Parliamentary Priveleges

Marquette Intellectual Property Law Review
Volume 11 | Issue 1 Article 3
The Proper Scope of Patentability in International

Law
Shawn J. Kolitch
Northwestern School of Law of Lewis & Clark College, kolitch@lclark.edu
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Part of the Intellectual Property Commons
Repository Citation
Shawn J. Kolitch, The Proper Scope of Patentability in International Law, 11 Intellectual Property L. Rev. 149 (2007).
Available at: http://scholarship.law.marquette.edu/iplr/vol11/iss1/3
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KOLITCH ARTICLE (ONLINE)
THE PROPER SCOPE OF PATENTABILITY

IN INTERNATIONAL LAW
SHAWN J. KOLITCH*
INTRODUCTION ..........................................................................................150
I. THE ENVIRONMENTAL AND PUBLIC HEALTH CONSEQUENCES
OF PATENTED TECHNOLOGY ............................................................154
II. THE SCOPE OF PATENTABILITY .......................................................160
A. A Brief Examination of Patentable Subject Matter in the
United States ..................................................................................161
1. Formal Requirements.............................................................162
2. The Substantive Scope of Patentable Subject
Matter .......................................................................................162
B. Patentable Subject Matter in Foreign Laws and
International Treaties....................................................................165
1. Exclusions for Harmful Inventions .......................................165
2. Exclusions for Beneficial Inventions ....................................167
3. Exclusions in International Treaties .....................................169
III. A PROPOSED INTERNATIONAL STANDARD FOR THE SCOPE
OF PATENTABILITY ............................................................................173
A. Harmful Inventions: What to Exclude .......................................173
1. Banned Substances .................................................................174
2. Other Inherently Reasonable Exclusions ............................176
3. Scientific Uncertainty and True Precaution ........................176
B. Beneficial Inventions and Selective Exclusion ...........................177
CONCLUSION ..........................................................................................178
* J.D. 2006, Northwestern School of Law of Lewis & Clark College; Ph.D. 1996, University
of California; M.S. 1990, B.S. 1989 with honors and distinction, Columbia University. Email:
kolitch@lclark.edu.
KOLITCH ARTICLE
150 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 11:1
INTRODUCTION
The primary goal of patent law is to promote technological
1
progress. To this end, a patent generally provides an inventor with the
incentive of a temporary monopoly on the right to make, use, and sell a
2 3
patented invention, in return for full public disclosure of the invention.
However, both the incentive to invent and the reward for inventing may
have unintended and undesirable consequences because the harm
caused by some inventions, or in some cases simply by the grant of the
monopoly, may outweigh the benefits of the disclosure. On one hand,
society may not wish to provide an incentive to invent in areas where
the potentially harmful effects of an invention outweigh its putative
benefits. On the other hand, even for an entirely beneficial invention,
providing a patent may limit public access to the invention by allowing
monopolistic pricing during the term of the patent. In such cases, the
patent incentive is arguably misplaced.
Rather than ignoring the unintended—but nonetheless, harmful—
effects of granting a patent, and focusing solely on maximizing the
economic benefit to the inventor, patent law should counteract those
effects by selectively limiting both the incentive to invent and the
reward for inventing. This Article examines the undesirable
consequences that may result from the patent incentive currently
provided under U.S. and international law, and proposes a method by
which those impacts can be limited by selectively narrowing the legal
scope of patentability.
In this country, the United States Patent and Trademark Office
(USPTO) is required by federal law to grant patents without
considering either an invention’s possible harmful impacts or the effects
4
on public health of monopoly pricing resulting from a patent. Instead,
U.S. law requires only a showing of utility, novelty, and
1. In the United States, this goal is explicitly announced in the Constitution, which
authorizes Congress “[t]o promote the Progress of Science and useful Arts, by securing for
limited Times to Authors and Inventors the exclusive Right to their respective Writings and
Discoveries.” U.S. CONST. art. I, § 8, cl. 8.
2. 35 U.S.C. § 271 (2000) (defining infringement of a U.S. patent).
3. Id. § 112 (describing the requirements of patent disclosure).
4. See id. §§ 101–103, 131, 151. Patentable subject matter is broadly defined and does
not generally exclude inventions on the basis of their possible future impacts on public health
or the environment. This Article will consider in more detail the current U.S. patent system,
including currently excluded subject matter. See discussion infra Part II.
KOLITCH ARTICLE
2007] THE SCOPE OF PATENTABILITY 151
5
nonobviousness, with patentable subject matter broadly defined to
6
include “anything under the sun that is made by man.” This policy has
two important consequences. First, the USPTO routinely grants patents
7
for inventions that are harmful to the environment and public health.
Second, by indiscriminately granting patents on beneficial inventions,
U.S. law allows monopoly pricing of many such inventions without
regard to the impact of such pricing. This may, for example, contribute
to the high costs of pharmaceuticals and of health care generally in this
8
country. Although such costs may be appropriate in the United
States—and in other highly industrialized and relatively wealthy
9
nations —monopoly power can severely limit access to pharmaceutical
drugs and other beneficial inventions in developing nations. The
problem is exacerbated by the fact that many developing nations lack
the effective antitrust regulations of the United States.
5. 35 U.S.C. §§ 101–103. In addition, a patent application must meet various formal and
procedural requirements. Id. § 112.
6. S. REP. NO. 82-1979, at 5 (1952), as reprinted in 1952 U.S.C.C.A.N. 2394, 2399; H.R.
REP. NO. 82-1923, at 6 (1952); e.g., Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
7. For example, the USPTO has granted at least seventeen patents for inventions
claiming aerosol uses of chlorofluorocarbons (CFCs) since the United States signed the
Montreal Protocol banning production of CFCs in 1990. These patents are all directed to
using CFCs as blowing agents to produce various types of aerated materials: U.S. Patent No.
5,605,936 (filed Mar. 28, 1996) (issued Feb. 25, 1997); U.S. Patent No. 5,693,686 (filed Feb. 10,
1994) (issued Dec. 2, 1997); U.S. Patent No. 5,426,126 (filed Dec. 30, 1992) (issued June 20,
1995); U.S. Patent No. 5,199,962 (filed Feb. 14, 1992) (issued Apr. 6, 1993); U.S. Patent No.
5,140,052 (filed Feb. 3, 1992) (issued Apr. 18, 1992); U.S. Patent No. 5,162,384 (filed Sep. 13,
1991) (issued Nov. 10, 1992); U.S. Patent No. 5,089,033 (filed July 2, 1991) (issued Feb. 4,
1992); U.S. Patent No. 5,286,759 (filed Mar. 8, 1991) (issued Feb. 15, 1994); U.S. Patent No.
5,086,083 (filed Jan. 30, 1991) (issued Feb. 18, 1991); U.S. Patent No. 5,102,923 (filed Jan. 14,
1991) (issued Apr. 7, 1992); U.S. Patent No. 5,030,664 (filed Dec. 4, 1990) (issued July 9,
1991); U.S. Patent No. 5,250,582 (filed July 23, 1990) (issued Oct. 5, 1993); U.S. Patent No.
5,071,881 (filed May 22, 1990) (issued Dec. 10, 1991); U.S. Patent No. 4,960,804 (filed Mar. 30,
1990) (issued Oct. 2, 1990); U.S. Patent No. 5,001,164 (filed Aug. 19, 1988) (issued Mar. 19,
1991); U.S. Patent No. 4,994,217 (filed Dec. 29, 1988) (issued Feb. 19, 1991); and U.S. Patent
No. 4,992,222 (filed Dec. 29, 1988) (issued Feb. 12, 1991).
8. For example, one recent study found that in the year 2000, the average cost of
pharmaceuticals in the United States was the highest among a group of eight industrialized
nations, and it was up to 3.5 times greater than the cost of the same drugs in the other
countries studied, which included Canada, the United Kingdom, Sweden, France, Spain,
Australia, and New Zealand. PRODUCTIVITY COMM’N, INTERNATIONAL
PHARMACEUTICAL PRICE DIFFERENCES: RESEARCH REPORT (2001), available at
http://www.pc.gov.au/study/pbsprices/finalreport/pbsprices.pdf.
9. The United States currently ranks seventh in the world in gross domestic product, at
$41,600 per capita. CIA, The World Factbook, Rank Order, https://www.cia.gov/cia/
publications/factbook/rankorder/2004rank.html (last visited Dec. 22, 2006) [hereinafter CIA
World Factbook].
KOLITCH ARTICLE
Denying a patent based on the potentially harmful impacts of an

invention is complicated by the fact that scientific consensus regarding
the environmental and public health impacts of a new technology often
arrives years, or even decades, after the technology itself. In the
interim, the state of knowledge regarding the potential impacts of an
invention generally progresses from scientific ignorance, when any
harmful impacts of the invention are completely unknown and
unsuspected, to scientific uncertainty, when harmful impacts are
suggested by some scientific evidence, but the scientific community has
not yet reached consensus, and finally to scientific certainty, when
harmful impacts, if any, are well accepted by the scientific community.
For example, the USPTO granted the first patents on
10
chlorofluorocarbons (CFCs) for use as refrigerants in the early 1930s,
and CFCs were still considered “miracle chemicals” as late as the
11
1950s. However, scientists later hypothesized that chlorine radicals
12
from CFCs destroy atmospheric ozone, resulting in a wide range of
13
harmful impacts. In the late 1980s, scientists accepted as conclusive the
14
link between CFC emissions and ozone depletion, and in 1990, the
United States signed an international treaty banning CFCs from
15
production starting in 2000. There are many other notable examples of
10. U.S. Patent No. 1,833,847 (filed Feb. 8, 1930) (issued Nov. 24, 1931); U.S. Patent No.
1,886,339 (filed Dec. 31, 1928) (issued Nov. 1, 1932).
11. Daniel C. Esty, Environmental Protection in the Information Age, 79 N.Y.U. L.
REV. 115, 132 (2004).
12. Mario J. Molina & F.S. Rowland, Stratospheric Sink for Chlorofluoromethanes:
Chlorine Atomc-atalysed [sic] Destruction of Ozone, 249 NATURE 810 (1974).
13. These include, for example, harm to the skin, eyes, and immune systems of humans
and animals. UNITED NATIONS ENV’T PROGRAMME, MONTREAL PROTOCOL ON
SUBSTANCES THAT DEPLETE THE OZONE LAYER: 2002 ASSESSMENT REPORT OF THE
TECHNOLOGY AND ECONOMIC ASSESSMENT PANEL (2003), available at http://ozone.unep.
org/teap/Reports/TEAP_Reports/TEAP2002.pdf; UNITED NATIONS ENV’T PROGRAMME,
MONTREAL PROTOCOL ON SUBSTANCES THAT DEPLETE THE OZONE LAYER: 1998
ASSESSMENT REPORT OF THE TECHNOLOGY AND ECONOMIC ASSESSMENT PANEL (1998)
[hereinafter UNEP ASSESSMENT REPORT 1998], available at http://ozone.unep.org/teap/
Reports/TEAP_Reports/TEAPAS98.pdf.
14. See, e.g., J.G. Anderson et al., Ozone Destruction by Chlorine Radicals Within the
Antarctic Vortex: The Spatial and Temporal Evolution of ClO-O3 Anticorrelation Based on in
Situ ER-2 Data, 94 J. GEOPHYSICAL RES. 11,465, 11,465–79 (1989) (finding a conclusive link
between chlorine molecules dissociated from CFCs and stratospheric ozone depletion).
15. Montreal Protocol Parties: Adjustments and Amendments to the Montreal
Protocol on Substances that Deplete the Ozone Layer, June 29, 1990, 30 I.L.M. 537, 539
[hereinafter Amendment to the Montreal Protocol]. There are limited exceptions to the ban
for “essential uses,” defined roughly as uses necessary for public health and safety. The only
currently allowed essential uses of CFCs in the United States are in the space program, as a
propellant for metered dose inhalers, and when necessary for laboratory research. See U.S.
KOLITCH ARTICLE
patented innovations that have later proven harmful, two of which—

dichlorodiphenyltrichloroethane (DDT) and asbestos—will be discussed
16
in more detail below.
Analyzing the effects of patentability on the pricing of beneficial
inventions is also complicated, but by economic rather than scientific
considerations. Although granting a patent for an invention results in
less competition and higher prices in the marketplace, removing the
patent incentive entirely gives rise to the possibility that a product will
never reach the market at all. For some of the most beneficial products,
such as pharmaceuticals, research and development involves large sunk
costs, lengthy development times, and great financial risk. As a result,
the lure of monopoly pricing may be the deciding factor that induces a
company to develop the product in the first place. Therefore, any
proposal to limit patent rights must maintain a financial incentive
sufficient to justify the risk and expense of developing beneficial new
products. In other words, the law should strike a balance between
providing inventors with a sufficient incentive to invent, and maximizing
the number of people who can afford to purchase the resulting products.
A key to striking this balance may lie in the large disparity in wealth
among various nations. For example, in 2004, per capita gross domestic
product (GDP) ranged from a low of $400 in East Timor to a high of
17
$69,900 in Bermuda, a difference of more than two orders of
magnitude. As this huge discrepancy indicates, regardless of the
presence or absence of a patent incentive, the citizens of different
nations are not equally able either to develop high-cost inventions or to
pay monopoly prices for those inventions.
EPA, Essential Use Exemptions and Metered Dose Inhalers (MDIs), http://www.epa.gov/
ozone/title6/phaseout/mdi/ (last visited Nov. 4, 2006) (listing the current essential use
exemptions and describing the requirements for a use to be essential under the Montreal
Protocol).
16. DDT was first patented in the United States as a highly promising insecticide in
1943. U.S. Patent No. 2,329,074 (filed Mar. 4, 1941) (issued Sept. 7, 1943). It was eventually
banned in 1973 due to its negative ecological and public health impacts. Press Release, U.S.
Envtl. Prot. Agency, DDT Ban Takes Effect (Dec. 31, 1972) [hereinafter DDT Ban Press
Release], available at http://www.epa.gov/history/topics/ddt/01.htm. Asbestos was first
patented in 1828 as an insulating material in steam engines and ultimately banned from most
products as a carcinogen in 1989. See Chris Obrion, Asbestos Through the Ages, THE
ROANOKE TIMES, Oct. 5, 2003, at A1, available at http://whitepages.roanoke.com/roatimes/
special_sections/asbestos/asbestostimeline10_5.pdf (outlining the history and evolution of
patents); U.S. EPA, Asbestos Ban and Phase Out, http://www.epa.gov/asbestos/pubs/
ban.html (last visited Nov. 4, 2006) [hereinafter EPA Asbestos Ban] (explaining the EPA
final rule to ban asbestos-containing products). See infra Part I.
17. CIA World Factbook, supra note 9.
KOLITCH ARTICLE
This Article examines the environmental and public health

consequences of patent laws around the world and argues that the
patent incentive should be selectively removed to mitigate the harmful
effects of granting patents without regard to the invention-specific
impacts of doing so. After examining the scope of patentable subject
matter provided by the domestic laws of the United States, the laws of
other nations, and several international treaties, I conclude that
patentable subject matter should be universally limited to exclude from
patentability inventions that are known or strongly suspected to cause
certain sufficiently harmful impacts, and it should be selectively limited
to exclude from patentability certain classes of beneficial inventions in
developing nations.
Part I examines the phenomenon of the undesirable patent,
exploring, in particular, several past instances in which the widespread
use of a patent has led to significant environmental and public health
consequences. In the context of such cases, I will explore the extent to
which patent laws not only permitted, but facilitated, the development
of harmful technologies. Part II examines various national laws and
international treaties that address the scope of patentability. This
includes a brief examination of the evolution of U.S. patent law toward
an increasingly broader scope of patentable subject matter without
adequate evaluation of the public welfare impacts of patents. I then
focus, in particular, on the attempts by other nations to institute
precautionary measures to mitigate harms caused by unlimited patent
incentives. Part III offers an assessment of the current inadequacies of
existing patent laws, ultimately concluding that placing selective limits
on the scope of patentable subject matter, which will exclude protection
for some inventions, is warranted as a necessary means to counteract the
possible undesirable effects of unrestrained patent incentives. Part III
also presents some specific suggestions regarding the proper scope of
patentability, including an examination of what should be excluded in
accordance with necessary public policy considerations.
I. THE ENVIRONMENTAL AND PUBLIC HEALTH CONSEQUENCES OF

PATENTED TECHNOLOGY
As technology evolves, opportunities for improvement are identified
and instituted, but the passage of time may also bring with it new
information and insight into the unintended consequences of that
technology. Our understanding of the implications of various patented
technologies for the environment and public health progresses through
eras of scientific ignorance, uncertainty, and then finally to some degree
KOLITCH ARTICLE
of certainty regarding the potential consequences. Throughout this

time, successive generations of improvements and modifications
typically result in the issuance of an increasing array of patents.
An examination of past practice of the USPTO in granting patents
for inventions at various times during the evolution of scientific
knowledge concerning the impacts of the underlying technology is
instructive in better understanding this phenomenon. In three notable
cases involving CFCs, DDT, and asbestos, patents were issued for
substances that the scientific community ultimately—and universally—
later came to recognize and accept caused serious harm to the
environment and public health. Yet in each of these instances, the
USPTO granted related patents not only during the era of scientific
ignorance, but also at times of scientific uncertainty and certainty
regarding the harm caused by the substances.
One of the most dramatic illustrations of how U.S. law keeps the
patent incentive in place, regardless of whether harmful impacts of a
technology are suspected or known with scientific certainty, is the case
with respect to CFCs. CFCs are a class of synthetic chemicals and were
introduced in the United States in the early 1930s as an ostensibly safer
alternative to refrigerants such as sulfur dioxide and the ammonia-based
18
refrigerants that were then commonly used. Shortly thereafter, the
19
USPTO began granting U.S. patents related to CFCs. Unfortunately,
scientists later determined that the widespread use of CFCs as
20
refrigerants, aerosol propellants, cleaning solvents, and blowing agents
had led to depletion of stratospheric ozone in the earth’s atmosphere,
resulting in a variety of serious environmental and public health
consequences due to increased transmission of ultraviolet radiation to
21
the earth’s surface. However, the link between stratospheric ozone
depletion and CFCs in the atmosphere was not hypothesized until
18. THEO COLBORN ET AL., OUR STOLEN FUTURE: ARE WE THREATENING OUR
FERTILITY, INTELLIGENCE, AND SURVIVAL? A SCIENTIFIC DETECTIVE STORY 243 (1996);
Glenn B. Raiczyk, Future Development, Montreal Protocol on Substances that Deplete the
Ozone Layer: Conference Calling for Accelerated Phase-out of Ozone-Depleting Chemicals Is
Planned for 1992, 5 TEMP. INT’L & COMP. L.J. 363, 365–66 (1992).
19. U.S. Patent No. 1,833,847 (filed Feb. 8, 1930) (issued Nov. 24, 1931); U.S. Patent No.
1,886,339 (filed Dec. 30, 1928) (issued Nov. 1, 1932).
20. See UNITED NATIONS ENV’T PROGRAMME, MONTREAL PROTOCOL ON
SUBSTANCES THAT DEPLETE THE OZONE LAYER: 1991 ASSESSMENT REPORT OF THE
TECHNOLOGY AND ECONOMIC ASSESSMENT PANEL § 2.1 (1991), available at
http://www.ciesin.org/docs/011-494/011-494.html (describing the various uses of CFCs).
21. See generally, e.g., UNEP ASSESSMENT REPORT 1998, supra note 13.
KOLITCH ARTICLE
22
1974, and the scientific community only accepted this link as
23
conclusively proven in 1987, at which time the patent incentive for
development of CFC-related inventions had already been in place for
over fifty years.
Although the original CFC patents were granted—and expired—
during an era of scientific ignorance with regard to the harmful effects
of CFCs on the ozone layer, the USPTO continued granting CFC-
related patents throughout the subsequent eras of scientific uncertainty
and certainty regarding the destructive effects of the compounds. For
example, during the era of scientific uncertainty between 1974 and 1987,
the USPTO granted several new patents for CFC-related aerosol
24
products, irrespective of the debate then being waged between
environmentalists—who asserted a link between CFCs and atmospheric
ozone depletion—and the CFC industry, which consistently denied any
25
such link. Even in the post-1987 era of relative scientific certainty
regarding the negative impacts of CFCs, the USPTO continued granting
new patents for CFC-related products and methods. Disturbingly, the
USPTO continued this practice even after twenty-three primary CFC-
producing nations, including the United States, signed the Montreal
26
Protocol in an effort to reduce CFC concentrations in the atmosphere.
Despite such a clear indication of a national policy to avoid further
production and dissemination of CFCs, and even after the United States
signed the Protocol’s 1990 amendment requiring a phase out of CFC
27
production by the year 2000, the USPTO granted at least seventeen
28
patents specifying aerosol uses of CFCs.
A second example illustrating the USPTO practice of granting
patents on environmentally toxic substances is DDT. DDT is an organic
chemical compound that was introduced commercially in 1938 as a
22. Molina & Rowland, supra note 12.

23. See Anderson et al., supra note 14 (finding a conclusive link between chlorine
molecules dissociated from CFCs and stratospheric ozone depletion).
24. See, e.g., U.S. Patent No. 4,508,631 (filed Aug. 2, 1983) (issued Apr. 2, 1985)
(claiming a dehydrating refrigeration fluid including a CFC refrigerant); U.S. Patent No.
4,407,982 (filed Feb. 3, 1982) (issued Oct. 4, 1983) (claiming a method of producing
polyurethane foam including use of a CFC blowing agent); U.S. Patent No. 4,518,557 (filed
May 18, 1981) (issued May 21, 1985) (claiming a method of producing a polymer plastic using
a CFC blowing agent); U.S. Patent No. 4,174,295 (filed Aug. 9, 1977) (issued Nov. 13, 1979)
(claiming an aerosol propellant including 40–95% CFCs by weight).
25. Anderson et al., supra note 14, at 12.
26. Montreal Protocol on Substances that Deplete the Ozone Layer, Sept. 16, 1987, S.
Treaty Doc. No. 100-10 (1987), 1522 U.N.T.S. 3 [hereinafter Montreal Protocol].
27. See Amendment to the Montreal Protocol, supra note 15.
28. See supra note 7.
KOLITCH ARTICLE
highly promising insecticide with the potential to curtail insect-borne

29
diseases. Since its introduction, DDT has been successfully used in
many countries to combat epidemics of such serious illnesses as typhus
30
and malaria. However, questions about the harmful environmental
effects of DDT quickly arose, and scientists began voicing reservations
31
about DDT “almost as soon as it first went into use” because it was
found to persist in soil “for several years and could become magnified in
32
a food chain.” Scientists now classify DDT as a “persistent organic
33
pollutant” (POP), and it is well-accepted that DDT in the environment
leads to a number of adverse human health effects, including genital
34
abnormalities and decreased fertility.
However, as required by current U.S. law, the USPTO continued to
grant DDT-related patents when the era of scientific ignorance
regarding DDT ended and even after scientific uncertainty gave rise to
an era of scientific certainty about DDT’s harmful effects. As in the
case of CFCs, the patent incentive for DDT remained in place even
when other U.S. government action clearly indicated the existence of a
national policy to eliminate virtually all domestic use of the chemical.
Specifically, studies commissioned by the U.S. Department of
Agriculture (USDA) in the late 1960s confirmed that DDT had
numerous harmful consequences and persisted residually in the
35
environment, and as a result, the USDA cancelled the registration of
many uses of DDT in 1969, effectively outlawing harmful uses of the
36
chemical. The U.S. Environmental Protection Agency (EPA) followed
suit in 1973 by banning the domestic use of DDT due to its negative
37
ecological and public health impacts, subject to a small number of
38
public health exceptions. However, despite these actions by other U.S.
29. COLBORN ET AL., supra note 18, at 68.

30. History of POPs Discovery, Use and Ban, http://www.cneac.com/article/list.
asp?id=25 (last visited Nov. 5, 2006).
31. Id.
32. Id.
33. See Elizabeth B. Baldwin, Note, Reclaiming Our Future: International Efforts to
Eliminate the Threat of Persitent [sic] Organic Pollutants, 20 HASTINGS INT’L & COMP. L.
REV. 855, 856 (1997) (describing compounds classified as POPs and their global effects).
34. Id. at 857.
35. N. AM. COMM’N FOR ENVTL. COOPERATION, HISTORY OF DDT IN NORTH
AMERICA TO 1997, http://www.cec.org/files/pdf/POLLUTANTS/HistoryDDTe_EN.PDF
(last visited Nov. 5, 2006) [hereinafter HISTORY OF DDT].
36. Id.
37. DDT Ban Press Release, supra note 16.
38. These exceptions include “[p]ublic health, quarantine, and a few minor crop
uses . . . as well as export of the material.” Id. Export of DDT is permitted because DDT is
KOLITCH ARTICLE
government agencies, the USPTO continued to grant patents for

39
inventions related to insecticidal use of DDT. Under U.S. patent law,
the USPTO would be legally compelled to grant such a patent even
now, if an inventor met all of the statutory requirements for
40
patentability.
A third and especially compelling example is that of asbestos-related
inventions, which illustrates how the state of knowledge regarding the
effects of a substance on public health has no impact on the
patentability of the substance under U.S. law. Processed asbestos fibers
are very strong and have excellent insulating properties, and as a result
asbestos has been used for centuries in many products. These products
include, for example, floor tiles, plaster, wallboard, pipe insulation, and
41
roof shingles, among many others. However, asbestos is
carcinogenic—particularly when inhaled—and human exposure to its
dust can lead to a host of maladies, including cancers such as lung cancer
42
and mesothelioma, among others.
Health hazards related to asbestos have been known since at least
1898, when factory inspectors noticed the harmful consequences of
43
breathing asbestos particles. More generally, asbestos has a long and
well-documented history of producing human illness among those
exposed to the substance. Asbestosis, a scarring of the lungs that can
still considered the best way to prevent the spread of malaria in some developing nations,
despite its adverse effects. Id.
39. See, e.g., U.S. Patent No. 4,751,082 (filed Aug. 20, 1986) (issued June 14, 1988)
(claiming an insecticide comprising a combination of DDT and a fungus); U.S. Patent No.
3,400,093 (filed Mar. 11, 1966) (issued Sept. 3, 1968) (claiming an insecticide solution
comprising DDT); U.S. Patent No. 2,329,074 (filed Mar. 4, 1941) (issued Sept. 7, 1943) (the
original DDT patent). Note that in contrast to the case of CFCs, the export market for DDT
has provided a production incentive extending beyond the final ban on domestic use of the
chemical.
40. Although DDT is not currently manufactured in the United States, its manufacture
and export are in fact not prohibited by law, presenting a possible market incentive to further
develop products related to its pesticidal use in other nations. See HISTORY OF DDT, supra
note 35, at 2 (noting that Congress has not yet acted to prohibit domestic production of
DDT).
41. See Where Can Asbestos Be Found?, http://www.epa.gov/asbestos/pubs/asbuses.pdf
(last visited Nov. 5, 2006) (listing several dozen categories of products in which asbestos is
commonly found).
42. BARRY I. CASTLEMAN, ASBESTOS: MEDICAL AND LEGAL ASPECTS 90–100 (1984).
43. See EUROPEAN ENVTL. AGENCY, LATE LESSONS FROM EARLY WARNINGS: THE
PRECAUTIONARY PRINCIPLE IN THE 20TH CENTURY 1 (Poul Harremoẽs et al. eds., 2002)
(noting that although a factory inspector in the United Kingdom observed the harmful effects
of white asbestos dust on factory workers in 1898, the government of the United Kingdom did
not ban the substance until one hundred years later, resulting in hundreds of thousands of
arguably foreseeable deaths).
KOLITCH ARTICLE
lead to breathing problems and heart failure, “was by 1935 widely

recognized as a mortal threat affecting a large fraction of those who had
44
regularly worked with the material.” An international panel of lung
cancer experts, chaired by an American doctor affiliated with the U.S.
National Cancer Institute, convened in 1952 to discuss recent worldwide
45
increases in the rate of lung cancer. The following year, the panel
published a report—the so-called “Louvain report” of 1953—
46
unequivocally acknowledging that asbestos was carcinogenic. Action
by the U.S. government eventually followed in 1989, when the EPA
formally banned the production and sale of most products containing
47
asbestos. Although this ban was later partially reversed by the U.S.
48
Court of Appeals for the Fifth Circuit, the reversal was for legal rather
49
than scientific reasons, and many asbestos-containing products remain
banned domestically as a result of the 1989 EPA action.
Nevertheless, the USPTO has been continuously granting patents
50
for asbestos-containing products since the early nineteenth century.
Because patentability in this country is completely decoupled from
actions by other U.S. government agencies relating to public health, the
patent incentive for asbestos-related inventions remains in place despite
even the formal ban on asbestos by the EPA, and the USPTO has
51
granted many patents on asbestos-containing products since then. Put
differently, despite a longstanding era of scientific certainty with respect
to the harmful public health impacts of asbestos, the USPTO has
continued to grant U.S. patents for asbestos-containing inventions
essentially up to the present day.
Furthermore, the cases of CFCs, DDT, and asbestos are by no
means isolated. Other notable instances of patented technologies that
44. CASTLEMAN, supra note 42, at 31.

45. Id. at 68.
46. Id.
47. EPA Asbestos Ban, supra note 16.
48. Corrosion Proof Fittings v. Envtl. Prot. Agency, 947 F.2d 1201, 1230 (5th Cir.
1991).
49. See id. at 1229 (describing the EPA’s failure to consider congressionally mandated
alternatives to an outright ban as the basis for the Fifth Circuit’s decision partially reversing
the ban).
50. See Obrion, supra note 16 (describing the first U.S. patent for an asbestos-
containing product, issued in 1828).
51. See, e.g., U.S. Patent No. 6,642,164 (filed Nov. 21, 2001) (issued Nov. 4, 2003)
(claiming a frost-resistant insulating building material having asbestos as a possible
component); U.S. Patent No. 4,546,024 (filed Dec. 5, 1983) (issued Oct. 8, 1985) (claiming
load-bearing horizontal tiles that may be constructed from asbestos).
KOLITCH ARTICLE
have given rise to harmful consequences include patents for various

52
other chemical pollutants such as polychlorinated biphenyls (PCBs),
carcinogenic food and beverage additives such as some food, drug, and
53
cosmetic (FD&C) dyes, and mechanical inventions such as the two-
54
stroke internal combustion engine. The proliferation of such patents—
in some cases even concurrent with attempts by other government
agencies to ban the substances—evidences the inadequacies of our
current laws. At present, there is simply no connection between
scientific evidence indicating that a substance has harmful effects,
domestic and international attempts to ban the substance, and the
patent incentive.
II. THE SCOPE OF PATENTABILITY

A patent essentially provides to the patentee a temporary right to
exclude others from manufacturing, selling, using, or importing a
proprietary invention. This concept was apparently first set forth in
writing in the fourth century B.C. by Aristotle (who attributed the idea
55
to Hippodamus), but Renaissance-era Venice provides the first known
regulated system of granting patents. In fact, according to one
56
commentator, the Venetian Senate’s 1474 Act includes
most of the essential features of a modern patent statute. It
defines its coverage (“devices”); provides for registration with a
specific administrative agency; requires inventions to be “new
and useful,” “reduced to perfection,” and “not previously made
in this Commonwealth”; specifies a fixed term of ten years; and
52. PCBs were first synthesized in the late nineteenth century. See, e.g., Environmental
Literacy Council, Persistent Organic Pollutants, http://www.enviroliteracy.org
/article.php/1176.html (last visited Nov. 4, 2006) (describing the history of PCBs). PCBs were
ultimately banned by Congress in 1976 due to their toxic effects. Toxic Substances Control
Act, Pub. L. No. 94-469, 90 Stat. 2003 (codified as amended at 15 U.S.C. § 2605(e) (2000)).
53. See, e.g., FDA, Ctr. for Food Safety and Applied Nutrition, Color Additives Fact
Sheet, http://www.cfsan.fda.gov/~dms/cos-221.html (last visited Nov. 22, 2006) (describing the
history of various banned food dyes).
54. Two-stroke engines in snowmobiles and other off-road vehicles are a subject of
much current controversy. Although they produce “as much harmful pollution in seven hours
as a passenger car driven for 100,000 miles,” these engines are not yet banned domestically on
a large scale. Press Release, Envtl. Def., Envtl. Def. Blasts Snowmobile Pollution Standards
(Sept. 13, 2002), available at http://www.environmentaldefense.org/pressrelease.cfm?Content
ID=2300.
55. ROBERT PATRICK MERGES & JOHN FITZGERALD DUFFY, PATENT LAW AND
POLICY: CASES AND MATERIALS 1 (3d ed. 2002).
56. Id. at 3.
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sets forth a procedure to determine infringement, as well as a

57
remedy.
Notably, however, the 1474 Act did not provide any statutory exclusions
to patentability due to policy considerations such as an invention’s
potential harm to public health, national security, or the environment.
While this remains the case under current U.S. law, many other nations
have chosen to incorporate such exclusions into their contemporary
58
patent statutes. The current scope of patentability under the laws of
the United States and foreign nations are briefly considered in this
section.
A. A Brief Examination of Patentable Subject Matter in the United States

U.S. patent law grants to inventors the temporary right to exclude
others within this country from making, using, selling, or importing the
59
patented invention, as defined by the “claims” of the patent. Violating
any of these prohibitions is called infringing the patent, and a party who
does so may be subject to civil penalties including an injunction,
60
damages, and attorney fees. With some relatively minor exceptions,
the right to exclude currently extends from the date the USPTO issues
the patent, to a date twenty years from the filing date of the patent
61
application. To obtain a patent, an inventor must satisfy a number of
formal and substantive requirements. These are intended to ensure the
novelty and authenticity of the invention, as well as to require sufficient
public disclosure in return for the right to exclude. To check that these
requirements are properly met, every patent application is evaluated by
62
one or more professional Patent Examiners employed by the USPTO.
57. Id. at 4.
58. See infra Part II.B.
59. 35 U.S.C. § 271 (2000).
60. Id. §§ 281–285.
61. Id. § 154(a)(2). The exceptions are first, if the application refers to one or more
earlier filed applications, the term begins to run from the earliest filing date of all of the
applications to which the current application refers. Id. Second, the term of a patent
resulting from an application filed before June 8, 1995, runs for the longer of either seventeen
years from the date of issue of the patent or twenty years from the date of its application. See
MERGES & DUFFY, supra note 55, at 59 (describing this exception). Finally, the term of a
patent may be extended due to delays in the examination process attributable to the USPTO.
35 U.S.C. § 154(b).
62. 35 U.S.C. § 131.
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1. Formal Requirements
To ensure adequate public disclosure of an invention in return for
the temporary right to exclude others from its practice, a patent
application must include a specification of the invention, to be published
upon the grant of a patent, which contains the following:
[A] written description of the invention, and of the manner and
process of making and using it, in such full, clear, concise, and
exact terms as to enable any person skilled in the art to which it
pertains, or with which it is most nearly connected, to make and
use the same, and shall set forth the best mode contemplated by
63
the inventor of carrying out his invention.
In addition to the development incentive offered by the possibility of a
temporary monopoly, public disclosure via the patent specification is the
primary mechanism by which patent law seeks to promote technological
progress. By requiring enough disclosure to allow others in the same
field to copy, refine, and improve the patented invention, the written
specification requirement is designed to ensure that inventors can build
upon the prior ideas of others, presumably leading to more rapid
progress in that field. The patented invention itself must be precisely
described in an application by at least one patentable “claim,” which
must be supported by the language of the written disclosure, and which
64
legally defines the subject matter of the invention. Finally, the USPTO
also imposes a large number of additional formal and stylistic
65
requirements upon patent applications. These are largely designed
with clarity of the public record and agency efficiency in mind, and are
not of particular concern here.
2. The Substantive Scope of Patentable Subject Matter

U.S. patent law also imposes four substantive requirements to obtain
a patent. These include sufficient utility, novelty, and nonobviousness
of the invention, and also a requirement that the invention fall within
the confines of patentable subject matter. Patentable subject matter is
66
defined in the United States both by statute and by the common law.
The Patent Act states broadly that “[w]hoever invents or discovers any
new and useful process, machine, manufacture, or composition of
63. Id. § 112.

64. Id.
65. See, e.g., id. §§ 113, 115, 119 (requiring a drawing when necessary, an oath of
originality by the inventor, and a statement claiming priority to any earlier filed applications).
66. Id. §§ 101–103.
KOLITCH ARTICLE
matter, or any new and useful improvement thereof, may obtain a

patent therefor, subject to the conditions and requirements of this
67
title.” However, once Congress has spoken, it is the “province and
68
duty of the judicial department to say what the law is,” and the limits
of patentable subject matter have been further developed at common
law. As a result, certain categories of inventions have been specifically
excluded from patentable subject matter in the United States, including
physical phenomena, abstract ideas, and naturally occurring substances
69
that have not been purified or otherwise refined by the inventor. Thus,
for example, a physicist may not patent a newly discovered theory, and a
70
geologist may not patent a newly discovered mineral. In addition, for
obvious national security reasons, separate federal legislation excludes
from patentability “any invention or discovery which is useful solely in
the utilization of special nuclear material or atomic energy in an atomic
71
weapon.”
Although the exclusions described above limit patentable subject
matter in various narrowly defined ways, the courts have given only
limited attention to the more general question of whether to exclude an
invention from patentability merely because of its possible negative
impacts upon society. This exclusionary doctrine of so-called
72
“beneficial utility” dates back at least to 1817, when the court in
73
Lowell v. Lewis summarized the nineteenth-century view of the
doctrine in stating that “the law requires . . . the invention should not be
frivolous or injurious to the well-being, good policy, or sound morals of
74
society.” However, beneficial utility no longer plays a significant role
67. Id. § 101.

68. Marbury v. Madison, 5 U.S. (1 Cranch) 137, 177 (1803).
69. See, e.g., O’Reilly v. Morse, 56 U.S. (15 How.) 62, 119–20 (1853) (holding
unpatentable the abstract idea of using electromagnetism to produce written characters at a
distance); Parke-Davis & Co. v. H.K. Mulford & Co., 189 F. 95, 103 (S.D.N.Y. 1911) (finding
a purified form of naturally occurring adrenaline salt patentable, but suggesting that it would
be unpatentable if the inactive organic substances in the naturally occurring salt had not been
removed from the patented product).
70. The distinction between an abstract idea and an invented process is not entirely
clearly defined, and it has been shifting towards allowing greater patentability in recent years.
For example, computer programs and business methods are currently both patentable, if they
produce a “useful, concrete, and tangible result.” State St. Bank & Trust Co. v. Signature
Fin. Group, Inc., 149 F.3d 1368, 1373 (Fed. Cir. 1998) (citation omitted).
71. 42 U.S.C. § 2181(a) (2000).
72. See generally MERGES & DUFFY, supra note 55, at 216–28 (defining and describing
the history and current status of the doctrine).
73. Lowell v. Lewis, 15 F. Cas. 1018 (C.C.D. Mass. 1817) (No. 8568).
74. Id. at 1019.
KOLITCH ARTICLE
in defining the boundaries of patentable subject matter in this country.

For instance, in an opinion upholding the patentability of an invention
that had the effect of misleading consumers as to the source of the
75
purchased product, the Federal Circuit noted that “the principle that
inventions are invalid if they are principally designed to serve immoral
76
or illegal purposes has not been applied broadly in recent years.” As a
result, even inventions specifically designed to facilitate breaking the
law may be deemed patentable. For example, in Whistler Corp. v.
77
Autotronics, Inc., the court enforced a patent directed toward radar
detectors designed to help motorists avoid speeding tickets. In stating
that the court “cannot and should not substitute its own views in place
78
of those of . . . the several legislatures, or the Congress,” the Whistler
court declined to carve out a legality-based exclusion to the broad
statutory standard of patentable subject matter laid out in the U.S.
Patent Act, instead indicating that this carving out should fall to
Congress.
In fact, the trend in recent decades has been for courts in the United
States to define the bounds of patentable subject matter ever more
broadly. Other than the requirements of utility, novelty, and
nonobviousness, Congress has carved out only two relatively minor
statutory exceptions from patentable subject matter: inventions the sole
79 80
use of which is to build a nuclear weapon, and human clones. Thus,
the bounds of patentable subject matter in this country currently
incorporate no statutory or common law exclusions related to legality,
81
public health, or the environment, and in fact the current U.S. practice
is that “anything under the sun that is made by man” should be
82
patentable. As a result, the USPTO routinely grants patents for
inventions that have harmful impacts on public health and the
75. Juicy Whip, Inc. v. Orange Bang, Inc., 185 F.3d 1364, 1367 (Fed. Cir. 1999).
76. Id. at 1366–67.
77. Whistler Corp. v. Autotronics, Inc., 14 U.S.P.Q.2d 1885 (N.D. Tex. 1988).
78. Id. at 1886.
79. 42 U.S.C. § 2181(a) (2000); see supra text accompanying note 71.
80. However, Congress has recently passed a single morality-based statutory exclusion
to prevent patenting of human clones: “None of the funds appropriated or otherwise made
available under this Act may be used to issue patents on claims directed to or encompassing a
human organism.” Consolidated Appropriations Act, Pub. L. No. 108-199, § 634, 118 Stat. 3,
101 (2004). Furthermore, as previously noted, Congress has barred certain nuclear materials
from patentability for national security reasons. See supra note 71 and accompanying text.
82. S. REP. NO. 82-1979, at 5 (1952), as reprinted in 1952 U.S.C.C.A.N. 2394, 2399; H.R.
REP. NO. 82-1923, at 6 (1952).
KOLITCH ARTICLE
83
environment, and is required by law to do so. This is true regardless of
whether the harmful impacts of the invention are merely suspected or
are known with scientific certainty, and it remains true even if the
actions of other U.S. government agencies indicate a national policy to
eliminate the subject matter of the invention from public use. Figure 1
below illustrates the broad scope of patentability under current U.S.
law.
Not useful
Human
Nuclear
clones
weapons
Not
novel
Novel but
obvious
Figure 1
The scope of patentability in the United States
as of 2004, with areas excluded from
patentability indicated by shading. In addition
to the requirements of utility, novelty, and
nonobviousness, Congress has carved out only
two relatively minor statutory exceptions from
patentable subject matter: inventions the sole
use of which is to build a nuclear weapon and
human clones.
B. Patentable Subject Matter in Foreign Laws and International Treaties
1. Exclusions for Harmful Inventions

In contrast to the broad scope of patentable subject matter in the
United States, the laws of many other nations incorporate provisions
designed to remove the patent incentive for sufficiently harmful
83. Before outlining any exceptions and requirements, including the novelty
requirement, § 102 states that “[a] person shall be entitled to a patent.” 35 U.S.C. § 102
(2000) (emphasis added).
KOLITCH ARTICLE
inventions. For example, Brazilian patent law provides a number of

statutory exclusions from patentability, which limit the scope of
patentable subject matter to exclude various categories of inventions for
policy reasons. These exclusions apply regardless of whether the
invention otherwise meets the basic requirements of utility, novelty, and
nonobviousness in the Brazilian patent code. The Brazilian exclusions
84
include not only nuclear technology and human clones as in the United
States, but also “anything contrary to morals, standards of respectability
85
and public security, order and health.”
The Brazilian exclusions to patentable subject matter are typical of
86
precautionary exclusions in the patent laws of many nations. In
general, nations have adopted similar exclusions to patentable subject
matter based on at least five criteria: morality, public policy (or public
order), legality, public health, and environmental harm. More
87
specifically, of at least 142 nations having independent patent laws with
clearly delineated patentability standards, as of 2004, approximately 104
had a morality exclusion, 83 had a public policy or public order
exclusion, 38 had a legality exclusion (barring patents on inventions the
88
use of which would conflict with other national laws), 21 had a public
89 90
health exclusion, and 11 had an environmental harm exclusion. Only
27 of the 142 nations, including the United States, did not exclude
91
inventions from patentability based on any of these five factors. Figure
2 illustrates the scope of patentability with sufficiently harmful
inventions excluded.
84. Decreto No. 9.279, de 14 de maio de 1996, D.O.U. de 14.05.1996. (Brazil).

85. Id.
86. See generally PATENTS THROUGHOUT THE WORLD (Alan J. Jacobs ed., 4th ed.
2006) (summarizing the patent laws of over 150 nations and cooperative treaties).
87. The author has compiled the statistics cited in the text through an independent
study of Patents Throughout the World. Id.
88. In addition, nine nations specifically disclaim a legal exclusion. For example, the
patent laws of the United Kingdom provide that a patent shall not be granted “for an
invention the publication or exploitation of which would be generally expected to encourage
offensive, immoral or anti-social behaviour,” but that “behaviour shall not be regarded as
offensive, immoral or anti-social only because it is prohibited by any law in force in the
United Kingdom.” Patents Act, 1977, c. 37, §§ 1(3)–(4) (Eng.).
89. The nations whose patent laws are known to include a statutory public health
exclusion are Costa Rica, Ghana, India, Iran, Japan, Kenya, South Korea, Mongolia,
Mozambique, Nepal, Nicaragua, Panama, Peru, Portugal, Saudi Arabia, Somalia, Taiwan,
Thailand, Trinidad and Tobago, Uruguay, and Vietnam. See supra note 87.
90. The eleven nations are Bolivia, Colombia, Ecuador, Jordan, Kenya, Mongolia, Peru,
Saudi Arabia, Trinidad and Tobago, Uruguay, and Venezuela. See supra note 87.
KOLITCH ARTICLE
Not useful
Sufficiently
harmful
Not
novel
Novel but
obvious
Figure 2
The scope of patentability with sufficiently
harmful inventions excluded, as provided, for
example, by the patent law of Brazil. Many
other national laws and some international
treaties exclude from patentability inventions
deemed harmful to morality, public policy,
legality, public health, and/or the environment.
2. Exclusions for Beneficial Inventions

At first glance, providing patent protection for inventions that have
purely beneficial impacts appears entirely appropriate, and this is true
with respect to incentivizing development of such inventions. However,
when monopoly pricing is combined with the tremendous disparity in
wealth that exists between the people of various nations today, the
result may be that only the wealthiest citizens gain access to beneficial
products, some of which may be vital to maintain the public health. To
combat this possibility, many nations have historically excluded various
beneficial inventions from patentability, although the number of such
nations has been steadily decreasing under pressure from the United
92
States and other industrialized countries. For example, prior to 2005,
the patent law of India excluded the following from patentability:
92. For example, a United Nations survey in the 1970s showed that “about 90
developing countries and a few developed countries including France, Germany, Italy, Japan,
Switzerland and Sweden had enacted national laws on patents which excluded
pharmaceutical products from patent production.” K. Balasubramaniam, Advisor &
Coordinator, Health Action Int’l Asia–Pacific, Patent Policies and Pharmaceutical Prices,
KOLITCH ARTICLE
(g) a method or process of testing applicable during the process

of manufacture for rendering the machine, apparatus or other
equipment more efficient or for the improvement or restoration
of the existing machine, apparatus or other equipment or for the
improvement or control of manufacture;
(h) a method of agriculture or horticulture; [and]
(i) any process for the medicinal, surgical, curative, prophylactic
or other treatment of human beings or any process for a similar
treatment of animals or plants to render them free of disease or
93
to increase their economic value or that of their products.
Indian law further provided that for inventions “claiming substances
intended for use, or capable of being used, as food or as medicine or
drug . . . no patent shall be granted in respect of claims for the
94
substances themselves.” In other words, prior to 2005, Indian law
excluded from patentability efficiency testing methods, agricultural
methods and products, and medical methods and products, including
pharmaceutical drugs. However, although a substantial number of
developing nations have attempted to mitigate monopoly pricing of
beneficial products through their domestic patent laws, regional and
international treaties such as the North American Free Trade
95
Agreement (NAFTA) and the Agreement on Trade-Related Aspects
96
of Intellectual Property Rights (TRIPs Agreement) have forced those
nations to undo these mitigating patentability exclusions and to provide
97
patent protection equivalent to that of the most developed nations.
Figure 3 illustrates the scope of patentability with both sufficiently
harmful and various beneficial inventions excluded.
Lecture delivered to Post Graduate Diploma in Health Development, Faculty of Medicine at

the University of Colombo (Oct. 16, 2004), http://www.haiap.org/unipaper.htm. As of 1988,
there were approximately fifty such nations. Julio Nogués, Patents and Pharmaceutical
Drugs: Understanding the Pressures on Developing Countries 4 (Int’l Econ. Dept., The World
Bank, Working Paper No. 502, 1990), available at http://www-wds.worldbank.org/servlet/
WDSContentServer/WDSP/IB/1990/09/01/000009265_3960929170142/Rendered/PDF/multi0p
age.pdf.
93. Patents Act, No. 39 of 1970, Acts of Parliament, 1970.
94. Id.
95. North American Free Trade Agreement, U.S.-Can.-Mex., Dec. 17, 1992, 32 I.L.M.
605 (1993) [hereinafter NAFTA].
96. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15,
1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal
Instruments—Results of the Uruguay Round, 33 I.L.M. 1125, 1197 [hereinafter TRIPs
Agreement].
97. For example, to comply with the TRIPs Agreement, India amended its Patent Act
in 2005 to remove section 5, which had excluded pharmaceuticals from patentability. Patents
(Amendment) Act, 2005, No. 15, Acts of Parliament, 2005.
KOLITCH ARTICLE
Not useful Sufficiently

harmful
Novel but Not

obvious novel
Agricultural
methods Pharmaceuticals
Efficiency testing
Figure 3
The scope of patentability with all sufficiently
harmful and some beneficial inventions excluded,
as exemplified by the patent law of India prior to
2005. In addition to excluding harmful inventions
from patentability, Indian law also excluded
certain beneficial inventions to preclude
monopoly pricing for those inventions. The
excluded categories included testing methods for
improving manufacturing efficiency, agricultural
methods and products, and perhaps most
significantly, pharmaceutical drugs.
3. Exclusions in International Treaties

As noted above, a number of international treaties also govern
patentability. Rather than serving as distinct sources of law, these
treaties generally require signatory nations to conform their national
laws to the treaty provisions or face economic sanctions. For example,
98
the European Patent Convention, which governs the patent laws of
99
thirty-one member states, provides that patents shall not be granted for
“inventions the publication or exploitation of which would be contrary
98. Convention on the Grant of European Patents, Oct. 5, 1973, 1065 U.N.T.S. 199
[hereinafter European Patent Convention].
99. A list of the thirty-one member states of the European Patent Organization (EPO)
is available on the EPO Web site. See EPO Member States, http://www.european-patent-
office.org/epo/members.htm (last visited Nov. 14, 2006).
KOLITCH ARTICLE
100
to ‘ordre public’ or morality.” Even more broadly, the Eurasian
101 102
Patent Convention, ratified by ten Eurasian nations, provides that
Eurasian patents shall not be granted for . . . inventions, the
commercial use of which it is essential to prevent, for the
purposes of protecting public order or morality, including the
protection of the life and health of people and animals or the
protection of plants, or in order to prevent serious damage being
103
caused to the environment.
Significantly, the exclusions provided by the European and Eurasian
conventions are mandatory, rather than optional. In other words, the
thirty-one states party to the European Patent Convention must
incorporate a morality exclusion into their national patent laws, and the
ten states party to the Eurasian Patent Convention must incorporate
exclusions based on public morality, public health, and environmental
104
harm.
In contrast, a second set of treaties allow for optional patentability
exclusions for harmful inventions. For example, NAFTA provides that
[a] Party may exclude from patentability inventions if preventing
in its territory the commercial exploitation of the inventions is
necessary to protect ordre public or morality, including to protect
human, animal or plant life or health or to avoid serious
prejudice to nature or the environment, provided that the
exclusion is not based solely on the ground that the Party
prohibits commercial exploitation in its territory of the subject
105
matter of the patent.
Similarly, the TRIPs Agreement provides that
[m]embers may exclude from patentability inventions, the
prevention within their territory of the commercial exploitation
of which is necessary to protect ordre public or morality,
including to protect human, animal or plant life or health or to
100. European Patent Convention, supra note 98, art. 53.

101. Eurasian Patent Convention, Sept. 9, 1994, Industrial Property Laws & Treaties,
text 2-013, available at http://www.wipo.int/clea/docs_new/pdf/en/ea/ ea001en.pdf.
102. These nations are the Republic of Azerbaijan, the Republic of Armenia, the
Republic of Belarus, Georgia, the Republic of Kazakhstan, the Kyrgyz Republic, the
Republic of Moldova, the Russian Federation, the Republic of Tajikistan, and Ukraine.
Eurasian Patent Organization (EAPO), States Party to the Convention, http://www.eapo.org/
eng/information/about.html (last visited Nov. 14, 2006).
103. Patent Regulations Under the Eurasian Patent Convention, ch. II, R. 3(4), Dec. 1,
1995, Industrial Property Laws & Treaties, text 2-014, available at http://www.eapo.org/eng/
documents/doc/ea002en.pdf.
104. See supra notes 98–103.
105. NAFTA, supra note 95, art. 1709 (first emphasis added).
KOLITCH ARTICLE
avoid serious prejudice to the environment, provided that such

exclusion is not made merely because the exploitation is
106
prohibited by domestic law.
However, since the patentability exclusions provided in NAFTA and
the TRIPs Agreement are merely optional, neither treaty should be
viewed as providing meaningful limits to the scope of patentability.
Instead, these optional exclusions simply render NAFTA and the TRIPs
Agreement compatible with the laws of nations already requiring
exclusions for harmful inventions, such as the signatories to the
European and Eurasian conventions.
In fact, NAFTA and the TRIPs Agreement have the overall effect of
significantly broadening patentability scope worldwide by forcing
member nations to provide patents for all inventions other than those
subject to the optional exclusions noted above. For example, the TRIPs
Agreement provides that aside from the optional exclusions, “patents
shall be available for any inventions, whether products or processes, in
all fields of technology, provided that they are new, involve an inventive
107
step and are capable of industrial application.” This apparently
includes, inter alia, efficiency testing methods, agricultural methods, and
pharmaceuticals, i.e., all of the exclusions carved out by Indian law.
That the TRIPs Agreement requires patentability of these and other
beneficial inventions is highly significant to the world economy. As an
agreement promulgated by the World Trade Organization (WTO), the
108
TRIPs Agreement applies to all WTO member nations, of which there
are currently 149, with another thirty-two “observer” nations committed
109
to eventual membership. Thus, the TRIPs Agreement—and to a
110
lesser extent NAFTA —essentially precludes all patentability
106. TRIPs Agreement, supra note 96, art. 27 (first emphasis added). The treaty also
allows optional exclusions for medical methods, for animals, and for plants other than plant
varieties, which must remain patentable. Id.
107. Id. (emphasis added).
108. See WTO, Intellectual Property (TRIPS), Frequently Asked Questions,
http://www.wto.org/english/tratop_e/trips_e/tripfq_e.htm (last visited Nov. 14, 2006)
[hereinafter WTO TRIPS FAQ] (noting that that the TRIPs Agreement “applies to all WTO
members”).
109. See WTO, Understanding the WTO, Members, http://www.wto.org/english/
thewto_e/whatis_e/tif_e/org6_e.htm (last visited Nov. 14, 2006) (providing lists of current
members and observers, and noting that “observers must start accession negotiations within
five years of becoming observers”).
110. Note that NAFTA applies only to the United States, Canada, and Mexico. See
NAFTA, supra note 95.
KOLITCH ARTICLE
exclusions designed to counteract monopoly pricing of beneficial

111
inventions, in virtually every country in the world.
Not surprisingly, developing nations have searched for loopholes in
the TRIPs Agreement that might allow them to continue the practice of
excluding some beneficial products, particularly pharmaceuticals, from
112
patentability. One possibility is to characterize the exclusions as
necessary for public health, thus bringing them within the scope of the
113
optional exclusions explicitly allowed by the TRIPs Agreement.
However, proving that limits to patentability are “necessary” may be
difficult or impossible, and nations may not want to risk possible WTO
trade sanctions if a dispute arises. A second option is compulsory
licensing, which is authorized by the TRIPs Agreement in cases of “a
national emergency or other circumstances of extreme urgency or in
114
cases of public non-commercial use,” or if “the proposed user has
made efforts to obtain authorization from the right holder on
115
reasonable commercial terms and conditions.” These conditions also
may be difficult to meet, or may result in high prices for the product
despite the compulsory license. Furthermore, a license is useless to a
nation that lacks the capability to manufacture the invention. Finally,
116
parallel imports are allowed by the TRIPs Agreement, enabling
developing nations to import products from international resellers
rather than exclusively from the patent holder, thus providing
111. One exception is that “least developed countries” have been granted an extension
until 2016 to provide for patentability of pharmaceuticals. WTO TRIPS FAQ, supra note
108.
112. In fact, developing nations attended the WTO Ministerial Conference in Doha,
Qatar, in November 2001, for the express purpose of finding legal strategies to mitigate the
harmful effects of the TRIPs Agreement to their citizenry. The result was the Doha
Declaration, a political statement that affirmed that the TRIPs Agreement allows both
compulsory licensing and parallel imports. World Trade Organization, Ministerial
Declaration of 14 November 2001, WT/MIN(01)/DEC/1, 41 I.L.M. 746 (2002) [hereinafter
Doha Declaration].
113. See TRIPs Agreement, supra note 96, art. 27. The TRIPs Agreement also
explicitly provides that “[m]embers may, in formulating or amending their laws and
regulations, adopt measures necessary to protect public health and nutrition, and to promote
the public interest in sectors of vital importance to their socioeconomic and technological
development, provided that such measures are consistent with the provisions of this
Agreement.” Id. art. 8(1).
114. Id. art. 31.
115. Id.
116. See Doha Declaration, supra note 112; see also TRIPS and Public Health: The
Situation Before Cancún, http://www.wto.org/English/tratop_e/trips_e/health_background
_e.htm (last visited Nov. 14, 2006) (noting that the TRIPs Agreement allows parallel
imports).
KOLITCH ARTICLE
competition between sources of the same product. However, despite

the presence of these various loopholes in the TRIPs Agreement, its
general effect has been to broaden the worldwide scope of patentability
117
and to raise pharmaceutical prices in developing nations.
III. A PROPOSED INTERNATIONAL STANDARD FOR THE SCOPE OF

118
PATENTABILITY
From a purely economic standpoint, providing the broadest possible
scope of patentability makes sense because it provides the greatest
range of incentives and profits to inventors and to the manufacturers
who fund their research. However, as described above, this can have
undesirable non-economic consequences, including damaging impacts to
the environment and public health. As has been illustrated, to
counteract the undesirable consequences of incentivizing harmful
inventions and offering monopolies that limit access to beneficial
inventions, some national laws and international treaties have limited
the permissible scope of patentability to exclude both harmful and
beneficial inventions in various circumstances. The scope of
patentability should be limited still further. This section provides a
proposal for the appropriate scope of patentability in international law.
The proposed scope would require utility, novelty, and nonobviousness,
would uniformly exclude from patentability sufficiently harmful
inventions, and would selectively exclude sufficiently beneficial
inventions only in qualifying developing nations.
A. Harmful Inventions: What to Exclude

I propose that provisions be added to domestic laws and
international treaties to universally remove the incentive to create
117. In India, implementation of the TRIPs Agreement will likely cause drug prices to
rise dramatically. For example, in 1995 the drug Zantac (generically known as ranitidine)
retailed in India for 18.53 rupees, in the United Kingdom at the equivalent of 484 rupees (26.1
times as much), and in the United States at the equivalent of 1050 rupees (56.7 times as
much). In Pakistan, which has an economy similar to India but allows pharmaceutical
patents, Zantac retailed in 1992 for the equivalent of 261 rupees, 14.1 times the price in India
three years later. See Jean O. Lanjouw, The Introduction of Pharmaceutical Product Patents
in India: “Heartless Exploitation of the Poor and Suffering”? 37 (Nat’l Bureau of Econ. Res.,
Working Paper No. 6366, 1998), available at http://www.oiprc.ox.ac.uk/JLWP0799.pdf.
118. In an earlier work, I outlined a related proposal for incorporating a precautionary
principle into the patent laws of the United States. See Shawn Kolitch, Comment, The
Environmental and Public Health Impacts of U.S. Patent Law: Making the Case for
Incorporating a Precautionary Principle, 36 ENVTL. L. 221, 249−55 (2006). Portions of Part
III are gleaned from that work.
KOLITCH ARTICLE
harmful inventions. In the United States, for example, this would

require amendment to the applicable patent statutes. The U.S.
Congress would need to amend 35 U.S.C. § 101, which currently reads:
“Whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new and useful
improvement thereof, may obtain a patent therefor, subject to the
119
conditions and requirements of this title.” For purposes of U.S. law, I
propose that Congress add to § 101 the phrase: “However, a patent will
not be granted for an invention the use of which is deemed sufficiently
detrimental to the environment or public health.” Likewise,
comparable provisions should be added to the domestic laws of other
nations, and international treaties should be modified to allow these
domestic provisions.
The essential policy question for undertaking to devise and
implement provisions limiting the scope of patentability for harmful
inventions is exactly what would be the new legal limits of patentable
subject matter. In other words, how detrimental is “sufficiently
detrimental” to exclude an invention from patentability? Presumably
the answer to this question should balance environmental and public
health interests on one hand, with both the development incentive and
the economic interests of potential inventors and other would-be patent
120
owners on the other hand. It is important to consider the policy
question of where to draw the line for precautionary exclusion from
patentability, while still maintaining a sufficient economic patent
incentive to promote technological progress and innovation in
appropriate areas.
1. Banned Substances
No reasonable justification exists for maintaining the patent
incentive to develop inventions involving substances that a government
has clearly indicated should be removed from domestic production and
use. Therefore, as a matter of public policy, patent provisions should
exclude from patentability all inventions claiming substances facing an
imminent domestic production ban or phase out at the time of the
121
patent application.
119. 35 U.S.C. § 101 (2000).

120. A patent owner is not necessarily the inventor named on the patent. For example,
an employee of a corporation may (and typically does) assign to her employer all patent
rights related to work done in the scope of her employment.
121. The same exclusion would apply to substances whose production is already
banned. However, this situation is unlikely to arise in practice because if an inventor cannot
KOLITCH ARTICLE
Excluding banned (or nearly banned) substances from patentability

would merely remove the patent incentive to invent in areas where
regulatory action leading toward a ban already clearly indicates
government recognition that a substance is harmful. Because bans are
typically enacted only in the face of incontrovertible evidence regarding
the harmful effects of a substance, placing such limits would essentially
allow removal of the patent incentive at least for inventions known with
scientific certainty to be harmful. More generally, the practice would
close an existing loophole that maintains the patent incentive during the
interval between regulatory action leading towards a ban on production
of a substance, and the production ban taking final effect. Removing
the patent incentive in such cases is inherently reasonable because an
imminent ban or phase out of production strongly suggests that use of
the banned substance in a proposed invention is “sufficiently
detrimental” to exclude the invention from patentability.
Similarly, patentable subject matter should exclude inventions
involving substances facing an imminent ban or phase out on domestic
use—as opposed to production—at the time of the patent application.
Typically, a ban on domestic use will be accompanied by a production
ban, but in rare cases a regulation may ban domestic use of a substance
without a commensurate ban on domestic production, indicating that
the substance still may be used in other nations. One might argue that
the patent incentive in such cases should be preserved to induce
prospective inventors to “improve” these fields of invention for the
benefit of companies producing and exporting the related products.
However, inducing research in alternative technologies by removing the
patent incentive for clearly harmful substances would better serve
ultimate policy goals, including the articulated purpose of patents under
122
U.S. law to promote the “Progress of Science and useful Arts.” Of
course, removing the patent incentive does not in and of itself constitute
a ban of any sort, and excluding from patentability a substance whose
domestic use is banned would in no way affect either domestic
production or foreign use of previously patented inventions related to
the substance. Rather, limiting the patent incentive would serve only as
produce the invention domestically, there would be little reason to pursue a U.S. patent. In
the strange scenario where domestic production was banned but domestic use was not
banned, an inventor planning to produce the invention in another country conceivably might
pursue a U.S. patent to prevent other foreign manufacturers from selling similar products in
this country. In that unlikely event, the exclusion should apply.
122. U.S. CONST. art. I, § 8, cl. 8.
KOLITCH ARTICLE
a subtle force to move future technological development in a more

beneficial direction.
2. Other Inherently Reasonable Exclusions

Aside from imminent regulatory bans on production and use of a
substance, other indicators of scientific certainty regarding the harmful
impacts of the substance should be used to exclude related inventions
from patentability as “sufficiently detrimental.” Such alternative
indicators, which often serve as the precursors of bans, could include
reports by scientific panels, scientific review articles, conference
proceedings, and so forth. While such a change in our patent incentive
scheme might not prevent the production and use of some products
containing undesired substances, development of those products might
be significantly decreased in favor of safer alternatives for which the
patent incentive remains intact. In general, removing the patent
incentive immediately upon the arrival of scientific consensus regarding
a substance’s harmful impacts, rather than waiting years or decades for
the announcement of a regulatory ban or phase out of the substance,
seems most consistent with the notion of using patents to promote
developments and advancements.
3. Scientific Uncertainty and True Precaution

Most controversially, but also perhaps most importantly, a truly
precautionary step would be to exclude from patentability inventions
merely suspected of causing sufficient harm to the environment or public
health. For instance, an invention’s potential harm could be assessed in
consultation with the agencies that provide lists of substances that are
banned or otherwise known with relative certainty to have “sufficiently
detrimental” environmental or public health effects. In borderline
cases, risk assessments could be performed with appropriate domestic
agencies. Although the precise standards for such assessments would
have to be defined with regard to patentability, these details could
presumably be promulgated by appropriate agency regulations.
Whereas the political climate might make compromising patent rights in
favor of environmental concerns an unpopular notion, the practical
obstacles to instituting a well-defined precautionary standard of
patentability seem to be surmountable.
KOLITCH ARTICLE
B. Beneficial Inventions and Selective Exclusion

While it is beyond the scope of this Article to discuss in detail the
economic and social effects of granting patents for beneficial inventions,
both common sense and available data indicate that doing so will
increase prices, limiting availability of beneficial products in developing
nations, while providing greater profits to manufacturers in developed
nations. To counteract this, domestic and international laws should
selectively allow developing nations to exclude certain classes of
inventions from patentability. Excluded categories should include, at a
minimum, agricultural methods and products, and medical methods and
products, but should preferably be extended to all inventions sufficiently
beneficial to public welfare. Nations allowed to make these exclusions
should include at least those thirty-two member nations recognized as
123
“least-developed” by the WTO, and should preferably include all
nations whose GDP falls below a certain threshold level. For example,
the exclusions could be allowed to all nations having a GDP less than
the worldwide mean or median GDP, which would effectively limit
monopoly pricing to only wealthier nations. Figure 4 illustrates the
proposed scope of patentability with sufficiently harmful inventions
universally excluded and with sufficiently beneficial inventions
selectively excluded.
Unfortunately, as indicated by the advent of the TRIPs Agreement,
international law appears to be evolving towards a broader scope of
patentability rather than a narrower one. This is due primarily to the
influence of the United States and other developed nations, which have
the most to gain from a worldwide policy of broad patentability.
Although the language of the TRIPs Agreement allows some flexibility
in national laws that seek to preclude patentability of harmful
inventions, this language should be mandatory rather than optional.
Furthermore, rather than preventing developing nations from excluding
pharmaceuticals and other beneficial inventions from patentability, the
TRIPs Agreement and other international treaties should explicitly
allow these exclusions. This would effectively require developed
nations to recoup research and development costs from within their own
ranks, while providing the benefits of the research to rich and poor
countries alike. However, so long as the wealthiest and most developed
nations continue to set the policy agenda of the WTO and other
123. See WTO, Understanding the WTO, Least Developed Countries,

http://www.wto.org/English/thewto_e/whatis_e/tif_e/org7_e.htm (last visited Nov. 14, 2006)
(providing a list of these nations).
KOLITCH ARTICLE
international trade organizations, such beneficial reforms to

international patent law are unlikely to occur.
Not useful
Sufficiently
harmful
Not
Novel but novel
obvious
Sufficiently
beneficial
Figure 4
The author’s proposed patentability scope.
The proposed scope would require utility,
novelty, and nonobviousness, would
uniformly exclude sufficiently harmful
inventions, and would selectively exclude
sufficiently beneficial inventions only in
qualifying developing nations (as indicated
by the dashed boundary line).
CONCLUSION
Patent law purports to be an incentive system, in which the lure of
temporary monopoly power spurs both the development of new
technologies and public disclosure of the resulting innovations.
However, if the patent incentive is offered indiscriminately, both the
development and the monopoly power may come at a high domestic
and international price. Some innovation has undesirable
consequences, and maintaining the patent incentive without regard to
the harmful impacts of an invention may result in the development of
harmful technologies and may slow the development of safer
alternatives. On the other hand, some innovation is so beneficial that
the grant of even a temporary monopoly may limit access to an
invention to the wealthy, and thus conflict with basic notions of fairness
KOLITCH ARTICLE
and human rights. This is particularly true with respect to

pharmaceuticals, medical methods and devices, and agricultural
methods and products.
The scope of patentable subject matter can—and should—be shaped
to counteract the problems described above. In the domestic laws of all
nations, the patent incentive should be removed for many harmful
inventions by excluding from patentability all subject matter known or
suspected to have sufficiently detrimental impacts on the environment
or public health. Furthermore, to give universal access to beneficial
medical and agricultural advances, the patent incentive for this subject
matter should be retained only in nations whose citizens can afford to
pay the resulting monopoly prices. In other nations, and particularly in
the thirty-two member nations recognized as “least-developed” by the
WTO, this beneficial subject matter should be excluded from
patentability. Finally, all relevant international treaties, particularly the
TRIPs Agreement, should be amended to allow these exclusions from
patentable subject matter. Unfortunately, this would require a reversal
of the current trend of expanding patentable subject matter for the
primary benefit of industrialized nations.

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Marquette Intellectual Property Law Review

Volume 11 | Issue 1 Article 3

The Proper Scope of Patentability in International

Follow this and additional works at: http://scholarship.law.marquette.edu/iplr

THE PROPER SCOPE OF PATENTABILITY

150 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 11:1

2007] THE SCOPE OF PATENTABILITY 151

152 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 11:1

Denying a patent based on the potentially harmful impacts of an

2007] THE SCOPE OF PATENTABILITY 153

patented innovations that have later proven harmful, two of which—

154 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 11:1

This Article examines the environmental and public health

I. THE ENVIRONMENTAL AND PUBLIC HEALTH CONSEQUENCES OF

2007] THE SCOPE OF PATENTABILITY 155

of certainty regarding the potential consequences. Throughout this

156 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 11:1

22. Molina & Rowland, supra note 12.

2007] THE SCOPE OF PATENTABILITY 157

highly promising insecticide with the potential to curtail insect-borne

29. COLBORN ET AL., supra note 18, at 68.

158 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 11:1

government agencies, the USPTO continued to grant patents for

2007] THE SCOPE OF PATENTABILITY 159

lead to breathing problems and heart failure, “was by 1935 widely

44. CASTLEMAN, supra note 42, at 31.

160 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 11:1

have given rise to harmful consequences include patents for various

II. THE SCOPE OF PATENTABILITY

2007] THE SCOPE OF PATENTABILITY 161

sets forth a procedure to determine infringement, as well as a

A. A Brief Examination of Patentable Subject Matter in the United States

162 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 11:1

2. The Substantive Scope of Patentable Subject Matter

63. Id. § 112.

2007] THE SCOPE OF PATENTABILITY 163

matter, or any new and useful improvement thereof, may obtain a

67. Id. § 101.

164 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 11:1

in defining the boundaries of patentable subject matter in this country.

2007] THE SCOPE OF PATENTABILITY 165

B. Patentable Subject Matter in Foreign Laws and International Treaties

1. Exclusions for Harmful Inventions

166 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 11:1

inventions. For example, Brazilian patent law provides a number of

84. Decreto No. 9.279, de 14 de maio de 1996, D.O.U. de 14.05.1996. (Brazil).

2007] THE SCOPE OF PATENTABILITY 167

2. Exclusions for Beneficial Inventions

168 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 11:1

(g) a method or process of testing applicable during the process

Lecture delivered to Post Graduate Diploma in Health Development, Faculty of Medicine at

2007] THE SCOPE OF PATENTABILITY 169

Not useful Sufficiently

Novel but Not

3. Exclusions in International Treaties

170 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 11:1

100. European Patent Convention, supra note 98, art. 53.

2007] THE SCOPE OF PATENTABILITY 171