King Pharmaceuticals markets Altace (ramipril), which is indicated for the treatment of high blood pressure. Until last year, when the Federal Circuit invalidated King's compound patent on ramipril, King earned about $700 million annually from U.S. sales of Altace.
Although Lupin was the ANDA filer who prevailed against King in the patent litigation, Cobalt Labs, as the first ANDA filer, won the 180-day exclusivity rights. In a letter dated January 29, 2008, to attorneys for Lupin, FDA explained that Cobalt's exclusivity was triggered on December 10, 2007, and will expire on June 7, 2008.
Recently, on May 16, 2008, King submitted a citizen petition requesting that FDA require ANDA applicants for generic ramipril to submit a paragraph III or IV certification to U.S. Patent No. 7,368,469, which issued May 6, 2008, prior to final approval. The '469 patent claims methods "for reducing the risk of a cardiovascular event" by administering an ACE inhibitor such as ramipril.
According to the FDA website, at least seven ANDA filers have tentative approval for ramipril and thus appear to have planned on obtaining final approval on June 7, when Cobalt's 180-day exclusivity expires. Those plans may now be in doubt, as it may take FDA some time to decide how to rule on King's petition.
RELATED READING:
- Sept. 11, 2007 OBB post on Fed. Cir. decision
- Oct. 8, 2007 OBB post on FDA request for comments re: 180-day exclusivity
- Nov. 6, 2007 OBB post on comments submitted to FDA
- Feb. 4, 2008 OBB post on FDA decision re: 180-day exclusivity
It would seem that any applicant could simply do a section viii "carve-out."
The drug was approved in 1991 and the patent has priority only to 1999, so either the patent is claiming a method that can (in theory) be carved out, or it is invalid (e.g, on an inherency argument). Giving the benefit of the doubt to King on validity, a carve-out would seem appropriate.
According to the OB, there are multiple exclusivities for different uses, so it would seem that a section viii carve-out would be the simple solution to the problem for a generic applicant.
However, that might lead to a delay in approval, for labeling review, so King (& Cobalt) might benefit from this maneuver anyway.
Posted by: Sean | May 28, 2008 at 03:26 PM