Indian patent office has revoked a patent granted for tiotropium bromide monohydrate under the Spiriva brand, paving the way for Cipla to continue selling its generic version in the Indian market
After Novartis lost its monopoly on its blockbuster anticancer drug Glivec around two years ago in India, Germany company Boehringer Ingelheim's chronic obstructive pulmonary disease treatment, Spiriva, has met the same fate, following opposition by Indian drug major Cipla.
In a landmark decision that is bound to open the floodgates once again about India's patent laws, or the lack thereof, the Indian patent office has revoked a patent granted to the German multinational.
Boehringer Ingelheim (BI) sells tiotropium bromide monohydrate under the Spiriva brand. The revocation for the asthma drug paves the way for the Indian firm to continue selling its generic version in the Indian market.
BI was granted a patent on tiotropium bromide monohydrate in 2012, valid until 2021. Initially, a pre-grant opposition was filed by Intermed Labs in 2007. However, it was rejected by the patent controller, and BI was granted a patent in 2012.
Although tiotropium bromide monohydrate is a molecule that was patented prior to January 1995, BI filed for a patent for the crystalline salt of tiotropium bromide monohydrate on the grounds that it is more stable.
Cipla has been marketing the generic version of tiotropium bromide monohydrate under the brand name Tiova since 2003. The product is available in inhalers and rotocaps. The Indian company said that initially, the patent office had granted the patent but with Cipla filing a post-grant opposition, the decision to grant the patent was reversed.
The Indian Patents Act clearly excludes grant of patents to molecules invented before January 1995. Also, under Section 3(d) of the Patents Act, the law bars grant of patents to salts, esters of substances invented before January 1995, unless efficacy is significantly enhanced.
Cipla had filed an opposition to Boehringer's patent on Spiriva in 2013, claiming the drug was 'obvious'. The patent was revoked after it was granted, though it had undergone intense scrutiny and examination. Cipla argued that tiotropium bromide monohydrate did not demonstrate any significant change in 'therapeutic efficacy'. The order notes that simply tweaking the structure of a molecule doesn’t make it eligible to be patented.
A company has a three month window to appeal to the Intellectual Property Appellate Board to seek a review on the order issued by the patent office.
Incidentally, following the launch of Tiova, Cipla also introduced two more combination drugs tiotropium + formoterol under the brand name Duova and tiotropium + formoterol + ciclesonide under the brand name Triohale.