The case of Novartis AG v. Union of India (Civil Appeal Nos. 2706-2716 of 2013), is the most distinguished judgment on the Patent rights in India. Novartis was not allowed to patent the drug ‘Imatnib Mesylate’ marketed under the name “Gleevec”, for lack of invention, novelty and non-obviousness. This judgment was decided on April 1st, 2013, by a 2-judge bench of the Supreme Court, constituting Hon’ble Justice Aftab Alam and Hon’ble Justice Ranjana Prakash Desai.
Novartis, the Swiss Company (Appellants) had filed in Chennai Patent Office a patent application for Imatinib Mesylate in the beta crystalline form on 17th July 1998 claiming July 18, 1997, as the priority date from Switzerland. At that time there was a different patent regime in India and therefore the appellants had made a mailbox application for which they got a grant of Exclusive Marketing Right on 10th November 2003 for a period of 5 years, and grant of a patent would be considered later.
When the grant of the patent was considered after January 1, 2005, the patent application attracted 5 oppositions under Section 25 (1) on the grounds of not being novel, being obvious, and also being barred under Section 3(d). The Assistant Controller of Patents and Designs before whom all the opposition matters were heard all the parties and rejected the appellant’s patent application on the ground that the claimed invention was already foreseen by an earlier publication, the Zimmermann patent; and therefore the invention was obstructed by the section 3(d) of the Act.
The Appellants challenged the orders of Assistant the Controller by filing writ petitions in the High Court of Madras. Two other writ petitions were also filed by the Appellants seeking that Section 3(d) of the Act is unconstitutional as it violates Article 14 of the Indian Constitution and that it does not comply with “TRIPS”.
After the constitution of Intellectual Property Appellate Board, the five writ petitions that challenged the orders of the Assistant Controller were moved from Madras HC to IPAB. The two other writ petitions which challenged Section 3 (d) were heard in the HC and subsequently dismissed by the judgment delivered on 6th August 2007. It was observed by the HC that the main purpose of Section 3 (d) was to avert evergreening; to give easy access to residents of the nation to various life-saving medications and to fulfil their commitment of providing quality healthcare service to the citizens of the country. This matter was not appealed any further.
The other appeals before IPAB were heard and dismissed on 26th June 2009. The findings of the IPAB were opposed to that of the Asst. Controllers’ on the aspects of anticipation and non-obviousness, but it concurred that the patentability of the subject was affected by Section 3 (d) of the Act. The IPAB 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 in relation to the high pricing of the drug. Hence, The IPAB refused the product patent to the beta crystal form of Imatinib Mesylate.
The decision of the IPAB was challenged by the appellants before the Supreme Court in the current matter.
Ø Whether the new invention ‘Imatinib Mesylate’ can be qualified to be a new patentable product?
Ø Whether the new product included any advancement in technology or pre-existing knowledge so that it comes under the category of non-obviousness?
Ø Whether the provisions of Section 3 (d) will be violated if the Patent is granted to the new invention?
Ø Whether Section 3 (d) is in violation of the provisions under TRIPS and also Section 14 of the Constitution of India?
Ø Section 2 (1) (j) of the Patent Act, 1970
This provision defines the expression ‘invention’ as “a new product or process involving a new product or process involving an inventive step and capable of industrial application.”
Ø Section 2 (1) (ja) of the Patent Act, 1970
This provision defines “inventive step” as “a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.”
Ø Section 3 (d) of the Patent Act, 1970
The clause (d) of Section 3 read as:
“3. What are not inventions – The following are not inventions within the meaning of this Act-
(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation – For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties regard to efficacy.”
The answer to the issues raised in this case depended on the chances of the appellant to get the Patent applied for i.e. Imatinib Mesylate. According to the definition of a ‘new invention’ in the Indian Patents (Amendment) Act, 2005, it is laid down that no invention which has been anticipated by any publication or taken in use in any part of the world before the date of filing of the application for patent which should include complete specification. In other words, it’s not a part of the public domain and also does not form a part of the State of the Art under Section 2 (1) (l).
Deciphering ‘inventive step’ as under Section 2 (1) (ja) of the above act, it means that the invention should include a technical advance when compared to the knowledge existing presently, or should attain an economic significance, or both which should ultimately make that invention as not obvious to any person who is skilled in that art.
Therefore, it can be derived from the above-mentioned definitions that any pre-existing thing or knowledge cannot be patented.
Section 3 (d) is important to note here as it prohibits the grant of Patent to any kind of derivative made out of known substances, but the exception is that such derivatives must show an “enhanced efficacy.” Now, post 2005 amendment, it is required under Section 3(d) that the invention for which a patent claim has been filed, shall be more efficacious than the ‘known substance’ out of which the newly claimed invention has been derived.
In the present case, the Appellants thought that it would be easier to prove greater efficacy for ‘Imatinib Free Base’ which is to be identified as the ‘known substance’ instead of ‘Imatinib Mesylate’. But the problem arises, as this was preceded by prior art & subsisted before the claimed invention, and therefore, it would come under the category of ‘known substance’.
While rejecting the argument of Novartis for a broader interpretation of the term ‘efficacy’, SC made it clear that it only included ‘therapeutic efficacy’. It was made clear that only those properties are relevant that directly connect to efficacy and not all advantageous or beneficial properties, and in cases of medicine, it is therapeutic efficacy.
On the issue of Bioavailability, it was said that it is the growth potential of a drug to dissolve in the bloodstream of a patient. It was decided that protection can be given under Section 3 (d) in case of a growth of 30% in bioavailability, also, if it can be proved that such increase can lead to greater therapeutic efficacy.
To further check the therapeutic efficacy, the efficacy of the claimed invention with the known substance was compared by the Court & reached the conclusion that the properties do not qualify under Section (d) as it does not contribute to an increase in ‘therapeutic efficacy’.
This judgment is much celebrated as it prevents the ever-greening of patented products and the Section-3(d) of Patent Act, 1970 prevents that the giant pharma corporations like Novartis in this case, cannot obtain a second Patent just by introducing minor changes in the pre-existing knowledge or technology. Novartis ultimately could not prove that the therapeutic efficacy of “Beta Crystalline form of Imatinib Mesylate” is higher when the comparison is made to the therapeutic efficacy of “Imatinib Mesylate”.
The Supreme Court held that the beta form of Imatinib Mesylate was not an invention as it was obvious 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 moreover a polymorph attracts Section 3(d) of the Act.
The Court interpreted the expression ‘efficacy’ under Section 3(d) of the Act, to be therapeutic efficacy meaning ability of the medicine to cure the disease. Hon’ble Justice Aftab Alam in his decision opined that the beta crystalline form of Imatinib Mesylate had failed the requirement of enhancement 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.
The Supreme Court upheld the rejection of a patent application made by Novartis and also upheld the validity of Section 3(d) and an amendment made to it and therefore, held it to be constitutional and also in consonance with the provisions of TRIPS as well.
The SC judgment comes as an immense help for those individuals who can’t bear the cost of the lifesaving drugs produced by the huge pharma colossus. These corporations earning billions of dollars keep individuals from buying the medications at lower prices in this way jeopardizing the very existence of the poor by getting the products patented. The significance of the patent can’t be denied if the accessibility of such an invention is provided to all the people at a reasonable price. Despite what might be expected, corporations like Novartis are setting a monopoly in the market and thereby putting the life of the poor individuals in question. In any case, this judgment clarified that India is a developing nation and the accessibility of drugs at a reasonable cost is vital for the lives of 1 billion individuals. The SC is right in its decision to prohibit the liberal approach and entertain only those inventions which are proved to be genuine and worthy while granting Patents.
Ø M/s. Cancer Patients Aid Association, NATCO Pharma Ltd., CIPLA Ltd., Ranbaxy Laboratories Ltd., Hetro Drugs Ltd filed the 5 pre-grant oppositions.
Samiksha hails from the Symbiosis International University and spends her most of the time volunteering for the NGOs. Her interest area lies in the latest judicial pronouncements and legal developments. Badminton, sketching and painting are her other interest areas. For any clarifications, feedback, and advice, you can reach her at firstname.lastname@example.org