The Indian patent office has revoked a Boehringer Ingelheim patent for Spiriva on grounds 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” and that it is not patentable under section 3(d) of the Patents Act. The BI patent, titled “Crystalline Tiotropium Bromide Monohydrate and Process Thereof” was issued in December 2012. Cipla filed a challenge to the patent in February 2013.
Among the reasons for overturning the patent, the ruling says, “In order to establish the ground of Inventive step as mandated under section 2(1)(j) of the Patent Act, the Patentee had asserted that the claimed crystalline had an unexpected surprising advantageous technical effect in meeting the stringent requirements imposed on pharmaceutically active substances to be used for inhalation. However it is crystal clear that the applicant has failed miserably to disclose any surprising advantageous technical effect in the description and in the evidences and therefore cannot be relied upon for assessing inventiveness. As such there is no evidence, sufficient enough in the description to make it specious that unexpected surprising advantageous technical effect is achieved by the claimed crystalline Tiotropium bromide monohydrate compound as claimed by the Patentee in his admission, the purity and stability (among the unexpected effects) could not be predicted by one person skilled in the art over the cited document D3-D6. Thus for skilled artisan it would be easily possible to arrive at the invention based on the above teachings & disclosure made in documents D3-D6, thus the claims are obvious.”
Read the India Patent Office ruling.
