BioMarin Technologies B.V. or BioMarin Nederland B.V. is known for developing therapeutics. The Company functions as an entity discovering and developing ribonucleic acid-modulating therapeutics for the diagnosis of genetic disorders. BioMarin Nederland has operated in the healthcare industry throughout the Netherlands.
In India, the research of BioMarin Technologies B.V. focuses on TPP-1 formulations and methods for treating CLN2 disease, histone deacetylase inhibitors, adeno-associated virus factor VIII vectors, manufacture of active highly phosphorylated human N-acetylgalactosamine-6-sulfatase and uses thereof and manufacture of active highly phosphorylated human lysosomal sulfatase enzymes and uses thereof.
BioMarin Technologies B.V. filed a patent application numbered 8300/DELNP/2014 that is titled RNA MODULATING OLIGONUCLEOTIDES WITH IMPROVED CHARACTERISTICS FOR THE TREATMENT OF NEUROMUSCULAR DISORDERS. The patent has been filed in the field of Bio-Chemistry. This Patent Application has been granted as Patent Number 349579. This invention relates to an oligonucleotide consisting of 2’-O-methyl RNA nucleotide residues, having a backbone wherein all phosphate moieties are replaced by phosphorothioate moieties, wherein said oligonucleotide comprises or consists of a repetitive nucleotide unit (XYG)m, wherein m is an integer from 4-12 and each X is C or 5-methylcytosine, and each Y is U or 5-methyluracil, wherein a minimum of one X is 5-methylcytosine and/or a minimum of one Y is 5-methyluracil, wherein said oligonucleotide hybridizes to a repetitive element having CAG as repetitive nucleotide unit.
During the patent examination, the patent examiner raised objections under Section 3(d) of the Indian Patents Act, 1970. It was indicated that the claims where inadmissible under section 3(d) as the preamble of the said claims relate to an oligonucleotide comprising a 2′-0-methyl RNA nucleotide residue; which is directed towards the new use/new form of a known substance as oligonucleotide is already disclosed in the prior art.
As a response, the Applicant submitted that the claims were directed towards a well-defined novel product. The novelty of which was acknowledged by the Learned Controller himself. Accordingly, the preclusion of Section 3(d) does not apply to the amended claims as the claimed oligonucleotide provides surprising and unexpected results.
Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.
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