Patentable inventions and

Non- Patentable inventions

Rights and Benefits of Patents under Section 48 of the
Patent Act, 1970
• Exclusive Rights of the Patentee: the patentee has the exclusive right to Prevent others from
using, making, commercially exploiting, or importing the invention without consent.
• Competitive Advantage: Patentees gain a competitive edge in the market by utilizing patented
inventions, leading to Improved market power, Increased profits, Royalties when others use their
patented technology.
• Invention Protection: Exhibit their invention at trade shows or exhibitions without fear of
copying and to Reduce or eliminate competition, leading to increased sales.
• Monetization Opportunities: Licensing their invention to others for a fee, Assigning the patent
for monetary benefits.
• Fundraising and Financial Leverage: Sold, licensed, or assigned for financial benefits.
• Cross-Licensing and Negotiations: Cross-licensing, where companies exchange patent rights to
avoid hefty royalty fees, Cost-effective collaboration and technology acquisition.
• Facilitation of Innovation and Collaboration: Patents foster partnerships by enabling businesses
to negotiate effectively, share innovations, and collaborate for mutual benefits.
 Territorial application of patent laws
• Patent laws are territorial and governed by the specific laws of the country where the patent is
registered. Intellectual Property (IP) rights are generally governed by domestic laws.
WTO and TRIPS Agreement:
• Countries that are members of the World Trade Organization (WTO) must align their domestic laws
with the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.
• The WTO oversees global trade agreements and resolves disputes among member countries.
Goals of TRIPS Agreement (Article 7):
• Promote technological innovation.
• Facilitate the transfer and dissemination of technology for mutual benefit.
• Balance social and economic welfare with the rights and obligations of stakeholders.
Country-Specific Variations:
• Despite the broad patent framework under TRIPS, variations exist among countries regarding
patentability and non-patentability of inventions.
We have a long way to go…
In 1421, Filippo Brunelleschi
received the world's first
patent for an invention. He
created a method of
transporting marble more
cheaply via a paddleboat.

His patent gave him the

right to burn any ship
borrowing his design for
three years.
 What is an Invention?
Sec.2(1)(J)
“Invention” means a new product or process
involving an inventive step and capable of
industrial application
 Patentable inventions
• Patentable inventions are those that meet specific criteria set by patent laws.
Generally, for an invention to be patentable, it must be novel, nonobvious, and
useful.
• Examples include new devices, methods, or compositions of matter that demonstrate
a clear inventive step and offer a tangible benefit.
• Novel – An invention will be patentable if it is novel or new in the light of prior art
or it is not anticipated by prior art. It must be new and not known to public before
filing.
• Inventive Step- A feature of an invention that involves technical advance as
compared to the existing knowledge that makes the invention not obvious to a person
skilled in the art.
• Industrial application- Capable of being made or used in an industry. It must relate to
commercialization of patented product for public and society purpose.
PATENTABLE INVENTIONS

An invention relating either to a product or process that is new,

involving an inventive step and capable of industrial application can be
patented.
1 A Process- (method)
2. Machine
3. Article of manufacture
4. Composition (of matter)
5. A "new use" of one of the first four.
• Machine – Screwdriver
• Machine: This refers to a device or apparatus that performs a specific function or task. In this case,
a screwdriveris a machine designed to insert or remove screws.
• Patentability: A screwdriver can be patented as a machine if it is a novel and non-obvious invention. For
example, if the screwdriver includes a new mechanism for automatically driving screws or a unique design,
it could be patentable.
• Example: An electric screwdriver with a new, innovative mechanism for adjusting torque levels.
• Improved Machine – Better Screwdriver
• Improved Machine: This refers to a modified or enhanced version of an existing machine that brings about
some advantage, such as improved functionality, ease of use, or efficiency.
• Patentability: An improvement to a machine (e.g., a screwdriver) can be patented if it meets the criteria of
novelty, inventive step, and industrial applicability. The improvement must be non-obvious and offer
a technological advantage over the existing version.
• Example: A screwdriver with an ergonomic handle design or a mechanism that prevents the screwdriver
from slipping out of the screw
• . Compositions – New Drugs
• Compositions: In the context of patents, a composition refers to a mixture or combination of
substances, typically chemicals or pharmaceutical ingredients, that results in a product with specific
properties.
• Patentability: New pharmaceutical compositions, such as drugs, can be patented if they are novel (not
previously known), non-obvious (not an obvious modification of existing drugs), and useful (for
treating a disease or medical condition).
• Example: A new drug formulation that combines existing active ingredients in a unique way to
enhance therapeutic efficacy or reduce side effects.
• 4. Methods of Making
• Methods of Making: This category refers to the process or method of producing a product. It can
involve any new or innovative way of manufacturing, synthesizing, or preparing an invention or
composition.
• Patentability: A method of making can be patented if it is new, inventive, and industrially applicable.
For example, a novel way of making a screwdriver or a drug formulation could be patented.
• Example: A new method for manufacturing a drug that uses a novel chemical synthesis technique or a
unique manufacturing process for creating a screwdriver handle.
• . Methods of Using
• Methods of Using: This refers to a new or innovative way of using a product, often in a specific application or scenario.
The method involves applying a product or composition in a new and useful way.
• Patentability: A method of using an invention can be patented if it is novel and provides a new solution to a problem. For
example, a new way of using a drug for a different therapeutic purpose could be patentable.
• Example: A new method of using a screwdriver in a particular industrial setting where its unique design enhances
efficiency.
• 6. Methods of Treatment – e.g., A Method for Treating a Disease
• Methods of Treatment: These involve specific methods or techniques used to treat a particular medical condition or
disease. These methods can include steps for administering a drug, performing a medical procedure, or using a device for
treatment.
• Patentability: In some jurisdictions, methods of treatment can be patentable if they are novel, inventive, and useful for
treating a disease or medical condition. However, some legal systems, including India’s, may have restrictions on
patenting certain medical treatment methods or therapies that involve surgical or therapeutic procedures.
• Example: A method for treating a specific type of cancer using a novel drug combination or a method for performing a
non-invasive surgery.
• 7. Business Methods
• Business Methods: These refer to new, innovative methods or systems for conducting business, often involving
technologies like software, financial techniques, or specific organizational processes.
• Patentability: The patentability of business methods varies by jurisdiction. In many jurisdictions, pure business
methods (e.g., methods involving only abstract concepts like a new way of running a business or marketing strategy) are
not patentable. However, if the business method involves technical aspects (e.g., a new software or technological
process that supports a business method), it may be eligible for a patent.
• Example: A new software application for processing financial transactions that streamlines the business of stock trading.
 Invention Vs. Know-how

Invention: Does not require to disclose the information in the specification,

be sufficient for Commercial Exploitation of invention
Know-how: Covers all informations necessary to commercialise the invention
e.g. setting up a production plant, details of production method, the design,
drawing, etc. Know-how is traded when transferring technology
Invention Vs. Discovery

Invention: Adds to the amount of human knowledge but not merely by

disclosing something. It involves suggestion of the act while results new
process, products etc.
Discovery: Adds only to the amount of human Knowledge
Unity of Invention: Singh Inventive Concept
Obviousness: Something which is open to the eye or mind and perfectly evident to a
person thinking on the subject

To Whom it is obvious ?

(a) A skilled technician – Acquainted with techniques (b) Inventor (C) Expert
In Bishwanath Prasad Radheshyam Vs. Hindusthan Metal
Industries, [(1979) 2 SCC 511],”.

• Supreme Court of India addressed the criteria for determining whether an

invention involves an inventive step, a fundamental requirement for patentability.
Background:
• The dispute centered on a patent granted to Hindustan Metal Industries for a
machine designed to clean and polish utensils. Bishwanath Prasad Radheshyam
challenged the patent, asserting that the invention lacked novelty and inventive
step.
Key Issues:
1.Inventive Step: Whether the patented machine involved an inventive step
beyond the existing knowledge and practices in the field.
2.Obviousness: Whether the invention was obvious to a person skilled in the art at
the time of its creation.
5/29/2014 12
 In Bishwanath Prasad Radheshyam Vs. Hindusthan Metal Industries,
[(1979) 2 SCC 511],”.

COURT'S FINDINGS:
• Supreme Court held that “the object of patent law is to encourage scientific
research, new technology and industrial progress.
• . It held that an invention must not be obvious to a person skilled in the art,
and the mere application of known principles or methods does not suffice to
establish an inventive step. The Court further stated that the invention must
involve a degree of ingenuity that is not apparent to someone with ordinary
skill in the relevant field.
• Grant of exclusive privilege to own, use or sell the method or the product
patented for a limited period, stimulates new inventions of commercial utility.
• The price of the grant of monopoly is the disclosure of the invention at the
Patent Office, which after the expiry of the fixed period of the monopoly,
passes into the public domain”.
13
 Inventions Not Patentable in India
• Section 3 and Section 4 of the Patent deals with the list of non-patentable inventions
a) Inventions that are frivolous and contrary to natural laws: Inventions which are
frivolous or contrary to well established natural laws.
Example– Inventions that are against the natural laws that are any machine giving 100%
efficiency, or any machine giving output without an input cannot be considered as obvious
and cannot be patented.
For instance, a machine that claims to generate energy without any input would be frivolous
as it contradicts the law of energy or a machine claiming to teleport people. A perpetual
motion machine would not be patentable as it would defy the laws of thermodynamics
b) Inventions which go against public morality: Inventions in which the primary or
intended use or commercial exploitation of which could be contrary to public order or
morality (that is against the accepted norms of the society and is punishable as a crime)
or which causes serious prejudice to human, animal or plant life or health or to the
environment.
Example– As in Biotechnology, termination of the germination of a seed by inserting a gene
sequence that could lead to the disappearance of butterflies, any invention leading to theft or
burglary, counterfeiting of currency notes, or bioterrorism.
Example– The Oncomouse, genetically modified to develop cancer for the purposes of
medical research is not patentable because cancer can be transmitted to public.
inventions that use human embryos for commercial purposes or inventions which modify
the genetic identity of humans or animals or cause them suffering.
c) Inventions that are a mere discovery of something that already exists in
nature: The mere discovery of a scientific principle or the formulation of an
abstract theory or discovery of any living or non-living substances occurring in
nature.
Explanation– Mere discovery of something that is already existing freely in nature is a
discovery and not an invention and hence cannot be patented unless it is used in the
process of manufacturing an article or substance.
• the mere discovery of a micro-organism is not patentable.
• Discovery of micro-organism.
d) The mere discovery of a form already existing in nature does not lead to
enhancement of efficacy: 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.
Example: new use of aspirin for heart ailments
Example: Mere new uses of Neem.
 Novartis AG vs. Union of India (2013)
• Facts:
Novartis AG sought a patent for a crystalline form of Imatinib Mesylate (a known substance), arguing that its
invention involved a two-step process, unlike a one-step discovery. They claimed that the new crystalline form
(beta form) was not a mere change of form, but rather a significant invention that should not fall under Section
3(d), which disallows patenting minor modifications of known substances.
• Issue:
Whether the new crystalline form of Imatinib Mesylate should be patented or if it falls under Section 3(d) of the
Indian Patent Act, which excludes mere modifications of known substances unless they exhibit enhanced
therapeutic efficacy.
• Judgment:
The Supreme Court held that the invention did not meet the criteria for patentability under Section 3(d). It
noted that the beta form of Imatinib Mesylate was not a new substance, as it was anticipated and obvious.
Additionally, the Court emphasized that for a modification to qualify under Section 3(d), it must demonstrate
significantly enhanced therapeutic efficacy. Novartis’s drug did not qualify because the change did not enhance
efficacy. Therefore, the appeal was dismissed.
• Key points from the judgment:
1. Therapeutic efficacy must be considered when assessing pharmaceutical patents.
2. Section 3(d) was designed to prevent evergreening of patents, especially in pharmaceuticals.
3. A change in form (such as the crystalline form) that does not improve therapeutic efficacy cannot be patented.
Glochem Industries Ltd vs. Cadila Healthcare Ltd (2009)
• Facts:
Glochem Industries held a patent for a specific pharmaceutical formulation. They accused
Cadila Healthcare of infringing their patent by producing a similar drug formulation.
• Issue:
The main question was whether Cadila’s formulation was sufficiently similar to Glochem's
patented formulation to constitute infringement. Cadila challenged the patentability of
Glochem's product.
• Judgment:
The Bombay High Court examined the patent's validity by applying the standard criteria of
novelty, inventive step, and industrial application. The Court assessed whether Cadila's
formulation fell within the scope of Glochem's patent. The judgment focused on whether
the alleged infringement was substantial enough to violate the patent, considering the
criteria for patentability.
Comparison
1. Novartis case: The decision emphasized the importance of enhanced therapeutic efficacy
for incremental changes to pharmaceuticals, especially to prevent evergreening of patents.
2. Glochem case: The Court scrutinized the patent's validity based on novelty and inventive
step to determine if the infringement claim was valid.
 Reference to Monsanto vs. Bowman (2013)
The Supreme Court relied on key points from the Monsanto vs. Bowman (2013) case to reinforce the importance of therapeutic
efficacy and the principles underlying Section 3(d) of the Indian Patent Act, 1970. Here’s a breakdown of the points made in the
Novartis case:
1. Therapeutic Efficacy:
The Court confirmed that efficacy, particularly in the context of drugs, refers to therapeutic efficacy. This means that for a
pharmaceutical product to be patentable, it must demonstrate a therapeutic benefit or improvement over existing products.
2. Purpose of Section 3(d):
Section 3(d) was enacted to prevent the evergreening of patents—a practice where companies make minor, non-substantive
changes to existing drugs to extend the patent life and thereby block generics. This section ensures that incremental
modifications, such as changes in form without therapeutic advancement, cannot be patented.
3. No Exhaustive Definition:
The Court acknowledged that it is difficult to provide an exhaustive definition of what constitutes therapeutic efficacy.
Instead, it must be evaluated based on the facts and circumstances of the specific case. It is essential to assess whether the
change in knowledge results in enhanced therapeutic efficacy.
4. Changed Forms of Molecules:
A change in the form of a molecule, such as its crystalline structure, does not automatically satisfy the criteria under Section
3(d). Even if such changes make the molecule more soluble or thermodynamically stable, these improvements should impact
the therapeutic efficacy. If they do not lead to better therapeutic outcomes, they do not qualify for a patent under Section
3(d).
5. Enhanced Efficacy Required:
The Court emphasized that to avoid disqualification under Section 3(d), the new form of the substance must
show significantly enhanced therapeutic efficacy. In Novartis’s case, the beta crystalline form of Imatinib Mesylate did not
meet this requirement, as it was not a new substance nor did it provide significant therapeutic benefits over the original
form.
e) Mere admixing of mixtures leading in the aggregation of properties are non-
patentable: A substance obtained by a mere admixing of two or more mixtures resulting
only in the aggregation of the properties of the components thereof or a process for
producing such substance is not considered the invention.
Example: Paracetamol + brufen
Solution of sugar and color additives in water to form a soft drink.

f) Mere aggregation or duplication of devices working in a known way is not an

invention: The mere aggregation or re-arrangement or duplication of known devices
each functioning independently of one another in a known way.
Example: A Bucket fitted with torch.
An Umbrella with fan.
A Clock and radio in a single cabinet.
h) Method of Agriculture or Horticulture: Any method of agriculture or horticulture is not
an invention.
Example: A method of producing a plant or a method of producing improved soil or a method
of producing mangoes cannot be patented.
Cultivation of algae ,
Producing new form of a known plant,
Preparation of an improved soil.

But Agricultural Equipments are patentable.

Patentability of Agricultural Inventions
Agricultural inventions that may qualify for patent protection:
Biotechnological Advances:
• Innovations in Genetically Modified Organisms (GMOs) or new plant strains produced using genetic
engineering techniques may be patentable if they involve novel, inventive steps and have industrial
applicability.
• Gene-editing technologies like CRISPR and other biotechnological methods that lead to improved plant
characteristics could also be considered patentable if they offer a significant advancement over existing
methods.
Agricultural Machinery and Equipment:
• New machinery or equipment innovations that enhance efficiency or functionality in agriculture are eligible
for patents if they involve a technical innovation. These could range from more efficient irrigation systems to
advanced harvesters.
Novel Formulations and Compositions:
• Chemical formulations for fertilizers, pesticides, or herbicides can be patented if they provide a novel and
non-obvious solution to specific agricultural problems, such as pest control or soil nutrient enhancement.
 Decco Worldwide Post Harvest Holding vs.
Controller of Patents and Designs (2023)
• 3(h) and 3(i) of the Indian Patents Act, 1970, particularly concerning agricultural inventions. In this case, Decco
Worldwide Post Harvest Holding had applied for a patent for a fungicidal treatment for Black Sigatoka, a disease
affecting banana plants. The treatment was claimed to be cost-effective, environment-friendly, and capable of
reducing disease resistance while improving plant health and yield.
• The Controller of Patents initially rejected the patent application, arguing that the treatment was a method of
agriculture under Section 3(h).
• The appellant countered by claiming the invention was a process for treatment of plants to make them disease-free,
falling under Section 3(i), which deals with medicinal or therapeutic processes for humans, animals, or plants.
• The Court found that:
• Section 3(h) pertains to methods of agriculture and horticulture but does not cover treatment of plants to cure
diseases.
• Section 3(i), as amended in 2002, no longer includes plants as part of processes that are not patentable. Thus, the
court ruled that the process in question did not fall under the non-patentable category.
• The Court set aside the Controller’s decision and sent the case back for reconsideration based on this clarification of
the law.
i) Medicinal, curative, prophylactic, diagnostic, therapeutic for
treating diseases in human and animals are non-patentable: Any
process for the medicinal, surgical, curative, prophylactic, diagnostic,
therapeutic or other treatment of human beings or any process for a
similar treatment of animals to render them free of disease or to
increase their economic value or that of their products.
Example: Removal of cancer tumor.
Removal of dental plaque and carries.
Surgical processes.
j) Essential biological processes for the production or propagation of animals and
plants is not an invention: Plants and animals in whole or any part thereof other than
micro-organisms but including seeds, varieties and species and essentially biological
processes for production or propagation of plants and animals.
Example: Clones and new varieties of plants.
A process for production of plants or animals.
if it consists entirely of natural phenomena such as crossing or selection i.e, Essentially
biological Process.
Patentability of Plants and Biological Processes
(Section 3(j))
• Plants and seeds, along with biological processes for their propagation,
are generally not patentable under Section 3(j), except
for microorganisms.
• Plant varieties and products derived from them, such as seeds or plants
themselves, cannot be patented under the Indian Patents Act. However,
new plant varieties can be protected under the Protection of Plant
Varieties and Farmers' Rights Act, 2001 (PPVFR Act).
• The PPVFR Act allows for the registration of new plant varieties if they
meet the criteria of novelty, distinctness, uniformity, and stability.
 Patentability of Plants and Biological Processes
(Section 3(j))
• Novelty: The new variety must not have been sold or disposed of without the
breeder’s consent, either in India or abroad, for a specified period (one year for
most plants, up to six years for trees and vines).
• Distinctness: The new variety must have at least one characteristic that makes it
clearly distinguishable from existing varieties.
• Uniformity: The new variety must exhibit consistent characteristics, with variations
limited to those expected from its method of propagation.
• Stability: The essential characteristics of the variety should remain consistent even
after repeated propagation.
This sui generis system recognizes both farmers' and breeders' rights, offering
protections for both public sector breeding institutions and farmers, ensuring a
balance between innovation and farmers' access to plant materials.
k) Simple mathematical or business or computer programs are not an invention: A
mathematical or business method or a computer program per se or algorithms;
Explanation– any mathematical calculation, any scientific truth or act of mental skills any
activities related to business methods or algorithms (which are like the law of nature) cannot
be patented.
Computer program by itself or as a record on a carrier, But combination of hardware and
software is patentable.
Online chatting method

l) Aesthetic creation is not an invention: A literary, dramatic, musical or artistic work or

any other aesthetic creation whatsoever including cinematographic works and television
productions.
Explanation– such activities like writings, painting, sculpting, choreographing,
cinematographing all these which are related to creativity cannot be patented and fall under
the gamut of Copyright Act, 1957.
m) Mental act, rule or method is not an invention: A mere scheme or rule or method of
performing mental act or method of playing a game.
Explanation- playing a game such as chess, sudoku etc are not considered as inventions
rather these are mere brain exercises and hence are not patented.
Method for solving a crossword puzzle,
Method of learning a language

n) Presentation of information is non-patentable: Explanation- a mere presentation of

information by tables, chars is not an invention and hence are not patentable, for example,
railway timetables, calendars etc
spoken words
symbols
diagrams
o)The topography of integrated circuits is non-patentable: Such as semiconductors used
in microchips are not patented.
Mask works -circuits layout

p) Traditional Knowledge is not an invention: An invention which in effect, is traditional

knowledge or which is an aggregation or duplication of known properties of the traditionally
known component or components.
Explanation- the traditional knowledge is know-how, skills, that is passed from generations to
generations of a community and is already known cannot be patented for example the
antiseptic properties of turmeric.

Section 4: Atomic-Energy inventions are non –patentable: inventions relating to atomic

energy, that are also not patentable and that fall within sub-section (1) of section 20 of the
Atomic Energy Act, 1962.
Inventions relating to compounds of Uranium, Beryllium, Thorium, Plutonium, Radium,
Graphite, Lithium are not patentable
Patentability of Product Patents in the
Pharmaceutical Industry in India
• Before India's independence, the patent law was governed by the Patents and Designs Act, 1911,
which allowed both product patents and process patents. However, it was later realized that the
patent system was benefiting foreign interests more than domestic Indian innovators. The system
was seen as hindering industrialization and scientific progress, especially in the pharmaceutical
sector.
• To address these issues, the Tekchand Committee and the Ayyangar Committee were formed to
review and suggest reforms to the patent law. The Ayyangar Committee recommended that
patents in the pharmaceutical and chemical sectors should be restricted to process
patents and product patents should not be granted for substances intended for use in food,
medicine, or drugs. This led to the enactment of the Patents Act, 1970, which replaced the 1911
law.
Patentability of Product Patents in the
Pharmaceutical Industry in India
• Under Section 5 of the 1970 Act, India excluded product patents for substances that were intended for
use in food or medicine. This exclusion greatly benefited the Indian pharmaceutical industry, enabling
the production of generic drugs at lower costs and making India a global leader in affordable
medicines.
The WTO and TRIPS Agreement
• India's position on product patents changed after the Uruguay Round of negotiations under
the General Agreement on Tariffs and Trade (GATT). As a result of the TRIPS Agreement (1995), India
was required to align its patent laws with global standards, which included allowing product patents for
pharmaceuticals and agricultural chemicals.
Key Amendments and Impact
• To comply with TRIPS, the Indian government made several amendments to the Patents Act, 1970:
1. 1994 Amendment: The Patents (Amendment) Ordinance allowed patents for pharmaceutical
products and the grant of exclusive marketing rights for products that met the patent criteria.
2. 1999 Amendment: The Patents Act, 1970 was formally amended to align with the TRIPS Agreement.
3. 2004 Amendment: The Patents Amendment Ordinance removed Section 5 of the 1970 Act, which
had previously excluded product patents for pharmaceutical substances. This opened the door for
granting product patents in the pharmaceutical sector.
 Concerns and the Need for a Balanced Approach

• While the amendment allowed for product patents in pharmaceuticals, there were
concerns about the affordability of life-saving medicines. A significant portion of
India's population relies on affordable generic medicines, and the introduction of
product patents was feared to lead to high drug prices, limiting access for the poor.
• To address these concerns, the Indian government introduced Section 3(d) of the
Patents Act. This provision was designed to prevent the evergreening of patents in
the pharmaceutical sector, where companies could repeatedly patent minor
modifications to existing drugs without offering any new therapeutic benefit.
• Section 3(d) and the Concept of Enhanced Efficacy
• Section 3(d) specifically addresses pharmaceutical inventions, stating that the mere
discovery of a new form of an existing substance (such as a new salt or polymorph)
does not qualify for a patent unless it demonstrates enhanced efficacy.
• The provision ensures that only genuinely innovative drugs that provide a significant
therapeutic advantage are eligible for patent protection, while minor
modifications of existing drugs cannot be patented to prevent monopolies on basic
medicines.
 N0VARTIS AG VERSUS UNION OF INDIA
(2013) 6 SCC 1
• One of the predominant pharmaceutical companies, Novartis International (The Appellant)
filed an application for patent registration of a drug called ‘Glivec’. This drug was invented
using the Beta Crystalline form of "Imatinib mesylate" used to treat cancer.
• Initially, the application in India was not considered because Section 5 of the Patents Act,
1970 restricted the grant of a patent for products. After the 2005 amendment, which included
patents for products along with processes, the application for patenting Glivec was taken
into consideration.
• This application was placed in a "mailbox" until India's patent laws were amended in 2005
to comply with the TRIPS agreement, allowing product patents.
• The application by the appellant, when first filed, was rejected by the Madras Patent Office
as well as the IPAB, on the grounds that the drug in question is a known substance and does
not induce any ‘enhanced efficacy’ than the previous drug ‘Zimmermann’ patented in the
US. Thus, it cannot be considered to include an inventive step under Section 3(d) of the Act.
• The IPAB’s reasoning for the rejection involved the prevention of ‘evergreening’ of an
already patented product which would eventually cause an obstacle in the provision of
affordable medicines .
• Thus, a SLP was filed by the appellants in the Supreme Court of India under Article 136.
 N0VARTIS AG VERSUS UNION OF INDIA
(2013) 6 SCC 1
ISSUES
• Whether the ‘inventive step’ requirement under section 2(1)(j) is fulfilled by the appellant?
• Whether Section 3(d) of the Act bars the registration of the appellant’s patent?
LAW
• Section 2(1)(j), Indian Patents Act, 1970 – Defines Invention as a new product or process
which includes an inventive step and is capable of
• industrial application.
• Section 2(1)(ja), Indian Patents Act, 1970 – Defines Inventive step to mean a non-obvious
feature which involves a technical advancement when compared to a previous product.
• Section 3(d), Indian Patents Act, 1970 – New form of a known substance which does not
result in an enhanced efficacy is not patentable.
• Section 83, Indian Patents Act, 1970- The general principles applicable to the working of
patented inventions
 N0VARTIS AG VERSUS UNION OF INDIA
(2013) 6 SCC 1
ANALYSIS
• The Appellant primarily argued that the Zimmerman patents registered in the US differ from Glivec in
terms of the form of the substance used. The appellant’s product is in a beta crystalline form which satisfies
the novelty requirement because the Zimmerman does not constitute the beta crystalline form of imatinib
mesylate. It was contended that since the Zimmerman patent contains no mention of a crystalline structure
or teach a person how to prepare a particular polymorph of the salt, the process of production of the salt
and the synthesis of the relevant crystalline form would possess the characters to pass the Novelty test.
• When the court analysed this contention, it concluded that since the substance in question was already a
known substance, it does not qualify the test of invention as under section 2(1)(j).
• Secondly, the appellant had stated that their product in the beta crystalline form has an enhanced efficacy
over the imatinib mesylate used in the previously registered drug, thus it satisfies the test of selection under
Section 3(d).
• The Respondents denied these arguments and stated that imatinib mesylate in beta crystalline form is not
original or non-obvious as there are preexisting publications about the component in addition to the
disclosures in the Zimmerman registration application. Further, in order to prove the novelty of the same, it
was contended that ‘efficacy’ in Section 3(d) should be considered as a therapeutic efficacy and not merely
physical efficacy.
• The court accepted this argument and rejected the appeal filed by Novartis by stating that although the beta
crystalline is a new form of a known substance (Imatinib Mesylate),the efficacy of the substance is already
well known.
 N0VARTIS AG VERSUS UNION OF INDIA
(2013) 6 SCC 1
• This is one of the landmark judgments of the supreme court which ensured
affordable access to medicines for all while defining the scope of the patents
(amendment) act, 2005. The court, in effect, emphasised that while considering the
efficacy in case of any drugs or medicine, the efficacy under section 3(d) always
refers to ‘therapeutic efficacy’ as contented.
• Further, it stated that the intention of the amendment provisions to the patents act,
1970 also includes ensuring that patented products do not get ‘evergreen’ protection.
• The Indian patent office does not take a liberal approach towards the grant of patent
protection for pharmaceutical products to ensure prevention of unaffordability of life
saving drugs. Section 3(d) by barring all incremental inventions achieves this
objective. The hon’ble court in its judgement, clearly stated that since India is a
developing country, the availability of medicines at affordable rates is a necessity.
F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (2009):

• F. Hoffmann-La Roche Ltd. (Roche), a Swiss multinational healthcare company, held

an Indian patent (No. 196774) for the drug Erlotinib Hydrochloride, marketed
under the brand name "Tarceva."
• Cipla Ltd., an Indian pharmaceutical company, announced plans to manufacture
and sell a generic version of Erlotinib under the brand name "Erlocip."
• In January 2008, Roche initiated a lawsuit against Cipla in the Delhi High Court,
alleging patent infringement and seeking an injunction to restrain Cipla from
manufacturing and selling Erlocip.
• Cipla contested the validity of Roche's patent, arguing that Erlotinib Hydrochloride
lacked novelty and inventive step, and that the patent was invalid under Section
3(d) of the Indian Patents Act, which prevents "evergreening" of patents.
 F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (2009):
KEY ISSUES
• 1. Patent Validity: Whether Roche's patent for Erlotinib Hydrochloride was valid.
• 2. Infringement: Whether Cipla's generic version, Erlocip, infringed upon Roche's patent rights.
• 3. Public Interest: Whether granting an injunction against Cipla would adversely affect public interest by limiting
access to a life-saving cancer drug.
• COURT'S FINDINGS:
• Patent Validity: The court upheld the validity of Roche's patent, rejecting Cipla's claims of lack of novelty and
inventive step.
• Infringement: The court found that Cipla's Erlocip infringed upon Roche's patent.
• Public Interest: Despite finding infringement, the court denied Roche's request for an injunction, emphasizing the
need to make life-saving medications accessible and affordable.
IMPLICATIONS:
• This judgment underscored the importance of balancing patent rights with public health considerations, setting a
precedent for future cases involving essential medicines.
• It highlighted India's commitment to preventing the "evergreening" of patents, ensuring that monopolies on
critical drugs do not hinder access to affordable generics.
 Term of Patent:
• The patent has a limited term of 20 years, which is counted from the date
of filing of the patent application, irrespective of whether it is filed with
provisional or complete specification.
• Payment of Renewal Fee: It is important to note that a patentee has to
renew the patent every year by paying the renewal fee, which can be
paid every year or in lump sum.
• Restoration of Patent: A request for restoration of patent can be filed
within eighteen months from the date of cessation of patent along with
the prescribed fee. After the receipt of the request, the matter is notified
in the official journal for further processing of the request.
 Patentable Inventions
• BlackBerry Limited v. Controller of Patents and Designs (2024, Delhi High Court)
Facts:
•BlackBerry sought a patent for features of “automatic selection” and “updating by a cache manager” as
technical advancements.
•The Controller rejected the application, claiming the invention fell under Section 3(k) of the Patents Act
(computer programs per se).
Issue:
Whether the subject matter constituted a computer program per se, thereby barred under Section 3(k).
Judgment:
• The court held the invention introduced novel elements, such as confidence level categorization, file size
filtering, and a specific cache manager.
• These were considered technical advancements beyond prior art, satisfying the requirements of novelty and
inventive steps.

• The rejection was overturned, and the invention was deemed patentable
Biotron Limited v. Controller General of Patents
and Designs (2023, Calcutta High Court)
Facts:
• The invention pertained to a novel composition for treating viral infections like HIV and dengue.
• The Controller rejected the patent, citing lack of inventive step under Sections 2(1)(j) and 2(1)( ja), and
claimed it was barred under Section 3(d).
Issue:
• Whether the invention lacked an inventive step and fell under Section 3(d).
Judgment:
• The court found the invention demonstrated technical advancements over prior art, with cyclic substitutions
being more effective than acyclic ones.
• The court clarified Section 3(d) does not exclude incremental innovations if they show significant
improvement.
• The application was sent back for reconsideration, with directions to account for its inventive steps.
 Non-Patentable Inventions
• OpenTV INC vs. Controller of patents and designs, (2023) Delhi High Court
• Facts: The appellant, a company providing interactive television solutions, sought
a patent for a “system and method to provide gift media.” The invention involved
a network architecture enabling the exchange of interactive digital or tangible
media content.
• Issue:
Does the invention fall under the exclusion of patentability provided in Section
3(k) of the Indian Patents Act, 1970?
• Judgment:
The court held that the invention relied on adapting known components and
technologies to automate the gifting process, except for initial user input. This
constituted a business method, which is expressly excluded from patentability
under Section 3(k). The court reiterated that the exclusion for business methods is
absolute, and no patent can be granted for such subject matter.
 Essential Panchasheel
Creativity

Entrepreneurship Invention
Success

IPR Innovation
What IP can do for you

• Wealth creation
• Legitimate ownership
• Monopoly – market advantage
• Entry into the big league
• Bargaining power
• Talent attraction
• Collaborations
• Image of a trustworthy organisation
• Stay in business and keep others out!