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Re: RockRat post# 130050

Wednesday, 11/02/2011 1:07:01 PM

Wednesday, November 02, 2011 1:07:01 PM

Post# of 257253
BG-12 IP:

According to Biogen's 10Q
http://www.sec.gov/Archives/edgar/data/875045/000095012311092986/b87796e10vq.htm

We have several patents and other rights applicable to BG-12. In the U.S., we are entitled to the five-year data exclusivity given to new chemical entities and we own a patent covering the administration of dimethyl fumarate (DMF), the active ingredient in BG-12, to treat MS and other autoimmune diseases. This patent expires in 2020 with a possible term extension to be determined. In the E.U., we have a patent covering our BG-12 formulation and the method of treating MS and other autoimmune diseases with our formulation that expires in 2019 and which may also be eligible for patent term extension in some countries. In addition, while there are a number of ways to obtain data exclusivity in the E.U., we believe that we are entitled to 8 years

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data exclusivity plus 2 years market exclusivity based on our submission of a new regulatory package. In August 2011, we received confirmation from the EMA that BG-12 would, in principle, be eligible for such data protection through the European centralized filing pathway.

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