CASE ANALYSIS ON Novartis vs union of India and ors

BACKGROUND

Novartis AG was the largest Swiss multinational pharmaceutical company in the world. Novartis challenged the dismissal of its patent application by the Intellectual Property Appellate Board (IPAB) which was an anti-cancer medication marketed under the names “Gleevec” or “Glivec”, developed from the “Beta Crystalline”. The company claimed that the life-saving drug would reach both developing and developed nations. The judgement is considered to be a landmark as it came as a relief to the common man and resulted in easier access to medicines at a lower cost.

FACTS

The patent application was filed by Novartis in India in 1998, after India had agreed to enter the World Trade Organization and to abide by worldwide intellectual property standards under the TRIPS agreement. Prior to this, in 1997, Novartis, had already 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. India didn’t have a patent for drugs till 2005. As part of TRIPS agreement, India made changes to its patent law which came in 2005 and in prior to this change, the patents in products were not allowed. In 2006, the Madras Patent Office rejected the application made by Novartis’s Patent application for drug Gleevec by stating that the drug did not exhibit any major changes in therapeutic effectiveness over its pre-existing form which had been already patented in more than 35 jurisdictions outside India. The Madras Patent Office which had rejected the application threw light on section 3(d) of the Patents Act which states that a known substance can be only patented if the new element exhibits ’Enhanced efficacy’. So, the company filed two writ petitions under Article 226 of the Constitution before the Madras High Court and alleging that section 3(d) of the Indian Patents Act was violative of Art.14 along with TRIPS agreement. 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. Also, according to Intellectual Property Appellate Board in 2007, the beta-crystalline was considered as a form of imatinib mesylate and new & inventive step but denied to grant a patent. In 2009, Novartis moved to the Supreme Court by filing the Special Leave Petition under Article 136 of the Constitution of India but in 2013 the SC rejected the appeal and held that the Beta Crystalline form of Imatinib Mesylate was already well known. They also stated that it was to prevent the evergreening of patented products and provide relief to those who could not afford the life conserving drug as the pharmaceutical companies sell these drugs at peak.

ARGUMENT OF THE PARTIES

NOVARTIS

An attempt was made to patent imatinib mesylate in beta crystalline form rather than imatinib or imatinib mesylate. They stated that beta crystalline was enhanced as it had better flow properties, better thermodynamic stability and lower hygroscopicity. To prove novelty and inventive step they also argued that the Zimmermann patent did not teach a skilled person the art to select the beta crystalline form in preference to other compounds. Further, even if the beta crystalline form was selected, the Zimmermann patent did not teach that person to prepare polymorph of the salt. According to their contention the inventors had to further research  to ensure that particular salt form of imatinib was suitable for administration in a solid oral dosage form. Further, the  Zimmermann patent contained no mention of polymorphism or crystalline structure hence, the relevant crystalline form  needed to be invented. This, according to Novartis the new properties present in the form for which patent is sought makes the product new and superior.

UNION OF INDIA

According to the Respondents, imatinib mesylate in beta crystalline form  was neither novel nor non-obvious. They also argued that imatinib mesylate was “known” and it existed already. The respondents quoted extensively from Doha Declaration, to highlight the public policy dimension of arguments in regards to easy affordability and availability of life saving drugs.

JUDGEMENT

The Supreme Court rejected the appeal filed by Novartis AG by stating that beta-crystalline form of Imatinib Mesylate did not qualify the test under section 3(d) of the Patents Act, 1970. According to the court, if the discovery of a new form of the drug did  not exhibit any major changes in the therapeutic efficacy when compared to the already existing patent- Zimmermann, then it cannot qualify for being a patent. The SC turned down the appeal regarding the increased efficacy because the new product properties directly contribute in an increase in “therapeutic efficacy” and a minimum increase of 30% in bioavailability. Also the SC rejected the appeal by Novartis due to lack of evidence and material to prove the increased efficacy of “Gleevec” which failed to abide  by the requirements of Sec 3(d) of Indian Patent Act. It is pertinent to note that when the appeal was filed before the Supreme Court,treatment by Gleevec costed Rs. 1 lakh per month; whereas treatment by local, generic drugs costed between Rs. 8,000 to Rs. 10,000.

CONCLUSION BY COURT

The judgement came as a relief to the average person, who would have had to endure the most if the patent was allowed as it would increase the cost of life-saving medications, making it hard to be purchased. As India is a developing nation and the demand for medicines keeps increasing, the life-saving drugs should be accessible to them at an affordable price. The court did not allow Novartis from evergreening their patent. Thus the analysis could be concluded by three factors viz TRIPS, section 3(d) and the impact it had on Indian patent regime.

TRIPS AGREEMENT

Under Article 27 of the TRIPS agreement it has been stated that Patent shall be available to any product provided they are new, involves an inventive step and capable of industrial application. The definition provides flexibility to every country to formulate their own definition of Patent. So, according to the judgement passed by the SC was that section 3(d) did not violate TRIPS Agreement.

SECTION 3(d)

The said section was intentionally used so as to prevent pharmaceutical companies from obtaining a secondary patent for an existing invention 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.

IMPACT ON INDIAN PATENT REGIME

The mechanism which was put to place for making sure that the corporate giants do not resort to the evergreen strategy, the decision by SC was widely appreciated. The impact can be noted both in domestic and international. Section 3(d) has been held as a significant yardstick for granting of patents. t was also observed that section 3(d) was cited in 69% of the cases where the IPO rejected the applications, post the Novartis Judgment. Countries like South Africa and Thailand have also used section 3(d) as a model to promote a stringent patentability criterion in their respective countries. Due to this judgement, the development of blueprint regarding anti-evergreening started.

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