Patents Guide MTech

Patents
•Kanhaiya kumawat
•M.Tech. ICT Mumbai
KANHAIYA KUMAWAT M.TECH. 1

PATENTS
ESSENTIALS OF DRAFTING A PATENT
SPECIFICATION
PROCEDURE FOR REGISTRATION OF
PATENT IN INDIA
PATENT CO-OPERATIONTREATY (PCT)
MTech

What is patent???
Exclusive privilege granted by government to
the patentee for a limited period of time for
commercial gain in consideration of full
disclosure of his invention

What rights a Patent confers on the
patentee (section 48)
If the patent is for a product :
- the right to prevent others from
- making
- using
- offering for sale
- selling
- importing the patented product

If the patent is for a process :-
the right to prevent others from:
- using the process
- offering for sale the product using the
process
- selling the product using the process
- importing the product using the process
What rights a Patent confers on the
patentee (section 48)

What is Invention
The Patent Acts, 1970, Section 2
“Invention” means a new product or process involving
an inventive step and capable of industrial
application; section 2(1)(j),
New Invention: an invention or technology which has
not been anticipated by prior publication or used in
the country or elsewhere in the world before filing of
the patent application with complete specification
(i.e. subject matter not in public domain) section
2(1)(l),

What is Invention
The Patent Acts, 1970, Section 2• “inventive step” means a 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; section 2 (1) (ja)
• “capable of industrial application”, in relation to an invention, means that the
invention is capable of being made or used in an industry; section 2 (1) (ac)

Who can file Patent Application in India
Either alone or jointly
• By any person claiming to be true and first inventor(s)
• By any person being the assignee of person claiming to
be true and first inventor(s)
• By the legal representative of any deceased person who
can immediately before his death was entitled to make
such application

An invention must be....
•new or novel, that is, it must show some new
characteristic which is not known in the body of
existing knowledge (called “prior art”) in its
technical field
•non-obvious or involve an inventive step, that is,
it could not be deduced by a person with
average knowledge in the technical field
•useful or capable of industrial application
•finally, the invention must be part of the so-
called “patentable subject matter” under the
applicable law.

Protecting your invention
•The most common and efficient way of protecting
an invention is by obtaining a patent
•A patent is granted by the patent office of the
country in which you wish to protect your invention
•Patent rights are granted in return for the inventor’s
full disclosure of the technology to the public in the
patent application

Trade Secret
• Another way of obtaining protection is to keep the technology secret, and
to rely on what is referred to as trade secrets.
• Trade secrets protection allows the preservation of the confidential nature
of information from being unduly revealed and used by unauthorized
people.
• Be sure no one else patents your “trade secret”
• Life of patent is 20 yrs whereas that of trade secret is life time.
• What is more profitable? Pros and cons

Essentials of Drafting a Patent
Specification

Contents•Title
•Preamble of the invention
•Name, address and nationality of the applicant
•Field of Invention
•Prior Art
•Problem to be solved
•technical advancement
•Object of Invention (may be more than one)
•General statement of invention

Contents
•Detailed description of the drawings, if any
•Detailed Description of Invention
•Best method /example of working of the invention
•Statement of claims
•Signature with date
•Drawings
•Abstract

Title
•Give a fair indication of the art or industry to which the
invention relates.
•Brief
•No Fancy expressions
•No ambiguity
•Precise and definite
•Normally within 15 words
•In conformity with the claimed subject matter

Title
•Inventor’s name; the word ‘Patent’; words in other
languages; the abbreviation “etc”; fancy words
•Washwell Soap, Universal Rest Easy Patent Chair
•Improved folding chair; railway rail chair;
improvements in pneumatic tyres; motorcar
differential gear; filaments for electric lamps;

Preamble• ProvisionalApplication
“The following specification describes the invention”
• Complete Specification
“The following specification particularly describes the invention and the
manner in which it is to performed”

Name, address and nationality
• Full name and address along with nationality of the applicant
• The address could be of either place of business or residence

Field of the invention and use of Invention
Begin with a short general statement of the invention so as to show its scope,
and to indicate briefly the subject matter to which the invention relates

Prior Art and problem to be solved
• Status of the technology in the field of invention
• Reference to experiments going on in the field, patents and
pending patent applications in the specific art
• Short statement of the closest prior art
• Clear distinction from such closest prior art

Detailed Description of Invention
• Sufficient detail so as to give a complete picture of the invention
• The nature of improvements or modifications effected with respect to the prior
art
• Sufficient for a person skilled in the art to perform the invention by developing
necessary technical know-how by himself
• Include examples / drawings or both for clearly describing and ascertaining the
nature of invention

• Sufficient number of examples must be included in the description
especially in the case of chemical inventions
• Reference to the drawings should be specific and preferably in the
following form: “This invention is illustrated in the accompanying
drawings, through out which like reference letters indicate
corresponding parts in the various figures”

• Terms in other languages, if any, used in the description should be accompanied
by their English equivalents
• Sequence listing may also be numbered in the specification if necessary in the
case of Biotechnology Inventions
• Sequence listing should be given in electronic form

Best Method ofWorking
• The best method of performing the invention known to the
applicant
• including that, which the applicant may have acquired during the
period of provisional protection prior to the date of filing the
complete specification

Biological Materials
• Deposition at International depository Authority (IDA)
• Should not be made later than date of filing of the patent application in
India
• Name, address of the depository
• Date and number of the deposit
• Access to material available only after date of application of patent in
India
• Disclose source and origin of the biological material

Statement of Claims
• Claims constitutes a techno-legal part of the complete specification
• The description should end with a claim(s) when a complete
specification is filed

Objectives of the claims
To define clearly and with precision the
monopoly claimed so that other may know the
exact boundaries of the invention within which
they will be invaders or infringers of the patent
rights conferred on the patentee

Contents of the claims
• Claims should relate to single invention or group of
inventions, which constitute a single inventive concept
• Should be clear & concise in terms of matter for which
protection is sought
• Should be fairly based on the matter disclosed in the
specification
• Principal claim should define all essential, novel &
inventive features of the invention
• Preferred & optional features should be disclosed in
subordinate claim(s)

Signature with date
Below the signature the name(s) of the applicant(s)/or the authorized
registered patent agent be written legibly along with the date

Drawings
•Drawing should be filed on a standard A4 size sheet in
duplicate
•Total number of sheets and consequential sheet number
should be mentioned
•the signature of the applicant/agent
•A reference letter/numerals as used in the description
should also be used in denoting the corresponding
component/part in the figure

Drawings
• No descriptive matter should appear on drawings
• flowchart, chemical and other reaction are allowed

Abstract
•brief technical information on the invention
•Should give concise summary of the invention
•preferably within 150 words
•on a separate page after claim(s)
•technical field to which the invention belongs, technical
problem and solution to the problem through the
invention and principal uses of the invention

Abstract
• most relevant figure of the drawings should also be included along with
features of the invention.
• Where necessary, the abstract shall contain the chemical formula, which
characterises the invention

Approval by National Biodiversity
Authority
Biological Diversity Act 2002: Section 19 (2)
Any person who intends to apply for a patent or any
other form of intellectual property protection whether
in India or outside India referred to in sub section (1) of
section 6, may make an application in such form and in
such manner as may be prescribed to the National
Biodiversity Authority
Also refer Indian patent Act Form 1, declaration by
applicant (para 12 (iii))

references
• http://www.ipindia.nic.in/ipr/patent/patents.htm
• The Indian Patent Act, 1970
• http://mtcc.imtech.res.in/
• http://nbaindia.org/content/25/19/1/act.html
• Biological Diversity Act, 2002

Procedure for registration of patent in
India

Type of Patent Applications
• Ordinary application
– application with provisional specification
– application with complete specification
• Application for patent of addition
• Convention application
• PCT National Phase Application

Provisional Specification
• It should describe the nature of invention & contain the description of
essential features of the invention
• No need to include claims & details of the manner in which it to be
performed

Advantages of Provisional Specification
•Priority for invention
•No risk of loosing priority
•Liberty to develop
•Disclose to interested person to obtain financial
support
•Virtually extend the term
•Utilize for exploring commercial feasibility
•Avoid incurring further expenses, if no commercial
possibility

Contents of Complete Specification
•Title of the invention
•Field & background of the invention
•Use of the invention
•Prior art in the said field of invention & its drawback(s)
•Comparison between prior art & present invention
•Object (aim) of the present invention
•Summary of the present invention
•Brief description of drawings, if any
•Statement of the invention
•Detailed description of the invention w.r.t. drawings, if any
•Working examples for best method of the invention
•Claims for legal monopoly

Documents Required
•Application Form (Form 1)
•Proof of Right to Apply (Paragraph 12 of Form 1)
•Provisional or Complete Specification (Form 2)
•Statement of Foreign Filing (Form 3)
•Declaration as to Inventorship (Form 5)
•Request for Early Publication (Form 9)
•Request for Examination (Form 18)
•Power of Attorney, if Required (Form 26)
•CertifiedCopy of Convention Application, if required
•Abstract of Invention
•Drawing(s),if Any

Publication of Patent Application
•Every application for patent shall be published in
Patent Office Official Journal on expiry of period of 18
months form the date of filing or date of priority,
whichever is earlier & shall be open for public
inspection
•Except in the case, where the application –
• in which secrecy direction is imposed
• has been abandoned
• has been withdrawn 3 months prior to 18 months

Request for Examination
•No application shall be examined unless the
applicant or any other interested person makes a
request for examination after publication & within
48 months from the date of filing or date of priority,
whichever is earlier
•If, no request by the applicant or any other
interested person within 48 months from the date
of filing or date of priority, whichever is earlier, the
application shall be treated as withdrawn by the
applicant

Pre-grant Opposition
•On publication of the application, any time before grant
of patent, any person may represent by way of pre-
grant opposition against grant of patent on any of the
grounds (a) to (k) of Section 25(1)
•Pre-grant opposition will be considered only when
request for examination has been filed
•Application may be refused based on statement and
evidence in support or amended by giving notice to the
applicant &/or after being heard in the matter

Grounds of Opposition
Under Section 25(1) & (2)
• Patent invention is wrongfully obtained
• Prior publication in any document any where in world
• Prior claiming in the specification filed in India
• Prior public use
• Obviousness (lacking inventive step)
• Not an invention (non-patentable invention)
• Insufficiency of description
• Failure to disclose information regarding corresponding foreign
applications (u/s. 8)
• Conventional application is filed after 12 months from the date of filing
in conventional countries.
• Not disclose/wrongly mention geographical origin of biological material
• Anticipated byTraditional Knowledge

Examination of Application
•Every application after request for examination shall be
examined for –
• whether application is in accordance with the requirements of the Act
or the rules made there under
• whether there is any lawful ground of objection to the grant of patent
• whether the novelty & inventive step is anticipated by prior claiming in
India or publication anywhere in the world
• any other matter which may be prescribed under the Act

Examination
• Patentable subject matter
• Novelty Analysis/anticipation
• Inventive step/obviousness
• Industrial applicability
• specification

Grant or Refuse or Abandon
If, within 6 months from the date FER (with provision
for extension of 3 months on a request made to the
controller):
• all requirements met, patent will be granted immediately with seal of the Patent
Office (Letters Patent) & grant publication
• requirement(s) not met, patent application will abandoned or
• requirement(s) met/ not met after hearing: patent granted/or refused
• Term of patent: 20 years form the date of filing

Grant of Patent
• Date of Patent
• Territory
• One patent granted for one invention only
• No suit for infringement or other proceedings can be commenced
or prosecuted for infringements committed before the date of
publication of the application

Can I Publish Before Patenting? Or
Market? Or Sell? OrTalk toVendors?
• What Can I Publish Before Patenting?"
• Can I start my marketing campaign?
• Can I disclose this to potential manufacturing partners?

The Patent Grace Period
India
•Anticipation by public display, etc. -An invention claimed in a
complete specification shall not be deemed to have been
anticipated by reason only of-
•the display of the invention with the consent of the true and
first inventor or a person deriving title from him at an industrial
or other exhibition to which the provisions of this section have
been extended by the Central Government by notification in
the Official Gazette, or the use thereof with his consent for the
purpose of such an exhibition in the place where it is held;
•the publication of any description of the invention in
consequence of the display or use of the invention at any such
exhibition as aforesaid;

•the use of the invention, after it has been displayed or used at
any such exhibition as aforesaid and during the period of the
exhibition, by any person without the consent of the true and
first inventor or a person deriving title from him; or
• the description of the invention in a paper read by the true and
first inventor before a learned society or published with his
consent in the transactions of such a society, if the application
for the patent is made by the true and first inventor or a person
deriving title from him[not later than twelve months] after the
opening of the exhibition or the reading or publication of the
paper, as the case may be.

•Under U.S. Patent Law an early disclosure by any means will
not destroy the novelty of the invention if it is made less than
one year prior to the filing of the patent application.
•In other words, in the U.S., if you publish a paper, or disclose
your invention by selling it, or marketing it, a clock starts
ticking and you have one year to file a patent.
•This is a big deal – It is understood that 20% of all U.S. patent
applications take advantage of the one year grace period.

The Patent Grace Period•By contrast - most of the rest of the world operates under
what is called absolute novelty
•You publish your invention - you cannot patent
•There are a few exceptions - Canada now has a one year grace
period, and Japan, Russia, Germany, Austria, Hungary, and the
Czech Republic offer versions of a 6 month grace period
•The rules around the world are in flux though and your best bet
is to assume absolute novelty in your planning
•Unless of course you are absolutely sure you will be filing in the
U.S. only
•A word of caution about the U.S. grace period.When the one
year is over - it is over.Twelve months after an early disclosure
there is an absolute bar to patentability

What is Early Disclosure?
•Disclosure normally means disclosing your invention - not your
product benefits.
•It is often possible to carefully write any marketing material or
public papers so that they do not disclose the actual invention
•How about academic papers??
• No reason to publish a potential invention that the University might later
want to patent simply because of an upcoming important conference
• If you are taking the time to write a good publication for an academic
conference you are in effect writing an excellent invention disclosure
• the first draft of your paper should ideally be draft of your provisional
application for filing. It should be a standard practice
• The same applies to any company that makes presentations to
conferences

Summary Recommendations
• If you can file before you publish, demonstrate, or offer for sale -
then by all means file your patent application first
• When you cannot file first - then take precautions:
• if you have to give a private presentation or speech - do not provide
handouts. A private presentation is not considered a public disclosure
• if you must publish before filing - limit your description of the actual
invention - talk about the benefits, not the invention
• if you need to make an offer of sale - present it as a solution to a
problem - without describing the actual invention
• when dealing with business partners - always work through NDA's
• if timing is of the essence - make use of a provisional application
filing

Public Use and Offers for Sale
•The public use of your invention or an offer for sale is a bar to
patentability after the one year grace period in US
•Even if you are able to sneak this by the patent office, your
patent can be easily invalidated during any litigation
•In litigation, your opponent has access to powerful discovery
tools, including the right to compel testimony under oath and
to compel the production of relevant documents. Once it is
discovered , your patent will be held invalid and you will not be
able to stop others from infringing it
•In addition the failure to disclose these things is also unethical
conduct

What About Early Disclosure to Potential
Business Partners,Vendors, etc?
• For commercialisation or up scaling of a technology we need to
outsource prototyping, manufacturing, and testing of new
developments
• Ideally you should file a patent before doing any of these but in
reality it is often almost impossible
• This is where you must insist on a rigid policy of obtaining Non-
Disclosure Agreements (NDA) from any partner.
• Even when you have NDA in place - move quickly to file a patent
application once you have made the decision to patent and any early
disclosures are imminent

Post-Grant Opposition• Any time after the grant or before expiry of 1 year from the date of
publication of grant, any interested person may give notice of opposition
on any of the grounds (a) to (k) of Section 25(2)
• Opposition board after completion of proceeding & maturation of case for
hearing will examine the matter & submit its report
• On receipt of report & after hearing the patentee & opponent, patent will
be either maintained or amended or revoked

Patent Grant Procedure
Filing of patent application
Publication after 18 months (form 9)
Pre Grant Opposition /
Representation by any person.
Request for examination form 18/form 18A
Examination: Grant or Refusal
Publication of Grant of patent
Post Grant Opposition to grant of patent
(Constitution of Opposition Board)
Early Publication
Decision By Controller

Appropriate office for filing
patent

Non Patentable Inventions
[Under Section 3]
Following are not inventions within the meaning of this Act -
(a) an invention which is frivolous or which claims anything
obvious contrary to well established natural laws;
(b) an invention the primary or intended use or commercial
exploitation of which could be contrary to public order or
morality or which causes serious prejudice to human, animal
or plant life or health or to the environment;
(c) the mere discovery of a scientific principle or the formulation
of an abstract theory or discovery of any living things or non-
living substance occurring in nature;KANHAIYA KUMAWAT M.TECH. 62

(d) 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 mew 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
Explanation – For the purpose of this clause, salts, esters, ethers, polymorphs,
metabolites, pure form, particle size isomers, mixtures of isomers,
complexes, combinations and other derivatives of known substances
shall be considered to be the same substance, unless they differ
significantly in properties with regard to efficacy;
(e) a substance obtained by a mere admixture resulting only in
the aggregation of the properties of the components thereof
or a process for producing such substance;

(f) the mere arrangement or re-arrangement or duplication of
known devices each functioning independently of one another
in a known way;
(g) Section 3(g) of the Patents Act,1970 has been omitted by The
Patents (Amendment Act, 2002);
(h) a method of agriculture or horticulture;
(i) any process for the medicinal, surgical, curative, prophylactic,
diagnostic, therapeutic or other treatment of human being 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;

(j) plants and animals in whole or any part thereof other then
microorganism but including seeds, varieties and species
and essentially biological processes for production or
propagation of plants and animals;
(k) a mathematical or business method or a computer
programme per se or algorithms;
(l) a literary, dramatic, musical or artistic work or any other
aesthetic creation whatsoever including cinematographic
works and television productions;

[Under Section 3]
• Synergistic compositions of new or known micro-organisms
can also be patentable, as can processes for isolating such
substances.
• To remove any ambiguity, the act was amended in 2002 to
include “biochemical, biotechnological and microbiological
processes” within the definition of potentially patentable
chemical processes.

• Although the act does not define an ‘essentially biological
process’, in Monsanto (2013) the Intellectual Property Appellate
Board (IPAB) provided some guidelines on what constitutes one.
• The patent application under consideration claimed a method of
producing a transgenic plant.
• Although the patent application was rejected on other grounds,
the IPAB overturned the IPO’s objection that it was an essentially
biological process. The IPAB agreed with Monsanto’s submission
that the plant cell in the claimed process was transformed as a
result of human intervention in the manner claimed in the
application, and was therefore patentable.
• Thus, although genetically modified plants or seeds are not
patentable in India, processes for the genetic modification of
plants are patentable.
• Further, a sui generis system for protection for plant varieties is
available under the Protection of Plant Varieties and Farmers’
Rights Act 2001. KANHAIYA KUMAWAT M.TECH. 67

Section 3(i) Unpatentable subject matter
Category Unpatentable example
Medicinal methods A process of administering medicines orally, through
injection, topically or through a dermal patch.
Surgical methods A stitch-free incision for cataract removal.
Curative methods A method of cleaning plaque from teeth.
Prophylactic methods A method of vaccination.
Diagnostic methods Identification of the nature of a medical illness by
investigating its history and symptoms and applying
tests.
Therapeutic methods Prevention and treatment or cure of diseases.
Methods of treatment to render animals free of disease
or increase their economic value (or that of their
products)
A method of treating sheep for increasing wool yield.

(m) a mere scheme or rule or method of performing mental act or
method of playing game;
(n) a presentation of information;
(o) topography of integrated circuits;
(p) an invention which, in effect, is traditional knowledge or
which is an aggregation or duplication of known properties of
traditionally known component or components.

No patent shall be granted in respect of an invention relating
to Atomic energy falling within sub section (1) of section 20
of the Atomic Energy Act, 1962.
e.g. Inventions relating to compounds of Uranium, Beryllium,
Thorium, Plutonium, Radium, Graphite, Lithium and more as
notified by Central Government from time to time.
Atomic Energy Related Inventions

Section 5 of the Patents Act, 1970
has been omitted
In view of TRIPS compliance the provision of Product patent in
respect of food, medicine or drug and a substance prepared or
produced by chemical processes is introduced.

Patent Co-operationTreaty (PCT)
• A multilateral treaty
• Concluded/signed inWashington in June, 1970
• Operational in June 1978 with 18 States
• Administered by the International Bureau (IB) of theWorld
Intellectual Property Organization (WIPO), Geneva,
Switzerland
• As of now, the PCT has 152 Contracting States
• The decision on granting patents is made exclusively by
national or regional Offices in the national phase
• India joined PCT in 1995

Patent Co-operationTreaty (PCT)
• facilitates obtaining of patent protection for
inventions in any or all of the PCT Contracting States
• filing of one patent application (“the international
application”), with effect in several States,
• includes designations for regional patents in respect
of States :
– the African Regional Intellectual Property Organization
(ARIPO)
– the Eurasian Patent Convention (EAPC),
– the European Patent Convention (EPO), and
– The Agreement establishing the African Intellectual
Property Organization (OAPI)KANHAIYA KUMAWAT M.TECH. 73

PCT Contracting States

PCT-the international patent system
•does not eliminate the necessity of prosecuting the
international application in the national phase
•Facilitate prosecution by virtue of the procedures carried
out on all international applications during the international
phase of processing
•The formalities check, the international search and the
optional supplementary international search(es) optional
international preliminary examination carried out during the
international phase
• automatic deferral of national processing

Traditional patent system vs. PCT system
Fees for:
--translations
--Office fees
--local agents
0 12
File local
application
File
applications
abroad
(months)
Traditional
(months)
File PCT
application
12 30
International
search report &
written opinion
16 18
International
publication
(optional)
File
demand for
International
preliminary
examination
File local
application
Enter
national
phase
22 28
(optional)
International
preliminary report
on patentability
PCT 0
Fees for:
--translations
--Office fees
--local agents

Receiving Office and languages
• Receiving Office (RO)
• The patent office, at Kolkata, New Delhi, Mumbai and Chennai (RO/IN)
• International Bureau (RO/IB),Geneva Switzerland
• Language of filing
• RO/IN: English, Hindi
• RO/IB: any IB language: Arabic, Chinese, English, French, German,
Japanese, Korean, Portuguese, Russian or Spanish

Elements of International
Application
• Request (PCT/RO/101)
• Description
• One or more claims
• Abstract
• Drawings
• Fees
• PA/GPA

Number of copies/Fees
• RO/IN: 3 copies
• Record copy
• Search copy
• IB copy
• RO/IB: 1 copy
• Fees:
• Transmittal fee: INR 3250, 8800 (small entity) and 17600 (other than
natural person)
• International filing fee: USD 1363
• ISA fee

(months)
File PCT
application
120 30
International
search report
& written
opinion
16 18
International
publication
(optional)
File demand for
International
preliminary
examination
File local
application
Enter
national
phase
22 28
(optional)
International
preliminary
report on
patentabilityTypically a
national
patent
application in
the home
country of the
applicant
PCTTime line

(months)
File PCT
application
120 3
0
International
search report
& written
opinion
16 18
International
publication
(optional)
File demand
for
International
Preliminary
examination
File local
application
Enter
national
phase
22
28
(optional)
International
preliminary
report on
patentabilityTypically filed in
same national
patent office--one
set of fees, one
language, one set
of formality
requirements--and
legal effect in all
PCT States
PCTTime line

(months)
File PCT
application
120 30
Internationa
l
search
report &
written
opinion
16 18
International
publication
(optional)
File demand for
International
preliminary
examination
File local
application
Enter
national
phase
22 28
(optional)
International
preliminary
report on
patentability
Report on state of
the art (prior art
documents and their
relevance) + initial
patentability opinion
PCTTime line

(months)
File PCT
application
120 30
International
search report
& written
opinion
16 18
Internationa
l
publication
(optional)
File demand for
International
Preliminary
examination
File local
application
Enter
national
phase
22 28
(optional)
International
preliminary
report on
patentability
Disclosing to
world content of
application in
standardized
way
PCTTime line

(months)
File PCT
application
120 30
International
search report
& written
opinion
16 18
International
publication
(optional)
File demand for
International
preliminary
examination
File local
application
Enter
national
phase
22 28
(optional)
International
preliminary
report on
patentability
Request an additional
patentability analysis
on basis of amended
application
PCTTime line

(months)
File PCT
application
120 30
International
search report
& written
opinion
16 18
International
publication
(optional)
File demand for
International
preliminary
examination
File local
application
Enter
national
phase
22 28
(optional)
International
preliminary
report on
patentability
Additional
patentability
analysis, designed to
assist in national
phase decision-
making
PCTTime line

(months)
File PCT
application
120 30
International
search report
& written
opinion
16 18
International
publication
(optional)
File demand for
International
Preliminary
examination
File local
application
Enter
national
phase
22 28
(optional)
International
preliminary
report on
patentability
Express
intention and
take steps to
pursue to grant
in various
states
PCTTime line

Advantages of PCT system

brings the world within reach
• Legal effect of a regular national patent
application in all PCT States
• Savings in document preparations, translations and
communications
• Only one copy of priority document to be submitted
• Streamlines the process of fulfilling diverse
formality requirement
• Increases visibility
• world’s major corporations
• universities and research institutions

postpones major costs
• Translations of the patent applications (which are highly
technical documents) into various national languages
• Official fees for payment to national/regional patent
offices (for example, filing fees, claims fees, etc.)
• Fees for the services of local patent agents/attorneys in
the designated states

• Chapter I (before the international publication)
– International Search Report (ISR)
– Written Opinion of the International SearchingAuthority
• Chapter II (after international publication)
– International Preliminary Report on Patentability (IPRP Chapter II)
guideline for patenting decisions

PCT filing fees•International filing fee (1363 USD)
•Search fee (depending on the ISA chosen)
•Transmittal fee at the receiving office (filing by
natural person: 3250; filing by small entity 8,800,
other than natural person: INR 17,600)
•Fee reductions available depending on applicant,
applicant from developing country for international
filing fee
•Some ISA also provide reductions in search fee
•ISA: AT,AU,CN, EP,IN,SE, US.
•http://www.wipo.int/export/sites/www/pct/en/fees.pdf

ISA and IPEA for Indian nationals
•Australia
•Austria
•EPO
•USPTO
•Sweden
•China
•India

References
• http://www.wipo.int/pct/en/faqs/faqs.html
• http://www.wipo.int/pct/guide/en/gdvol1/pdf/gdvol1.pdf
• www.wipo.int/pct-safe/en/

TECHNOLOGY LICENSING
M.Tech BPT class

Transfer of patent rights
• Assignment
• Transfer of ownership
• License
• Authorisation to exercise the patent rights

Validity of assignment/license
• Term & Conditions, including rights and responsibilities should be written
and executed in an agreement
• Register the title or interest at the patent office
• Application to controller of patents through form 16
• Certified copies to be submitted within six months of execution of such
agreement
• Such details are entered into the register of patent at the IPO.

Case study
• National Research Development Corporation vs. ABS Plastics Ltd.
• Tech for manufacture of Terploymers of Acrylonitrile (ABS Resigns)
• Invention developed and patented (two patents) by Sri Ram Institute
under NRDC funding of CSIR
• Assigned to NRDC
• NRDC licensed to ABS plastics for a period of eight years (from 1975)
• Lump sum royalty of Rs. 60,000 and & running royalty of 1% on net ex-
factory sale price.
• ABS failed to pay royalty, NRDC filed suit to force enforcement

Courts decision
• License agreement not valid & therefore not enforceable
• Agreement was not registered at the patent office as per section 68 of
the Indian Patent Act. 1970
• Agreement shall not be valid after Oct, 31st, 1979 and May 2nd, 1981 since
the patent expired on mentioned dates

License
• A patentee may by a license, permit others to make, use, or exercise, the
invention that would otherwise be illegal for them to do
• A license is not valid unless it is writing and an application for
registration of the document embodying the term of license is filled with
the Controller
• A license may be express, implied or statutory
• It may be exclusive, non exclusive or limited
• Statutory license includes compulsory license and licenses or right

Express license
In an express license, the license is made in express terms stating down
the terms and conditions of the license

Implied license
In an implied license, the permission is not given in express terms
but it is implied from the circumstances
example: if the employee invents something
while on company time, the employer receives
an implied license to use the invention, even if
no contract exists to assign rights to the
employer.This is sometimes referred to as shop
right

License
• There are two different types of patent licenses: exclusive and
non-exclusive
• An exclusive license is what most licensees will prefer, since it
grants them “exclusive” rights to capitalize on the patent
• It ensures them some protection against competition and also
allows them to enforce violations of the patent
• Non-exclusive licenses, then, let you, the licensor, keep the
right to license the patent to someone else
• One needs to decide which of these two licenses one is most
comfortable with and try to get the licensee to go along with it

Licenses
• In an exclusive license, the license can exclude all other person including the
patentee from right to use the invention
• "exclusive licence" means a licence from a patentee which confers on the licensee,
or on the licensee and persons authorised by him, to the exclusion of all other
persons (including the patentee), any right in respect of the patented invention, and
exclusive licensee shall be construed accordingly (definition as per Indian Patent
Act)
• “sole licences” are those in which the licence is exclusive in the meaning that there
would be no more licensees, but the licensor also reserves full rights to exploit
his/her intellectual property.
• But in the case of non exclusive license, a number of licensees can be granted by
patent rights
• "co-exclusive licence”: a middle-ground between exclusive and non-exclusive
• The licensor grants a licence to more than one licensee
• agrees that it will only grant licences to a limited group of other licensees
• The group of licensees may be identified by name, description (a licence will only
be granted to licensees who meet certain criteria), or simply by number (a limited
number of licenses will be granted by the licensor)
• Cross license KANHAIYA KUMAWAT M.TECH. 104

License more
Patent are granted to encourage inventions
They are not granted merely to enable the
patentees to enjoy monopoly for the importation of
patent article
The patent system has to ensure that the
inventions are worked in India or commercial scale

Compulsory License
• CL under the patent systems is an involuntary contract between a
willing buyer and an unwilling seller imposed by the state
• The WTO states compulsory licensing is when a government allows
someone else to produce the patented product or process without
the consent of the patent owner
• CL has been in existence since the 1830s. It has been popular in
Britain as early as 1850s
• Later this system was recognised by the international community
through Paris convention of 1883

Compulsory License
• Provisions of granting CL existing in Patent laws of countries such as Canada,
UK, USA, Australia (developed countries) and Zimbabwe, Ghana, Brazil,
Equador, Malaysia,Thailand and India (developing countries)
• India joinedTRIPS and deadline for complyingTRIPS obligations was January 1,
2005
• The Patent Act 1970 was amended thrice to make it fullyTRIPS compliant in the
years 1999, 2002 and finally 2005
• Vide patent amendment act 2002, the provisions relating to CL, i.e Chapter XVI
of Patent Act 1970, were substituted with a completely new one
• It allowed product patent to be granted for drugs, which was not allowed under
the earlier 1970 Act

CL History
• Article 27.1 of theTRIPS Agreement requires WTO members to
make patents “available for any inventions, whether products or
pocesss, in all fields of technology”, which includes patents for
pharmaceutical processes and products.
• At the same timeTRIPS also provides a reasonable fetter on the
rights of the patentee in the form of Article 30 and 31, in line with the
Paris convention, thereby allowing member of countries to enact
provisions, inter alia, for granting compulsory provisions to prevent
abuse of patent right.

Conditions for grant of CL
• Reasonable requirements of public not satisfied
• Patented invention not available to the public at a reasonable
affordable price
• Patented invention not worked in the territory of India

Reasonable requirements
• Patent holder does not grant license of the patented technology
because of which
• Trade or industry in India or its development or establishment is
hampered
• Demand for the patented product is not adequately met on reasonable
terms
• A market for export of the patent article manufactured in India is not
supplied or developed
• Establishment or development of commercial activities in India is
hampered or prejudiced

Reasonable requirements
• The patent holder imposes conditions governing the license sale or
use of patented product or process, which:
• Prejudice the manufacture or sale of non-patented materials in India
• Prejudice the development of any trade or industry in India

Reasonable requirements•Patent holder includes the following conditions in license:
•Exclusive grant back on improvements in products or process
•Clauses amounting to coercive package license
•Patent holder does not work the patented invention to fullest
extent in territory of India
•The working of patented invention on a commercial scale is
being hindered due to importation of patented invention
•By the patentee
•Person purchasing by the patent holder, directly or indirectly
•Any person against whom the patent holder has not taken
infringement action

Other conditions
• Reasonable Affordable Price
• Price should be reasonable and nor beyond the capacity of general public
• Worked in territory of India
• Objective of granting of a patent is to work on a commercial scale in
India

Procedure for grant of CL
• Interested person
• After expiry of 3 years from grant of patent
• Nature of interest, facts in support of application and conditions the applicant is
willing to accept
• Form 17
• Controller of prima facie satisfied, directs applicant to send copies to the
Patentee or any other person having interest in the patent
• Controller publishes the application for CL
• Opposition to CL can be filed within two months of publication of such
application for CL
• Notice of opposition should state the grounds of opposition, terms and
conditions acceptable by the opponent and necessary evidence in support of
opposition
• Notice of oppositions served on to the applicant
• Controller fixes a date and makes decision of CL after hearing the Parties

Procedure for grant of CL
• Controller if not prima facie satisfied:
• Notifies the applicant
• Applicant may request hearing within ONE month of such notification
• The controller after the hearing decides whether to allow or refuse the
application

Factors in deciding grant of CL in
India• Nature of invention, time lapsed since grant of patent, measures
taken by the patentee/ any licensee to make full use of the invention
• Ability of the applicant of CL to work the invention to the public
advantage
• Capacity of applicant of CL to undertake risk in providing capital and
working of invention
• Efforts made by the applicant to obtain license from the patentee on
reasonable terms and conditions for a period of six months
• However, such factors shall not be considered under case of national
emergency, public, non-commercial use or on establishment of a
ground anti-competitive practices adopted by the patent holder

Terms and conditions
• Reasonable consideration to the patent holder, nature of
invention, money spent on creation, protection,
development and enforcement of the invention/patent
• Non-exclusive
• Non-assignable
• For the balance term of the patent
• License primarily for supply in Indian market
• Can allow for export, if license is based on anti-competitive
practices of patent holder

CL on Related patents• Controller can grant CL on patents related to a patent which is subject of a
CL
• X has patent on wheel and spiked used in the wheel.
• Wheel can be used only with the patented spiked
• So if a CL is applied for the wheels, a CL for spikes can also be granted
• CL may also be granted if working of a patented invention is prevented or
hindered because of the existence of another patented invention
• Applicant of CL is capable and willing to grant, procure the grant of licenses over
the patent/license held by him to the holder of patent or his licensee
• The invention that is subject of the patent held or licensed by applicant of CL has
substantial contribution to establishment or development of
commercial/industrial activities in India

Compulsory License in Emergency
• National emergency, extreme emergency, public non-commercial
use by notification of Central Govt in official gazette
• Controller will grant CL to the applicant , ensuring that
• Invention is available to public at lowest price
• Interests of patent holder
• Normal procedure not applicable if controller satisfied of the above
conditions, including public health crisis,AIDS, HIV, tuberculosis,
malaria and other epidemics

CL for Export
• Manufacture and export of patented pharmaceutical products to
any country having insufficient or no manufacturing capacity in
Pharma sector
• Can be granted on any drug, formulation, including ingredients of a
product, or diagnostic kits for the use of the product
• Introduced through amendment of Patent Act, based on the Doha
Declaration, which permitted WTO members to allow the export of
phrama products to other developing or underdeveloped countries
• Such CL granted only if the country has granted a CL relating the
product, or has allowed importation of the said pharmaceutical
products from India

Revision of terms and termination
of the CL
•Holder of CL can make an application for
revision of terms and conditions of CL
•After 12 months from date of grant of CL
•Form 20 with facts and evidence in support of
application and relief sought by the applicant
•Termination by Controller on application made
in form 21, along with evidence

Natco v. Bayer CL Litigation
• Present case is the first of its kind in the history of Patent Act
1970, wherein the provisions of section 84 have been invoked
by the Applicant herein for seeking the grant of compulsory
license. And as such there is no precedent to guide this
tribunal.
• The office of CG of Indian Patent Office granted a non-
exclusive and non-assignable CL to Bayer’s Indian Patent No.
215758

The Patentee• M/S Bayer Corporation, USA: an internationally renowned
manufacturer of innovative drugs
• Invented a drug celled ‘Sorafenib’ (caroxy Substituted Diphenyl
Ureas); useful in treatment of advanced stages of liver and kidney
cancer in 1990
• The patentee filed for a US patent on 13-01-1999 and subsequently a
PCT international Application on 12-01-2000
• It entered national phase in on 05-07-2001
• Indian patent was granted for the drug on 03-03-2008
• It developed the drug and launched it in 2005 under the name
Nexavar for the treatment of Renal cell Carcinoma-RCC (kidney
cancer) in 2007 and subsequently received additional approval for
treatment of Hepatocellular Carcinoma-HCC (live cancer)
• The patentee received regulatory approval for importing and
marketing the drug in India an launched it in India in the year 2008

The Drug
• ‘Sorafenib tosylate’ is covered under patent No. 215758 in India and
sold under the brand name NEXAVAR by the Patentee is used for
the treatment at the advanced stages of kidney and liver cancer
• The drug stops the growth of new blood vessels and targets and
other important cellular growth factors
• It is a life extending drug and not life saving drug
• It enhances life span for a kidney cancer patient for about 4-5 years
and a liver cancer patient for about 6-8 months. Cost of therapy is
Rs. 2,80,428/- per month.

The Applicant
• Natco Pharma Ltd., Hyderabad: reputed Indian generic drug
manufacturer
• The applicant has developed the process to manufacture the said drug
and received license from Drug Controller General of India for
manufacturing the drug in bulk and for marketing it in tablets in April
2011
• Applicant filed for CL on 29-07-11 under section 84(1) ofThe Patents
Act 1970
• Earlier it approached the Patentee with a request for a voluntary
license to manufacture and sell the drugKANHAIYA KUMAWAT M.TECH. 125

The Applicant
• The applicant proposed to sell the drug at a price of Rs.
8800/- for one month therapy.Three years had lapsed since
the date of grant of patent when the application was filed.
The applicant is also the person interested within the meaning
of the act
• A prima facie case was established under Section 87 (1) and
the Applicant was directed to serve a copy of the application
upon the patentee

Main issues to be decided in the
case
• The Applicant pleaded the following three substantial issues
in the Application (section 84 (1) (a, b, and c) i.e.
• The reasonable requirements of the public with respect to the patented
invention have not been satisfied
• The patented invention is not available to the public at a reasonably
affordable price
• The patented invention is not worked in the territory of India

The Scope of CL
• It is limited in scope to only making, using, selling and
offering to sell (not importing) the generic version of the
drug within India
• The CL will be for the remaining term of the patent
• NATCO will have to make quarterly payments of 6% on its
net sales.
• It will charge only INR 8900 (USD 180) for the required
monthly dose and to donate supplies to 600 needy patients
each year
• It will not attempt to pass of it products as that of Bayer’s in
terms of trade marks/trade name as well as the packaging of
the product

The Facts of the Case
• Bayer’s disclosure will be critical in the light of Natco’s lawyer
alleging in the first hearing that Nexavar was developed as an
orphan drug
• Such drugs normally receive government grants and other
concessions, lowering R&D costs
• An orphan drug is one that addresses a tiny patient population that’s
normally ignored by researchers and manufacturers as it doesn’t
make commercial sense for them
• Natco had earlier unsuccessfully approached Bayer for a voluntary
licence to allow it to manufacture and sell a generic version

The Facts of the case
• Bayer’s lawyer said his client refused the voluntary licence as
Natco’s “approach was not appropriate” and the
correspondence in this regard implied “a tone of a threat”
that it may seek a compulsory licence
• According to Natco’s lawyer, Bayer imported only 200 bottles
of the drug, which was insufficient to meet market demand.
A compulsory licence applicant has to prove that it’s capable
of selling the product at a lower cost to meet demand
• Bayer’s working status filing to the patent office for fiscal
2010 showed that it posted sales of Rs.16 crore for the drug

Grounds for granting the CL
• For not meeting the public requirement for the patented drug
• That the patented invention is not available at a reasonably
affordable price
• That the patented invention is not worked in the territory of India

Practice Pointers
• “Working” means “manufacturing”:To avoid grant of a CL patentee
needs to manufacture the patented drug to a reasonable extent within
the territory of India
• Working statement (form 27) A crucial evidence: it will be considered a
material information as to the extent to which the drug was made
available in India
• Supply of alleged Infringing products: Supply of alleged generic
substitutes will be disregarded in assessing whether the reasonable
requirement of the public has been met
• “Reasonable Price”:The term “Reasonably affordable price” has to be
construed with reference to public at large and therefore the patentee
may seriously consider differential pricing arrangements for Indian
conditions
• Detailed offer to obtains voluntary license may not be necessary
• CL may be offered not just for life saving drugsKANHAIYA KUMAWAT M.TECH. 132

Other case studies
• In the second case of Compulsory licensing in India, the Controller
rejected BDR Pharmaceuticals’ application for compulsory license
(made on March 4, 2013) for BMS cancer drug, SPRYCEL
• The Controller rejected the compulsory license application made by
BDR for stating that BDR has failed to make prima facie case for
the making of an order under section 87 of the Act.
• Controller in the said case observed that BDR Pharmaceuticals had
not made any credible attempt to procure a voluntary license from
the Patent holder and the applicant has also not acquired the
ability to work the invention to the public advantage.

Other case studies
• Lee Pharma, a Hyderabad based Indian pharma company, filed an
application for compulsory license (dated 29.06.2015) for the
patent covering AstraZeneca’s diabetes management drug
Saxagliptin.
• In order to make a prima facie case, Lee Pharma strived to show
that their negotiations for a voluntary license with the patent
owner were not rewarding as they did not receive any response
from the Patent owner within a reasonable period.The grounds
alleged by Lee Pharma were that:
• the patentee has failed to meet the reasonable requirements of the
public,
• the patented invention is not available to the public at a reasonably
affordable price, and
• the patented invention is not worked in India.

Other case studies
• All the three grounds of Lee Pharma were rejected by the Controller
General and the Compulsory license application was refused
• The application was rejected on the basis that Lee Pharma failed to
demonstrate what the reasonable requirement of the public was with
respect to Saxagliptin.
• It failed to demonstrate the comparative requirement of the drug
Saxagliptin vis-a-vis other drugs which are also DPP-4 inhibitors.
• Further, Controller General held that all the DPP-4 inhibitors were in
the same price bracket and the allegation that Saxagliptin alone was
being sold at an unaffordable price was unjustified.
• The Controller General also stated that Lee Pharma failed to show the
exact number of patients being prescribed the patented drug and
those that were unable to obtain it due to its non-availability and
consequently it was difficult to hold whether manufacturing in India
was necessary or not.

Patent Rights
and Infringement

Patent Rights
• A patent holder has exclusive rights over the patented
process/product and can exclude any third party from exercising
any exclusive rights over the patented invention without his
consent and permission i.e
• Right to make
• Right to use
• Right to sell or offer for sake the patented product or product produced
by a painted process
• right to import the patented product or the peoduct made by the
patented process

Patent Rights
• Joint holders get equal and undivided rights/shares in the patented
invention
• Each patent holder owns complete rights over the patent and can
exercise all the rights over the patent independent of the co-owner
• However, a patent holder cannot assign or license the patent
without the consent of the other patent holder.

Term andTerritory

Infringement
• A person is liable for patent infringement if he exercises any of the
exclusive rights over the patented invention without the patent
holder’s permission in the territory of India
• The product or process in question falls within the scope of at least one
claim of the patent
• The person exercises the exclusive right of the patent holder over the
product or process in India without permission from patent holder

Infringements
•by Patent holder
•A patent holder can be liable for patent infringement, if his
invention infringes a patent of another person
•Overlapping patents/ within the scope of other person’s
patent
•by improved product or process
•Independent and dependent claim
•A product or process infringing an independent claim of a
patent, may not be liable for infringement of all claims
dependent on the said independent claim
•If a product or process does not infringe the independent
claim, it will definitely not infringe its dependent claims

Jurisdiction
• Not less than a district court
• High Court (if counterclaim for revocation is filed)
• Appeal of decision to Supreme Court

Persons entitled to Sue
• Patent holder
• Exclusive Licensee
• Entitled to cost, damages and lost profits
• Compulsory Licensee

Infringement andTypes
• Infringement
• Product or process falls within the scope of at least one claim in the
patent
• Person exercises exclusive rights of patent holder without patent holders
permission
• Types of infringement
• Literal/Direct Infringement
• Indirect Infringement

Infringement
Direct Infringement Indirect Infringement
A third party wilfully and intentionally steals the
invention from the patent holder
Refers to unfair practice that does not give clear
indication that the patent is bought or sold in the
market
When a third party directly makes, use, sells or imports
the invention without the permission of the patent
holder in the territory of India
e.g. a third party supplies a product that can only be
used to make a parented device
i.e. Manufacture patented technology Sells parts that can only be reasonably used in a
patented invention
Use patented technology; sell or offer for sale the
patented technology; import patented technologyOR
pass of the patented technology
Licenses an invention covered in another’s patent
Sell material components that has been especially
made for use in patented invention only and has no
other commercial use

Determination of Infringement
• ClaimConstruction
• Identify the elements
• Steps in the claims
• Ascertain meaning and scope of each element and step
• Patent specification, prosecution history, prior art in the field, scientific
dictionary and other relevant documents in that order
• Prosecution history/ file wrapper
• Pith and marrow of the claimed invention and its scope is to be
considered

Claim comparison
• Product or process must be compared with the patent claims
• Comparison to be done claim by claim and step by step
• If all elements of at-least one claim in a patent are present in the
product, it is said to be literally infringing
• Similarly for steps of a process

Equivalence analysis
Infringement by equivalence
• Equivalence test required when literal infringement not established
• If literally different claim elements and steps are present in the
product then the product or process can be infringing by
equivalence

Example
• Movable table comprising rectangular wood, four solid steel rods of
equal length to support the rectangular wood; wherein each rod is
connected to the one corner each of the rectangular wood and
wherein each rod is supported by a caster to the other end
• Y makes a table which is circular, with four long circular legs, made
of wood and connected to wheel assembly .

Remedies of Infringement
• Injunctive relief
• Damages
or
• An account for profits

Burden of Proof
• Burden to proving infringement of a patent lies on patent holder
• In case of infringement of a process to obtain a product, burden of
proof, shifts to alleged infringer
• If patent holder proves that product in question is identical to that made
by the patented process
• Patent is over a process to obtain a new product
• Patent holder is unable to determine the process used by the alleged
infringer
• Alleged infringer shall not be required to disclose the trade secrets
if such disclosure is unreasonable to the alleged infringer

Defences to Patent Infringement
• All grounds of revocation of a patent (Section 64)
• If making, using importation or distribution of any machine, apparatus, or any
other article or the use of any process or importation, use or distribution of any
medicine or drug is in accordance with one or more conditions specified in section
47

Experimental use or educational Use Section
47 of the Indian Patent Act, 1970
• Use of patented invention for research /experiments or educational purposes is
exempted from infringement
• Scientist can use for research or experimental purposes
• Professor can use for teaching purpose

Government use
• Use by government for merely its own purposes
• Govt or any person on behalf of govt can manufacture or import a patented
process without infringing liability
• Government meaning not defined
• Central / State too??
• Bombay HC: exemption limited to mere use of govt’s own use and would
extend only to govt department for carrying out its functions or by govt
agents/officers
• Delhi HC: Exemption would also extend to any person on behalf of govt
under govt contract
• Sale of patented invention not covered under the scope of exemption
• Any use, sale or manufacture of patented inventions authorised by Govt for
purposes of govt or govt undertaking must be done on terms agreed by the
patent holder or under terms determined by the HC

Government use of medicine and
drugs
• Purposes of its own use
• Distribution to dispensary, hospital, or medical institutions being
run by govt or on behalf of govt
• Distribution to dispensary, hospital, or medical institutions
rendering public service and recognised by the govt by notification
in official gazette

Certain acts not considered infringement

Use for government Approval
• Use of patented invention for obtaining govt approval
• For developing and submission of information to govt authority required
under law
• Manufacture, sale, use and importation of patented products and
processes for uses reasonably related to requirements under either
Indian or foreign laws that regulates the manufacture and construction
of the product.

Parallel Imports
• Importation of patented product from another country without patent
holder’s permission
• After legally purchasing from an authorised person in that other country
• Doctrine of patent exhaustion- patent holder loses all rights over patented
product once he sells it to another person
• First sale doctrine
• Exemption will not hold if purchase have been made in a country where
patent protection for the product does not exist

Gillette Defence
• If the patent is not novel at the time of patent filing, such a product or
process would not be infringing
• If X proves that in infringement action that his product forms part of a
publication on or before date of filing of the patent, the product will be
exempt from infringement
• Patent can face risk of revocation

Claims and Claim drafting

Claims Forms and Format
• Placement after specification: the claims should conclude the
specification
• Single sentence: each claim should be of a single sentence
• The claim block should begin, “I/We claim,” or “The invention claimed is,”

Claim Forms and Format
• Numbering and order
•claims should be numbered consecutively
• Numbering during prosecution?
•claims should be ordered with the broadest claim
first, and similar claims should be grouped
together
•a patent claiming both a process and its product
should group the claims to each concept

Claim Forms and Format
• Preamble: Every claim should have an introductory section called a
“preamble” indicating the statutory class of the invention and describing it
as a whole
• shorter preambles are preferred

Preamble Scope
• The preamble should be consistent with the scope of the actual claim, and should
be revised if the claim scope is modified
•it’s important that the preamble match the invention
described in the specification
• For instance if the specification calls for a bicycle, the claim should not specify “vehicle”;
similarly, if the invention is useful on bicycles or motorcycles, the claim should not specify
“bicycle”

Preamble limitations• should not include unnecessary limitations
• a composition having density w and color x, comprising materials y and z”;
• “a composition comprising materials y and z, whereby the composition has density w and
color x”)
• preambles with additional nouns may make the transition ambiguous
• “apparatus for shaking articles comprising…”
• do the following limitations apply to the apparatus or the articles?
• “apparatus for shaking articles, the apparatus comprising…”

Preamble as claim limitation
• Precedent is split as to whether preambles limit the claims
• the general rule is that the preamble is a limitation if it “breathes life and
meaning into the claim”, and is not a limitation if it “simply states the
intended use or purpose of the invention”

Transition term
• The word between the preamble and the claim body materially affects the
claim – two most common transition terms: “comprising” and “consisting
of”
• these terms may be used to describe sub-elements in a claim, and are
similarly interpreted in that context

TransitionTerms: “Comprising”
• This term means “including the following elements but not excluding
others”;
• this is an “open” transition term, allowing,
• synonyms: “including,” “having,” “containing,” and even “wherein”

TransitionTerms: Consisting of
•This term means “including the following elements, no
more and no less”
•synonyms: “composed of,” “constituting,” and “being”
•“consisting of” is always used for Markush groups
•a composition “consisting of” certain elements may
contain trace amounts of other non-functional
elements, but no more than that – however, a
competing product may still infringe if it adds an
element that is non-functional

“Consisting essentially of”
•This is slightly broader version of “consisting of”
allows the addition of elements that do not “affect the
basic and novel characteristics of the invention”
•typically used for compositions of matter, but may
also be used in methods – synonym: “composed of” is
sometimes interpreted with this scope

Claim body
• The body of a claim recites the elements of the claim and describes how they
cooperate structurally, physically, or functionally to form an operative
invention
• the claim language should be technical, not laudatory or surplus
• Claim elements are usually specified as a list, separated by commas or
semicolons

Independent claim design
•Independent claims should recite the invention as
broadly and with as few limitations as possible
•of course, the independent claim should be broader
and less limited than any claim that depends on it
• if the invention has several novel features, several
objectives, or several structural designs that achieve
the same purpose, then multiple independent
claims should be written to cover each aspect

Dependent claims
•A dependent claim includes the whole text and
limitations of the parent claim on which it depends
•the “infringement test” of dependency: the dependent
claim “shall not conceivably be infringed by anything
which would not also infringe the basic claim”
• a dependent claim cannot remove any limitation of
the parent claim
•“the device of claim 1 without element (x)”;

Preambles in dependent claims
• A dependent claim implicitly, if not explicitly, includes the text of the parent
claim
• it’s incorrect to specify an invention in a dependent claim that is broader in
any aspect than its parent claim
• “the apparatus of claim 1, further comprising…”

Claim filing fee
For revised fee structure refer to:
• http://ipindia.nic.in/ipr/patent/patent_FormsFees/Fees.pdf

Reference
http://www.djstein.com/IP/Files/Landis%20on%20Mechanics%20of
%20Patent%20Claim%20Drafting.pdf

Statutory classes
• four main classes of patentable inventions (as per USPTO)
• “machine,”
• “process,” (method)
• “manufacture,” or article of manufacture
• “composition of matter*”
• “combinations” and “improvements” thereof
• *Definition: all compositions of two or more substances and all composite
articles, whether they be the results of chemical union, or of mechanical
mixture, or whether they be gases, fluids, powders or solids.

APPARATUS OR MACHINE CLAIMS

Overview
• “Apparatus” includes machines, devices, electrical circuits,
computer related items, and hydraulics
• essentially, an apparatus is any item containing mechanical and/or
electrical parts that cooperate for a useful purpose

Example
Apparatus for shaking articles, which comprises:
a. a container for the articles;
b. a base;
c. a plurality of parallel legs, each leg connected pivotally
at one end to the container and the other end to the
base to support the container for oscillating movement
with respect to the base; and
d. means for oscillating the container on the legs to shake
the articles

Preamble class
• “apparatus”, or synonyms “machine”, “device”,
• the “device” could have a generic name
• “circuit”, “carburetor”, “lawn sprinkler”, etc.

“Inferential” claiming
• One general rule is that each element should refer only to elements
previously introduced
• an element should not be “inferentially” introduced in a claim featuring
another element as its subject
• if elements A and B are attached, claiming “element A attached to
element B, and element B…..” is wrong
• “element A, and element B attached to element A” is correct

Claim elements
• The broadest independent claims should feature the minimum number of
elements to support patentability
• in the example claim above, the container, base, legs, and oscillating
means are all necessary

Elements of apparatus claims
• An “element” is a structural part of the apparatus
• a “workpiece” or “article” is an item on which an apparatus works, and usually
modifies, but is not a part of the actual apparatus

Parts or features of elements
•Where relevant to functionality, the features of an element
(the size, shape, geometry, construction material, constituent
parts, apertures, orientation, etc.) should be mentioned
•such features should not be described relatively (“thick”), but
with reference to something else (“thicker than element X”)

The Claim language
• active verbs should be avoided
• “element A is connected to element B”
• Reads as an instruction of constructing the apparatus
• “element A connected to element B”
• Reads as a description

Claim support
• All terms and phrases used in the claims must have “clear support or
antecedent basis in the description so that the meaning of the terms in the
claims may be ascertainable by reference to the description”

Drawings• A drawing should be filed with an application if necessary to understand it
• the drawings must show every feature specified in the Claims
• but even where this is the case, the specification should also describe
them, and
• the claims, specification, and drawings should be consistent

Naming elements
•Each element should be given a specific name in the
claim, and should be consistently referenced by that
name throughout the claims and specification
•the exact term chosen is not important, as long as it
fairly captures the function of the element, either in its
ordinary usage or as explicitly defined in the
specification
•“fastening element” is broader than “screw” or “nail”
•two similar elements should be given distinct names,
like “holding means” and “support means”
Or
•“first holding means” and “second holding means”

Claiming embodiments
• Each embodiment that is disclosed must be encompassed in one or more
claims – failing to do so may cause the embodiment to be dedicated to the
public
• What is not claimed is disclaimed

Reference numerals in claims
• A claim may refer to elements shown in drawings by numerals, so long as
the numerals are enclosed by parentheses, and their use has no effect on
the scope of the claim

Antecedent basis
• Every element should be introduced by an article, usually “a” or “an”
• every subsequent reference to a previously-introduced element should be
prefaced “the” or “said”
• For example: “a handle connected to the gear, the handle being axially
aligned with the support member”

Whereby clause
•This clause is used to describe a function, operation, or result
that necessarily follows from the recited structure or
method
•“a container for the articles, having apertured walls, the
apertures of which are smaller in size than the articles to be
shaken, whereby the articles are retained in the container as
they are shaken”

CHEMICAL AND
PHARMACEUTICAL
CLAIMS

Types of Claims
• Product Claims
• “New Chemical Entity” including a molecule or a compound
• Combination
• Compositions
• Process Claims

New Chemical Entity
• A chemical molecule developed in the early discovery stage which later
translates into a drug product is generally referred to as a new chemical
entity.
• Actual molecular structure of the NCE in the claim

Actual Structure Example
• A compound having the formula
X-R,
• Scope of protection rendered by the claim stated in the illustration is
limited to the compound bearing the molecular structure.

Markush Claims
•Markush claims were named after Eugene Markush, the first
inventor to claim.
•"functionally equivalent" chemical entities allowed in one or
more parts of the compound
•"In claims that recite... components of compositions, it is
sometimes important to claim, as alternatives, a group of
constituents that are considered equivalent for the purposes
of the invention.... It has been permissible to claim such an
artificial group, referred to as a 'Markush Group,' ever since
the inventor in the first case... won the right to do so."

Limitation of markush claims
• The elements listed in the group from which a selection is being made
must share a characteristic or property.
• For example, the elements in the group should “belong to a recognized
physical or chemical class or an art-recognized class”

Markush Claim
A compound having the formula
X-R,
wherein R is a radical selected from the group consisting of A, B, C, D, and E,
-the examiner may require a provisional election of a single species, XA, XB,
XC, XD, or XE.

Example
•an alkali metal selected from the group consisting of lithium,
sodium, and potassium
• What the above claim does in one claim, would otherwise take
three claims
• while the group of “alkali metals” is a well-defined group with six
metal comprising the full family
• the sub-group of alkali metals listed in the example have no
proper nomenclature to identify such a sub-group
• the Markush claim, out of necessity, helps to create a generic
name for some sub-group that may otherwise have no well-
defined name

Example
• consider a table as an invention, where a claim is claiming how legs may be
attached to the table.
• In Markush claim language, such a claim might read, “…wherein a fastener
selected from the group consisting of nails, screws, and bolts.”
• Or instead this claim could be addressed with a means for claim of, “a
means for fastening…”

For example
•A “means for” clause works here because
there exists a word to generically describe
the intended function here, i.e. “fastening.”
• Where no such generic word exists, the
Markush claim makes sense

Framing of claim
• “an alkali metal selected from the group consisting of lithium,
sodium, and potassium”
Or
• An alkali metal is lithium, sodium or potassium

Fingerprint claim
•When the exact structure is not known but the
characteristics of the structure is sufficient to
distinguish the compound from existing prior art. e.g.
•What is claimed is
• A chemical entity characterized by molecular weight of 280, having a pH of 6.5,
which has a melting point of 123 degree Celsius and a boiling point of 180 degree
Celsius.

Fingerprint claims
• The difficulty lies in defining the compound in such a way that it can be claimed
unambiguously
• It may well be possible to obtain the compound in pure form and define it in
terms of propertieswhich may be: physical, for example melting-point,
ir/nmr spectrum; crystal form; physico-chemical, such as solubility in various
solvents; chemical, such as its action with various reagents; or biochemical, for
example its effect upon various bacteria.

Product by process claim
• When the product cannot be clearly defined and is best defined by the
process of preparing the same
• They are only allowable if the product is patentable as such, and if the
product cannot be defined in a sufficient manner on its own, i.e. with
reference to its composition, structure or other testable parameters, and
thus without any reference to the process
• does not depend on its method of production

Product-by-process
• A product-by-process claim is a product claim where the product is
defined by its process of manufacture, especially in the chemical and
pharmaceutical industries.
Example :
"Product obtained by the process of claimX,“
"Product made by the steps of . . .," and the like.

Claim formation: example
1. A process for the manufacture of a zeolite which comprises:
• adding a metal oxide that is essentially free of alkali metal to an aqueous solution of
hexamethylenediamine to form a mixture that is essentially free of alkali metal;
• stirring the mixture to form a gel; and
• heating the gel,
• wherein the zeolite is essentially free of alkali metal.
2. A zeolite manufactured by the process of claim 1.

Product by Process Claims
• The protection conferred by product-by-process claims should not be
confused with the protection conferred to products by pure process
claims, when the products are directly obtained by the claimed
process of manufacture.

Omnibus Claim
• Reference is made to the specification
• “a device substantially as shown and described,” or “any and all features of
novelty prescribed, referred to, exemplified, or shown”
• used to be very common; It’s a play safe claiming strategy
• now considered non-statutory for failing to “particularly point out and distinctly
claim” the invention
• Usually not allowed in most jurisdiction

Omnibus Claim Example
• A compound for treating Hemophilia, wherein the compound is substantially
as discussed in the specification.
• A process as claimed in claims 1 to 9 wherein polyamide composite
membrane for reverse osmosis and method of producing the same
substantially as herein described
with references to the examples accompanying this specification.

Chemical Composition or Combination
Claims
• Novel Combination product patents including two or more already known
chemical compounds
• These compounds may be available in the public domain
• But so long as the combination is novel, they can be patented
• A composition claim usually shall include several components both essential
and non essential for the invention

Example
What is claimed is:
1. A shampoo composition comprising
• 25 % of Alkyl ether sulphate;
• 10% of Dimethicone;
• 2% of imidazole and
• 63% water

Example
What is claimed is
1. A shampoo composition comprising 20- 30% of at least one
Surfactant; 5-15% of at least one conditioning agent; 1-3% of
atleast one anti fungal agent and water.
2. The shampoo composition as claimed in claim 1, wherein the
antifungal agent is selected from a group consisting of
pyrazole, imidazole, triazole, tetrazole and pentazole.
3. The shampoo composition in claim 1 wherein said anti
fungal agent is imidazole.

Example
1. A shampoo composition comprising
• 20- 30% of at least one Surfactant;
• 5-15% of at least one conditioning agent;
• 1-3% of atleast one anti fungal agent and
• Water
wherein the antifungal agent is selected from a group consisting of pyrazole,
imidazole, triazole, tetrazole and pentazole.

Process related claims
• A process claim enumerates the step wise process for manufacturing
the compound or formulation
• Steps to be enumerated in the logical order

Antibody and Antibody Kit
Antibody
1. An isolated antibody or fragment thereof comprising the amino
acid sequence of theVH andVL domains of SEQ ID No. 1
Antibody Kit
2. A kit comprising the antibody or fragment thereof of claim 1
or
2. A kit for producing a protein, at least comprising the nucleotide
sequence of claim 1, or a gene expression vector at least
comprising the nucleotide sequence of Claim 1.

Diagnostic methods
• Product
• Process

Product
• A diagnostic kit used for detecting malaria antibodies in a biological sample
comprising of the protein according to claim 3 where the said protein is
brought in contact with the biological sample under appropriate conditions
which allow the formation of an immune complex, wherein said peptide is
labeled with a detectable label.

Diagnosis: Process Claim
A method for in vitro diagnosis of malaria antibodies in
a biological sample, comprising
i. contacting said biological sample with a
composition comprising a protein according to
claim 3 under appropriate conditions which allow
the formation of an immune complex, wherein said
peptide is labeled with a detectable label, and
ii. detecting the presence of said immune complexes
visually or mechanically.

Swiss-type Claims
• Swiss-type claim or "Swiss type of use claim" is a formerly used claim
format intended to cover the first, second or subsequent medical use (or
indication of efficacy) of a known substance or composition.
• Consider a chemical compound which is known generally, and the
compound is known to have a medical use (e.g. in treating headaches). If it
is later found to have a second medical use (such as combatting hair loss),
the discoverer of this property will want to protect that new use by
obtaining a patent for it.
• Use of a substance or composition X for the manufacture of a medicament for
therapeutic application Z,

Exercise: Herbal Preparation
• The medicinal preparation comprises of:
a. Melon Extract (40%)
b. Aloe vera Extract (10%)
c. Saffron (5%)
d. Papaya extract (20%)
e. Water

Herbal Preparation
1. A personal care composition comprising of
a. 20-60% of melon extract
b. 0-10% of moisturizing agent
c. 3-7% of anti oxidative agent
d. 10-30% of cleansing agent and
e. A suitable solvent.
2. The personal care composition claimed in claim 1 where the
cleansing agent is selected from a group consisting of
papaya extract, cucumber extract and strawberry extract.
3. The personal care composition claimed in claim 1 and 2
where the cleansing agent is papaya extract.

Jepson Claims
• Whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new and
useful improvement thereof, may obtain a patent therefor, subject to the
conditions and requirements of this title.”

Claim formation
• A preamble comprising a general description of all the
elements or steps of the claimed combination which are
conventional or known,
•A phrase such as “wherein the improvement
comprises,” and
•Those elements, steps, and/or relationships which
constitute that portion of the claimed combination
which the applicant considers as the new or improved
portion.

Jepson Claims
•These claims are good for differentiating the prior-art
combination and the new elements, thereby avoiding
“old combination” rejections
•Example: In a device comprising A, B, and C somehow
interacting with each other, the improvement
comprising an additional element D somehow
interacting with the basic device.

1. A process of preparing a metal-modified novolac phenolic resin by reacting a
metal compound, an ammonia base and a novolac phenolic resin, the
improvement comprising charging as reactants an oxide of the metal, a
carboxylic acid, an ammonia base and the novolac phenolic resin.
2.The product of the process of Claim 1.

Means-plus-function Claims
•A means-plus-function claim is a claim including a technical
feature expressed in functional terms of the type
"means for converting a digital electric signal into an analog
electric signal".
A variant known as a "step-plus-function" claim style may be
used to describe the steps of a method invention ("step for
converting... step for storing...")
•Means-plus-function claims are governed by the various
statutes and laws of the country or countries in which a patent
application is filed.

Unity of Invention
• unity of invention is a formal administrative requirement that must
be met by a patent application to become a granted patent.
Basically, a patent application can relate only to one invention or a
group of closely related inventions.

Unity of Inventions
•Where a group of inventions is claimed in one and the
same application, the requirement of unity of
invention shall be fulfilled only when there is a
technical relationship (single Inventive concept)
among those inventions involving one or more of the
same or corresponding special technical features

Unity of Inventions
•The expression “special technical features” shall
mean those technical features that define a
contribution which each of the claimed inventions,
considered as a whole, makes over the prior art

Unity of invention
Claim 1: Compound A.
Claim 2: An insecticide composition comprising
compound A and a carrier.
•Unity exists between claims 1 and 2.
•The special technical feature common to all the
claims is compound A.

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