The battle to make generic Oracea available to the public is heating up. Recently filed documents in Delaware show that Lupin Pharmaceuticals, which are based in India have filed for an abbreviated new drug application to manufacture and distribute a generic form of Oracea.
Lupin Pharmaceuticals, based in Mumbai India, is a company specialising in the production of generic medicines.
Galderma Laboratories Inc. et al. v. Lupin Ltd. et al.
1:10-cv-01112; filed December 17, 2010 in the District Court of Delaware• Plaintiffs: Galderma Laboratories Inc.; Galderma Laboratories L.P.; Supernus Pharmaceuticals Inc.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals Inc.Infringement of U.S. Patent No. 7,749,532 ("Once Daily Formulation of Tetracyclines," issued July 6, 2010), licensed to Galderma, following a Paragraph IV certification as part of Lupin’s filing of an ANDA to manufacture a generic version of Galderma’s Oracea® (doxycyline delayed release capsules, used to treat inflammatory lesions of rosacea). View the complaint here.
In October this year we learned that Mylan Pharmaceuticals is also hoping to show that the so-named Chang Patent 7,749,532 is invalid, and thus also be allowed to sell their copy of Oracea.
The basis of the claim is pursuant to 505 (j)(2)(A)(vii)(IV), saying the the 7,749,532 patent is invalid and/or are not infringed by Lupin selling their formulation of generic Oracea. If you drill down through the FDA rules for New Drug Applications, you will find this exception ;
SEC. 505. [21 USC §355] New Drugs
(j) Abbreviated new drug applications.
(2)(A) An abbreviated application for a new drug shall contain
(vii) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the listed drug referred to in clause (i) or which claims a use for such listed drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under subsection (b) or (c)—
(IV) that such patent is invalid or will not be infringed by the manufacture, , use, or sale of the new drug for which the application is submitted
So Lupin will be arguing, along with Mylan that this patent exclusively licensed by Galderma is not a barrier to them manufacturing generic Oracea.
This is more good news for those that consider that Oracea is too expensive.
