The Novartis Patent Case: The Full Supreme Court Ruling

Agence France-Presse â€" Getty Images A demonstration against Swiss drug manufacturer Novartis in Mumbai, Maharashtra, on Dec. 21, 2012.

India’s Supreme Court ruled Monday against Swiss drug-maker Novartis, which was seeking patent protection for a form of its popular cancer drug Gleevec.

The highly-technical 112-page ruling delves into the intricate chemistry of drug compound formulation, the definition of efficacy, confusing changes to India’s patent laws since before Independence, the growth of the pharmaceutical industry in India and the need to protect India’s role as a cheap drug provider. On page two, the court notes:

The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our Constitutional scheme) at the minimum. Arguments were made about India’s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India’s status as “the pharmacy of the world.”

Novartis first applied for patent protection for a form of Gleevec, which is based on the chemical compound Imatinib Mesylate, in India in Chennai in 1998, the court noted:

In the application it claimed that the invented product, the beta crystal form of Imatinib Mesylate, has (i) more beneficial flow properties: (ii) better thermodynamic stability; and (iii) lower hygroscopicity than the alpha crystal form of Imatinib Mesylate. It further claimed that the aforesaid properties makes the invented product “new” (and superior!) as it “stores better and is easier to process”; has “better processability of themethanesulfonic acid addition salt of a compound of formula I”, and has a “further advantage for processing and storing.”

In fairness to Novartis, the court notes, the application was made under a different patent regime, and lay dormant under something called “the mailbox procedure” until January 2005. But that, too, worked against Novartis’s push to differentiate it:

It is seen above that in the US the drug Gleevec came to the market in 2001. It is beyond doubt that what was marketed then was Imatinib Mesylate and not the subject product, Imatinib Mesylate in beta crystal form. It is also seen above that even while the appellant’s application for grant of patent lay in the “mailbox” awaiting amendments in the law of patent in India, the appellant was granted Exclusive Marketing Rights on November 10,2003, following which Gleevec was marketed in India as well. On its package, the drug was described as “Imatinib Mesylate Tablets 100 mg” and it was further stated that “each film coated tablet contains: 100 mg Imatinib (as Mesylate)”. On the package there is no reference at all to Imatinib Mesylate in beta crystalline form. What appears, therefore, is that what was sold as Gleevec was Imatinib Mesylate and not the subject product, the beta crystalline form of Imatinib Mesylate.

If that be so, then the case of the appellant appears in rather poor light and the claim for patent for beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country.