HETERO DRUGS GETS NOD TO PRODUCE 1% NADIFLOXACIN CREAM

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IN A relief to Hyderabad-based pharma company Hetero Drugs, the Supreme Court on Friday gave it the green signal to manufacture 1% Nadifloxacin cream used for treating various skin ailments.

A bench comprising Justice BP Singh and Justice HS Bedi vacated an earlier order of the apex court which had said that the Madras High Court order restraining the company from manufacturing and marketing 1% Nadifloxacin in any form will be confined to its cream type only as Wockhardt has exclusive marketing rights for it. However, the apex court had permitted Hetero Drugs to manufacture and sale other forms of 1% Nadifloxacin. The order was passed taking into account the Bombay High Court order which had refused to grant any interim relief to Wockhardt challenging rejection of its application seeking product patent.

Senior counsel AM Singhvi and advocate Pratibha Singh appearing for Hetero Drugs said that the application of Wockhardt seeking product patent has been rejected by the authority. As it had obtained the exclusive marketing rights under provision of the Patent Act, 1970, on the basis of that application, the restrain order on the petitioner company should be lifted, said Mr Singhvi.

The patent office in its May 18, 2006 order had refused to grant product patent on the ground that the pharmaceutical compositions of racemic Nadifloxacin and its antibacterial activity/property in form of oral, parental and topical form is disclosed in the US Patent

Hetero Drugs in its application said that Japanese pharmaceutical company Otusuka Pharmaceuticals was given a patent for Benzoquinolizine, also called Nadifloxacin, by the a US patent office.

“After the Otusuka Pharmaceuticals patent, the component 1% Nadifloxacin came into public domain and was published, therefore the essential requirement of patentability that is “novelty of invention” was lost forever”, said the application of Hetero Drugs.

On April 7, 2006, the Supreme Court had modified the Madras High Court order to the extent of manufacture of the Nadifloxacin cream only.

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