In 1998, one of the most profound pharmaceutical company named Novartis International AG made an application as according to the TRIPS agreement in front of the Chennai Indian patent office for the grant of the grant of the patent for a drug which is ‘anticancer’ named as ‘Glivec’ this one is used to treat Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumors, this was found and formulated from Beta crystalline form of ‘Imatinib mesylate’. This is precisely used in curing cancer and is also patented in many countries approximately 35.

When Novartis applied for the patent, the grant of the same was restricted to methods and processes and not to products in India, this is given under Patent Act, 1970 Section 5. After the Amendment in 2005 the section 5 of the patent act was annulled and now the products were also granted the patents.

In 2005 Novartis again filed for the patent but the Madras Patent Office again rejected it on the ground that the drug was anticipated by earlier publication and has failed to satisfy the necessity of novelty and non-obviousness. And it further stated that this invention is un-patentable under the section 3(d) of Patent Act, 1970 as this drug does not exhibit any vast alterations in therapeutic efficacy over its pre-existing formula that is Zimmermann patent.  

After this rejection, Novartis filed two writ petitions in the Madras High Court in the year 2006 under Article 226 of the Indian Constitution. The petition mentioned that the section 3(d) of the Patent Act, 1970 is unconstitutional as it does not comply with that of TRIPS agreement and it also infringes fundamental right under Article 14 of the Indian Constitution. This case was passed to the IPAB (Intellectual Property Appellant Tribunal) in the year 2007 and they also stated that this was hit by the section 3(d) of the Patent Act, 1970 and therefore the prevention of already patented product with slight alteration is not required.

At the end Novartis moved to the Supreme Court in 2009 by filing SLP (Special Leave Petition) against the order passed by IPAB under Article 136 of Indian Constitution.

1. What is the known substance according to the provision of Section 3(d) of Patent Act, 1970?
2. What does the word efficacy mean here in Section 3 (d) of Patent Act, 1970?
3. Does increase in bioavailability qualify as increase in therapeutic efficacy according to section 3(d) of Patent Act, 1970?

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In April 2013, the bench of two judges of the 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 matter i.e. Imatinib Mesylate, wherein the efficacy was well known. The Supreme Court declared clearly that in the case of medicine "Efficacy" in section-3(d) only means "Therapeutic Efficacy" and held that all properties of a drug are not appropriate, the properties which unswervingly relate to efficacy in the case of medicine is its therapeutic efficacy. The Apex Court in the third issue ruled that about 30% increase in bioavailability succeeds as increase in therapeutic efficacy under section-3(d) of Patent Act, 1970 if proof 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 found that none of these properties add to upsurge 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 matched to the efficacy of "Imatinib Mesylate.

The judgment given by the Hon'ble Supreme Court is to prevent the ever-greening of patented products and provide relief to those who cannot afford the life conserving drug as these pharmaceutical companies sell such lifesaving drugs at peak prices hence too expensive for the common man. The Supreme Court in its judgement made clear that India is a developing country and the readiness of medicines at a cheaper rate is essential for the lives of 1 billion people. Section-3(d) of Patent Act, 1970 avoids obtaining secondary patents by introducing minor alterations in prevailing 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 plea of Novartis for patent overruled by Supreme Court.