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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 cases01Table of statutes02Introduction03Research Methodology04Origin of Patents and its History in India06An Overview of Indias Patent Policy in relation to TRIPS08Patentable Subject-matter; the prevailing policies13Medical Procedures: Meaning and an Introduction on their patentability15The Development of the Exclusion of medical procedures17Departure from the Exclusion20The case for Patentability of Medical treatment22Conclusion and Suggestions29Bibliography31

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

1TABLE OF STATUTES

UK Patents Act,1977

Australia Patents Act,1990

The Patents Act, 1970

2I. 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 the invention to the public1. 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 treatment, physicians must always be free in their choice of treatment2. 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 policy grounds".3 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.

3Research 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 Aspects of Intellectual Property Rights 19954, or "generally inconvenient" (from section six of the Imperial Statute of Monopolies 16235) 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).

4University, Bangalore and e-resources have played a crucial role to bring out specialist material of the dissertation.

5II -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 third century AD by Athenaeus in the Banquet of the Learned6 and the first letters of patent were granted in 1440 to John of Shiedame who introduced a method of manufacturing salt on a scale never before attempted in England (Bristol Myers Squibb Co v F H Faulding Co Ltd7). 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 raising prices of commodities at home, or hurt of trade, or generally inconvenient"8. 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 been described as "the touchstone of patentability9 and still is in force today in Australia, New Zealand, and Israel (Patents Act 1990 (Cth),10S 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

8English 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.

6in 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.

7III-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 and there will be no profiteering from life and death11.

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 thereof to the largest section of the public.12 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.

12Government of India, Ministry of Industry and Supply, Patent Enquiry Committee, Interim Report, August 1949.

8reports concluded that foreigners held 80-90% of the patents in India and were exploiting the system to achieve monopolistic control of the market13.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.

9An 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.

10Licensing 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 protects intellectual property."14 Industrialised nations conceive of patents as a fundamental right comparable to the right of physical property, whereas developing nations view it as "fundamentally as an economic policy question."15 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.

11promote economic development.16The following table illustrates the basic differences between India's patent system and TRIPS:

COMPARISON OF INDIA'S PATENT ACT AND TRIPS17

The Indian Patents Act, 1970TRIPSOnly process not product patents in food,Process and product patents in almost all fieldsmedicines, chemicals.of technology

Term of patents 14 years; 5-7 in case ofTerm of patents 20 yearschemicals, drugs

Compulsory licensing and license of rightLimited compulsory licensing; no license of

right

Government allowed to use patented inventionVery limited scope for governments to useto prevent scarcitypatented 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 pharmaceutical industry.18

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.

12IV -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 is patent eligible if it satisfies the requirement of a patentable invention.19 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 shall not be regarded as inventions. The exclusions on this list are either abstract or technical21.

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];

13The 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 reviewed four years after the date of entry into force of the WTO Agreement.22

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.

14V-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 the skin or body orifice by any means.23

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 drug.24 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 disease.25 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

15pitted 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.

16VI -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 and throughout the ages27.

The United Kingdom

Methods of medical treatment have long been excluded from patenting in the UK. The exclusion can be traced back to the 1914 case of In the Matter of C & W's Application for a Patent28.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 any form of manufacture or of trade, thus lacking commercial value.29

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 product",30 a product that can be sold.In Eli Lilly & Company's Application31 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 such a decision was the earlier decision in Schering's Application in 1971.32

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.

17It 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 patent system.33 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 4(2) of the new legislation34. The report also played a significant role in the development of the exclusion of medical treatment patents.35

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 medical treatment as the courts in the United Kingdom, the general practice was similar.36 A grant for patent protection in France and Italy, for example, would be denied if the alleged invention were lacking in industrial character (Whitford J in Schering's Application37). In Austria38 and Switzerland39 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.

18In 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).

In the 1904 case of Badewasser,40 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 later decision of the federal Supreme Court of September 26, 196741

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 being not "susceptible of industrial application.42 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 provisions, declaring such methods as not industrially applicable.43 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.

42Article 52(4) of the European Patent Convention. Munich: 1973

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=main-h.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).

19VII -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, grants of patent have been available for methods of medical treatment.45

The Supreme Court of Israel in Wellcome Foundation Ltd. V. Plantex Ltd., 46considered 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 body is not abolished outright.47

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

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

20while performing a medical or surgical procedure.48 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.

21VIII -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 accepted form of dissemination, 49but 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 requirement is expressed in section 40 of the (Patents Act 1990,50). 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.

22of articles may not be significantly different from the delay in publication of patents. Patent Convention Treaty applications are required to be published 18 months after filing,51 and in some countries inventors are required to publish immediately after filing.52But 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 licensing.53Alternatively, an unlicensed physician may avoid supplying a patient with the best available method in order to avoid license fees.54

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.

23or 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 patient's right to privacy, as a patentee may be entitled to access medical records.55 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 cost of health care.56 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.

24infringement. Thus, if a physician is uncertain he or she may simply refrain from performing the procedure.

Ethical Obligations57

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 Position Statement -Medical and Surgical Procedure Patents

25

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 and independent medical judgment.58 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 International Code of Medical Ethics, 17.A.

26

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 each other on a regular basis is unlikely to enhance the standing of the profession.59

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 medical care.60 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.

28IX -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.

293. Encourages national medical associations to make every effort to protect physicians' incentives to advance medical knowledge and develop new medical procedures.61

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 and there will be no profiteering from life and death".62

World Medical Association Statement on Medical Process Patents-Position Adopted by the 51st 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

BIBLIOGRAPHY

BOOKS

Dr. Elizabeth Verkey, Law of Patents, 1st ed., 2005, Eastern Book Company.

Dr. Raghbir Singh, Law Relating to IPR, 1st ed., 2004, Universal Law Publications.

Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries, Oxford University Press. John Rawls, A Theory of Justice. Cambridge: Harvard University Press, 1971.

Lionel Bentley and Spyros Maniatis, Intellectual Property and Ethics, 1998 ED., Sweet and Maxwell Publications. NB. Zaveri, Patents for the Future, pt ed., 2001. Vakils, Feffer and Simons Limited

Nuno Pires de Carvalho, The TRIPS Regime of Patent Rights, 1st ed., Kluwer Law International Publications. P. Narayanan, Patent Law, 3rd ed., 2005, Eastern Law House.

Philip Cullet, IPR and Sustainable Development, 2005 Edn, Butterworths Publications.

S.K. Verma and Raman Mittal, Intellectual Property Rights-A Global Vision, 2004 ed., ILI Publications. Sheila, McLean, Genetics and Gene Therapy, Ashgate Publications.

ARTICLES

O Mitnovetskil and D Nicol, Are patents for methods of medical treatment contrary to the ordre public and morality or "generally inconvenient"?

Chris J Katopis , Patients v. patents? Policy implications of recent patent legislation By St. John's Law Review, spring 1997. Susan Leach DeBlasio, Patents on Medical Procedures and The Physician Profiteer,Tillinghast Licht Perkins Smith & Cohen, LLP .

Elizabeth Verkey, Patenting of medical methods-need of the hour.

Position Statement -Medical and Surgical Procedure Patents.

Gerald J. Mossinghoff, Remedies Under Patents on Medical and Surgical Procedures.

WEB RESOURCES

31

http://www.aaos.org/about/papers/position!1131.asp

http://clea.wipo.int/clea/lpext.dll?f=templates&fn=main-h.htm&2. 0

http://www.ipmall.info/hosted Jesorces/lipa/patents/English _Statute 1623.pdf

http://www.liebertonline.com/doi/abs/10.1089/ten.1996.2.235

http://www.oblon.com/Pub/mossinghoff-120.html

http://www.phrma. org/issues/intl/india. html

http://www.wma.net/e/policy/p29.htm

MISCELLANEOUS

Agreement on Trade Related Aspects of Intellectual Property Rights Act. 1995 (TRIPS). London: The Stationery Office, 1995, articles 27 and 33. Athenaeus. Banquet of the learned. London: Henry G Bohn, 1854.

Banks committee report). London: HMSO, 1970 (Cmnd 4407, paras 237-40

European Patent Convention. Munich: 1973: article 52(4).Government of India

(1949).

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 economics. Cardozo Law Rev 1997; 18:1527-46. [Medline] Government of India, Ministry of Industry and Supply, Patent Enquiry Committee, Interim Report, August 1949.

Industrial Property Advisory Committee. Patents, innovation, and competition in Australia. Canberra: Patent Office, 1994, 39-41 at 41.

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, p. 1 Loughlan P. Of patents and patients: new monopolies in medical methods. AIPJ 1995;5:1-15,.

Moufang R. Methods of medical treatment under patent law. IIC 1993;24:18-26

Patents Act 1977 (UK). London: HMSO, 1977, S 25.

Patents Act 1990 (Cth). Canberra: Australian Government Publishing Service, 1991, Ss 65 and 67

Patent Issue, Ban on Medical Use Patents in Works -Tissue Engineering, Vol. 2, No. 3, 1996, Mary Ann Liebert, Inc.

32Pila J. Methods of medical treatment within Australian and United Kingdom patents law. Univ NSW Law J 2001;24:420-61. Rukmini Parthasarthy, "The CEO's Guide to The New Patents Regime "Business Today (Bombay), September 22, 1998, p. 58

R. Gadbow and Richards, eds., Intellectual Property Rights: Global Consensus, Global Conflict?, (Boulder, 1988), p. 2

Terence P. Stewart, ed, The GATT Uruguay Round: A Negotiating History 19861992,

vol. 2 Commentary (Netherlands, 1993), p. 2255

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

33