A study on: Novartis AG V. Union of India

Introduction:

Intellectual property is an intangible form of property while a ‘Patent’ is a subset of intellectual property. Granting of a patent provides a statutory right by the state to the inventor of the invention to exclude others from making, using, or selling their invention for the limited duration of 20 years. The judgment given by the two judge bench of the Hon’ble Supreme Court of India in the case of Novartis AG V. Union of India is one the landmark judgments in India. In this case Novartis challenged the rejection of its patent application by IPAB for Beta crystalline form of “Imatinib mesylate” wherein such challenge was rejected by the Supreme Court of India on the ground that the said drug did not produce an enhanced or superior therapeutic efficacy as compared to the known substance i.e., “Imatinib mesylate” means that the said drug did not involve an inventive step. One of the major reasons for rejecting the patent application of Novartis was to avoid ever-greening of already patented products by introducing minor changes.

Facts:

In 1998, one of the largest international pharmaceutical companies i.e. Novartis International AG filed an application as per the TRIPS agreement before the Chennai Indian patent office for the grant of a patent for an anticancer drug ‘Glivec’ which is used to treat Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumours (GIST) invented from Beta crystalline form of “Imatinib mesylate”. This drug is famously used in the treatment of cancer and the same is patented in more than 35 countries.

When Novartis filed its patent application, the grant used to be restricted to methods or processes and not for products in India, as defined under section-5 of Patent Act, 1970. After the Patent (Amendment) Act, 2005 section-5 was repealed and patents came to be granted for methods or processes but also for products.

In 2005 patent application of Novartis for the drug Glivec was taken into consideration and the same was rejected by Madras Patent Office on the ground that the drug was anticipated by prior publication and failed to satisfy the requirement of novelty and non-obviousness, further stating the alleged invention  as un-patentable under the provision of section-3(d) of Patent Act, 1970 as the said drug did not exhibit any major changes in therapeutic efficacy over its pre-existing form i.e. Zimmermann patent.

After that Novartis filed two writ petitions in Madras High Court in the year 2006 under Article-226 of Constitution of India. The appeals subsequently stated that the section-3(d) of Patent Act, 1970 is unconstitutional because it is not in compliance with TRIPS agreement and also violates Article-14 of Constitution of India and the other against the order passed by Madras Patent Office. Madras High Court transferred the case to IPAB (Intellectual Property Appellant Tribunal) in 2007. This appeal was finally heard and dismissed by IPAB stating that the invention satisfied the tests of novelty and non-obviousness but the patentability of the product was hit by section-3(d) of the Patent Act, 1970. The judgment given by IPAB is to prevent ever-greening of already patented product by introducing minor changes and to provide easy access to the citizens of India to life saving drugs.

After that Novartis filed SLP (Special Leave Petition) in 2009 before the Supreme Court of India against the order passed by IPAB under Article-136 of Constitution of India.

Issue:

1.According to the provision of section-3(d) of Patent Act, 1970 what is a known substance?

2. According to section-3(d) of Patent Act, 1970 what is the meaning of Efficacy?

3. According to section-3(d) of Patent Act, 1970 whether increase in bioavailability qualify as increase in therapeutic efficacy?

4. Whether the invention “Beta crystalline form of imatinib mesylate” claimed by Novartis is more efficacious than the substance that it was derived from i.e. “Imatinib mesylate”?

  1. According to the provision of section-3(d) of Patent Act, 1970 what is a known substance?
  2. According to section-3(d) of Patent Act, 1970 what is the meaning of Efficacy?
  3. According to section-3(d) of Patent Act, 1970 whether increase in bioavailability qualify as increase in therapeutic efficacy?
  4. Whether the invention “Beta crystalline form of imatinib mesylate” claimed by Novartis is more efficacious than the substance that it was derived from i.e. “Imatinib mesylate”?

Judgment:

In April 2013, the two judge bench of Supreme Court of India rejected the appeal filed by Novartis and upheld that the beta crystalline form of Imatinib Mesylate is a new form of the known substance i.e., Imatinib Mesylate, wherein the efficacy was well known. Supreme Court made it crystal clear that in the case of medicine “Efficacy” in section-3(d) only means “Therapeutic Efficacy” and states that all properties of drug are not relevant, the properties which directly relate to efficacy in case of medicine is its therapeutic efficacy. Supreme Court in third issue ruled that about 30% increase in bioavailability qualifies as increase in therapeutic efficacy under section-3(d) of Patent Act, 1970 if evidence is provided for the same. Supreme Court compared the efficacy of “Beta Crystalline form of Imatinib Mesylate” with “Imatinib Mesylate” with reference to its flow properties, better thermodynamic stability and lower hygroscopicity, and held that none of these properties contribute to increase in therapeutic efficacy according to section-3(d) of Patent Act, 1970 and Novartis not provided any document that shows that the efficacy of “Beta Crystalline form of Imatinib Mesylate” is more as compared to the efficacy of “Imatinib Mesylate”.

Conclusion:

The judgment given by the Hon’ble Supreme Court is to prevent the ever-greening of patented products and gives relief to those who can’t afford the lifesaving drug as these pharmaceutical companies sell such lifesaving drugs at a very high price hence unaffordable for the common man. Supreme Court in its judgement made clear that India is a developing country and the availability of medicines at a cheaper rate is necessary for the lives of 1 billion people. Section-3(d) of Patent Act, 1970 prevents by obtaining secondary patent by introducing minor changes in existing technology from these big pharmaceutical companies. Novartis failed to prove that the therapeutic efficacy of “Beta Crystalline form of Imatinib Mesylate” is more as compared to the therapeutic efficacy of “Imatinib Mesylate”.So that the application of Novartis for patent rejected by Supreme Court.

Author: Mohammad Suleman Palwala, University of Petroleum and Energy Studies, Dehradun , Intern at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at
niharika@khuranaandkhurana.com

References:

[2] https://blog.ipleaders.in/analysis-novartis-g-vs-union-india/

[3] http://notesforfree.com/2018/01/18/patent-case-brief-novartis-v-union-india/

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