Patenting and Intellectual

Property Rights
Presented By: Mohit Patwardhan
B.Pharma; MS(IPR); LLB; LLM; Registered Patent Agent
 What is Intellectual Property?

• Intellectual property refers to creations of the mind: inventions; literary and

artistic works; and symbols, names and images used in commerce

• Industrial Property includes patents for inventions, trademarks, industrial

designs and geographical indications.

• Copyright covers literary works (such as novels, poems and plays), films,
music, artistic works (e.g., drawings, paintings, photographs and sculptures)
and architectural design. Rights related to copyright include those of
performing artists in their performances, producers of phonograms in their
recordings, and broadcasters in their radio and television programs.
 TYPES OF IP
• Patents

• Designs

• Trademarks

• Copyrights

• Trade Secrets

• Geographical Indications
 Advantages of Trademark
• Exclusive Rights: The owner of Registered Trademark enjoys exclusive right over the trademark:

• Builds trust and Goodwill: Ex- Tata

• Differentiates Product: Ex- Original Vs Fake or counterfeit

• Recognition to product's Quality:

• Creation of Asset:

• Use of ® symbol:

• Protection against infringement:

• Minimum Protection for 10 Years:

6
• Low Cost in filing:
IDENTIFY
THESE
TRADEMARKS
Types of IP What’s Protected Examples Protection Lasts for
Patent Inventions Product. Process, 20 years from the date of
Machines, Equipment's filing regular patent
application
Designs Ornamental (non functional) designs Unique shape of electric 10 years + can be renewed
guitar, design for a lamp for further 5 years
Trademark Words, symbols, logos, designs, or Coca‐Cola name and 10 years initially but has to
slogans that identify and distinguish distinctive logo, be renewed for further 10
products or services Pillsbury doughboy years.
character

Copyright Books, photos, music, fine art, Michael Jackson’s The life of the author plus
graphic images, videos, films, Thriller (music, artwork 70 years.
architecture, computer programs and video), Windows
operating system

Trade Secret Formulas, methods, devices or Coca‐Cola formula, As long as information

compilations of information which is KFC Burger remains confidential and
confidential and gives a business an functions as a trade secret
advantage

Geographical sign used on products that have a Kolhapuri Chappal, Initial 10 years and can be
Indications specific geographical origin and Alphonso Mango, further renewed for 10
possess qualities or a reputation that Basmati Rice, years
are due to that origin Darjeeling Tea
 Trademarks:
• Made by "Nokia"
• Product "N95"
• Software "Symbian", "Java“

Patents:
• Data-processing methods
• Semiconductor circuits
• Chemical compounds
• Battery/Power Control
• Antenna
Some IP Found in
Mobile Phone Copyrights:
• Software code
• Instruction manual
• Ringtone
•…
Trade secrets:
• ???
Designs (some of them registered):
• Form of overall phone
• Arrangement of buttons in oval shape
• Three-dimensional wave form of buttons
• Sliding screen
 Diamond Vs Chakrabarty – US Supreme
Court
• “Anything under the Sun made by Man is Patentable”
• Breakthrough Case
• Case established patent protection cannot be denied on grounds that it relates to living matter
• a patent on genetically engineered bacteria capable of breaking down multiple components of crude oil
proposed to treat oil spills. This property is possessed by no naturally occurring bacteria.
• The application asserted 36 claims related to Chakrabarty’s invention of “a bacterium from the genus
Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids
providing a separate hydrocarbon degradative pathway”
 Patent claim on 3 types
• 1st -Process claim-method of producing bacteria
• 2nd -Claims for innoculum
• 3rd- Claim to bacteria themselves
PATENTS AND INDIAN PATENT
ACT
HISTORY OF INDIAN PATENT SYSTEM – Source -http://www.ipindia.nic.in/history-of-indian-patent-system.htm
1856 – The Act VI of 1856 on protection of inventions based on the British Patent Law of 1852, Repealed in 1857..
Certain exclusive privileges granted to inventors of new manufacturers for a period of 14 years.

1859 - The Act modified as act XV Patent monopolies called exclusive privileges (making. Selling and using inventions in
India and authorizing others to do so for 14 years from date of filing specification).

1872 - The Patterns & Designs Protection Act.

1883 - The Protection of Inventions Act.
1888 - Consolidated as the Inventions & Designs Act.

1911- The Indian Patents & Designs Act. Amended from time to time in 1920,1930 and 1945. Patent Administrator
1972 – The Patents Act (Act 39 of 1970) came into force on 20 th April 1972.

1999 – March 26,1999 Patent Amendment Act came into force grant of Exclusive Marketing Rights

2002 – The Patent Amendment Act 2002 came into force from 20 th May 2003

TRIPS
2005 – The Patents Amendment Act 2005 COMPLIANT
 INDIAN PATENT ACT
• Department of Industrial Policy and Promotion- Ministry of
Commerce
• Headed by Controller General of Patents, Designs and Trademarks
• 23 Chapters; 162 Sections
 Advantages/ Functions of Patents –

• Protection against infringement or copying

• Lawfully enforce against infringers after patent is granted
• Patentee can get monetary reward in lieu of licenses, Royalty etc.
• To encourage research and development
• Induces an inventor to disclose in invention – in return gets monopoly
• Encourages technology development
• Encourages development of new industry
• Provides motivation to Innovators
• Protect the creativity of individual
• Rewards the inventor
• Avoids duplication of research
• Keeps abreast with latest technology
• Helps industry to improve existing technology and bring innovative, new, better
and cheap technology
 Basic Concepts for Patents
• Personal Property – A patent can be bought, sold, licensed, etc.

• Limited Monopoly – A patent expires after a fixed time period (20 years)

• The Exchange – Patent Specification and Claims –

Full disclosure must be provided for the monopoly
• Government Agency – Patents by the Government Agency

• Subject – Product, Process, Machine, Manufacture, or Composition of Matter

• Patentability – The innovation must be new, useful, & non-obvious

• Timing – File a patent application before any disclosure or use of the invention

• Priority Date – Gives a priority date to the invention

• First to File system – Whoever files first will get a patent

 What is a Patent??
• Right granted to an inventor by the government that permits the inventor to exclude others
from making, selling or using the invention for a limited period of time.

• The patent system is designed to encourage inventions that are unique and useful to
society.

• Term of Patent is 20 years from date of filing

• Negative Right

• Exclusive Right

• Territorial Right

• Licensable Right
 • Patent – Section 2(m) of the Indian Patent Act – means a
patent for any invention granted under this Act. Example
– Product Patent (Active Pharmaceutical Ingredient (API),
NCE( New Chemial Entity); Process Patent, Composition
of Matter; Formulation, Method

• Invention – Section 2(j) of the Indian Patent Act – means

a new product or process involving an inventive step and
Definitions capable of industrial application

• Conditions of Patentability/ Prerequisites for

Patentability:
- New Invention
- Inventive Step
- Industrial Application
Conditions/ Prerequisites of Patentability
- New invention – Section 2(l) of the Indian Patent Act – means any invention or technology which
has not been anticipated by publication in any document or used in the country of elsewhere in
the world before the date of filing of patent application with complete specification; i.e the
subject matter has not fallen in public domain or that it does not form part of the state of the art.

- Inventive Step – Section 2 (ja) of the Indian Patent Act – means a feature of an invention that
involves technical advance as compared to the existing knowledge or having economic
significance or both and that makes the invention not obvious to a person skilled in the art.

- Capable of Industrial Application – Section 2 (ac) of the Indian Patent Act means – in relation to
an invention, means that the invention is capable of being made or used in an industry.
 Inventive Step

India

2(ja) ‘… feature of an invention that involves technical advance as compared

to the existing knowledge or having economic significance or both
that makes the invention not obvious to a person skilled in the art’

US
103(a)…if the differences between the subject matter sought to be patented
and the prior art are such that the subject matter as a whole would have been
obvious at the time the invention was made to a person having ordinary skill
in the art to which said subject matter pertains

EPC
Art. 56 An invention shall be considered as involving an inventive step if,
having regard to the state of the art, it is not obvious to a person skilled in
the art
- examined using the "problem and solution approach"
 What are not inventions- Section 3 and 4
• 3a- frivolous or claims obviously contrary to the well established patent law. Ex –
machine giving output without input
• 3b- contrary to the public order or morality or which causes serious prejudice to
human, animal, plant life or health Ex – Apparatus for Gambling
• 3c – mere discovery or formulation of abstract theory
• 3d- New form of known substance; mere discovery of new property; new use of
known substance . Ex – Polymorphs, Salts, Ethers, Esters
• 3e- mere admixture resulting in aggregation of property – Ex- a mixture of Sugar
• 3f- mere arrangement or rearrangement or duplication of known device each
functioning independently Ex – Umbrella with a fan
• 3h- method of agriculture or horticulture
• 3i- method of treatment
• 3j- plants and animals as in whole
• 3k – a mathematical or business method or computer programme per se or
algorithm
• 3l- literary, dramatic, musical or artistic work or
cinematographic work
• 3m- a mere scheme or mental rule or method or
performing mental act or method of playing games
• 3n- presentation of information
• 3o – topography of integrated circuit
• 3p- traditional knowledge- Ex- Tulsi Case

Section 4 – Inventions related to Atomic Energy falling

within subsection (1) of Section 20 of Atomic Energy Act,
1962
Section 6 – Persons Entitled to Apply for Patents
• (1) An application for a patent may be made, by any of the following
persons, that is to say;
• a) true and the first inventor
• b by any person being the assignee of the person claiming to be the
true and first inventor in respect of the right to make such invention.
• c) by the legal representative of the deceased person who
immediately before his death was entitled to make such an
application
(2) An application under sub-section (1) may be made by any of the
person referred to therein either alone or jointly with any other person.
 Contents of a Patent Application
• Title of the Invention

• Abstract

• Background of the Invention

• Summary of the Invention

• Figures with brief descriptions (In case of Pharma/ Chemicals- Examples)

• Detailed description or “specification”

• Fully discloses what the invention is

• How it is made?
• How it can be used?
• Claim(s): sets the legal boundaries of protection -Provides Protection – A Patent EXCLUDES others from trespassing
(i.e infringing) on the claimed invention!
• Claims provides metes and bounds of the rights that the patent confers to exclude others from “trespassing” of the
inevntion

• Independent – Broadest Possible Claim; Do not depend on any other claims. Main Claim,
• Dependent – Depend on Independent Claims; Multiple Dependent Claim, Narrower than Independent Claims
 It’s all about the claims!
• Claims define the scope of the protection

• Claims define the boundary in the patent specification

• Protection is limited to what is claimed. Claims must particularly point out and distinctly claim
what applicant regard as his invention

• During prosecution, claims are searched, may be rejected, amended, and allowed

• Specification may include numerous embodiments and elements but only subject matter
claimed is afforded protection

• Examiner works with the Applicant to focus the claims on novel aspects of the invention

• Search of invention may extend to unrelated areas

 Structure of Claims
1. Preamble

2. Transition

3. Body

<Preamble> <Transition> <Body>

Example 1 - Claim:
A pharmaceutical composition comprising: (i) an angiotensin receptor blocker (ARB), (ii)
a calcium channel blocker (CCB) and (iii) a diuretic

<A pharmaceutical composition> <comprising>: <(i) an angiotensin receptor blocker

(ARB), (ii) a calcium channel blocker (CCB) and (iii) a diuretic>
 Preamble:
• A introductory phrase in a claim to set the context of the claim
• Limitations in preamble may or may not give effect
• Short preamble is better when possible

Transition:
Some Examples:
“comprising”
Open
Means “included but not limited to”
“consisting/ consisting essentially of”
Closed
Useful in chemical arts
“Consisting essentially of”
Partially Open
Useful in chemical arts

Body:
Defines a particular embodiment of invention
 Transition
Some Examples:
“comprising”
• Open
• Means “included but not limited to”
“consisting/ consisting essentially of”
• Closed
• Useful in chemical arts
“Consisting essentially of”
• Partially Open
• Useful in chemical arts
 Case Study
• A Pharmaceutical Composition comprising an active therapeutic
agent, a gelling polymer and an antioxidant

Transition
Preamble Body

<A Pharmaceutical Composition> <comprising> <an active therapeutic agent, a gelling polymer and an antioxidant>
 Bibliographic Page – 1st page

Title
PATENT GRANT
DATE

Priority Date
 Claims
1. A pharmaceutical composition comprising
(i) a pharmaceutically effective amount of valsartan or a pharmaceutically acceptable salt thereof,
(ii) a pharmaceutically effective amount of amlodipine or a pharmaceutically acceptable salt thereof, and
(iii) a pharmaceutically effective amount of hydrochlorothiazide or a pharmaceutically acceptable salt
thereof.

2. The pharmaceutical composition of claim 1, wherein said composition is a fixed dose combination.
3. The pharmaceutical composition of claim 2, wherein said fixed dose combination is in the form of a
capsule or tablet.
4. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is present in an amount from about
20 to about 640 mg; amlodipine is present in an amount from about 1 mg to about 60 mg; and
hydrochlorothiazide is present in an amount from about 5 mg to about 200 mg.
5. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is present in an amount from about
40 to about 320 mg; amlodipine is present in an amount from about 2.5 mg to about 10 mg; and
hydrochlorothiazide is present in an amount from about 5 mg to about 25 mg.
6. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is present in an amount from about
160 to about 320 mg; amlodipine is present in an amount from about 5 to about 10 mg; and
hydrochlorothiazide is present in an amount from about 12.5 to about 25 mg.
7. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is present in an amount of about 160
mg; amlodipine is present in an amount of about 10 mg; and hydrochlorothiazide is present in an amount of
about 12.5 mg.
8. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is present in an amount of about 160
mg; amlodipine is present in an amount of about 10 mg; and hydrochlorothiazide is present in an amount of
about 25 mg.
9. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is
present in an amount of about 320 mg; amlodipine is present in an amount of
about 10 mg; and hydrochlorothiazide is present in an amount of about 25 mg.
10. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is
present in an amount of about 160 mg; amlodipine is present in an amount of
about 5 mg; and hydrochlorothiazide is present in an amount of about 12.5 mg.
11. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is
present in an amount of about 160 mg; amlodipine is present in an amount of
about 5 mg; and hydrochlorothiazide is present in an amount of about 25 mg.
12. The pharmaceutical composition of claim 7, wherein amlodipine is present in
a pharmaceutically acceptable besylate salt form.
13. The pharmaceutical composition of claim 8, wherein amlodipine is present in
a pharmaceutically acceptable besylate salt form.
14. The pharmaceutical composition of claim 9, wherein amlodipine is present in
a pharmaceutically acceptable besylate salt form.
15. The pharmaceutical composition of claim 10, wherein amlodipine is present
in a pharmaceutically acceptable besylate salt form.
16. The pharmaceutical composition of claim 11, wherein amlodipine is present
in a pharmaceutically acceptable besylate salt form.
 Case Study
Competitor A:
Your Claim: Competitor B:
Prior Art A bicycle with:
A bicycle comprising: A bicycle with:
A vehicle with: two wheels,
Two wheels, two wheels,
A wheel, two pedals,
two pedals, two pedals,
Two pedals, and a seat,
a seat, and a seat, and
A seat handlebars, and
handlebars. a steering wheel.
a horn.

Q1: Can you get a patent on your claimed invention?

Yes – at least the handlebars are novel and probably non-obvious.

Q2: Does Competitor A infringe your patent?

Yes – Competitor A’s bike includes each element of your patent claim (additional elements do not avoid infringement).

Q3: Does Competitor B infringe your patent?

Probably Not – depends on whether the steering wheel would meet your “handlebars” requirement.

Issue: Will you obtain claims with commercially significant coverage?

 TYPES OF PATENT APPLICATIONS
• Ordinary Application:
1. Provisional Specification – Gives Priority before others; Concept is enough, No claims required. Cost
is very cheap.
2. Complete Specification – Has to be filed within 12 months from date of provisional application,
otherwise PS is abandoned

• Conventional Application – Paris Convention

• PCT Application – Patent Cooperation Treaty

• Patent of Addition – Any improvement over existing patent

Prosecution Strategies

• Divisional Application – No Unity of Invention

• Continuation/ Continuation in part - USA

 Provisional Applications

FACTS ADVANTAGES
 it will never be examined  21 years patent term
 it will never become a patent  Cost-effective
 it cannot claim priority or benefit - Filing fee
from any other application - Attorney fee
 It need not have claims  Multiple Provisional Applications
 it does not start a 20 year patent with different embodiments
term

A Provisional Application has to mature into a Non Provisional Application

within the first anniversary. Otherwise it gets abandoned
 Provisional Applications
• File as early as possible!
• Low cost approach to get
Case I – Not Preferred
idea on paper with patent
office quickly
• Can be narrative based;
Triggering Event Provisional Non Provisional
12 months
12 months no claims required
Case II - Ideal • No working prototype
needed
Triggering Event

Provisional Non Provisional • Must be followed by non-

12 months
provisional application
within one year
A word of caution…
Provisional should satisfy patentability criteria Written Description, Enablement, Best mode
requirements
 IMPORTANCE OF FIRST
FILING!!
Company A Vs. Company B

A Conceives A Files

B Conceives B Files

Result – Since A has filed the invention before B, it would retain priority even
though B has conceived its invention before A
 STAGES - FILING TO GRANT OF PATENT
FILING OF APPLICATION • IF P.S.IS FILED C.S. TO BE FILED WITHIN 12MONTHS
PROVNL. / COMPLETE

PUBLICATION OF APPLICATION • PROMPTLY AFTER 18 MONTHS FROM P.D.

REQUEST FOR EXAMINATION • WITHIN 48 MONTHS FROM F.D.

EXAMINATION-ISSUE OF FER
• ALL OBJECTIONS TO BE COMPLIED WITHIN 6
MONTHS
GRANT OF PATENT

Decision of
Controller

Appeal
Revocation/Amendment
Appellate Board
 Right of Patentee – Section 48 of the Indian Patent Act 1970

Subject to the other provisions contained in this Act and the conditions specified in section 47, a patent
granted under this Act shall confer upon the patentee—

(a) where the subject matter of the patent is a product, the exclusive right to prevent third parties,
who do not have his consent, from the act of making, using, offering for sale, selling or importing for those
purposes that product in India;

(b) where the subject matter of the patent is a process, the exclusive right to prevent third parties,
who do not have his consent, from the act of using that process, and from the act of using, offering for sale,
selling or importing for those purposes the product obtained directly by that process in India:
 Section 107A
Certain acts not to be considered as infringement (Bolar Like Provision)

For the purposes of this Act,—

(a) any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably
related to the development and submission of information required under any law for the time being in force, in India, or in
a country other than India, that regulates the manufacture, construction, use, sale or import of any product;
(b) 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, shall not be considered as a infringement of patent rights.

“This provision has been made to ensure prompt availability of products, particularly generic
drugs, immediately after expiry of the term of the patent. The amendment in this clause has
been made to make a provision in consonance with the Bolar provisions at the global level”."
 Roche Vs Bolar
• Roche is a swiss multinational company, Basel, Switzerland
• The company introduced a class of tranquilisers called benzodiazepenes in 1957
• First antidepressant iproniazide in 1956
• The company is also credited for isotretinoin (Acne) and Oseltamavir (Bird Flu)
• During 1960, the company started working on developing substituted
benzodiazepine- a class of sleep inducing drugs, in order to prepare longer acting
analogs
• They ended up with Flurazepam – Sleeping Drug
• Roche obtained a patent on this drug and launched under the Brand name
Dalmane
• The patent was valid until 1984. The patent no is US3299053
• Bolar Pharmacuetical – a small US based generic pharma company, found
that flurazepam had great sale and Dlamane had become a popular brand
• Bolar decided to launch generic version of Flurazepam as soon as after
patent expired. Success of generic product depends upon how quickly it
can come into the market
• In about 1983, Bolar obtained 5kg of Flurazepam from Foreign
manufacturer
• Without waiting for the patent to expire, they started forumating into
cpausles, did stability studies, dissolution rate and bioequivalence study to
generate data required to file at the FDA
• Bolar intended to launch its product just after next daye of patent expiry
• Roche filed a case in Eastern District of New York for infringement of its patent by
Bolar
• Roche Argued- Bolar infringed its patent rights by doing studies for experimental use.
They had economic intention behind the experimental use. Bolar should be stopped
from doing activities
• Bolar argud and said “Suppose we start the bioequivalence study after the patent
expiry, it will take time for the studies and approval of the product by FDA. Say for eg
it will take 2 years. Meanwhile in that period also there will be monopoly of the
patentee. Thus patentee will enjoy monopoly even after patent expires
• Court said “As per Patent Act on one is allowed to USE the invention with the
intention of the business. Bolar infringed the rights of Roche. So as per Roche request
of relief the Data generated by Bolar during its study should be confiscated and
destroyed and it will have to bear its own losses
• At the same time Court asked the American Congress to tackle the experiemnatl sue
issue
• Shortly after this case in around 1984, The American Congress did pass a law that
permitted the use of patented product in Experiments and Research in order to
obtain FDA approval (Drug Price Competition and Patent Term Restoration Act 1984.
ie Hatch Waxman Act)
In short what can you do (Rights and Obligations
of Patentee – Chapter 7- P Narayanan)
• Right to exploit the patent
• Right to assign and license
• Right to surrender
• Rights before sealing
 Section 47

Grant of patents to be subject to certain conditions

The grant of a patent under this Act shall be subject to the condition that—

(1) any machine, apparatus or other article in respect of which the patent is granted or any article made by using a
process in respect of which the patent is granted, may be imported or made by or on behalf of the Government
for the purpose merely of its own use;

(2) any process in respect of which the patent is granted may be used by or on behalf of the Government for the
purpose merely of its own use;

(3) any machine, apparatus or other article in respect of which the patent is granted or any article made by the use
of the process in respect of which the patent is granted, may be made or used, and any process in respect of
which the patent is granted may be used, by any person, for the purpose merely of experiment or research
including the imparting of instructions to pupils; and

(4) in the case of a patent in respect of any medicine or drug, the medicine or drug may be imported by the
Government for the purpose merely of 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 may, having regard to the public service that such dispensary, hospital
or medical institution renders, specify in this behalf by notification in the Official Gazette.
Provisional Specification Complete Specification

Should be filed as soon as inventive idea comes in mind Necessary to get a patent

Should describe the nature of the invention and contain Should describe the invention and details of the
the description of essential feature of the invention manner in which it is to be performed

No need to include Claims Must have Claims

 • Direct : directly file separate patent applications
at the same time in all of the countries in which
patent is desired (for some countries, regional
patents are available)
INTERNATIONAL APPLICATION
How to file a • Paris Convention: having filed the first patent
application in a Paris Convention country (one of
patent application the Member States of the Paris Convention for
the Protection of Industrial Property), file
simultaneously in separate patent applications in other Paris
different Convention countries within 12 months from the
filing date of that first patent application, with the
countries? benefit of claiming the filing date of the first
application in all other countries
• • Patent Cooperation Treaty : file an application
under the PCT, directly or within the 12-month
period provided for by the Paris Convention from
the filing date of a first application, which is valid
in all Contracting States of the PCT
 INTERNATIONAL FILING
INDIAN FILING (Claiming Priority)

CONVENTIONAL
PCT FILING
PROS FILING
• Allows to postpone decisions (30 (PARIS
Months)
• Streamlines formalities initially CONVENTION)
• Provides search report and written PROS
opinion • Faster Examination
CONS • When Country choice is
• Incurs Costs Certain
• Creates Examination Delays CONS
• Less time to take decisions
• Costs start fast
History of PCT
• Washington Diplomatic Conference on Patent Cooperation Treaty May 25 to June
19,1970
• PCT Treaty was signed on June 19,1970
• Came into force on Jan 24,1978 initially with 18 contracting states
• The first application was filed on June 1,1978
• Amended in 1979,1984 and 2001
• A majority of Worlds countries are signatory to this treaty
• In August 1998 India joined the PCT by acceding to Paris Convention on
Intellectual Property
• The Indian Patent Office is one of the designated office for receiving PCT
applications
What IS PCT?
• The Patent Cooperation Treaty (PCT) is an international treaty with
more than 153 Contracting States. It is administered by the World
Intellectual Property Organisation (WIPO), Geneva
• • The PCT makes it possible to seek patent protection for an invention
simultaneously in a large number of countries by filing a single
“international” patent application instead of filing several separate
national or regional patent applications.
• The granting of patents remains under the control of the national or
regional patent Offices in what is called the “national phase”.
• A patent “filing” system, not a patent “granting” system
Advantages
• A single application in a single language filed in a single country called the international application

• • This single application has the effect of filing simultaneously in different countries (designated countries)

• •One international patent application

• •One form
• •One language
• •One office
• •One set of fees
• •Has the effect of a regular national filing in each Member State
• Brings the world within reach (“Internationalization” of a single PCT application providing near global
geographical coverage)
• International Search which provides for a written opinion of the International Searching Authority

• Time delay (additional time for decision)- 30/31 months only if applicant wish to proceed. Postpones the major
costs for filing in respective countries of interests
 Paris Convention-
Reference - https://www.wipo.int/treaties/en/ip/paris/summary_paris.html

• The Paris Convention for the protection of Industrial Property, signed in Paris,
France on March 20,1883, was one of the first intellectual property treaties.

• It was revised at Brussels in 1900, at Washington in 1911, at The Hague in 1925,

at London in 1934, at Lisbon in 1958 and at Stockholm in 1967, and was
amended in 1979.

• The Paris Convention applies to industrial property in the widest sense, including
patents, trademarks, industrial designs, utility models (a kind of "small-scale
patent" provided for by the laws of some countries), service marks, trade names
(designations under which an industrial or commercial activity is carried out),
geographical indications (indications of source and appellations of origin) and the
repression of unfair competition.
 Salient Features

• National Treatment

• Right of Priority

• Common Rules.
National Treatment
• Under the provisions on national treatment, the Convention provides
that, as regards the protection of industrial property, each Contracting
State must grant the same protection to nationals of other Contracting
States that it grants to its own nationals. Nationals of non-Contracting
States are also entitled to national treatment under the Convention if
they are domiciled or have a real and effective industrial or
commercial establishment in a Contracting State.
 Right of Priority
• The Convention provides for the right of priority in the case of patents (and utility models where they
exist), marks and industrial designs.

• This right means that, on the basis of a regular first application filed in one of the Contracting States, the
applicant may, within a certain period of time (12 months for patents and utility models; 6 months for
industrial designs and marks), apply for protection in any of the other Contracting States.

• These subsequent applications will be regarded as if they had been filed on the same day as the first
application.

• These subsequent applications, being based on the first application, will not be affected by any event that
takes place in the interval, such as the publication of an invention or the sale of articles bearing a mark or
incorporating an industrial design.

• One of the great practical advantages of this provision is that applicants seeking protection in several
countries are not required to present all of their applications at the same time but have 6 or 12 months to
decide in which countries they wish to seek protection, and to organize with due care the steps necessary
for securing protection.
 Common Rules

• A) Patent:
- Patents granted in different Contracting States for the same invention
are independent of each other:
- The inventor has the right to be named as such in the patent.
- The grant of a patent may not be refused, and a patent may not be
invalidated, on the ground that the sale of the patented product, or of a
product obtained by means of the patented process, is subject to
restrictions or limitations resulting from the domestic law.
- Compulsory License Provisions Independent
• B) Trademarks
- The Paris Convention does not regulate the conditions for the filing and registration of
marks which are determined in each Contracting State by domestic law.
- Consequently, no application for the registration of a mark filed by a national of a
Contracting State may be refused, nor may a registration be invalidated, on the ground
that filing, registration or renewal has not been effected in the country of origin.
- The registration of a mark obtained in one Contracting State is independent of its
possible registration in any other country, including the country of origin;
consequently, the lapse or annulment of the registration of a mark in one Contracting
State will not affect the validity of the registration in other Contracting States.
- Where a mark has been duly registered in the country of origin, it must, on request,
be accepted for filing and protected in its original form in the other Contracting States.
Nevertheless, registration may be refused in well-defined cases, such as where the
mark would infringe the acquired rights of third parties; where it is devoid of
distinctive character; where it is contrary to morality or public order; or where it is of
such a nature as to be liable to deceive the public.
Advantages of Paris Convention Patent Filing

1. Paris Convention is truly appropriate for the patent applicants who have a limited
spending plan and need the patent protection promptly.

2. Paris Convention filing is additionally useful in managing the nations where the
particular nation isn’t a signatory to the PCT, like Argentina, Taiwan or Pakistan.
Numerous eastern and African nations like Jordan and Ethiopia separately are
additionally not a signatory to the PCT and numerous enterprises like steel, coal and
so on require patent for their work, which is accomplished by the immediate
recording.

3. If an inventor needs the patent in the maximum number of the countries, then
he/she ought to reasonably consider both the courses for generally speaking financial
development for his/her business
 Patent Opposition - India
• A patent is an exclusive right granted to the original inventor for a
novel product or a novel process that provides, a unique way of
doing something, or which discloses a new technical solution to a
problem.
• It provides monopoly right to the inventor to make, sell his invention
or product.
• Hence it is very essential that patent is only awarded to those
innovations which justify the exclusive right and comply with the
patentability criteria.
• Opposition proceedings are structured to restrain wrongful obtaining
of patents and claiming of the frivolous or petty inventions.
• Laws providing under Indian patent act for pre grant and post grant
of patent are essential to obstruct the unlawful grant of patent.
• Under Indian Patent act, there are two provisions when opposition
may be filed either via pre-grant opposition (Section 25(1) or post-
grant opposition Section 25(2) provision depending upon the stage
of the patent.
• Revocation under Section 64 – Intellectual Property Appellate Board
Pre-Grant Opposition
• Section 25(1) of the Act and Rules 55 of the Patent Rules, 2003

• Initiated by any person after publication of patent and before grant of

the patent

• No Form and Fees required as such

• Only considered in Request for Examination is filed by the applicant

 Opponent can file a
representation along with
statement and evidences

Controller gives notice to the

applicant along with the
representation

Applicant can reply to the

representation within 3 months
from the notice

Upon receiving the documents the

Controller may refuse the patent or may
ask for amendment of the patent within
one month of receiving the reply

If hearing is initiated the Controller may

grant or reject the patent depending on
the merit
 Pre-grant opposition grounds - section 25(1) (a) to (k) of the Patent Amendment Act, 2005:

• Wrongfully obtaining the invention

• anticipation by prior publication
• anticipation by prior date, Prior claiming in India
• Prior public knowledge or public use in India
• Obviousness and lack of inventive step
• non patentable subject matter
• insufficiency of description of the invention
• non-disclosure of information as per the requirement or providing materially
false information by an applicant
• Patent application not filed within 12 months of filing the first application in a
convention country
• nondisclosure/ wrong mention of source of biological material
• Invention anticipated with regard to traditional knowledge of any community,
Post Grant Opposition
• Section 25(2) of the Act and Rules 55A to 70 of the Patent Rules, 2003

• Person Interested

• Within 1 year after grant of the patent.

• Has to be filed on the Prescribed Form

• Fee involvement
 Procedure
• Rule 55A- Notice of opposition in Form 7 and send to the Controller in Duplicate

• Rule 56 – Constitution of Opposition Board- 3 members

• Rule 57 – Filing of written statement of opposition and evidence

• Rule 58 - Filing of rely statement and evidence

• Rule 59 – Filing of reply evidence by opponent

• Rule 60 – Further evidence to be left with the leave of the Controller

• Rules 61 – Copies of document to be supplied

• Rule 62 - Hearing
 Revocation of a Patent
• When a patent has been sealed or granted, it is not always the case that the
patent shall stay unhindered by any third party till the life of the patent.
• The patent can be challenged by certain people on different grounds, and a
method to cause the same is by filing a revocation petition/ post-grant
opposition proceedings.
• As per Section 64 of the Patent Act, 1970, the following persons can file the
petition in the High Court:
• any person interested1;
• the Central Government
• the person making the counter-claim in a suit for the infringement of a
patent
• Thus, a revocation petition can be filed in the Intellectual Property Appellate
Board by the interested person or the Central Government, or it can be
filed as a counter-claim in a suit for infringement at the High Court.
 Section 64 – Grounds of Revocation
1. the invention, so far as claimed in any claim of the complete specification, was claimed in a
valid claim of earlier priority date contained in the complete specification of another patent
granted in India;
2. the patent was granted on the application of a person not entitled to apply therefor;
3. the patent was obtained wrongfully in contravention of the rights or the petitioner or any
person under or through whom he claims;
4. the subject of any claim of the complete specification is not an invention;
5. the invention so far as claimed in any claim of the complete specification is not new, having
regard to what was publicly known to publicly used in India before the priority date of the
claim or to what was published in India or elsewhere in any of the documents referred to in
Section 13;
6. the invention so far as claimed in any claim of the complete specification is obvious or does
not involve any inventive step, having regard to what was publicly known or publicly used in
India or what was published in India or elsewhere before the priority date of the claim;
7. the invention, so far as claimed in any claim of the complete specification, is not useful;
8. the complete specification does not sufficiently and fairly describe the invention and the
method by which it is to be performed, that is to say, that the description of the method or
the instructions for the working of the invention as contained in the complete specification
are not by themselves sufficient to enable a person in India possessing average skill in, and
average knowledge of the art to which the invention relates, to work the invention, or that it
does not disclose the best method of performing it which was known to the applicant for the
patent and for which he was entitled to claim protection;
9. that the scope of any claim of the complete specification is not sufficiently and clearly
defined or that any claim of the complete specification is not fairly based on the matter
disclosed in the specification;
10. that the patent was obtained on a false suggestion or representation;
11. that the subject of any claim of the complete specification is not patentable under this
Act;
12. that the invention so far as claimed in any claim of the complete specification was
secretly used in India, otherwise than as mentioned in sub-section (3), before the priority
date of the claim;
13. that the applicant for the patent has failed to disclose to the Controller the
information required by section 8 or has furnished information which in any material
particular was false to his knowledge;
14. that the applicant contravened any direction for secrecy passed under section 35
15. that leave to amend the complete specification under section 57 or section 58 was
obtained by fraud.
16. that the complete specification does not disclose or wrongly mentions the source or
geographical origin of biological material used for the invention;
17.that the invention so far as claimed in any claim of the complete specification was
anticipated having regard to the knowledge, oral or otherwise, available within any local
or indigenous community in India or elsewhere
• Section 65 – Revocation of Patent or amendment of complete
specification on directions from the Government in cases relating to
Atomic Energy

• Section 66- Revocation of Patent in Public Interest

IPAB
• Section 116- Appellate Board
Section 83 of the Trademarks Act 1999
Point of Comparison Pre-grant opposition Post-grant opposition Revocation

Section 25 (1) 25 (2) 64

Person Interested, Central

Locus Standi Any person Person Interested Government or alleged
infringer in a counter-claim

Intellectual Property
Jurisdiction Patent Office Patent Office Appellate Board (IPAB) and
High Court

At any time after the grant of

Any time after publication of the
Timelines application till the grant of the
patent
patent but before the expiry
Any time after grant of the
of a period of one year from
patent
the date of publication of
grant of a patent

Limited to those provided by Limited to those provided by Not limited to the grounds
Grounds
section 25 (1) section 25 (2) provided by Section 64
Compulsory License
• CL is an involuntary contract between a willing licensee and an
unwilling patentee imposed and enforced by law.
• Up on grant of the CL, the licensee can manufacture the patented
product for the remaining term of the patent, unless the CL is revoked
earlier.
• The CL may be granted by the government suo moto in situations of
national emergency, extreme urgency or may be granted on an
application of any person interested.
• The Controller determines the royalty payable by the grantee of the
CL to the patentee.
 Compulsory License- Chapter 16 – Section 83 to 94
• Section 83 – General Principles applicable to working of Patented
Invention
- Encourage inventions, worked in India and reasonable practicable
- Not granted to patentee to enjoy monopoly
- Promotion and technological innovation, social and economic welfare
- Do not impede protection of public health and nutrition
- Do not in anyway prohibit Central Government in taking measures to
protect public health
- No abuse by the patentee
- Affordable at reasonable prices
The reasonable requirements of the public
shall not deemed to have been satisfied
• (a) if, by reason of the refusal of the patentee to grant a licence or licences
on reasonable terms,-(i) an existing trade or industry or the development
thereof or the establishment of any new trade or industry in India or the
trade or industry in India or the trade or industry of any person or class of
persons trading or manufacturing in India is prejudiced; or
• (ii) the demand for the patented article has not been met to an adequate
extent or on reasonable terms; or
• (iii) a market for export of the patented article manufactured in India is not
being supplied or developed; or
• (iv) the establishment or development of commercial activities in India is
prejudiced
• (b) if, by reason of conditions imposed by the patentee upon the grant of licences
under the patent or upon the purchase, hire or use of the patented article or process,
the manufacture, use or sale of materials not protected by the patent, or the
establishment or development of any trade or industry in India, is prejudiced; or
• (c) if the patentee imposes a condition upon the grant of licences under the patent to
provide exclusive grant back, prevention to challenges to the validity of patent or
coercive package licensing; or
• (d) if the patented invention is not being worked in the territory of India on a
commercial scale to an adequate extent or is not being so worked to the fullest
extent that is reasonably practicable; or
• (e) if the working of the patented invention in the territory of India on a commercial
scale is being prevented or hindered by the importation from abroad of the patented
article by-(i) the patentee or persons claiming under him; or
• (ii) persons directly or indirectly purchasing from him; or
• (iii) other persons against whom the patentee is not taking or has not taken
proceedings for infringement.
• Section 85 – Revocation of Patents by the Controller for non-working

• Section 86- Adjournment of Applications

• Section 87 – Dealing with applications under Section 84 and 85

• Section 88 – Powers of Controller in Granting Compulsory License

• Section 89 – General Purpose for Granting Compulsory License

 Royalty and other renumeration; expednture incurred
by the patentee

Patented invention worked to the fullest extent

Section 90 – Patented invention avalailabe to the public at

Terms and reasonable affordable prices

Conditions of Non-exclusive

License
Non-assignable

License for balance term of the patent

 • National Emergency

Section 92- Special • Extreme Urgency

Provisions for
Compulsory • Public- Non Commercial use
License on
notification by • No provisions of Section 87 apply in
this case
Central
Government • AIDS, HIV, TB, Malaria or other
epidemics
 • CL available for manufacture and
export of patented pharmaceutical
product to any country having
insufficient or no manufacturing
Section 92A – CL for capacity in the pharmaceutical sector.
export of patented
pharmaceutical • The CL has to be granted by such
products in certain country.
exceptional
circumstances • Relates to a Pharmaceutical product
• Section 93 – Order of license to operate as a deed between parties
concerned

• Section 94 – Termination of Compulsory License

INFRINGEMENT
AND
REMEDIES
 What is Patent Infringement?
• Patent Infringement is the commission of a prohibited act with
respect to the patented invention without permission from the
patent holder.
• It occurs when someone violates the patent rights of an
inventor of his invention by making, using, selling the
invention without the patent owners permission
• Object of the Infringement – Patent must be valid
• Infringement behavior – The infringer must infringe with the
purpose of operation or behavior
• Violation of legal rules – The behavior is carried out without
the permission of patentees
• It’s All About claims

• Claims are important

• Broader Claims

• Claims are the one which are infringed

• Understanding the meaning and scope of the claims is important to

undermine infringement
Possible Consequences of Patent Infringement

• A huge barrier for independent innovation

• Great challenge to the social civilization and sanctity of law

• A damage to the economic laws and law of value

• An illegal behavior that destroys the fair and orderly market

competitive value
Necessary Parties to an Action for Infringement

• The valid and rightful owner of intellectual property rights may initiate an action for infringement
against any person who infringes them.
• Either a licensee or an exclusive licensee can also initiate such an action. An exclusive license-
holder shall have the same right as the patentee to institute a suit in respect of any infringement of
intellectual property rights committed after a licence has been granted.

• Under The Patents Act 1970, Section 110, a licensee is entitled to put the patentee on notice of the
infringement and to call on him or her to start proceedings to prevent infringement.

• If the patentee does not do so within two months of the request, the licensee may institute
proceedings as if it were the patent-holder, making the patent-holder a defendant in the
proceedings.
Chapter XVIII- Suits Concerning Infringment
of Patents
• Section 104- No suit for a declaration under section 105 or for any
relief under section 106 or for infringement of a patent shall be
instituted in any court inferior to a district court having jurisdiction to
try the suit:
Provided that where a counter-claim for revocation of the patent is made
by the defendant, the suit, along with the counter-claim, shall be
transferred to the High Court for decision.
• 104A- Burden of Proof in case of suits concerning infringement –
Defendant – Process

107- Defense in suits for infringement –

107A – Bolar Like Provisions

108- Relief in suits of infringement

 Courts with Jurisdiction
• Under The Patents Act 1970, the District Court is the court of first instance for patent infringement
actions.
• If the defendant seeks to challenge the validity of the patent during an infringement action, the
action must be transferred to the High Court.
• The Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts
Act 2015 provide fast-track courts for the resolution of certain commercial disputes. Intellectual
property rights are included in the definition of commercial disputes.
• Under the Act a commercial dispute valued at or above approximately USD4,200 is to be filed in
the fast-track courts. If the suit is valued below that amount, then the suit will not be filed here but
in the ordinary civil court that has jurisdiction.
• Each district has such fast-track court, referred to as a Commercial Court. Each High Court is to
have a Commercial Appellate Division to hear appeals from the District Commercial Courts. All
High Courts have appellate, constitutional and review jurisdiction.
• However, few High Courts also have ‘original’ jurisdiction, which means civil cases including IPR
suits can be filed directly in the High Courts of Delhi, Bombay (Mumbai), Madras (Chennai),
Calcutta (Kolkata) and Himachal Pradesh (Shimla). All appeals from the orders of a District Judge
will lie to the High Court. All appeals from orders of a Division Bench (an Appellate Bench) of a
High Court or Commercial Appellate
• Declaration – as stipulated in the relief act, a patent owner can pray
that the action of the infringer is declared unlawful and therefore
should be compensated by the infringer

• Certificate of Validity – the patentee can ask the court to declare the
certificate of patency valid and period of the certificate to be declared
valid to protect it against any form of infringement

• Costs – may ask the court to recover from the infringer

Defences Against Infringement

• The Patents Act 1970 provides for the following statutory defences against infringement:
• use of patented inventions on foreign vessels or aircraft temporarily or accidentally within the territory of
India (Section 49);
• The Bolar exemption: the patented invention may be used, constructed, made, sold or imported for the
reasons solely related to the development and submission of information to regulatory authorities in India or
elsewhere (Section 107A(a));
• Parallel imports: importation of patented products by any person from a person who is duly authorised under
law to produce and sell or distribute the product. India follows the doctrine of international exhaustion of
patent rights (Section 107A(b)); and
• Government use: A patented article or an article made through a patented process can be imported by the
government for its own use (Sections 47(1), (2) & (3) and 100); and
• The research exemption: the use or making of a patented invention for the purposes of experiment or research
or imparting knowledge to students (Section 47(3)).
• In addition to the above-mentioned statutory defences the alleged infringer can raise the following defences:
• Validity of a patent: in any suit for infringement of a patent, every ground on which it may be revoked shall
be available as a ground for defence and a counterclaim challenging the validity of patent may be filed;
• A compulsory license: the alleged infringer, may approach the Controller of Patents for the grant of a
compulsory license while the infringement suit is pending; and
• The ‘Gillette’ defence: Indian courts recognise the Gillette defence as a valid defence in an infringement
action. The defendant can demonstrate that the act complained of was merely what was disclosed in a prior
publication (which can also be relied on against the validity of the patent), without any substantial or
patentable variation made (Hindustan Lever Ltd v Godrej Soaps Ltd and Raviraj Gupta v Acme Glass Mosaic
Industries). Therefore, either the defendant does not infringe, or the patent is invalid, if the patent covers prior
art.
Defenses Continue
• Plaintiff not entitled to sue for Infringement
• Denial of Infringement or any threat or intention to infringe
• Leave or license express or implied
• Estoppel or res judicata
• Claims invalid
• Acts complained are in accordance with Section 47
 Role of IPR in Pharmaceutical Product
Launch
• Protection against infringement or copying
• Lawfully enforce against infringers after patent is granted
• Patentee can get monetary reward in lieu of licenses, Royalty etc.
• To encourage research and development
• Induces an inventor to disclose in invention – in return gets monopoly
• Encourages technology development
• Encourages development of new industry
• Provides motivation to Innovators
• Protect the creativity of individual
• Rewards the inventor
• Avoids duplication of research
• Keeps abreast with latest technology
• Helps industry to improve existing technology and bring innovative, new, better and
cheap technology
• Protection of invention:
• You have designed or developed a drug and you need to protect it or else it is going
to be stolen from you. So the way to protect is either by getting it patented or under
trade secret. The problem with trade secret is that it the drug can be reverse
engineered and hence your invention can be stolen. Whereas patent provides a much
more water tight protection.
• Economic growth and competitiveness
• IPR is very important for economic growth of a company. Awarding sole rights to
the inventor gives him the privilege of reaping the profits without any division. The
marketing rights over the product are solely the inventors and he can sell it or
license it. The company can earn a lot and reinvest it. Investing in research and
development is very important for a company as it has to stay in the forefront.
• Protects consumers and families
• IPR’s main interest lies in public safety. Protection and safety of public is always
given importance. IPR helps the consumer in making the right choice when
selecting a product. IPR helps in ensuring a standard and assures quality which
helps the consumer make his choice and puts him at ease
• Generate solutions to global challenges
• Promoting innovation is very important but at the same time you need funding to
do it. IPR gives you the right encouragement to do it. There is a need for
developing new drugs and vaccines as there are new diseases being discovered
daily or there is resistance development by the pathogen.
• Encourage innovation and reward entrepreneurs
• It is very important that the right push is given for inventors to keep them
motivated. It is also important that they are recognized for their work. IPR gives
them this encouragement.
• It enables a free flow of information by enabling a safe environment. When you
know it is safe to share your invention then there is going to be a safe channel for
exchange.
• PROTECTION AGAINST POTENTIAL INFRINGERS
• Intellectual property rights allow pharmaceutical companies to take strict actions
against counterfeit drugs. Without such rights, countries across the globe would
have a difficult time in ensuring the safety of their medical inventions.
Other Factors to Consider
• Patents – Infringement Analysis, Freedom to Operate, Patent
Landscape to develop and launch niche uncovered product, file
patents before launch.
• Trademarks – Check out any prior trademarks exists, do a due
diligence
• Copyright – With regard to any marketing material
• Tradesecrets – Keep Confidential agreements with the employees and
contractors.
Patent – Impact on Pharmaceutical Industry
Bad Good
Competition from MNC’s Growth of Pharma Industries
Litigation More resources would be devoted to basic research
Price rise Global Research Industry
Outsource