Replies to post #57510 on Biotech Values

[Bull Trader]

ASTM - any thoughts??? lots of BUZZZZZZZZZZZ.

[DewDiligence]

Well done! (eom)

[exwannabe]

"In short, the Solodyn patent does not expire until 2018 but is useless and they know it."

Yes an no. The patent can still be effective even if it doesn't preclude the FDA from acting. Hatch-Wacman has no effect on patent rights (other than precluding a holder from suing to prevent FDA action).

The question or marketing the aproved generic will be for the courts to decide (if MRX goes that way). It is certainly possible for an FDA aproved generic to not be marketable due to patent issues.

You may be right in the particular example, since the only aproved patent held by MDX is not for the drug per se, but for the formulation. Thus, the generic may very well not be ifringing THAT patent (you still have some pending patents that might apply according to MDX).

[genisi]

New Law Provides Hatch-Waxman Exclusivities to Antibiotic Drugs

On October 8, 2008, President Bush signed into law the Qualifying Individual Program Supplemental Funding Act of 2008. Section 4 of the law, titled "Incentives for the Development of, and Access to, Certain Antibiotics," makes the patent and marketing exclusivity provisions of the Hatch-Waxman Act applicable for the first time to many older antibiotic drugs. The stated purpose of the law is to spur the development of new antibiotics, including new uses of existing drugs. It will also expand the U.S. FDA's ability to approve generic versions of some drugs, however, and all companies involved in the development and marketing of antibiotics should immediately begin to focus on this important change in the law.
For further reading:

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2008/09/new-life-for-ol.html