‘Evergreening’ Pharmaceutical Patents

Novartis AG v. Union of India (UOI) and Others on April 2013

A landmark decision by the Indian Supreme Court to deny Novartis a patent for a modified version of its anti-cancer drug Glivec (imatinib) marks the end of a seven year long litigation battle fought by Novartis. This decision has come down hard on the common practice of “evergreening” of pharmaceutical patents by preventing the extension of patents on flimsy grounds.

In 1996 the United States granted Jurg Zimmerman a patent on behalf of Novartis for imatinib derivatives (N-phenyl-2-pyrimineamine). In 2000, Novartis filed for separate patents on the beta crystalline form of imatinib mesylate (the mesylate salt of imatinib), the patent was granted in 2005. When the law in India changed to allow the filing of product patents, Novartis attempted to patent imatinib in its beta crystalline form in India.

The Intellectual Property Appeal Board (IPAB) ultimately rejected the application stating that, the drug is a modified version of a known compound and that it failed to provide a significant increase in efficacy of the drug as required in section 3(d) of the Indian Patent Act. Section 3 of the Indian Patent Act indicates that the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance is not patentable.
Novartis appealed directly to the Supreme Court and argued that imatinib in beta crystalline form has enhanced efficacy over imatinib as previously patented. Novartis stated that the crystalline from has more beneficial flow properties, better thermodynamic stability and increased bioavailability.

The Supreme Court found that the application is neither novel nor non-obvious and that even though the product has increased physical efficacy, no evidence has been offered to indicate that the product has increased therapeutic efficacy.
According to Senior Advocate Anand Grover, “The judgement is a victory and will enable generic drug companies to continue manufacturing cheaper drugs which will be beneficial to many middle income countries.”

The debate surrounding ‘evergreening’ remains controversial. Many being of the opinion that this issue is “much ado about nothing” when considering the fact that the initial patent is not extended by filing a patent application for an improved or modified version of the drug and, therefore, nothing stands in the way of generic companies manufacturing and selling the drug as first patented.

This decision may possibly be a major stumbling block for pharmaceutical companies around the world which attempt to patent incremental improvements on existing drugs. However, this is not the case in non-examining countries, such as South Africa where patents are granted without examination. Novartis obtained a patent in South Africa on imatinib in beta crystalline form. The onus to disprove the patent’s validity, rests on generic companies or any other interested third party.