18 Court Decisions Related to the Experimental Use
Exception under Common Law and under Statute Law(Bolar Provision) in the United States
Researcher: Kunihisa Masuoka(*)

In the pharmaceutical/biotechnological fields, various acts of experiment and research are generally
conducted for many years until a single product (drug) is successfully developed. Also, the academia, such asuniversities, makes significant contributions in these fields. Indeed, it has become common for universities toconduct research jointly with companies or research commissioned by companies in recent years. Therefore, it isimportant particularly for a foreign owner of a U.S. patent to sufficiently identify and understand the differences
between the U.S. practice and the practice in his/her own country in determining whether an unauthorized
person's act of using his/her patented invention within the United States for purposes of experiment or researchcorresponds to patent infringement.
Thus, the paper firstly analyzes recent U.S. court decisions related to common law exception and the pointsof contention. Then, it studies the development of court decisions related to application of the Bolar Provision,
including decisions by lower courts. The paper then compares the identified/analyzed court decisions with thetheories/court decisions in Japan and major European countries that are recognized to allow application ofexperimental use exception to a far broader scope of acts than the United States. Lastly, the paper attempts toexamine the problems in the case of legislating experimental use exception provisions that could cover a broader
scope of acts in the United States, and the relation with fair use of copyright.

Ⅰ Common Law Exception
In the United States, the question of whether
or not the effects of a patent right extend to"working of a patented invention for purposes ofexperiment or research" has been solely left tocommon law, tracing its origins to an opinion by
Justice Story. This section introduces the recent
U.S. court decisions related to common law
exception and the points of contention.
[Recent court decisions]
1Embrex, Inc. v. Service Engineering Corp.
(2000)In this case, the Court of Appeals for theFederal Circuit (CAFC) did not allow the common
law exception for an act of experiment conductedfor designing around a process invention. The caseclarified anew that experimental use exception is
only applied to extremely limited acts in the UnitedStates.
2Madey v. Duke University (2002)

This case has clarified anew that common law
exception is only applied in extremely limited
cases.

[Points of Contention Related to Common
Law Exception]
1

The de minimis exception

The de minimis exception is applied very
narrowly, similar to the common law exception.
2

Legitimate businessIn addition to the "use for profit" standard that
had already been known, Madey v. Duke Universityclarified that even acts of nonprofit universities
could constitute patent infringement, similar toresearch activities of ordinary companies, if theuniversities are engaged in legitimate business.
3

Philosophical inquiry

Since it was about 200 year ago thatphilosophical inquiry was indicated as one type ofact subject to experimental use exception, the typeof acts that people of those times could recognize
from the language "philosophical inquiry" may notnecessarily coincide with the type of acts thatpeople nowadays can recognize.

Ⅱ Statutory Exception: The BolarProvisionThis section firstly introduces the cases that(*) Patent attorney, Intellectual Property Department, Takeda Pharmaceutical Company Limited

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have lead to the establishment of the Bolar
Provision and the background of those cases, andsummarizes the judicial precedents relating toapplication of the Bolar Provision, then attempts toanalyze the modes of acts that are exempted frompatent infringement based on the Bolar Provision.
1

Roche v. Bolar, the Drug Price
Competition and Patent Term Restoration
Act, and the Bolar Provision[Court decisions]Roche Products, Inc. v. Bolar Pharmaceuticals Co.,
Ltd. (1983, District Court)
Roche Products, Inc. v. Bolar Pharmaceuticals Co.,
Inc. (1984, CAFC)[The Drug Price Competition and Patent Term
Restoration Act (Hatch-Waxman Act)]The Hatch-Waxman Act introduced a patentterm extension system to allow R&D companies torestore a certain period of the patent term that haspractically been consumed for obtaining approval of
the approving authority. At the same time, it
enabled use of the abbreviated new drug application(ANDA) system by generic drug manufacturers.
With these two measure, the act aims to simplify
the application for the pre-market approval for
generic drugs and to promote entry of genericdrugs into the market.
With the enactment of the Hatch-Waxman Act,
the ANDA system was legislated, and provisions toallow patent term restoration under certain
conditions and provisions to exclude acts of using
patent inventions for collecting necessary
information for obtaining FDA approval from patent
infringement (35 U.S.C. §271(e)(1): the Bolar
Provision) were added to the Patent Act.
The judicial decision in Roche Products, Inc. v.
Bolar Pharmaceuticals Co., Inc. was reversed bylegislation
withtheenactment
oftheHatch-Waxman Act and introduction of the Bolar
Provision.
2

Trend of court decisions overinterpretation of the Bolar Provision(1) Interpretation of "solely for uses
reasonably related to"This section analyses the following court
decisions.
(i) Scripps Clinic & Research Foundation v.
Genentech, Inc. (1986, District Court)(ii) Scripps Clinic & Res. Found. v. Baxter Travenol
Labs., Inc. (1988, District Court)(iii) American Standard, Inc. v. Pfizer Inc. (1989,District Court)(iv) Telectronics Pacing Systems, Inc. v. Ventritex,Inc. (1992, CAFC)(v) Intermedics, Inc. v. Ventritex, Co. (1993, CAFC)(vi) Chartex International PLC v. M.D. Personal
Products (1993, CAFC)(vii) Abtox, Inc. v. Exitron Corporation (1997,CAFC)(viii) NeoRx Corp. v. Immunomedics, Inc. (1994,District Court)(ix) Amgen Inc. v. Hoechst Marion Roussel, Inc.
(1998, District Court)(x) Biogen, Inc. v. Shering AG (1996, District
Court)(xi) Bristol-Myers Squibb Co. v. Rhone-PoulencRorer (2001, District Court)(xii) Integra Lifesciences I, Ltd. v. Merck KgaA (2003,CAFC)(2) Disputes over Interpretation of the
Patented Inventions Covered by theBolar Provision(i) Eli Lilly and Company v. Medtronic, Inc. (1990,Supreme Court)(ii) Chartex International 1 PLC v. M.D. Personal
Prods (1993, CAFC)(iii) Abtox, Inc. v. Exitron Corporation (1997,CAFC)(iv) Bristol-Myers Squibb Co. v. Rhone-Poulenc
Rorer (2001, District Court)[Summary of the trend of interpretation of theBolar Provision]
The general application standards for the Bolar
Provision, which have been indicated or confirmedin the above cases, can be summarized as below.
The first standard is the following: "we should
ask: would it have been reasonable, objectively, fora party in the defendant's situation to believe that
there was a decent prospect that the "use" inquestion would contribute (relatively directly) to
the generation of the kind of information that waslikely to be relevant in the processes by which theFDA would decide whether to approve theproduct?"
The second standard is that the Bolar
Provision only indicates its application to acts solely
for uses related to FDA approval, etc. and theunderlying intent (such as an intent ofcommercialization) or alternative uses (such astests related to patent licensing) are irrelevant tothe application of the Bolar Provision.
The third standard is that the Bolar Provision
covers acts conducted before the lapse of the patentthat are "reasonably related to" obtainment of FDA
approval for an already marketed drug.
The fourth standard is that the Bolar Provisionalso applies to matters other than those subject topatent term extension (drug products [includinganimal drugs], medical devices, food additives, andcolor additives).

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Ⅲ Comparison with theExperimental Use Exception
Provisions in Japan and Europe
1Comparison with the experimental use
exception provisions in JapanThe report examines how the types of actsthat are subject to experimental use exception
under prevalent Japanese theories are treated inthe United States.
(1) Patentability research/function research
In light of the application standard for U.S.
common law exception, which is "for amusement,
to satisfy idle curiosity, or for strictly philosophicalinquiry," the experimental use exception is unlikely
to be applied when patentability research orfunction research has been conducted as part of theresearch activities of a company or a university. Inaddition, even if the patented invention was a drug
invention, such research is unlikely to "contribute(relatively directly) to the generation of the kinds ofinformation that was likely to be relevant in theprocesses by which the FDA would decide whether
to approve the product," which is an application
standard for the Bolar Provision. On the other hand,the court has held that a use for confirming theeffects disclosed in the patent specification was notpatent infringement in Whittemore v. Cutter, so
there could also be a view that either experimental
use exception or the de minimis exception isapplicable.
In any case, these acts may formally constitutepatent infringement in the United States, but
considering the extent of damage that could beinflicted on the patentee, it would be very unlikely
for a patentee to file a patent infringement suit
solely based on these acts.
(2) Experiments for the purposes ofimprovement/development
There are theories supporting exemption ofexperiments for the purposes of improvement/development from patent infringement also in theUnited States. A similar opinion is also stated in theamicus brief submitted by the Association ofAmerican Medical Colleges and others to request
the Supreme Court to review the Madey v. Duke
University decision.
However, the U.S. common law exception is
only applied to an extremely narrow scope of acts,
which are acts "for amusement, to satisfy idle
curiosity, or for strictly philosophical inquiry," andthe exception is not applied if there is even "theslightest commercial implication." In addition, theexperimental use is not applied even to acts for anon-commercial purpose, if the uses are "in keepingwith the legitimate business." In this way, theUnited States does not possess the ideology ofIIP Bulletin 2004

making experiments for the purposes ofimprovement/development exempt from patent
infringement.
Therefore, at present, in United States, there
are limits in making all experiments for thepurposes of improvement/development subject toexperimental use exception even with the current
interpretation of the common law exception andinterpretation of the Bolar Provision. In order tomake such acts subject to experimental use
exception, a legislative resolution would benecessary, as mentioned in the statement
submitted by the Solicitor General to the SupremeCourt.
2Comparison with the experimental use
exception provisions in Europe

Major European countries also haveexperimental use exception provisions like Japan.
However, unlike § 69(1) of the Japanese Patent Law,
the provisions clearly state that the experiments
must relate to the subject matter of the invention.
In Clinical Trials II in Germany, the Supreme Court
followed the indication in Clinical Trials I, andaffirmed application of the experimental use
exception to the defendant's acts as well as clearlyindicatedthefollowing
threeimportantdetermination standards for application ofexperimental use exception.
(i) The sole requirement for application of theexperimental use exception is that the evaluation oranalysis derives findings [including usage] related
to the subject matter of the invention, and thosefindings are directed to eliminating present
uncertainties.
(ii) Existence of a research purpose beyond thepresent experimental purpose or an intention to
use the experiment results for other purposes, suchas for commercial profits, are irrelevant todetermination of experimental use exception.
(iii) The following research is not subject to theexception: (a) research totally irrelevant to thepatented invention; (b) research of a scale
unjustifiable for an experimental purpose; (c)research conducted for the purpose of impeding orblocking the inventor's sales expansion of thepatented product.
This section examines what the outcome
would be if the above-mentioned U.S. cases weredisputed in Germany, and categorizes the cases asfollows.

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Exception is likely to be applied both in the United States and Germany
NeoRx Corp. v. Immunomedics, Inc.
Amgen Inc. v. Hoechst Marion Roussel, Inc.
Biogen, Inc. v. Shering AG
Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer
Exception is likely to be applied in Germany, though not in the United States
Embrex, Inc. v. Service Engineering Corp.
Scripps Clinic & Research Foundation v. Genentech, Inc.
Scripps Clinic & Res. Found. v. Baxter Travenol Labs., Inc.
Exception is not likely to be applied either in the United States or Germany
Madey v. Duke UniversityRoche Products, Inc. v. Bolar Pharmaceuticals Co., Inc.
Exception may be applied in Germany depending on how the invention is perceived, though not in the United States
Integra Lifesciences I, Ltd. v. Merck KGaA

Ⅳ Study of Future Desirable
Experimental Use Exception
Provisions in the United States
This section attempts to examine theproblems in the case of legislating experimental use
exception provisions that could cover a broader
scope of acts in the United States, and the relation
to fair use of copyright.
1Legislating experimental use exception
provisions

As far as the U.S. court decisions areconcerned, the modes of acts to which theexperimental use exception is applied areextremely limited. Application of common law
exception is not applied as long as there is acommercial purpose, and application of the Bolar
Provision is likely to be operated strictly afterIntegra Lifescience I, Ltd. v. Merck KGaA in light ofthe purpose of legislation, as mentioned above.
On the other hand, theories supporting broad
application of the experimental use exception had
existed from the past. In order to achieve broad
application of the experimental use exception asindicated by the theories, interpretation of thecommon law exception and statute law exception
would not be sufficient, but a legislative solution
would be the most realistic.
In fact, bills attempting to legislate
experimental use exception provisions haveactually been submitted to U.S. Congress in thepast. There was an attempt to legislate theexperimental use exception for uses of transgenic
animals for experiment/research in 1988, but thebill was not enacted.
Furthermore, in 1990, a bill attempting tointroduce broad experimental use exception
provisions similar to those in Japan and major
European countries was submitted to Congress,
and although it passed the House, it was notenacted.
Recently, a bill was submitted byRepresentative Rivers (Rivers Bill) in 2002. The
bill was aimed at eliminating the adverse effects ofgenetic patents by providing limited restrictions tothe effects of genetic patents. However, the bill wasrepealed without even passing the House.
These bills were submitted before thedecisions of Madey v. Duke University and Integra
Lifescience I, Ltd. V. Merck KGaA. Thus, consideringthat these two decisions have indicated anextremely narrow interpretation of application of
the experimental use exception, it is highly
probable that movements toward enacting a bill
similar to the Rivers Bill will become more activein the future.
Also, it should be pointed out that, even if theexperimental use exception were legislated in theUnited States in the future, compliance with theTRIPS Agreement must also be taken intoconsideration.
When a bill, which resembles the billsubmitted in 1998 to exempt experimental uses oftransgenic animal-related inventions or the billsubmitted in 2002 to provide limited restrictions tothe effects of genetic patents, is to be submitted in
the future, it is necessary to sufficiently consider
that the bill will not create "discrimination as to thefield of technology" as set forth in Art. 27.1 of theTRIPS Agreement and it ensures the "legitimate● 133 ●IIP Bulletin 2004

interests of the patent owner" as set forth in Art. 30of the TRIPS Agreement.
2

Fair use under copyright law

Four determination standards for fair use areprescribed in § 107 of the U.S. Copyright Law: (1)the purpose and character of the use, including
whether such use is of a commercial nature or is fornonprofit educational purposes; (2) the nature of
the copyrighted work; (3) the amount andsubstantiality of the portion used in relation to the
copyrighted work as a whole; and (4) the effect of
the use upon the potential market for or value ofthe copyrighted work.
Comparing these with the determination
standards for the common law exception, it isobvious that the fair use doctrine under copyright
law leaves room for flexible application to various
specific cases.
In order to apply the experimental use
exception to such types of acts, it would be
important to flexibly apply the exception according
to the specific cases similar to the fair use doctrine
under copyright law.

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