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Pharma major Pfizer has received two process patents related to its blockbuster drug etanercept, sold under the brand name Enbrel in several countries including the United States of America, by winning against pre-grant oppositions filed by Mylan and Biocon.
The decision was taken on two patent applications, one for production of polypeptides and another for production of TNFR-Ig Fusion Protein. Both applications were filed by Pfizer Ireland Pharmaceuticals in 2007 to process patents for Etarncept, legal sources close to the development said.
The drug is a biopharmaceutical aimed at treating autoimmune diseases including rheumatoid arthritis, psoriatic arthritis and plaque psoriasis.
Mylan Laboratories and Biocon Ltd had filed pre-grant oppositions with the Indian patent office, seeking it to refuse Pfizer's claims on the grounds that mere application does amount to invention.
Biocon, for its part, argued that the inventions were obious, and thus not patentable. There is a lack of sufficient disclosure and the applications were an attempt to secure multiple patents for the same invention, it said further.
These oppositions were however dimsissed by the Assistant Controller of Patents and Designs, Patent Office, New Delhi.
Pfizer had a co-marketing tie up with Amgen to sell the drug in US and Canada, while the company recorded sales from other markets for the drug, according to reports.
The order comes at a time when Enbrel, one of the top selling drugs of Pfizer, is expected to face the threat of biosimilars in the US and European market, said reports.
According to compnay's acnnual records, Enbrel had in 2015 earned a revenue of $3.33 billion, following closely the $6.24 billion Prevnar family and the $4.83 billion Lyrica.
