Cipla, India's fourth-largest drugmaker by sales, filed its opposition to Boehringer's patent on Spiriva in 2013.

Boehringer is the latest in a growing list of Western drug companies coming up against the Indian patent office in favour of India-based generics companies.

In 2012, German drugmaker Bayer lost its appeal against the Indian Government’s decision to grant a compulsory licence for its cancer drug Nexavar (sorafenib). India issued a compulsory licence to India-based generics firm Natco Pharma enabling them to produce generics of Nexavar, claiming the price made it unaffordable for many patients [1].

In the same year, Novartis challenged India for denying it a patent for Glivec (imatinib mesylate), its blockbuster cancer drug [2]. Other cases that have come before the Indian courts include Roche’s attempt to protect its lung cancer drug Tarceva (erlotinib). The Indian court upheld Roche’s patent for Tarceva, but said that Cipla’s generic version, Erlocip, did not infringe on Roche’s patent as the molecular structure of Cipla’s generic version was different to that of Roche’s drug [2].

The Indian Government has issued several compulsory licences for patented drugs to Indian drugmakers, allowing local companies to launch generic versions of the drugs before the patents expire on the originator drugs. The idea behind compulsory licensing is to provide low cost medicines and increase access to medicines for poorer people in a public health crisis [3].

Following the Spiriva decision, a spokeswoman at Boehringer's India office said that the company will be ‘evaluating carefully the basis for the recent decision once the detailed reasons thereof are available.’

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References
1.   GaBI Online - Generics and Biosimilars Initiative. Bayer loses Nexavar compulsory licence appeal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20]. Available from: www.gabionline.net/Generics/News/Bayer-loses-Nexavar-compulsory-licence-appeal
2.   GaBI Online - Generics and Biosimilars Initiative. India issues more compulsory licences [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20].  Available from: www.gabi-journal.net/news/india-issues-more-compulsory-licences 
3.   GaBI Online - Generics and Biosimilars Initiative. India’s patent laws coming under repeated challenges [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20].  Available from: www.gabionline.net/Policies-Legislation/India-s-patent-laws-coming-under-repeated-challenges 

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