NOVARTIS V. UNION OF INDIA & OTHERS
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By Navya Yadav[1]

In Supreme Court of India

NAME OF THE CASENovartis v. Union of India & Others
CITATIONAIR 2013 SC 1311,(2013) Civil Appeal No. 2706-2716 of 2013
DATE OF THE JUDGEMENT1 April, 2013
APPELLATENovartis
RESPONDENTUnion of India & Others
BENCH/JUDGEAftar Alam and Ranjana Prakash Desai
STATUTES/CONSTITUTION INVOLVEDIndian Patents Act, 1970 Constitution of India
IMPORTANT SECTIONS INVOLVEDIndian Patents Act, 1970– Section 3(d), 2(1)(j), 133, 24A. Constitution of India- Article 136

ASTRACT

The judgment of this case named Novartis v. Union of India proved to be one of the landmark judgements by Supreme Court of India. This case decision made a relief to millions of people around thr world so that they can have access to medicines at lower cost and it also prevented the pharmaceutical industries from getting their patents ‘evergreening’. The judgement focuses on availability of life saving drugs to people of India and elsewhere at affordable price it also defined the scope of Section 3(d) of Indian Patents (Amendment) Act, 2005. In this case Supreme Court refused to grant a patent to a drug of Novartis AG and said that the drug did not involve an invention which makes it capable enough to be patent under Indian Law.

INTRODUCTION

This case proved to be one of the landmark case in the history of Indian Patent System. Patent is a subset of intellectual property these are the kind of property which are intangible in form, thus granting of a patent provides a statutory right by state to inventor to exclude others from using, making or selling their inventions for the limited duration of 20 years. In this case the judgement was given by the two judge bench of Supreme Court of India, Novartis a pharmaceutical companie challenged the rejection of its patent application in Supreme Court of India wherein this challenge was also rejected by Supreme Court of India saying that the said drug drug did not produce an enhanced or superior therapeutic efficacy as compared to the known substance i.e.,“Imatinib Mesylate” means  that the said drug did not involved an inventive step the main reason for rejection of the patent application was to avoid ever greening of already patented products by introducing minor changes in it, the application by Novartis was rejected by Supreme Court on April 2013 for beta crystalline form of imatinib mesylate and is the most stable form which Novartis formulated into an anti-cancer drug “Gleevec”. Supreme Court said that the Gleevec does not qualify under Section 3(d) of Indian Patents Act[2].

FACTS OF THE CASE

Novartis was one of the largest international pharmaceutical company which filled an application before the Madras Indian Patent Office in 1997 as per the TRIPS agreement for grant of patent for an anticancer medicine named ‘Gleevec’. The drug was used against “Gastrointestinal Stromal Tumours” and “Myeloid Leukaemia”, the application was rejected by The Indian Patent Office in 2006 on failure by Novartis to show “significantly enhanced efficacy” of the beta crystlline form over its original salt as required under section 3(d) of Indian Patents Act, 1970.

In 2006 Novartis filed 2 writ petitions in High Court of Madras under article 226 of constitution. The appeal stated section 3(d) of Patents Act is unconstitutional as it is not in compliance with TRIPS and violated Article 14 of the Constitution and secondly the appeal was against the order passed by Madras Patent Office.

The case was further transferred to Intellectual Property Appellant Tribunal (IPAB) in 2007 the appeal was heard and dismissed by IPAB stating that that invention was satisfing the test of novelty as well as non-obviousness but the patentability of product was hit by Section 3(d) of the Patent Act. Novartis challenged the order passed by IPAB and filled Special leave petition before the Supreme court[3].

ISSUES RAISED BEFORE THE COURT

  1. Whether the invention of the drug is in consistent with the Section 3(d) of the patent act?
  2. What is the meaning of Efficacy according to Section 3(d) of the Patents Act, 1970?
  3. Whether the increase in bioavailability qualify as increase in therapeutic efficacy According to Section 3(d) of Patent Act, 1970?
  4. Whether invention of “ Beta crystalline form of imatinib mesylate” clamed by Novartis is more efficient than the substance from which it is derived from i.e. “ Imatinib Mesylate”?

ARUGUMENTS RAISED BY THE APPELLATE

  • 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 substances 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.

ARGUMENTS RAISED BY THE RESPONDENT

Many 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.

RELATED PROVISIONS

Indian Patents Act, 1970

Section 3(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 with regard to efficacy[4].

Section 2(1)(J)– invention” means a new product or process involving an inventive step and capable of industrial application; “inventive step” means 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[5].

Section133- Any country, which is a signatory or party or a group of countries, union of countries or intergovernmental organisations which are signatories or parties to an international, regional or bi‑lateral treaty, convention or arrangement to which India is also a signatory or party and which affords to the applicants for patents in India or to citizens of India similar privileges as are granted to their own citizens or citizens to their member countries in respect of the grant of patents and protection of patent rights shall be a convention country or convention countries for the purposes of this Act[6].

Section 24A- Application for grant of exclusive rights[7].

Constitution of India-

Article 136- Special leave to appeal by the Supreme Court

  • Notwithstanding anything in this Chapter, the Supreme Court may, in its discretion, grant special leave to appeal from any judgment, decree, determination, sentence or order in any cause or matter passed or made by any court or tribunal in the territory of India
  • Nothing in clause ( 1 ) shall apply to any judgment, determination, sentence or order passed or made by any court or tribunal constituted by or under any law relating to the Armed Forces.

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 the 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 a 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 the evergreening of pharmaceutical patents garnered international support from various organizations.

CONCLUSION

The SC judgement comes as a huge relief for those people who can’t afford the lifesaving drugs manufactured by these big pharma giants. These companies who have already made billions of dollars prevent people from purchasing the drugs at low price thus endangering the very life of the poor people by acquiring patents over their drugs. The importance of patent cannot be denied to prevent a new invention provided such invention is available to all the individuals at a reasonable rate. On the contrary, companies like Novartis are putting the life of these poor people at stake by obtaining a monopoly over its drugs. However, the Supreme Court in its judgement made clear that India is a developing country and the availability of medicines at a cheap price is necessary for the lives of 1 billion people. The Supreme Court is thus justified in its decision thereby prohibiting the liberal approach in granting patents and granting patents only to genuine inventions as against frivolous inventions.

[1] Author is 3th semester student of Amity Law School, Lucknow.

[2] Indian Kanoon, https://indiankanoon.org/doc/165776436/ ( Last Visited Jul. 22,2022).

[3] Blog Ipleader, https://blog.ipleaders.in/analysis-novartis-g-vs-union-india/ ( Last visited Jul. 22,2022).

[4] The Indian Patents Act, 1970, § 3(d) No.39, Act of Parliament, 1970(India).

[5] The Indian Patents Act, 1970, § 2(1)(j) No.39, Act of Parliament, 1970(India).

[6] The Indian Patents Act, 1970, § 133 No.39, Act of Parliament, 1970(India).

[7] The Indian Patents Act, 1970, § 24A No.39, Act of Parliament, 1970(India).

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