FDA's "ministerial role" in patent listing should include requiring ANDA applicants to re-certify to an innovator's patent each time a change is made to the CMC section of the ANDA, a Jan. 2 citizen petition submitted on behalf of Biovail says.

"It is consistent with the Agency's 'ministerial' role in patent listing matters" that "FDA should require all Paragraph IV ANDA filers to include in all ANDA amendments a certification that it will provide to the NDA holder and patent owner a new notice of patent certification" the citizen petition says. The petition was submitted by the law firm Keller & Heckman.

If the amendment does not include changes to the chemistry, manufacturing and controls section of the ANDA, then the generic applicant should state that in a notice to the innovator, Biovail said.

A new certification for each CMC change is necessary because "any amendment of the CMC section of the ANDA redefines the product that is covered by the application and, at the very least, requires a fresh assessment of whether infringement has arisen," the petition maintains.

A new certification would delay generic approval by triggering a new 30-month stay of approval or extending the existing stay, Biovail acknowledged.

Biovail is requesting that "FDA refuse to approve Andrx' ANDA 75-401" for a generic version of Biovail's Tiazac (diltiazem) "until such time as it has ensured that the Andrx ANDA contains an 'accurate' patent certification."

Andrx' patent certifications are inaccurate because they have not been updated despite "at least a dozen amendments" to the ANDA, Biovail said.

FDA must not approve Andrx' ANDA "until a new, 'accurate' patent certification has been submitted to reflect the changes that have been make to the generic product for which Andrx is seeking approval," the petition maintains.

Andrx' generic version of Tiazac, Taztia XT, has been tentatively approved at FDA since Sept. 29, 2000. The company had originally expected to launch the generic in February 2001 but was delayed after Biovail listed a new formulation patent in the "Orange Book" Jan. 8, 2001. That action required Andrx to certify to the patent and triggered an additional 30-month stay.

A Sept. 19, 2001 Miami federal court decision said the 30-month stay should be lifted because the listing was intended to "impede or delay the expeditious resolution of the patent actions," but left the issue of delisting the patent to FDA (¹ Also see "Andrx Generic Tiazac Open For Approval; Court Lifts 30-Month Stay" - Pink Sheet, 24 September, 2001., p. 12). A trial is set for June 3, 2002.

Biovail's citizen petition maintains that because first-to-file status rather than a successful patent challenge determines eligibility for 180-day exclusivity, there is a "new-found emphasis" on "'submit first and fix later.'" The company suggested that "one option for handling these changes would be to consider any such submission following a tentative approval letter to constitute a 'major' amendment to the ANDA."

The petition maintains that a policy under which CMC amendments automatically trigger the need for a new Paragraph IV certification would not go beyond FDA's ministerial role in listing patents.

"Biovail is not asking FDA to consider substantive patent issues as part of its ANDA review," the petition says. "Rather, the point is that the product an ANDA applicant expects to have approved (following numerous amendments and other changes) may not be the product described in its original ANDA and that was the subject of patent certification given many months (if not years) earlier. In that case, the applicant's patent certification would no longer be considered accurate."

"Biovail is well aware of FDA's unwillingness to involve itself in evaluating substantive patent matters because of the agency's professed lack of expertise in this area," the company notes.

An antitrust case against Bristol-Myers Squibb brought by a group of state attorneys general is looking at abuse of Orange Book listings by brand name companies. A Jan. 8 amicus brief filed by the FTC maintains that Bristol's listing of a patent covering Buspar is not exempt from antitrust scrutiny because Orange Book patent listings are informational filings that do not call for FDA judgement or decision-making (see ² Also see "“Orange Book” Listings Are Not Immune From Antitrust Scrutiny, FTC Says" - Pink Sheet, 14 January, 2002. ).

ANDA Amendments Should Trigger New Paragraph IV Certifications – Biovail

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