Bolar exemption

[James Love <love@cptech.org>]

Subject: Re: Bolar Roche
       Date: Wed, 11 Feb 1998 14:36:04 -0800
      From: "Michael H. Davis" <Michael.Davis@law.csuohio.edu>

  [snip]

The patent act was amended, in 1988, to reverse the holding of the Bolar
Roche case. The Bolar Roche case held that conducting studies and
engaging in activities designed to gain approval of a patented drug for
production, sale, and distribution, after the expiration of the patent
was NOT within the experimental use exception of the patent act. In
other words, such activities were not exempt from liability, and
constituted patent infringement. The experimental use exception is a
judicial doctrine of very ambiguous dimensions and has never been very
helpful as a defense. As a result, Congress amended the patent act to
state explicitly that such activities ARE exempt from liability, and do
not constitute infringements. It is my understanding that stockpiling
the drug or warehousing it in anticipation of the expiration date would
still be infringing. The exempt activities must be aimed at obtaining
FDA approval, and not aimed at preparing for commercial use and sale. I
hope this helps.


Prof. Michael H. Davis
Cleveland State University
College of Law
1801 Euclid Ave.
Cleveland, OH 44105
216-687-2228
216-687-6881 (FAX)
212-475-0436 (OFFICE)
212-358-0569 (FAX)