India’s patent office revokes Boehringer’s Spiriva patent

In a ‘landmark’ case, India's Patent Office has revoked a patent on family-owned German pharma major Boehringer Ingelheim’s asthma drug Spiriva (tiotropium bromide monohydrate), after it was challenged by Indian generics company Cipla (BSE: 500087).

The patent was revoked on grounds that it lacks inventive step, fails to demonstrate therapeutic efficacy and therefore fails the requirements of Section 3 (d). The Patent Office’s order said: “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.”

Legal experts quoted by India’s The Economic Times said: “This is a landmark case as the patent was revoked after it was granted, with much scrutiny and examination, and after the pre-grant opposition had been dismissed a few years back.”