Proposed Rule – Marching On

Today, we delve into the issues of court decisions impacting the 30-month stay.  This area of the Rule is complex and dependent on the actions of the courts and the applicants.

End of the 30-Month Stay Period

The Proposed Rule tracks the Medicare Modernization Act (MMA) in regard to the impact of certain court actions.  To summarize, the trigger for the end of the 30-month stay is the date of the District Court decision declaring the patent invalid, not infringed or unenforceable, unless the decision is appealed.  If the decision is appealed, then the end of the 30-month period is the ended on the date of the mandate of the appeals court finding the patent is invalid, not infringed, or unenforceable.  “This proposal reflects the Agency’s current practice in implementing section 505(c)(3)(C)(ii) and (j)(5)(B)(iii)(II) of the FD&C Act, which recognizes that a party may request rehearing by the appellate panel or rehearing en banc. In such circumstances, it would be premature to terminate the 30-month stay and possibly approve the 505(b)(2) application or ANDA while a decision regarding patent noninfringement, invalidity, or unenforceability was being reheard by the court of appeals.”  In either case, the 505(b)(2) or ANDA application can be approved on the date of the decision, but only if the application is otherwise approvable.

If the District Court decision is not appealed, then the date specified by the district court will dictate when the 30-month period expires.

Often, settlement agreement may be made where the NDA holder or patent holder agrees to permit the ANDA applicant to go to market prior to patent expiration.  In such cases, a written notice from the NDA/patent holder can permit the FDA to approve the 505(b)(2) or ANDA application prior to patent expiration.  This usually results in a license of the patent.  The FDA has taken this position since the inception of the Hatch-Waxman Act, but is codifying the practice in this Proposed Rule.

FDA is proposing to add § 314.107(b)(3)(vii) to clarify that if a court enters an order requiring the termination of the 30-month stay (or 7½ years where applicable), the 505(b)(2) application or ANDA, if otherwise ready for approval, may be approved in accordance with the court order.

In addition, FDA is proposing to add § 314.107(b)(3)(viii) to codify FDA’s policy that court entry of an order of dismissal, with or without prejudice, of patent infringement litigation that was timely initiated in response to notice of a paragraph IV certification will terminate the 30-month period (or 7½ years where applicable,), if such order does not state a finding of patent infringement.  It is appropriate that a 30-month stay terminates under these circumstances because the statutory purpose of the stay is to allow time for claims of patent infringement to be litigated prior to approval of the potentially infringing drug product.  If the patent owner or exclusive patent licensee dismisses the patent infringement action on terms that the court considers proper, then there should be no further delay of approval of a 505(b)(2) application or ANDA otherwise eligible for approval.

If this does not make your head swim, you are likely a lawyer or a Hatch-Waxman nerd.  In any event, we will continue our march through the rest of the rule soon.