DIVYA IPR

PATENTABILITY OF LIFE FORMS

Patenting of life forms in India for many years has been perplexing for the stakeholders. The Indian
Patent Office has evolved over time to come up with various initiatives to address the issues
surrounding patenting of life forms. Even though the initiatives have helped in addressing the
confusions to an extent there still needs some work to be done to provide a clarity for the
stakeholders.

A life form could be a unit or a being that is alive in nature. As an example, it may be anything from
plant or an animal or a virus to a human being. This provokes a question whether living beings can
be patented?

Before diving into the Indian regime, lets take a look at few US Cases 0n this subject.

Merck and co vs Olin Mattheison- This case is regarding the product of nature. The contention was
on product patent. The district court had said that vitamin B12 was a product of nature and patent
cannot be on product of nature. Before this invention, the only source of B12 active complex was the
liver. The US court of appeal held: There is nothing in the language of the Act which precludes the
issuance of a patent upon a "product of nature" when it is a "new and useful composition of matter"
and there is compliance with the specified conditions for patentability. All of the tangible things with
which man deals and for which patent protection is granted are products of nature in the sense that
nature provides the basic source materials.

In the case of Malcolm Bergy, John H Coats and Vedpal Malik, the court followed an indirect
approach. It compared the living microorganism with a chemical compound and held that the end
product can be considered to be a manufactured or composition of matter which are very well
patentable therefore, it should also be made patentable. The court in this case has not clearly
declared that microorganisms are patentable subject matter in themselves.

 In Diamond vs Chakraborty, patent was applied for bacteria that could turn crude oil to
biomass. It was a genetically-engineered bacteria. The question which arose before the court
was whether genetically engineered organism be called product of nature/ can it come
under patentable subject matter? The committee report which was informing the 1952 act
said that the intended subject matter would be anything under the sun made by man.
(Thomas Jefferson). There is human ingenuity involved in making the bacteria hence it would
come under the term manufacture of composition of matter. The question to be asked is not
if the subject matter is living or non-living but whether it is a product of nature (not
patentable) or a man-made (patentable) product. It was held that just because MO is living
doesn’t mean it is product of nature.

Now coming to the Indian scenario.

Till 2002, as per the prevailing practice in the Patent Office, patents were not granted for inventions
relating to (a) living entities of natural or artificial origin, (b) biological materials or other materials
having replicating properties, (c) substances derived from such materials and (d) any processes for
the production of living substances/entities including nucleic acids.

 Indian government's stance on patenting life forms has gradually changed over time. Couple
of decades earlier, India was against granting patents to life forms. The same is apparent
based on India's demand on review of Article 27.3 of TRIPS and support for the African group
 proposal on review of Article 27.3 presented in 1999, which suggested that patents on life
should be prohibited, including those on microbiological processes. However, TRIPS had
directed the member countries to allow patents to all technologies and microorganisms as
well. To comply with the direction of TRIPS, amendments to the Indian Patents Act, 1970
were made between the years 1999-2005 in order to suit India's international commitments
under TRIPS. Particularly, an amendment to the Act was made in the year 2002 which
allowed patents on microorganism. The amendment opened up new possibilities to secure
patent rights for new microorganisms and other areas involving microorganisms.

In order to patent a living form in India, the invention must meet the requirements stipulated by the
Act. The requirements include sufficient disclosure of the invention, the invention is new, non-
obvious and useful, the invention meets the vendibility test, and the invention is in the public
interest. Since, the Patents Act does not grant patent for the discovery of "any living thing or non-
living substance occurring in nature," the product or process that is to be patented is ought to be
secluded from nature by application of human intervention.

The judgment by the Calcutta High court in the case Dimminaco A G v/s Controller of Patent Designs
& Ors" on January 2001 completely flipped the panorama of patenting life forms in India. Dimminaco
A G, a Swiss company approached the Hon'ble High Court of Calcutta upon getting a refusal on its
process patent that pertained to preparation of a live vaccine for Bursitis. The company got denial on
the grounds that, the invention containing a living organism was not patentable as under section
2(1)(j). The Controller of Patents determined that the process was not an invention, since the end
product produced by the corresponding process contained a living organism, thereby making it not
patentable. On the contrary, the High Court applied the vendibility test to the invention and deemed
that the process results in a vendible item that is new and useful. Since the process resulted in a
vendible item, patent was granted.

Further, the Act was amended in the year 2002, to include Section 3(j) which does not allow
patenting biological processes for production of plants and animals, or plants and animals in whole
or in part other than microorganisms. This amendment opened gates for patenting living forms
(microorganisms) and not just the processes of producing the life form. It is still uncertain how far
Section 3(j) would aid in patenting of microorganisms as there is an ambiguity in defining what
constitutes a microorganism. Therefore, it is vital to have a clear working definition for
"microorganism" as a legislative amendment in India.

However, there is a clarity in the matter of patenting Genetically Modified Organisms (GMOs). GMOs
are also categorized under life forms, and even though GMOs are living beings, they do not occur
naturally in nature. A significant human intervention is necessary for the development of GMOs.
Hence, the Act provides more leeway for patenting GMOs.

It is to be noted that biotech companies make huge investments in the research and development to
come with new improved microorganisms. Considering the huge money that is invested and the risk
that is taken by these companies it is virtuous that these companies are rewarded for their work.
Denying patents for microorganisms that are developed as a result of intensive research and huge
investment is highly demoralizing to the companies. It is also to be considered that genetic
engineering and biotechnology is an important player in the development of a country. The
developed nations such as USA, Japan and European countries recognized this and have framed the
legislation that makes it easier to patent life forms. The Indian government over the time has made
necessary amendments to address the issues surrounding the patenting of life forms. However, it is
not sufficient and there is scope for improvement. Considering all of the above, it is imperative for
the Indian government to come up with legislations to clear the ambiguities clouding the patenting
of life forms.

India joined the Budapest Treaty on the International Recognition of the Deposit of Microorganisms
for the Purposes of Patent Procedure on 17th December 2001. Consequently, section 10 of the Act
was amended in 2002 to provide for deposition of the biological material and its reference in the
patent application in case the invention relates to a biological material which is not possible to be
described in a sufficient manner and which is not available to the public. The Patents Act, 1970 was
amended by the Patents (Amendment) Act, 2005 paving the way for the grant of product patents in
any field of technology including biotechnology with certain exceptions keeping in view the national
policy to protect the public interest. The Act, as amended, recognizes the International Depository
Authorities (IDAs) under the Budapest Treaty.

In conclusion, microorganisms are patentable in India but the same should be an invented MO
through technical means and should not be naturally existing. (new and not already in existence).
For larger organisms, the law is different. In India it is not patentable but the same is patentable in
USA with conditions. When it comes to biological processes, the bar on patentability is on essential
biological processes. Non-essential biological, processes for protection and propagation of animals
and plants are patentable.
EVERGREENING OF PATENTS

Ever-greening of patent, as the name suggests, is a corporate, legal, business, and technological
strategy for extending / elongating the term of a granted patent in a jurisdiction that is about to
expire, in order to retain royalties from them, by taking out new patents.

patent is a monopoly right given exclusively to an inventor for a limited period of time in return of
his/her disclosure of an invention that is a new, nonobvious, and useful product and/or process.

In India, patents are granted for a maximum term of 20 years (provided it is maintained by paying
annuity fees). After the expiry of the patent, the invention goes into the public domain which is free
for use, manufacture, sell, or import. However, sometimes the patentees (mostly pharmaceutical
companies) attempt to extend this monopoly right beyond the limited period of 20 years. When the
term of the patent is about to end, these companies make trivial /insignificant variations (which
does not actually affects the efficacy) to the existing patented invention and file for a new patent,
thus extending their monopoly. This is known as the Ever-greening of a patent. 20 years is
considered enough time period for the patentee to recover the cost of research and earn reasonable
profit.

Efficacy is not defined in the act. Some consider it to be a lacuna but some consider it to be a
legislative wisdom because efficacy would be different for each type of field. There are numerous
fields and numerous criteria of efficacy for each field. So, it is not a lacuna but legislative wisdom.
Another argument is that the absence of the definition would give arbitrary discretion to the
controller of patents and could result in arbitrary use of power as was raised in the Novartis case.

NOVARTIS AG VS UOI- Novartis AG, an international pharmaceutical company, applied for the grant
of a patent for an anticancer drug 'Glivec’ which was invented from Beta crystalline form of "Imatinib
mesylate". This drug is famously used in the treatment of cancer.

In 2005 patent application of Novartis for the drug Glivec was taken into consideration and the same
was rejected by Madras Patent Office on the ground that the drug was anticipated by prior
publication and failed to satisfy the requirement of novelty and non-obviousness, further stating the
alleged invention as un-patentable under the provision of section-3(d) of Patent Act, 1970 as the
said drug did not exhibit any major changes in therapeutic efficacy over its pre-existing form i.e.
Zimmermann patent.

After that Novartis filed two writ petitions in Madras High Court in the year 2006 under Article-226
of Constitution of India. The appeals subsequently stated that the section-3(d) of Patent Act, 1970 is
unconstitutional because it is not in compliance with TRIPS agreement and also violates Article-14 of
Constitution of India and the other against the order passed by Madras Patent Office. Madras High
Court transferred the case to IPAB (Intellectual Property Appellant Tribunal) in 2007. This appeal was
finally heard and dismissed by IPAB stating that the invention satisfied the tests of novelty and non-
obviousness but the patentability of the product was hit by section-3(d) of the Patent Act, 1970. The
judgment given by IPAB is to prevent ever-greening of already patented product by introducing
minor changes and to provide easy access to the citizens of India to life saving drugs.

After that Novartis filed SLP (Special Leave Petition) in 2009 before the Supreme Court of India
against the order passed by IPAB under Article-136 of Constitution of India. The Supreme Court of
India rejected the appeal filed by Novartis and upheld that the beta crystalline form of Imatinib
Mesylate is a new form of the known substance i.e., Imatinib Mesylate, wherein the efficacy was
well known. Supreme Court made it crystal clear that in the case of medicine "Efficacy" in section-
3(d) only means "Therapeutic Efficacy" and states that all properties of drug are not relevant, the
properties which directly relate to efficacy in case of medicine is its therapeutic efficacy.

The judgment given by the Hon'ble Supreme Court is to prevent the ever-greening of patented
products and gives relief to those who can't afford the lifesaving drug as these pharmaceutical
companies sell such lifesaving drugs at a very high price hence unaffordable for the common man.
Section-3(d) of Patent Act, 1970 prevents by obtaining secondary patent by introducing minor
changes in existing technology from these big pharmaceutical companies. Novartis failed to prove
that the therapeutic efficacy of "Beta Crystalline form of Imatinib Mesylate" is more as compared to
the therapeutic efficacy of "Imatinib Mesylate". So that the application of Novartis for patent
rejected by Supreme Court. Further, talking about the contention of Novartis that S 3(d) is not in
compliance with the TRIPS agreement. The Doha declaration is not merely a declaration but is said
to be an interpretation of the TRIPS agreement. So this declaration has to be considered as having
some value wrt TRIPS agreement. Since the Doha declaration gives member states greater flexibility
to make laws for protecting public health, so S 3(d) would not be contrary to TRIPS.

There was a debate about the meaning of the term efficacy after this case also. Prof Basheer said
that if a new form of medicine is safer than the earlier form, then also it would be considered as
improved efficiency and hence patentable.

In India Section 3 (d) incorporated in the Patent Act initiates the resistance to the ever-greening of
patents. section 3(d) of the Patent Act, 1970 states that the "mere discovery of a new form of a
known substance which does not result in the enhancement of the known efficacy of that
substance or the mere discovery of any new property or new use for a known substance or of
the mere use of a known process, machine or apparatus unless such known process results in a new
product or employs at least one new reactant", is not patentable under the Indian Patent Act.

A corollary to the above stated law is that if someone takes two already known integers and
combines them but they work independently and there is no creation of a new product, then it is not
patentable but if there is working inter relations between them which results in improved efficiency
or create a new result then it would be patentable.

In the case of Asia Electronics vs Havells, Asian electronics applied for grant of patent for Conversion
Kit to change the fluorescent lighting units inductive operation to electronic operation.

The Plaintiff company claims that when it bought and dismantled the Defendant company’s product,
it discovered that almost all the essential features of its patented invention had been literally copied
by the Defendant.

The HC held that no patent can be granted for the mere re-arrangement of known components
unless such re-arrangement leads to a radically different result i.e. not obvious to a person skilled in
the art. In light of the statutory provisions, as also the weight of common law, the Judge made a
prima facie finding of not only obviousness but also one of non-patentability on the basis of Section
3(d) and Section 3(f).
PATETABILITY OF BUSINESS METHODS

A business method may be defined as "a method of operating any aspect of an economic
enterprise". Business Method Patents are a class of Patents which disclose and claim new methods
of doing business and include new types of e-commerce, insurance, tax compliance etc. Business
method patents are a relatively new species of patent and there have been several reviews
investigating the appropriateness of patenting business methods. Every company has its own
strategy and goals and accordingly evolves an approach to achieve them. 

In the case of Bilski vs Kappos, Petitioners' patent application seeks protection for a claimed
invention that explains how commodities buyers and sellers in the energy market can protect, or
hedge, against the risk of price changes. The patent examiner rejected the application on the
grounds that the invention is not implemented on a specific apparatus, merely manipulates an
abstract idea, and solves a purely mathematical problem. The Board of Patent Appeals and
Interferences agreed and affirmed. The United States Court of Appeals for the Federal Circuit
affirmed. 

Although the US patent act does not give a list of exclusions like India, The U.S. Supreme Court's
precedents provide three specific exceptions to 35 U.S.C.S. § 101's broad patent-eligibility principles:
laws of nature, physical phenomena, and abstract ideas.

The federal circuit court gave a new test in this case, known as the ‘Machine or transformation test’.
It claimed that the invention had to be either 1. Applied on a machine or apparatus or 2. It should
transform one thing from one state to another thing/state. By virtue of this test, the federal court
rejected the patent. Here, federal court deviated from earlier test given in state street bank case
where the test was whether the invention produced ‘useful, concrete, and tangible’ results.

The US SC had modified the above-mentioned test and said that the US patent at gives 3 categories
for excluding patent-eligibility – “laws of nature, physical phenomena, and abstract ideas”. Machine
or transformation test can be used as a tool to test patentability. So, it says business methods are
not excluded by the statutory language. It says business methods are patentable and machine or
transformation test can be used as a tool to access patentability and it can be excluded only if it falls
within the 3 categories. But since there can be a flood of business method patent claims, so these
patents are not be granted lightly. There is a bar which is set higher than the normal patents. As far
as the present case was concerned, the court held that the case was about an abstract idea and
hence it was not patentable.

[discussing it as itbshows a contrast bw ind and usa]

[diff 1 in ind diect staturory exclusion of bm but not so in usa. Since there is clear bar on bm in india
then what woud be the implication of the transformation test on us as it was not rejected by us sc]

Now, coming to the Indian scenario.

A business model is not a patentable subject matter in India as per Section 3(k) which says that a
mathematical or business method or a computer programme per se or algorithms are not inventions
within the meaning of The Patent Act, 1970 (India).

The Manual of Patent Office Practice and Procedure, version 01.11, as modified on March 22, 2011
(Para 08.03.05.10 c) relating to business methods and considered the definition provided therein
stating that “Business Methods” claimed in any form are not patentable subject matter. The term
‘Business Methods’ involves whole gamut of activities in a commercial or industrial enterprise
relating to transaction of goods or services. With the development of technology, business activities
have grown tremendously through e-commerce and related B2B and B2C business transactions. The
claims are at times drafted not directly as business methods but apparently with some technical
features such as internet, networks, satellites, tele-communications etc. This exclusion applies to all
business methods and, therefore, if in substance the claims relate to business methods, even with
the help of technology, they are not considered to be a patentable subject matter.”

In the case of Yahoo Inc vs Assistant controller of patents and designs, the claim was regarding
bidding for placement of website on a higher position in search list when an item is searched in
search list. The patent application was titled “System and method for influencing a position on a
search result listing generated by a computer network search engine”, and the title was later
amended to “A method of operating a computer network search apparatus.” They tried to show it
was a patentable computer program when in reality it turned out to be a bm. They are suggesting
it’s a patentable subject matter because in section 3(k) the position is that computer programs per
se are not patentable i.e., that computer programs standing alone by itself are not patentable but
computer programs in certain circumstances wherein for eg it has a technical effect or its solving a
technical problem maybe in conjunction with hardware or a process then there is a probability that
something involving a computer program would be patentable but a pure stand alone computer
programs are not patentable. There is absolute bar on patentability of bm and comuter program
standing alone.

The IPAB referred to the Manual of Patent Procedures 2008 definition of business methods, The
2011 manual talks about bm in a similar sense, and came to the decision that what was claimed was
essentially a subject matter that is not patentable and it is in its essence a bm and there is an
absolute exclusion to the patentability of bm. While applying this reason they had relied upon a UK
case i.e., CFPH LLC’S Application. In this case the court said that there are policy reasons for
exclusion. There are certain exclusions that are soft and there are certain exclusions that are hard
exclusion. For eg, discovery is a soft exclusion in the sense that one cannot claim it to be a patent
subject matter or a patentable invention but in case a useful artifact or a useful process has been
devised from such discovery then it is patentable. In this sense it’s a soft exclusion. But if we talk
about hard exclusion for eg computer software. A computer software is not patentable even if it is
given a new state or form, as in the above soft exclusion example ,and hence patentable, no. It is just
not patentable i.e., it’s a hard exclusion Likewise, a bm is a hard exclusion. One cannot patent it by
presenting it to be a patentable subject matter in one way or another.

As far as transformation test is concerned, ipab is leaning towards it in the same way as the bilski
case. From the observations ipab is making, they are not stating the transformation test as a test for
the determination of the patentability but the way it is putting it out in the ipab order is akin to the
reasoning in the bilski case. When ipab concluded that technical advance was claimed over the
existing art, it was only an improvement in the method of doing business. The fact that there is an
advance would not help the applicant in any way because of it being a hard exclusion. So the
improvement upon the subject matter which is not patentable would not be made patentable on the
ground that it has now been improved upon. Although it is an improvement to the way of doing
business as compared to what was being earlier done but that improvement doesn’t make the
subject matter patentable as there is a specific exclusion.

Generally speaking, the bilski approach has stated a caution that we should be mindful while
granting business method patents. The reasons are:
The basic nature of patent is to confer monopoly to the patentee to the exclusion of others. From
bm perspective, the need to devise an improved bm is always there in order to make more money.
Therefore, granting of bm patent would not be an incentive for devising improved bm as eventually
every business will do so.

Secondly, exclusion of competition may really be counter productive to the technological prosperity
of the society.

UTILITY REQUIREMENTS FOR PATENTS- INDUSTRIAL APPLICATION

The standards for meeting patentability criteria under the Patents Act 1970 are emphasised to
reward the contributors of an invention. Among these criteria, novelty is a vital and absolute
condition for patentability. Whether an invention is a "new invention" (possesses novelty) in India is
determined against the definition assigned under s 2(1)(l) of the Indian Patents Act 1970. Novelty as
a requirement is there so that the art moves forward. It helps in progress of the art. If patent would
be granted on already existing thing, then it would restrict free access to material already in public
domain.

When we talk about new, it has to be in comparison with some base line. That base line is prior state
of the art. Novelty means "new compared to prior art"; it states the requirement that, to be
patentable, an invention must somehow be different from all published articles, known techniques,
and marketed products.

AIMS OF THE PROV:

 To create a baseline.
 To encourage an inventor to disclose the invention as early as possible.

Therefore, novelty is in fact a question of whether the invention has been anticipated by a previous
patent or publication, or by prior use.

ANTICIPATION

There are two ways of proving anticipation, the enabling disclosure and the inevitable result route. 
First, if the prior art describes something falling within its scope, then, assuming that the description
is enabling, the claim is anticipated. The patentee may decide that the only way to avoid
anticipation, other than by amendment of his claims, is to demonstrate that, notwithstanding its
disclosure, the prior art is not enabling. He can do this by proving that what is described could not be
achieved on the basis of the disclosure. 

The second way of proving anticipation is by showing that the inevitable result of carrying out what
is described in the prior art would be a product or process falling within the scope of the claim.

Standard of Anticipation

Novelty involves a comparison between the invention, in any of its embodiments, and the thing that
is revealed by (a) prior publication, or (b) publicly known/use.

Prior Publication- Section 29 of the Act refers to prior art. In patent law, in order to render a
document a prior publication, it must be shown that it contains all that is material to instruct the
public how to put the invention in practice. ( Pope Alliance Corp. v. Spanish River Pulp & Paper Mills
Ltd., A.I.R. 1929 P.C. 38).

In General Tire & Rubber Company v Firestone Tyre & Rubber Company Limited, Sachs LJ
summarized the law on anticipation by prior publication as follows: If the earlier publication, so
construed, discloses the same device as the device which the patentee by his claim, so construed,
asserts that he has invented, the patentee's claim has been anticipated, but not otherwise. In such
circumstances the patentee is not the true and first inventor of the device and his claimed invention
is not new within the terms of section 32(1)(e)" (this corresponds to s 64(1)(e) of the Indian Patents
Act).
Publicly Known/Use- The "publicly known or publicly used" expression is not a ground for the
opposition of a patent application. There is a distinction in this section as to what is publicly known
and what is merely published. Mere publication is not sufficient to establish public knowledge. On
the other hand, a thing is publicly known, without being published in a document, if it has been
publicly used. The use of an invention for purposes of trade, whether by the inventor himself or by
others may constitute public user of the invention ( Lallubhai Chakubhai v. Chimanlal Chunilal & Co.
A.I.R. 1936 Bom. 99). Public sale of article is strong evidence that the user is commercial and not
experimental (lallubhai case)

In Monsanto Co. V. Coromandel Indag Products (P) Ltd. 1986 A.I.R. 712, it was held that “to satisfy
the requirement of being publicly known as used in clauses (e) and (f) of section 64(1), it is not
necessary that it should 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 consumers.“

Before the 2003 amendment, non-obviousness requirement was not there and the same was read in
with the term novelty itself. So, both anticipation and non-obviousness was looked into while
determining novelty. (Bishwanath Prasas Rradhe Shyam v. Hindustan Metal Industries).

For anticipation there are two requirements:

1. Requirement of identity.
2. Requirement of enablement

If claimed, invention identifies with a single prior art document? If yes, would the prior art enable a
person having ordinary skill in the art to come up with that invention?

If the answer to both the above questions is yes then the invention was anticipated by prior art and
is not novel. For determination of novelty an exact citation in a single document is necessary. In the
case of obviousness many documents can be considered.

PRIORITY DATE

Disclosure can be of two types: Provisional and complete. From the date of filing for provisional
specifications, 12 months time is given to file complete specifications. Now, the question arises that
what if some other person files complete specs within the 12 month period? Who would get
priority? It will be given to the person who filed provisional specs first.

Priority date is the date of filing provisional specs. Novelty would be adjudged on date of filing
complete specs but priority date would be on the date of filing prov specs. Hence, one should not
wait for completion of invention for filing complete specs. Prov specs should be filed as soon as
possible so that you would get priority over others for filing complete specs.
NON-OBVIOUSNESS REQUIREMENT UNDER PATENT LAW

Non-obviousness of the invention is one of the three requirement for the grant of Patent, others
being novelty and industrial application. It is defined under Section 2(ja) of the Patents Act, 1970.
Simply put nonobvious as a patent term means that the invention shall not be obvious or apparent
to a person ordinary skilled in the field relating to the invention. Basically the invention shall contain
an inventive step over the prior art. It should not be mere a workshop improvement or general re-
arrangement of components / features of the invention. ( Gillette vs yeshwant)

This test of non-obviousness is to be made with the perspective of a person having ordinary skill in
the art i.e. having average skills, and not an expert in that technology. The test is very essential and
subjective too, while deciding the inventive step the adjudicator needs to assess the "inventive step"
on the scale and parameters of a person ordinarily skilled in that art.

Non obviousness draws a line between what is merely new and what is a truly inventive step.

In the case of Hotchkiss vs greenwood, Plaintiffs filed an action alleging the infringement of the
plaintiffs’ patent right for a new and useful improvement in making door knobs of clay. The Court
noted that the application of an old machine to some new purpose is not the foundation of a patent;
but an improvement of an old machine, in order to apply it to the same purposes more
advantageously, is the subject of a patent. The difference was formal and lacking of ingenuity or
invention. The improvement was the work of the skillful mechanic, not that of the inventor.
Therefore, there was no patent infringement.

In the case of Reckendorfer vs faber, the patent claim was for a pencil with an attached eraser.
According to the Supreme court decision the patent was invalid because the two parts; pencil and
eraser were used no differently when combined then when used separately. “A combination, to be
patentable, must produce a different force, effect, or result in the combined forces or processes from
that given by their separate parts. There must be a new result produced by their union; otherwise it
is only an aggregation of separate elements. A combination, therefore, which consists only of the
application of a piece of rubber to one end of the same piece of wood which makes a lead pencil is
not patentable.”

In India, the 2002 amendment to the patent act was the first time that the term inventive step was
added. Further, in the 2005 amendment, advance step to prior art was added.

The Supreme Court of India laid down the following criteria for assessing inventive step in M/s.
Bishwanath Prasad Radhey Shyam Appellant v. M/s. Hindustan Metal Industries: “To be patentable
the improvement or the combination must produce a new result, or a new article or a better or
cheaper article than before. The combination of old known integers may be so combined that by
their working interrelation they produce a new process or improved result. Mere collection of more
than one integers or things, not involving the exercise of any inventive faculty, does not qualify for
the grant of a patent.”

In Gillette Industries Ltd., v. Yeshwant Bros. A.I.R., 1938. Bom. 347., it was held that mere simplicity
is not necessarily an objection to the subject matter of an invention, though matters of ordinary
skilled designing or mere workshop improvements are not inventions. When the invention is just an
automatic or obvious extension of Prior Art, the invention lacks in inventive step.

The question is therefore, does the invention make available to the person skilled in the art
something that he would not reach by normal exercise of his skill? If so, the inventor has made a
contribution to the art which provides the consideration justifying the grant of a patent. This is not
to say that it must be technically complex; simplicity does not count against an invention.

For determination of novelty an exact citation in a single document is necessary i.e., a single art is to
be considered but in non-obviousness, we look at multiple arts for assessment of prior art.

The US Supreme Court has discussed the aspects involved in the non-obviousness analysis in the
landmark case Graham et al. v. John Deere Co. of 2 Kansas City et al3. Three factors were laid down
as tests for which should be looked into while determining obviousness, these are commonly known
as Graham factors:

1. the scope and content of the prior art;

2. the differences between the prior art and the claims at issue; and

3. the level of ordinary skill in the pertinent art.

Apart from the above factors the US Apex Court also laid down secondary considerations as:

1. commercial success of the invention,

2. long felt but unsolved need, and,

3. failures of others could serve as evidence of non obviousness

United States v. Adams is an example of a case satisfying the requirement for non-obviousness of a
combination of known elements. The patent under consideration, relates to a nonrechargeable
electrical battery composed of two electrodes - one of magnesium and the other of cuprous chloride,
with a plain or salt water electrolyte.

The Government argued that wet batteries comprising a zinc anode and silver chloride cathode were
old in the art; and that the prior art showed that magnesium could be substituted for zinc and
cuprous chloride for silver chloride.

"Despite the fact that each of the elements of the Adams battery was well known in the prior art....
[K]nown disadvantages in old devices which would naturally discourage the search for new
inventions may be taken into account in determining obviousness."

The Supreme Court's Adams opinion invokes several secondary considerations in favor of

TSM TEST

TSM test is the Teaching, Suggestion and Motivation test. It simply means, when analysing the
obviousness of an invention while comparing it with prior art, these are the three questions that
have to be asked:

 Is the prior art quoted instrumental in teaching the reader the method of producing the
invention?

 Does the prior art or any of its contents suggest any method of producing the invention in
question?
  Does the prior art talk about problems related to a particular technology motivating an
invention in a particular manner?

It must be well understood by now that to receive a patent over an invention there has to be leap. A
sufficient “leap” beyond what is already known that can be demonstrated as objectively as possible.
As laid down in Hotchkiss v. Greenwood, 52 U.S. 248, 267 (1850), what is looked for is the evidence
of “more ingenuity and skill… than were possessed by an ordinary mechanic acquainted with the
business.”

An “ordinary mechanic” just combines or substitutes old elements. It can also represent someone
just producing the next step in the evolution of an innovation, which anyone knowledgeable would
“know” how to do. This is equivalent to the low objective, non-novelty, standard (A+B=C).

Courts have defined what is not patentable: inventions that do not make a sufficient leap (iterations
beyond the first order), or more specifically, those inventions that are obvious. Determining
obviousness by assessing a sufficient leap is subjective. To cut down on the variability of this
determination, obviousness is evaluated from the perspective of a Person Having Ordinary Skill in
the Art (PHOSITA).

An invention therefore is obvious, and therefore not patentable, if a PHOSITA would find that the
leap was insufficient to make the invention non-obvious. Also, Winner Int’l Royalty Corp. v. Wang,
considered the TSM test, saying there must be a suggestion or teaching in the prior art to combine
elements shown in the prior art in order to find a patent obvious. Thus, in general the critical inquiry
is whether there is something in the prior art to suggest the desirability, and thus the obvious
nature, of the combination of previously known elements.

KSR IMP- https://unctad.org/ippcaselaw/sites/default/files/ippcaselaw/2020-12/KSR