[Ip-health] US Federal Circuit narrows the scope of the Patent Research Exemption

[Judit Rius Sanjuan]

http://www.orangebookblog.com/2008/08/federal-circuit-narrows-the-scope-of-=
the-section-271e1-research-exemption.html

Case: Proveris Scientific Corp. v. Innovasystems, No. 2007-1428 (Fed.
Cir. 2008)

35 U.S.C. =A7 271(e)(1) states:

     It shall not be an act of infringement to make, use, offer to
sell, or sell within the United States or import into the United
States a patented invention . . . 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 or veterinary
biological products.

This statute, passed as part of the Hatch-Waxman Act in 1984, provides
a "safe harbor" from claims of patent infringement based on activities
related to the pursuit of FDA approval of drug products.  For example,
it exempts ANDA applicants from allegations of patent infringement
based on R&D done for the purpose of establishing bioequivalence.

Proveris Scientific owns U.S. Patent No. 6,785,400, which is directed
to a system and apparatus for characterizing aerosol sprays used in
drug delivery devices, such as nasal spray pumps and inhalers.  Innova
makes and sells a device that, although not itself subject to FDA
approval, is used in connection with FDA regulatory submissions.
Specifically, the device is used to measure the physical parameters of
aerosol sprays used in nasal drug delivery devices.

Proveris filed suit against Innova, alleging infringement of the '400
patent.  As part of its defense, Innova invoked the safe harbor
provision of section 271(e)(1).  Innova argued that its allegedly
infringing activities are immunized because its device is used by
third parties solely for the development and submission of information
to the FDA.  At trial, the district court ruled as a matter of law
that Innova could not avail itself of section 271(e)(1).  In an
opinion released yesterday, the Federal Circuit affirmed the district
court.

Innova argued on appeal that it is entitled to the benefit of section
271(e)(1) because it offered to sell its device only to pharmaceutical
companies and the FDA, and that its device was used exclusively in
relation to applications for FDA approval.  Proveris responded that
the section 271(e)(1) safe harbor is applicable only to products that
are subject to patent term extensions under 35 U.S.C. =A7 156(f)--
namely, drug products, medical devices, food additives, and color
additives.  According to Proveris, section 271(e)(1) does not immunize
infringement of patents on laboratory or manufacturing equipment.

The Federal Circuit framed the issue as this:  "whether section 271(e)
(1) immunizes the manufacture, marketing, or sale of Innova's device,
which is used in the development of FDA regulatory submissions, but is
not itself subject to the FDA premarket approval process."

The court concluded that section 271(e)(1) provides no such immunity,
reasoning that Congress did not intend for section 271(e) to apply to
parties like Innova, whose device is not subject to FDA premarket
approval, and who therefore faces no regulatory barriers to market
entry upon patent expiration.

The Federal Circuit explained that its conclusion "achieves the same
kind of fit, or symmetry" that the Supreme Court spoke of in the Eli
Lilly v. Medtronic case, which also dealt with section 271(e)(1).
According to the court, "Because Proveris's patented product is not
subject to a required FDCA approval process, it is not eligible for
the benefit of the patent term extension afforded by 35 U.S.C. =A7
156(f).  At the same time, because Innova's device also is not subject
to a required FDCA approval process, it does not need the safe harbor
protection afforded by 35 U.S.C. =A7 271(e)(1)."

[Note: Jeff Light of "Patients not Patents" filed an amicus brief in
this case}


Judit Rius Sanjuan
Attorney
Knowledge Ecology International / Essential Information
www.keionline.org / www.cptech.org
Phone: +1.202.332.2670, x18