There are certainly some interesting issues that are going to be codified if the Proposed Rule publishes in final the way it is currently written.  Many of the proposals are being formalized into the regulations that represent the Agency’s past practice.  Here are highlights of a few more of some of these important issues that should be of interest to our readers.

Court Order of Dismissal without a Finding of Infringement

The statute does not specifically address what happens to the 30-month stay (is it terminated?) when there is a settlement order and court dismissal with or without prejudice of timely filed paragraph IV litigation.  FDA is codifying long-standing policy that such an order does constitute the type of court decision that terminates a 30-month stay.  FDA notes in the Proposed Rule that this is a situation that it frequently encounters, thus the cover of formalizing its position is prudent.

The Agency further explains:

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.

Tentative Approval Where Court Finds Infringement or Issues an Injunction after 505(b)(2) or ANDA Approval

FDA will issue a tentative approval (TA) letter to an application where the court has issued an order or injunction that states the application may be approved at some later date if all other approval requirements are met.  This tracks the requirements for TAs that are used only when there is a patent or exclusivity bar to approval and now will also give that same effect to court orders.

Interestingly, the FDA also indicates that it is clarifying “that if a court enters an order requiring that the date of approval be delayed for an already approved 505(b)(2) application or ANDA, FDA will convert the approval to a tentative approval, if appropriate.  This scenario may occur, for example, if a patent infringement action is initiated after the 45-day period described in section 505(c)(3)(C) and (j)(5)(B)(iii) of the FD&C Act and results in a judgment of patent infringement. Proposed § 314.107(b)(4) would expressly describe FDA’s practice of giving effect to the court order under 35 U.S.C. 271(e)(4)(A), irrespective of whether the order relates to a patent associated with a 30-month stay of approval.” This appears to differ slightly in the way that FDA does things now, in as much as they typically rescind the approval, but, now, they are stating they will convert the approval letter to a TA letter, but don’t mention in the proposal the rescinding of the approval letter.  My guess is this is only a bit of semantics, but watch for comments on this part of the proposal.

No 180-day Forfeiture Regulations in This Proposed Rule

FDA notes that, at this time, the Agency is not attempting to issue regulations explaining the forfeiture provisions of the statute, but will continue to regulate that issue directly from the statute and will continue to make decisions on a case-by-case basis.   It is likely that, at some time in the future, and because of the complexity of the forfeiture provisions, FDA will take a crack at drafting proposed regulations to deal with the forfeiture provisions.  Right now, however, this Proposed Rule, which comes some 12 years after the passage of the MMA (and I might add an additional 2 years longer than it took for the final implementing regulations for Hatch-Waxman), is about enough for anyone to deal with.

Trigger of 180-Day Exclusivity

Before the passage of the Medicare Modernization Act (MMA), there were two triggers that could start the 180-day exclusivity period, first commercial marketing and failure to pursue application approval in a diligent manner.  The MMA changes the trigger to first commercial marketing (including the marketing of an authorized generic) as the trigger.  In previous legislation, the 180-day period began on the date of notification by the applicant of first commercial marketing.  The MMA modified that language to the date of first commercial marketing and to assure early notice to the FDA, the proposed regulation will require the first applicant to provide this notice in correspondence to FDA no later than 30 days after first commercial marketing.  If an applicant fails to make a timely notice to the Agency, FDA will deem the date of first commercial marketing to be the date of approval, which may have the effect of shortening the 180-day period of exclusive marketing.  This is a provision that may be ripe for challenge if it stands the way it is written.

That’s it for today.  If some of this stuff does not make you excited and anxious to read more, then you are not a true Hatch-Waxman geek.  We, on the other hand, are like the Geek Squad of the Hatch-Waxman regulations.  Give us a shout if you have any questions!