In a decision given by the Kolkata patent office for Applicant Merck and CIE, the IPO refused the patent application for falling within the ambit of invention relating to atomic energy.

Section 4 of the Indian Patents Act reads as follows: “Inventions relating to atomic energy not patentable. -No patent shall be granted in respect of an invention relating to atomic energy falling within sub-section (1) of section 20 of the Atomic Energy Act, 1962 (33 of 1962).”.

This application was first filed with the Department of Atomic Energy (DAE) to seek their approval however the DAE denied the same stating that the invention relates to Atomic Energy.

The patent applicants at the IPO, contended in their submissions that the instant invention relates to novel folate conjugates and the corresponding metal-chelate complexes as well as pharmaceutical compositions thereof, their methods of production and use in diagnostic and therapeutic medical applications, such as in diagnostic imaging and radiotherapy. The novel folate conjugates according to the invention can form a stable chelate with venous radio nuclides suitable for diagnostic imaging and radio therapeutic applications. The present invention is directed towards a new method of synthesis of 18 – folate radio pharmaceuticals, wherein at least one L8F-isotope is attached to a folic acid or derivative thereof, through direct radio labeling with 18F.

The applicants held that the invention has no relevance or use in the field of atomic energy and do not attract the provisions of Section 4 of the Patents Act. The applicants also referred to some instances wherein patent applications relating to similar subject matter, i.e. the use of radio nuclides in compounds, complexes or conjugate for different purposes, including medical applications such as for radio imaging, diagnostics and radiotherapy amongst others have been granted by the IPOs in the past.

They also submitted that it is obvious from the disclosure that the complexes according to the invention are used only for radiotherapy and diagnosis and not for the production of atomic energy in any form. The invention does not, in any way relate to the production, control, use of disposal of atomic energy or the prospecting, mixing, extraction, production, physical and chemical treatment, fabrication, enrichment, canning or use of any prescribed substance or radioactive substance as required by section 20(1) of the Atomic Energy Act. They pleaded to waive off said objection, submitting that there is no link between compounds according to the instant invention and the “Prescribed Substance” as defined in Section 2, item (i), paragraph (g) of the Atomic Energy Act, and therefore the claims do not attract Section 4 of the Patents Act.

However, the IPO did not give a reasoned order elaborating upon its reasons to refuse the patent application but cited the refusal of the instant application by DAE as their conclusive decision.


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