I’ll Take “Orange Book History” for $1,500, Alex . . . .

November 6, 2008

By Kurt R. Karst –

Answer: "October 24, 2008" . . . .  queue Jeopardy!  think music . . . .  Question: "What is the date on which patent information was first listed in the Orange Book covering an old antibiotic drug product?"  Alex Trebek: "Correct!"   

On October 24, 2008, the Electronic Orange Book listed information on three patents covering MiddleBrook Pharmaceuticals' MOXATAG (amoxicillin extended-release) Tablets – specifically, U.S. Patent Nos. 6,544,555, 6,669,948, and 6,723,341.  MOXATAG, a once daily product, was approved earlier this year under NDA #50-813 for tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years and older.  Hyman, Phelps & McNamara, P.C. is proud to have assisted MiddleBrook in its efforts to obtain Orange Book patent listing.   

The Orange Book listing of patent information on old antibiotic drug products – i.e., antibiotic active ingredients (and derivatives of such ingredients) included in an application submitted to FDA for review prior to November 21, 1997, the date of enactment of the FDA Modernization Act – was made possible with the October 8, 2008 enactment of Section 4 – "Incentives For The Development Of, And Access To, Certain Antibiotics" – of the "QI Program Supplemental Funding Act of 2008" (Pub. L. No. 110-379).  As we previously reported, the 1984 Hatch-Waxman Amendments excluded antibiotic drugs, which were then approved under FDC Act § 507, from the Act's patent and non-patent market exclusivity provisions (except for the availability of a patent term extension); however, Pub. L. No. 110-379 amended the FDC Act to add § 505(v) – "Antibiotic Drugs Submitted Before November 21, 1997" – to make Hatch-Waxman benefits available. 

With respect to Orange Book patent listing, Section 4(b)(1) of the new law states that for "a patent issued before [October 8, 2008], any patent information required to be filed with [FDA] under [FDC Act § 505(b)(1) or (c)(2)] to be listed on a drug to which [FDC Act § 505(v)(1)] applies, shall be filed with [FDA] no later than 60 days after the date of enactment of this Act."  Section 4(b)(2) of the Act requires FDA to  publish such patent information in the electronic version of the Orange Book "as soon as it is received, but in no event later than the date that is 90 days after enactment of this Act."  Generic companies that amend their pending ANDAs not later than 120 dates after enactment of the new law to include a Paragraph IV certification to a newly-listed old antibiotic drug patent are considered "first applicants" for 180-day exclusivity purposes.  Provided FDA interprets the law consistent with changes made to the FDC Act by the Medicare Modernization Act, generic applicants that amend a pending ANDA to include a Paragraph IV certification should not be subject to a 30-month stay of approval if sued by the NDA holder or patent owner for patent infringement within the statutory 45-day period.  Presumably a company that first submits an ANDA containing a Paragraph IV certification after patent information is listed in the Orange Book could be subject to a 30-month stay if such generic applicant is sued for patent infringement within the statutory 45-day period.    

Categories: Hatch-Waxman