Here in this article, we discuss case law titled Novartis vs. Union of India [Supreme Court of India], wherein it is been discussed that whether Patent can be granted by doing a slight change in already Patented Product.

Case Name: Novartis vs. Union of India [Supreme Court of India]

Facts: Novartis filed an application before Madras Patent office for grant of patent for its drug ‘Glivec’. Patent office denied Novartis patent application on the ground that it failed to satisfy the requirements of non-obviousness and novelty.

In the year 1998, Novartis International AG which was one of the largest international pharmaceutical companies, filed an application before the Madras Indian patent office for granting a patent for an anticancer drug namely ‘Glivec’ which was meant to be used to treat Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumours (GIST) invented from Beta crystalline form of “Imatinib mesylate” which was commonely used in the treatment of cancer and was patented in more than 35 countries.

The patent was granted to Novartis for restricted purposes i.e. methods or processes and not for products in India as per Section 5 of the Patent Act, 1970

However, this Act of 1970 was repealed and replaced by the Patent (Amendment) Act, 2005 and granting of patents was allowed for products along with methods or processes.

In the year 2005, Novartis filed an application before Madras Patent office for grant of patent for its drug ‘Glivec’. Patent office denied Novartis patent application on the ground that it failed to satisfy the requirements of non-obviousness and novelty and as the said drug did not exhibit any major changes in therapeutic efficacy over its pre-existing form i.e. Zimmermann patent.

Novartis thereafter filed an appeal against Patent office in IPAB which again rejected Novartis Patent application holding that although Novartis invention satisfies novelty and non-obviousness but its patentability was hit by Section 3(d) of Patent Act. It therefore, only granted process patent to Novartis.

Novartis therefore, filed an appeal against the order of IPAB in Supreme Court.

Issue: Under Section 3(d) of Patent Act, what is known as ‘substance’ and what qualifies as ‘therapeutic efficacy’?

Conclusion: Court in conclusion observed that a where the efficacy of a substance is well-known, the substance will be a known substance.

It further observed that all the properties of a drug is not relevant and only the properties which directly relates to efficacy, in case of a medicine will be known as therapeutic efficacy.

Court further observed that the object of Patents Act is to provide adequate return in monetary form to the patent holder. However, its purpose is not to grant such patent for an indefinite period.

Supreme Court dismissed the appeal of Novartis by holding that patent cannot be granted if there is just slight change in the product efficacy.