In two recent decisions, India’s patent office struck major blows to German drug makers Bayer and Boehringer Ingleheim, saying their respective patents for Nexavar and Spiriva fail to meet the inventiveness requirements under the country’s controversial Patents Act.

Background

India’s patent system has been a source of frustration for western drug makers, who have argued for intellectual property (IP) reform in the country. India is also listed on the US Trade Representative’s Priority Watch List for countries that “present the most significant concerns regarding insufficient [IP] protection or enforcement.” India’s approach to IP has its supporters as well, with groups such as Médecins Sans Frontières (MSF), saying India’s stringent patent review makes drugs more affordable in developing countries.

For more information on western drug makers’ stance on intellectual property in India please see the section on India in the Pharmaceutical Research and Manufacturers of America’s (PhRMA) Special 301 Submission 2015.

The provision in India’s Patents Act that has created the most controversy in recent years is Section 3(d), which prevents pharmaceutical companies from “evergreening” their products. The section has allowed India’s patent office to take a strict and narrow approach to reviewing drug patents. Section 3(d) reads:

"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 or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant [are not inventions within the meaning of this act].”

This clause has been used to deny patents for several drugs, including the Novartis cancer drug Glivec and Gilead’s Sovaldi, for failing to meet the standards of inventiveness and enhanced efficacy established in Section 3(d).

Nexavar Patent Rejected

In February, India’s patent office rejected one of Bayer’s patents for its drug Nexavar following a series of hearings in which two opponents contested the inventiveness of the compound described in Application No. 1690/DELNP/2007. Bayer’s patent application was opposed by Natco Pharma Ltd. and Fresenius Kabi Oncology Ltd.

After hearing Bayer and its opponents’ cases, Ajay Thakur, assistant controller of patents and designs, ruled that Bayer’s application “is refused on the ground of lack of inventive step (Section 2(1)(j), Section 3(d), Section 3(e) and finally Section 25(1)(h) of the Patents Act.” Thakur found that the compound described by the patent did not demonstrate an improvement in “therapeutic efficacy … in the treatment of cancer.”

This is not the first time Bayer has fought with the patent office over Nexavar. In 2012, India issued its first-ever compulsory license to the Indian generic drug maker Natco to make Nexavar. Bayer challenged the decision, but ultimately lost its bid to stop Natco from producing its Nexavar copy when India’s Supreme Court ruled against the company.

Spiriva Patent Revoked

In a decision posted last week, India’s patent office revoked the patent for Boehringer’s Spiriva. The patent in question was first filed in April 2003 and granted in December 2012, after its validity was challenged by Intermed Labs Pvt. Ltd. in 2007.

In this case, Cipla Ltd. filed a post-grant opposition against Boehringer’s Patent No. 254813, stating that the claims about Boehringer’s product do not meet the standards of inventiveness in Section 3(d).

After hearing the two companies’ arguments in November 2014, Thakur found that Boehringer’s application failed to demonstrate a significant improvement in therapeutic efficacy, as the patent “relates to the crystalline tiotropium bromide monohrydrate which is a polymorph of tiotropium bromide, however there is no disclosure in the specification as to enhancement in the therapeutic efficacy as compared to its structurally similar compounds.”

Bayer Decision, Boehringer Decision