Author- Shalaka S. Karkar

INTRODUCTION

            THE JUDGMENT passed by the Supreme Court of India[1] is a landmark judgment in the field of Patent Law and has been a precedent for acquiring patent for Medicines and Drugs in India. The ruling puts social justice over commercial interests and also helps India’s own domestic industry. Novartis A. G. availed this life saving Glivec drug at the cost of Rs. 1,20,000 per person/ month while the same generic drug would cost for Rs. 8,000 to 10,000 per person/month. Therefore, this case had a significant importance on not only development of Patent law in India but also the impact of Medicine and Drug Patent on Public Health of this country as well as on other developed and under-developed countries which depends on India’s Generic Industry.

BACKGROUND

            India’s patent law since early stages was one to protect the general welfare of the public and to encourage invention simultaneously. However in the field of medicine and health, India took a socialist view of giving maximum importance to the Public Health rather than paying attention to the Industrial welfare and their outcry for gaining profit out of it. This Indian Patent law was based on the Ayyangar Committee report which suggested that Patents should not be granted to Drugs or Medicines but instead should only be granted to the processes or methods of these Drugs and Medicine.

            This recommendation given by the Ayyangar Committee report was adopted in Indian Patent Act, 1970. According to the Act, Patent was not granted to Drugs and Medicines[2] but Patent for Processes and Methods of these Drugs and Medicines were granted by the Controller of the Patents Office.[3]

            This gave rise to Generic Companies in India. Generic Companies are those companies which manufactured a drug or medicine by using substitute elements of a patented drug, after the patent expires, but are as effective as the patented drug or medicine. These Generic medicines were cheaper than the patented medicine and thus giving poor people all around the world access to these life saving drugs. Due to the Indian Patent Law, India became one of the highest exporters of Drugs and Medicines in the world and these cheap Generic drugs were a boon to other developing and poor nations as they got access to cheap life saving medication.

            However, the scenario changed when India became a member of TRIPS and a signatory to Paris Convention, Doha Convention as well as the Patent Co-operation Treaty. According to these treaties product Patent was to be granted to Drugs and Medicines. In order to adhere to these International agreements, India amended the Indian Patent Act, 1970 (hereinafter known as “The Principal Act”). The major amendment was done in the year 2005, by The Patents (Amendment) Act, 2005( hereinafter known asThe Patent Act”) which gave permission to the Controller to grant Product Patent to Medicines and Drugs in order to encourage the research and innovation in this field and it also omitted Section 5 of the Principal Act.

FACTS OF THE CASE

            As per the facts given in the judgment, Novartis AG (hereinafter referred as Appellant) filed an application for patent for their therapeutic drug known as “Glivec” on the basis of the beta crystalline form of Imatinib Mesylate(hereinafter known asproduct”) in the Madras Patent Office in 1998. The application remained Dormant in their “mailbox” box for 7 years and finally in the year 2005 the application was taken out for consideration to grant patent. During these 7 years, in 2003 Appellant got Exclusive Marketing Rights for the Glivec drug which came to an end as it was amended from the Act. The Madras Patent Office refused to grant patent and the appeal against the same was laid before The Madras High Court which was later transferred to The Intellectual Property Appellate Board (IPAB) after its establishment under the Act in 2007. The IPAB also refused to grant patent to the Glivec drug stating that it did not satisfy the condition laid down in section 3(d) of The Patent Act[4]. The appeal against this judgment was made by Appellant before the Supreme Court of India under Art. 136 of the Indian Constitution and leave was granted by the court.

The Supreme Court, in its judgment has analyzed the product as follows –

  1. Imatinib – It’s a compound invented by Jürg Zimmermann and patent for this compound was granted. This compound is also commonly known as Zimmermann Patent.[5]
  2. Imatinib Mesylate- This compound was developed by Novartis. The compound is based on the Zimmermann Patent.
  3. Beta crystalline form of Imatinib Mesylate- This compound was also developed by Novartis and it is based on the earlier compound of Imatinib Mesylate. On basis of this compound Novartis has claimed patent for their drug.(hereinafter referred asbeta crystalline form”)

Therefore, the brief description given above of the product is on basis of which Appellant had applied for the patent. As both Imatinib Mesylate and Beta crystalline form are a part of Glivec drug and are inter-dependent on each other, both of them needs to be examined by the Court. The judgment carefully examines each and every aspect of these compound and scrutinize the same with The Patent Act to decide whether the product qualifies for Patent or not.

CASE ANALYSIS

            The first issue in this case was the Locus Standi of the Special Leave Petition admitted before the Hon’ble Supreme Court. The Respondents argued that the appeal to this case lies before the High Court under Art. 226 of the Indian Constitution. This issue arose as nowhere in the Patent Act, has it been specified where the appeal lies against the judgment of the IPAB. Hence, the jurisdiction of this matter was open for discussion. The Supreme Court granted leave to the petition but it stated that “any attempt to challenge the IPAB order directly before this court, side-stepping the High Court, needs to be strongly discouraged and this case is certainly not to be treated as a precedent in that regard.” Therefore, the Supreme Court granted leave to the SLP only due to its importance and merits.

            The second issue in this case discussed about the Patentability of the Product. The judgment has in detail discussed the various aspects of “invention” and related it with the product to determine if it qualifies as an invention. The product must satisfy the conditions as laid down in section 2(1)(j) read with section 2(1)(ja) to be an invention under the Patent Act. These conditions are as follows –

  1. It must be new;
  2. It must be capable of industrial application;
  3. It must come into being as a result of invention and has technical advance in existing knowledge or it has economic significance or both ; and
  4. The invention must not be obvious to person skilled in the art.

As observed by the court and stated in the judgment the Product does not satisfy first and the fourth condition. The patent application for Imatinib[6] disclosed the compound of Imatinib Mesylate as a possible compound as well as its pharmacological properties and the same had also been published in an article in the Cancer Research Journal.[7] Therefore, the Imatinib Mesylate compound is not an invention but rather a known substance as it was anticipated in the Zimmermann Patent application and published in a Journal. In the case of Monsanto Co. v. Coramandal Indag Products (P) Ltd.[8] the Court defined known substance as ‘ It is not necessary that it should be widely used to the knowledge of the consumer public. It is sufficient if it is known to the persons who are engaged in the pursuit of knowledge of the patented product or process either as men of science or men of commerce or consumers’. Therefore, thisproduct isnotaninventionaccordingtothePatentAct.

            The Third issue in this case is about interpretation of enhanced efficacy in Section 3(d) of Indian Patents Act, 1970. The beta crystalline form of Imatinib Mesylate is developed from the compound of Imatinib Mesylate. This beta crystalline form was neither anticipated or disclosed in the Zimmerman Patent nor was it published anywhere. Therefore it is a new form of a known substance and thus it has to satisfy section 3(d) of the Patent Act in order to acquire patent for it.

According to section 3(d) of the Patent Act, 1970, the new form of a known substance must have enhanced efficacy or must result in new product or a new reactant. The section was amended in 2005, this amendment was made to grant patent for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of patent term on spurious grounds. In this particular case, the Court held that efficacy means the ability to a desired or intended result[9]. In the present case as Glivec drug is a therapeutic drug, the new product must have higher efficacy in the therapeutic effect of the drug than its former form of drug. However, Appellant has failed to prove that the beta crystalline form is more enhanced therapeutically than Imatinib Mesylate and nor does it produce a new product or a new reactant.

            Therefore, the application for Patent must be rejected as the Glivec drug does not satisfy any conditions of The Indian Patent Act, 1970 in order to acquire Patent for it. Therefore, as laid down in the Judgment, the Hon’ble Supreme Court of India rejects the Application and the Patent is not granted to Novartis A G.

INTERNATIONAL OUTLOOK

            This verdict had a massive impact internationally, the 3,00,000 patients currently taking the drug and their advocates welcomed the verdict.[10]The Médecins Sans Frontières (MSF) International President Dr Unni Karunakara also hailed the verdict of the Court and praised the Indian Patent System. Also, this outcome has served an important role model to other developing countries; it is relevant that both Argentina and Philippines adopted a Law similar to section 3(d) of The Indian Patent Act, 1970.[11]The Director of Novartis India Ltd. Opposed the judgment stating that it is a setback to the advancement of medical science. The executive vice president of advocacy at the Pharmaceutical Research and Manufacturers of America also opined that this verdict will deteriorate innovation environment in India.[12] The U.S and The European Union also opposed this verdict of the Court.

CONCLUSION

            The Court knew that the judgment delivered would impact the availability of this life-saving drugs and whether it would be beyond the reach of many people not only in this country but also in other developing and under-developed countries, which are dependent on generic drugs from India. One of the major reason for rejecting Novartis application was to avoid ever-greening of already patented products by introducing minor changes. The ruling puts social justice over commercial interests and also helps India’s own domestic industry. The Supreme Court made it evident in its judgment that in a country of 1 billion people, procuring medicines and drugs at cheaper rate is necessary and the same cannot be barred by Section 3(d) of the Patent Act by making minor changes in the medicine or the drug. The Judgment delivered by the Court is appreciable as it was made out of good conscience and in tune with the Patent Act.


[1] AIR (2013) SC 1311.

[2] Section 3(i) of The Indian Patents Act, 1970.

[3] Section 5(a) of The Indian Patents Act, 1970

[4] Patents (Amendment) Act, 2005.

[5] U.S.Patent No. – 5,521,184 ;and European Patent No – EP-A-0 564 409

[6] The Zimmermann Patent.

[7] In Issue of January 1996 under the title “ Inhibition of the AblProtein-Tyrosine Kinase in Vitro and in Vitro by a 2-Phenylaminopyrimidine Derivative.”

[8] (1986) 1 SCC 642

[9]The New Oxford Dictionary of English, Edition 1998.

[10] Venkatesan J. Landmark verdict gives big boost to cancer patients. The Hindu (2013). http://www.thehindu.com/news/national/landmark-verdict-gives-big-boost-to-cancer-patients/article4569056.ece

[11] Chatterjee P. Novartis loses patent bid: lessons from India’s 3(d) experience. Intellectual Property Watch. 2013. http://www.ip-watch.org/2013/04/01/novartis-loses-patent-bid-lessons-from-indias-3d-experience/

[12] Gardiner Harris and Katie Thomas for the New York Times. 1 April 2013 Published: 1 April 2013 Top court in India rejects Novartis drug patent

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