As far as section 3(d) issue was concerned, it was ruled against Novartis. The Appellate Board concluded that the bioavailability is not as same as therapeutic efficacy and hence cannot be considered to prove significant efficacy under section 3(d). What is worth noting is that during discussion over section 3(d), Novartis Counsel argued to the Appellate Board that since it was already acknowledged during the hearing that patent application for beta-crystalline variant of imatinib mesylate is novel and constitute inventive step, so section 3(d) should not be applicable. In reply, the Appellate Board reasoned that since the application for beta-crystalline imatinib mesylate falls under drugs/pharmaceuticals/pharmacology, hence section is applicable.
To sum up the whole IPAB proceedings: the patent application for beta-crystalline variant of imatinib mesylate is found novel and non-obvious (inventive step) but still not allowable under section 3(d). Does this judgment really make sense? In other words, a patentable invention which is novel, non-obvious and industrially applicable will not be allowable under section 3(d). Is this the purpose behind section 3(d) to stop patentable inventions? Or was it included to stop frivolous inventions? The Appellate Board has not only made very irrational reasoning for applying section 3(d) for patentable inventions but also diluted the spirit of patent law. However, the Appellate Board reasoning does not end here they moved a step further to reject application for beta-crystalline imatinib mesylate under section 3(b) on the grounds of public morality (considering pricing issue). The Appellate Board specifically reasoned that Glivec price is too unaffordable to the poor cancer patients in India and hence not allowable under section 3(b). However, we will running a quick post analyzing section 3(d) exclusively and will try to bring clarity and spirit behind the inclusion of section 3(d).
Hi Varun,
ReplyDeleteIf you read the act, preamble of section 3 says "What are not inventions" while the term invention is defined in section 2(1)(j)as a new process or product involving an inventive step and capable of industrial application.
The actual purpose of section is to expressly bar the patenting of certain categories of invention. When rejecting an application on grounds of section 3, its prima facie acknowledged that application is an invention under the meanings of the act and thus eligible for a patent.
The term "frivolous" is a very subjective term and its definition would vary for person to person. I personally feel that this term is creating a lot of unwanted noise and issues instead of doing any good. What now remains to be seen is, in light of the decision, how would be the term frivolous be interpreted by Indian patent examiners and controllers hence forth!
Aliasgar