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