the expression ‘infringement’ is not defined under the Patents Act, it is understood to mean any intrusion into the

‘scope of
the invention for which protection is claimed’. Acts which violate the rights of a patentee, against which the patentee has a
remedy.’ infringement of a patent is an action founded on tort. Infringement is in effect the violation of the exclusive right of a
patentee granted under the Patents Act.

 Patents Rules 2003. As it was before the patents (Amendment) Rules 2006,
The exclusive right to prevent third parties from making, using, offering for sale, selling or importing patented
product in India / using the process in India and offering for sale, selling or importing for those purposes the product
obtained directly by that process in India, for a term of twenty years from the ___day __ 20 _and of authorising any
other person to do so.

the scope of monopoly rights conferred on the patentee; the conditions subject to which a patent is granted, and the
exceptions to infringement.

 Provisions Under the Patents Act 1970

1. The Patents Act defines infringement indirectly. A combined reading of Ss 10(4)(c) and 48 will detail the scope of
the monopoly rights of the patentee for which protection can be claimed.
2. A patent is granted under the Patents Act subject to certain conditions detailed in s 47. Any action within the
purview of s 47 will not amount to an infringement.
3. The Patents Act also specifically excludes certain acts from infringement; In Ss 49 and 107A. Under s 107, a person
against whom an infringement action is instituted may take up as a defence any ground on which a patent may be
revoked under s 64.

protection is contained in the claim of a specification which defines the scope of the invention. alleged act came within the
scope of the specification and the claims. determine whether there has been an infringement the following questions have to
be considered:

1. Whether the alleged act fell within the scope of the invention as defined in the claims.
2. Whether the alleged act violated any right of the patentee as defined under the Patents Act.
3. Who is liable for the alleged act?
4. Whether the alleged act fell within the acts which do not amount to infringement under the Patents Act or under any
other valid exception.

the scope of the invention

The first step in determining whether there has been an infringement of a patent would be to determine the scope of
protection offered to the invention. As patents are granted for inventions patentable under the Patents Act, infringement has
to be determined with regard to what is claimed as an invention under the Patents Act. A patent protects the invention which
is claimed in the claim. As issues of validity and infringement are likely to arise in the same proceedings, the standards of
construction must necessarily be the same in revocation and infringement proceedings.

Farbwerke Hoechst AG v Unichem Laboratories AIR 1969 Bom 255,

In an infringement action the ‘main function of the court is to construe the claims which are alleged to have been infringed,
without reference to the body of the specification, and to refer to the body of the specification only if there is any ambiguity
or difficulty in the construction of the claims in question’. the scope of the protection offered to the invention is determined
by applying the principles of construction,

Act VIOLATES THE RIGHTS OF THE PATENTEE

The second step involves a determination whether the alleged act violated any right of the patentee under s 48 of the Patents
Act. The right to take action on infringement accrues only after the grant of a patent, that too in respect of acts committed
after the date of publication of the application. An infringement action would lie only if there is infringement of the claims as
published and as granted. The term of a patent may come to an end due to any of the circumstances mentioned in the Patents
Act, like expiry of term, non-payment of renewal fees, surrender or revocation. The acts that constitute infringement are
essentially the acts which violate the right of a patentee under the Patents Act. The rights of a patentee are detailed in s 48 of
the Patents Act
‘Without consent

only an act done without the consent of the patentee will amount to an infringement.

Dunlop Pneumatic Tyre Co v Neal (1899) 16 RPC 247

But where the patentee gave no instructions to the defendant to do a specific act, the defendant's act of repairing the
product of the patentee will amount to infringement."

Infringement of a Product

‘Making’

making and selling separate parts of a patented instrument, whose parts can be put together without any difficulty by any
ordinary skilled workman, will constitute an infringement of the patented product.” The person who manufactures the parts
and the customers who assemble will be liable as joint tortfeasors. Section 140(4)(c) of the Patents Act makes provisions for
repair of patented article. Repair involves the replacement or renewal of part or parts of an article. By definition, a repair of a
patented article 1s an act which does not amount to the making of it Repairing a patented product will come under the ambit
of the term ‘making’ if such repair is only a guise for making the product.” A repair of a patented article has been compared
with an implied licence, such that ‘any purchaser of such an article, whether from the patentee or from a licensee of the
patentee or from a purchaser from the patentee or such a licensee or purchaser, is impliedly licensed to carry it out or to
contract with someone else to carry it out for him’.

‘Using

Possession with the intention of ‘using’ the articles for trade purposes and for the securing of a profit would amount to an
infringement. But possession by a carrier or a warehouseman, who innocently carried or stored the infringing goods for a
consignor or consignee, will not amount to an infringement.” An injunction, in respect of a patented product, may be granted
even if there is no actual infringement by the user of the product. Even if there is no actual use, an injunction may be granted
where there is a threat of potential use.

‘Offering for sale’

‘Offering for sale’ would include an advertisement or a pre- contractual negotiation to supply a patented product.”* If,
pursuant to the offer, the supply of the product happens during the term of the patent, it would certainly amount to
infringement. An injunction may be obtained to restrain such acts.”” But negotiations during the term of a patent to supply
after the expiry of the patent will not amount to infringement.”

Selling’

The expression ‘selling’ or ‘sale’ would include any form of commercialisation. There can be no infringement if the property is
passed on to a purchaser in a foreign country. if the patentee has assigned his rights in the patent, the patentee will not be
allowed to manufacture the product abroad and import them to sell the same in a country where the said patent has already
been assigned. ‘importing with a view of selling in export market’, ‘purchase and possession with a view to sale’, etc.*° An
injunction may be granted to restrain the defendants from exporting the allegedly infringing goods.

‘Importing’

‘Importing’ should be understood in the context in which it is used in s 48(a) of the Patents Act. the import for the purposes of
‘making, using, offering for sale or selling’ a product in India without the consent of the patentee. Both the vendor and the
purchaser will be liable for infringement. Regardless of the person in whom the property in the goods vested, they would be
jointly implicated in a transaction the effect of which was to infringe the patent law of the country, and they will both be liable
as principals in the transaction.”” In determining an importer, the court shall have regard to the person who has possession to
the title of the goods.” uses relating to the development and submission of information required under any law in India or
abroad that regulates the import of any product will not amount to an infringement. importation of patented products by any
person from a person who is duly authorised under the law to produce and sell or distribute the product will also not amount
to an infringement of such a product.
 Infringement of a Process

Use of the Process

The use of a patented process can amount to an infringement of that process. The use of the process is different from use of
information relating to the process.

‘Product obtained directly from that Process

In Section 48(b) The expression ‘obtained directly will mean obtained without an intermediary. It would signify products which
are the direct and immediate result of applying the process. The product will be considered to have been ‘obtained directly’
even if the product is subject to further processing such that it does not lose its identity and retained its essential
characteristics.’ But if the output of a patented process was transformed by further processing into an inseparable component
of a composite object, it can no longer be regarded as a product directly obtained by a process.

principal will be liable for the acts

commited by his agents and servents.

wokman who aids in the infringement

Agent innocently shall not be liable for the
infringement

employer will be vicariously liable for the acts

od his employees

Infringement by whom
the person must have conspire with teh tortfeasor or procures or
induced his commission of the tort. in other words, there must be a
common dsign to do an act. such common design should result in an
Joint Tortfeasors
act committed in furtherence of such design. the conduct of a person
that makes him liable as a joint tortfeasor will depend on the fact and
cercumstances of each case

a director of the defendent company may be joined as a party

to an infringement suit if common design can be shown with
corporate regard to the acts committed by the defendents. a director
entity shall not be made liable for an act of infringement unless his
involvement would make him liable as a joint tortfeasor if the
company had not existed

the knowledge or the intention is not relevant. But where the patentee acquiesced, by his conduct, from taking any action on
the infringement, he will be denied the relief of injunction. However, a defendant will be not be liable for damages or an
account of profits if he proves that at the date of the infringement he was not aware or had no reasonable grounds to believe
that the patent existed.
Act Must NOT BE AN EXCLUDED ACT

Government Use Sections 47(1) and 47(2)

A patent is granted subject to the condition that the government may employ it for its own use. Any process or product which
is the subject matter of a patent may be imported or made by the government for its own use. The government may also use
any process which is a subject matter of a patent for its own use. These acts shall not amount to an infringement of a patent.

Experiment and Research: Section 47(3)

any person may make or use any patented product or a product made by a patented process or use a patented process for the
purpose of experiment or research. Imparting instructions to pupils is expressly covered under the sub-section.’ Expression
experiment’ will be understood better when one reads it along with the expression ‘research’ as it appears in the sub-section.
The kinds of experiment contemplated in this exception are the ones that lead to finding out something that is unknown.”

Monsanto Co v Stauffer Chemical Co, Dillon LJ

Trials carried out in order to discover something unknown or to test a hypothesis or even in order to find out whether
something which is known to work in specific conditions, eg of soil or weather, will work in different conditions can fairly, in
my judgment, be regarded as experiments.

Import of Medicine or Drug: Section 47(4)

government may import such medicine or drug for its own use or for distribution in any dispensary, hospital or other medical
institution maintained by or on behalf of the government or any other dispensary, hospital or other medical institution which
the Central _ Government, having regard to the public service rendered by such institution, may specify in the Official Gazette.

Patents in Foreign Vessels, Aircrafts, Vehicles: Section 49

acts mentioned in s 49 of the Patents Act will not amount to infringement. use of the invention in the body of the vessel or in
the construction or working of the aircraft or land vehicle.' The provision protects ships involved in inter-state passage. The
expression ‘temporarily’ refers to entry that is transient or for a limited period of time. The fact that the same journey is
repeated over and over again into the territorial waters, does not alter the temporary nature of the entry. The section works
on the principle of reciprocity.

Defences to Infringement: Section 107

every ground on which a patent may be revoked under s 64 shall be available as a ground for defence. The making, using,
importation or distribution in accordance with any one or more of the conditions in s 47 shall also be a ground for defence in
an infringement suit.

‘Bolar exemptions’ and ‘Parallel importation’: Section 107A

Section 107A(a) exempts certain acts done for procuring regulatory approval with regard to patented products during the
life of the patent. It incorporates what is commonly known as the ‘Bolar exemptions. Section 107A(a) allows generic
companies to make preparations during the lifetime of a patent for commercial exploitation upon its expiry. aids generic
companies to bring cheaper generic versions of a patented product into the market soon after the expiry of the patent. All
kinds of pharmaceutical research will be covered by the above provision.

Section 107A(b) deals with international exhaustion of patent rights. Parallel importation’ refers to the importation of
patented products from a country in which the products are legally on the market. Article 6 of the TRIPS Agreement
specifically states that the dispute settlement mechanism under the TRIPS Agreement shall not be used to address the
issue of exhaustion of intellectual property rights. The only way in which a provision on international exhaustion can be
challenged invoking the TRIPS Agreement, would be on the ground that international exhaustion is selectively applied to
pharmaceuticals by violating the mandate of art 27 of the TRIPS Agreement

.
Defences

Title of plaintiff
•Title of plaintiff to the patent, it must produce evidence to
that effect and also show that the grantor had the
necessaary title to make grant When the defendant denies infringement, the
plaintiff has to show:

(1) 40 that the defendant committed the acts

complained of (ie, use of the invention); and
Defendent has leave or a licence
(2) that such acts infringed the patents of the
plaintiff (ie, such use was unauthorised).

Denial of infringement

Section 107A(a) exempts certain acts done for

Grounds of revocation (s.64) procuring regulatory approval with regard to
•prior publication patented products during the life of the patent. It
•prior use
•publicly known incorporates what is commonly known as the ‘Bolar
•what are not inventions exemptions.
•insufficiency
•person not entitled Section 107A(b) deals with international exhaustion
of patent rights. Parallel importation’ refers to the
importation of patented products from a country in
Defence to relief in damages or account of profit
which the products are legally on the market.
•innoent infringement s.111(1)
•non renewal of patent s.111(2)
•amendments after publication111(3)

The right to repair can be a defence against

right to continue manufacture s.11A(7) infringement and the same has to be specifically
•a patent holder cannot institute an infringement suit against a pleaded.
person who had made significant investment in respect of
pharma product under certain cercumstances mentioned in
s.11A(7) If the defendant is entitled to the grant of the
patent and if the patentee had wrongfully
obtained the patent, the pleadings should
acquiescence, laches and estoppel expressly state so.

•estoppel by judgment (s.11 CPC)

Barred by Limitation If the suit is barred by
•order 2rule 2 CPC
limitation, the defence must be expressly
pleaded.

right to repair s.140(4)(c)

Gillette Safety Razor Co v Anglo-American
Trading Co

patent is wongfully obtained he defence that ‘the alleged infringement was

not novel at the date of the plaintiff's letters
patent’ is a good defence in law, and would
barred by limitation sometimes obviate the great length and expense
of patent cases if the defendant could and would
put forth his case in this form, and thus spare
infringement not noval himself the trouble of demonstration on which
horn of the well-known dilemma the plaintiff
had impaled himself, invalidity or non-
infringement.
 The conditions for patentability
definition of ‘invention in s 2(1)(j). a patent would be granted if the three ingredients of novelty, inventive step and industrial
application are satisfied and if the invention does not fall under the statutory exceptions.

Any product or process could qualify for a patent if the following four requirements are met:

1. The invention must be new (novelty);

2. The invention must involve an inventive step (inventive step or non-obviousness);
3. It should be capable of industrial or commercial application (industrial application or utility);
4. It should not come under the inventions which are not patentable mentioned in ss 3 and 4 of the Act
(inventions not patentable).
5. Complete specification

The first three requirements, also known as positive requirements, are contained in s 2(1)(j) of the Act. It provides that the
invention must be ‘involve an inventive step and ‘capable of industrial application’.

The fourth requirement is a negative requirement which is contained in ss 3 and 4. A patent will be granted for an invention
only if it satisfies the first three requirements, and does not come under the fourth requirement. As stated above, the exceptions
in ss 3 and 4 have to be applied first before determining whether the conditions for patentability in s 2(1)(j) are satisfied.

The invention must be new (novelty)

A patent may be revoked on the ground 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 s 13. The above ground covers two kinds of anticipation,
ie:

(1) anticipation by disclosure (what was published in India or elsewhere) and;

(2) anticipation by use (what was publicly known or used in India).”

Novelty depends on various constituent concepts, such as ‘the state of the art’, ‘publicly known’, ‘publicly used’, ‘published’,
etc, which have been statutorily defined or judicially interpreted and understood by the patent laws of other countries. A
particular problem arises from the fact that these critical concepts have not been defined under the Patents Act.

To form a part of the state of the art there is no need for the information to be put to actual use. The mere fact that it was
available and was capable of being used by the public is sufficient. The possibility of accessing the information by a person will
determine whether it formed a part of the state of the art, even if ‘the public has not recognised their potential or taken
advantage of them’.

Priority Date
Section 2(1)(L) states that the date at which the novelty is to be assessed is the date of filing of the patent application with the
complete specification, ie the priority date. The state of the art includes information that is in the public domain before the
priority date. Though the priority date is usually the date of filing the patent application,’ there are instances where the priority
date is calculated from a previous date.”

Under the Patents Act, a patent may be held to be invalid due to the applicant’s own acts and disclosures which destroy novelty.
Thus priority date is relevant not only for assessing novelty but also for exploiting the invention without jeopardising any
potential patent.

INDUSTRIAL APPLICATION

The phrase ‘capable of industrial application’ is defined in s as 2(1) (ac) as follows: ‘capable of industrial application in relation
to an invention, means that the invention is capable of being made or used in an industry. The definition of invention does not
expressly provide for the utility of an invention as a criterion for a grant of a patent. However, lack of utility still remains a
ground on which a patent can be revoked. The phrase ‘capable of industrial application’ implies usefulness or utility. Before the
Patents (Amendment) Act 2002 substituted a new definition for the term ‘invention’, the term ‘industrial application’ did not
figure in the Patents Act. Though it is quite likely that the term ‘industry’ will be given a very wide connotation so as to include
any commercial undertaking, was given to the term ‘manufacture’ under the earlier provision,” a contrary view has also been
espoused. Under the old definition of ‘invention, an invention to be patentable had to be useful in addition to being a new
manufacture. The present definition of invention does not expressly provide for the utility of an invention as a criterion for a
grant of a patent. However, lack of utility still remains a ground on which a patent can be revoked. The old definition stipulated
the condition that for an invention to be patentable it must relate to a new and useful manner of manufacture

At one point of time, intellectual property was also known as industrial property.”’ Industry or trade was the area in which
intellectual property could be applied.” Similarly, ‘commercial application’ and ‘industrial application’ have been regarded as
related terms, and have been used alternatively. The term ‘industry’ should be given a wide interpretation. But, under the
Patents Act, the term will not include a method of agricultural operation. The term ‘industry’ shall be interpreted in the
broadest sense to include agricultural industries as well. Thus, there seems to be no express bar on inventions relating to
agriculture save the limited restriction that a method of agriculture cannot amount to an invention under the Patents Act. To
qualify as an invention, the claim must be tied down to the industrial activity so that it becomes a valuable invention restricted
to its proper sphere.

INVENTIONS NOT PATENTABLE

Apart from satisfying the three prerequisites of novelty, inventive step and industrial application, to qualify for a patent, an
invention should not be excluded from the categories mentioned in ss 3 and 4. These sections contain a list of inventions that
are not patentable. The list includes matters which are incapable of being the subject of legal monopoly (like an invention
contrary to established natural laws), matters excluded by policy (like inventions relating to atomic energy) and matters which
are protected by other forms of intellectual property rights (like copyright). The exceptions in these sections are exhaustive as
there is no express statutory wording to the contrary.’

zzzzzzzThe exceptions to patentability in ss 3 and 4 may be broadly divided into two forms of exceptions:

absolute and limited or conditional exceptions.

Absolute exceptions are unqualified exceptions which cannot be derogated from. Section 4 illustrates an absolute exception on
patentability of inventions pertaining to atomic energy.

Limited or conditional exceptions are those exceptions to patentability which are limited to particular circumstances or which
make the invention patentable if a particular condition exists. Section 3(e) illustrates a limited exception to patentability. An apt
illustration of a conditional exception is found in the first and the third parts of s 3(d) where the presence of certain conditions
can take the invention out of the purview of s 3.

A) 2.38 Frivolous Inventions and Inventions Contrary to Natural Laws: Section 3(a)

Any invention which is frivolous or which claims anything obviously contrary to well established natural laws is not patentable.
A patent will not be granted if it claimed a perpetual motion machine as it contravenes the laws of physics. A patent involving
a revolutionary concept will not be entertained if the person of average skill in the art would not be able to fill in the missing
details from his own knowledge or following reasonable trial and error. A patent for an improved plan for subterranean utility
distribution whereby housing estates are provided with supplies of gas, electricity and water and sewage disposal facilities was
held not patentable as the same was considered mischievous to the state by being generally inconvenient.

B) Inventions Contrary to Public Order or Morality: Section 3(b)

Inventions whose primary or intended use or commercial exploitation is contrary to public order or morality or which causes
serious prejudice to human, animal or plant life or health or to the environment are not patentable. The phrase ‘serious prejudice
to human, animal or plant life or health or to the environment’ was introduced to accommodate and clarify the expanding
meaning of the words ‘public order or morality’. (i) New Technologies 2.40 An invention should not be excluded as being not
patentable merely because a technology is dangerous. There is a general perception that new technologies will involve new
risks. In determining the merit of new technology there must be a careful weighing up of the risks vis-a-vis the positive aspects.
In the Harvard Onco-mouse case, the invention involved a provision of a type of test animal useful in cancer research, which
helped in a reduction in the amount of testing on animals. The case involved conflicting issues pertaining to the basic interest of
mankind to remedy widespread and dangerous diseases on one hand, and the protection of environment against the
uncontrolled dissemination of unwanted genes and cruelty to animals on the other hand. The Examining Division held that the
invention was useful in developing new and improved human anti-cancer treatments for the benefit of mankind, and concluded
that the invention could not be considered as immoral or contrary to public order.”

Article 53(a) of the EPC contains a similar provision on the prohibition of patents, the grant of which may seriously prejudice the
environment.” The scope of 53(a) was considered by the EPO in the Harvard Onco-mouse case

it was held that the ‘possible risks to the environment’ should be determined by weighing the purpose of the present invention
and the risk which may be associated by practising the invention in the purpose-limited way. In this case, the purpose of the
invention was to provide animal test models which were to be used exclusively in the laboratory under controlled conditions by
qualified staff. There was no scope for the release of such animals into the general environment. There could be a risk of an
uncontrolled release only in cases of intentional misuse or blatant ignorance on the part of the laboratory personnel carrying
out the tests. The Examining Division held that the mere fact that such uncontrollable acts are conceivable, cannot be a major
determinant for deciding whether a patent should be granted.

and in Plant Genetic Systems case

the Technical Board of Appeal of the EPO gave a wide connotation to the term ‘ordre public (public order) or morality’ so as to
cover not only protection of public security and physical integrity of individuals as part of society, but also to include the
protection of environment. It further stated that inventions the exploitation of which is likely to breach public peace or social
order or to seriously prejudice the environment are to be excluded from patentability as being contrary to public order. In
interpreting the word ‘morality’ the Technical Board of Appeal opined that the concept of morality is founded on the totality of
accepted norms which are deeply rooted in a particular culture, and inventions, the exploitation of which is not in conformity
to the culture in the European society, are to be excluded from patentability as being contrary to morality.

C) Discovery not an Invention: Section 3(c)

Generally an idea or a discovery cannot be a subject matter of a patent. mere discoveries or ideas cannot be the subject
matter of a patent, but discoveries or ideas which have a technical aspect or make a technical contribution will be patentable.
There are instances of early grants for discoveries. Discovery of ores of alum in abundance with a practical method of
extracting them were granted patent in the United Kingdom. However, the incorporation of a discovery, which is an excluded
matter, will not render the invention patentable.

The courts have drawn a clear distinction between a discovery and an - a invention. A discovery of any living or non-living
thing occurring in nature could not qualify for a patent protection. Similarly a ‘mere’ discovery of a scientific principle does
not amount to an invention. The use of the word ‘mere’ to qualify discovery raises doubts as to whether a substantial
discovery would qualify for a patent. A mere discovery is devoid of any contribution from the patentee. The British courts
have observed that the discovery of a principle will qualify for a patent, if that principle could be applied to the production
of a new manufacture. The Patents Act also prohibits the grant of a patent for a mere discovery of a new form of a known
substance and the mere discovery of any new property or new use of a known substance.’ But where the patentee makes a
contribution or an addition to the discovery and produces a new and useful thing or result, or new and useful method of
producing an old thing and result, such invention may qualify for a patent

D) Inventions Pertaining to Known Substances etc: Section 3(d)

 Section 3(d) includes a category of inventions pertaining to known substances and known processes that are not
patentable.

 For the purposes of argument, the Court accepted that the β crystalline form of imatinib mesylate was new and
not obvious.

 The crucial question was whether Novartis could be granted a patent for the β crystalline form of imatinib
mesylate in view of Section 3(d) as amended.

 The Court noted the parliamentary debate during the 2005 Patents Act amendments, with concerns about
ever-greening in pharmaceutical patents.

 Section 3(d) was directed at preventing such practices.

 In interpreting the new provisions, the Court held that the Act provided for the duality of the concepts of invention
and patentability.
  Not all inventions under the Act were patentable, as illustrated by Sections 3 and 4.

 The Court rejected the submission by Novartis that Section 3(d) was a trifling change.

 It held that different standards are set by the Act for medicines and other chemical substances.

 Section 3(d) was enacted to prevent ever-greening.

 Imatinib mesylate is a new form, and Section 3(d) would apply.

 Novartis argued that neither imatinib nor imatinib mesylate had known efficacy, so no comparison could be
made with a “known substance” with “known efficacy” under Section 3(d).

 This was rejected by the Court, which held that the expression "publicly known" means known to those
engaged in the pursuit of knowledge, either as men of science, commerce, or consumers.

 The Court examined the efficacy of:

 Imatinib free base

 Non-crystalline form of imatinib mesylate
 β crystalline form of imatinib mesylate

 It was noted that it was Novartis’s case that all the properties of the imatinib free base were possessed by the β
crystalline form of imatinib mesylate.

 The Court questioned how there could be enhanced efficacy in the β crystalline form of imatinib mesylate.

 Novartis filed two affidavits to show compliance with Section 3(d).

 One affidavit claimed that the β crystalline form had a 30% increase in bioavailability compared to the
imatinib free base.

 The Court noted that the non-crystalline form of imatinib mesylate was known.

 It found that Novartis was required to show enhanced efficacy of the β crystalline form over the non-crystalline
form, which it failed to do.

 The Court opined that the bioavailability of the β crystalline imatinib mesylate was due to the salt form (the
non-crystalline form).

E) Invention Pertaining to Mere Admixture or Arrangement: Section 3(e)

 Any substance obtained by a mere admixture cannot be regarded as an invention if it results only in the
aggregation of the properties of the components.
 Similarly, a process for producing such a substance shall not be regarded as an invention.
 A mixture of different kinds of medicines, forming a cocktail of drugs, to cure multiple diseases will not be a
patentable invention.
 For instance, a composition of two drugs, i.e., Paracetamol (Acetaminophen) and Ibuprofen for curing fever
and pain or a process of preparation thereof, will not be patentable as the composition is a mere admixture of
two drug components resulting in an aggregation of analgesic and anti-inflammatory actions of their
respective components.
 But a distinction has been drawn with regard to admixture resulting in synergistic properties.
 The Patent Office does not consider an admixture which results in unexpected results or synergistic properties
as a ‘mere’ admixture and may regard such mixtures to be patentable.
 F) Inventions Pertaining to Arrangement: Section 3(f)

 A mere arrangement or re-arrangement or duplication of known devices each functioning independently of

one another in a known way cannot be the subject matter of a patent.
 A mere collocation will not qualify as an inventive step.
 On the issue of collocation, Lord Tomlin had remarked in British Celanese Ltd v Courtaulds Ltd:
o “A mere placing side by side of old integers so that each performs its own proper function
independently of any of the others is not a patentable combination.”
o “But where the old integers when placed together have some working inter-relation producing a new
or improved result, then there is patentable subject-matter in the idea of a working interrelation
brought about by the collocation of the integers.”

(i) Workshop Improvements

 A workshop improvement is a normal development of an existing manner of manufacture which does not
involve anything novel to be outside the probable capacity of a person skilled in the art.
 To qualify as a patentable invention, an improvement on something known before or a combination of
different matters already known should be something more than a mere workshop improvement.
 It must independently satisfy the test of invention.
 For an improvement to be patentable, it must yield a new result or a new article hitherto unknown.
 It is possible for a combination of old, known integers to be combined in such a manner that by their working
they produce a new process or improved result.
 The Supreme Court has held that the mere collection of more than one integer or things, not involving the
exercise of any inventive faculty, does not qualify for the grant of a patent.
 But the case laws on the point do not give a clear picture as to what distinguishes a workshop improvement
from a patentable improvement.

(ii) Combination of Known Integers

 In Bishwanath Prasad Radhey Shyam v Hindustan Metal Industries, the Supreme Court held that the patented
machine is merely an application of an old invention, known for many decades, and used for the traditional
purpose of scraping and turning utensils.
 There was only a slight change in the mode of application, which was held to be no more than a workshop
improvement.
 Similarly, the application of known articles to an analogous purpose, the mere collection of more than one
integer not involving the exercise of any inventive faculty, etc. do not qualify for the grant of a patent.

 A new combination of well-known devices and its application to a new and useful purpose may be the subject
matter of a patent.
 Applying the test set out in earlier decisions, Jayasimha Babu J has summed up the eligibility criteria in such
cases:
o The product patented by the plaintiff, though when dissected and as part taken separately may not
show inventiveness,
o A combination of the same, and the fact that a new use has been discovered for a combination of
known integers,
o And the further fact that inventive steps by way of ingenuity and skill were required to be and have
been displayed in bringing about such a combination and discovering the mode of application of
known integers for a product,
o Whose usefulness has been demonstrated by the large number of units sold by the plaintiffs,
o Establish that the patent granted in favour of the plaintiffs cannot be regarded prima facie as invalid.
  Where an applicant combined one feature of an earlier specification with one feature of another existing
specification to secure no advantage other than the addition of their respective merits,
 The alleged invention will be disallowed on the ground of obviousness.

G) Method of Testing: Section 3 (g)

The above section now stands omitted in the Patents Act.”! Consequently, a method of testing can now be a subject matter of
a patent. A method of testing which could be applied to the improvement or control of manufacture could qualify for a patent
in the United Kingdom.

H) Method of Agriculture or Horticulture: Section 3(h)

A method of agriculture or horticulture cannot be the subject matter of a patent under the Patents Act. In United Kingdom, a
method of producing a new form of a known plant (Poinsettia) was held not to be a manner of manufacture even though the
invention involved modifying the conditions under which natural phenomena would pursue their inevitable course. However, a
process for the production of edible mushroom tissue was held to constitute a manner of manufacture as it did not produce a
plant or an animal, and was carried out in a laboratory.

I) Methods of Medical Treatment of Human and Animals: Section 3(i)

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 from disease or to increase their economic value cannot be
a subject matter of patent. The above provision will not allow Swiss claims to be filed for medical uses. For detailed account on
Swiss claims,

J) Plant and Animal Varieties: Section 3(j)

Plants and animals, in whole or in their parts, are excluded from patent protection. Seeds, varieties and species are also included
under this section. The section also excludes ‘essentially biological processes.’ However, micro-organisms can be a patentable
invention. Plant varieties are protected by a sui generis system under the Protection of Plant Varieties and Farmers’ Right Act
2001. For a detailed account on patents for plants, animals and micro-organisms, see ch 4. (

K) Business Method, Computer Program etc: Section 3(k)

A mathematical or business method or a computer program per se or algorithms is not patentable under the Patents Act. In
India, patent protection is not afforded to business methods and computer programs though art 27 of the TRIPS Agreement
does not exclude them from patentability.

computer program
 Computer programs are excluded from patent protection as they are protected as a literary work under the Copyright
Act 1957.”
 Though patent for a computer program per se is not patentable, a claim expressed as a computer arranged to produce
a particular result, and computer programmes which have the effect of controlling computers to operate in a particular
way” may be the subject matter of a patent.
 The prevailing view is that where the subject matter as claimed makes a technical contribution to the known art, the
patentability should not be denied merely on the ground that a computer program was involved in its implementation
1) Different Approaches on Computer Programs
In the United Kingdom, the courts have relied on different approaches in deciding whether computer programs will
qualify for a patent. An illustrative summary of the different approaches followed in granting patents for computer
programs, which is an excluded matter under s 1(2) of the UK Patents Act and art 52(2) of the EPC, is given by the Court
of Appeal in Aerotel Ltd v Telco Holdings Ltd: Our summary of the various approaches which have been adopted is as
follows:
o The contribution approach Ask whether the inventive step resides only in the contribution of excluded matter—
if yes, Art 52(2) applies.
o This approach was supported by Falconer J in Merrill Lynch,” but expressly rejected by this Court.
 The technical effect approach
 o Ask whether the invention as defined in the claim makes a technical contribution to the known art—if no, Art
52(2) applies. A possible clarification (at least by way of exclusion) of this approach is to add the rider that novel
or inventive, purely excluded matter does not count as a ‘technical contribution’.
o This is the approach (with the rider) adopted by this Court in Merrill Lynch. It has been followed in the
subsequent decisions of this Court, Gale’! and Fujitsu. The approach (without the rider as an express caution)
was that first adopted by the EPO Boards of Appeal, see Vicom, IBM/Text processing’ and IBM/ Data processor
network.
 The ‘any hardware’ approach
Ask whether the claim involves the use of or is to a piece of physical hardware, however mundane (whether a computer
or a pencil and paper). If yes, Art 52(2) does not apply.
This approach was adopted in three cases, Pension Benefits, Hitachi and Microsoft/Data transfer (the ‘trio’). It was
specifically rejected by this Court in Gale. However there are variants of the ‘any hardware’ approach:
(i) Where a claim is to a method which consists of an excluded category, it is excluded by Art 52(2) even if
hardware is used to carry out the method. But a claim to the apparatus itself, being ‘concrete’ is not so
excluded. The apparatus claim is nonetheless bad for obviousness because the notional skilled man
must be taken to know about the improved, excluded, method.

This is the Pension Benefits approach.

(ii) A claim to hardware necessarily is not caught by Art 52(2). A claim to a method of using that hardware
is likewise not excluded even if that method as such is excluded matter. Either type of claim is
nonetheless bad for obviousness for the same reason as above.

This is Hitachi, expressly disagreeing with Pensions Benefits about method claims.

(iii) Simply ask whether there is a claim to something ‘concrete’ eg an apparatus. If yes, Art 52(2) does not
apply. Then examine for patentability on conventional grounds — do not treat the notional skilled man
as knowing about any improved excluded method.

This is Microsoft/Data transfer.

In the above case, the Court of Appeal went on to accept the technical effect approach with the rider rejecting all other
approaches. It detailed the said approach as follows: The approach is in 4 steps:

 properly construe the claim;

 identify the actual contribution;
 ask whether it falls solely within the excluded subject matter;
 check whether the actual or alleged contribution is actually technical in nature.

The above approach followed by the Court of Appeal is the one likely to be followed under the Patents Act. It is likely that the
Patent Office would allow patents for computer programs which provide a technical advancement over the existing knowledge.
The applicant will be required to show the technical contribution to the prior art where the invention involves a computer
program. An invention which would be patentable in accordance with conventional patentability criteria should not be excluded
from protection by the mere fact that computer programs are used for its implementation. However, any objection to
patentability will be considered if the actual protection was offered to the patenting of a mental act in the guise of a computer
program. In most cases involving computer programs, the claims would be directed both to a method of using a piece of
hardware, in the form of a programmed computer, and to the piece of hardware programmed to carry out the method.

L) Literary, Dramatic, Musical or Artistic Work etc: Section 3 (L)

Matters which are subject matters of copyright protection cannot be the subject matter of a patent. A copyright
infringement action may be clubbed along with a suit for infringement of a patent if both the issues flow from a common
set of actions.“ (
M) Scheme or Rule: Section 3(m)
A scheme does not amount to a manner of manufacture as it is a mere idea.*” Here too, an exception is entertained
with regard to those ideas which could have a practical effect.*° Of course, every invention should have begun as an
idea. An invention may lie in an idea or in the way in which the idea is carried out or both. Such an idea must either
suggest a new way of making something or it should show a new way of producing a new article.” An invention will not
be regarded as a scheme or plan if the invention can function only in a certain way when it has the appropriate series
of cards appropriately punched and inserted into it.** (
N) Presentation of Information: Section 3 (n)
 The Act excludes a presentation of information from the ambit of patent protection. But the British courts, under the
UK Patents Act 1949, have distinguished a mere novelty i in information®” from novel methods of presenting
information.” The court explained the difference with the following illustration: A distinction is drawn between, for
example, a printed book, a book being a manner of manufacture where the only novelty is in the literary content, which
it is said cannot on any basis be patentable, and, for example, the first book ever printed in Braille, which it is said would
have been, as at its date, a manner of new manufacture, whatever the nature of the literary content of the work in
question.?! 2.64 This distinction was arrived at by considering a particular presentation of information as being a
manner of new manufacture. The wording of s 3(n) will include both novelty in information and novel methods of
presenting information.” Information contained in punched cards inserted into a data processing machine cannot be
classified as being purely intellectual, literary or artistic, if the object of the punched cards isto ensure that the old
machine functions in a particular way which it is : alleged is new.
O) Topography of Integrated Circuits: Section 3(o)
lopography of integrated circuits cannot be the subject matter of a patent protection. lopographies or lay-out designs
of integrated circuits are governed by the Semiconductor Integrated Circuits Layout-Design Act 2000. (
P) Traditional Knowledge: Section 3(p)
An invention which is a part of traditional knowledge cannot be the subject matter of a patent. Similarly, an aggregation
or duplication of known properties of traditionally known component or components is also excluded from patent
protection. An invention based on traditional knowledge may be opposed or revoked under the Patents Act on the
ground that the invention is anticipated.”* Clause 19 of the Doha Declaration provides that the Council for TRIPS shall
review the implementation of the TRIPS Agreement and examine, among other things, the relationship between the
TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore, and
other relevant new developments. The Biological Diversity Act 2002 imposes restrictions on obtaining patents with
regard to any invention based on any research or information on a biological resource obtained in India.” The said Act
also restricts certain persons from dealing with any biological resource occurring in India or knowledge associated
thereto for research or for commercial utilisation or for bio-survey and bio-utilisation.”© (
Q) Inventions Relating to Atomic Energy: Section 4
+Section 4 prohibits the grant of patents for inventions relating to atomic energy. It is widely accepted that countries
can provide for security exceptions for the protection of essential security interests relating to fissionable material.’’
Even if a patent is granted for an invention relating to atomic energy, the same may be revoked under s 65 of the
Patents Act. The provision relating to atomic energy inventions are contained in s 20 of the Atomic Energy Act 1962.°°
‘Prescribed substance’ mentioned in s 20(1) of the Atomic Energy Act 1962 is defined under s 2(1)(g) of that Act to
mean ‘any substance including any mineral which the Central Government may, by notification, prescribe, being a
substance which in its opinion is or may be used for the production or use of atomic energy or research into matters
connected therewith and includes uranium, plutonium, thorium, beryllium, deuterium or any of their respective
derivatives or compounds or any other materials containing any of the aforesaid substances.’ A detailed list of
prescribed substances is mentioned in the Schedule.”

PROVISIONAL AND COMPLETE SPECIFICATION

An application for patent is to be accompanied by a provisional or a complete specification. application or application Where an
application for a patent (not being a convention and filed under the PCT is accompanied by a provisional specification, a complete
specification shall be designating India) filed within twelve months from the date of filing of the application.

If the complete specification is not so filed, the application shall be deemed to have been abandoned, may The object of filing a
provisional specification is to fix the priority date in accordance with section 11. In between the period of filing provisional
specification and complete specification, the inventor further conduct research and improve his invention. A provisional
specification need not describe the invention fully and specifically.

In Imperial Chemical Industries Ltd. Application,'’ it was stated that a provisional specification needed to contain only a
description of the general nature of the invention, its field of application and anticipated result.

One complete specification in respect of several provisional specifications

Where two or more applications in the name of the same applicant are accompanied by provisional specifications in respect of
inventions which are cognate or of which one is a modification of another and the Controller is of opinion that the whole of such
inventions are such as to constitute a single invention and may properly be included in one patent, he may allow one complete
specification to be filed in respect of all such provisional specifications. The period of time specified above is to be reckoned
from the date of filing of the earliest provisional specifications.
Provisional specification and complete specification

The provisional specification is to ascertain and describe the nature of invention While the complete specification may also
explain in what manner the invention is to be carried out in execution and therefore, either in a complete specification or
amended specification, if an explanation is made to a provisional explanation, it cannot be said as if the patentee has abandoned
a part of his claim. The House of Lords held as follows: The purpose of the Provisional Specification is to ascertain and describe
the nature of the invention. But the Complete Specification must ascertain and particularly describe the nature of the invention
and also in what manner it is to be carried into execution.”

When complete specification is to be treated as provisional specification?

Where an application for a patent (not being a convention application or an application under PCT) is accompanied by a
specification purporting to be a complete specification, the Controller may on the request of applicant within 12 months, direct
that such application shall be treated as a provisional specification and proceed with the application accordingly.

Where a specification complete or where specification complete has been filed is after treated the as provisional specification
as aforesaid, the Controller may on the request of applicant at any time before the grant of patent, cancel the provisional
specification and postdate the application to the date of filing of the complete specification. provisional Post-dating of patent
can be done only to the date of filing of the complete specifications.

In Standipack Pvt. Ltd. v. Oswal Trading Co.

the Delhi High Court has held that where the application for the grant of patent was originally filed by the plaintiff on 11-4-1989
and the complete specification was filed on 11-10-1990, the post-dating of the patent by the Controller to 11-7-1989 prima facie
appeared to be in violation of the provisions of section 9 of the Patents Act, 1970.

Contents of specifications

The specification is a very crucial document. It can mainly be divided into two parts:

the description (which may be accompanied by diagrams or drawings) and the claim. The description is to disclose the invention
sufficiently, whereas the claim is to mark out the scope of monopoly rights which are likely to be conferred by the patent office
in case the patent is granted.

In EMI v. Lissen," Lord Russell stated:

The function of the claims is to define clearly and with precision the monopoly claimed, so that others may know the exact
boundaries of the area within which they will be trespassers. Their primary object is to limit and not to extend the monopoly.
What is not claimed is disclaimed.

Section 10 of the Patents Act, 1970 requires that every specification, whether provisional or complete is to describe the
invention. The specification is to begin with a title sufficiently indicating the subject-matter to which the invention relates.

In F. Hoffmann-la Roche Ltd. and Another v. Cipla Limited,

the court held that the application of anyone desirous of seeking patent has to contain specifications that are to conform to the
requirements of section 10.

Essential requirements of complete specification Every complete specification is to

(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; and
(d) be accompanied by an abstract to provide technical information on the invention.

Drawings, model or sample

The Controller may require the applicant to supply drawings for the purposes of any specification, whether complete or
provisional. Any such drawing shall, unless Controller directs otherwise, be deemed to form part of the the specification. Where
the Controller considers in any special case that the application should be supplemented by a model or sample of anything
illustrating the invention, he may require such sample or model to be furnished. Such model or sample is to be furnished before
the application is found in order for grant of a patent. Such model or sample shall not be deemed to form part of the
specification.

Claim

The claim should fully and particularly describe the invention and its operation or use and the method by which it is to be
performed. It should also disclose the best method of performing the invention, which is known to the applicant and for which
he is entitled to claim protection; and end with a claim or claims defining e scope of the invention for which protection is
claimed.”

The function of the claims is to define clearly and with precision the monopoly claimed, so that others may know the exact
boundaries of the area within which they will be trespassers. Their primary object is to limit and not to extend the monopoly.
What is not claimed is disclaimed.”

In Ram Narain Kher v. Ambassador Industries New Delhi and Another,’

the Delhi High Court stated that the function of the claim was “to define the scope of the invention claimed.” Claim must be
clear. The applicant must describe the advantage sought to be achieved by his invention in the claim.

In Clyde Nail Company Ltd. v. Russel,’ Lord Parker observed: [T]hat in describing and ascertaining the nature of an invention
consisting in the selection between possible alternatives, advantages to be gained or the disadvantages to be avoided, ought to
be referred to.

The proper way to construe a specification is not to read the claims first and then see what the full description of the invention
is, but first to read the description of the invention, in order that the mind may be prepared for what it is, that the invention is
to be claimed, for the patentee cannot claim more than he desires to patent.”

In Parkinson v. Simon,’' Lord Esher, M.R. enumerated that as far as possible the claims must be so construed as to give an
effective meaning to each of them but the specification and the claims must be looked at and construed together.

Abstract

The abstract shall contain a concise summary of the matter contained in the Specification. The summary shall indicate clearly
the technical field to which the invention belongs, technical problem to which the invention relates and the solution to the
problem through the invention and principal use or uses of the invention. Where necessary, the abstract shall contain the
chemical formula, which characterizes the invention. The Controller may amend the abstract for providing better information
to third parties. 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) above, and if such material is not available to the public, the application is to be completed by
depositing the material to an international depository authority under the Budapest Treaty.

The applicant is required to comply with the following conditions, namely:

(i) the deposit of the material is to be made not later than the date of filing the patent application in India
and a reference thereof is to be made in the specification within the prescribed period;
(ii) all the available characteristics of the material required for it to be correctly identified or indicated are
included in the specification including the name, address of the depository institution and the date and
number of the deposit of the material at the institution;
(iii) access to the material is available in the depository institution only after the date of the application for
patent in India or if a priority is claimed after the date of the priority;
(iv) disclose the source and geographical origin of the biological material in the specification, when used in
an invention.

International application

In case of an international application designating India, the title, description, drawings, abstract and claims filed with the
application are to be taken as the complete specification. Declaration as to inventor ship

A declaration as to the inventorship of the invention shall in prescribed cases be furnished with the complete specification or
within prescribed period after the filing of that specification. Claims in respect of developments of invention complete
specification filed after a provisional specification may include claims in respect of developments of, or additions to, the
invention which was escribed in the provisional specification, being developments or additions in respect of which the applicant
would be entitled to make a separate application for a patent.

PRIORITY DATES OF CLAIMS OF A COMPLETE SPECIFICATION

Section 11 provides that there shall be a priority date for each claim of a complete specification.

 Where a complete specification is filed in pursuance of a single application accompanied by a provisional specification;
or a specification which is treated as provisional specification under section 9(3), and the claim is fairly based on the
matter disclosed in such provisional specification, the priority date of that claim shall be the date of the filing of such
provisional specification.
 Where the complete specification is filed or proceeded with in pursuance of two or more applications accompanied by
such provisional specifications as aforesaid, and the claim is fairly based on the matter disclosed in one of those
specifications, the priority date of that claim shall be the date of the filing of the application accompanied by that
specification.
 Where the claim is fairly based on the matter disclosed partly in one and partly in another, the priority date of that claim
shall be the date of the filing of the application accompanied by the specification of the later date.
 Where a complete specification based on a previously filed application in India has been filed within 12 months from
the date of that application and the claim is fairly based on the matter disclosed in the previously filed application, the
priority date of that claim is to be the date of the previously filed application in which the matter was first disclosed.
 Where the complete specification has been filed in pursuance of a further application made by virtue of section 16(1)
and the claim is fairly based on the matter disclosed in any of the earlier specifications, provisional or complete, as the
case may be, the priority date of that claim shall be the date of the filing of that specification in which the matter was
first disclosed.
 Where any claim of a complete specification would have two or more priority dates, the priority date of that claim shall
be the earlier or earliest of those dates.

In any case to which any of the aforesaid provisions do not apply, the priority date of a claim shall be the date of filing of the
complete specification. or A claim in a complete specification of a patent shall not be invalid by reason only of — (i) the
publication or use of the invention so far as claimed in that claim on after the priority date of such claim; or (ii) the grant of
another paten which claims the invention, so far as claimed in the first mentioned claim, in claim of the same or a later priority
date.