Case Study: Novartis A.G v. Union of India
Author: Shaik Abdul Matheen
One of the largest international pharmaceutical giants, Novartis, the Swiss Company, applied in 1998, as per the TRIPS agreement before the Chennai Indian patent office for the grant of a patent for an anti-cancer drug 'Glivec' which is used to treat Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumours (GIST) invented from Beta crystalline form of "Imatinib mesylate". This drug is popularly utilized in the treatment of cancer and has also been patented in more than 35 countries.
The pharmaceutical giant Novartis filed a patent application, the grant was restricted to methods but not the products in India as mentioned in Section-5 of Patent Act, 1970. After the Patent (Amendment) Act, 2005 section-5 was revoked and patents were to be granted for methods or processes but also products.
The patent application of Novartis for the drug “Glivec” was taken into consideration and the same was rejected by Madras Patent Office in 2005 on the ground that the drug was anticipated by prior publication and failed to satisfy the requirement of novelty and non-obviousness, further asserted that the alleged invention as un-patentable under the provision of section-3(d) of Patent Act, 1970 as the said drug did not manifest any major changes in therapeutic efficacy over its pre-existing form i.e. Zimmermann patent.
Novartis filed two writ petitions after that in Madras High Court in the year 2006 under Article-226 of Constitution of Indiaand it does not comply with “TRIPS”. And it also violates Article 14 of the Indian Constitution. And then in 2007,the Madras High Court transferred the case to IPAB. The other appeals before IPAB were dismissed in 2009. IPAB observed thatthe patentability of the subject was affected by Section 3 (d) of the Act and it noted that India has a higher standard of the requirement of inventive steps by establishing Section 3(d) of the Act. The IPAB also made observations about the high pricing of the drug, which resulted in the refusal of the product patent to the beta crystal form of Imatinib Mesylate.
1. Whether the new invention ‘Imatinib Mesylate’ can be qualified to be a new patentable product?
2. Whether the new product included any advancement in technology when compared to the preexistingform i.e., Zimmermann patent?
3. Whether the provisions of Section 3 (d) will be violated if the Patent is granted to the new invention?
4. Whether Section 3 (d) violates the provisions under TRIPS and also Section 14 of the Constitution of India?
The Apex Court held that the beta form of Imatinib Mesylate was not an invention as it was evident from the teachings of Zimmermann’s Patent for the free base form of Imatinib Mesylate, and its properties were also known. Thus, it did not meet the requirements of “invention” as mentioned in Section 2(1) (j) and (ja) of the Patent Act, 1970. It was further held that the beta crystalline form of Imatinib Mesylate being a pharmaceutical substance and a polymorph attracts Section 3(d) of the Act.
Hon’ble Justice Aftab Alam in his decision opined that the beta crystalline form of Imatinib Mesylate had failed the requirement of improvement of efficacy in Section 3(d) and is thus, not patentable. Therefore, the Court while dismissing the appeals stated that the beta crystalline form of Imatinib Mesylate failed in both the tests of invention, as under the clause (j) (ja) of Section 2(1) and patentability, as under the clause Section 3 (d) of the Act.
Hence, it cannot be granted a patent if that does not fulfill the test of section 3(d) the division bench further notified that the patent applicants should further notice that there is a significant improvement in therapeutic efficacy and hence is patentable under Indian Law.
As the Apex Court’s Judgement gave a huge relief to the masses who cannot afford the lifesaving drugs manufactured by the pharmaceutical giants. These companies sell these lifesaving drugs at a very high price and the majority of the people cannot afford this. The SC mentioned that there should be a clear and significant improvement from the pre-existing substance and also that it must be at a cheaper rate as India is a developing country and also a very populated country. And also, Section-3(d) of Patent Act, 1970 prevents obtaining a secondary patent for minor changes in the preexisting formula by these international pharmaceutical giants. It was also stated that the patent will be granted only to genuine inventions as against superficial inventions. So as Novartis failed to prove the improvement in therapeutic efficacy the application for the patent was rejected by the Supreme Court.
(1) Novartis A.G. (vs) Union of India &Ors. CA No. 2706-2716 of 2013, https://indiankanoon.org/doc/165776436/
Mohammad Suleman Palwala, A Study on: Novartis AG v. Union of India, Mondaq, https://www.mondaq.com/india/patent/826478/a-study-on-novartis-ag-v-union-of-india