CASE COMMENTARY ON NOVARTIS AG Vs. UNION OF INDIA & Ors.

Quorum: Justice Aftab Alam and Justice Ranjana Prakash Desai

Date of Judgment: 01 April, 2013

Citation: (2013) 6 SCC 1

INTRODUCTION

India has been the Vanguard of building an alternate model of patent law which many developing countries have since followed, especially to address the issue of evergreen concept in the field of Pharmaceutical industry. To deal with the subject of ‘evergreening’, the Indian Parliament introduced Section 3(d) by way of the 2005 Amendment to the Patents Act, 1970 which categorically excludes the derivatives, salts to the known compounds as not being inventions under the Act.

But then the big pharma companies have been disparaging India's Section 3(d) as being too oppressive on them and against the TRIPS principles and claim that Section 3(d) is a discouragement to the innovators towards incremental inventions in the pharmaceutical field.

This is a case commentary on the landmark decision passed by the Supreme Court involving the concept of evergreen principle and Section 3(d) of the Act.

Facts in brief

In 1997, Novartis, a pharmaceutical Giant filed an application to patent to an anti-cancer drug Gleevec which is used for the treatment of a severe form of blood cancer (Chronic Myeloid Leukaemia) and gastro-intestinal stromal tumors on the ground that it invented the beta crystalline salt form of the free base. This drug was already patented in more than 35 jurisdictions.

India didn’t have a patent for drugs till 2005, and after the amendment of 2005 in the patent system, the mailbox opened and the application of Novartis was examined. In 2006, the Madras Patent Office rejected the application made by Novartis’s Patent application for drug Gleevec stating that the drug did not exhibit any major changes in therapeutic effectiveness over its pre-existing form, which had been patented outside India and threw light on section 3(d) of the Patents Act which provides a known substance can be only patented if the new element exhibits ’Enhanced efficacy’.

Subsequently in 2006 May, the company filed two writ petitions under Article 226 of the Constitution before the Madras High Court alleging that section 3(d) of the Indian Patents Act is violative of Art.14 and TRIPS agreement and contested the order of the Madras Patent Office. The HC rejected the petitions on the ground that it did not have jurisdiction to ascertain whether a domestic law is contradictory to an International Agreement. Further next stage of litigation started in the Intellectual Property Appellate Board where IPAB considered the beta-crystalline as a form of imatinib mesylate as a new and inventive step but denied to grant a patent to Novartis as it came under the regime of section 3(d) of the Act. Novartis proceeded to challenge the order of IPAB before the SC through a petition for Special Leave.

Issues addressed

1. What is the true purpose of section 3(d) of the Patents Act, 1970? How does it interplay with clauses (j) and (ja) of section 2(1)?

2. As per section 3(d) of the Patent Act, what is the meaning of efficacy?

3. Whether increase in bioavailability amounts to increase in therapeutic efficacy?

4. Whether the product for which the appellant claims patent, qualifies as a new product which involves technical advance over the existing knowledge that makes it non-obvious to the person skilled in the art?

5. In case the appellant’s product qualifies as an invention under clauses (j) and (ja) of section 2(1), whether it can be rejected solely on the ground that section 3(d) puts it out of the category of invention?

Contention of the parties

Novartis’ contention was that the beta-crystalline form of imatinib mesylate should be compared with imatinib. Novartis’ second argument stated that section 3(d) was ex majore cautela. It was argued that 3(d) is not meant to be an exception to clauses (j) and (ja) of section 2(1) of the Act and it was alleged that the subject product having satisfied the tests of invention under section 2(1) cannot be denied patent for not satisfying the test under section 3(d)[1]. While on the other side, the Union of India and others wanted to draw the nexus with imatinib mesylate because they supposed that such a parallel would make it fair enough and claimed due to the lack of Novel element, it would be difficult for Novartis to prove improvement in efficacy. In order to solidify the argument, the UOI were to initially establish that imatinib mesylate was “known” and existed already during the period prevailing between the 1993 Zimmerman patent for imatinib and the beta-crystalline form of imatinib mesylate.

Novartis countered by trying to establish how increase in bioavailability results in enhancement of therapeutic efficacy from the known substance. It also claimed that the new properties present in the form for which patent is sought makes the product new and superior.

Verdict

The Supreme Court rejected the appeal filed by Novartis AG, and held that the beta-crystalline form of Imatinib Mesylate does not qualify the test laid down under section 3(d) of the Patents Act, 1970. It was observed by the Supreme Court that pharmaceutical products for which patents are sought, must pass the test laid down under section 3(d) i.e, the test of enhanced efficacy, in addition to clauses (j) and (ja) of section 2(1).

With regard to questions posed on the need for section 3(d), the Court observed that

“The amended portion of section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for new and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds”.[2]

Hence, it was clearly established by the Court that compliance of section 3(d) was mandatory for chemical substances, more particularly pharmaceutical products, as it aimed at preventing ‘evergreening’ of patents. Further, it was observed by the Court that patentability and invention are distinct and separate concepts. While considering the legislative history behind incorporating Part II into the Patents Act, it becomes evident that 3(d) cannot be viewed as an extension of clauses (j) and (ja) of section 2(1). It can be observed that the Act sets different standards for patentability for different inventions and sets the threshold even higher for pharmaceutical substances by virtue of section 3(d) of the Act.

While it was contended by the Appellants that the beta-crystalline form had enhanced properties when compared to Imatinib and Imatinib Mesylate in terms of flow properties, better thermodynamic stability, increased bioavailability, lower hygroscopicity, etc, the Court held that efficacy implies only to therapeutic efficacy.

“The test of efficacy would depend on the function, utility or the purpose of the product under consideration. Therefore, in case of a medicine that claims to cure a disease, the test of efficacy can only be therapeutic efficacy. With regard to the genesis of section 3(d), and more particularly the circumstances in which section 3(d) was amended to make it even more constrictive than before, we have no doubt that the therapeutic efficacy of a medicine must be judged strictly and narrowly”[3].

It was further observed by the Court that flow properties, hygroscopicity and thermodynamic stability had nothing to do with the therapeutic efficacy and hence, does not satisfy the test laid down under section 3(d). Responding to the claim made by Novartis with regard to the increase in bioavailability, the Court found that the increase in bioavailability was not in comparison with the already “known” mesylate salt form which was soluble, but instead to the free base form which was not marketed due its reduced solubility. As the increased bioavailability was not established, the Court rejected Novartis’ patent application citing that section 3(d) was not complied with.

Analysis and Conclusion

The Authors are trying to evaluate the legal reasoning and framework through which the Court has decided this path breaking judgment. This evaluation would be done in 3 folds- (1) TRIPS Compatibility; (2) element of section 3(d); and (3) Impact on Indian Patent regime.

(1) TRIPS Compatibility:

Brief perusal of the judgment would put one to ponder whether the Apex Court has ducked the existence of TRIPS agreement but it is to be noted that under Article 27 of the TRIPS agreement, it stipulates that Patent shall be available to any product provided they are new, involves an inventive step and capable of industrial application. This definition provides flexibility to the discretion of each country to formulate their own definition of Patent. Thus both Apex Court and High Court have come to a conclusion that section 3(d) is not violative of TRIPS agreement.

(2) Element of Section 3(d) in Patent Regime:

While considering the discussions in the parliament with regard to the Patents (Amendment) Act, 2005 it is pertinent to note that section 3(d) was proposed by the Government of India as a safeguard against patenting insubstantial inventions. While addressing the questions relating to availability of medicines for the Indian population, the parliament adopted section 3(d) in the amendment, alongside an explanation, which posed an additional requirement that patents can be granted only when there is a substantial enhancement in efficacy over an existing product. Hence, it can be understood that the principle intention behind inclusion of section 3(d) is to prevent pharmaceutical companies from obtaining a secondary patent for an existing invention and exercising dominance over the market, thereby resulting in an increase in the price of medicinal drugs. While the patent regime underwent significant changes by way of the 2005 Amendment by allowing product patents, it was important to put in place a preventive mechanism to prevent monopolization of markets, and section 3(d) was incorporated to cater to this purpose.

(3) Impact on Indian and International Patent system:

While analyzing the legislative history involved in including section 3(d) in the Patents Act, it is pertinent to note that it was a mechanism put in place to make sure corporate giants do not resort to the evergreen strategy, wherein trifling and frivolous changes are made to an existing product and claimed as a new invention. This was widely appreciated and welcomed for its anti-evergreening safeguard.

The impact of this judgment can be noted both on the Domestic and International fronts. The two representatives of two main civil societies – Cancer Patients Aid Association (CPAA) and Delhi Network of HIV Positive People (DNP+), opined that this decision has helped them in their campaign for affordable medicines. They also remarked that the 2013 Supreme Court judgment had significantly lowered the price of Gleevec from INR 15,000 to INR 6,000.[4]

Several studies on how patents are granted and denied in India have been conducted subsequent to the Novartis verdict, and it has been observed that the Indian Courts have upheld section 3(d) as a significant yardstick for granting patents and thwarted the attempts made by the Multinational Corporations to evergreen their patents. One such study, titled ‘Rejection in India’ authored by Dr. Feroz Ali, Dr. Sudharsan Rajagopal, Mohammed Mustafa and Chinnasamy Prabhu stated that the increased application of section 3(d) by the IPO soon after the Novartis case could be due to the legal certainty provided by the Supreme Court in upholding the rejection of the patent application rejected under that section. It was also observed that section 3(d) was cited in 69% of the cases where the IPO rejected the applications, post the Novartis Judgment.

On the International front, this judgment has inspired patent regimes across the globe. The ‘Report of the United Nations Secretary General’s High Level Panel on Access to Medicines’ released in 2016, lays emphasis on curtailing evergreening of patents, which is viewed as a footprint left by the Novartis verdict. Several civil groups in nations such as South Africa and Thailand have used section 3(d) as a model to promote a stringent patentability criterion with their governments.

It can therefore be observed that this judgment has served as a blueprint for developing countries in devising their anti-evergreening safeguards. This case illustrates how the Indian patent law aligns itself with the international standards whilst safeguarding the interests of the people. This ruling has clearly accorded more value to social justice over commercial needs of multinational corporations.

[1] Novratis AG V. Union of India , (2013) 6 SCC 1 , pg. 99 [2] (2013) 6 SCC 1, pg.103 [3] Supra, pg. 180 [4] Patralekha Chatterje., Five Years After The Indian Supreme Court's Novartis Verdict Intellectual Property Watch

(2018), https://www.ip-watch.org/2018/05/20/five-years-indian-supreme-Courts-novartis-verdict/ (last visited Jul 4, 2020).

Authored by:

ISHWARYA SUNDAR

5th-year B.Com; LL.B (Hons)

School of Excellence in Law, The Tamil Nadu Dr. Ambedkar Law University, Chennai.

SRUTHI M

4th-year B.B.A; LL.B (Hons)

School of Excellence in Law, The Tamil Nadu Dr. Ambedkar Law University, Chennai.