Search Team

Search by Last Name
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z

IP Updates Newsletters

Fish Special Federal Circuit Bulletin: Proveris Sci. Corp. v. Innovasystems, Inc.

August 6, 2008

IP Updates Newsletters

Fish Special Federal Circuit Bulletin: Proveris Sci. Corp. v. Innovasystems, Inc.

August 6, 2008

Back to News Listing

Recent decision on the scope the 35 U.S.C. § 271(e)(1) safe harbor provision
Proveris Sci. Corp. v. Innovasystems, Inc.

Summary: On August 5, 2008, the Federal Circuit issued a decision interpreting the scope of patented inventions that are immunized from infringement by the safe harbor provision codified at 35 U.S.C. § 271(e)(1). The case, Proveris Sci. Corp. v. Innovasystems, Inc., (Case No. 2007-1428), concerned whether the safe harbor protects an unregulated device being used exclusively to obtain information for the FDA approval of other regulated products. The Federal Circuit held that the safe harbor was restricted to those patented inventions that are themselves subject to a FDA premarket approval process.

The Federal Circuit’s construction of the statute may have the result of excluding research tools from the safe harbor because such tools are not generally subject to pre-market approval. The decision is thus the court’s first precedential answer to the research tool question reserved by the Supreme Court in Merck v. Integra. Research tool manufacturers and academic institutions are likely to welcome this decision, which may, on the other hand, increase the costs of research and development for drug discovery.

Even so, the decision leaves many outstanding questions about research tools unanswered, particularly whether reach-through royalties are available where a research tool patent is infringed. That question is pivotal for determining the value of research tool patents, especially after the Supreme Court’s eBay decision limiting the availability of injunctive relief. In addition, despite its plain reasoning, the Proveris decision leaves open some questions about the scope of the safe harbor. For example, does the safe harbor apply to chemical intermediates and equipment that are integral and essential to producing a regulated drug or device?

It is too early to know whether the defendant in Proveris will petition the Supreme Court to review the Federal Circuit’s decision, but, given the Supreme Court’s current interest in patent law and its previous expansive readings of the safe harbor provision, it is certainly a possibility.

Stay current with Fish Sign up for our Newsletter