Managing Intellectual Property, March 2013, 145

 

GENE PATENT PRACTICE DIVERGES FROM THE U.S.

 

To be patent-eligible, apart from being novel, non-obvious and industrially applicable, patent laws require an invention must not fall within the list of subject-matter specifically excluded from patent protection. Such a listing in Pakistan effectively precludes patenting of “substances that exist in nature or if isolated therefrom”. However, the absence of any judge-made law of the land, the extent of exclusion has invited controversies.

In terms of law, naturally occurring substances ‘as such’ or substances isolated from their natural environment such as gene/DNA sequences are considered ‘embodiments of information’; hence are not patent eligible. Seen in this backdrop, mere isolation of previously recognized gene/DNA sequences for which a function is already ascribed; or reproduction using recombinant DNA technology or chemical synthesis is a ‘known desideratum’ lacking non-obviousness unless such an isolation or reproductions adds to the resulting product a characteristic  or value not known for the native.

The patent eligibility of isolated gene/DNA molecules had been considered by CAFC in the Association of Molecular Pathology et al v USPTO (Fed. Cir. 2011). The question surrounding the entire controversy was whether isolated DNA molecules corresponding to two human breast-cancer genes: BRCA1 and BRCA2 are ‘product of nature’ (patent ineligible) or composition of matter (patent eligible). Recognizing the long-standing practice of the USPTO, CAFC ordained that the isolated DNA molecules are patent eligible composition of matter; though US Supreme Court while applying the same logicality it did in Mayo Collaborative v Prometheus Industries case vacated the CAFC’s decision on March 26, 2012 holding that ‘companies cannot patent observation about a natural phenomenon”.

To the extent of CAFC decision, the patent practice in Pakistan stands in congruity with the net effect of the ruling but it diverges on several points. At times, two different reasons are veering-off. Firstly compared to the position in Myriad case, “mere isolation of known substances” from their natural environment is not subject to patent protection. For an isolated substance to be patent-eligible, it must have previously unrecognized existence and must be shown to have some specific and substantial utility preferably proved by some experimental data or testing. Secondly, against the US “practices on the human or animal body” criterion for diagnostic methods exclusion from patentability, methods for diagnosis whether performed in vivo (on or inside the human body) or in vitro (performed on samples from human body), if meant for the treatment of humans or animals, are excluded. Methods for identifying/screening to determine curative value of one or more target compounds are, however, treated differently from the method of diagnosis.

“Existence in nature” is the very test of exclusion for a “product of nature” to be patentable. The test of “existence” is qualified by the “knowledge of existence”. And where there is no knowledge there is no “existence”. Therefore, isolation of previously unrecognized natural substances for which a specific, concrete and credible function is assigned, should receive appropriate patent protection elsewhere.