Diary of a Hatch-Waxman Addict: Day 3,655 – What About Untimely (Late) Notice?

December 9, 2013

By Kurt R. Karst –      

Our hopes that FDA might publish a proposed rule to implement at least some of the changes made to the Hatch-Waxman Amendments to the FDC Act by the Medicare Modernization Act (“MMA”), enacted on December 8, 2003, before the 10-year anniversary of the law were dashed when December 8th came and went without a peep out of the Agency.  We’re now at day 3,655 and counting.  And because this is Hatch-Waxman we’re talking about – where day calculations really count – we should be clear that the 3,655-day period was calculated from and including Monday, December 8, 2003, to and including Monday, December 9, 2013.  By comparison, FDA – and the U.S. Patent and Trademark Office for that matter – took significantly less time to implement the 1984 Hatch-Waxman Amendments:

  • Proposed ANDA Regulations (Hatch-Waxman Title I): 1751 days (from and including Monday, September 24, 1984, to and including Monday, July 10, 1989)
  • Final ANDA Regulations (Hatch-Waxman Title I): 1023 days (from and including Tuesday, July 11, 1989, to and including Tuesday, April 28, 1992)
  • Final ANDA Regulations; Patent and Exclusivity Provisions (Hatch-Waxman Title I): 1911 days (from and including Tuesday, July 11, 1989, to and including Monday, October 3, 1994)
  • Proposed Patent Term Restoration Regulations (Hatch-Waxman Title II): 656 days (from and including Monday, September 24, 1984, to and including Friday, July 11, 1986)
  • Final Patent Term Restoration Regulations (Hatch-Waxman Title II): 605 days (from and including Saturday, July 12, 1986, to and including Monday, March 7, 1988)

C’est la vie . . . C’est la vie.  Perhaps 2014 – the 30th anniversary of the enactment of the Hatch-Waxman Amendments (on September 24, 1984) – will be the year when we see a proposed rule.  We understand that FDA is quite close to getting something out to the public.

Because we don’t yet have a proposed rule to talk about, we need something to fill the void.  So, we decided on the Paragraph IV notice provisions amended by the MMA.  Earlier this week we addressed “premature notice” (see our post here).  This post addresses the other side of the notice period: late notice and its consequences. 

Under FDC Act § 505(j)(2)(B)(ii), as added by the MMA:

(ii) TIMING OF NOTICE.—An applicant that makes a [Paragraph IV] certification . . . shall give notice as required under this subparagraph—

(I) if the certification is in the application, not later than 20 days after the date of the postmark on the notice with which the Secretary informs the applicant that the application has been filed; or

(II) if the certification is in an amendment or supplement to the application, at the time at which the applicant submits the amendment or supplement, regardless of whether the applicant has already given notice with respect to another such certification contained in the application or in an amendment or supplement to the application.

Prior to the MMA’s enactment, FDC Act § 505(j) provided specific instruction with respect to notice timing only as it concerned ANDA amendments.  Specifically, FDC Act § 505(j)(2)(B) (2002) stated:

(i) An applicant who makes a [Paragraph IV] certification described . . . shall include in the application a statement that the applicant will give the notice required by clause (ii) to –

(I) each owner of the patent which is the subject of the certification or the representative of such owner designated to receive such notice, and

(II) the holder of the approved application under subsection (b) for the drug which is claimed by the patent or a use of which is claimed by the patent or the representative of such holder designated to receive such notice.

(ii) The notice referred to in clause (i) shall state that an application, which contains data from bioavailability or bioequivalence studies, has been submitted under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of such drug before the expiration of the patent referred to in the certification.  Such notice shall include a detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid or will not be infringed.

(iii) If an application is amended to include a [Paragraph IV] certification . . . , the notice required by clause (ii) shall be given when the amended application is submitted.

FDA’s regulation at 21 C.F.R. § 314.95(b), which implemented the statutory notice provision under the Hatch-Waxman Amendments for original ANDAs, states, in relevant part, that an ANDA sponsor must provide notice of its Paragraph IV certification “when it receives from FDA an acknowledgment letter stating that its [ANDA] is sufficiently complete to permit a substantive review.”  As FDA has previously stated, “[t]he term ‘when’ was subject to multiple interpretations by industry, resulting in ANDA applicants providing notice to NDA holders and patent owners at times ranging from immediately upon receipt of an acknowledgement letter to months after such receipt.”  FDA’s regulation at 21 C.F.R. § 314.95(d), which implemented the statutory notice provision under the Hatch-Waxman Amendments for amended ANDAs, states: “[i]f an abbreviated application is amended to include [a Paragraph IV] certification . . . , the applicant shall send the notice required by paragraph (a) of this section at the same time that the amendment to the abbreviated application is submitted to FDA.”

Pre-MMA, FDA and the courts addressed the question of timing of Paragraph IV notice in a couple of cases concerning amended ANDAs (both involving Purepac) for generic versions of NEURONTIN (gabapentin): Purepac Pharmaceutical Co. v. Thompson, 354 F.3d 877 (D.C. Cir. 2004), aff’g TorPharm, Inc. v. Thompson, 260 F.Supp.2d 69 (D.D.C. 2003).  (Further litigation involved a challenge to FDA’s patent-by-patent interpretation of the pre-MMA statute permitting multiple periods of 180-day exclusivity – see here).

In summary, Purepac amended its ANDA with a Paragraph IV certification in late May 2000, but waited until June 13, 2000 to send notice of the certification to the NDA owner/patent owner.  In contrast, TorPharm, another ANDA sponsor, simultaneously amended its ANDA and sent notice to the NDA sponsor/patent on June 13, 2000.  FDA received TorPharm’s amended ANDA on June 16th and deemed the Paragraph IV certification filed on that day.  FDA concluded that the penalty for Purepac’s failure to provide simultaneous notice should be postponement of the effective date of the certification.  Ultimately, FDA refused to nullify Purepac’s notice (as argued by TorPharm) and FDA awarded Purepac 180-day exclusivity because Purepac completed both tasks before TorPharm.  The U.S. District Court for the District of Columbia found this to be a reasonable exercise of FDA’s discretion, and the D.C. Circuit affirmed.

With respect to timely notice and original ANDAs, two Citizen Petitions were submitted to FDA post-MMA concerning pre-MMA 180-day exclusivity for generic versions of two drugs: (1) RISPERDAL (risperidone) Tablets, the subject of an IVAX Citizen Petition, FDA Docket No. 2004P-0520 (Nov. 19, 2004); and DUONEB (albuterol sulfate and ipratropium bromide) Inhalation Solution, the subject of a Mylan Citizen Petition, FDA Docket No. 2006P-0245 (June 12, 2006).  Both petitions contend that Congress effectively directed FDA to apply the same notice rule to original and amended ANDAs.  FDA did not substantively respond to either petition.  In the case of Risperidone Tablets, the patent at issue expired and 180-day exclusivity was granted with respect to a later-listed patent (see here).  In the case of generic DUONEB, FDA apparently resolved the notice issue and granted exclusivity contrary to what was requested in the petition (see here). 

Post-MMA, we’re not aware of an instance in which FDA has publicly resolved a notice dispute concerning an original ANDA pursuant to FDC Act § 505(j)(2)(B)(ii)(I).  But we’re going to make an educated guess here as to how FDA would handle the issue (and how it might be described in proposed regulations to implement to MMA).  Consider the following scenario and the underlying rule that a Paragraph IV certification is perfected when notice is timely sent within the statutory timeframe.

The Reference Listed Drug is listed in the Orange Book with information on a single patent and has been granted 5-year New Chemical Entity (“NCE”) exclusivity.  Thus, the date on which the first ANDA can be submitted to FDA containing a Paragraph IV certification – the so-called “NCE-1 date” – qualifying an ANDA sponsor as a “first applicant” eligible for 180-day exclusivity is known to all potential ANDA applicants.  ANDA Applicant Nos. 1 and 2 submit their applications on the NCE-1 date.  Both ANDAs are received on the same date and the applicants receive notice of that receipt on the same day.  ANDA Applicant No. 1 provides notice of its Paragraph IV challenge within 20 days of receiving FDA’s receipt notice.  ANDA Applicant No. 2 delays sending notice of its Paragraph IV challenge until 23 days after receiving FDA’s receipt notice.  What happens? 

We think FDA will propose that untimely notice postpones the effective date of the Paragraph IV certification (whether in an original ANDA or in the case of an amended ANDA).  That is, with respect to the scenario above, ANDA Applicant No. 1 would be a first applicant eligible for 180-day exclusivity because its ANDA was received as of the date of submission of the ANDA (i.e., the NCE-1 date).  ANDA Applicant No. 2, however, would not be a first applicant eligible for 180-day exclusivity because its ANDA was not received as of the date of submission of the ANDA.  That is, we think FDA would add on an additional 3 days to the initial ANDA submission date, such that the ANDA is considered received as of the NCE-1 date plus 3 days (to account for the untimely notice period).  Are we correct?  We’ll see when FDA finally proposes some MMA regulations implementing FDC Act § 505(j)(2)(B)(ii).