In a major relief to Mumbai-based drugmaker Cipla, the Patent Office of India revoked German drugmaker Boehringer Ingelheim’s patent on asthma drug Spiriva, paving the way for the Indian firm to continue selling its generic version of the drug in the Indian market.
FE has reviewed a copy of the Patent Office’s order issued March 4.
Cipla’s chairman YK Hamied told FE that the company has been committed towards providing affordable medicines in India. “We have been marketing Tiova (Cipla’s generic version of Spiriva) in India. I think if we would have lost the case, the people of India would have suffered since we would have had to withdraw the product from the market,” he said.
Cipla had challenged Boehringer Ingelheim’s patent, arguing that the crystalline salt tiotropium bromide monohydrate, sold under the brand name Spiriva, did not demonstrate any significant change in “therapeutic efficacy”. Cipla has been marketing the generic version of this drug since 2003.
The 92-page order says in effect that simply tweaking the structure of a molecule doesn’t make it eligible to be patented because it doesn’t have any material impact on the therapeutic efficacy of the drug.
“It is to be noted at the outset that there is nothing in the specification nor any data has been adduced by the applicant (Boehringer Ingelheim) which goes to demonstrate any enhancement in the therapeutic efficacy of crystalline tiotropium bromide monohydrate over tiotropium bromide”, the order states.
According to section 3(d) of the Patents Act, 1970, all alterations in the molecular combination or structure shall be considered to be the same substance unless there is a significant difference in therapeutic efficacy. In April 2013, the Supreme Court had clarified that efficacy has to be proved in the context of therapeutic efficacy in matters relating to patents.
A company has a three-month window to appeal to the Intellectual Property Appellate Board in case it seeks a review on the order issued by The Patent Office. According to sources, Boehringer Ingelheim has not filed a review petition yet.
The Cipla scrip slipped 0.5% to end at R729.70 on the BSE.
Trade wars
* Cipla had challenged the patent, arguing that the drug did not demonstrate any significant change in ‘therapeutic efficacy’
* Cipla has been marketing the generic version of asthma drug Spiriva since 2003
* In April 2013, the SC had clarified that efficacy has to be proved in the context of therapeutic efficacy
* According to sources, Boehringer Ingelheim has not filed a review petition with the Intellectual Property Appellate Board yet