"The MMA generally precludes multiple 30-month stays for those applications to which it applies." That is a statement from the FDA in a draft guidance document entitled "Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement and Modernization Act of 2003," published in October 2004. But in the same document, FDA also stated, "Multiple 30-month stays, however, still may be possible in certain cases." This is one such case.
In 2008, Minrad, Inc. (now Piramal Critical Care, Inc.) filed an ANDA for a generic version of Suprane (desfluorane, USP) and submitted a paragraph IV certification to Baxter Healthcare's U.S. Patent No. 5,617,906. Minrad sent a paragraph IV notice letter to Baxter, which Baxter received on December 12, 2008. Within 45 days, Baxter filed suit against Minrad for infringement of the '906 patent, triggering a 30-month stay that expired on June 12, 2011.
On June 7, 2011, just days before the 30-month stay expired, FDA granted Baxter's citizen petition requesting that FDA confirm that Baxter is entitled to a second 30-month stay. The FDA's petition response explains:
On June 23, 2009, Minrad changed the container closure system for its drug product and submitted an amendment to ANDA 90-363 to include the new closure system. Once Minrad submitted the second paragraph IV certification to the '906 patent in connection with the revised product and sent notice to Baxter, and Baxter subsequently sued Minrad within 45 days of receiving that notice, the statutory requirements for a 30-month stay with respect to this paragraph IV certification were met.
The FDA's response continues:
The statute is unambiguous. When a paragraph IV certification has been made to a patent for which information was submitted to FDA before the ANDA was submitted, and an action is brought for infringement of the patent that is the subject of the certification, a 30-month stay dating from receipt of the notice applies (section 505(j)(5)(B)(iii) of the Act). Even if the statute were ambiguous, we would interpret it, consistent with its intent to provide an opportunity to litigate questions concerning patent infringement, to begin a 30-month stay when as here, an ANDA is amended to include a new certification reflecting a change in the product covered by the ANDA.
As a result, FDA granted Baxter second 30-month stay, which will not expire until January 7, 2012.
The lesson for generic drug companies: if possible, do not change your drug product during the approval process. If you do change your product, try to avoid having to send another paragraph IV notice letter. On the flip side, the lesson for brand-name drug companies: if you receive another paragraph IV notice letter from a company you've already sued, file another complaint against that company. You may earn an additional 30-month stay.
Hat tip to Steve Auten's Hatch-Waxman ANDA Litigation Forum on LinkedIn.
POSTSCRIPT: The '906 patent claims an "anaesthetic agent container for supplying a liquid anaesthetic" comprising certain physical features. None of the claims recites desflurane--or any other pharmaceutical. Thus, Minrad may have a viable argument that the '906 patent is improperly listed in the Orange Book. It appears from Minrad's Answer, however, that Minrad has not sought the delisting of the '906 patent.