Novartis v. Union of India [CIVIL APPEAL Nos. 2706-2716 OF 2013]
This is a landmark case in which the Hon’ble Supreme Court of India on 1st April 2013 held that the appellants, a Swiss based pharmaceutical company having business in India Novartis AG was not entitled to patent beta crystalline form of the compound Imatinib Mesylate, a therapeutic drug for chronic myeloid leukaemia and certain kinds of tumours, marketed under the name “Glivec” or “Gleevec” for the lack of invention, novelty and patentability.
The facts of the case are as follows:
- Novartis Pharmaceuticals, a Swiss company, manufactured a drug named Glivec which consisted of compound named Imatinib Mesylate.
- The compound was originally invented by a drug chemist Jurg Zimmerman and was basically made out if derivatives of Nphenyl-2-pyrimidineamine.
- One was its derivatives was named Imanitib by World Health Organisation (WHO) as non-proprietary name which contained enzymes useful for the treatment of cancer in warm blooded animals.
- A patent for Imanitib and other derivatives was granted to Novartis by US PTO in 1996 and later it granted patent for a more stable compound i.e. beta crystalline form of Imanitib as well to Novartis.
- Novartis applied for patent of all the above stated derivatives in India as well in 1998. This application was took up for consideration in 2005 when India became party to TRIPS.
- In 2006 Madras Patent Office denied the patent application stating that it did not no therapeutic changes and enhance efficacy as claimed by the applicant were evident in the patent applied and that it was already patented outside India.
- This denial of Patent was based on S. 3(d) of Patent Act 2005.
- In 2006 Novartis filed two writ petitions in Hon’ble Supreme Court of India challenging
- The denial of patent application by the Madras Patent Office, and
- That S. 3(d) of the act was not in compliance with TRIPS and is vague, arbitrary and violates of Art. 14 of the constitution..
- The Madras High Court refused both petitions stating that firstly it did not had jurisdiction to decide upon the contravention of national laws with that of international treaties and secondly that S. 3(d) is not arbitrary as it was drafted to ensure easy access of life saving drugs to the people.
- The case was then put up in Intellectual Property Appellate Board which decided positively upon the new and inventive step argument of Novartis but denied patent grant as it was still in contravention of provision of S. 3(d) of the Act.
- The matter was then taken before the Supreme Court in the form of an SLP.
The issues that rose before the Hon’ble Supreme Court were as follows:
- Whether the product Imaninib Mesylate qualify as a new product in order to be patentable.
- Whether the product had characteristics that involves a technical advance over existing knowledge which would make the invention non obvious to a person skilled in the art.
- Whether the grant of patent will violates provisions of S. 3(d) of the Act.
- Whether S. 3(d) was in contravention of provisions of TRIPS and was arbitrary and violative of Art. 14 of Constitution.
Judgement and decision
The Supreme Court observed and held as follows:
- Mischief rule was applied to S. 3(d) of the act and it was held that the purpose of the said section is evergreening and easy access of life saving medicines to the people so as to ensure constitutional objective of better health care for the citizens.
- Section 3(d) was also found after many discussions not to be in contravention of provisions of TRIPS but complies by the basic precepts of it.
- The amendment made in S. 3(d)was to provide for a second tier check for the pharmaceutical and chemicalproducts so as to avoid any repetitive effort to get patent and at the sametime leave doors open for the new and true inventions to get patent.[
- The Hon’ble court on the issue of novelty and technical advance stated that for a medicine to be novel, ‘therapeutic efficacy’ needs to be proved. But in this instance, the enhanced efficacy as claimed by the appellants may be beneficial to some patients but still it did not meet all the parameters to be claimed as increased therapeutic efficacy.
- It was stated therefore that the essential of novelty could not be seen in the product Imanitib Mesylate as it was already a derivative patented by Zimmermann and there was no technical advance sufficient in the existing knowledge that would make the invention not obvious to a person skilled in the art.
- Since all pharmaceutical properties of beta crystalline form of Imanitib Mesylate were present in the previous substance Imanitib in its free form, requirement of newness could not be sufficed in the application.
- So, the product Imanitib Mesylate could not be held to be a new product according to the requirement of S. 2(1)(j) and 2(1)(ja) and therefore Madras Patent Office was held to be right on denying the patent in first place.
- Hence the Supreme Court by this judgement upheld the rejection of patent application made by Novartis for Glivec before the Madras Patent Office in year 1998.
- Supreme court also upheld the validity of S. 3(d) and amendment made to it and thereby held it constitutional and in compliance with the provisions of TRIPS as well.