Section 3(D) of Indian Patent Act Strikes Again

India revoked yet another drug patent granted to a German MNC, Boehringer Ingelheim, for its respiratory drug, Spiriva (crystalline tiotropium bromide monohydrate) at a time when the US is putting pressure on the Indian government for not providing adequate patent protection to multinational drug companies. In its decision, the patent office held that Boehringer failed to establish any technical advancement or any economic significance for the compound, and the monohydrate crystal form also fails to demonstrate any new therapeutic efficacy and therefore cannot fulfill the requirement of a patentable invention under Section 3(d) of the Patents Act.

Facts and highlights of the case:

• Boehringer Ingelheim filed a patent application (558/DELNP/2003) for crystalline tiotropium bromide monohydrate in Patent Office, Delhi on 16th April, 2003.
• A pre-grant opposition was filed by Intermed Labs Pvt. Limited on 05th November 2007 against the grant of this patent application. The said pre-grant opposition was heard by the then Learned Controller Mr. S.K.Roy. However, the application was recommended for Grant of the Patent on 21st December 2012 and was allotted the Patent No. IN254813.
• CIPLA filed a post-grant opposition to Boehringer’s patent, claiming the drug was ‘obvious’, and the crystalline tiotropium bromide monohydrate did not demonstrate any significant change in ‘therapeutic efficacy’.
• Indian Patent office issued an order in March 2015 to revoke the Boehringer’s patent (IN 254813) covering the crystalline tiotropium bromide monohydrate.

This is considered as a landmark case as the patent was revoked after it was granted, with much scrutiny and examination, and after the pre-grant opposition had been dismissed a few years back.

Tiotropium bromide, being a pre-1995 molecule, was not patented in India as the Indian patent law did not provide patent protection for “products” till 1995. However, Boehringer filed a patent application for the crystalline tiotropium bromide monohydrate on the grounds that the monohydrate form is stable under rigorous manufacturing conditions and post-manufacture, and this specific form exhibits stable particle size distribution make it effective as an inhalable drug.

Cipla had filed a post-grant opposition to Boehringer’s patent in 2013, claiming the drug was ‘obvious’, and the monohydrate crystal form of tiotropium bromide did not demonstrate any significant change in ‘therapeutic efficacy’ as required under Section 3(d) of the Patents Act.

In its decision, the Patent office ordered,

“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, adding the compound is “a product of mere trial and error” and does not “involve any inventive skill”.

“The data as submitted by the applicant relating to stability test provided in the reply statement fails to prove clearly the superior properties of the Monohydrate form in comparison with the prior art form, as stability does not have any relation with the therapeutic efficacy”, Assistant controller Ajay Thakur said.

“In the present case, I would say that the Patentee achieved lowering of crystal growth of the activities during the micronization process and such reduced particle size is effective to penetrate the lungs. But this cannot be considered to translate or exhibit enhanced therapeutic activity over the known substance “, Assistant controller Ajay Thakur said.

The Assistant controller further added that,

“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 the 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'”.

Cipla (an Indian Pharma major) has been marketing the generic version of tiotropium bromide monohydrate under the brand name “Tiova” since 2003. The revocation of the patent paves the way for the Indian firm to continue selling its generic version in the Indian market.

Boehringer Ingelheim has a three-month window to appeal to the Intellectual Property Appellate Board to seek a review on the order issued by the patent office.

Section 3(d) was incorporated in the amended Patent Act with the objective of blocking the pharmaceutical companies’ attempt to claim the patent right for incremental innovation involving new forms of a known molecule with no significantly enhanced efficacy. MNCs have been constantly trying to circumvent this provision ever since the Patent Act was amended in 2005. In view of the Public interest, the Indian government does not want pharmaceutical companies to unjustifiably profiteer from pharmaceutical substances that involve only incremental innovation.

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at [email protected]