Roche Products Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir.

04/23/1984)
(United States Court of Appeals for the Federal Circuit, 23 April 1984)
Prepared by UNCTAD’s Intellectual Property Unit

Summary
The Court of Appeals for the Federal Circuit (CAFC) ruled that the experimental use
exception in US patent law is truly narrow. Where the subject matter of a patent is made
or used as an experiment, whether for the gratification of scientific tastes, or for curiosity,
or for amusement, the interests of the patentee are not antagonized, the sole effect being
of an intellectual character in the promotion of the employer's knowledge or the
relaxation afforded to his mind. But if the products of the experiment are sold, or used for
the convenience of the experimentor, or if the experiments are conducted with a view to
the adaptation of the invention to the experimentor's business, the acts of making or of
use are patent infringements. This decision was taken prior to the introduction into US
law of a new regulatory review exception under the Drug Price Competition and Patent
Term Restoration Act ("Hatch-Waxman Act").

Facts
Roche Products, Inc. (Roche) – a large research-oriented pharmaceutical company – was
the assignee of the rights in a U.S. patent issued on January 17, 1967 that expired on
January 17, 1984. The patent claimed flurazepam hydrochloride – the active ingredient in
Roche's successful brand name prescription sleeping pill “Dalmane.”
In early 1983, Bolar Pharmaceutical Inc – a manufacturer of generic drugs – became
interested in marketing, after the patent expired, a generic drug equivalent of Dalmane.
Bolar, not waiting for the patent to expire, decided to immediately begin its effort to
obtain marketing approval for its generic Dalmane. The decision of Bolar was due to the
fact that a generic drug's commercial success is related to how quickly it is brought on the
market after a patent expires, and because its marketing approval from the United States
Food and Drug Administration (FDA) can take more than 2 years. In order to submit its
request for approval of the generic version of the drug, in mid-1983 Bolar obtained from
a foreign manufacturer 5 kilograms of the active ingredient to develop the capsule dosage
form of the drug, to obtain stability data, dissolution rates, bio-equivalency studies, and
blood serum studies necessary for a New Drug Application (NDA) to the FDA.
Upon the complaint of Roche, on October 11, 1983, the United States District Court for
the Eastern District of New York held that Bolar's use of the patented active ingredient
for federally mandated testing was not infringement of the patent in suit because Bolar's
use was de minimis and experimental. Roche filed its notice of appeal to the CAFC on the
same day.
Legal Issues
According to the CAFC, the issue is narrow: does the limited use of a patented drug for
testing and investigation strictly related to FDA drug approval requirements during the
last 6 months of the term of the patent constitute a use which, unless licensed, may
constitute patent infringement? Bolar claimed two grounds for exception justifying its use
of the patented compound: the experimental use exception and the ground that public
policy favors generic drugs and thus mandates the creation of a new exception in order to
allow FDA required drug testing during the life of a patent. The CAFC rejected both
grounds.
Experimental use defense
The CAFC argued that by 1861 the so-called experimental use defense was well-settled
in that an experiment with a patented article for the sole purpose of gratifying a
philosophical taste, or curiosity, or for mere amusement is not an infringement of the
rights of the patentee.
Along these lines, the CAFC elaborated that the interest of the patentee, though not
always taking the shape of money, is of a pecuniary character. Where the subject matter
of a patent is made or used as an experiment, whether for the gratification of scientific
tastes, or for curiosity, or for amusement, the interests of the patentee are not antagonized,
the sole effect being of an intellectual character in the promotion of the employer's
knowledge or the relaxation afforded to his mind. But if the products of the experiment
are sold, or used for the convenience of the experimentor, or if the experiments are
conducted with a view to the adaptation of the invention to the experimentor's business,
the acts of making or of use are patent infringements.
Bolar conceded that its intended use of the active ingredients did not fall within the
"traditional limits" of the experimental use exception. Instead, it argued the experimental
use rule deserved a broad construction.
The CAFC held that the experimental use exception is truly narrow, and that it will not
expand it under the present circumstances. Bolar's intended "experimental" use was
solely for business reasons and not for amusement, to satisfy idle curiosity, or for strictly
philosophical inquiry. Bolar's intended use of the active ingredient to derive FDA
required test data was thus an infringement of the patent. The CAFC refused to construe
the experimental use rule so broadly as to allow a violation of the patent laws in the guise
of "scientific inquiry," when that inquiry has definite, cognizable, and not insubstantial
commercial purposes. The CAFC further concluded that it is a misnomer to call Bolar’s
intended use as de minimis. The use is no trifle in its economic effect even if the quantity
used is small.
Public policy justification for a new exception
Bolar argued that even if no established doctrine exists with which it can escape liability
for patent infringement, public policy requires that the CAFC create a new exception to

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the prohibition of use of a patent. Along those lines the CAFC must resolve a conflict
between the Federal Food, Drug, and Cosmetic Act (FDCA), as amended in 1962 and the
Patent Act of 1952, or at least the Acts' respective policies and purposes.
The amendment of the FDCA caused a substantial increase in the time required for
development and approval of a pioneer new drug by requiring NDA to contain proof of
efficacy (effectiveness) and safety. No drug can be marketed except with the FDA’s
affirmative approval. Since the amendment, it can take on average from 7 to 10 years for
a pharmaceutical company to satisfy the current regulatory requirements. The remaining
effective life of patent protection may be as low as 7 years. Litigation such as this is one
example of how research-oriented pharmaceutical companies have sought to regain some
of the earning time lost to regulatory entanglements. They gain for themselves, it is
asserted, a de facto monopoly of upwards of 2 years by enjoining FDA-required testing of
a generic drug until the patent on the drug's active ingredient expires.
Bolar argued that the patent laws are intended to grant to inventors only a time-limited
property right to their inventions so that the public can enjoy the benefits of competition
as soon as possible, consistent with the need to encourage invention. The FDCA, Bolar
contended, was only intended to assure safe and effective drugs for the public, and not to
extend a pharmaceutical company's monopoly for an indefinite and substantial period of
time while the FDA considers whether to grant a pre-marketing clearance to a generic
competitor.
According to the CAFC, courts are not at liberty to pick and choose among congressional
enactments, and when two statutes are capable of co-existence, it is the duty of the courts,
absent a clearly expressed congressional intention to the contrary, to regard each as
effective. The CAFC noted that Congress is well aware of the economic and societal
problems which the parties debate here, and has before it legislation with respect to these
issues: "Drug Price Competition Act of 1983"–to allow faster marketing of new generic
drugs equivalent to approved drugs; and "Patent Term Restoration Act of 1983" – to add
to the patent grant a period of time equivalent to that lost due to regulatory delay. No
matter how persuasive the policy arguments are for or against these proposed bills, the
CAFC stated that it is not the proper forum in which to debate them. Where Congress has
the clear power to enact legislation, the role of courts is only to interpret and apply that
legislation.
Accordingly, the decision of the district court holding the patent not infringed was
reversed. The CAFC remanded the case with instructions to fashion an appropriate
remedy, including injunction, requested by Roche.

Points of significance
In 1984 the United States Congress enacted the Drug Price Competition and Patent Term
Restoration Act (also know as "Hatch-Waxman Act"). The Act basically provides a new
exception to patent rights as suggested by Bolar in the case at hand. This new “Bolar”
exception (in technical terms “regulatory review exception”) provides that:
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

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 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.
The Act also provided for, among others:
• An extension of patent terms for not more than 5 years or for a total of 14 years
from the date of the drug approval to compensate for delay in the marketing
authorisation of the originator’s drug;
• Exclusive rights in data submitted to the FDA by originators of new drugs and
• The requirement for NDA applicants to notify a patent that claims a drug or
method of using a drug and with respect to which a claim of infringement can
reasonably be asserted (patent linkage).

In 2000, the WTO panel in Canada-Patent Protection of Pharmaceutical Products

Key words: experimental use, Bolar exception, New Drug Application, generic drug. $
Available at: http://biotech.law.lsu.edu/cases/IP/patent/roche_v_bolar.htm

1 See the summary in this database.