Novelty-As Qualifier of Patentability vis-a-vis Relevancy of

Section 3(D) Of Patents Act: A Critical Analysis of Indian

Approach
Dr.ParthaPratim Paul1

I.Introduction
The definitionof “invention” in Patents Act (India)is found as: anew
product or process involving an inventive step2 and capable of industrial
application3. Therefore, any invention, if it deserves to have “patent” over
it, must have, as first qualifier of patentability a newness- in the form of a
new product or new process.In the legal parlance, it is commonly known
as NOVELTY all over the world. Accordingly, “new invention” has been
defined as: “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”4;in another words “an invention is novel (new) if it does not form
part of the existing “state of the art”; and the “state of the art” comprises
all matters which are known to the public before the priority date of
claimed invention by written or oral description, by use or in any other
way5.In the legal phraseology, again “novelty” (newness) denotes that
the invention regarding the subject matter of patent is not
anticipated, on the basis of prior existing knowledge; Anticipation is
the main narrative, put in place by the judiciary in India, United
Kingdom or anywhere else, just to find the presence of “novelty” in
any of the inventions. Second qualifier of patentability i.e. “inventive-
step”6is to be determined after thatwhich is followed by “industrial

1
Assistant Professor, Dept. of Law, Assam University, Silchar.
2
Patents Act, 1970, s.2(j).
3
Patents Act, 1970, s. 2(j).
4
Patents Act, 1970, s. 2(l).
5
Quantel v. Spaceward, (1990) RPC 83.
6
Patents Act, 1970, s 2(ja). “inventive step” means 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.
62
application” as the third qualifier. While satisfying the three test
formula i.e. sine-qua-none of patentability, Patents Act specifically
excludes some inventions from patentability as INVENTIONS NOT
PATENTABLE7; one of such is “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 reactant8.”If it is seen that the
invention falls under that above-mentioned exclusion clause, in that case,
patent cannot be granted as it is not worthy to be considered for an
invention or if the patent already it was granted, (if challenged) it has to
be withdrawn by following a procedure.
II. Meaning of “Anticipation”
The notion of “novelty” is centred around, of “anticipation”; therefore,the
term ‘anticipate’ needs to be explained. It means (a). to seize or take
possession beforehand; (b). to use in advance; (c). to take up or deal with
(a thing) or perform (an action) before another person or agent has had
time to act, so as to gain an advantage; to deal with beforehand; (d). to
observe or practice in advance of the due date; to cause to happen earlier;
(e). to occur earlier9. It indicates (a). to take into consideration or mention
before the due time; (b). to observe or practice in advance of the due time;
to cause (a future event) to be a reality beforehand, (c). to introduce in
advance of a part of a chord which is about to follow; (d). to contemplate
to consider in advance10. In another words, “anticipate” implies (a). to
imagine and expect that something will happen, sometimes taking action
in preparation for it happening11. Similarly, it denotes (a). to make happen
earlier; (b). to foresee and perform in advance; (c). to be ahead of in doing
or achieving; (d). to precipitate; (e). to use or enjoy in advance12. It is

7
Patents Act, 1970, s 3.
8
Patents Act, 1970, s.3(d).
9
The Oxford English Dictionary, Volume-1, 2nd Edition, 1991, (prepared by
J.A.Simpson), Clarendon Press, Oxford, Page-522.
10
The New Shorter Oxford English Dictionary, Volume 1, 4th Edition, 1993 (edited
by Lesley Brown), Clarendon Press, Oxford, Page-88.
11
International Dictionary of English, 1st Edition, 1995, Cambridge University
Press, Cambridge, Page-50.
12
Webster’s New World Dictionary, 3rd Edition, 1991, (edited by Victoria
Neufeldt), Webster’s New World, New York, Page-59.
63
seen that the commonality in all the definitions is “knowledge”; it
signifies that a person educated in the relevant art, who already has
apriori knowledge in the cognitive field, regarding the outcome of
later invention, reflected in the specifications13(of the earlier
invention, over which there is existing patent or the term of patent
was over) or in other recognised ways, can foresee without any iota of
doubt that it will happen in that particular way or it is like this. So
there is nothing novelty (newness) in it-it can be anticipated very
clearly and cogently, on the basis of “prior art”.
III. Basic Attributes of “Anticipation” (R)
The question of “novelty”essentially involves afactual investigation. A
careful consideration is required between the claimed invention, in any of

13
Complete specifications: (1) Where an application for a patent (not being a
convention application or an application filed under the Patent Cooperation
Treaty designating India) is accompanied by a provisional specification, a
complete specification shall be filed within twelve months from the date of filing
of the application, and if the complete specification is not so filed, the application
shall be deemed to be abandoned.
Contents of specifications: (1) Every specification, whether provisional of
complete, shall describe the invention and shall begin with a title sufficiently
indicating the subject-matter to which the invention relates. (2) Subject to any
rules that may be made in this behalf under this Act, drawings may, and shall, if
the Controller so requires, be supplied for the purposes of any specification,
whether complete or provisional; and any drawings so supplied shall, unless the
Controller otherwise directs be deemed to form part of the specification, and
references in this Act to a specification shall be construed accordingly. (3) If, in
any particular case, the Controller considers that an application should be further
supplemented by a model or sample of anything illustrating the invention or
alleged to constitute an invention, such model or sample as he may require shall
be furnished before the application is found in order for grant of a patent, but
such model or sample shall not be deemed to form part of the specification. (4)
Every complete specification shall (a) fully and particularly describe the
invention and its operation or use and the method by which it is to be performed;
(b) disclose the best method of performing the invention which is known to the
applicant and for which he is entitled to claim protection; and (c) end with a
claim or claims defining the scope of the invention for which protection is
claimed; (d) be accompanied by an abstract to provide technical information on
the invention: Provided that (i) the Controller may amend the abstract for
providing better information to third parties; and (ii) if the applicant mentions a
biological material in the specification which may not be described in such a way
as to satisfy clauses (a) and (b), and if such material is not available to the public,
the application shall be completed by depositing the material to an international
depository authority under the Budapest Treaty and the following conditions.
64
its embodiments, and the thing that is revealed by the prior publication or
use. But the larger question remains: What are its determinant factors of
“being anticipated”? The answers to these questions are solely dependent
on the nature and characteristics of “a priori knowledge, in the forms of
written or oral description; this vital point needs to be explainedon the
basis of next set of questions: when can it be anticipated or why is it to be
anticipated? Otherwise, it will be difficult in grasping the whole gamut of
“anticipation”, the basic of “novelty” in any invention, deserves to be
conferred patent.Over here the reliance on judicial decisions of U.K (only
court of records) is pertinent because both in U.K and India, common law
principles are also followed. The judgments pronounced by “courts of
records” in U.K (though have persuasive values for Supreme Court of
India), unfold those nature and characteristics of “anticipation”.
Therefore, a perusal is perusal of the legal provisions with regard to
“novelty” in the law of U.K is required. Accordingly in U.K, a patent may
be granted only for an invention in respect of which the following
conditions are satisfied: (a) the invention is new; (b) it involves an
inventive step; (c) it is capable of industrial application; (d) the grant of a
patent for it is not excluded by subsections (2) and (3) or section 4A
below; and references in this Act to a patentable invention shall be
construed accordingly.14 It is hereby declared that the following (among
other things) are not inventions for the purposes of this Act, that is to say,
anything which consists of-(a) a discovery, scientific theory or
mathematical method; (b) a literary, dramatic, musical or artistic work or
any other aesthetic creation whatsoever; (c) a scheme, rule or method for
performing a mental act, playing a game or doing business, or a program
for a computer; (d) the presentation of information; but the foregoing
provision shall prevent anything from being treated as an invention for the
purposes of this Act only to the extent that a patent or application for a
patent relates to that thing as such.15 A patent shall not be granted for an
invention the commercial exploitation of which would be contrary to
public policy or morality.16 For the purposes of subsection (3) above
exploitation shall not be regarded as contrary to public policy or morality
only because it is prohibited by any law in force in the United Kingdom or

14
The Patents Act, 1977, Patentability, Section 1 (1).
15
Ibid, section 1 (2).
16
Ibid, Section 1 (3).
65
any part of it.17 The Secretary of State may by order vary the provisions of
subsection (2) above for the purpose of maintaining them in conformity
with developments in science and technology; and no such order shall be
made unless a draft of the order has been laid before, and approved by
resolution of, each House of Parliament.18
An invention shall be taken to be new if it does not form part of the state
of the art.19 The state of the art in the case of an invention shall be taken to
comprise all matter (whether a product, a process, information about either,
or anything else) which has at any time before the priority date of that
invention been made available to the public (whether in the United
Kingdom or elsewhere) by written or oral description, by use or in any other
way.20 The state of the art in the case of an invention to which an
application for a patent or a patent relates shall be taken also to comprise
matter contained in an application for another patent which was published
on or after the priority date of that invention, if the following conditions are
satisfied, that is to say (a) that matter was contained in the application for
that other patent both as filed and as published; and (b) the priority date of
that matter is earlier than that of the invention.21
A clear directiveis given in Flour Oxidising v. Carr22: “this then is the test:
if the claim is for a method of use or process, the anticipation must give
‘clear and unmistakeable directions to do what the patenteeclaims to have
invented”23. Van Der Lely v. Bamfords24 is more focussed on nature of
“anticipation”: “If it is for an article, apparatus or substance, the qualified
reader must be enabled at once to perceive and understand and be able
practically to apply the discovery without the necessity of making further
experiments”. Very aptly, House of Lords, inAsahi KK’s Application25
explained: “In the case of a publication describing a new substance but
not how to make it, if common general knowledge in the industry would
not permit a skilled person to select or secure the starting material or make
intermediate products, there has been no sufficient description of the
17
ibid, Section 1 (4)
18
Ibid, Section 1 (5).
19
Ibid, Section 2 (1),
20
Ibid, Section 2 (2).
21
Ibid, Section 2 (3).
22
Flour Oxidising v. Carr, (1908) 25 R.P.C. 428 (457).
23
Flour Oxidising v. Carr, (1908) 25 R.P.C. 428 (457).
24
Van Der Lely v. Bamfords, (1963) R.P.C. 61 (71).
25
Asahi KK’s Application, (1991) R.P.C. 485 (H.L).
66
invention and accordingly there is no anticipation. To satisfy these
criteria, there must be an enabling disclosure.”
What are emanating as features of “anticipation” are firstly; “prior
disclosure” and secondly; “enabling disclosure”; these are evident not
only from the specifications of earlier patent application but also other
forms of “prior art”, to be kept in view to ascertain or negate novelty in
any invention.W.R.Cornish looks at “anticipation” as: “not infrequently, a
question of anticipation centres on whether the prior document does
sufficiently disclose the later invention. This may be so when the alleged
anticipation is ‘unintentional’; but the issue is by no means confined to
such cases”26. A person, educated27in the respective field of art
(knowledge in science and technology), on the basis of (pre-existing)a
priori knowledge, after making a comparison, while going through the
“specifications” or other documents, will not anticipate the post-ri
knowledge. In another words, the knowledge in claimed invention is
not non-existent in the public domain and the personseducated in the
relevant art know what has been done; how does it work; why it is
resulting in such a way.After this, the process to determine “inventive
step” starts-the next qualifier of patentability.
These two inalienable parts attached to “anticipation” have been nicely
explicated very recently by House of Lords, in Synthon BV v.
Smithkline Beecham Plc28 judgment:
(a). Disclosure
The concept of “disclosure” has been explained in two judgments of
unquestionable authority. The first is Lord Westbury LC in Hill v
Evans29: “the antecedent statement must be such that a person of
ordinary knowledge of the subject would at once perceive,
understand and be able practically to apply the discovery without
the necessity of making further experiments and gaining further
information before the invention can be made useful. If something

26
W.R.Cornish, Page-155
27
The author prefers to use ‘educated’ rather than ‘skilled’ in the context of
novelty as related to knowledge and not application part of knowledge; while
determining ‘inventive step’ the use of the term ‘skilled’ is preferred as it is
pertinent to application related matter.
28
(2005) UKHL 59.
29
(1862) 31 LJ(NS) 457, 463.
67
 remains to be ascertained which is necessary for the useful
application of the discovery, that affords sufficient room for another
valid patent.
The second authoritative passage is in General Tire and Rubber Co.
v Firestone Tyre &Rubber Co Ltd30: “To determine whether a
patentee’s claim has been anticipated by an earlier publication it is
necessary to compare the earlier publication with the patentee’s
claim. If the earlier publication discloses the same device as the
device which the patentee by his claim, asserts that he has invented,
the patentee’s claim has been anticipated, but not otherwise. If the
prior inventor’s publication contains a clear description of, or clear
instructions to do or make, something that would infringe the
patentee’s claim if carried out after the grant of the patentee’s
patent, the patentee’s claim will have been shown to lack the
necessary novelty. The prior inventor, however, and the patentee
may have approached the same device from different starting points
and may for this reason, or it may be for other reasons, have so
described their devices that it cannot be immediately discerned from
a reading of the language which they have respectively used that
they have discovered in truth the same device; but if carrying out
the directions contained in the prior inventor’s publication will
inevitably result in something being made or done which, if the
patentee’s claim were valid, would constitute an infringement of the
patentee’s claim, this circumstance demonstrates that the patentee’s
claim has in fact been anticipated.
If, on the other hand, the prior publication contains a direction
which is capable of being carried out in a manner which would
infringe the patentee’s claim, but would be at least as likely to be
carried out in a way which would not do so, the patentee’s claim
will not have been anticipated, although it may fail on the ground of
obviousness. To anticipate the patentee’s claim the prior publication
must contain clear and unmistakeable directions to do what the
patentee claims to have invented. A signpost, however clear, upon
the road to the patentee’s invention will not suffice. The prior
inventor must be clearly shown to have planted his flag at the
precise destination before the patentee.”

30
[1972] RPC 457, 485-486.
68
 To summarise the effect of these two well-known statements, the
matter relied upon as prior art must disclose subject-matter which,
if performed, would necessarily result in an infringement of the
patent. That may be because the prior art discloses the same
invention. But patent infringement does not require that one should
be aware that one is infringing: “whether or not a person is working
an invention is an objective fact independent of what he knows or
thinks about what he is doing”.Whether or not it would be apparent
to anyone at the time, whenever subject-matterdescribed in the prior
disclosure is capable of being performed and is such that, if
performed, it must result in the patent being infringed, the
disclosure condition is satisfied. The flag has been planted, even
though the author or maker of the prior art was not aware that he
was doing so.
Therefore, first element of “anticipation” requires prior disclosure of
subject-matter of the later claimed patent, resulting in the infringement
(notional) of the later patent.
(b).Enablement
Enablement means that the ordinary skilled person would have been
able to perform the invention which satisfies the requirement of
disclosure. This requirement applies whether the disclosure is in
matter which forms part of the state of the art by virtue of section
2(2) or, as in this case, section 2(3). The latter point was settled by
the decision of this House in Asahi Kasei Kogyo KK’s
Application31.
Asahi’s case was decided on the assumed facts that there had been a
prior disclosure of the same invention but that neither the disclosed
information nor common general knowledge would have enabled
the skilled man to make it. The House therefore did not have to
consider the test for deciding what degree of knowledge, skill and
perseverance the skilled man was assumed to have. But the concept
of enablement is used in other contexts in the law of patents “the
specification of the patent does not disclose the invention clearly
enough and completely enough for it to be performed by a person
skilled in the art”.

31
[1991] RPC 485.
69
So, the dimension of newness or novelty, is setting out a higher order,
with “enabling disclosure”.
IV. “Anticipation” to Determine or Negate Novelty and its
Application in India
In Monsanto Company v. CoramandalIndag Products (P) Ltd32, Supreme
Court of India, observed “anticipation” in the following way33, after
ascertaining that the emulsifying agent in Butachlorand the process of its
emulsification can be anticipated, hence lacks novelty in it:
Butachlor (CP 53619) was discovered, even prior to 1968 as a
Herbicide possessing the property of nontoxic effect on rice. The
formula for the Herbicide was published in the report of the
International Rice Research Institute for the year 1968 and its
common name Butachlor was also mentioned in the report of the
International Rice Research Institute in 1969. No one patented the
invention Butachlor and it was the property of the population of the
world. Before Butachlor or for that matter any Herbicide could be
used for killing weeds, it had to be converted into an emulsion by
dissolving it in a suitable solvent and by mixing the solution with an
emulsifying agent. Emulsification is a well-known process and is no
one’s discovery. In the face of the now undisputable fact that there
is no patent for or any secrecy attached to Butachlor, the solvent or
the emulsifying agent and the further fact that the process of
emulsification is no new discovery, the present suit based on the
secrecy claimed in respect of the active agent Butachlor and the
claim for the process of emulsification must necessarily fail.To
satisfy the requirement of being publicly known (as anticipated)
as used in clauses (e) and (f) of sec. 64(1), it is not necessary that
it should be widely used to the knowledge of the consumer
public. It is sufficient if it is known to the persons who are
engaged in the pursuit of knowledge of the patented product or
process either as men of science or men of commerce or
32
1986 SCR (1) 120
33
Section 64(1) (e), Patents Act, 1970 (that the invention so far as claimed in any
claim of the complete specification is not new, having regard to what was
publicly known or publicly used in India before the priority date of the claim or
to what was published in India or elsewhere in any of the, documents referred to
in Section 13.

70
 consumers. The section of the public who, as men of science or
men of commerce, were interested in knowing about Herbicides
which would destroy weeds but not rice, must have been aware of
the discovery of Butachlor. There was no secret about the active
agent Butachlor as claimed by the plaintiffs since there was no
patent for Butachlor, as admitted by the plaintiffs. Emulsification
was the well-known and common process by which any Herbicide
could be used. Neither Butachlor nor the process of Emulsification
was capable of being claimed by the plaintiff as their exclusive
property. The solvent and the emulsifier were not secrets and they
were admittedly not secrets and they were ordinary market
products. From the beginning to the end, there was no secret and
there was no invention by the plaintiffs. The ingredients, the active
ingredient, the solvent and the emulsifier, were known; the process
was known, the product was known and the use was (also) known.
In the same way, in Bishwanath Prasad Pandey v. Hindusthan Metal
Industries34, the Supreme Court did not accept the improved devise and
method for the manufacture of utensils especially shallow dishes (with more
convenience, speed, safety and better finish) has novelty in it by looking at
anticipation as getting possessedbeforehand:
The patented machine is merely an application of an old
invention35, known for decades, for the traditional purpose of
scraping and turning utensils, with a slight change in the mode of
application, which is no more than a ‘workshop improvement’, a
normal development of an existing manner of manufacture not
involving something novel which would be outside the probable
capacity of a craftsman. The alleged discovery does not lie outside
the track of what was known before.
This aspect of the law relating to patentable inventions, as
prevailing in Britain, has been neatly summed up in Encyclopaedia
Britannica, Vol. 17, page 453. Since in India, also, the law on the

34
AIR 1982 SC 1444.
35
The old method of manufacturing utensils, particularly shallow dishes, was to
turn scrap and polish them on some sort of headstock without a tailstock, the
utensils either being fixed to the headstock by thermoplastic cement or held in the
jaws of a chuck fixed to the headstock. This system was, however, fraught with
risk to the workers inasmuch as the utensils used to fly off from the headstock.
71
 subject is substantially the same, it will be profitable to extract the
same hereunder: “A patent can be granted only for ‘manner of new
manufacture’ and although an invention may be ’new’ and relate to
a ‘manner of manufacture’ it is not necessarily a ’manner of new
manufacture’-it may be only a normal development of an existing
manufacture.” A patentable invention, therefore, must involve
something which is outside the probable capacity of a craftsman-
which is expressed by saying it must have ’subject matter’ or
involve an ’inventive step’. Novelty and subject matter are
obviously closely allied. In fact, ‘subject matter’ is the crucial test,
for which they may well be novelty not involving an ‘inventive
step’, it is hard to conceive how there can be an ‘inventive step’
without novelty.”
Whether an alleged invention involves novelty is a mixed question
of law and fact, depending largely on the circumstances of the case.
Although no absolute test uniformly applicable in all circumstances
can be devised, certain broad criteria can 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 is ‘yes’, it will negative novelty or
’subject matter’. Prior public knowledge of the alleged invention
which would disqualify the grant of a patent can be by word of
mouth or by publication through books or other media. “If the
public once becomes possessed of an invention”, says Hindmarch
on Patents “by any means whatsoever, no subsequent patent for it
can be granted either to the true or first inventor himself or any
other person; for the public cannot be deprived of the right to use
the invention, the public already possessing everything that he
could give.

Lack of Novelty in ImatinibMesylate (Beta Crystal Form)

In Novertis A G v. Union of India36the apex Court very clearly
explained the term “new” or “novelty” as not having been anticipated
by the “prior art”. Accordingly, Supreme Court did not accept

36
Novertis A G v. Union of India, (2013) 6 SCC 1.
72
IMATINIB MESYLATE (BETA CRYSTAL FORM) as new or novel as
it was very much anticipatedby the “prior art” for the following reasons:
Firstly,NATCO Pharma Ltd., (one objector) had marketed a drug called
VEENAT 100 in UK. A legal notice by NovertisA G was served to
NATCO Pharma Ltd. by stating that it was the proprietor of European
Patent (EP-A-0 564 409: Zimmermann patent) and that this patent is all
about Imatinib and acid addition salts of that compound i.e. Mesylate Salt.
The drug, which asNATCO Pharma Ltd. was selling, was made of active
pharmaceutical ingredient of ImatinibMesylateof Zimmermann patent; it
has infringed the patent. but as a result of out of court settlement, NATCO
Pharma Ltd.stoppedthe marketing of the medicine:
It would be clear that Gleevec directly emanates from the
Zimmermann patent and comes to the market for commercial sale.
Since the grant of the Zimmermann patent, the appellant has
maintained that Gleevec (that is, ImatinibMesylate) is part of the
Zimmermann patent. It obtained drug approval for Gleevec on that
basis. It claimed extension of the term of the Zimmermann patent
for the period of regulatory review for Gleevec, and it successfully
stopped NATCO Pharma Ltd. from marketing its drug in the UK on
the basis of the Zimmermann patent. Not only the appellant
(Novertis A G) but the USBPA, while granting patent for beta
crystalline form of ImatinibMesylate, proceeded on the basis that
though the beta crystal form might not have been covered by the
Zimmermann patent, the Zimmermann patent had the teaching
for the making of ImatinibMesylate from Imatinib, and for its
use in a pharmacological compositions for treating tumours or in a
method of treating warm-blooded animals suffering from a tumoral
disease. This finding was recorded by the USBPA, in the case of the
appellant itself, on the very same issue that is now under
consideration.
Secondly, the apex Court, cited two articles written by Zurg Zimmermann
himself, as instances of “prior art” which re-establishes that IMATINIB
MESYLATE IN BETA CRYSTAL FORM, could be anticipated from
original Zimmermann patent.
A journal called Cancer Research, in its issue of January 1996,
published an article under the title “Inhibition of the Abl Protein-
Tyrosine Kinase in Vitro and in Vivo by a 2-
73
Phenylaminopyrimidine Derivative”. This article was authored by
several people, including Jurg Zimmermann. In this article there is a
detailed discussion about the antitumoral properties of Imatinib and
its methanesulfonate salt, i.e., ImatinibMesylate. In the abstract at
the beginning of the article, it is stated as under: “ABSTRACT
Oncogenic activation of Abl proteins due to structural modifications
can occur as a result of viral transduction or chromosomal
translocation. The tyrosine protein kinase activity of oncogenic Abl
proteins is known to be essential for their transforming activity.
Therefore, we have attempted to identify selective inhibitors of the
Abl tyrosine protein kinase. Herein we describe an inhibitor
(CGP 57148 as IMATINIB IN FREE BASE FORM) of the Abl
and platelet-derived growth factor (PDGF) receptor protein-
tyrosine kinases from the 2-phenylaminopyrimidine class,
which is highly active in vitro and in vivo. Submicromolar
concentrations of the compound inhibited both v-Abl and PDGF
receptor autophosphorylation and PDGF-induced c-fosmRNA
expression selectively in intact cells. Furthermore, anchorage-
independent growth of v-abl- and v-sis-transformed BALB/c 3T3
cells was inhibited potently by CGP 57148. When tested in vivo,
CGP 57148 showed antitumor activity at tolerated doses against
tumorigenic vabl- and v-sis- transformed BALB/c 3T3 cells. In
contrast, CGP 57148 had no antitumor activity when tested using
src-transformed BALB/c 3T3 cells. These findings suggest that
CGP 57148 may have therapeutic potential for the treatment of
diseases that involve abnormal cellular proliferation induced by Abl
protein-tyrosine kinase deregulation or PDGF receptor activation.”
128. Under the heading “MATERIALS AND METHODS”, it is
stated as under: “Materials. CGP 57148 and its methane sulfonate
salt (CGP 57148B as IMATINIB MESYLATE IN NON-
CRYSTAL FORM) were synthesized by CIBA Pharmaceuticals
Division, as will be described elsewhere. For in vitro and cellular
assays, a stock concentration of 10 mM CGP 57148 was prepared in
Me2SO and stored at-20oC. No significant difference in results
could be seen between the two forms of CGP 57148. The form used
in in vitro experiments is indicated in the text and legends. All in
vivo experiments were performed using CGP 57148B.”

74
The article goes on to discuss the in vivo experiments and the in
vitro selectivity of CGP 57148 for inhibition of protein kinases:
Identification of CGP 57148 as an inhibitor of v-Abl kinase. The
article also discussed the in vivo anti-tumour activity of CGP
57148B and it states as follows: “In Vivo Antitumor Activity. The
maximally tolerated dose for a single p.o. or i.p. administration of
CGP 57148B in BALB/c mice was >500 mg/kg. BALB/c AMuLV
and BALB/c 3T3 v–sis cells, which were sensitive in the colony-
forming assay, were used to test CGP 57148B for antitumor activity
in female BALB/c nude mice. Once daily i.p. applications of 50,
12.5, or 3.13 mg/kg CGP 57148B given for 30 consecutive days
resulted in a strong antitumor effect against AMuLVtransformed
BALB/c 3T3 tumors (Fig. 5A). Similarly, anti-tumor experiments
using v–sis- transformed BALB/c 3T3 cells revealed dose-
dependent antitumor activity (Fig. 5B). Maximal T/C (X100%)
values of 4% (AMuLVtumors) and 11% (v–sis tumors) were
obtained when CGP 57148B was administered at 50mg/kg body
weight. In contrast, CGP 57148B showed no antitumor activity
against tumors derived from NIH-527src cells when 50 mg/kg were
administered p.o. once daily for 30 days (T/C, 102%). Using the
same route of application, T/C values of 7 and 22% against AMuLV
and v–sis tumors, respectively, were obtained when 50 mg/kg CGP
57148B were given.” It is further stated in the article: “CGP 57148
selectively inhibited the in vitro activity of the v-Ablproteintyrosine
kinase and showed preferential inhibition of v-
Ablautophosphorylation in cells. We have examined the specificity
of CGP 57148 by analyzing its effects on signal transduction via
different tyrosine kinase receptor-mediated pathways. Although the
ligand-induced activation of the EGF, bFGF, insulin, and IGF-1
receptor tyrosine kinases were not affected by CGP 57148, the
PDGF pathway was sensitive to inhibition by the compound. The
antiproliferative activity of CGP 57148 against both v-abl- and v-
sistransformed BALB/c 3T3 support the selectivity profile of CGP
57148 further.” The article concludes by observing as follows: “The
reported findings with CGP 57148 suggest that it may be a
development candidate for use in the treatment of Philadelphia
chromosome-positive leukemias. Additional potential applications

75
 for CGP 57148 may include proliferative diseases that involve
abnormal PDGF receptor activation.”
An article was published in Nature Medicinemagazine of the year
1996 under the title “Effects of a selective inhibitor of the Abl
tyrosine kinase on the growth of Bcr-Abl positive cells”. This
article, too, was authored by several people, including Jurg
Zimmermann. In this article also, there is a discussion about
Imatinib as a compound designed to inhibit Abl protein tyrosine
kinase.
In the face of the materials referred to above, (there is
impossibility) to see how ImatinibMesylate can be said to be a
new product, having come into being through an “invention”
that has a feature that involves technical advance over the
existing knowledge. ImatinibMesylate is all there in the
Zimmermann patent. It is a known substance from the
Zimmermann patent.
Lastly, it is found that the specifications of IMATINIB MESYLATE
IN BETA CRYSTAL FORM, are quite identical to specifications
ofZimmermann patent.The following is a glaring example (as
Zimmermann inventionrelated to N-phenyl-2-pyrimidine-amine
derivatives (called, “formula I” in the patentapplication), and the
compounds thereof, the process for their preparation, and to
theirtherapeutic uses, in the later patent application, it was expressly
stated that the compounds offormula I included their respective salts):
Salt-forming groups in a compound of formula I are groups or
radicals havingbasic or acidic properties. Compounds having at
least one basic group or atleast one basic radical, for example a free
amino group, a pyrazinyl radical or apyridyl radical, may form
acid addition salts, for example with inorganicacids, such as
hydrochloric acid, sulfuric acid or a phosphoric acid, or
withsuitable organic carboxylic or sulfonic
acids.”Further:“Owing to the close relationship between the novel
compounds in free form andin the form of their salts, including
those salts that can be used as intermediates,for example in the
purification of the novel compounds or for the identificationthereof,
hereinbefore and hereinafter any reference to the free

76
 compoundsshould be understood as including the
corresponding salts, whereappropriate and expedient.
As regards the pharmacological properties of the compounds of
formula I it wasstated in the application:“The compounds of
formula I have valuable pharmacological properties andcan be used,
for example, as anti-tumoral drugs and as drags (sic drugs)
againstatherosclerosis.”
“The compound according to claim 1 of the formula I, said
compound being N-{5-[4-(4-Methyl-piperazino-methyl)-
benzoylamido]-2-methyl-phenyl}-4-(3-yridyl)-2-pyrimidine-amine
or a pharmaceu-tically acceptable salt thereof.”
The above-mentioned four instances, aptly give the narrative of
anticipation of the ImatinibMesylate (beta crystal form). It is therefore,
inferred, ImatinibMesylatein beta crystal form is not outside the
Zimmermann patent and does not constitute an invention as understood in
the law of patent in India, In light of the discussions made above, it can
be deduced that ImatinibMesylate(beta crystal form) is not a new
product; it is not above the anticipatory power of Zimmermann
patent to any extent.Zimmermann patent itself had the capacity of
teaching of beta crystal form of imatinibmesylate, not upto
“imatinibmesylate” only.ImatinibMesylate is a known substance in
Zimmermann patent itself. Not only is ImatinibMesylate known as a
substance in Zimmermann patent, but all its pharmacological
properties are also publicly known not only from Zimmermann
patent, but also from the articles published in the afore-mentioned
international journals.
V. Invention Not Patentable (Section 3 D, Patents Act)
Next point of debate cropping up in the domain of patent is section 3(d) of
patents Act. The apex Court in NovertisA G v. Union of India, by
upholdingsection 3(d), as representing “patentability”, a concept distinct
and separate from “invention”, which can supersede “novelty”, rejected
IMATINIB MESYLATE IN BETA CRYSTAL FORM as not patentable
invention: 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. The larger questions remain to be answered: is section
3(d) a higher standard above “novelty” to be determined after ascertaining

77
“novelty” or is the determination of “novelty” sufficient enough to prove
that it is not barred by section 3(d)?
V.I. Higher Standard of Patentability Above Novelty
It is evident from the relevant part of the judgment, that this exclusion
clause sets a higher order of patentability. It implies that after fulfilling
the criteria of “novelty”, the claimed invention has to cross another hurdle
i.e. section 3(d), for obtaining patent:
102. But examined in thelarger perspective of the development of
the law of patent over the past 100 years andespecially keeping in
mind the debates in the Parliament preceding the 2005 amendment,
itwould appear completely unacceptable.There is noforce in this
submission that section3(d) is a provision ex majorecautela. To our
mind, the submission completely misses thevital distinction
between the concepts of invention and patentability-a distinction
that wasat the heart of the Patents Act as it was framed in 1970, and
which is reinforced by the2005 amendment in section 3(d).
103. The importance of the amendment made in section3(d), cannot
be under-estimated. It is seenabove that, in course of the
Parliamentary debates, the amendment in section 3(d) was theonly
provision cited by the Government to allay the fears of the
Opposition membersconcerning the abuses to which a product
patent in medicines may be vulnerable. Therefore, (there is) no
doubt that the amendment/addition made in section 3(d) is meant
especiallyto deal with chemical substances, and more particularly
pharmaceutical products. Theamended portion of section 3(d)
clearly sets up a second tier of qualifying standards forchemical
substances/pharmaceutical products in order to leave the door
open for true andgenuine inventions but, at the same time, to
check any attempt at repetitive patenting orextension of the
patent term on spurious grounds.
Therefore, according to apex Court, section 3(d) throws up a “second tier
of qualifying standard” or “an extension of the definition of
invention” “a different standard for qualifying as “invention”or ‘sets
the invention threshold further higher”. This challenges the very
basic of patentability criteria.
V.II. Enhanced Efficacy Test
78
With regard to the second part of exclusion clause, (invoked by
Supreme Court), the Supreme Court is of the view that that there is no
enhanced efficacy in IMATINIB MESYLATE BETA CRYSTAL FORM
than what was existingin IMATINIB (including MESYLATE) for the
following reasons:
The patent application contains a clear and unambiguousaverment
that all the therapeutic qualities of beta crystalline form of
ImatinibMesylate arealso possessed by Imatinib in free base. The
relevant extract from the patent application isonce again reproduced
here:“It goes without saying that all the indicated inhibitory
andpharmacological effects are also found with the free base, 4-
(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)
pyrimidin-2-ylamino) phenyl] benzamide, or other cells thereof.
The present inventionrelates especially to the b-crystal form of the
methanesulfonic acid additionsalt of a compound of formula I in the
treatment of one of the said diseases orin the preparation of a
pharmacological agent for the treatment thereto.”
Now, when all the pharmacological properties of beta crystalline
form of ImatinibMesylate are equally possessed by Imatinib in free
base form or its salt, where is thequestion of the subject product
having any enhanced efficacy over the known substance ofwhich it
is a new form?
The highersolubility that is attributed to the beta crystalline form of
ImatinibMesylate may actuallybe a property of
ImatinibMesylateitself. One does not have to be an expert in
chemistry toknow that salts normally have much better solubility
than compounds in free base form. Ifthat be so, the additional
properties that may be attributed to the beta crystalline form
ofImatinibMesylate would be limited to the following:i. More
beneficial flow properties,ii. Better thermodynamic stability, andiii.
Lower hygroscopicity.
What is “efficacy”? Efficacy means37 “the ability to produce a
desired or intendedresult”. In other words, the test of efficacy would
depend upon the function, utility or thepurpose of the product under
consideration. Therefore, in the case of a medicine thatclaims to

37
The New Oxford Dictionary of English, Edition 1998.
79
 cure a disease, the test of efficacy can only be “therapeutic
efficacy”. Thequestion then arises, what would be the parameter of
therapeutic efficacy and what are theadvantages and benefits that
may be taken into account for determining the enhancementof
therapeutic efficacy? With regard to the genesis of section 3(d), and
more particularlythe circumstances in which section 3(d) was
amended to make it even more constrictivethan before, we have no
doubt that the “therapeutic efficacy” of a medicine must be
judgedstrictly and narrowly. Our inference that the test of enhanced
efficacy in case of chemicalsubstances, especially medicine, should
receive a narrow and strict interpretation is basednot only on
external factors but there are sufficient internal evidence that leads
to the sameview. It may be noted that the text added to section 3(d)
by the 2005 amendment laysdown the condition of “enhancement of
the known efficacy”. Further, the explanationrequires the derivative
to “differ significantly in properties with regard to efficacy”.
Whatis evident, therefore, is that not all advantageous or beneficial
properties are relevant, butonly such properties that directly relate
to efficacy, which in case of medicine, as seenabove, is its
therapeutic efficacy.
In whatever way therapeutic efficacy may be interpreted, this much
is absolutely clear: that the physico-chemical properties of beta
crystalline form of ImatinibMesylate, namely (i) more beneficial
flow properties, (ii) better thermodynamic stability, and (iii) lower
hygroscopicity, may be otherwise beneficial but these properties
cannot even be taken into account for the purpose of the test of
section 3(d) of the Act, since these properties have nothing to do
with therapeutic efficacy.
The position that emerges is that just increased bioavailabilityalone
may not necessarily lead to an enhancement of therapeutic efficacy.
It is quite clear thatIMATINIB MESYLATE(beta crystal form)has not
yielded in any further efficacy compared to what was existing in
IMATINIB IN FREE BASE FORM (including IMATINIB MESYLATE).
This is due to the reason that all forms of IMATITIB, belong to same
species and do not fall under different genre.Moreover, as it is “mere
discovery”, it is quite conceivable that it would not be able to show any
enhanced efficacy, then that of IMATINIB itself.Moreover, had there

80
been any “enhanced efficacy”, the question of its being“novelty” would
not have arisen.
VI. Some Concluding Comments
i. Section 3(D), Patents Act is Unnecessary
The first part of section (3) (d)38which has been invoked by Supreme Court
to negate the patentability of ImatinibMesilate, (beta crystalline form)is:
“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.”
While negating the claim for patent on IMATINIB MESYLATE, BETA
CRYSTAL FORM, Supreme Court has invoked the said section
erroneously; the truth is that the section 3(d) itself is faulty and does not in
any way sets a higher standard of patentability (as second qualifierto prove
invention, as has been interpreted by the apex Court) by making some
inventions patentablewhile excluding some others. It is not at all an
extension of the definition of invention. Neither section 3(d) of Patents Act
(India) sets a second tier of qualifying standard nor does it set the invention
threshold further on higher ground. If this is so, it becomes inconsistent
with WTO-TRIPS, which mandates the sovereign states to follow a
uniform and minimum standard of patentability and the states are not
in any way, are allowed to deviate from that threshold, by putting up a
further stiff condition: “Members shall give effect to the provisions of
this Agreement. Members may, but shall not be obliged to, implement
in their law more extensive protection than is required by this
Agreement, provided that such protection does not contravene the
provisions of this Agreement39”.

But, that does not necessarily mean that the decision of the apex Court is
untenable as it did not endorse the claim of patent. Without invoking
section 3(d) in a wrong way, the Supreme Court of India could have done
it; in fact it did relying on “novelty” criteria. As the Supreme Court of
India, did it on the basis of wrongful interpretation of section 3(d), by
rejecting the claim of IMATINIB MSYLATE (BETA CRYSTAL FORM)
as an invention, it sent a wrong message to the IPR world that India has

38
Patents Act 1970.(Act No. 39 of 1970).
39
PART I, GENERAL PROVISIONS AND BASIC PRINCIPLES, Article 1,
Nature and Scope of obligations, Agreement on Trade Related Aspects of
intellectual Property Rights, page 319.

81
heightened the standard of patentability criteria over and above WTO-
TRIPS, by not complying with it.
Secondly, section 3(d) can never be an exception to section 2(1) (j) of
Patents Act. Any ‘invention’ after having satisfied the tests of novelty,
inventive step and industrial application, cannot be denied patent simply for
failing to satisfy the tests laid down in its 3(d). This question even does not
arise at all. By definition, a trifling change can never be able to live up to
the threshold of “novelty”. Once an ‘invention’ becomes anpatentable
after fulfilling the criteria of ‘novelty’, ‘inventive step’ and “industrial
application”, it goes without saying that it is not mere discovery of a
new form of a known substance which does not result in the
enhancement of the known efficacy of that substance. First of all,
neither an invention cannot be treated as “mere” nor can “mere” be
‘novel’ in nature and in characteristic. Secondly,the word ‘discovery’
prefixed with new form of a known substance which does not result in
the enhancement of the known efficacy of that substance, is
diametrically opposite to the concept ‘invention”.DISCOVERY cannot
be an INVENTION in any way; similarlyINVENTION can never be
DISCOVRY; DISCOVERY as such will never be able to satisfy the
tests of ‘novelty’ and others. As section 3(d) is all meant for
“discovery”, it will always remain outside the purview of any
“invention” so far. Though the wisdom of the parliamentarians are not
being questioned (as this is only point to allay the fears from their minds to
give assent to the amendment in Patents Act), but the fact remains that the
criteria of “novelty”, “inventive-step” and “industrial application” are fair
enough to repudiate any of the trivial claims for patent. Therefore,
ImatinibMesylete (beta crystaline form) is not at all ‘novel’ in true sense.
i.e. 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” under section 2(l).
Hence, section 3(d) is a provision put in ex abundanticautela non nocet40to
alley all the reasonable doubts. The preliminary purpose of section 3(d) is to

40
Abundant caution does no harm.
82
prevent “ever-greening41” of patent and to encourage genuine inventions. It
is absolutely right that the sub-section concerned becomes operational only
as ex majorecautela42.

Additionally, ‘efficacy test’ could also have come under section 2(l) of
Patents Act. As, the documents, accepted as “prior art” regarding all the
derivatives of N-phenyl-2-pyrimidine-amine, do not show anything novelty
in IMATINIB MESYLATE BETA CRYSTAL FORM; which is why, it
could not show any “enhanced efficacy” stemming from IMATINIB
MESYLATE BETA CRYSTAL FORM. Had it shown anything new or
novelty, definitely it would have resulted in an enhanced efficacy. If it
cannot pass the test of “novelty”, it is not possible to pass the “enhance
efficacy test”. But if it passes the “enhanced efficacy test”, without any
difficulty, it also would be able to pass the hurdle of “novelty”.
Similarly, if any product or process does not result in “enhanced
efficacy”, it is absolutely impossible for it to be “novel” in nature. So
“enhanced efficacy” and “novelty” are interlinked and both mutually
inclusive. This is also evident that the relevantderivative of N-phenyl-2-
pyrimidine-amine i.e. ImatinibMesylateand its various forms (including
beta crystal form), is “prior art” and disclosure of all thenatural
physic-chemical properties of ofImatinibMesylate(beta crystalline
form) goes along with it, (which does not in any way enhance the
efficacy of the so called new anti-cancer drug than that of the earlier
one).So while determining the fact that whether to grant or not to grant
patent, there is no need to turn to section 3(d) of Patents Act.If any
medicine based on a little improvement of the basechemical materials,
does not actually enhance in the “pharmaceutical efficacy” of that
medicine, from the earlier one, it cannot be termed as
“novel”.Therefore, section 3(d) should be deleted from the Actas for its
redundancy; it cannot be even ex majorecautela as it deals with
“discovery”.
ii. Innovation Should Be Encouraged as New Form of Intellectual Property

41
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. The coverage/protection afforded by the alleged new
invention is then used to extend the patentee’s exclusive rights over the product,
preventing competition.
42
Out of abundant caution.
83
Attempt for ever-greening of patent in India, is occurring, which is a
disturbing feature. One of the reasons is that there is no recognition of petty
patent, a legal mechanism to encourage small or incremental innovations
but just short of invention. As has been pointed out earlier as there is no
“petty patent” or similar types of IPR protection India, therefore, companies
or individuals are seeking to get their small innovations patented, through
various means though those are not worthy to be called as inventions.
Sometimes, people by indulging in manipulations or by tweaking are
pursuing the wrong inventions to get patent cover. Absence of law
encourages people to resort to corrupt practices. Law should not be a
mechanism to encourage corruption in the society. Had there been legal
provisions, the scientists or researchers could have applied for “petty
patent” or similar type of IPR protection for their genuine innovations
(which otherwise could not have been patented).This is one shortcoming of
the legal framework (IPR) of India. A model law for IPR protection in a
country must have some mechanism to motivate innovations. As far as
number of patent applications (by Indians) and grantof patents are
concerned, India is seriously lagging behind than countries likes USA, UK,
JAPAN, CHINA. Times of India reported43 the following truth:
India is the top region for innovation in Asia, as per a recent report.
This might seem like excellent news, till we ask how much of this
innovation is truly Indian? According to Patent Office, over 70% of
the patents filed in the country are by MNCs. Indian companies and
academia share the remaining 30%. Currently we rank 66th on the
Global Innovation Index List. That places us 41 places behind China.
According to the World Intellectual Property Organisation (WIPO)
India filed 1,423 international patents in 2015, US filed 57,385, Japan
44,235, China 29,846 and South Korea 14,626. On a list of the
world’s most innovative companies, only one Indian organisation
Asian Paints ranks in the top 20 at 18. Hindustan Unilever comes in
at 31. The top 10 list is dominated by the US.
The report shows a very dismal performance of Indian scientists and
researchers in the global map of Intellectual Property Rights. A time has
come to take some bold decisions so that in near future India can emerge as
innovation capital of the world. National IPR Policy of India, should be to

43
The Times of India, April, 25, 2017, page 10. (Can India Innovate? )R.K.Mishra
and SarvSaravan).
84
encourage Indian scientists and researchers to invent moreat par with the
developed countries. But no one can expect that at one go, Indian scientists
and researchers suddenly, in large numbers will be inventing products and
processes which are worthy to be patented. The country has to prepare the
intellectual soil for its scientists and researchers so that one day they could
compete with other developed countries. On this journey, if there is a law
which will encourage innovations in the form of petty patents or similar
types of IPR, it will be creating a congenial eco-system. What can be better
motivating factor than insertion of required provisions in Patents Act itself
(without enacting another Act) for patty patents or similar types of IPR, for
those small innovations which cannot fulfil all the patentable criteria. As
Indian scientists or researchers are not in a position now to come up with
huge numbers of patents, thereby, at first, they should get accustomed with
innovations. Let Indian scientists and researchers apply their intelligentsia
and engage resources to come up with more innovative products or process
in the country. While doing this, little by little they will start inventing
products and processes which can fulfil patentability. Unless, innovations
are recognised, they will not be able to raise their intellectual minds and
augment capacity to the next higher level.
iii. [Innovative Patent44of Australia (along with some exceptions) are
worthy to me mentioned]:

Innovative step45: (4) For the purposes of this Act, an invention is to

be taken to involve an innovative step when compared with the
prior art base unless the invention would, to a person skilled in the
relevant art, in the light of the common general knowledge as it
existed (whether in or out of the patent area) before the priority date
of the relevant claim, only vary from the kinds of information set
out in subsection (5) in ways that make no substantial contribution
to the working of the invention; (5) For the purposes of subsection
(4), the information is of the following kinds:(a) prior art
information made publicly available in a single document or
through doing a single act;(b) prior art information made publicly
available in 2 or more related documents, or through doing 2 or
more related acts, if the relationship between the documents or acts
is such that a person skilled in the relevant art would treat them as a

44
Patents Act 1990, (Act No. 83, 1990) Australia.
45
Section 7 (4), (5), (6).
85
 single source of that information.(6) For the purposes of subsection
(4), each kind of information set out in subsection (5) must be
considered separately.
Patentable inventions for the purposes of an innovation patent46:
(1A) Subject to subsections (2) and (3), an invention is a patentable
invention for the purposes of an innovation patent if the invention,
so far as claimed in any claim:(a) is a manner of manufacture within
the meaning of section 6 of the Statute of Monopolies; and(b) when
compared with the prior art base as it existed before the priority
date of that claim:(i) is novel; and(ii) involves an innovative step;
and(c) is useful; and (d) was not secretly used in the patent area
before the priority date of that claim by, or on behalf of, or with the
authority of, the patentee or nominated person or the patentee’s or
nominated person’s predecessor in title to the invention.(2) Human
beings, and the biological processes for their generation, are not
patentable inventions.

iv. Likely to the innovative patent of Australia, Japan also has a utility
model to encourage small innovations47. The purpose is to
encourage devices by promoting the protection and the utilisation of
devices48:
Conditions for Utility Model49: A creator of a device that relates to
the shape or structure of an article or combination of articles and is
industrially applicable may be entitled to obtain a utility model
registration for said the device, except when the following applies:(i)
the device was publicly known in Japan or a foreign country, prior to
the filing of the application for a utility model registration
therefor;(ii) the device was publicly worked in Japan or a foreign
country, prior to the filing of the application for a utilitymodel
registration therefor; or(iii) the device was described in a distributed
publication, or a device that was made publicly available through an
electric telecommunication line in Japan or a foreign country, prior to

46
Part 3-Validity, Division 1, section 18.
47
Utility Model Act (Act No. 123 of 1959).
48
Article 1. (device means the creation of technical ideas utilising the laws of
nature, relating to the shape or structure of an article or combination of articles,
and thereby, to contribute to the development of industry.
49
Article 3 (1).
86
 the filing of the application for a utility model registration
therefor.(2) Where, prior to the filing of the application for a utility
model registration, a person ordinarily skilled in the art of the device
would have been exceedingly easy to create the device based on a
device prescribed in any of the items of the preceding paragraph, a
utility model registration shall not be granted for such a device
notwithstanding the preceding paragraph.

v. To have the IPR protection, in Australia, the innovation must be at

first “novel” and then it must show “innovative step”, a quality just
short of “inventive step”. In tune with Australia, India can have a
innovative patent regime. The first criterion is all about simple
“novelty’. As far as the second criteria is concerned, it is to be
ascertained that the claimed innovation makes some incremental
contributions, though it was obvious, but very much surprising (to a
person skilled in this art) as it was not thought of earlier to put in
place and not acted on it.In the same way, India can also have a
utility model, as new form of IPR, the way Japan grants.The criteria
for granting “utility model” is that the shape or structure of an
article or combination of articles, has not been described in the
“prior art”, not publicly known and obviously has not been worked
out. All that it emphasises is nothing but simple “novelty”. But the
second criteria are just short of inventive-step; to a person
ordinarily skilled in the art of the device or structure, it would
not have been exceedingly easy for that person in creating the
device or structure. It therefore, implies that the new device or
structure though obvious, but it was tough for any ordinary skilled
person in innovating the new device or structure (not exceedingly
easy). It does not necessarily mean that India must replicate those
AUSTRELIAN MODEL or JAPAN MODEL. India can have its
own sui generisIPR regime to encourage and protect innovations-
with “quasi-novelty”wherein the specific “a priori knowledge”
regarding product or process as the case may be, was not in use,
though there has been disclosure (in the form of coverage), but it
was not enabling in nature from any form of “prior art”. Second part
of the criteria is to be an “innovative step” likely. Or in the
alternative, simple “novelty” without considering “inventive-step”at
all, may be a ground for granting “petty patent” or similar type of
IPR in India. The second avenue is quite convenient, because the
87
 term “innovate” entails something new (therefore novel in
nature) sans “inventive step”. Both “innovation” and “new or
novel” are synonymous or similar in nature and content. The
term INNOVATE is therefore (i). to change (a thing) into
something new; (ii). to introduce (something) for the first time50;
(iii). to bring in or introduce novelties; (iv). to bring in
(something new) for the first time51.Hence, only on the basis of
“newness”or “novelty” in the field of science and technology,
without taking recourse to “innovative-step” a petty patentor
innovative patent can be granted, in India.
vi. Defence Mechanism is a Hindrance to Encourage Innovation
In an interview, Patrick Kilbride, Executive Director of International
Intellectual Property at US Chamber of Commerce’s Global intellectual
Property Centre52 highlighted some of the loopholes with India’s IPRs:
The only statement in that area of statute is that we are already TRIPs
compliant. That does not send a good message to innovative
industries. On the other hand, in terms of recognition of positive
contribution of intellectual property towards investment in the
innovative spaces it sends a different message. That’s why I say it
comes across as ambivalent. We think TRIPs by itself is insufficient
to launch India into the group of countries that are leading the global
knowledge economy. It is insufficient to drive large scale innovation
and investment in India. It would take two times TRIPs to put India
into that tier of countries. We are looking at how we can encourage
unilateral adoption of strong IP rights so that it is a sovereign policy
choice and not a concession in a free trade agreement. The case we
are trying to make is that intellectual property is not something you
do for your trading partner in order to gain access. It is something
that you invest in for the strength of your own economy for the sake
of domestic innovation. In many ways we would like to get out of the
trade agreement space and focus on countries acting unilaterally to

50
The New Shorter Oxford English Dictionary, Edited by Lesley Brown, Volume I,
Clarendon Press, Oxford, 1993, Page 1373.
51
The Oxford English Dictionary, (Second Edition), Volume-VII, Clarendon Press,
Oxford, (prepared by J.A.Simpson& E.S. Weiner, 1991, Page-997.
52
India is Trips Compliant; Our Response is Who Cares? The Times of India, April,
07, 2017 at page 7.
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 build their own legal infrastructure for innovation. We want it to be
organic.
What Mr. Patrick Kilbride is advocating, partially there is truth in it. In this
journey of making IPR regime robust and dynamic, USA also has a long
way to go, either by amending section 102 of US Code, which does not
recognise “prior use” in any other country except USAor by fully stopping
bio-piracy (sometimes in the name of bio-prospecting)where there is no
benefit-sharing with the holders of traditional knowledgeof Indian
medicinal plants. Keeping own country above any change, will not augur
well in this globalised world. However, in India there has to be a change in
the mindset of the policy makers. The approach so far has been to adopt a
‘defence mechanism’. This mechanism negatively teaches to take a decision
keeping in view to prevent the developed countries from taking any
advantage from the system. Which country would or might take the
advantage of a country’s law and national policy that should not be the
determining factor for a country’s march towards development.Determining
factor for a country’s law and national policy as far as IPR is concerned,
should be whether at present or in future will the country itself be able to
take the full advantage of it or not. From this perspective, the recognition
for petty patent or innovative patent for innovative products and processes,
will go a long way in encouraging innovations. This negative approach
cannot be a policy of a country which enriched with rich cultural heritage
like India, the country which now is trying to build up its fortune on
knowledge based economy and wants to become a global leader by 2022.
The country must be confident with its intelligentsia and capability to win
over other developed countries in the field of INTELLECTUAL
PROPERTY RIGHTS.Unless, Indian intelligentsia is forcefully or
otherwise, pushed into in innovating, no one can expect that suddenly they
would come out with big inventions. Before, the intelligentsia are
cognitively prepared in inventing, a preparation of soil is needed. So
recognition of petty patent or innovative patentis the preparation of that
intellectual soil. It is very surprising as to why was petty patent or
innovative not recognised earlier? Was there any national and international
conspiracy by some vested interested groups, to keep the Indian
intelligentsia dwarf or incompetent? So that Indian economy could never be
able to be knowledge based and as the Indian intelligentsia will not be
growing to invent, it would be easier to control the entire market.How long
time will this negative protection mechanism continue? Unless, scientists or
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researchers are given an eco-system to encourage innovative ideas, nothing
positive can happen in this country. And what can be more encouraging
than recognitionof IPR over innovations (something short of invention)
as new form of intellectual property right-a preparation of the
country’s intelligentsia for bright future,for making the fundamental
base of country’s economy in knowledge.

vii. No Place of Petty Patent in National IPR Policy, India

While pointing out the significance of strong and effective, IPR
protection in a country like India, in the introductory part, the
National IPR Policy53 stated:
Creativity and innovation have been a constant in growth and
development of any knowledge economy. There is an abundance of
creative and innovative energies flowing in India. The evolution of
the film and music industry; the contribution of the Indian
pharmaceutical sector in enabling access to affordable medicines
globally and its transformation to being the pharmacy of the world;
richness and versatility of the Indian systems of medicines such as
Ayurveda, Unani, Siddha and Yoga; the advances made in the
Indian space programme and the pioneering role of our scientists in
keeping it cost effective; these are but a few examples of these
energies.
While India has always been an innovative society, much of the
intellectual property (IP) created remains unprotected both on
account of lack of awareness and the perception that IP protection is
either not required or that the process to obtain it is unnecessarily
complicated. The rationale for the National IPR Policy lies in the
need to create awareness about the importance of intellectual
property rights (IPRs) as a marketable financial asset and economic
tool.
India has robust IP laws and a strong IP jurisprudence. The legal
framework does reflect the underlying policy orientation and
national priorities, which have evolved over time, taking into
account development needs and international commitments. An all-
encompassing IPR Policy will promote a holistic and conducive

53
National intellectual Property Rights Policy (2017), Department of Industrial
Policy and Promotion, Ministry of Commerce and Industry, Government of India.
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 ecosystem to catalyse the full potential of intellectual property for
India’s economic growth and socio-cultural development, while
protecting public interest. Such a policy will nurture the IP culture,
guiding and enabling all creators and inventors to realize their
potential for generating, protecting and utilizing IPRs which would
contribute to wealth creation, employment opportunities and
business development. This policy shall weave in the strengths of
the Government, research and development organizations,
educational institutions, corporate entities including MSMEs, start-
ups and other stakeholders in the creation of an innovation
conducive environment.
The policy lays down seven objectives for the accomplishment of
which the nodal Ministry or Department of Governments is expected
to undertake some steps. It is very unfortunate that the recognition of
innovative or petty patents (as new form of IPR to encourage and
protect innovations) is not figured out in those seven objectives of
India’s National Intellectual Property Rights Policy. Therefore, there
is no question of its being evident in the steps to be undertaken.
Unless and until, India enacts a law to grant petty or innovative
patents (without enacting a law also it is possible if, some new sections
are inserted in the existing Patents Act) then whatever may be the
VISION or MISSION STATEMENT of recently framed National IPR
Policy, (India), it would remain partially discontented.

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