The Gleevec Verdict: India's Supreme Court Draws the Line Against Evergreening in
Novartis AG Vs Union of India:Invention" and "patentability" are distinctly separate concepts under the Patents Act, 1970
Introduction
Few patent law judgments anywhere in the world have generated as much attention, debate, and global consequence as the Supreme Court of India's decision in Novartis AG v. Union of India, delivered on April 1, 2013. At its core, this case was about a cancer drug called Gleevec or Glivec, marketed by Novartis AG, a Swiss multinational pharmaceutical giant, and whether the drug's active substance in a particular crystal form deserved a patent in India. But the implications reached far beyond one drug or one company. The judgment went to the very heart of the tension between the rights of patent-holding pharmaceutical corporations and the right of millions of patients in developing countries to access life-saving medicines at affordable prices. It also addressed, for the first time with such depth and clarity by the Supreme Court, the meaning of "evergreening," the controversial practice by which pharmaceutical companies seek to extend their patent monopoly by making minor tweaks to an already known substance and claiming a fresh patent for the slightly modified version. The Court's ruling was a resounding rejection of Novartis's patent claim and a definitive statement that Indian patent law, as amended in 2005, imposes a high bar for the patentability of pharmaceutical products, one that is deliberately higher than that set by many Western patent systems.
Factual and Procedural Background
The story of this litigation begins with a German scientist named Dr. Jürg Zimmermann, who invented a class of compounds , ne of these compounds was Imatinib, which was found to have remarkable anti-tumoral properties and became the key ingredient in a drug for the treatment of chronic myeloid leukaemia and certain types of tumours. Dr. Zimmermann filed an application for patent for these compounds in the United States on February 4, 1993, which later became US Patent No. 5,521,184, granted on May 28, 1996. This patent, commonly called the Zimmermann Patent, covered Imatinib and its pharmaceutically acceptable salts, including Imatinib Mesylate, which is the methanesulfonic acid addition salt of Imatinib. After Ciba Geigy merged with Sandoz in 1996, the resulting company became Novartis AG, the appellant in this case.
Gleevec or Glivec, as it is known commercially, is directly derived from the Zimmermann Patent. Novartis has always maintained that Gleevec is fully covered by Zimmermann Patent No. 5,521,184. In the United States, Novartis sought and obtained extension of the Zimmermann Patent's term for the period of regulatory review for Gleevec. When a US company called NATCO sought to market its drug Veenat 100 (containing Imatinib Mesylate as its active ingredient) in the United Kingdom, Novartis successfully stopped it on the basis of the Zimmermann Patent. Before filing its Indian patent application, Novartis made an application in 2002 for the grant of Exclusive Marketing Rights (EMR) for the subject product under Section 24-A (since omitted) of the Patents Act, 1970. The Patent Office granted EMR to the appellant in 2003.
Now comes the critical point of the case. Novartis AG filed an application on July 17, 1998, before the Indian Office of Controller of Patents and Designs, for grant of a patent not for Imatinib or Imatinib Mesylate (the known salt), but specifically for the beta-crystalline form of Imatinib Mesylate, which Novartis referred to as beta-IM or β-IM. The priority date claimed was July 18, 1997, being the date on which the patent was applied for in Switzerland. The Indian Patent Office put the application on hold by adopting the mailbox procedure on account of expected changes in the patent regime in India. It was only after the Patents Act, 1970, was amended in 2005, that the application was taken up for consideration.
On January 25, 2006, the Assistant Controller of Patents vide five separate orders rejected the appellant's patent claim for β-IM, holding that the invention claimed by the appellant was anticipated by prior publication, specifically by Zimmermann Patent No. 5,521,184, and that the same was obvious to a person skilled in the art in view of the disclosures provided in Zimmermann Patent No. 5,521,184 specifications. The Assistant Controller further held that the patentability of the alleged invention was disallowed by Section 3(d) of the Patents Act as amended.
Aggrieved, Novartis appealed to the Intellectual Property Appellate Board (IPAB). By its order dated June 26, 2009, the IPAB held that although β-IM satisfied the test of invention/inventive step prescribed in Sections 2(1)(j) and (ja) of the Patents Act, 1970, it failed the test of enhanced efficacy prescribed in Section 3(d) thereof. The IPAB dismissed the appeals filed by the appellant on this ground. However, in a partial relief to Novartis, the IPAB held that the appellant could not be denied a process patent for the preparation of β-IM. The appellant challenged the IPAB order before the Supreme Court of India directly under Article 136 of the Constitution. The parties who had opposed the patent claim before the authorities below, including Cipla Ltd., NATCO Pharma Limited, the Cancer Patients Aid Association, and others, were permitted to file SLPs in the Supreme Court against the partial ruling in favour of the appellant regarding the process patent. Thus, all parts of the IPAB order were appealed against, and all issues were open for determination by the Supreme Court. The Civil Appeals before the Supreme Court were Civil Appeals Nos. 2706-716 of 2013 (with Civil Appeal No. 2728 of 2013 and Civil Appeals Nos. 2717-27 of 2013).
The Dispute
Before the Supreme Court, the central question was deceptively simple but deeply consequential: could Novartis AG obtain an Indian patent for the beta-crystalline form of Imatinib Mesylate (β-IM), which it marketed as Gleevec/Glivec for the treatment of chronic myeloid leukaemia? This question broke down into several layered issues.
The first was whether β-IM was a new substance altogether, or merely a new form of an already known substance. This was crucial because Section 3(d) of the Patents Act, 1970, as amended in 2005, specifically deals with the situation where a new form of a known substance is claimed for patent, and imposes a requirement that the new form must show significantly enhanced efficacy compared to the known substance.
The second was what the correct legal test for "invention" was under Indian law, specifically under Sections 2(1)(j) and 2(1)(ja) of the Patents Act, 1970. Did β-IM satisfy this test?
The third, and perhaps the most intensely debated, question was the meaning, scope, and applicability of Section 3(d) of the Patents Act, 1970, as amended by the Patents (Amendment) Act, 2005. Novartis strenuously argued that Section 3(d) was an exception provision, operating only in the manner of a caution or as an "ex majore cautela" clause, and that if an applicant passed the test of invention under Sections 2(1)(j) and (ja), it could not be denied a patent merely on the basis of Section 3(d). The respondents argued the opposite: that Section 3(d) represented an independent and additional tier of requirement for chemical substances and pharmaceuticals, deliberately designed to prevent evergreening.
The fourth question was what "efficacy" meant under Section 3(d) and its Explanation. Novartis argued that β-IM had enhanced bioavailability (it was 30% more bioavailable than Imatinib in free base form), and that bioavailability was a form of efficacy. The respondents argued that "efficacy" in the context of a medicine must mean therapeutic efficacy, that is, the ability to cure or treat the disease for which the medicine is prescribed, and that mere physicochemical properties or enhanced bioavailability did not constitute enhanced therapeutic efficacy.
Novartis submitted before the Supreme Court through its Senior Advocate Mr. Gopal Subramanium that both Imatinib Mesylate and β-IM were new products produced as a result of two inventions; that beginning from Imatinib-in-free-base-form, in a two-stage invention they first produced Imatinib Mesylate and then developed β-IM; that Zimmermann Patent No. 5,521,184 did not teach a person how to prepare Imatinib Mesylate from Imatinib-in-free-base; and that Section 3(d) operated only ex majore cautela and was not meant to be an exception to the test of invention. The respondents, including Cipla Ltd. through Senior Advocate Mr. Harish Salve and Mr. Harish Salve and Ranbaxy through Ms. Prathiba Singh, strongly opposed all these positions.
Reasoning and Analysis of the Court
This Supreme Court's judgment is a masterly piece of legal analysis that combines an examination of the statutory provisions, their legislative history, the parliamentary debates, international treaty obligations, and the specific facts of the case.
The Court began by setting out the framework of the Patents Act, 1970, noting that "invention" and "patentability" are two distinctly separate concepts under Indian law. Section 2(1)(j), which defines "invention," requires a new product or process involving an inventive step that is capable of industrial application. Section 2(1)(ja) defines "inventive step" as a feature of an invention that involves technical advance as compared to existing knowledge or economic significance, or both, and that makes the invention not obvious to a person skilled in the art. Section 2(1)(ac) defines "capable of industrial application" as a product that is capable of being made or used in an industry. Together, these provisions mean that to qualify as an invention under Indian law, a product must be new (not anticipated), must involve an inventive step (not obvious), and must be capable of industrial application. The Court emphasized that something may be an "invention" in the general sense and yet may not qualify as a patentable invention under the 1970 Act, and something may even satisfy the definition of "invention" under the 1970 Act and yet be denied a patent for other larger considerations, as stipulated in Section 3 of the Act.
Section 3 of the Patents Act lists things that "are not inventions within the meaning of this Act." Section 3(d), as amended in 2005, is the provision that became the epicenter of this litigation. It states that the following shall not be deemed to be an invention: "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." The Explanation to Section 3(d) is equally significant: "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."
The Court then undertook a detailed examination of the legislative history and parliamentary debates around the 2005 amendment to determine the precise intent of Section 3(d). The Court found that India had an absolutely unenviable task in amending the Patents Act, 1970, to make it TRIPS-compliant without compromising on public health considerations. The TRIPS Agreement had aroused grave concerns about its impact on public health, particularly the inverse relationship between product patents in pharmaceuticals and the availability of essential medicines at affordable prices. The Court noted that India had, after the patent system in India barred the grant of patents for pharmaceutical and chemical substances, developed a pharmaceutical industry that became a major supplier of drugs at cheap prices to a number of developing and underdeveloped countries. Ninety per cent of the drugs India had been supplying to sub-Saharan Africa for treating AIDS were generic drugs whose prices had dramatically fallen because of the competition. The reintroduction of product patents in the Indian patent system through the TRIPS Agreement became a cause of alarm, particularly from the standpoint of public health and the supply of medicines to poor countries.
In Parliament, the government introduced Section 3(d) as the specific provision that would prevent the abuse of product patents in pharmaceutical substances and check the practice of evergreening. In fact, the Court noted that the whole Parliamentary debate on the Patents Amendment Bill centred on medicines and drugs, with about 80% of the debate focusing on medicines and drugs and the remaining 20% on agricultural chemicals. The Court held that the amended portion of Section 3(d) of the 1970 Act sets up a second tier of qualifying standards for chemical substances and pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.
On the question of whether Section 3(d) was an ex majore cautela clause or an independent substantive provision, the Court firmly rejected Novartis's argument. The Court held that Section 3(d) is not a provision ex majore cautela and is applicable to the subject product β-IM. The submission of Novartis that Section 3(d) has no application to the subject product because it has satisfied the tests of invention as provided in Sections 2(1)(j) and (ja) was completely misconceived, for the reason that Section 3 was designed to defeat an application for patent which passed through the definition of invention. Section 3 was not a mere cautionary provision; it was a substantive disqualifying provision. If clause (d) is isolated from the rest of Section 3, and the legislative history behind the incorporation of Chapter II in the Patents Act, 1970, is disregarded, then it may be possible to see Section 3(d) as an extension of the definition of "invention" and to link Section 3(d) with Sections 2(1)(j) and (ja). In that case, on reading Sections 2(1)(j) and (ja) with Section 3(d), it would appear that the 1970 Act sets different standards for qualifying as "inventions" — for medicines and drugs and other chemical substances, the 1970 Act sets the invention threshold further higher, by virtue of the amendments made in Section 3(d) in the year 2005.
Next, the Court turned to the specific facts to determine whether β-IM was covered by Zimmermann Patent No. 5,521,184. Novartis had argued that Zimmermann Patent No. 5,521,184 did not teach how to prepare Imatinib Mesylate from Imatinib free base. The Court examined the Zimmermann Patent in painstaking detail, noting that the patent related to N-phenyl-2-pyrimidine-amine derivatives, that Example 21 in the patent exemplified Imatinib (referred to as CGP 57148), and that Claim 23 listed Imatinib along with its pharmaceutically acceptable salts. A key article from the journal Cancer Research, published in January 1996, further showed that even before the Indian patent application, there was a detailed discussion about the anti-tumoral properties of Imatinib and its methanesulfonate salt (i.e., Imatinib Mesylate), with CGP 57148B referring specifically to Imatinib Mesylate. Critically, the US Board of Patent Appeals, in the case of the appellant itself, when granting US Patent Zimmermann Patent No. 6,894,051 B1 for β-IM, had proceeded on the basis that Zimmermann Patent No. 5,521,184 had the teaching for making of Imatinib Mesylate from Imatinib for any person skilled in the art. The Court noted the deeply ironic position Novartis found itself in: in the United States it had always maintained that Gleevec was part of Zimmermann Patent No. 5,521,184, used that position to extend the patent term, and relied on the Zimmermann Patent to stop NATCO from marketing its generic drug in the UK. But before the Indian authorities, it was now claiming that Imatinib Mesylate was not taught by or covered by the Zimmermann Patent. The Court held that Novartis was bound by the finding recorded in its own case in the United States. Accordingly, "Imatinib Mesylate" was a known substance under Zimmermann Patent No. 5,521,184. Therefore, β-IM was a new form of a known substance, and Section 3(d) was directly applicable.
On the question of what "efficacy" means for the purposes of Section 3(d) of the Patents Act as applied to medicines, the Court adopted a strict and narrow interpretation. The Court referred to the New Oxford Dictionary of English (1998 Edition) which defines "efficacy" as "the ability to produce a desired or intended result." The Court held that the test of efficacy in each case would depend upon the function, utility or purpose of the product under consideration. In the case of a medicine, the efficacy must be its therapeutic efficacy — its ability to produce the desired therapeutic result, meaning to cure or treat the disease for which it is prescribed. The Court held that mere improvement in physicochemical properties like better flow, thermodynamic stability, lower hygroscopicity, and enhanced bioavailability do not automatically lead to an inference of better therapeutic efficacy. It was absolutely clear, the Court stated, that the physico-chemical properties of β-IM, namely more beneficial flow properties, better thermodynamic stability, and lower hygroscopicity, had nothing to do with therapeutic efficacy. On bioavailability, the Court noted that Novartis claimed that β-IM had 30% increased bioavailability compared to Imatinib in free base form. However, even accepting this claim, the Court reasoned that bioavailability by itself may not necessarily lead to enhanced therapeutic efficacy. The Court relied on a medical commentary which stated that bioavailability studies are meant to determine the rate and extent of absorption of a drug substance; if a drug product is not bioavailable, it cannot be regarded as effective, but a determination that a drug product is bioavailable is not in itself a determination of effectiveness. The Court further noted that the enhanced therapeutic efficacy of β-IM over Imatinib Mesylate had to be specifically claimed and established by research and empirical data, and this had not been done. Indeed, the Court pointed to the clear and unambiguous averments in the subject Indian patent application, in which all the references were to Imatinib in free base form (or to the alpha crystalline form of Imatinib Mesylate in respect of flow properties, thermodynamic stability, and lower hygroscopicity), but there was no claim of any therapeutic advantage for β-IM over Imatinib Mesylate itself.
The Court also addressed an important factual point regarding the drug Gleevec as actually marketed in India (and also in the United States). Gleevec/Glivec was described on its package as "Imatinib Mesylate tablets 100 mg" with no reference to β-IM at all. This meant that the claim for a patent for β-IM was actually an attempt to obtain a patent for "Imatinib Mesylate," which would otherwise be impermissible given the Zimmermann Patent's coverage. The Court found this an attempt to obtain patent for "Imatinib Mesylate" which would otherwise be impermissible.
The Court also addressed the broader principle of patent coverage versus patent disclosure. Indian patent law, the Court held, does not permit the scope of patent coverage or claims to be wider than the disclosures or teachings contained in the patent. A limited monopoly is granted to the patentee in return for making his knowledge available to the public domain. Patent coverage or claim cannot be wider than the disclosures and teachings contained in the patent. This was significant because Novartis, in claiming that its Indian patent application covered a new and separate product from the Zimmermann Patent, was effectively trying to claim protection beyond what it had disclosed.
The Court also rejected Novartis's argument that Indian patent law should be aligned with the standard of a "manipulative step" used in United States patent law. In the United States, when the US Board of Patent Appeals granted β-IM a patent, it recognized it as involving a "manipulative step" which may not necessarily involve an "inventive step." The Court held that the standard under Indian law is "inventive step," not "manipulative step," and the two are clearly different things. The requirement of "inventive step" under Indian law is a higher standard than the "manipulative step" recognized in the US context. Indian patent law, the Court stated, lays down a high requirement of "inventive step" in Section 2(1)(ja) and "enhanced efficacy" in Section 3(d) for incremental improvements of known substances or processes to qualify for patent protection. Standard of inventiveness is high under Indian patent law, and patent law in India should not develop in a manner where the scope of patent is determined based not on the intrinsic worth of the invention but by artful drafting of its claims by skilful lawyers, where patents are traded as a commodity not for production and marketing of patented products but to search for someone who may be sued for infringement.
Final Decision of the Court
The Supreme Court dismissed the appeals filed by Novartis AG. It held that the subject product, β-crystalline-Imatinib Mesylate (β-IM), failed both the test of invention under Sections 2(1)(j) and (ja) of the Patents Act, 1970, and the test of enhanced efficacy/patentability as laid down under Section 3(d) read with its Explanation. The Court therefore held that β-IM was not entitled to the grant of an Indian patent. The Court further dismissed the cross-appeals of the other parties (Cipla, NATCO, Cancer Patients Aid Association, and others) against the partial relief granted by the IPAB in favour of Novartis regarding the process patent, holding that the question of a process patent for β-IM was not strictly a part of the subject matter before the Court.
Points of Law Settled in the Case
This judgment settled several vital and enduring principles of Indian patent law, particularly in relation to pharmaceutical products.
The most foundational principle established is that "invention" and "patentability" are two distinctly separate and cumulative concepts under the Patents Act, 1970. A substance may satisfy the definition of "invention" under Sections 2(1)(j) and (ja) and yet be denied a patent if it fails the requirements of Section 3(d). Section 3(d) is not an ex majore cautela provision; it is a substantive, independent tier of qualifying standards specifically for chemical substances and pharmaceuticals.
The Court definitively interpreted the meaning of "efficacy" under Section 3(d) and its Explanation for the purpose of pharmaceutical products: efficacy means therapeutic efficacy, that is, the ability of the medicine to produce its desired therapeutic result in treating the disease for which it is prescribed. Mere improvements in physicochemical properties such as better flow, greater stability, lower hygroscopicity, or improved bioavailability do not by themselves constitute enhanced therapeutic efficacy unless it is specifically established with research and empirical data that the enhanced physicochemical property or bioavailability actually translates into enhanced therapeutic effect.
The Court established that a new pharmaceutical product in the context of Section 3(d) and its Explanation must not mean something entirely new or unfamiliar; it may mean something "different from a recent previous" product or a product "regarded as better than what went before" or a product "in addition to another or others of the same kind." Such new pharmaceutical products, however, must additionally pass the test of enhanced efficacy to qualify for patent protection.
The Court held that the standard of inventiveness under Indian patent law is high, deliberately set to require a genuine technical advance and not merely a manipulative step, in contrast to the US standard. This means that incremental improvements of known pharmaceutical substances or processes, unless they genuinely advance the state of the art in a way that is not obvious to a person skilled in the art and demonstrate enhanced efficacy, will not qualify for patent protection in India.
The Court settled the principle that the scope of a patent claim cannot be wider than the disclosure or teaching contained in the patent. The patentee's monopoly is limited to what has been disclosed in the patent specification. This prevents companies from using artful claim drafting to secure broader protection than they have actually invented and disclosed.
The Court also settled the principle that an applicant for a patent is bound by positions taken and findings recorded in patent proceedings in other jurisdictions, particularly when the applicant itself has relied on those findings. Novartis, having always maintained in the United States and elsewhere that Gleevec was part of the Zimmermann Patent, could not turn around and claim before Indian authorities that Imatinib Mesylate was not disclosed in the Zimmermann Patent.Case Details
Title: Novartis AG v. Union of India and Others
Date of Order: April 1, 2013
Case Numbers: Civil Appeals Nos. 2706-716 of 2013
Citation: (2013) 6 SCC 1
Name of Court: Supreme Court of India
Hon'ble Judges: Aftab Alam, J. and Ranjana P. Desai, J.
Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
Disclaimer: Readers are advised not to treat this as a substitute for legal advice as it may contain errors in perception, interpretation, and presentation.
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Headnote
Under the Patents Act, 1970, "invention" and "patentability" are two distinct and cumulative concepts. For a pharmaceutical or chemical substance that is a new form of a known substance, the applicant must satisfy not only the test of "invention" as defined in Sections 2(1)(j) and (ja) but also the separate and independent test of enhanced efficacy prescribed in Section 3(d) read with its Explanation. Section 3(d) is a substantive disqualifying provision and not an ex majore cautela clause. For the purposes of Section 3(d) of the Patents Act, 1970, and its Explanation, "efficacy" in the case of a medicine means therapeutic efficacy — the ability of the medicine to cure or treat the disease for which it is prescribed. Mere improvement in physico-chemical properties such as better flow, thermodynamic stability, lower hygroscopicity, or enhanced bioavailability does not constitute enhancement of known efficacy unless specifically established with research and empirical data to result in enhanced therapeutic effect. Beta-crystalline Imatinib Mesylate (β-IM), the active ingredient of the cancer drug Gleevec/Glivec, being a new form of Imatinib Mesylate, which was itself a known substance disclosed in Zimmermann Patent No. 5,521,184, failed both the test of invention and the test of enhanced efficacy, and was accordingly held not entitled to an Indian patent. The standard of inventiveness under Indian patent law is deliberately high and differs from the standard of a "manipulative step" recognized in United States patent law. Indian patent law disallows evergreening and sets up a second tier of qualifying standards for pharmaceutical products to permit genuine inventions while preventing repetitive patenting or extension of patent term on spurious grounds.
