Sens. Bill Nelson [D, FL] and Sen. Herbert Kohl [D, WI] have introduced a bill (s. 1315) to amend the Federal Food, Drug, and Cosmetic (Hatch-Waxman) Act to define the term “first applicant” for purposes of filing an abbreviated new drug application (ANDA) in order to give generic drug makers challenging brand-name patents an chance to get a 180-day market exclusivity.
Under the present law, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) § 505(j)(5)(B)(iv)(II)(bb) defines the term “first applicant” to mean:
As used in this subsection, the term ‘first applicant’ means an applicant that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug.
S. 1315 would amend the definition to:
As used in this subsection, the term ‘first applicant’ means
(AA) an applicant that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug; or
(BB) an applicant for the drug not described in item (AA) that satisfies the requirements of subclause (III).’; and
(III) An applicant described in subclause (II)(bb)(BB) shall–
(aa) submit and lawfully maintain a certification described in paragraph (2)(A)(vii)(IV) or a statement described in paragraph (2)(A)(viii) for each unexpired patent for which a first applicant described in item (AA) had submitted a certification described in paragraph (2)(A)(vii)(IV) on the first day on which a substantially complete application containing such a certification was submitted;
(bb) with regard to each such unexpired patent for which the applicant submitted a certification described in paragraph (2)(A)(vii)(IV), no action for patent infringement was brought against the applicant within the 45-day period specified in paragraph (5)(B)(iii), or if an action was brought within such time period, the applicant has obtained the decision of a court (including a district court) that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity, and including a settlement order or consent decree signed and entered by the court stating that the patent is invalid or not infringed); and
(cc) but for the effective date of approval provisions in subparagraphs (B) and (F) and sections 505A and 527, be eligible to receive immediately effective approval at a time before any other applicant has begun commercial marketing.’
In the end, this would mean that an applicant that that would have been considered a subsequent applicant subject to a first applicant’s 180-day exclusivity eligibility could now qualify as a first applicant gaining co-exclusivity of the 180-day exclusivity for all first applicants if there is no timely filed patent infringement lawsuit arising from its Paragraph IV certification, or if there is a court decision of patent invalidity or non-infringement or a substantive determination that there is no cause of action for patent infringement or invalidity.
In a related matter, the U.S. Supreme Court declined to hear the reverse payment case Arkansas Carpenters Health and Welfare Fund, Paper, A.F. of L., et al. v. Bayer AG and Bayer Corp., et al. where the Question Presented was:
Are pharmaceutical “reverse payment” agreements—whereby the manufacturer of a brand-name drug (and patent holder) pays a generic manufacturer (and alleged patent infringer) to not launch a generic version of the brand-name drug—per se lawful without regard to the amount of cash paid or the strength of the underlying patent challenge?
For now, the Supreme Court has left stand the earlier decision by the Federal Circuit upholding the district court decision granting Bayer’s motion for summary judgment, holding that any anti-competitive effects caused by the settlement agreements between Bayer and the generic defendants were within the exclusionary zone of the patent, and thus could not be redressed by federal antitrust law.
