DUSA has an exclusive use patent on ALA covering the US, Japan, and elsewhere. It does not cover Europe. Any use for treatment of any type is covered by the patent.
Here is the relevant section from the DUSA 10-K:
All United States patents and patent applications licensed from PARTEQ
relating to ALA are method of treatment patents. Method of treatment patents
limit direct infringement to users of the
methods of treatment covered by the patents. The Company currently has patents
and/or pending patent applications in the United States and in a number of
foreign countries covering unique physical forms of ALA, compositions containing
ALA, as well as ALA applicators, light sources for use with ALA, and other
technology. The Company can give no assurance that any pending patent
applications will mature into issued patents.
Even with the issuance of additional patents, other parties are free to
develop other uses of ALA, including medical uses, and to market ALA for such
uses, assuming that they have obtained appropriate regulatory marketing
approval. Certain forms of ALA are commercially available chemical products. ALA
in the form commercially supplied for decades is not itself subject to patent
protection. Subject to any other protection that may be available to the Company
regarding its proprietary technology, any third-party is free to use ALA in the
form now commercially available for any indication not covered by the Company's
patents, assuming that such third-party has obtained appropriate approval. In
fact there are reports of several third-parties conducting clinical studies with
ALA for the treatment of certain conditions in countries outside the United
States of America where PARTEQ may not have patent protection.
DUSA might well get some Waxman-Hatch protection, though.
Peter |
