Hatch-Waxman Safe Harbor Inapplicable To Research Tools
In a decision that will have far reaching implications for
drug and medical device development, the Court of Appeals for
the Federal Circuit held yesterday that the Hatch-Waxman safe
harbor of 35 U.S.C. § 271(e)(1) is inapplicable to
patented research tools that are not themselves subject to the
FDA review process. While the decision is good news for
the providers of research tools such as drug screening assays,
it will make drug and medical device development in the United
States costlier and more risky.
The case is
Proveris Scientific Corp. v. Innovasystems, Inc.
(.pdf) (No. 2007-1428), decided August 5, 2008. In
rejecting the § 271(e)(1) exemption, the court
reasoned that Congress must have intended that the safe harbor
protect only those entities adversely affected by the de facto
extension of patent life at the end of the patent term while
they await FDA approval for a product that is subject to
regulatory review. Unless the defendant is within the
category of entities for whom the safe harbor was intended to
provide relief, the court ruled, the exemption does not
apply. The defendant, Innovasystems, is now weighing its
further appellate options.
The Proveris decision departs from a line of
earlier cases holding that the safe harbor protects the
infringing use of any patented invention as long as the use is
"reasonably related to the development and submission of
information" in support of FDA approval of a new product
covered by the FDCA. The decision thus changes the focus
of § 271(e)(1) from whether the defendant's
infringing use of the patented invention is "reasonably
related" to developing the types of information relevant
to the FDA, to whether the patented invention itself is the
product on which the defendant intends to seek FDA
approval.
The court's decision appears to implicate the full
panoply of research tools used in drug discovery and
development, including monoclonal antibodies, cell lines,
membrane preparations, cDNA's and drug screening
assays. To the extent the safe harbor protection now
turns on whether the defendant is seeking FDA approval to
market the product that is the subject of the patent-in-suit,
the decision could produce anomalous results. For
example, the infringing use of a monoclonal antibody may be
outside the scope of the safe harbor if it is used only as a
research tool to isolate a subset of cells, but may fall within
the safe harbor if the same antibody becomes a candidate for a
therapeutic drug...
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