[Ip-health] New U.S. Patent May Protect Avonex (Interferon-beta) From Competition Until 2026

[Biotech. Info. Inst.]

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Biogen-Idec has received U.S. 7,588,755 concerning methods of use of
recombinant interferon-beta, which it markets as Avonex mostly for
treatment of multiple sclerosis (MS).  Patent protection was expected
to expire in 2013, at which time biosimilars would likely enter the
market, but this patent will be in force into 2026 (17 years from now,
31 years from the application filing date, and 45 years from the
earliest priority date).   For further information, see http://www.patentdo=
cs.org/2009/09/biogen-idec-receives-methodofuse-patent-on-human-=DFinterfer=
on.html
.

As explained in this article, with changes in the law in recent years
regarding patent terms, the remarkably lengthy term of this patent's
coverage is primarily attributed to patent office delays and and
changes in the patent laws (not due to stalling by the company), and
"Understanding the history of this patent defuses any apprehension
about the likelihood of similar outcomes going forward, and the
Avonex=AE patent estate can be seen to be nothing more than a historical
accident that cannot be replicated."  However, despite this route to
patent extension no longer being available (for more recent filings),
there will likely be some who will use this patent in arguments
against inclusion of lengthy data exclusivity periods in pending
biosimilars' legislation.  But is this case even relevant to this
debate?

Note, the article cited does not speculate on the effect this patent
may have on other interferon-beta products marketed in the U.S., such
as Rebif from EMD Merck (Merck Serono) and Betaseron from Bayer
Schering (and equivalent/relabeled Extavia from Novartis).  The patent
could very well cover these other products.  It is also not fully
clear the extent to which this will actually provide protection in the
marketplace, notably whether the patent covers use for MS treatment.

Ronald A. Rader
President / Author & Publisher, BIOPHARMA:  Biopharmaceutical Products
in the U.S and European Markets
Biotechnology Information Institute
1700 Rockville Pike, Suite 400
Rockville, MD 20852
Phone:  301-424-0255
E-mail:  biotech@biopharma.com
Web sites:  www.biopharma.com; www.bioinfo.com;
     www.biopharmacopeia.com; www.biosimilars.com