Source: Times of India
10 Mar 2015
MUMBAI: India’s Patent Office has revoked a patent on asthma drug, Spiriva (tiotropium bromide monohydrate) held by German major Boehringer Ingelheim on an opposition filed by generic company, Cipla. The patent was revoked on grounds that it lacks inventive step, fails to demonstrate therapeutic efficacy as well as requirements of Section 3 (d).
“This is a landmark case as the patent was revoked after it was granted, with much scrutiny and examination, and after the pre-grant opposition had been dismissed a few years back“, legal experts say.
After Novartis lost its monopoly on blockbuster anti-cancer drug Glivec two years ago, section 3 (d) of the Patent Act has emerged as an important safeguard, specifically relevant for pharma and chemical industries, which prohibits grant of patents to new forms of known substances, unless the new form results in enhanced efficacy over the known substance.
“It is clear that applicant have failed to establish any technical advancement or any economic significance of the compound Tiotropium bromide monohydrate over the disclosures of prior art”, the Patent Office said in its 92-page order, adding the invention fails to demonstrate therapeutic efficacy and therefore fails to fulfill the requirement of a patentable invention under Section 3(d) of the Patents Act.
When contacted, a BI spokesperson said BI’s Indian Patent relating to tiotropium bromide monohydrate had been previously granted and all other requirements of patentability had been confirmed by the Patent Office. BI will be evaluating carefully the basis for the recent decision once the detailed reasons are available.
“The physical stability of the compound during formulation cannot be considered as a sole factor for improvement of therapeutic efficacy of the drug under as required under section 3 (d) of the Indian Patent Act, almost the same view was expressed in the landmark decision issued by Hon’ble Supreme court in Novartis case”, the order said, adding the compound is “a product of mere trial and error” and does not “involve any inventive skill”.
The safeguard is being used to prevent “evergreening” of patents in chronic ailments, not just cancers and hepatitis C, but also others like asthma and lung diseases. Cipla was represented by S Majumdar & Co, while BI by Anand & Anand.
The German MNC was granted a patent on tiotropium bromide monohydrate in 2012, which was valid till 2021. Initially when the patent application was filed in the Delhi Patent Office, a pre-grant opposition was filed by Intermed Labs in 2007. This was however rejected by the patent controller, and the company was granted a patent in 2012.
“Grant of a patent in other countries cannot be cited as a proof of inventiveness (the fact as clear from the Chinese prosecution, where the Supreme People’s Court of People’s
Republic of China upheld the invalidity of Boehringer’s crystalline tiotropium bromide monohydrate patent application reasoning that it lacked ‘unexpected technical effects’ and hence was not ‘creative’, Assistant controller Ajay Thakur said.