PRABHA SRIDEVAN,CHAIRMAN - (1.) THIS appeal is against the rejection of the application filed by the appellant on the ground that a new use for a known product cannot be patentable.
(2.) THE application for patent IN/PCT/2002/00543 filed by FUMAPHARM AG on 26/04/2002 for their investigation relating to "Fumaric Acid Derivatives effective against mitochondrial Diseases". They claimed priority from the application filed in Germany 10000577.2 dated 10/01/2000. It was filed as a national phase application in India subsequent to the filing of international application PCT/EP00/12504 dated 11/12/2000 through PCT. The claim 1 of the invention is filed related to use of individual or a mixture of fumaric acid derivatives for preparing a pharmaceutical composition for treating mitochondrial diseases."
(3.) THE application was examined and the First Examination Report raise the following objections. Claims 1 to 12 do not constitute an invention and the invention lacks inventive step on the basis of prior art US documents US5538968. The appellant respondent saying that claims 1 to 12 were suitably amended, and therefore, it should not be held to fall within the scope of S. 2(1)(j) of the Act. The reply also stated that the prior art did not disclose the unexpected efficacy of fumaric acid derivatives in the treatment of mitochondrial diseases. The explanation was not accepted and the Office informed the appellant that the subject matter was involved in respect of the prior art US 5424332 published on 13/06/1995 which disclosed a pharmaceutical preparation fumaric acid salts in combination for treatment of psoriasis. After the hearing, the Controller held that S. 3 clearly indicates what are not inventions and the present application was failed. The learned counsel for the appellant submitted that what is not patentable is a mere discovery of a new property, new use for a known substance. But this is not a mere discovery and is the result of extensive experiments then new property will not be hit by S. 3(d). The learned counsel submitted that the new property of the known substance had been discovered by experiment and research and that the Novartis Case decided by the Hon'ble Madras High Court will not be applicable. According to the learned counsel, Example 4 in Table 1 show that this new property was evolved for the first time in the instant invention by experimentation. He also submitted that inventive ingenuity lies in arriving at the new property. He submitted that patentability should not be considered only from the structural aspect but also from the functional aspect as seen from the S. 3(d) which speaks of enhanced efficacy. He also submitted that efficacy should be understood as a maximum therapeutic effect that a particular drug is capable of producing. Therefore, if the known substance produces a new therapeutic effect, then it will not attract S. 3(d). Invention must be held to be patentable.;