Plaintiff challenges the FDA's grant to Novopharm of 180
days of marketing exclusivity for 75 mg OTC strength
ranitidine hydrochloride, on the ground that the FDCA
precludes the FDA from granting exclusivity periods for ANDA
applications that concern the same patents involved in
previously approved drugs of different strengths.
I. Chevron Analysis
Under the Administrative Procedure Act, a court must "hold
unlawful or set aside agency action" that is "arbitrary,
capricious, an abuse of discretion, or otherwise not in
accordance with law." 5 U.S.C. § 706(2). Agency action is
defined as "the whole or part of an agency rule, order,
license, sanction, relief or the equivalent, or denial thereof,
or failure to act." 5 U.S.C. § 551(13).
In reviewing an agency's interpretation of a statute it is
charged with administering, the Court must be guided by the
framework of Chevron, U.S.A Inc. v. Natural Resources Defense
Council, Inc. 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694
(1984). See Natural Resources Defense Council, Inc. v. Browner,
57 F.3d 1122, 1125 (D.C. Cir. 1995). Under the Chevron two-step
test, "[i]f the intent of Congress is clear, that is the end of
the matter; for the court, as well as the agency, must give
effect to the unambiguously expressed intent of Congress."
Chevron, 467 U.S. at 842-43, 104 S.Ct. 2778. "[I]f the statute
is silent or ambiguous with respect to the specific issue,
[however,] the question for the court is whether the agency's
answer is based on a permissible construction of the statute."
Id. at 843, 104 S.Ct. 2778. A court does not reach this second
step "if a court, employing traditional tools of statutory
construction, ascertains that Congress had an intention on the
precise question at issue, that intention is the law and must
be given effect." Id. at 843 n. 9, 104 S.Ct. 2778.
II. Step One of the Chevron Analysis
Plaintiff challenges the exclusivity period granted to
Novopharm and contends that the three ranitidine hydrochloride
products rely upon the same underlying patent. The Court in
Glaxo, Inc. v. Boehringer Ingelheim, 954 F. Supp. 469 (D.Conn.
1996) (final judgment entered in 962 F. Supp. 295 (D.Conn.
1997)), determined that the 300 mg and 150 mg versions of the
generic drug product did not infringe upon Glaxo's patent.
Plaintiff argues that the FDA grants exclusivity periods for
specific patents, which in this case have already been
litigated, while the FDA argues that it grants exclusivity
periods for specific drug products as they relate to the
patents. The Boehringer Ingelheim Court however, made no
determination as to whether 75 mg ranitidine hydrochloride
infringed upon Glaxo's patent.
Under step one of Chevron, the question before the Court is
whether the "paragraph IV" language is clear. If Congress'
intent is clear, then this Court's review must end there.
See Chevron, 467 U.S. at 842-43, 104 S.Ct. 2778; see also
Halverson v. Slater, 129 F.3d 180, 184 (D.C. Cir. 1997). Not
coincidentally, all the parties assert that the meaning of the
statute is clear on its face and that the Court can resolve the
merits of this case under the first prong of Chevron. "Under
this analysis, the court must first exhaust the traditional
tools of statutory construction to determine whether Congress
has spoken to the precise question at issue." Halverson, 129
F.3d at 184 (citation omitted). The statute states that:
(iv) If the application contains a certification
described in subclause (IV) of paragraph
(2)(A)(vii) and is for a drug for which a previous
application has been submitted under this
subsection [containing] such a certification, the
application shall be made effective not earlier
than one hundred and eighty days after —
(I) the date the Secretary receives notice from
the applicant under the previous
application of the first commercial marketing of
the drug under the previous application, or
(II) the date of a decision of a court in an
action described in clause (iii) holding the
patent which is the subject of the certification
to be invalid or not infringed.
whichever is earlier.