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US patent office rejects claims on Forest's Bystolic

This article was originally published in Scrip

Executive Summary

Forest Laboratoriessaid that during a re-examination the US Patent and Trademark Officerejected claims on a US patent, No 6,545,040, covering its beta-blocker product Bystolic (nebivolol). The company said that the PTO rejected all claims on the active ingredient as unpatentable in view of the cited prior art. "We believe the claims are patentable over the cited art and we will continue to prosecute the re-examination application," Forest stated. Forest licensed the US and Canadian rights to Bystolic from Mylan, and Mylan had licensed the rights from Janssen (Johnson & Johnson). Janssen submitted the patent for re-examination by the government last year. Natixis Bleichroeder analysts have stated that, in a worst-case scenario, the decision could result in Bystolic facing generic competition as early as 2015 instead of 2022.




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