Mesylate was made with its alpha crystal form. There was no claim of superiority of the beta crystal form of Imatinib Mesylate in regard to any property over the starting material Imatinib, or even over Imatinib Mesylate in amorphous form or any form other than the alpha crystal form.
The court also noted that the case fell in the transitional period between two fundamentally different patent regimes. In 1998, when the application was made on behalf of Novartis, the Patents Act, 1970, had a provision in section 5 that barred the grant of patent to substances intended for use, or capable of being used, as food or medicine or drug, or prepared or produced by chemical processes. The application was then put in the “mailbox” and was taken out for consideration when many changes had been made in the Patents Act, with effect from January 1, 2005, to make the patent law in the country compliant with the terms of an international agreement entered into by
the Government of India. The most significant change in the law was the deletion of section 5 from the Patents Act, which opened the doors to product patents in the country. However, the removal of section 5 was accompanied by amendments in clauses (j) and (ja) of section 2(1), as well as amendments in section 3, which redefined the concepts of invention and patentability.
The Verdict
The Supreme Court of India rejected Novartis AG’s application for a patent for the beta crystalline form of Imatinib Mesylate. The court held that the patentability of the subject product was hit by section 3(d) of the Act. The court observed that since India has a requirement of a higher standard of inventive step by introducing the amended section 3(d) of the Act, what is patentable in other countries will not be patentable in India. The court also referred to the pricing of the drug Gleevec by Novartis while it enjoyed EMR over it, and held that the patentability of the subject product would also be barred by section 3(b) of the Act.
Implications of the Judgment
The judgment had far-reaching implications for the pharmaceutical industry, patent law, and public health. It set a precedent for the interpretation of section 3(d) of the Patents Act, 1970, and its interplay with clauses (j) and (ja) of section 2(1). The court’s decision also highlighted the need to strike a balance between promoting research and development in science and technology and minimizing private monopoly. The judgment underscored the importance of making life-saving drugs accessible to the multitude of ailing humanity not only in India but in many developing and under-developed countries, dependent on generic drugs from India. The case also underscored the importance of India’s commitment to its obligations under international treaties and the need to protect India’s status as “the pharmacy of the world”.