The Supreme Court’s ruling against Novartis’ patent claim for the cancer drug Glivec paves the way for generic drug companies to keep crucial, life-saving drugs affordable to the common people. By V. VENKATESAN

IN their 112-page judgment delivered on April 1, Justice Aftab Alam and Justice Ranjana Prakash Desai of the Supreme Court began with a simple proposition: in order to understand what the law really is, it is essential to know the “why” and the “how” of the law. In seeking to resolve the question whether the anti-cancer drug Glivec qualifies as an invention justifying Novartis’ claim for a patent under the Indian Patents Act, the Aftab Alam-Ranjana Prakash Desai Bench enquired into why the law is what it is and how it came to be in its present form.

This journey into the history and philosophy of patent legislation in the country enabled the Bench to note clearly the thin dividing line between patent and monopoly and what a blurring of this distinction could mean to making life-saving drugs affordable to patients suffering from serious ailments across the world. The Bench concluded that Glivec was not an invention and that Novartis had failed to prove its claims over its patentability.

The facts of the case were simple enough: Novartis, the appellant, challenged the June 26, 2009, order of the Intellectual Property Appellate Board (IPAB) rejecting its claim of a patent over Glivec. Natco Pharma Ltd, a generic drug company, and the Cancer Patients Aid Association (CPAA), a non-governmental organisation (NGO), had also challenged portions of the IPAB order that had favoured Novartis. The IPAB, while holding that Glivec was not patentable, however, found that Novartis’ “invention” satisfied the tests of novelty and non-obviousness.

Right at the outset, the Supreme Court was conscious of the broad framework of the debate before it. The court believed that it had to strike a balance between the need to promote research and development in science and technology and the need to keep private monopoly (called an “aberration” under our constitutional scheme) at a minimum.

India’s obligation to faithfully comply with its commitments under international treaties had to be met without compromising the responsibility to protect India’s status as “the pharmacy of the world”—a compliment to India’s emergence as a major supplier of affordable generic medicines to countries that lack the capacity and resources to produce the drugs or pay the high prices demanded by those claiming patents. The court clearly understood that an error of judgment would put life-saving drugs beyond the reach of ordinary people not only in India but also in many developing and underdeveloped countries dependent on generic drugs from India.

But these broader, altruistic considerations could not have determined the outcome of the case as they could be construed as extralegal issues. Therefore, the Bench plunged into the crux of the case before it. The Bench acknowledged that the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, which came into force on January 1, 1995, had led to the concern that patent protection given to pharmaceutical and agricultural-chemical products might have the effect of putting life-saving medicines beyond the reach of a very large section of people. Therefore, the Bench sought to know how the Indian Parliament addressed this concern while harmonising the patent law in the country with the provisions of the TRIPS Agreement, and how India strove to balance its obligations under the international treaty and its commitment to protect and promote public health considerations.

Amending the Patents Act in 2005 to allow for grant of product patents for pharmaceutical and agricultural chemical substances was the one final step needed to make the law compliant with the mandate of TRIPS. This was achieved through the Patents (Amendment) Ordinance, 2004, as the government was under pressure to meet the deadline of January 1, 2005, to avoid retaliatory action under the World Trade Organisation (WTO) disputes mechanism. Having availed itself of the entire 10-year transition period provided under the TRIPS Agreement, India had no legal basis to defend its default on the deadline. The ordinance had to be replaced by an Act of Parliament before it lapsed on March 31, 2005.

The Supreme Court noted that under the twin pressures of time and anxiety to safeguard public health objectives, Parliament was called upon to deliberate over the amendments required in the patent law to make it fully compliant with the TRIPS Agreement. The Bench observed: “The Bill [to replace the ordinance] evoked a highly insightful and informed debate [in Parliament] on the subject. To anyone going through the debate on the Bill, Parliament would appear keenly alive to national interests, human rights considerations and the role of India as the producer and supplier of drugs to different parts of the world where impoverished humanity is critically in need of those drugs at cheap and affordable prices.”

Some of the very important amendments that were incorporated in the Bill related to Section 2(1) (ja) and Section 3(d), and the insertion of the provision for pre-grant opposition to the grant of a patent.

Section 2(1) (ja) defines “inventive step” to mean a feature of an invention that involves technical advance as compared to the existing knowledge, or having economic significance, or both, which makes the invention not obvious to a person skilled in the art. Something may be an “invention” as the term is generally understood and yet it may not qualify as an invention for the purposes of the Act. Further, something may even qualify as an “invention” as defined under the Act, and yet may be denied a patent because of other, larger, considerations as may be stipulated in the Act.

Section 3 explains “what are not inventions”. Section 3(d) says the following are not inventions within the meaning of the Patents Act: 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.

Section 3(d) is followed by an Explanation which says: “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.”

According to a scholar, this efficacy clause has been borrowed from a directive of the European Parliament relating to the drug regulation of medicinal products for human use. The provision is also traced to a class of patents, known as “selection patents” in English jurisprudence, according to which patent protection is granted only to those members of the class that can demonstrate a new use or form.

The Bench took note of the introduction of subtle changes in these provisions, and the addition of the Explanation through the 2005 amendment as proof of Parliament’s intention to set up a second tier of qualifying standards for chemical substances/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.

Evergreening

Evergreening is a term used to label practices wherein a trifling change is made to an existing product and claimed as a new invention. The coverage/protection afforded by the alleged new invention is then used to extend the patentee’s exclusive rights over the product, preventing competition. Section 3(d) aims to prevent evergreening.

The Bench refused to accept the view of Novartis’ counsel that Section 3(d) is ex majore cautela (out of abundant caution). This submission, the Bench said, completely missed the vital distinction between the concepts of invention and patentability—a distinction that was at the heart of the Patents Act as it was framed in 1970, and which is reinforced by the 2005 amendment in Section 3(d).

The Bench observed that the amendment in Section 3(d) was the only provision cited by the government to allay the fears of the opposition members concerning the abuses to which a product patent in medicines may be vulnerable. Section 3(d) represents patentability, a concept distinct and separate from invention, as defined under Section 2.

Put in this legislative context, the Bench went on to examine the merits of Novartis’ application for a patent for imatinib mesylate, which is marketed under the name of Glivec.

In the face of the material before it, the Bench was completely unable to see how imatinib mesylate could be said to be a new product having come into being through an “invention” that has a feature that involves technical advance over the existing knowledge. The Bench found that imatinib mesylate is a known substance from the Zimmermann patent (a U.S. patent application granted in 1996). Novartis too had always maintained that imatinib mesylate was fully part of the Zimmermann patent and did not call for any separate patent.

In view of this, the Bench added that its pharmacological properties were also known in the Zimmermann patent. Therefore, imatinib mesylate did not pass the test of invention under the Patents Act, the Bench held.

It also held that the beta crystalline form of imatinib mesylate was a new form of a known substance, that is, imatinib mesylate, the efficacy of which was well known. The Bench drew attention to Novartis’ patent application, which had made a clear and unambiguous averment that all the therapeutic qualities of the beta crystalline form of imatinib mesylate were also possessed by imatinib in free base. Since all the pharmacological properties of the beta crystalline form of imatinib mesylate are equally possessed by imatinib in free base form or its salt, the question of the subject product, Glivec, having any enhanced efficacy over the known substance did not arise, the Bench opined.

Novartis argued before the court that in terms of invention, the beta crystalline form of imatinib mesylate was two stages removed from imatinib in free base form. The Bench, however, pointed out that this position was not reflected in the patent application, in which all the references were only to imatinib in free base form. Therefore, the court inferred that the beta crystalline form of imatinib mesylate was derived directly from imatinib free base.

The Bench also held that the mere change of form, with properties inherent to that form, would not qualify as “enhancement of efficacy” of a known substance. Thus, it held that the physical-chemical properties of the beta crystalline form of imatinib mesylate could not even be taken into account for the purpose of the test of Section 3(d) of the Act since these properties had nothing to do with therapeutic efficacy.

While concluding that the beta crystalline form of imatinib mesylate did not pass the test of Section 3(d) of the Act, the Bench made it clear that the provision did not bar patent protection for all incremental inventions of chemical and pharmaceutical substances.

Misleading application

The court questioned Novartis’ duplicity in applying for a patent for imatinib mesylate in beta crystalline form, whereas Glivec as sold in the United States and in India did not refer to this form. Novartis had obtained a patent on Glivec in 1993 for the amorphous molecule of imatinib mesylate. The beta variant of the molecule is already present in this amorphous salt. India did not recognise this patent as at that time product patents were not in vogue. Novartis used the transition to product patents in 2005 to apply for a patent for the beta variety. It argued that since the beta variant was better absorbed in the body, it constituted therapeutic efficacy under Section 3(d).

The Bench said: “The case of the appellant appears in rather poor light and the claim for patent for beta crystalline form of imatinib mesylate would only appear as an attempt to obtain patent for imatinib mesylate, which would otherwise not be permissible in this country.”

The Bench observed in a footnote: “Here it will be unfair not to state that in course of hearing of the case when the court expressed its bewilderment over the price of the drug, it was strenuously stated on behalf of the appellant (Novartis) that they also ran a huge charitable programme under which the drug was supplied free to the needy persons. However, to the question by the court why the appellant could not abolish the charitable programme and at the same time bring down the price of the drug so as the total revenue from the sale of the drug remains the same as it is with the abnormally high price and the charitable programme, no satisfactory answer was provided on behalf of the appellant.”

Imatinib mesylate helps in the treatment of chronic myeloid leukaemia, a form of blood cancer. According to a study, it controls the cellular action that allows the cancer to grow but does not cure the disease. It has been patented in many countries by Novartis, which has, therefore, questioned the merits of the Supreme Court’s judgment. It has been reported that Novartis currently sells Glivec for Rs.4,115 a tablet, while Resonance, an Indian generic drug company, sells it for Rs.30 a tablet. Novartis had secured exclusive marketing rights (EMR) in 2003 to market Glivec, and this was challenged by the companies selling its generic variety at much cheaper rates.

Healthy precedent

Frontline’s comprehensive coverage of the issue in its May 4, 2012, edition had brought out how India’s ability to produce and market life-saving drugs at affordable prices faced a stiff challenge from some global pharmaceutical companies fighting to prolong their patent monopolies beyond the mandatory 20-year period. The Novartis case in the Supreme Court marked such a challenge, which has been decisively resolved in favour of the legislative intention behind the 2005 Patents Act amendments. Observers expect the judgment to benefit not just cancer patients but others suffering from serious ailments such as HIV, diabetes and hepatitis. The ruling may well set a healthy precedent for the remaining legal battles between generic manufacturers and fraudulent patent seekers.