1

TABLE OF CONTENTS

INTRODUCTION.............................................. ................... 03

MEANING OF PATENT......................... ...............................03

ESSENTIALS OF PATENT....................................................03-10

WHAT ARE NOT INVENTIONS...........................................10-15

CAN PATENT BE GRANTED FOR DISCOVERY OF

IDEAS?.......................................................................................15-16

PATENTING OF BIOTECHNOLOGICAL
INVENTIONS........... ............................................................16-17

CONCLUSION.............. ..............................................................17

BIBLIOGRAPHY..........................................................................17

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Introduction
Patent is a monopoly right conferred by Patent Office on an inventor to exploit his invention
subject to the provisions of Patents Act for a limited period of time During this period, the
inventor is entitled to exclude anyone else from commercially exploiting his invention. Patent
relates to invention. As per Halsbury's Laws of England, the word patent is used for denoting
a monopoly right in respect of an invention. 1 In Telemecanique & Controls Limited V.
Schneider Electric "Industries SA, 2 the Division Bench of Delhi High Court observed that
patent created a statutory monopoly protecting the patentee against any unlicensed user of the
patented device. "A monopoly of the patent is the reward of the inventor."

The expression "patent" connotes a right granted to anyone who invents or discovers a new and
useful process, product, article or machine of manufacture, or composition of matter, or any
new and useful improvement of any of these. It is not an affirmative right to practice or use the
invention, it is a right to exclude is nets from making, using, importing, or selling patented
invention, during term. It is a property right, which the state grants to inventors in exchange
with their covenant to share its details with the public.3
The exclusive rights conferred by the Patents Act on the inventor can be exercised by a person
other than the inventor with the latter's previous authorization. The person to whom a patent is
granted is known as patentee.

MEANING OF PATENT

Patent is a monopoly right conferred by Patent Office on an inventor to exploit his invention
for a limited period of time. According to section 2(1)(m), “patent” means a patent for any
invention granted under, this Act.

Invention

“Invention” means a new product or process involving an inventive step and capable of
industrial application. A bare perusal of the definition of invention clearly shows that even a
process involving an inventive step is an invention within the meaning of the Act. It is,
therefore, not necessary that the product developed should be a totally new product. Even if a
product is substantially improved by an inventive step, it would be termed to be an invention. 4

New Invention

1
Bojaj Auto Lad, v. TVS Motor Company Ltd., 2008 (36) PTC 417 (Mad) at p. 439.
2
2002 (24) PTC 632 (Del) (DB)
3
F. Hoffmann-la Roche Ltd. and Another v. Cipla Limited, 2008 (37) PTC 71 (Del.).
4
Dhanpat Seth & Others v. Nil Kamal Plastic Crates Ltd., 2008 (36) PTC 123 (HP) (DB) at p. 127.

3
“New invention” means any invention or technology which has not been anticipated by
publication in any document or used in the country or elsewhere in the world before the date
of filing of patent application with complete specification, i.e. the subject matter has not fallen
in public domain or that it does not form part of the state of the art.5

In order to be patentable, an invention should either be new or novel and result in a new product
or process involving an inventive step and should be capable of industrial application.

New or novel
The Patents Act, 1970 requires an invention to be new in the sense that on the date of filing of
patent application. it should not form a part of the state of the art/ The state of art comprises all
matter made available to the public before the priority date of the invention by written or oral
description, by use or in any other way. This means that in order to be patentable, an invention
should not be found in any matter whether a product, a process, information about either of
anything else, which has at any time been made available to the public anywhere in the world
by written or oral description, by use, or in any other way.

In Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries, 6 the Supreme Court
observed:

The fundamental principle of Patent Law is that a patent is granted only for an invention which
must be new and useful. That is to say, it must have novelty and utility. It is essential for the
validity of a patent that it must be the inventor's own discovery as opposed to mere 14
verification of what was already known before the date of the patent. 7

The Court further stated that whether an alleged invention involved novelty and an "inventive
step" was a mixed question of law and fact, depending largely on the circumstances of the case.
Although no absolute test that was uniformly applicable in all circumstances could be devised,
certain broad criteria could be indicated. Whether the "manner of manufacture" patented, was
publicly known, used and practised in the country before or at the date of the patent? If the
answer to this question was "yes", it would negative novelty or "subject-matter." Prior public
knowledge of the alleged invention which would disqualify the grant of a patent could be by
word of mouth or by publication through books or other media. If the public once became
possessed of an invention by any means whatsoever, no subsequent patent for it could be
granted either to the true or first inventor himself or any other person as the public could not
be deprived of the right to use the invention because it was already possessing everything that
the inventor or any other person could give it.

5
Section 2(1)(1), Patents Act, 1970
6
(1979) 2 SCC 511
7
ibid

4
A new manufacture does not mean only a new article of manufacture, but also means a new
process or method of manufacturing something new. It does not mean a new principle of
manufacture. A principle cannot be an invention but it means a new application of the principles
so as to produce a new method or a new manufacture.8

Lord Davey stated in Rickmann v. Thierry. 9 that it was not enough that the purpose was new or
that there was novelty in the application, so that the article produced was new in that sense but
there must be novelty in the mode of application. In adopting the old contrivance to the new
purpose, there must be culties to be overcome, requiring what was called invention. Difficulties
some ingenuity in the mode of making the adoption.

The novelty or the Invention has to be succinctly stated in the claim. 10 Novelty is lost where an
inventor uses the invention secretly till the time it becomes a success and than apply for patent
at the most advantageous moment. The invention will be no more a new invention.

In Novartis AG & Ors. V. Union of India & Ors11., the Supreme Court stated that “new product
in chemicals and especially pharmaceuticals may not necessarily mean something altogether
new or completely unfamiliar or strange or not existing before. It may mean something
“different from a recent previous” or “one regarded as better than what went before” or “in
addition to another or others of the same kind”. However, in case of chemicals and especially
pharmaceuticals if the product for which patent protection is claimed is a new form of a known
substance with known efficacy, then the subject product must pass, in addition to clauses (j)
and (ja) of section 2(1), the test of enhanced efficacy as provided in section 3(d) read with its
explanation.”

Inventive step

Inventive step means a feature of an invention that involves technical advances as compared to
the existing knowledge or having economic significance or both and that makes the invention
not obvious to a person skilled in the art. 12 To meet the inventive step criterion, the patentee
will either have to show that the invention includes technical advancement or has economic
significance, or both. The requirement of technical advancement is, therefore, compromised
and diluted by the fact that a patent could simply be granted on economic significance alone.

8
Lalhubhai Chakubhal Jariwala v. Samaldas Sankalchand Shah, AIR 1934 Bom 407.
9
(1896) 14 RPC 105 (HL)
10
Ram Narain Kher v. Ambassador Industries New Delhi and Another, AIR 1976 Delhi 87.
11
2013 (54) PTCI (SC) at p. 80
12
Section 2(1)(ja), Patents Act, 1970

5
If the invention was obvious, there could be no inventive step whatsoever.13 An “inventive
step” which is a necessary ingredient of invention in order to make an applicant eligible for
grant of patent under the Act must be relating to an invention involving technical advance or
having economic significance or both along with a necessary factor that such invention should
make it “not obvious to a person skilled in the art. 14

An inventive step was, by the amendment of 2002, defined as a step that makes the invention
not obvious to a person skilled in the art. By further amendment în 2005, “inventive step” has
now been defined to mean “a feature of an invention that involves technical advance as
compared to the existing knowledge or having economic significance or both and that makes
the invention not obvious to a person skilled in the art,” The inventive step should be such as
could not have been discernableto the unimaginative person skilled in the art and not
somethingwhich was published in the prior art.15

In Dhanpat Seth & Others v. Nil Kamal Plastic Crates Ltd 16. 24 the Division Bench held:

The mere fact that the device is made of polymeric material instead of bamboo is not an
inventive step involving any novelty. There is nothing new about the process of manufacturing
the traditional Kilta made of natural material from synthetic material. Even nylon straps now
added are virtually copies of the ropes used in the traditional Kilta. The ropes in the Kilta can
also be adjusted by the user keeping in view the height of the person using the Kilta and the
weight being carried by him. The mere introduction of buckles would not amount to a new
device being called an invention or an inventive step.

An "Inventive step” which is a necessary ingredient of invention in order to make an applicant

eligible for grant of patent under the Act, must be relating to an invention involving technical
advance or having economic significance or both along with a necessary factor that such
invention should make it not obvious to a person skilled in the art. Therefore, a patent must
have characters of novelty. Non-obviousness and enablement, out of which, enablement being
the concept of putting the novelty into action and all the above said ingredients must
consecutively be present to have a valid patent. 17

A "person skilled In the art” would presuppose that the said person would have the knowledge
and the skill in the said field of art and will not be unknown to a particular field of art and it is

13
Press Metal Corporation Limited v. Noshir Sarabji Pochkhanwalla and Another, AIR 1983 Bom
14
Bajuj Auto Lad. v. TVS Motor Company Ltd., 2008 (36) PTC 417 (Mad.) at p. 440.
15
F. Hoffmann-la Roche Lid, and Another v. Cipla Limited, 2008 (37) PTC 71 (Del TVS Motor Company
Limited V. Bajaj Auto Limited, 2009 (40) PTC 689 (MadDB) P .no 720 where the court observed that the
technical advance which had not so far fallesin public domain in an industrial application and which was
not obvious before pronouncement, such technical advance though might be miniscule in nature could
still be recognised as an invention.
16
2008 (36) PTC 123 (HP) (DB).
17
Mariappan V. A.R. Safiullah & Others, 2008 (38) P PTC 341 (Mad. (DB) at p. 369. The definition of
Inventive step" does not accord any differential treatment to any " particular type of invention such Cipla
Lad Mumbai as medicinal, chemical industrial etc. See F. Hoffmann-La Roche Led & Ar Central, Mumbai
at p. 69.

6
from that angle one has to see that if the said document which is prior patent if placed in the
hands of said person skilled in art whether he will be able to work upon the same in the
workshop and achieve the desired result leading to patent which is under challenge. If the
answer comes in affirmative then certainly the said invention under challenge is anticipated by
the prior art or in other words, obvious to the person skilled in art as a mere 27 Workshop result
and otherwise it is not.18

Non-obviousness

In order to be patented, an invention needs to be non-obvious. The essential element of novelty

and inventive step would depend on the given facts of each case. If the particular manner of
manufacture is the same, then there cannot be any novelty in the subject matter. If there is no
inventive step, it implies that it is obvious. 19

In Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries, 20 the Supreme Court
observed that the expression “does not involve any inventive step” used in section 26(1)(e) of
the Patents and Designs Act, 1911 and its equivalent word “obvious”, had acquired special
significance in the terminology of patent law. The “obviousness” had to be strictly and
objectively judged. For this determination several forms of the question have been suggested.
The one suggested by Salmond, L.J. in Rado v. John Two & Son Ltd., 21 was “whether the
alleged discovery lies so much out of the track of what was known before as not naturally to
suggest itself to a person thinking on the subject, it must not be the obvious or natural
suggestion of what was previously known.”

Another test of whether a document was a publication, which would have negative existence
of novelty or an “inventive step”, was suggested, as under:

“Had the document been placed in the hands of a competent draftsman (or engineer as
distinguished from a mere artisan), endowed with the common general knowledge at the
‘priority date’, who was faced with the problem solved by the patentee but without knowledge
of the patented invention, would he have said, ‘this gives me what I want? 22 To put it in another
form: Was it for practical purposes obvious to a skilled worker, in the field concerned, in the
state of knowledge existing at the date of the patent to be found in the literature then available
to him, that he would or should make the invention the Subject of the claim concerned?23
In Graham v. John Deere Co., 24 the U.S. Supreme Court laid down certain factors to be
considered to find out whether the invention was obvious or not. The Court observed that to

18
The observations made by Supreme Court in Biswanath Prasad Radhey Shyam v Hindustan metal
industries AIR 1982 .
19
Bileure Lid. v. Amartara Pvt. Ltd., 2007 (34) PTC 419 (Del) at p. 434.
20
(1979) 2 SCC 511 at p. 519. 30.
21
(1967) RPC 29.
22
Encyclopaedia Britannica, Vol. 17 at p. 453.
23
Quoted by Vimadalal, J. of Bombay High Court in Farbwerke Hoechst & B. Corporation v. Unichem
Laboratories, AIR 1969 Bom 255 from Halsbury, 3rd edn., vol. 29 at p. 42.
24
383 U.S. 1 (1966) at p. 1142.

7
determine obviousness, courts should consider (i) the scope and content of prior art; 25 (ii) the
difference between the prior art and the claims at issue; and (iii) the level of ordinary skill in
the pertinent art. In addition, courts may use secondary considerations such as (a) commercial
success; (b) long felt but unsolved needs; and (c) the failure of others to solve the problem.

In respect of inventive step or non-obviousness, the House of Lords observed in Biogen v.

Medeva Plc.26

Whenever anything inventive is done for the first time it is the result of the addition of a new
idea to the existing stock of knowledge. Sometimes, it is the idea of using established
techniques to do something, which no one had previously thought of doing. In In that case, the
inventive idea will be doing the new thing. Sometimes, it is finding a way of doing something,
which people had wanted to do but could not think how. The inventive idea would be the way
of achieving the goal. In yet other cases, many people may have a general idea of how they
might achieve a goal but not how to solve a particular problem, which stands in their way. If
someone devises a way of solving the problem, his inventive step will be that solution, but not
the goal itself or the general method of achieving it.

Primary evidence on the issue whether an invention involves inventive step or 36 not comes
from qualified experts. 27

A person claiming a patent has not only to allege the improvement in art in the form but also
that the improvement effected a new and very useful addition to the existing state of
knowledge.28

In Graham v. John Deere Co. of Kansas City, 29 the US Supreme Court held that obviousness
should be determined by looking at

1. The scope and content of the prior art;

2. The level of ordinary skill in the prior art;

3. The differences between the claimed invention and the prior art; and
4. Objective evidence of non-obviousness.

25
Prior art ordinarily means the knowledge existing in the public domain. The existing technologies can
be understood to mean prior art.
26
(1994) RPC.
27
Molntycke v procter Gamble (No.5) (1994) RPC 49, C.A. at [Link] 113.

28
Ram Narain Krocter & Gamidor Industries New Delhi and Another, AIR 1976 Delhi 87.
29
383 US 1 (1966).

8
In addition, the Court outlined factors that show “objective evidence of non- obviousness.”
They are;

(i) Commercial success;

(ii) Long-felt but unsolved needs; and

(iii) Failure of others.

There is a certain amount of elusiveness in what is obvious (or not obvious, depending on what
one is looking at). Obviousness, as a concept was “as fugitive, impalpable, wayward and vague
a phantom as exists in the whole paraphernalia of legal concepts.”

Even though the term “obvious” has not been defined under the Patents Act, it can be safely
stated to be a circumstance where a person of skill in the field, on going through the
specification would complete the product. Therefore, even if any of the two ingredients, viz.,
technical advance or economic significance or both are available, if such invention enables a
person of skill in the field, on going through the specification would complete the product, such
invention can never be treated as an “inventive step” and consequently no patent can be validly
issued. Therefore, it is clear that a patent must have the characters of novelty non-obviousness
and enablement, out of which, enablement being the concept of putting the novelty into action
and all the above said ingredients must consecutively be present to have a valid patent. In Bajaj
Auto Ltd. V. TVS Motor Company Ltd.30 The Madras High Court stated that in any event, the
test of “obviousness” which forms part of the term “inventive step” under section 2(ja) of the
Patents Act, 1970 will have to be decided only in an appropriate manner in a full-fledged trial.
Suffice it to say now at this stage, prima facie there is novelty in which means an invention and
the same has been registered under the Patents Act with priority date and the enablement of
novelty has been on the face of it proved by the applicant by marketing the product in such
large extent and also without objection fairly for long 5 years and it is not proved that so far
the product of the applicant is “obvious.”

Capable of Industrial Application

Capable of industrial application means that the invention is capable of being made or used in
an industry. 31 In Indian Vacuum Brake Co. Ltd. V. E.S. Luard 32 the court held that mere
usefulness was not sufficient to support a patent In the case of Young and Neilson v. Rosenthal
& Co., 33 rrove, J. described “utility” as meaning an invention better than the preceding
knowledge of the trade as to a particular article.

30
2008 (36) PTC 417 (Mad.) at p. 463.
31
Section 2(1)(ac), Patents Act, 1970.
32
AIR 1926 Cal 152.
33
(1884) 1 Pat. C. 1

9
PRODUCT PATENT AND PROCESS PATENT

Patent is granted for an invention which may either be a product or a process, but such product
or process should be new, involve an inventive step and capable of industrial application. Prior
to the Patents Amendment Act 2005, only process patents were granted in respect of food, drugs
and pharmaceuticals in India. No product patent was granted in respect of substance
themselves.

In Thomson Brandt v. Controller of Patents,34 the Delhi High Court held that a ‘process of
manufacture’ is independent of the substance produced by the manufacture. Process of
manufacture has a distinctive identity of its own unconnected with the product of manufacture.
In Farbewerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning Corporation v.
Unichem Laboratories and Others,35 the Bombay High Court observed that when a process
patent was obtained after prolonged and thorough research work, it might be possible to predict
that the substances produced by that process.

Patentee

“Patentee” means the person for the time being entered on the register as the grantee or
proprietor of the patent. 36

A firm cannot be said to have the capacity to invent. It cannot be called an inventor although
there may be no objection to its being registered as a patentee either by an assignment by a
patentee or jointly with the true and first inventor. A corporation cannot be the sole applicant
claiming to be the inventor.37

WHAT ARE NOT INVENTIONS?

Section 3 outlines various situations where an invention (properly so called) can yet be not
patentable.38 According to section 3, followings are not inventions within the meaning of the
Act

(i) An invention which is frivolous or which claims anything obviously contrary to well
established natural laws:

(ii) 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;

34
AIR 1989 Del 249 at p. 251. 44. AIR 1969 Bom 255.
35
AIR 1969 Bom 255.
36
Section 2(1)(p), Patents Act, 1970
37
V.B. Mohammed Ibrahim v. Alfred Schafranek, AIR 1960 Mys 173.
38
F. Hoffmanmed La Roche Ltd, and Another vs Cipla limited , 2008 (37) PTC 71 (Del).

10
(iii) The mere discovery of a scientific principle or the formulation of or discovery of any living
thing or non-living substance occurring in nature:

(iv) 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 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.

(v) A substance obtained by a mere admixture resulting only in the aggregation of the properties
of the components thereof or a process for producing such substance;
(vi) The mere arrangement or re-arrangement or duplication of known devices each functioning
independently of one another in a known way:

(vii) A method of agriculture or horticulture;

(viii) Any process for the medicinal, surgical, curative, prophylactic (diagnostic, therapeutic)
or other treatment of human beings or any process for a similar treatment of animals to render
them free of disease or to increase their economic value or that of their products;

ix) plants and animals in whole or any part thereof other than micro organisms but including
seeds, varieties and species and essentially biological processes for production or propagation
of plants and animals:

(ix) A mathematical or business method or a computer program per se or algorithm;

(x) A literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever
including cinematographic works and television productions;

(xi) A mere scheme or rule or method of performing mental act or method of playing game;

(xii) A presentation of information;

(xiii) Topography of integrated circuits;

(xiv) An invention which, in effect, is traditional knowledge or which is an aggregation or
duplication of known properties of traditionally known component or components.

In addition to the aforesaid, no patent is to be granted in respect of an invention relating to

atomic energy.39

Invention contrary to public order or morality

An invention contrary to public order may be one the primary use of which would be a criminal
act, punishable as a crime, such as an instrument for picking pockets or fraudulent appliances

39
Section 4, Patents Act, 1970.

11
or preparations. Further, invention of artificial sexual devices or sex toys may be against the
morality and therefore, may not be patentable. 40

In addition, inventions relating to cloning of human beings, processes for modifying the germ
line and genetic identity of human beings, uses of human embryos for industrial or commercial
purposes, and processes for modifying the genetic identity of animals that are likely to cause
them unnecessary sufferings may also fall under this category. 41

Mere discovery of a new form of a known substance [Section 3(d)]

Section 3(d), and its explanation, (as amended with effect from 1-1-2005), now prescribes a
class of discovery which cannot be subject matter of patent. The change, in 2005, is not without
significance. It has introduced the concept of need for the discovery of a new form of a known
substance (or a derivative, which is deemed to be a substance) to differ significantly in
properties with regard to the known efficacy. The Division Bench of the Delhi High Court in
[Link]-La Roche Lid. And Another v. Cipla Limited , 42 observed that section 3(d)
discouraged evergreening, 43 and prevented such derivative or already patented product being
granted patent unless the derther forms of the forms “differed significantly in properties in
regard to efficacy.”

Earlier the single judge in the same case observed that it was not possible to accept the
plaintiff’s contention that section 3(d) and its explanation were siberely clarificatory of the pre-
existing law. The Parliament consciously enacted the standard of non-obviousness as a
condition for patentability, it enacted the some matter, i.e., derivatives of substances which
were known to exist. Cinted they differed in properties, significantly, in the known efficacy.
Thus, it had to be concluded that the test of non-obviousness of an invention and discovery of
existence of significant enhancement in the known efficacy of a substance were pre-requisites
of patentability. In other words, even if non-obviousness of an invention in the pharmaceutical
or chemical industry were established, the applicant should also prove that if the invention
claimed was the derivative of a known substance, it did not fall within the excepted category,
in the explanation to section 3(d) as it comprehended a discovery of significant enhancement
in known efficacy of such known substance. 44

40
Pg.no490
41
Pg.no490
42
2009 (40) PTC 125 (Del) (DB) at p.148.
43
evergreening is a term used to label practices that have developed in certain jurisdictions wherein a
trifling change is made to an existing product and claimed as a new invention.
44
2008 (37) PTC 71 (Del) at p. 93. In F. Hoffmann La Roche Lid & Another v. Cipla Lid Mumbai Central,
Mumbai, 2012 (52) PTC (Del.) at p. 113, the court distinguished between inventive step under section
2(1)(a) and section 3(d). It is one thing to say that the patent lacks the inventive step in as much as the
same is obvious to the person skilled in at as the same may amount to workshop result which is per se
not patentable. However, the another thing to say the patent is a new form of the old substance which is

12
Having regard to the circumstances that no new product or any significantly different use of
the existing product, i.e. fluorescent lamp was disclosed, the court in Asian Electronics Ltd. V.
Havells India Ltd., 45stated that the patent could not sustain, as being an obvious one, and also
hit by the exclusions in section 3(d) and also section 3(f).

In Novartis AG v. Union of India 46, the Madras High Court interpreted section 3(d) in detail.
The court observed that “it is clear from the amended section and the explanation that in the
pharmacology field, if a discovery is made from a known substance, a duty is cast upon the
patent applicant to show that the discovery had resulted in the enhancement of a known efficacy
of that substance and in deciding whether to grant a patent or not on such new discovery, the
explanation creates a deeming fiction that all derivatives of a known substance would be
deemed to be the same substance unless it differ significantly in properties with regard to
efficacy. In our opinion, the amended section and explanation give importance to efficacy….
Scientifically it is possible to show with certainty what are the properties of a “substance.”
Therefore when theexplanation to the amended section says tific any derivatives must differ
explanatiotly in properties with regard, which are the sderivatives should contain such
properties which are significantly different with regard to efficacy to the substance from which
the derivative is made. Therewith in sum and substance what the amended section with the
explanation presefore is the test to decide whether the discovery is an invention or not is that
the pales applicant should show the discovery has discover the enhancement of the anown
efficacy of that substance and if the discovery is nothing other than the derivative of a known
substance, then, it must be shown that the properties in the derivatives differ significantly with
regard to efficacy.”
The Court further held that "the argument that the amended section must be held to be bad in
law since for want of guidelines it gives scope to the statutory authority to exercise it’s power
arbitrarily, has to be necessarily rejected since there are in- built materials in the amended
section and the explanation itself, which would control/guide the discretion to be exercised by
the statutory authority.”

In Novartis AG & Ors. V. Union of India & Ors.47, 55 the Supreme Court discussed the meaning
of the term “efficacy” in detail. Efficacy means “the ability to produce a desired or intended
result.” The test of efficacy in the context of section 3(d) would be different, depending upon
the result the product under consideration is desired or intended to produce. In other words, the
test of efficacy would depend upon the function, utility or the purpose of the product under
consideration. In the case of a medicine that claims to cure a disease, the test of efficacy can

pre-existing ade line may be blurred between the two but there lies a subtle difference. This is the reason
why even the legislature thought it appropriate to insert and define both the concepts separately under
section 2(j)(a) and section 3(d).
45
2010 (44) PTC 66 (Del.) at p. 75 .
46
(2007) 4 ML 15 Del them Inibustries Ltd. v. Cadila Healthcare Lid. & Others, 2010 (362 (Bom) (DB) at p.
369, the court stated tale stay was a comprehensive provision covering all fields of technology including
the field of pharmacology.
47
2013 (54) PTCI (SC) at pp. 76-77.

13
only be “therapeutic efficacy.” The question then arises what would be the parameter of
therapeutic efficacy and what are the advantages and benefits that may be taken into account
for determining the enhancement of therapeutic efficacy? With regard to the genesis of section
3(d), and more particularly the circumstances in which section 3(d) was amended to make it
even more constrictive than before, the therapeutic efficacy of a medicine must be judged
strictly and narrowly. The text added to section 3(d) by the 2005 amendment lays down the
condition of “enhancement of the known efficacy”. Further, the explanation requires the
derivative to “differ significantly in properties with regard to efficacy”. Not all advantageous
or beneficial properties are relevant but only such properties that directly relate to efficacy,
which in case of medicine, as seen above is its therapeutic efficacy.

Each of the different forms mentioned in the explanation have some properties inherent to that
form, e.g. solubility to a salt and hygroscopicity to a polymorph. These forms, unless they differ
significantly in property with regard to efficacy, are expressly excluded from the definition of
invention. Hence, the mere change of form with properties inherent to that form would not
qualify as “enhancement of efficacy” of a known substance. In other words, the explanation is
meant to indicate what is not to be considered as therapeutic efficacy.

The process of making combination drugs, of a chemical material and a micro organism is a
well accepted process and isolation of one of the ingredients by giving coating is also in a
coatin Instacare Laboratories well accepted process. In Cadila Pharmaceuticals Lid. V. Pvt. Ltd
48
. the court held that the process which the appellant claimed to have developed after years of
research and development was really in use for decades. The appellant, therefore, prima facie,
could not be said to have evolved a new process hitherto unknown to the pharmaceutical world.
It might be that the said process had been adopted for making a combination drug of penicillin
(an athe infective agent) and lactobacilli (a micro organism).

Substance obtained by a mere admixture

In an infringement suit M/s Stanipack Pvt. Ltd. V. M/s. Oswal Trading Co. Ltd. 49 The defendant
challenged the validity of the patent of plaintiff for the invention for the manufacture of pouch
for storage and dispensing of a liquid such as lubricating oil The Delhi High Court while
revoking the patent on the ground that the invention was not new and not an invention within
the meaning of section 3, observed:

[T]hickness of the plastic film/layer depends upon the tolerance of the contents of the pouch.
Thus the same is inerely an arrangement and re- arrangement of the mixture of the material and
cannot be termed as a novel concept and does not have any novelty. Such arrangement and re-

48
2001 PTC 472 (Guj). 57.
49
AIR 2000 Del 23.

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arrangement of mixture of the materials cannot become an invention, for it is only an
improvement by adding microns as per the strength of the layers.50

Process for the medicinal and surgical treatment of human beings or animals.

Any process for the medicinal. Surgical, curative, prophylactic (diagnostic, therapeutic) or
other treatment of human beings or animals to render them free of disease is not patentable.
For instance, more efficient or less harmful dosages in known treatment, the administration of
a bacterium to secure immunity from a disease 51 and the employment of known medical
equipment for new treatments, 59 remained unpatentable. Similarly, a method of reducing
gastric secretion in mammals by the systemic administration of certain compounds was held to
be a method of treatment of human ailment with a known substance and therefore, not a
patentable invention. 52 In Eli Lilly & Company’s Application 53A claim for a novel manner of
use of old chemical compounds for treatment of human disease has been held to be not
patentable. Patent was refused for a method of purifying blood by removing toxic substances
from blood by dialysis. 54

Business method

Business method is not an invention within the meaning of section of the Paberin Act, 1970.
The technological developments have provided conducive environment to companies and
business houses to do business through innovative business methods. Though the Patents Act
does not provide any patent protection to these business methods, nevertheless these entities
have incentives to develop to thesesiness methods, as the competitive market rewards those
who bring in innovations in their business methods and strategies. The reason for not giving
intent protection to business methods may che that it may unnecessarily cut competition and
promote monopoly, which may ultimately give rise to unnecessary litigations. 55

Traditional knowledge
An invention which, in effect, is traditional knowledge or which is an aggregation or
duplication of known properties of traditionally know component or components, is not
patentable.

50
Pg .no 493
51
Unilever's (Davis) Application, (1983) RPC 219, Duphar/Pig 11, (1988) EPOR 10.
52
Upjohn Company (Roberts) Application, (1977) RPC 94 (CA)
53
(1975) RPC 438.
54
Calmic Eng. Co. Lid's Application, (1973) RPC 684.
55
494

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In Dhanpat Seth & Others v. Nil Kamal Plastic Crates Ltd.,56 the court observed that a Kilta is
a traditional product which has been used since time immemorial for carrying produce
including agricultural produce in hill areas especially in the State of Himachal Pradesh. The
traditional Kilta is made of bamboo. The shape of a Kilta is conical having a wider circular
opening on the top and it tapers and narrows down at the bottom. There is virtually no
difference in the overall design of the traditional Kilta or the device’ developed by the plaintiffs
and the defendant. A visual comparison of the three items prima facie establishes that the
articles manufactured by the plaintiffs and the defendant are virtual copies of the traditional
Kilta. The only difference is that Kilta is made of bamboo and the Kilta made by the plaintiffs
is made of polypropylene copolymer (PP). The Kilta made by the defendant is also made of
polymeric material. The Kilta manufactured by the defendant is made of high density
polyethylene (HDP). In actual fact, both the materials are polymers in common parlance known
as plastic. The only visible difference is that device now being manufactured is having
detachable nylon straps with buckles.

The Division Bench held that "the device developed by the plaintiffs is in fact the result of
traditional knowledge and aggregation/duplication of known products such as polymers and,
therefore, cannot be said to be an invention.”

Can a patent be granted for discovery or an idea?

A discovery is not patentable as such. Patents are granted only for inventions. It is the practical
application of discovery which leads to patentability. 57 Discovery is the unearthing of causes,
properties or phenomena already existing in naturewhereas invention is the application of such
knowledge to the satisfaction of social needs.58

In Reynolds v. Smith, Buckley 59 L.J. observed “Discovery adds to the amount of human
knowledge, but it does so only by lifting the veil and disclosing something which before had
been 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 result, or a new process, or a
new combination for producing an old product or an old result.”

The Like discovery, an idea is also not patentable. Therefore, unless an idea or a discovery is
converted into an invention which is new, involves an inventive step and capable of industrial

56
2008 (36) PTC 123 (HP) (DB) at p. 127.
57
Gale's Application, (1991) RPC 305 (CA) at p. 323
58
Kolle quoted in W.R. Cornish, Intellectual Property, Universal Law Publishing, New Delhi, 2001, p. 177.
59
(1903) 20 RPC 123 at p. 126.

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application, it is not patentable. In Hickton’s Patent Syndicate v. Patents & Machine
Improvements, 60 Fletcher Moulton L.J. stated:

[I]nvention may lie in the idea, and it may lie in the way in which it is carried out, and it may
lie in the combination of the two; but if there is invention in the idea plus the way of carrying
it out, then it is good subject-matter for Letters Patent.

PATENTING OF BIO-TECHNOLOGICAL INVENTIONS

Bio-technology plays an important role in the fields of medicine, food, fertilizer, energy and
protection of environment. Bio-technology concerns living organisms, such as plants, animals
and micro-organisms, as well as non-living biological material, such as seed, cells, enzymes,
plasmids and the like.

Bio-technological inventions ordinarily fall into three categories. They are the processes for
the creation or modification of living organisms and biological materials; the results of such
processes; and the use of such results. 61

The TRIPs Agreement makes It obligatory for the Member States to protect bio-technological
inventions but allows them to exclude plants and animals from patentability. However, it is
obligatory for them to protect micro-organisms and essentially biological processes for the
production of plants or animals. It is also provided that Members shall also provide protection
for plant varieties either by patents or by an effective sui generic system or by any combination
thereof.

In United States, in Diamond v. Chakrabarty 62 , Mr. Ananda M. Chakrabarty created a

genetically engineered bacterium capable of breaking down multiple components of crude oil
and applied for patent on the ground that his bacterium possessed a trait not found in naturally
occurring bacteria, and therefore sought patent protection. The Patent and Trademark Office
rejected the patent application of Chakrabarty on the ground that the micro-organisms were
products Of nature and as living things non-patentable per se. On and appeal to Supreme Court,
the court held at microorganism spur saver patentable in the United states. This judgement
opened the door for painting of animals in United States .In India, after the amendments made
in the patent act 2002 microorganisms were made patentable .. This amendment was made to
fulfil our obligations under the TRIPs agreement.

CONCLUSION

60
(1909) 26 RPC 339 at 348.
61
WIPO, background reading material on intellectual property, Geneva, 1988 P. 375.
62
447 U.S 303 break (1980 ).

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Any creation, invention, idea or artistic work which is a result of the intellect of any person
falls within the ambit of intellectual property and the rights conferred upon such person for his
creation, work, idea or invention are known as intellectual property rights. Patents are a kind
of intellectual property. Any invention that results in the production of a new product or service
or the manufacturing of an already existing product through new means and technology can be
patentable provided that it does not fall into the list of non-patentable inventions. Patents in
India are governed by the Indian Patents Act, 1970, which has been amended twice in 2002
and 2005, respectively. There are certain essentials of patents that have to be fulfilled in order
to get a patent for an invention. The 3 essential requirements are novelty or newness, utility or
usefulness (capability of industrial application) and non-obviousness. However, there are
certain grounds on which the application for the patents can be refused. These grounds have
been described above in the article.

BIBLIOGRAPHY
• Law relating to Intellectual Property Rights by [Link] 3rd edition 2017
• Law relating to Intellectual Property by Dr [Link] 5th edition 2011
• Intellectual Property Rights by Dr Rakesh Kumar Singh & Arunabha
Banarjee 1st edition 2022
• Intellectual Property Rights by Neeraj Pandey 1st edition.

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