ABSTRACT

In the era of globalisation when the scope of intellectual property is expanding worldwide,
the people all over the world need laws to distinguish as what is the patentable subject matter
and what are not. In several countries different procedures has been followed so as to draw a
line between as to what are the patentable subject matter and what are not. This is only
because of the laws prevailing in that country. There is a changing treatment of patentable
subject matter in all respects. At the end, we see that though they are different in character
but sometimes they show similarity as they are adopted in one way or another from the other
country. Though it’s a vast topic yet some aspect has been covered under it.

INTRODUCTION
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The task of having to decide the types of subject matter that ought to be patentable invariably
generates conflict and uncertainty. This is because patent law inevitably finds itself dealing
with technologies that it may not yet understood. It is also because the task of having to
decide whether to grant patent rights in a particular of invention raises a complex mix of
legal, cultural, political and social questions.

As the Patents Act 1977 and the EPC 2000 provides that inventions only need to be
susceptible or capable of industrial application, this implies that there is no need to show
actual use. It is enough to show that the invention has the potential to be used or made in
industry. Where a product has been used, the commercial success of the product is not
relevant when deciding industrial applicability1.

The invention should also have some useful purpose in relation to biological research. The
reason for this is that although researchers have been successful in locating and identifying
new gene structures, so far as they have been much less successful in ascertaining what many
of these genes do2. Unless a useful purpose has been found for these genes, they will not be
industrially applicable and, as such, not patentable.

In India the Patents are governed by the TRIPS Agreement. In Europe by the European Patent
Convention 1973. In U.K by the Patent Act, 1977.

TREATMENT OF DIFFERENT SUBJECT MATTER

1. METHODS OF MEDICAL AND VETERINARY TREATMENT

The methods of medical and veterinary treatment is excluded from patentable subject
matter for a reason to ensure that people who carry out medical or veterinary
treatments are not inhibited by patents. This criterion makes them free to take actions
which they consider suited to diagnose illness by means of investigative methods.

This subject matter is not patentable in Europe. Article 53(c) EPC 2000 provides that
‘a patent shall not be granted for methods of treatment of the human or animal body
by surgery or therapy, and diagnostic methods practised on the human or animal
body’.

1 Harvard/Onco-mouse[2003]OJ EPO 473, 494

2 T. Wilkie, Perilious Knowledge(1993)

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 It is also not patentable in UK. Section 4A of the Patents Act 1977 also excludes it
from the patentable subject matter.

The US law also denies patent owners the right to enforce patents covering medical
or surgical procedures that do not involve patented drugs or devices. These
procedures performed on human body, organ or the use of animal in medical research
is also not patentable.

(a) Surgery: The branch of medicine which heals diseases, accidental injury or bodily
defects by operating on the living body is defined as surgery. It includes both
conservative as well as operative methods. The Enlarged Board of Appeal said
that surgery ‘includes ant physical intervention on the human body in which
maintaining life and health of the subject is of paramount importance’3. In the
General Hospital decision the Technical Board of Appeal said that surgical
treatment aims at protecting curative activities.4.It was held that surgical
treatments which were ‘neither clearly suitable nor potentially suitable for
maintaining or restoring the health, the physical integrity, or the physical well
being of human beings or animals’ did not fall with the exclusion in Article 52(4)
EPC 19735. It was also said that tattooing and piercing, whose only object is to
beautify the animal or human body, does not come under the category of Art
53(c).
(b) Therapy: It has been defined as the curing of a disease or the malfunction of the
human or animal body. Prophylactic treatments are included in it. The methods of
treatment that prevented pregnancies and removed lice were not caught by the
exclusion6. Therapeutic methods are often considered as cosmetic methods. A
method that lead to weight loss for the purpose of curing obesity would fall within
the exclusion7, in contrast, a method for weight loss that is undertaken for
cosmetic purposes would not and as such might be patentable8.

3 Diagnostic Methods, G01/04(2006) OJ EPO 334, 352(EBA)

4 General Hospital Corp/Hair Removal method T383/03(2005) OJ EPO 159, 165

5 Ibid, 166

6 Salimen/Pigs III. T58/87(1989)EPOR 125

7 ICI/Claening plaque T290/86[1999] EPQR 157

8 Du Pont/Appetite suppressant T144/83[1987] OJ EPO 301

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 (c) Diagnostic Methods: Despite the language of EPC 2000 and the 1977 Act, many
diagnostic methods will no longer be caught by the exclusion. It means that
common procedures such as percussion or palpitation on the human body could be
patented because they do not constitute a complete diagnosis.
(d) Treatment on or in the body: this method only applies to methods of treatment that
are practised in9 or on10 the human or animal body. It does not apply to methods
practised on substances that are removed from the body11. The treatment of blood
for storage in a blood bank or testing of blood samples is not excluded. Whereas a
treatment of blood by dialysis, where the blood is returned to the same body
would be excluded12. The Technical Board of Appeal held that ‘a method and
apparatus for preventing piglets from suffocating’ by blowing hot air under a
mother pig to discourage piglets from going under her was patentable. While the
invention protected the body, it was still patentable because the method was not
practised on the body of piglet13.

1. BUSSINESS METHODS

The approach that has been adopted by UK can be seen in Merrill Lynch’s Application
where the Court of Appeal held that an autocratic share-trading system operated by a
computer program was unpatentable because it merely amounted to a method of doing
business. This has been confirmed by a UK Patent Office Practice Notice and in a number of
subsequent decisions14.

A similar approach had been followed at the EPO. In Petterson/Queuing system15,

which concerned a patent for a system for handling customers’ queing at a number of
service points? The patent consisted of a turn-number allocating unit, an information
unit, a selection unit, and a computer program that decided which particular turn
number was to be served at a particular service point. While the patent was not
9 Salimen/Pigs III, T58/87[1989]EPOR 125

10 Siemen/ Flow meseaurment [1989] EPOR 241

11 EPO Guidelines C-4

12 EPO Guidelines, C-4, 4.8

13 Salimen/Pigs III, T58/87[1989]

14 [1989] RPC 561

15 T1002/92[1995]OJ EPO 605

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 accepted in Sweden, the Board of Appeal at the EPO held that the claimed apparatus
was clearly technical in character and thus patentable.16The Court of Appeal in
Aerotel said that business-method exclusion was limited to abstract ideas. There was
no need for an activity to be completed-for the cash registers to ring-for it fall within
the exclusion17.
The US Court of Appeal for the Federal Circuit in the case of State Street Bank &
Trust Co.v. Signature Financial Group Inc. , which involved a patent relating to a
huband-spoke system for monitoring and calculating financial information, enabling
several mutual funds to pool their funds into a single investment portfolio held that a
patent application relating to the transformation of data, representing discrete dollar
amounts, by a machine, through a series of mathematical calculations into a final
price, constitutes a practical application of a mathematical algorithm, formula or
calculation, and is thus patentable subject matter. It further said that certain types of
mathematical subject matter which represents nothing more than abstract ideas until
reduced to some sort of practical application,i.e. ‘a useful, concrete and tangible
result’. Thus a mathematical formula to a known method or process may as well
deserve to be patent protection.
2. PRESENTATION OF INFORMATION
In Broselow/Measuring tape18 x, where the invention was for a method of
ascertaining information about accident victims. It involved an ambulance officer
measuring the body length of the victim using a particular tape, which provided
information about how the patient was to be treated. The board of appeal held that
‘co-relation between the measured length and the information on the tape measure
results in the tape becoming a new gauge for directly measuring the patient treatment
values’. Such a gauge is clearly technical in nature. The Board added that ‘the subject
matter as a whole of a claim consisting of a mix of known technical elements and
non-technical elements is not excluded from patentability under Article 52(2) and (3)
when the non-technical elements interact with the known technical elements in order
to produce a technical effect’.
3. ANIMAL VARIETIES

16 T769/92[1992]EPOR 253, 258

17 Aerotel v. Telco Holdings [2007] 1 All ER 225, para 67-71

18 T77/92[1998] EPOR 266, 270

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 In the Harvard/Onco-mouse decisions19 related to a genetically modified non-human
mammal which had been modified so that it would be susceptible to cancer. The
resulting products were used in cancer research. The examining division held that the
invention was for an unpatentable animal variety20. The board of Appeal said that
Article 53(b) did not exclude animals in general. The Examining division said that
while the terms of the convention were not consistent it was not necessary to decide
the authoritative meaning for the convention.21 The claims in question related to non-
human mammals, a category that was neither a species nor a subunit of a species.
Consequently, the subject matter did not relate to an animal variety and as such was
not excluded by Article 53(b).
In 1988, the USPTO issued the first transgenic animal patent on this Harvard mouse
case. By nom several hundred transgenic or bioengineered animal patent have been
granted. These include mice, rats, rabbits, sheep, etc.
Under Section 3(j) of the Indian Patent Act, plants and animals in which or in any part
thereof other than microorganism but including seeds, varieties and species and
essentially biological process for production or propagation of plants and animals are
not patentable.
4. PLANT VARIETIES
Article 53(b) of the EPC 2000 and Section 1(3)(b) of the Patents Act, 1977 exclude
the patentability of plant varieties. Article 4(1) of the Biotechnology Directive
confirms that plant varieties are not patentable.
In India the protection of plant varieties is given under sui generis system22.
The EPC grant the following patents in plant varieties:
(a) Ciba Geigy propagating material, a claim to seed of any kind dressed with a
defined chemical in order to make it resistant to certain weed killers23.
(b) Lubrizal/hybrid plants; a claim to hybrid produce in accordance with a staged
sequence of selection of parent plants and then of crossing-testing, evaluation and
further multiplication.

19 [2003] OJ EPO 473, 499

20 Ibid, T19/90[1990] EPOR 4

21 EPC Art. 177(1)

22 Protection of Plant varieties and Farmers Right Act 1999

23 T49/83[1979-85] C EPOR 758

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 (c) Harvard/oncomouse: a claim to a mouse or other non human animal genetically
manipulated so as to insert an activated oncogene which could then be used in
cancer research
1. MICROBIOLOGICAL OR TECHNICAL PROCESSES
A microbiological process is defined as ‘any process involving or performed upon or
resulting in microbiological material’24. If an invention is for a microbiological or
technical process, it will not come under the exclusion of paragraph 3(f) of schedule
A2 to the Patents Act 1977. .
In Plant Genetic Systems x the Board of Appeal suggested that a plant variety that
was a product of a microbiological process would not have been caught by the
exclusion and thus would have been patentable.
This approach was rejected in Novartis25 when the Enlarged Board of Appeal said that
the plant variety exclusion applied irrespective of how the plant varieties were
produced. The mere fact that a plant variety was obtained by means of genetic
engineering does not give the producers of such plant varieties a privileged position26.
2. DNA AND GENE SEQUENCE
A DNA sequence which is without any indication of function and which does not
include any technical information is therefore not a patentable invention.27
Similarly, the Biotechnology Directive ant the Patents Act, 1977 in relation to gene
sequencing clearly specify that the industrial application of a sequenced or a partial
sequence of a gene must be disclosed in the application.28 Where a full or partial
sequence of a gene is used to produce a protein or part of a protein, the subject matter
will only satisfy the requirement of industrial applicability if the application specifies
which protein is produced or the function that it performs29.
In Icos Corporation the Opposition Division at the EPO denied patent protection for a
purified and isolated polynucleotide encoding for the amino acid sequence of the V28

24 Art.2(2) EPC Rule 23b(6)

25 G1/98[2000] EPOR 303,319(EBA)

26 G1/98[2000] EPOR 303,319(EBA)

27 Biotech. Recital 23

28 Ibid, Art.5(3)

29 Chiron v. Murex(No.12)[1996] FSR 153, 177

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 protein30. The Opposition Division said that it was not enough for the application to
disclosure uses that were merely speculative.31 It also added that ‘DNA sequences
with indications of function which are not substantial, specific, and credible shall not
be patentable inventions according to Article 52(1) EPC32.On this basis, it was said
that the application lacked industrial applicability and, as such, was not patentable.
3. CHEMICAL COMPOUNDS
A number of countries grant patents for the chemical compounds per se. Germany,
Japan, Netherland, Switzerland recognised such patents in the decade 1968-78.
Scandivian countries such as Austria, Spain, and Greece also did the same. There are
countries which still allow only process patents for production of chemical
compounds and not product patents. India also recognises patent in chemical
compounds. Majority of the applications filed in India originate from foreign
countries like USA, Germany, Japan, UK, France, Belgium, Denmark, etc.
4. PHARMACEUTICAL INVENTIONS
Pharmaceutical policy is a type of policy of health with the development and
medication of health care system. Novel compounds which have pharmaceutical
significance are patentable per se. The chemical compounds having pharmaceutical
application and therefore being patentable fall in the categories of-
(a) Prodrug and active metabolites
(b) Natural product such as antibiotics, isolated hormones, cytokines
(c) Combination preparations
(d) Drug delivery system
The essential qualification of novelty, utility, improvement, new result applies to
the above inventions. A recent decision by the United States Court of Appeal for
the Federal Circuit in Pfizer v. Apotex33 , held invalid a patent on the
“pharmaceutical Salt” formulation of a previously patent active ingredient.
In the USA a patent was granted for pure adrenalin isolated from adrenal gland
tissues, the pure adrenalin was medically useful while the crude gland extract was
not.
1. IMPROVEMENTS
30 [2002] OJ EPO 293 307

31 Recital 23

32 [2002] OJ EPO 293, 307

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 The definition of invention under the U.K. Patents Act does not include improvements
expressly; improvements have been recognised as patentable invention.
In Kynock & Coy. v. Webb,34 Lord Halsbury observed: “It is true that any machine
protected by a patent is susceptible of improvements, and as such improvement, if in
other respects conforming to the Patent Law, may be protected themselves, but they
can only be made use of by the license of the proprietor who is in command of the
master patent.”
In Lynotype & Machinery Ltd. V Hopkins35, Lord Loreburn, stated: “I think that any
part does constitute an improvement if it can be adapted to this machine and it would
make it cheaper and more effective and in any way easier or more useful and valuable
or in any other way make it a preferable article in commerce.”
2. BIO-TECHNOLOGY AND BIO-DIVERSITY
In 1873, a Patent was granted to Louis Pasteur for “yeast free from organic germs of
diseases, as an article of manufacture”.
In 1930 the United States Plant Patent Act was passed which provided protection to
“any person who has invented or discovered and asexually reproduced any distinct
and new variety of plant, other than a tuber-propagated plant.”
International efforts at securing protection of plant varieties resulted in the
International Convention for the Protection of New Varieties of Plant in the year
1961.
Agracetues an American company a subsidiary of WR Grace was granted Patent in
1992 and 1994 respectively in transgenic cotton and soya bean. The company was
granted a patent in India in violation of the Indian Patent Act which expressly
prohibits patents on life forms and agricultural biotechnologies. The patent was
subsequently revoked when this generated widespread opposition.
In the year 1972 microbiologist Ananda Chakrabarty applied for a patent in United
States for a genetically engineered bacterial strain which was capable of degrading
crude oil spills. The new micro-organism did not exist in the nature before. The patent
was claimed not only for the process of producing this bacterium but also for the
bacterium itself. The claim for the patent rejected twice, finally the US Supreme
Court ruled that the invention was entitled to a grant of patent.

34 (1900) 17 RPC 100 at 107

35 (1910) 27 RPC 109 at 113

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 The United States Department of Commerce applied for a patent on human cell line of
a woman from the Guaymi Indian Tribe of Panama, South America. The cell line
developed from her blood was found to be useful in research on AIDS and cancer.
The United States Government was forced to withdraw the patent application when it
attracted international criticism.
3. SOFTWARE-RELATED INVENTION
Software related inventions have been mostly protected by copyright the world over.
The availability of copyright protection for software is mandated by Article 10.1 of
the TRIPS Agreement. Patent protection if available would superior to copyright since
it would recognise broader protection for the basic concepts of the program and would
also protect against independent development.
Computer programs, mathematical method and many of the applications to which
they are put are considered unpatentable. The Fujitsu’s Application case36 is an
important precedent in this respect. The invention was a computer-based method of
modelling crystal structure, in particular of combining two known structures so as to
display the structure of a hypothetical combined product. The application for patent
was refused by the Patent Office and the same was appealed unsuccessfully to the
Patents Court.
In Gottschalk v. Benson37 , the inventor claimed a method for converting binary-
coded decimal numerals into pure numerals for use with a general-purpose digital
computer. The Supreme Court held that the invention was no more than a abstract
mathematical formula. The invention did not qualify as a process because it did not
result in the transformation or the reduction of anything ‘to different state or thing’. It
held that a mathematical algorithm itself is not patentable, but added it may be that the
patent law should be extended to cover computer programs.
In Parker v. Flook38 the Supreme Court once again rejected patent protection for
software, this time claimed as a ‘method for updating alarm limits’ in a chemical
process. The Court determined that while a process may be patentable even though it
contained a law of nature or a mathematical algorithm, ‘the process itself, not merely
the mathematical algorithm, must be new and useful’. Here the inventor had
discovered only the mathematical algorithm, not the process.

36

37 409 US 63, 1972

38 437 US584, 596, 1978

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 In 1981, in Diamond v. Diehr39 , the US Supreme Court finally opened the way for
patents on software systems when it ordered the USPTO to grant a patent on an
invention that utilised computer software. The invention was related to a method for
curing rubber. It utilized a computer to calculate and control the heating times for the
rubber. The Supreme Court held the invention was patentable because it was a process
for moulding rubber and merely a mathematical algorithm, even though the only
novel feature for this invention was the timing process controlled by the computer.
USA has adopted a liberal approach to the matter. Softwares which demonstrably
control and configure some computer hardware are patentable regardless whether they
include mathematical algorithms. Patent protection is available databases in
combination with some form of computer readable memory.
In India there has neither been any statuary enactment on software related inventions
nor there has been litigation which could set up a binding precedent, in the present
sate it is copyright protection which covers related inventions.
4. DISCOVERIES
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 is not an
invention within the meaning of the Patent Act, 197040.
In Reynolds v. Herbert Smith & Co. Ltd41, Buckley, J. Stated: “The difference
between discovery and invention is very familiar. Discovery adds to the amount of
human knowledge, but it does so only by lifting the veil and disclosing something
which before had unseen or dimly seen. Invention also adds to human knowledge, but
not merely by disclosing something. Invention necessarily involves also the
suggestion of an act to be done, and it must be an act which results in a new product,
or a new process, or a new combination for producing an old product or an old result.”

CONCLUSION
Hence, we can see that in different countries different methods have been adopted
regarding patent protection of different subject matter. There is no uniformity in the
sense that if in one country a particular patent is granted in other it will not be granted.
So, there has to be some similarity so as to make it less ambiguous and more versatile.

39 450 US 175, 1981

40 Section 3(c) of the Patent Act.

41 (1903)20 RPC 123 at 126

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