The Gleevec Drug case “NOVARTIS AG V. UNION OF INDIA”CIVIL APPEAL NO. 2706-2716 of 2013.
Novartis AG v. Union of India, popular as the Gleevec Drug case is a landmark decision of the Supreme Court of India in the year 2013 upon the rights of a patent in India. The case corresponds to some major issues upon pharmaceutical IP protection under the Patent Act, 1970 and the accessibility of medicines in India. Supreme Court’s decision of restricting the “ever-greening” of the patents by the pharmaceutical companies upon their medicines is in favour of the public as they could have life-saving expensive medicines or drugs at affordable rates. In this case, S. 3(d) of the Indian Patent Act, 1970 was identified upon its scope.
The drug “Gleevec” medically named “Imatinib Mesylate” was invented by Novartis AG, a Swiss pharmaceutical corporation (Appellants), for the treatment of Myeloid Leukemia, blood cancer and Gastrointestinal Stromal Tumor, stomach cancer. The drug was patented in more than 40 nations but was facing trouble to get a patent in India. The company filed the patent application for the drug in 1997. But before 2005, patents were not granted over medicinal drugs and agrochemical inventions in India under Patent Act, 1970. In 2005, in compliance to the TRIPS agreement, such inventions became patentable subject matters.
FACTS OF THE CASE
Based upon the patent application filed in 1997, in 2003, the appellant got the right of exclusively marketing the drug in India for 5 yrs. In 2005, after the amendment in the Patent Act, 1970, the application was again filed in the Patent Office of Madras which further fall in the opposition clauses under S.25 (1) on the ground that it is not novel and is also non-patentable under S. 3(d) of the Act, 2005.
Therefore, it was rejected by the Controllers of Patent of Madras for being patented in India. Writ Petition was filed by the appellant in Madras High Court challenging the decision of the Controller of Patents and that S.3 (d) of the Act, 2005 is unconstitutional and against TRIPS agreement provisions. The claim of S.3 (d) being unconstitutional was dismissed by the court in 2007 whereas the other claim got transferred to Intellectual Property Appellate Board (IPAB).
The appellate board dismissed the claim on the petition based on the ground that the drug does not meet the high patentability requirements under S. 3(d) of the Act, 2005 and also the price of the drug is high. Then the matter moved to the Supreme Court of India challenging the decision of IPAB.
ISSUES BEFORE THE COURT
- Whether Gleevec can be patentable?
- What is the scope of S. 3(d) of the Indian Patent Act, 1970?
- Whether S. 3(d) will get violated if Gleevec will be patented?
- Whether S. 3(d) violates A.14 of the Indian Constitution and TRIPS Agreement?
RULES APPLIED BY THE COURT
- S. 2 (1) (j) of the Indian Patent Act, 1970
S. 2 (1) (j) defines “Invention” under the act, 1970 which defines “Invention” as a novel product or any process which involves a novel product or any inventive move which is capable of being industrially applicable.
- S. 2 (1) (ja) of the Indian Patent Act, 1970
S. 2 (1) (ja) defines “Inventive Step” under the act, 1970 which defines “Inventive Step” as “any feature of a particular invention which involves some technical aspect other than something existing or have some economical significance or both which does not make invention non-obvious to the inventor”
- S. 3(d) of the Indian Patent Act, 2005
S. 3(d) contains what all cannot be said as an invention under the act, 1970. Under S. 3(d), simply a discovery of a new version of any existing substance which also does not lead to the enhancement of the existing efficacy of a particular substance or discovery of any original property or any new usage of an existing substance, process, apparatus or a machine unless such unique process leads to a formation of any new product or forms at least a single unique reactant.
JUDGEMENT OF THE COURT
The 2 judges bench of Supreme Court of India constituting J. Aftab Alam and J. Ranjana Prakash Desai, held in its judgment in the Gleevec Drug case that Gleevec, a beta version of Imatinib Mesylate is not an invention as it is the resembling its character from the invention of Zimmermann whose free base version of Imatinib Mesylate is patented.
Thus, Gleevec does not meet the patentability requirements under S. 2(1) (j) and S. 2(1) (ja) of the Indian Patent Act, 1970. The court further held in the Gleevec Drug case that the Gleevec, being just a beta crystalline version of the Imatinib Mesylate with polymorphic character falls under S. 3(d) of the Indian Patent Act, 1970.
The court further interpreted “efficacy” as the ability of a particular medicine to alleviate disease. J. Aftab Alam was of opinion that Gleevec, being a beta crystalline version of Imatinib Mesylate, failed to achieve the requirement needed for enhancement of efficacy of a substance under S. 3(d) and so is non-patentable matter. While dismissal of appellant’s appeal, Supreme Court stated in the Gleevec Drug case that Gleevec has failed both the essential tests of being considered as an invention under S. 2(1) (j) and S. 2(1) (ja) and falls under S. 3(d) of the Indian Patent Act, 1970.
The Hon’ble Supreme Court also upheld the application made by the appellant for rejection of patent application and the question upon the validity of S. 3(d) under Act 1970 and 2005 and thereby held that S. 3(d) is constitutional and complies with the TRIPS agreement.
The answers to the issues considered in this case depend upon the probability of the appellant winning the case and getting a patent for Gleevec in India. As per the definition of “invention” under Amendment Act, 2005, none of the inventions which was anticipated by any of the publication or has been used anywhere across the world prior to the date on which application is filed for patent shall include overall specifications meaning thereby that it is not an element of public domain and State of an Art within S. 2 (1) (j).
Coming to S. 2(1)(ja) of the Act, 1970 it simply says that an inventive step is one which involves some technical speciality in the existing substance having economical significance and making such invention as non-obvious to a person skilled with such art. This states that nothing could be patented if pre-existed.
Now, S. 3(d) of the Act, 1970, provides for such inventions which cannot be patented. Prior to 2005, for any invention to get patented shall have an element of more efficacy than the existing one.
In this case, the appellants were of the view that it can be much easier to prove the enormous efficacy of “Free Base of Imatinib” which is not a pre-existing substance rather than the “Imatinib Mesylate”. However, the issue arose when the claimed invention pre-existed and was a known substance.
By rejecting the argument of the appellant for having a broad interpretation of “efficacy”, Supreme Court said that the word “Efficacy” only includes therapeutic efficacy” and only such properties of the substance is countable which attracts efficacy.
To confirm the therapeutic efficacy of Gleevec, the efficacy of Gleevec was checked with that of the pre-existing substance and after confirming the court concluded that any of the properties of the Gleevec does not have therapeutic efficacy.
The judgment is a celebrated judgment over patent rights as it restricted the ever-greening of the patent in India. Also, the appellant was prevented from getting a patent under S. 3(d) of the Act, 1970 for the reason that it cannot obtain another patent just by making some minor changes in the pre-existing similar substance. Thus, the appellant was unable to prove the therapeutic efficacy of Gleevec as a Beta Crystalline version of Imatinib Mesylate higher than the other pre-existing version.
This judgment of the Supreme Court on the Gleevec Drug case was of ultimate benefit for those peoples who could not afford expensive life-saving medicines and now they can avail so at affordable rates. With this judgment, the court has established that since India is a developing country, affording expensive medications is not easy for billions of people. Thus the accessibility of the expensive and life-saving drugs is important to be sold at reasonable and affordable rates. It has further restricted the liberal way of granting patents and thereby patenting an only authentic invention and not re-discovered one.
- A Study on: Novartis AG v. Union of India-Intellectual Property. Mondaq. https://www.mondaq.com/india/patent/826478/a-study-on-novartis-ag-v-union-of-india.
- Novartis Ag vs Union of India &Ors on 1 April, 2013. Indian Kanoon. https://indiankanoon.org/doc/165776436/.
- Novartis Ag v. Union of India, (2013) 6 SCC 1. Supreme Court Cases. https://www.supremecourtcases.com/.