On August 3, 2012, the Federal Circuit issued a decision holding
that the safe harbor provision of the Hatch Waxman Act, 35 U.S.C.
§ 271(e)(1), covers post-approval testing as long as it is
"reasonably related" to the submission of information the
FDA. (Momenta Pharma v. Amphastar Pharma, Fed. Cir., No.
Amphastar received FDA approval to market a generic version of a
drug that prevents blood clots. Momenta was the assignee of a
patent covering a method for analyzing the drug for the presence of
a particular compound. Such quality control testing was required by
the FDA when manufacturing batches of the drug in order to confirm
the presence of the compound. Momenta brought a claim for patent
infringement against Amphastar, and the district court granted a
preliminary injunction preventing Amphastar from selling its
On appeal, the Federal Circuit found that the district court
incorrectly concluded that Momenta was likely to succeed on the
merits of its patent infringement claim because the district court
had interpreted the safe harbor provision too narrowly. The Hatch
Waxman safe harbor permits otherwise infringing activities to occur
if they are "solely for uses reasonably related to
the development and submission of information under a Federal law
which regulates the manufacture, use, or sale of drugs." 35
U.S.C. § 271(e)(1).
The Federal Circuit dismissed Momenta's argument that the safe
harbor only applies to testing that is conducted in order to obtain
regulatory approval of a product. The court found that the testing
in this case was reasonably related to the development and
submission of information to the FDA because the testing records
had to be retained for at least one year after the expiration date
of the batch and had to be available for FDA inspection at any
time. See 21 C.F.R. § 211.180. The court distinguished prior
cases by emphasizing the fact that these test results were not
"routine submissions" to the FDA, but were required to
maintain FDA approval of the drug. Based on its reading of the safe
harbor provision the Federal Circuit vacated the district
court's preliminary injunction and remanded the case.
In dissent, Judge Rader argued that the safe harbor provision
should cover only pre-approval activities and not post-approval
activities related to manufacturing. He argued that the narrower
reading of the safe harbor provision is supported by the
legislative history of the Hatch Waxman Act and Supreme Court
precedents. He also expressed concern that this decision would
reduce the value of manufacturing method patents.
What This Means for You
The Federal Circuit has held that the safe harbor provision
should be read broadly to include post-approval testing. Generic
drug companies will benefit from an expanded application of the
safe harbor. However, this decision could have a significant impact
on holders of patents for processes that are used to generate
information submitted to the FDA. It remains to be seen whether the
Federal Circuit will rehear the case en banc.
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