Transcript By Dr. Gopakumar G. Nair Advisor to Pharmexcil, India Gopakumar Nair Associates Url: www.gnaipr.net Email: [email protected] Ahmedabad, 24th November, 2010

By
Dr. Gopakumar G. Nair
Advisor to Pharmexcil, India
Gopakumar Nair Associates
Url: www.gnaipr.net
Email: [email protected]
Ahmedabad, 24th November, 2010
Property  Right
INTELLECT – PROPERTY – RIGHT
Idea  Expression  COPYRIGHT
Idea  Innovation  Invention  PATENT
Idea  Quality + Identity  TRADEMARK
Idea  Appearance  DESIGN
Idea  Keep Confidential
No Disclosure
 TRADE SECRETS
Intellectual property (IP) refers to
creations of the mind: inventions,
literary
and
artistic
works,
and
symbols, names, images, and designs
used in commerce.
Creativity is the ability to
 Think / come up with new idea
 design new “inventions”
 produce “works of art”
 solve problems in new ways, or
develop a new idea based on an
“original” knowledge.
 novel, or unconventional approach.
Think Away
From The
Box
Novel &
Inventive
Patent US7395821
Copyright
TM (Amendment)
Bill, 2009 passed
by Rajya Sabha on
10th August, 2010
Trademark
Multi-Haler™
Package Insert/
Information Leaflet
Trade Secret
Know-how
7
External
Appearance
Confidential Informn
&
Undisclosed Tech
Design
No. 211208
TRIPS
The TRIPS (Trade Related Aspects of
Intellectual
Property
Rights)
Agreement came into being with the
establishment of the WTO (World
Trade Organization) effective from 1st
January, 1995.
 UN
organization
dedicated
to
promoting the use and protection of
works of the human spirit.
 Headquarters in Geneva, Switzerland.
 184 nations as member states.
 Manages all IPs.
 Training through Academy and
Seminars
TRIPS – Article 27
Patentable Subject Matter
1.
Subject to the provisions of paragraphs 2 and 3, patents shall be
available for any inventions, whether products or processes, in all
fields of technology, provided that they are new, involve an
inventive step and are capable of industrial application.
[1] Subject to paragraph 4 of Article 65, paragraph 8 of Article 70
and paragraph 3 of this Article, patents shall be available and
patent rights enjoyable without discrimination as to the place of
invention, the field of technology and whether products are
imported or locally produced.
2.
Members may exclude from patentability inventions, the
prevention within their territory of the commercial exploitation of
which is necessary to protect ordre public or morality, including to
protect human, animal or plant life or health or to avoid serious
prejudice to the environment, provided that such exclusion is not
made merely because the exploitation is prohibited by their law.
TRIPS – Article 27
Patentable Subject Matter
3. Members may also exclude from patentability:
(a) diagnostic, therapeutic and surgical methods for the treatment of
humans or animals;
(b) plants and animals other than micro-organisms, and essentially
biological processes for the production of plants or animals other than
non-biological and microbiological processes. However, Members
shall provide for the protection of plant varieties either by patents or
by an effective sui generis system or by any combination thereof. The
provisions of this subparagraph shall be reviewed four years after the
date of entry into force of the WTO Agreement.
[1] For the purposes of this Article, the terms "inventive step" and
"capable of industrial application" may be deemed by a Member to be
synonymous with the terms "non-obvious" and "useful" respectively.
A patent is a protection given to a patentee for
an invention for a limited term by the
government for disclosing the invention
Right to exclude others from using your
invention.
Owner has a qualified right to use the invention
 A conditional grant
 Balance of Rights and Obligations
 Subject to other laws of land
 Granted to owner of invention/assignee
(Recent judgments of HC and SC takes note
of third party interests in granting /
refusing injunctions)
Three Statutory Benchmarks for Patentability
as per the Patents Act, 1970:
1. Novelty
2. Inventive Step (Section 2(1)(ja))
3. Industrial Applicability (Section 2(1)(ac))
An invention can be patented if it is
 NOVEL: Must be New,
Must DISTINGUISH from “State of the Art”
(PRIOR ART)
 Must have INVENTIVE STEP
Non-obvious to a person “Skilled in the Art”
 Must have INDUSTRIAL APPLICATION
Must be Useful
Must have Utility
 Must not be covered by Sec. 3 and Sec. 4.
THE DIFFERENCES BETWEEN THE
CLAIMED INVENTION and the PRIOR ART are
such that the subject matter as a whole WOULD
NOT HAVE BEEN OBVIOUS at the time the
invention was made to a PERSON SKILLED IN
THE ART, to which the subject matter pertains.
Section 2(1)(ja):
"inventive step" 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.
 Be Useful
 Must work / be workable
 At least one recognized, verifiable and
practical end-use
Prior use/ prior publication/ prior disclosure
Industrial applicability
Novelty
Non-obviousness- inventiveness
Sec. 3 - Not patentable
Written description / enablement
requirements
 Application/ specification/ claims
 Patent prosecution
 Maintenance / Defense after grant

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


What is not Patentable
(a) Frivolous, Contrary To Natural Laws
(b) Contrary To Public Order Or Morality,
Prejudice To Human, Animal Or Plant
Life Or Health Or To The Environment;
(c) Mere Discovery Of Scientific Principle,
Abstract Theory, Living Thing Or Nonliving Substances
(d) Mere Discovery Of New Form, New Property,
New Use Of A Known Process, Machine Or
Apparatus (EFFICACY)
What is not Patentable
(e) Mere Admixture (SYNERGY)
(f) Mere Arrangement, Re-arrangement,
Duplication of known devices.
(g) Omitted (Testing Methods)
(h) Method Of Agriculture Or Horticulture;
(i) Method Of Treatment.
(j) Plants, Animals, Including Seeds Varieties,
Species, Biological Processes.
Exception: Microorganisms
What is not Patentable
(k) Mathematical Or Business Method Or A
Computer Program Per Se Or Algorithms;
(l) Literary, Dramatic, Musical Or Artistic Work,
Other Aesthetic Work
(m) Mere Scheme, Rule, Method Of Performing
Mental Act, Playing Game;
(n) A Presentation Of Information;
(o) Topography Of Integrated Circuits;
(p) Traditional Knowledge
When to file :Earliest – as Provisional Application
Could continue working &
file Complete Specification later
To establish Priority Date
- To establish early Ownership
- To Pre-empt Others
- Complete specification to be filed within
12 months of filing Provisional Application
-
 Title
 Technical Field
 Background and Prior Art
 Current Problem / Drawback / Gap
 Solution to the problem/improvement
 Summary of Invention
 Detailed Description
 Experiments/Trials/Examples (incld. Tabular
column if any)
 Claims
 Abstract
1) Optional-Early Publication
OR
18 months publication (automatic)
2) Request for Examination
3) First Examination Report
4) Responses – to & fro
5) Acceptance for Grant OR Rejection
6) Patent Term – 20yrs from date of filing.
Filing of patent application
Early Publication
Prior art search
Publication after 18 months
Request for examination
Pre Grant Opposition /
Representation by any person.
Examination: Grant or Refusal
Publication of Grant of patent
Post Grant Opposition to grant of patent
(Constitution of Opposition Board)
Decision By Controller
 Inventor & Consumer friendly. (Balance of Rights &
Obligations).
 Research & Regulatory Exemption during Patent Life
(Sec 47(3), Sec. 107A(a)).
 Four Patent Offices in four regions (Unique to India).
 IAS - Senior Techno-legal officer appointed as CG.
 Patent Office procedures revamped, revitalized,
digitalized and made transparent.
 Out of box solutions being implemented to expedite
office actions.
 India becoming ISA / IPEA.
Prior Art
State of the Art
Patentability (Novelty & Obviousness)
Patent Validity / Expiration
Legal Status
Infringement Analysis – to Avoid / to Sue
Freedom to Market
Opposition
Potential Partners for Licensing In/ Licensing Out,
Alliances, M&A
 Working Around
 Patent Watch / Monitor Patent
 Patent Family









 Only National Filing
 Only Convention filing (US /EU etc.)
(With permission)
 National + Convention Country
 National + US + EU
 Only PCT
 National + PCT
Any or all 142 States (With permission)
Any or all 142 States
INTELLECTUAL PROPERTY RIGHTS
ARE TERRITORIAL
 Provisional Application
 Complete Application
 Convention Application
 Application for Patent of Addition (CIP)
 Cognate Application
 Divisional Application
 PCT International Application
 PCT National Phase Application
(Balance against unfair monopoly)
1. Inventive Step & Sec 3
2. Pre & Post grant opposition
3. Revocation through IPAB
4. Counter-claim for revocation in an
infringement suit.
COMPULSORY LICENSING
GOVERNMENT USE
RIGHTS
 Exclusive right to make,
use, sell or import the
patented invention.
 Exclude others from
unauthorized use of the
patented invention.
 Grant licenses, Assign
rights or enter into
agreements.
 To sue others for
infringement.
 To surrender patent rights.
quid pro quo
OBLIGATION/EXEMPTIONS
Disclosure of the invention
Exemption for research,
experimentation, imparting
instructions to pupils.
Use of Inventions for Government’s
own purposes or for public services.
Acquisition of Inventions by Central
Government.
Compulsory License / 3rd Party use.
Prohibit or Restriction of
publication of patent information
considered relevant for defense
purposes.
CBD
CONVENTION ON BIODIVERSITY
UPOV
Plant Varieties Protection Act
Data Exclusivity
GNAs
Sources

Incremental Innovations

Need-based Solutions

Intensive Research

Disruptive inventions

Serendipity
Famotidine
NCE/NME
API
Product Patent
Tiotidine
Process Patent
‘Me too’ derivatives – Imatinib, Erlotnib
Formulation
Dosage Forms – Tablet, Capsule, etc
Release Profile – Controlled, Slow etc.
NDDS - Transdermal Patches,
Transmucosal Drug Delivery.
 New Use – Aspirin (analgesic & blood
thinner)
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