Replies to post #52233 on Biotech Values

[DewDiligence]

> CBST – Any opinion on how serious a patent gaffe like this might be for Cubist?<

It will probably cost them the automatic 30-month stay on a generic launch even if they get the patent glitch corrected and reissued. In the meantime, the unnamed generic filer might decide to launch at-risk.

[DewDiligence]

Cubist Pharmaceuticals (CBST) said Wednesday that it found an error in a pharmaceutical composition patent, and subsequently has asked the Food and Drug Administration to delist the patent from the Orange Book, where the FDA publishes patent information on approved drug products.

The biopharmaceutical company said the technical error was related to U.S. patent No. RE39071, one of the patents for its lead product, Cubicin, an injectible antibiotic for skin infections. Specifically, the stereochemistry of an amino acid in the claimed chemical structures was incorrectly identified in the patent, which was originally issued to Eli Lilly (LLY) and is now owned by Cubist.

The error came to light while Cubist was preparing for another company's potential paragraph IV filing regarding Cubicin… Cubist said it will pursue the appropriate course of action in the U.S. Patent Office to correct the patent. "If and when the error is corrected, [the company] will ask FDA to re-list the corrected patent in the Orange Book," it said in a release.

The RE39071 patent is one of three patents challenged by Teva in a case that goes to trial in Apr 2011 with a Markman hearing scheduled for Jun 2010:

http://finance.yahoo.com/news/Trial-Date-Set-for-CUBICIN-bw-3160168087.html?x=0&.v=1

If the error cited above in the RE39071 patent has not been corrected by the time the Markman hearing begins, CBST had better hope the other two patents stand up!