This is a landmark case in the history of Indian patent system. On April 2013, the Supreme Court of India confirmed the rejection by the Indian Patent Office of a patent application (Patent number: 1602/MAS/1998) filed by Novartis International AG (hereinafter referred as Novartis) a Swiss drug maker. It was regarding beta crystalline form of imatinib mesylate and is the most stable form which Novartis formulated into an anti-cancer drug “Gleevec”. The Supreme Court (hereinafter referred as “the Court”) considered that Gleevec did not qualify as a patentable “invention” under Section 3(d) of the Indian Patents Act. Brief facts of the case are as follows:
- Novartis, one of the largest international pharmaceutical company filed an application as per the TRIPS agreement before the Madras Indian Patent Office in 1998 for grant of a patent for an anticancer medicament ‘Gleevec’.
- This drug was used against “Myeloid Leukaemia” and “Gastrointestial Stromal Tumours”, made from beta crystalline form of “Imatinib mesylate”.
- The Indian Patent Office rejected this application in 2006 based inter alia on the failure by Novartis to show “significantly enhanced efficacy” of the beta crystalline form over its original salt as required under Section 3(d) of the Indian Patents Act, 1970.
- The said drug did not exhibit any major changes in the therapeutic efficacy over its pre-existing form.
- In 2006, Novartis filed 2 writ petitions in Madras High Court under Article 226 of the Constitution of India. The first appeal stated that Section 3(d) of Patents Act, 1970 is unconstitutional and second appeal was against the order passed by Madras Patent Office.
- The Madras High Court held that the alleged offending provision is not a violation of Article 14 of the Constitution of India and transferred the case to the Intellectual Property Appellate Board [IPAB] in the year 2007.
- The IPAB overturned the patent controller’s findings on novelty and inventive step of beta crystalline form. However, Novartis alleged invention did not satisfy the test of Section 3(d). It is to prevent ever-greening of already patented product. Hence, IPAB rejected the appeal and refused to grant patent to Novartis.
Section 3(d) of the Indian Patent Act, 1970 is as below:
“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, is not patentable.”
After this, Novartis filed a Special Leave Petition before the Supreme Court of India in 2009 against the order passed by IPAB.
Issues
The main issues before the Hon’ble Court were:
- Whether the invention was inconsistent with respect to Section 3(d) of the Indian Patent Act, 1970?
- What according to Section 3(d) of Patents Act, 1970 the meaning of Efficacy and a known substance?
- Whether the claim by Novartis i.e. Beta crystalline form of “imatinib mesylate” more efficacious than the derivative form of “imatinib mesylate” is valid?
Arguments by the parties
- By Plaintiff i.e., Novartis
- Novartis contented that there is no clarity as to what constitutes “enhancement of efficacy” and “significant enhancement of efficacy” as required; therefore, the law is vague and led itself to arbitrary decision.
- Novartis challenged the IPAB’s finding on Section 3(d). They argued that this provision related to “discoveries” doesn’t apply to its patent application which satisfies the criteria of novelty, inventive step and industrial application and is an “invention” under Section 2(1) (j) of the Patents Act, 1970.
- Furthermore, they argued that the IPAB’s holding paid no attention to the fact that they held the beta-crystalline is an invention and passed the novelty test and then they applied Section 3(d), relating to discoveries and refused to grant a patent to Novartis invention.
- Disputing the IPAB’s holding that the term “efficacy” means therapeutic efficacy, they argued that one term in the statute could not have two different meanings. It was only the beta crystalline form of imatinib mesylate that had therapeutic effect unlike the original forms.
- They pleaded that improved biodiversity and thermodynamic stability are properties that improved efficacy and the beta crystalline form of imatinib mesylate manifested both these properties.
- Section 3(d) could only be applied for substance already in existence and urged that such efficacy had never been established for imatinib, it is not possible to demonstrate enhanced efficacy of the beta-crystalline form of imatinib mesylate.
By Defendants i.e., Union of India & Ors.
Various arguments were brought before the Apex Court but the focus was on proving that:
- Beta crystalline form of imatinib mesylate is neither new (novel) nor is it non-obvious due to publications about imatinib mesylate in Cancer Research and Nature in 1996, and that the efficacy as referred in the section 3(d) should be interpreted as therapeutic efficacy and not just physical efficacy.
- The respondents also quoted extensively from the Doha Declaration, they took excerpts from parliamentary debates, various petitions by NGOs, WHO, etc. to highlight the public policy dimension of the arguments relating to easy affordability and availability of life saving drugs.
Judgement
Court relying on various judgements held that:
“The Hon’ble Supreme Court held that imatinib mesylate lacked novelty, as it was already included in the claims to the original substance imatinib. The court analyzed a number of scientific articles that describe not only the free base i.e. imatinib but also its salt form i.e. imatinib mesylate. Court also stated that a patent holder cannot claim a wide scope of an existing patent in infringement litigation but then claim a narrow scope of the same patent in the context of examining novelty of a salt derivative. The court accepted the IPAB’s views that the beta crystalline form could not be considered novel, it did not meet the requirement of enhanced efficacy under Section 3(d) of the Patents Act and therefore constituted no patentable “invention”. The term efficacy refers to “therapeutic efficacy”. The true intention to enact section 3(d) was to prevent the concept of ever-greening of patents and thus without fulfilling the test in Section 3(d) no patent can be granted. It was also held that improved bioavailability does not necessarily result in improved therapeutic efficacy. Novartis claimed 30% increase in bio-availability which was held insufficient. This patent doesn’t bring out any improved efficacy in beta form. In this case, the Court emphasized that Novartis had failed to submit any evidence to show that increased bioavailability of the beta crystalline form actually increased the therapeutic effect of the substance on the human body. The court further said that Section 2(1) (j) defines “invention” to mean, “A new product, but the new product in chemicals and especially pharmaceuticals may not necessarily mean something altogether new or completely unfamiliar or strange or not existing before. It may mean something “different from a recent previous”. Thus, in view of the findings it was held that the beta crystalline form of imatinib mesylate, failed the test of invention and patentability.”
The Supreme Court made it clear that India is a developing country and medicines should be available at an affordable price to safeguard the lives and protect the interests of billions of people. A reasonable and liberal approach must be followed to grant patents. Hence, the appeal filed by Novartis is dismissed. The judgement against ever greening of pharmaceutical patents garnered international support from various organizations.
By: Runjhun Sharma, School of Law, Mody University
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