Yet Another Petition is Submitted to FDA Concerning the QI Act & 30-Month Stay Availability; Latest Petition Concerns CELLCEPT

February 27, 2009

By Kurt R. Karst –      

Over the past few weeks, we have posted (here and here) on citizen petitions submitted to FDA requesting that the Agency address whether the 30-month stay provisions of the Hatch-Waxman Amendments apply to a pending ANDA for a generic version of an old antibiotic drug, which ANDA contains a Paragraph IV certification to a patent listed in the Orange Book in accordance with § 4(b)(1) of the QI Program Supplemental Funding Act of 2008 (“QI Act”).  In the latest (third) citizen petition submitted to FDA concerning this issue, Hoffmann-La Roche and Roche Palo Alto LLC request that FDA address the issue with respect to another old antibiotic drug –  CELLCEPT (mycophenolate mofetil) Capsules and Tablets – for which U.S. Patent #4,753,935 was submitted to FDA for Orange Book listing in accordance with the QI Act.  Apotex reportedly submitted ANDAs (containing a Paragraph IV certification to the '935 patent) seeking approval for generic versions of Roche's CELLCEPT products and Roche sued Apotex within the statutory 45-day period.

Roche’s petition raises some of the same arguments raised in the previously submitted petitions concerning DORYX (doxycycline hyclate) Delayed-Release Tablets and SOLODYN (minocycline HCl) Extended Release Tablets; namely, that the plain language of the QI Act requires application of the 30-month stay provisions of the original Hatch-Waxman Amendments, rather than the version of the statute amended by the Medicare Modernization Act, which limits 30-month stays such that a generic applicant with a pending ANDA that amends its application to add a Paragraph IV certification to a later-listed patent is not subject to a 30-month stay in connection with that certification.  The Roche petition also argues that FDA should interpret the QI Act such that patents listed pursuant to QI Act § 4(b)(1) should be treated as having been filed with the original NDA, thus providing for 30-month stay availability.  Medicis makes a similar argument in the SOLODYN petition, but argues that patents covering old antibiotics listed in the Orange Book in accordance with QI Act § 4(b)(1) should be treated as having been filed in the original ANDA, instead of in an amendment.

Both Actavis and Teva have submitted comments requesting that the Agency deny such petitions and determine that a 30-month stay is not available. 

Categories: Hatch-Waxman