Indian pharmaceutical major Cipla has won a major victory against a German firm over a lung drug patent case. India’s Patent Office has revoked a patent on asthma drug, Spiriva (tiotropium bromide monohydrate) held by German major Boehringer Ingelheim following Cipla’s opposition. The patent was revoked on grounds that it lacks inventive step, fails to demonstrate therapeutic efficacy as well as requirements of Section 3 (d).
Legal experts say that this is a landmark case as the patent was revoked after it was granted, with much scrutiny and examination, and after the pre-grant opposition had been dismissed a few years back.
The Patent Office, in its 92-page order explained that the applicant has failed to establish any technical advancement and 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.
The move is another major development in the generics arena, a market coveted by Western firms. India has a $15-billion worth pharmaceuticals market and is working on revamping its intellectual property rights (IPR) policy.
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