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PATENT POLICY AND MEDICAL PROCEDURES: IS THERE

ANY JUSTIFICATION FOR GRANTING OF PATENTS?

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TABLE OF CONTENTS

Table of cases
01
Table of statutes
02
Introduction
03
Research Methodology
04
Origin of Patents and its History in India
06
An Overview of Indias Patent Policy in relation to TRIPS
08
Patentable Subject-matter; the prevailing policies
13
Medical Procedures: Meaning and an Introduction on their patentability
15
The Development of the Exclusion of medical procedures
17
Departure from the Exclusion
20
The case for Patentability of Medical treatment
22
Conclusion and Suggestions
29
Bibliography
31

TABLE OF CASES

Bristol Myers Squibb Co v FH Faulding & Co Ltd (2000):46 IPR C& W's Application for a
Patent: 31 RPC 235. (1914).
Case of Badewasser (1904) BLJPNZ 4.
Decision of the Appeal Board of the Austrian Patent Office of May 29, 1973 (1974) GRUR Int
180.
Decision of the Swiss Federal Court, September 24, 1946. 72 BGE 1, (1951) GRUR 283'
Decision of the Swiss Federal Court, February 24, 1975. 101 BGE Ib 18, (1975)
SchwPMMBl133, 1975 GRURInt 314.
Eli Lilly & Company's Application [1975]: RPC 438. Joos v The Commissioner of Patents (1972)
126 CLR 611.

McCoy T. Biomedical process patents. J Leg Med 1992; 13:501-19.[Medlinel Scherings

Application [1971] RPC 337.
The Pallin Case
Wellcome Foundation Ltd V.Plantex Ltd, 1974 RPC 514

TABLE OF STATUTES
UK Patents Act,1977
Australia Patents Act,1990
The Patents Act, 1970

I. INTRODUCTION
Patent legislation gives legal protection to new inventions, once they have been patented by
their owners. A patent is a temporary monopoly granted to the owner in return for disclosure of
1
the invention to the public . It is a monopoly right granted to a person who has invented a new
and useful article or an improvement of an existing article or a new process of making an
article. It consists of an exclusive right to manufacture the new article invented or manufacture
an article according to the invented process for a limited period. After the expiry of the duration
of patent, anybody can make use of the invention. Thus, both society and the inventor benefit
from the patent system. The inventor benefits by being able to exclude others from exploiting
the invention for 20 years, and the public benefits because when the patent expires, the
invention is freely available for others to use.
Patenting of methods of medical treatment of human beings is, however, a complicated issue for
it is not only based on patent law but also on medical law. Medical law has its origins in the
Hippocratic Oath, and the goal is the preservation of human life. Since the goal of patent law is
to encourage innovation by rewarding inventors, it is quite distinct from the goal of medical
law. Thus, there is a public policy concern that in order to ensure the best possible health
2
treatment, physicians must always be free in their choice of treatment . It must be also noted
that in the most recent Australian case, Bristol Myers Squibb Co v F H Faulding & Co Ltd,
Finkelstein J clarified that the "ethical grounds" should be understood as references to "public
3
policy grounds". Since a patent may restrict this freedom, it has been argued that methods of
medical treatment should be excluded from patent protection.
Approximately 80 countries around the globe prohibit methods of medical treatment from being
granted patent protection. The list includes all European countries and countries in Asia, Africa,
North America, South America, and Central America.

Articles 27 and 33 of the Agreement on Trade Related Aspects of Intellectual Property Rights Act, 1995.
Pila J, Methods of medical treatment within Australian and United Kingdom patents law, Univ NSW
Law J 2001, PP. 420-461.
3

Bristol Myers Squibb Co v FH Faulding & Co Ltd (2000) :46IPR 553 :586.

Research Methodology
This project examines the laws relating to the patenting of medical procedures prevalent in India
and other countries and the public policy considerations surrounding this matter. It concludes that
public policy considerations provide sufficient basis to justify a discrimination against patenting of
methods of medical treatment and that medical treatment patents are, indeed, contrary to the ordre
public and morality (this terminology comes from the international Agreement on Trade Related
4
Aspects of Intellectual Property Rights 1995 , or "generally inconvenient" (from section six of the
5

Imperial Statute of Monopolies 1623 ) and therefore, ought not to be granted.

With regard to the precise scope of this project, the following format will be adhered to:
Origin of Patents and its History
An Overview of India's Patent Policy in Relation to TRIPS
Patentable Subject-Matter; the Prevailing Policies
Medical Procedures: Meaning and an Introduction on their Patentability
The Development of the Exclusion of Medical Procedures
Departure from the Exclusion
The Case for Patentability of Medical Treatment
Conclusion & Suggestions
The researcher mainly depended on the Primary sources like Statutes and Committee report and
secondary sources like books, Articles and websites. Opinions of research scholars, experts in
the respective field, and opinions of professionals like Patent Agents, Trademark Attorneys and
Advocates who deal with this subject are used as real contribution to this work. Internet has
also provided with a major contribution of most relevant and latest information on the web,
which helped to explore the subject through various dimensions of Law, National Law School
of India

Agreement on Trade Related Aspects of Intellectual Property Rights Act. 1995 (TRIPS). London: The Stationery
Office, 1995, articles 27 and 33.
English Statute of Monopolies of 1623, 21 Jac 1, c 3: S 6, Available at http://www.ipmall.info/hosted
_resorces/lipa/patents/English _Statute 1623pdf (Last visited on 01/02/2007).

University, Bangalore and e-resources have played a crucial role to bring out specialist material
of the dissertation.

II -ORIGIN OF PATENTS AND ITS HISTORY IN INDIA

The Patent System Origins
The very first monopolies appeared about 500 BC according to Phylarchus, who was quoted in the
6
third century AD by Athenaeus in the Banquet of the Learned and the first letters of patent were
granted in 1440 to John of Shiedame who introduced a method of manufacturing salt on a scale
7
never before attempted in England (Bristol Myers Squibb Co v F H Faulding Co Ltd ). While
originally designed to encourage the setting up of new industries, the monopoly system began to be
abused by the Crown, in particularly by Elizabeth 1. It led to section six of the Statute of
Monopolies in 1623, which declared all monopolies void except those that are manners of
manufacture, but only in so far as they are: "not contrary to the law or mischievous to the state, by
8
raising prices of commodities at home, or hurt of trade, or generally inconvenient" . Section six was
destined to become the foundation of the patent law not only in England, but also throughout the
world. The requirement that there be a "manner of manufacture" in the Statute of Monopolies has
9
been described as "the touchstone of patentability and still is in force today in Australia, New
10

Zealand, and Israel (Patents Act 1990 (Cth), S 18 and schedule 1).

History of Patents in India

The patent system in India emerged when India was a colony of the British and therefore the British
used their own system as a drawing account while drafting the Indian Patent Act. The first Act for
the protection of inventions in India, Act VI of the 1856 On Protection of Inventions, was based on
the British Patent Law of 1852. Certain exclusive privileges were granted to the inventors of new
manufacturers for a period of 14 years. The Act was modified in 1859 and certain exclusive
privileges were granted to inventors for making, selling and using inventions in India and
authorising others to do so for 14 years from the date of filing specifications.

The Patents and Designs protection Act was enacted in 1872 and in 1883 the Protection of
Inventions Act was enacted. Both the acts were consolidated as the Inventions and Designs Act
Athenaeus. Banquet of the learned. London: Henry G Bohn, 1854.
Bristol Myers Squibb Co v FH Faulding & Co Ltd (2000) :46IPR 553 :586
8

English Statute of Monopolies of 1623, 21 Jac l c 3: S 6 , Available at http://www.ipmall.info/hosted

Jesorces/lipalpatents/English _Statute 1623.pdf ( Last visited on 05/04/2007).
Industrial Property Advisory Committee. Patents, innovation, and competition in Australia. Canberra: Patent Office,
1994, 39-41 at 41.
Sections 65 and 67 of the Patents Act 1990 (Cth). Canberra: Australian Government Publishing Service, 1991.

in 1888. The Indian Patents and Designs Act came into effect in 1911. After Independence the
national government decided to change the colonial patent Act amended in 1911. The study made by
two committees headed by Justice Bakshi Tek Chand and Justice N. Rajagopala Ayyengar led to the
emergence of the new patent Act. On 20th April, 1972, The Patents Act (Act 39 of 1970) came into
force. The 1970 Patent Act was later amended in 1999, 2002 and again in 2005.

III-AN OVERVIEW OF INDIA'S PATENT POLICY IN RELATION TO TRIPS

As previously mentioned, India has a long history of patent policy which was defined after
enormous study. India's approach to patents differs from those of industrialized countries in that
India sees patents as a tool of public policy. India's policy is being challenged by the demand to
reform IPR laws to conform to TRIPS. This section provides an overview of India's patent policy.

a. Indias Patent Policy Pre-TRIPS

India's patent policy focused on balancing developmental concerns with the need for promoting
innovations. India viewed patents as a tool for economic development and restricted the scope
and term of patents. The sentiment in India on the issue of patents, especially on
pharmaceuticals, is illustrated by an oft-quoted statement made by Indira Gandhi at the World
Health Assembly in 1982:
The idea of a better-ordered world is one in which medical discoveries will be free of patents
11
and there will be no profiteering from life and death .
Although patent policy has a long history in India, the actual attention of policymakers towards
patents began right after Independence. Two expert committees were established in independent
India to study patents and provide suggestions on the type of patent system that India should
implement. These committees conducted an extensive survey of patents in India. The Patent
Enquiry Committee (1948-50) reported that, "the Indian patent system has failed in its main
purpose, namely to stimulate inventions among Indians and to encourage the development and
exploitation of new inventions for industrial purposes in the country so as to secure the benefits
12
thereof to the largest section of the public. The second committee [the Ayyangar Committee
(1957-59)] noted that foreign patentees were acquiring patents not "in the interests of the
economy of the country granting the patent or with a view to manufacture there but with the
object of protecting an export market from competition from rival manufacturers particularly
those in other parts of the world". Thus, India is deprived of getting, in many cases, goods at
cheaper prices from alternative sources because of the patent protection granted in India. The
11

Jean Lanjow, "The Introduction of Pharmaceutical Product Patents in India: 'Heartless Exploitation of the Poor
and Suffering, Economic Growth Center, Yale University, August 26, 1997, Pg.1.

12

Government of India, Ministry of Industry and Supply, Patent Enquiry Committee, Interim Report, August 1949.

reports concluded that foreigners held 80-90% of the patents in India and were exploiting the
13
system to achieve monopolistic control of the market .The committees, therefore, suggested
that a patent system that focused on access to resources at lower prices would be beneficial to
India. This was in tune with the science and technology mission of developing indigenous
technology and fostering research & development activities in areas of national significance.
The Patent Act of 1970, the current legislation on patents in India, was based on the
recommendations of these committees. The main aim in India was to ensure that patents did not
lead to monopoly by foreign companies nor lead to high prices for medicines and food items.
The patent law of 1970 (the current law) restricts the field of patentability, only grants process
and not product patents in food, pharmaceutical and chemical fields, restricts the term of patents
and has an elaborate system of licenses to ensure that patents are worked in India. The act found
support among domestic firms and various political parties in India.
b. The Indian Patents Act, 1970
The Indian Patents Act has been hailed as model legislation for developing countries. It seeks to
balance both the need for granting rewards for inventors while ensuring that India's
developmental needs are not ignored.
The following essential features of the Act reveal the basic patents policy of India:
General Principle of Patent Grant: - (a) that patents are granted to encourage inventions and to
secure that the inventions are worked in India on a commercial scale and to the fullest extent
that is reasonably practicable without any delay; and (b) that they are not granted merely to
enable patentees to enjoy a monopoly for the importation of the patented article".
Principle of National Treatment -no limitations or restrictions on foreigners in applying for or
obtaining patents in India.
Inventions Not Patentable -The following are not patentable:
An invention which is frivolous or which claims anything obviously contrary to well
established natural laws;
13

FICCI (1996), Pg.8.

An invention the primary or intended use of which would be contrary to law or morality or
injurious to public health;
The mere discovery of a scientific principle or the formulation of an abstract theory;
The mere discovery of any new property or new use for a known substance or of the mere use
of a known process, machine or apparatus unless such known process results in a new product
or employs at least one new reactant;
A substance obtained by a mere admixture resulting only in aggregation of the properties of the
compounds thereof or a process for producing such substance;
The mere arrangement or re-arrangement or duplication of known devices each functioning
independently of one another in a known way;
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 control of
manufacture;
A method of agriculture or horticulture;
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 to increase their economic value or that of their products;
An invention relating to atomic energy;
Search for Novelty -compulsory search is required extending to prior publications not only in
India but also in any other part of the world.
Patentability of Inventions in the Area of Chemicals, Food and Drugs -In case of inventions
relating to substances intended for use as food, drug or medicines or substances produced by
chemical processes, Patentability will be limited to claims for the methods or processes of
manufacture only.
Term of Patent -The term of the patent in 14 years from the date of patenting, i.e., the date of
filling the complete specification. In the case of inventions in the field of food, drug or
medicine, the term will be 7 years from the date of filing or 5 years from the date of sealing,
whichever is shorter.

10

Licensing Provisions -2 types of licenses: compulsory licenses and license of rights.

Compulsory licenses enabling another party to work the patent can be applied for any time after
the expiry of three years from the date of sealing of the patent.
In the area of food, drug, medicine or chemical, after the expiry of three years from the date of
patent grant, they shall be endorsed with the word "License of Right". These enable any
interested person as a matter of right to be entitled to work on such patents.
Royalties -In the case of patents related to food, drug or medicines the royalty reserved to the
patentee under a license shall not exceed 4% of the net ex-factory sale price in bulk of the
patented article.
Use of Patented Inventions by the Government -In order to ensure that scarcity of a patented
article doesn't arise and lead to high prices, the government is vested with powers to make use
of or exercise any patented invention merely for its own purpose.
Appeals -In all cases, appeals will lie only in the High Court.
c. Indias Patent Policy and TRIPS.
The philosophy of India's Patent Act of 1970 varies enormously from the framework being
established under TRIPs. There are several knowledge and information areas which India considers
unpatentable. India has a large community of scientists and researchers among whom publication
rather than gaining patents has been a concern. G.V. Ramakrishna, Chairman of the Disinvestment
Commission points out that in India, "We (Indians) are accustomed to the notion that knowledge is
free. Our whole orientation has to change from one that stresses intellectual attainment to one that
14
protects intellectual property." Industrialised nations conceive of patents as a fundamental right
comparable to the right of physical property, whereas developing nations view it as "fundamentally
15
as an economic policy question." From the perspective of developed countries, intellectual
property is a private right that should be protected as any other tangible property, but for developing
nations, intellectual property is a public good that should be used to

Rukmini Parthasarthy, "The CEO's Guide to The New Patents Regime "Business Today (Bombay), September 22,
1998, Pg. 58.
R. Gadbow and Richards, Intellectual Property Rights: Global Consensus, Global .Conflict? 1st ed., 1988, Pg.2.

11

16

promote economic development. The following table illustrates the basic differences between
India's patent system and TRIPS:
COMPARISON OF INDIA'S PATENT ACT AND TRIPS

17

The Indian Patents Act, 1970

TRIPS
Only process not product patents in food,
Process and product patents in almost all fields
medicines, chemicals.
of technology
Term of patents 14 years; 5-7 in case of
Term of patents 20 years
chemicals, drugs
Compulsory licensing and license of right
Limited compulsory licensing; no license of
right
Government allowed to use patented invention
Very limited scope for governments to use
to prevent scarcity
patented inventions

These differences in patent systems led to disputes in the GATT negotiations on the inclusion of IPRs
in the WTO. The type of patent system that India established was clearly against the global IP regime
promoted by the US. The main objection of the US is to the provision in India's patent law that allows
for process but not product patents in the area of food, drug or medicine. The United States terms the
activities of India to find alternative processes as "piracy". According to the US, Indian firms are
copying technology developed by advanced nations. This is leading to large-scale losses for the US.
The Pharmaceutical industry in the US has been especially vocal on this issue. Phrma, the association
that represents US based pharmaceutical companies points out, "Based on the refusal of the
Government to provide pharmaceutical patent protection, India has become a haven for bulk
pharmaceutical manufacturers who pirate the intellectual property of the world's research-based
18
pharmaceutical industry.

Terence P. Stewart, The GATT Uruguay Round: A Negotiating History 1986-1992, vol. 2, 1993, Pg.2255.
Adapted from Patent Office Technical Society, Indian Patent Act, 1970 and Rules, 1991 and MVIRDC, GATT

Agreements: Results of the Uruguay Round, World Trade Centre, January 1995.
Available at http://www.phrma.org/issues/intl/india.html Last visited on 07/09/2007.

12

IV -PATENTABLE SUBJECT-MATTER: THE PREVAILING POLICIES

Patentable subject matter or patent eligibility means the subject matter that is open to patenting.
Patents are granted to inventions that satisfy the statutory requirements of novelty, inventive
step and industrial application. In addition to these statutory criteria, a patent will be granted
only where the invention is not an excluded category. Under the United States law an invention
19
is patent eligible if it satisfies the requirement of a patentable invention. In contrast to the
United States statutes, the European Patent Convention does not expressly state which sorts of
inventions are patent eligible. The drafters defined patent eligibility in the negative excluding
the following categories of inventions namely;
Discoveries, scientific theories and mathematical methods;
Aesthetic creations;
Schemes, rules and methods for performing mental acts, playing games or doing business, and
programs for computers;
The presentation of information.

20

The Indian Patent Act corresponds to the negative method of excluding the categories of
inventions that are not patent eligible. Patent law contains a non-exhaustive list of things which
21
shall not be regarded as inventions. The exclusions on this list are either abstract or technical .
35 USC Section 101
EPC, Art. 52, reads,
"1.Europeanpatentsshallbegrantedfor inventions(in all fields of technology ,as far as they are new, involve an
inventive step and are susceptible of industrial application.
The following in particular shall not be regarded as inventions within the meaning of Paragraph 1: a) discoveries,
scientific theories and mathematical methods;
b) Aesthetic creations;
c) Schemes, rules and methods for performing mental acts, playing games or doing business, and programs for
computers;
d) Presentation of information
The provisions of Paragraph 2 shall exclude patentability of the subject-matter or activities referred to in that
provision only to the extent to which a European patent application or European patent eates to such subject-matter
or activities as such.
Methods for the treatment of the human or animal body by surgery or therapy and diagnostic methods practiced.

21

Section 3 of the Indian Patents Act reads: "The following are not inventions within the meaning of this Act:
An invention which is frivolous or which claims anything obviously contrary to well established natural laws;

an invention the primary or intended use or commercial exploitation of which could be contrary to public order or
morality or which causes serious prejudice to human, animal or plant life or health or to the environment;
the mere discovery of a scientific principle or the formulation of an abstract theory [or discovery of any living thing
or non-living substances occurring in nature];

13

The TRIPS Agreement also defines patentable subject-matter as follows:

"Subject to the provisions of the Paragraphs 2 and 3, patents shall be available for any
inventions, whether products or processes, in all fields of technology, provided that they are
new, involve an inventive step and are capable of industrial application. Subject to Paragraph 4
of the Article 65, Paragraph 8 of Article 70 and Paragraph 3 of this Article, patents shall be
available and patent rights enjoyable without discrimination as to the place of invention, the
field of technology and whether products are imported or locally produced. Members may
exclude form 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 avoid serious prejudice to the environment, provided
that such exclusion is not merely because the exploitation is prohibited buy their law.
Members may also exclude from patentability:
Diagnostic, therapeutic and surgical methods for the treatment of humans or animals;
Plants and animals other than micro-organisms, and essentially biological processes for the
production of plants or animals other than non-biological and microbiological processes.
However, Members shall provide for the protection of plant varieties either by an effective sui
generis system or by any combination thereof. The provisions of this sub-paragraph shall be
22
reviewed four years after the date of entry into force of the WTO Agreement.
the mere discovery of a new form of a known substance which does not result in the enhancement of the known
efficacy of that substance or the mere discovery of any new property or new use for a known substance or the mere
use of a known process, machine or apparatus unless such known process results in a new product or employs at
least one new reactant;
a substance obtained by a mere admixture resulting only in aggregation of the properties of the components thereof
or process for producing such substances;
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one
another in a known way;
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;
a method of agriculture or horticulture;
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 to increase their economic value or that of
their products;
an invention relating to atomic energy;
in respect of food, medicine or drug, patents are granted only for the process of manufacture of the substance but
not for the substance itself; (such restrictions on the grant of product patents do not exist in almost all other
countries);
in respect of substances produced by chemical processes (including alloys, optical glass, semiconductors and
intermetallic compounds) patents are granted only for the process of manufacture but not for the substance itself".
22

TRIPS Agreement, Art. 27.

14

V-MEDICAL PROCEDURES: MEANING AND AN INTRODUCTION ON THEIR

PATENTABILITY
The Law Lexicon defines what medical treatment is. According to it, medical treatment is a
term which, in its enlarged sense, includes surgery, and in a restricted sense, as used in medical
parlance, may mean a division of the curative art, exclusive of surgery.
"Surgical procedure" has been defined as "a treatment for curing or preventing disease, injury,
illness, disorder, or deformity by operative methods, in which human tissue is cut, burned, or
vaporized by the use of any mechanical means, laser, or ionizing radiation, or the penetration of
23
the skin or body orifice by any means.
A "pure" surgical or medical procedure is a medical diagnostic procedure or treatment, or a
method or process, where the "invention" is independent of the use of a medical device and
24
drug. Medical procedures are considered procedures for the purpose of treatment or diagnosis
of a human or animal condition, whether or not the condition is medically defined as a
25
disease. Furthermore, "Medical diagnosis" has been defined as "the identification of a medical
condition or a disease or disorder of the body.

26

Patents on medical procedures are often called medical process patents. A medical process
patent or patent claim is one that only confers rights over procedural steps and does not confer
rights over any new devices.
There are differences between the legal system of various jurisdictions on the issue of patenting
of medical and surgical methods. Under the law of some jurisdictions methods of treatment of
the human body are patentable subject matter.
The patentability of methods of treatment or diagnosis is one of great sensitivity and indeed
controversy, in that moral arguments against the monopolization of such methods are firmly
Mary Ann Liebert, Patent Issue, Ban on Medical Use Patents in Works -Tissue Engineering, Vol. 2, No.3, 1996,
Pg.11.
Position Statement -Medical and Surgical Procedure Patents; Available at http://www.aaos.org/about!
papers/position/ 113l.asp( Last visited on 22/12/2007).
Patents on Medical Procedures and The Physician Profiteer By Susan Leach DeBlasio of Tillinghast Licht Perkins
Smith & Cohen, LLP.
Supra n.25

15

pitted against economic arguments in favour of patent disclosure. The debate is further
complicated by the fact that the moral objections raised against the control of methods of
treatment are not equally raised against the patentability of medicines and other healthcare
subject matter.

16

VI -THE DEVELOPMENT OF THE EXCLUSION OF MEDICAL PROCEDURES

Ancient Greek philosophers, such as those depicted in Aristotle's The Politics, advocated
recognition, awards, and honors for the achievements of discoverers. At the same time, the
Hippocratic Oath commands physicians to care for their patients ethically and selflessly.
These Hellenic ideas flourished and were widely embraced by civilizations around the globe
27
and throughout the ages .
The United Kingdom
Methods of medical treatment have long been excluded from patenting in the UK. The exclusion
28
can be traced back to the 1914 case of In the Matter of C & W's Application for a Patent .In this
case, the solicitor general refused an application for patent protection for a process of extracting
toxic lead from living human beings upon the ground that the alleged invention related simply to a
medical treatment. The basis for such refusal was that a medical treatment process did not employ
29
any form of manufacture or of trade, thus lacking commercial value.

Since that decision, for many years it was accepted as axiomatic that there could be no patents
for medical treatment, because they do not result in, or in the improvement of, a "vendible
30
product", a product that can be sold.
31

In Eli Lilly & Company's Application the court clearly stated that the restriction applied
regardless of other changes in law and refused a patent application, for the first time, on the
basis of the public policy. In that case the applicant discovered that certain chemical compounds
which were already known had unsuspected anti-inflammatory properties that could be used in
the symptomatic treatment of various inflammatory conditions present in humans and animals.
The court confirmed that the law at that time stood so that no patent could be granted for a new
method that claimed to be a cure or prevention of disease in human beings. The authority for
32
such a decision was the earlier decision in Schering's Application in 1971.

Chris J Katopis,Patients v. patents? Policy implications of recent patent legislation, St. John's Law Review, spring
1997 pp.120-121.
In the Matter of C & W's Application for a Patent: 3 1 RPC 235. (1914). 3/ Supra n 30 .
Ibid
Re GEC's Application (1942) 60 RPC 1, per Morton J at 4.
[1975]: RPC 438.

17

It must also be noted that in the 1970s the United Kingdom could have changed its attitude
toward patentability of medical treatment when the Banks committee reviewed the British
33
patent system. The committee considered a wide range of issues, including the question
whether applications for patents for medical treatment should be permitted. The committee
decided this was not desirable. As a consequence of the Banks committee's report, methods of
medical treatment were expressly excluded by the parliament of the United Kingdom in section
34
4(2) of the new legislation . The report also played a significant role in the development of the
35
exclusion of medical treatment patents.
The European Patent Convention
The European Patent Convention was negotiated by a group of European countries in the early
1970s with the aim of creating a uniform European law. Though the patent courts of other
European countries had not dealt so extensively with the issue of patentability of methods of
36
medical treatment as the courts in the United Kingdom, the general practice was similar. A
grant for patent protection in France and Italy, for example, would be denied if the alleged
37
invention were lacking in industrial character (Whitford J in Schering's Application ). In
38
39
Austria and Switzerland one of the grounds for refusal of medical invention was an ethical
consideration. In fact, up until 1974 no court decision in any of the member states of the EPC
had upheld a claim related to a method of medical treatment.

[1971] RPC 337

Banks Committee. The report of the committee to examine the patents system (Banks committee report). London:

HMSO, 1970 (Cmnd 4407, paras 237-40).

The Patents Act 1977 (UK).
Article 52(4) of the European Patent Convention. Munich: 1973.
Moufang R, Methods of medical treatment under patent law, IIC 1993; 24:18-26.
Supra n 31
Decision of the Appeal Board o/the Austrian Patent Office of May 29, 1973 (1974) GRUR Int 180.

Decision o/the Swiss Federal Court, September 24, 1946. 72 BGE 1, (1951) GRUR 283;
Decision o/the Swiss Federal Court, February 24, j975. 101 BGE 1b 18, (1975) SchwPMMBI. 133, 1975 GRUR Int
314.

18

In the early 1900s, the German Patent Office granted a few patents for medical methods,
including a method of removing deeper stitches from wounds (German patent no 150666); a
method for treating curvature of the human spine (German patent no 150699); a method of
removing magnetised objects from the eye or another part of the body (German patent 155294),
and a method of Tran illuminating parts of the body using x-rays (German patent 156389).
40

In the 1904 case of Badewasser, however, the German Patent Office changed its attitude
towards patentability of medical inventions, stating that the treatment of humans was an area for
which patent protection had not been created by the legislature. The case established a
precedent for future cases, that an industrially applicable invention could only be assumed to
exist if raw material was mechanically or chemically treated or processed, as demonstrated in a
41
later decision of the federal Supreme Court of September 26, 1967
In this climate, the EPC was signed in Munich in 1973 and came into effect in 1978. Article 52(4)
expressly excludes "methods of medical treatment of the human or animal body by surgery or
therapy, and diagnostic methods practiced on the human or animal body" from patentability, as
42
being not "susceptible of industrial application. Shortly after signing the EPC, the member states
began adjusting their legal systems to accord with European uniform law, and article 52(4) was
largely adopted. The United Kingdom, Germany, and France-for example, included mirror
43
provisions, declaring such methods as not industrially applicable. Denmark, Italy, and Sweden
treat them as non-inventions, and Switzerland treats them as legal exceptions to patenting.

44

Badewasser (1904) BlfPNZ 4.

BGHZ 313, (1968) GRUR 142.

Article 52(4) of the European Patent Convention. Munich: 1973

42

Patents Act 1977 (UK). London: HMSO, 1977, S 25; Patent Law (December 16, 1980, as last amended by the laws
of July 16 and August 6, 1998): S 5(2). Available at http://clea.wipo.intlclea/lpext.dll?f=templates&.fn=mainh.htm&2. 0; (Last visited on 09/09/2007.)

Available at http://clea. wipo. int/clea/lpext.dll?f=templates&fn-11'i"ain-htm&2. O. ( Last visited on 06/04/2008).

19

VII -DEPARTURE FROM THE EXCLUSION

There are some jurisdictions in which methods of treatment of the human body are considered
as patentable. Like English patent law prior to the 1977 Patents Act (UK), Australian patent law
does not expressly prohibit patenting of methods of medical treatment and the issue has been
left to the courts to determine. Despite similarities in the law with the UK, however, and early
opposition to the patenting of methods of medical treatment by the Australian courts and Patent
Office, both have departed from this long established view and lean towards patentability of
such methods. Since the High Court decision in Joos v The Commissioner of Patents in 1972,
45
grants of patent have been available for methods of medical treatment.
46

The Supreme Court of Israel in Wellcome Foundation Ltd. V. Plantex Ltd., considered an
action for infringement of a patent relating to the use of a known chemical substance in the
treatment of gout. The question arose as to whether the discovery of novel properties in a
known substance enabling it to be used for new and therapeutic purpose warranted the granting
of a patent at all. Whitkon, J. held that it did. He believed that injustice would not be done to the
recent developments in the world as regards the policy in respect of the grant of patents Of the
prohibition by which no patents are granted on methods of therapeutic treatment of the human
47
body is not abolished outright.
The U.S Position
35 U.S.C. Sec. 101 defines patentable subject-matter as including "any new or useful process,
machine, manufacture, or composition of matter, or any new and useful improvement thereof'
involving "the hand of man".
Although product patents for medical devices and drugs are common, the U.S. Patent and
Trademark Office only rarely granted patents for medical and surgical procedures before 1954.
Since then, the agency has awarded only a limited number. But as of July 1996 newly issued
medical process patents will no longer be enforceable against medical professionals who infringe

(1972) 126 CLR 611.

1974 RPC 514

st

Elizabeth Yerkey, Law of Patents, 1 ed., 2005, Pg.176.

20

48

while performing a medical or surgical procedure. This law makes new medical process patents
virtually worthless in the United States. However, in the United States there are still numerous
medical process patents which were issued prior to 1996 and which are still enforceable.

48

World Medical Association Statement on Medical Process Patents Adopted by the 51st World Medical Assembly
Tel Aviv, Israel, October 1999.

21

VIII -THE CASE FOR PATENTABILITY OF MEDICAL TREATMENT

The patentability of methods of treatment or diagnosis is one of great sensitivity and indeed
controversial. The law around the world permits the granting of patents for drugs and medical
devices. At the same time, patentability for a method of treatment of the same body is denied in
some countries on various public policy grounds. Is there any logical justification for this
distinction? Are methods of medical treatment not as vital to the health or even to the life of a
patient as drugs or medical devices? Are patents of methods of medical treatment "generally
inconvenient" or contrary to the ordre public and morality? In order to answer these questions it
is necessary to focus on the public policy considerations and the impact of the patents of
medical treatment on the medical profession and the society as a whole.
Dessimation of Information
One concern is that medical method patents may restrict dissemination of information. Since a
patent takes several years to issue, the publication of details of the invention is delayed. The
free flow of information through publication in medical journals, textbooks, and seminars is the
49
accepted form of dissemination, but inventors have to be careful not to disclose their
inventions prior to filing patents, because this will jeopardize the requirement of "novelty".
Advocates of medical method patents may challenge this position insisting that although it is well
known that the progress of medicine depends on the dissemination of ideas, it is not always
recognized, however, that one of the important features of patent law is that it actually facilitates
dissemination of information. Inventors share their ideas in return for the grant of patents. Patent
law is designed to reward the inventor, not merely for inventing something, but also for disclosing
the invention to society. Therefore, patent law around the world requires the inventor to fully
describe the invention and explain the best method of making and using it in such full, clear, and
succinct terms as to enable any person skilled in the art to use it. In Australia-for example, this
50
requirement is expressed in section 40 of the (Patents Act 1990, ). The patent specification can be
treated as a recipe or formula to copy a patented method. Medical journals, on the other hand, do not
have such strict requirements to provide a clear and succinct recipe for a discovered method.
Moreover, delays associated with the submission, review, and publication
49

Yang W, Patent policy and medical procedure patents: the case for statutory exclusion from Patentability,
BUJSCI & Tech L 1995, pp.1-29.

22

of articles may not be significantly different from the delay in publication of patents. Patent
51
Convention Treaty applications are required to be published 18 months after filing, and in
52

some countries inventors are required to publish immediately after filing.

But there is no a priori reason to believe that those holding medical process patents would make
patented medical procedures widely available. Patentees might attempt to maximize their
profits by making the procedure widely available through nonexclusive licensing with low fees.
Alternatively, they might attempt to maximize profits by limiting availability of the procedure
and charging higher prices to those for whom the procedure is extremely important and who
have the means to pay. Competition between organizations providing health care could provide
incentives for some organizations to negotiate exclusive licenses, or licenses which sharply
limit who else could practice the procedure. Such a license might provide the organization with
an advantage in attracting patients, if the organization could advertise that it was the only
organization in a region which could provide a particularly desirable service. Thus, at least
some of the time patentees will probably limit access to patented medical procedures.
Conflict of Interest
Another fear is the possibility of conflict of interest. This is based on the argument that if
physicians have paid license fees (licensed physicians) to enable them to use a patented method
this may affect their discretion when choosing the correct treatment. It has been argued that it
would be in the physician's financial interest to recommend the method that he/she is licensed
to perform (the licensed method) over others in order to recoup the costs of
53
licensing. Alternatively, an unlicensed physician may avoid supplying a patient with the best
54
available method in order to avoid license fees.
Harm to Physician-Patent Relationship
Another argument involves a patient's expectation of privacy in his/her relationship with a
physician. Enforcement of medical process patents can also result in invasion of patients' privacy
Patents Act 1990 (Cth). Canberra: Australian Government Publishing Service, 1991, Ss 65 and 67.
Article 21(2) (a) of the Patent Convention Treaty (PCT) Washington, 1970.
Article 52(4) of the European Patent Convention. Munich: 1973.
McCoy T, Biomedical process patents, J Leg Med 1992; 13:501-19. [Medline].
Meier B, The new patent infringement liability exception for medical procedures. J Legis 1997; 23:265-7.

23

or in the undermining of physicians' ethical obligation to maintain the confidentiality of

patients' medical information. The concern is that an infringement lawsuit may invade a
55
patient's right to privacy, as a patentee may be entitled to access medical records. Where
physicians practice in small groups or as sole practitioners, the most expedient methods for a
patentee to identify instances of infringement might be to look through patients' medical records
or to interview patients. Removing obvious identifiers for the record review would not
guarantee confidentiality, because identity can often be "reconstructed" with very few pieces of
information. This would be particularly true in small towns or small practices.
Increasing Health care cost
Another fear of opponents of medical methods patents is that they will drive up the already high
56
cost of health care. If medical process patents are obtained,
The cost of medical practice would likely increase because of licensing and royalty fees, and
because the cost of physicians' insurance would likely increase to cover patent litigation
expenses.
Some physicians capable of performing the patented procedure might not obtain licenses to
perform it. The number of licensed physicians might be restricted because certain physicians
cannot or will not pay the licensing fees or royalties, or because the patentee refuses to make
the license widely available. Limiting the number of licenses would, in some circumstances,
limit patients' choice of physicians.
Thus, if medical process patents are obtained, then patients' access to necessary medical
treatments might diminish and thereby undermine the quality of medical care.
Reluctance to perform a Patented Method for fear of Infringement
One of the most significant concerns is the fear of infringement, particularly related to emergency
procedures. The presence of patents may prevent physicians from undertaking even those
procedures which do not infringe. Devices can be labelled if they are patented, but procedures
cannot, and therefore it is not immediately obvious whether what one is doing infringes somebody
else's medical process patent. Lack of knowledge is no defense against patent
Garris J, The case for patenting medical procedures, Am JL and Med 1996; 22:85-93.
Gocyk-Farber B, Patenting medical procedures: a search for a compromise between ethics and Economic,
Cardozo Law Rev 1997; 18, pp1527-46.

24

infringement. Thus, if a physician is uncertain he or she may simply refrain from performing
the procedure.
Ethical Obligations

57

Physicians have ethical obligations both to teach skills and techniques to their colleagues, and
to continuously learn and update their own skills. The training of new physicians and
continuing medical education for practicing physicians are based on the free sharing and
passing on of knowledge, methods, and procedures. Medical process patents can undermine
these obligations. In addition, the enforcement of Medical Procedure Patents is a strong
disincentive for physicians to share the results of their professional experiences and/or
independent discoveries of similar existing methods with their colleagues, since this sharing
may identify themselves for a potential target for infringement suits. Thus, the granting of
Medical Procedure Patents undermines the process of peer review, evaluation, and critical
appraisal of medical innovation within the medical profession.
The advocates of medical method patents may explain that once a patent has issued on a
process, the process would be fully disclosed (this is one requirement for obtaining a patent);
However, those without licenses would not be able to practice it. Limiting who can practice the
procedure undermines the spirit of the ethical mandate to teach and disseminate knowledge. It
also undermines the obligation to update one's skills, because it does not do much good to
acquire skills which cannot be used legally.
The obligation to teach and impart skills may also be impaired if the possibility of patents
causes physicians to delay publishing new results or presenting them at conferences.
Physicians may be inclined to keep new techniques secret while waiting to complete a patent
application. This is because public use of a procedure or publication of a description of the
procedure, prior to applying for a patent may invalidate the application. Since it is in the patent
holder's interest to keep an "invention" a secret until the patent is granted, Medical Procedure
Patents actually discourage doctors from sharing medical information openly.

57

25

Position Statement -Medical and Surgical Procedure Patents

It is possible for the medical community to reach an untenable situation, where all medical
schools, and all medical and surgical societies or other entities providing medical education
would be prohibited from teaching certain procedures or would have to pay a licensing fee to
the inventor before teaching a course that includes the patented method. The cost of medical
education also will increase if medical schools are required to pay royalties to patent holders to
teach patented surgical and medical techniques. This serves as an additional disincentive to
utilize Medical Procedure Patents.
In sum, Medical Procedure Patents impede the advancement of medicine, impede medical
technology, curtail academic access, compromise peer review, place unreasonable limits on the
research community, directly interfere with the education of new physicians, and interfere with
the quality of medical care provided to the patient. Under these circumstances, the patenting or
protection of "pure" medical procedures or techniques is unethical. This position is also
consistent with the American Medical Association Report of the Council on Ethical and Judicial
Affairs on the Patenting of Medical Procedures.
Physicians also have an ethical obligation not to permit profit motives to influence their free
58
and independent medical judgment. For physicians to pursue, obtain, or enforce medical
process patents could violate this requirement. Physicians holding patents or licenses for
procedures might advocate for the use of those procedures even when they are not indicated, or
not the best procedure under the circumstances. Physicians who are not licensed to perform a
particular procedure might advocate against that procedure, even when it is the best procedure
under the circumstances.
Legality of the issue of medical method Patents.
No medical method or procedure is really "new" or innovative. Instead, every advancement in
medicine and in medical methods or procedures builds on existing knowledge. The consensus
in the medical community is that no medical process is really new. Every method innovation is
largely based on "prior art." Also, there is the real possibility of expensive litigation over
whether a Medical Procedure Patent should have been granted in the first place.
58

26

International Code of Medical Ethics, 17.A.

The consensus of the world community has been to ban these Medical Procedure Patents. More
than 80 countries throughout the world expressly prohibit Medical Procedure Patents, including
most European countries. The practice of excluding medical procedures from patentability is
consistent with the Uruguay Round of Amendments to the General Agreements on Tariffs and
Trade Agreement on Trade Related Aspects of International Property Rights (GATT-TRIPs),
which states: "Members may also exclude from patentability: (a) diagnostic, therapeutic and
surgical methods for the treatment of humans or animals" (Article 27). The granting of Medical
Procedure Patents poses a serious threat to medical advancement, medical education, and
patient care, as well as contributes to the spiraling costs of health care.
Professional Obligations
Physicians' professional obligations to practice their profession with conscience and dignity
(Declaration of Geneva) might be violated by the enforcement of medical process patents.
Lawsuits are rarely dignified or respectful enterprises, and the spectacle of physicians suing
59
each other on a regular basis is unlikely to enhance the standing of the profession.
Patents to encourage Investment in Research and Development
The advocates of medical method patents may insist that the purpose of patents is to encourage
private investment in research and development.
However, physicians, particularly those who work in research institutions, already have
incentives to innovate and improve their skills. These incentives include professional
reputation, professional advancement, and ethical and legal obligations to provide competent
60
medical care. Physicians are already paid for these activities, and public funding is sometimes
available for medical research. The argument that patents are necessary to spur invention of
medical procedures, and that without process patents there would be fewer beneficial medical
procedures for patients, is not particularly persuasive when these other incentives and financing
mechanisms are available.
World Medical Association Statement on Medical Process Patents Adopted by the 51st World Medical Assembly Tel
Aviv, Israel, October 1999.
International Code of Medical Ethics, 17.A.

27

Patents for product Development

Another argument of the advocates of medical method patents is that patents are necessary, not so
much for invention but for product development. This argument also is not persuasive in the case of
medical process patents. Unlike device development, this requires investment in engineers,
production processes, and factories, development of medical processes consists of physicians
attaining and perfecting manual and intellectual skills. As discussed above, physicians already have
both obligations to engage in these professional activities as well as rewards for doing so.

Patents are granted for medical Devices. Why not for Medical Procedures?
Whether or not it is ethical to patent medical devices does not bear directly on whether it is
ethical for physicians to patent medical procedures. Devices are manufactured and disseminated
by companies, whereas medical processes are "produced and disseminated" by physicians.
Physicians have ethical or legal obligations to patients and professional obligations towards
each other, which companies do not have. Having particular ethical obligations is part of what
defines medicine as a profession.

28

IX -CONCLUSION & SUGGESTIONS

In the final analysis, the cost to society of granting medical method patents outweighs the
benefits. Public policy considerations provide a sufficient basis to justify discrimination against
patenting of methods of medical treatment. Such inventions bring potential relief to numerous
sufferers, thus holding them to be available only to a few privileged would be contrary to the
ordre public and morality or "generally inconvenient". Methods of medical treatment or medical
procedures cannot be treated to be on the same plain as many other kinds of inventions such as
drugs, medical devices, and cosmetic treatment. Indeed, every argument raised for the patenting
of methods of medical treatment patents cannot be completely justified.
The granting of Medical Procedure Patents undermines the process of peer review, evaluation,
and critical appraisal of medical innovation within the medical profession, which in turn affects
the public good and, in particular, the quality of the community's health care. The patenting of
such treatment decreases the availability of health care and creates new obstacles different from
those already existing in the medical world.
The World Medical Association made up of and funded by voluntary national medical
associations which in turn represent over eight million doctors worldwide who are sworn to put
their patients' interest first, and to strive for the best possible health care for all, regardless of
race, creed, political allegiance or social standing, embracing a wide range of members with
their own diversity of languages, cultures and systems of health care delivery, but all sharing the
same ideals, and answerable to nobody save their patients, is also of the same view and as such
against the patenting of medical procedures.
The World Medical Association
States that the patenting of medical procedures poses serious risks to the effective practice of
medicine by potentially limiting the availability of new procedures to patients.
Considers that the patenting of medical procedures is unethical and contrary to the values of
professionalism that should guide physicians' service to their patients and relations with their
colleagues.

29

3. Encourages national medical associations to make every effort to protect physicians'

61
incentives to advance medical knowledge and develop new medical procedures.
I, personally, am of the opinion that no such patents ought to be granted unless every individual
in this world is capable of affording decent medical care.
Then what about the fame and recognition one deserves for the invention of new, useful medical
procedures? What about the reward and remuneration one deserves for such a novel act?

It is up to the respective governments and the community to grant reward and recognition to
such Persons. Perhaps a world body could be established to consider such matters and provide
the necessary remuneration and recognition one deserves. Or pubic funding, as suggested in the
earlier chapter, could be made available for such purposes. There are various other ways in
which this concern can be tackled, the patenting of medical methods being unnecessary and
unwarranted as it does not serve any useful purpose and ultimately hinders the progress of the
human kind in the right direction.
As was rightly stated by Indira Gandhi at the World Health Assembly in 1982:
"The idea of a better-ordered world is one in which medical discoveries will be free of patents
62
and there will be no profiteering from life and death".

World Medical Association Statement on Medical Process Patents-Position Adopted by the 51 st World Medical
Assembly Tel Aviv, Israel, October, 1999.
Jean Lanjow, "The Introduction of Pharmaceutical Product Patents in India: 'Heartless Exploitation of the Poor
and Suffering? Economic Growth Center, Yale University, August 26, 1997, Pg.123.

30

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33