Caraco loses at CAFC, but...

In a Hatch-Waxman case involving Prandin®, one has three opinions. Novo Nordisk did
come out the winner, but one sees a lot of disagreement here.

On statutory construction:

Statutory construction “begins with ‘the language of the statute.’” Hughes Aircraft
Co. v. Jacobson, 525 U.S. 432, 438 (1999) (quoting Estate of Cowart v. Nicklos Drilling
Co., 505 U.S. 469, 475 (1992)). This court derives the plain meaning of the statute from
its text and structure. Electrolux Holdings, Inc. v. United States, 491 F.3d 1327, 1330
(Fed. Cir. 2007) (citation omitted). If the statutory language is unambiguous, the inquiry
ends. Id. Nevertheless, this court may “look at the legislative history ‘only to determine
whether a clear intent contrary to the plain meaning exists.’” Sharp v. United States,
580 F.3d 1234, 1238 (Fed. Cir. 2009) (quoting Glaxo Operations UK Ltd. v. Quigg, 894
F.2d 392, 396 (Fed. Cir. 1990)). To overcome the plain meaning of the statute, the
party challenging it must establish that the legislative history provides “an ‘extraordinary
showing of contrary intentions.’” Id. (quoting Garcia v. United States, 469 U.S. 70, 75
(1984)).

The issue: In other
words, Novo reads “an approved method” in the counterclaim statute as “any approved
method” while Caraco reads it as “all approved methods.”

The CAFC opinion by Judge Rader found no ambiguity:

This court detects no ambiguity in the statutory language. When an indefinite
article is preceded and qualified by a negative, standard grammar generally provides
that “a” means “any.” See, e.g., American Heritage Dictionary of the English Language
1 (4th Ed. 2006) (defining “a” as “[a]ny” in the example “not a drop to drink”); Random
House Webster’s Unabridged Dictionary 1 (2d ed. 2001) (defining the indefinite article
“a” as “any” or “a single” in the example “not a one”); see also Barnhart v. Thomas, 540
U.S. 20, 26 (2003) (adopting a construction that is “quite sensible as a matter of
grammar”) (citation omitted).

The bottom line:

This court therefore reverses the district court’s grant of summary judgment on
Caraco’s attempted, but unsuccessful, counterclaim and vacates the injunction ordering
Novo to correct its use code for the ’358 patent listed in the Orange Book for PRANDIN.