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Indian Patent Office has refused patent application of Japanese drug manufacturer Otsuka Pharmaceuticals for certain forms of its anti-psychotic drug aripiprazole, a medicine it sells under the brand Abilify.
Torrent has been at loggerheads with Otsuka over the patent of Abilify in other countries earlier.
The patent application for “Hydrate A of Aripiprazole and a process of preparation thereof”, was filed by Otsuka Pharma in December 2002. Torrent Pharma filed its pre-grant opposition alleging that the invention claimed are already published. It stressed on the clause in the Patents Act, which restricts incremental innovations from claiming for patents, under Section 3(d) of the act.
Otsuka claimed that in the specification, it was clearly mentioned that each of the aripiprazole forms of the present invention reduced hygroscopicity, better solubility, more bioavailability and improved shelf life. Thus, such properties of the product renders the compounds superior to the compounds which are already known.
The Patent Office said that considering the pre-grant opposition, statements from both the parties and arguments, it is refusing to grant the patent. It has also re-examined the application based on the First Examination Report.
Otsuka filed various litigations in US after Torrent Pharma moved its abbreviated new drug application (ANDAs) allegedly infriniging the various patents covering Otusika’s aripiprazole product, Abilify.
According to reports, Alembic Pharma, Hetero Labs and Torrent Pharma received US Food and Drug Administration (FDA) approval for the generic versions of Abilify, used for the treatment of schizophrenia and bipolar disorders, in April 2015.