Of the science issue: Omeprazole is a potent inhibitor of gastric acid secretion, but it is susceptible to
degradation in acid-reacting and neutral media. Its stability is also affected by moisture
and organic solvents. To protect omeprazole from gastric acid in the stomach, a
pharmaceutical dosage can include an enteric coating that covers the drug core.
Enteric coatings, however, contain acidic compounds, which can cause the omeprazole
in the drug core to decompose while the dosage is in storage, resulting in discoloration
and decreasing omeprazole content in the dosage over time.
There was a discussion of the pediatric extension:
In this case, however, Astra was entitled to an additional six-month period of market
exclusivity (sometimes known as a period of “pediatric exclusivity”) under the Food and
Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296. A
provision of that Act, codified at 21 U.S.C. § 355a, authorizes the Food and Drug
Administration to make a written request to the holder of an approved new drug
application (“NDA”) for the holder to perform pediatric studies.
This case brings up "effective amount":
In the first wave trial in this case, the district court construed “effective amount” to apply
to both the amount of omeprazole and the amount of an ARC present in the core. The
court construed “alkaline reacting compound” as
(1) a pharmaceutically acceptable alkaline, or basic, substance having a
pH greater than 7 that (2) stabilizes the omeprazole or other acid labile
compound by (3) reacting to create a micro-pH of not less than 7 around
the particles of omeprazole or other acid labile compound.
Impax argues that Astra’s evidence satisfies only the first and third of those three
requirements because Astra did not introduce evidence of comparative stability testing
to prove the second. (...) We therefore find no clear error in the district court’s
conclusion that Astra’s pH data proved the presence of an “effective amount” of an ARC
in Impax’s ANDA formulation.
The case also brings up public use under 102(b)
Finally, Impax challenges the district court’s findings with respect to the public-
use bar under section 102(b). Astra filed its applications for the ’505 and ’230 patents
on April 20, 1987. (...)Impax correctly points out, however, that it is clear from this court’s case law that
experimental use cannot negate a public use when it is shown that the invention was
reduced to practice before the experimental use. See Cargill, Inc. v. Canbra Foods,
Ltd., 476 F.3d 1359, 1371 n.10 (Fed. Cir. 2007); Allen Eng’g Corp. v. Bartell Indus., Inc.,
299 F.3d 1336, 1354 (Fed. Cir. 2002); New Railhead Mfg., LLC v. Vermeer Mfg. Co.,
298 F.3d 1290, 1299 (Fed. Cir. 2002); EZ Dock, Inc. v. Schafer Sys., Inc., 276 F.3d
1347, 1357 (Fed. Cir. 2002) (Linn, J., concurring); Zacharin v. United States, 213 F.3d
1366, 1369 (Fed. Cir. 2000); Baxter Int’l, Inc. v. COBE Labs, Inc., 88 F.3d 1054, 1060
(Fed. Cir. 1996).
The district court's analysis of public use was not correct:
We therefore do not agree with the district court’s ruling that the experimental use exception served to negate the
public-use bar to patentability.
The CAFC invoked Pfaff, which is an on-sale bar case:
We may nevertheless affirm the district court’s conclusion that the claims were
not invalid under section 102(b) based on the court’s factual determination that the
claimed formulation was not ready for patenting until after the clinical studies were
completed. See Pfaff v. Wells Electronics, Inc., 525 U.S. 52, 67 (1998); Invitrogen
Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1380 (Fed. Cir. 2005)
The CAFC got into "reduction to practice":
At trial, Impax bore the burden of demonstrating by clear and convincing
evidence that the Phase III formulation had been reduced to practice before the testing
began. See z4 Techs., Inc. v. Microsoft Corp., 507 F.3d 1340, 1352 (Fed. Cir. 2007).
To demonstrate reduction to practice, a party must prove that the inventor (1)
“constructed an embodiment or performed a process that met all the limitations” and (2)
“determined that the invention would work for its intended purpose.” Id. (quoting Cooper
v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir. 1998)). “Testing is required to demonstrate
reduction to practice in some instances because without such testing there cannot be
sufficient certainty that the invention will work for its intended purpose.” Id. (quoting Slip
Track Sys., Inc. v. Metal-Lite, Inc., 304 F.3d 1256, 1267 (Fed. Cir. 2002)).
Impax has not demonstrated that, without
conducting the Phase III clinical tests, the inventors knew that the Phase III formulation
would achieve the goals of long-term stability and in vivo stability such that it would be
effective as a treatment for gastrointestinal disease. We therefore find no clear error in
the district court’s finding on this issue.