AIPLA Requests FDA to Open New QI Act Docket and Raises Interpretation Issues; Citizen Petition Requests 30-Month Stay

February 5, 2009

By Kurt R. Karst –      

The American Intellectual Property Law Association (“AIPLA”) recently submitted a letter to FDA concerning § 4 of the recently enacted “QI Program Supplemental Funding Act of 2008” (the “QI Act”).  (The "QI" stands for Qualifying Individual).  As we previously reported, the QI Act was enacted on October 8, 2008 and amended the FDC Act to add new § 505(v) – “Antibiotic Drugs Submitted Before November 21, 1997” – to create Hatch-Waxman benefits for so-called “old” antibiotics. 

In November 2008, FDA issued a draft guidance document describing the Agency’s current thinking on the implementation of § 4(b)(1), which includes three transition provisions on Orange Book patent listing, certification, and 180-day exclusivity for each ANDA applicant that not later than 120 dates after enactment of the QI Act (i.e., February 5, 2009) amends a pending application to contain a Paragraph IV certification to a newly listed antibiotic drug patent.  FDA’s latest Paragraph IV Certification List shows two entries with a “PIV received prior to 2/5/2009” notation: (1) DORYX (doxycycline hyclate) Delayed-Release Tablets; and (2)  SOLODYN (minocycline HCl) Extended Release Tablets.  Patent infringement lawsuits have been initiated with respect to the Orange Book patent listings for each drug product – see the compalints here (DORYX), here (DORYX), and here (SOLODYN).  (Also, as a point of interest, earlier this week, FDA responded to a citizen petition concerning generic SOLODYN.)

AIPLA’s letter to FDA requests that the Agency establish a docket requesting public comment on QI Act implementation, similar to the docket FDA established after the enactment of the 2003 Medicare Modernization Act (“MMA”).  In addition, AIPLA raises three issues for FDA to consider as the Agency works to implement the QI Act: (1) the availability of 30-month stays with respect to patents submitted to FDA for Orange Book listing under the QI Act transition provisions; (2) the availability of additional exclusivity given the limitations described in FDC Act § 505(v)(3)(A); and (3) the availability of exclusivity for old antibiotics covered under FDC Act § 505(v)(2)(A).  With respect to the availability of a 30-month stay, AIPLA comments that:

If FDA interprets the law such that the amendments made to the FDC Act by the MMA apply, then presumably no 30-month stay would apply to an ANDA applicant with a pending ANDA that amends such application to add a Paragraph IV certification to a newly-listed Orange Book patent.  It is unclear, however, whether FDA intends to interpret the law in such manner, or whether FDA believes that the law could be interpreted to permit a 30-month stay under such circumstances, similar to pre-MMA version of the FDC Act. 

FDA’s February 3, 2008 approval of an ANDA for generic SOLODYN (with 180-day exclusivity) does not address the availability of a 30-month stay, because a patent infringement lawsuit was not brought within the statutory 45-day period. 

FDC Act § 505(v)(3)(A) – “Limitations — Exclusivities And Extensions” – states that FDC Act §§ 505(v)(1)(A) and (2)(A) “shall not be construed to entitle a drug that is the subject of an approved application described in [FDC Act §§ 505(v)(1)(B)(i) or (2)(B)(i)], as applicable, to any market exclusivities or patent extensions other than those exclusivities or extensions described in [FDC Act §§ 505(v)(1)(A) and (2)(A)].”  AIPLA comments that “[w]hile FDC Act § 505(v)(3)(A) clearly places limits on how the new law can be interpreted, it is unclear whether it is also intended to limit the availability of” pediatric and orphan drug exclusivity under FDC Act § 505A and § 527, respectively. 

Finally, FDC Act § 505(v)(2)(A) states that an application for an antibiotic drug submitted to FDA after October 8, 2008, and which antibiotic drug was the subject of an application submitted under FDC Act § 507 but not approved by FDA before the enactment of the 1997 FDA Modernization Act “may elect to be eligible for, with respect to the drug,” a period of 3-year exclusivity “and” a period of 5-year NCE exclusivity, or a PTE under 35 U.S.C. § 156, subject to the requirements for obtaining such patent or non-patent exclusivity.  AIPLA’s letter notes that:

The use of the conjunctive “and” in FDC Act § 505(v)(2)(A) is curious.  It is unclear how a drug can simultaneously qualify for both 3-year “new use” exclusivity and 5-year [New Chemical Entity] exclusivity. . . . Congress’ use of the word “and” might have been intentional, such that an old antibiotic drug covered under FDC Act § 505(v)(2) can qualify for 3-year exclusivity for a new condition of use after an initial NDA approval that would qualify for 5-year exclusivity or a [Patent Term Extension] – as an old antibiotic drug covered under FDC Act § 505(v)(2) does not appear to convert to an old antibiotic drug covered under FDC Act § 505(v)(1) once it is initially approved. Under this interpretation, 3-year and 5-year exclusivity are not granted simultaneously, but rather sequentially, provided the requirements for granting such exclusivity are met.

Given the interest we have seen in QI Act implementation issues, FDA will likely receive substantial comment from interested parties if the Agency decides to open a public docket.   


  • FDA has received a citizen petition 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 (i.e., DORYX), which ANDA contains a Paragraph IV certification to a patent listed in the Orange Book in accordance with the QI Act.  The petition argues that the plain language of the QI Act requires application of the 30-month stay provisions of the original Hatch-Waxman Amendments, instead of the version of the statute amended by the MMA.
Categories: Hatch-Waxman