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DewDiligence

08/02/07 2:51 PM

#4455 RE: mblimon #4453

>…the time for DNA/BIIB's [CD20] product to become generic is not that long.<

I do not understand why you say this. In the U.S., the patents of greatest consequence for a second-generation humanized mAb have not even issued yet. Here’s an excerpt from BIIB’s latest 10K report:

http://www.sec.gov/Archives/edgar/data/875045/000095013507000981/b63632bie10vk.htm

>>
Our recently-granted patent in certain European countries claiming the treatment with anti-CD-20 antibodies of certain auto-immune indications, including rheumatoid arthritis, has been opposed by numerous third parties. This opposition proceeding is likely to be protracted and its outcome is uncertain at this time.

…In addition, we and our collaborator, Genentech, have filed numerous patent applications directed to anti-CD-20 antibodies and their uses to treat various diseases. These pending patent applications have the potential of issuing as patents in the U.S. and abroad covering anti-CD-20 antibody molecules for periods beyond that stated above for RITUXAN and ZEVALIN.

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Regards, Dew

DewDiligence

08/02/07 11:27 PM

#4457 RE: mblimon #4453

mlimon et al: Re: Patent expiration for CD20 IP

>so the time for DNA/BIIB's product to become generic is not that long<

I see now that you were referring to the 2014 date specified in today’s GTC PR. (I had previously assumed you were giving your own assessment of the CD20 patent life.)

The sentence of consequence in the PR is:

“The existing relevant CD20 antibody patents will expire by 2014.”

However, the word existing changes the complexion of the sentence substantially. As noted in #msg-21771786, BIIB says in its SEC filings that key CD20 patents for which it has applied have not yet issued. Moreover, if you search the patent applications that relate to therapeutic CD20 mAbs on the USPTO website, there are a great many hits.

In other words, despite the 2014 date in GTC’s PR, I highly doubt that the patent landscape for mAbs targeting CD20 is as simple as today’s PR makes it seem. Regards, Dew