E-DRUG: Bolar Roche exemption (cont'd)

[Michael Davis <Michael.Davis@law.csuohio.edu>]

E-drug: Bolar Roche exemption (cont'd)
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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)
e-mail: Michael.Davis@law.csuohio.edu
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