by dr. gopakumar g. nair advisor to pharmexcil, india gopakumar nair associates url: email:...

ByDr. Gopakumar G. NairAdvisor to Pharmexcil, IndiaGopakumar Nair AssociatesUrl: www.gnaipr.netEmail: gopanair@gnaipr.netAhmedabad, 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 Think Away From The From The

BoxBox

7

Patent US7395821

TrademarkMulti-

Haler™

Design No.

211208

Trade SecretKnow-how

Copyright

TM (Amendment) Bill, 2009 passed

by Rajya Sabha on 10th August, 2010

Novel & Inventive

External Appearance

Confidential Informn&

Undisclosed Tech

Package Insert/ Information Leaflet

TRIPSTRIPS

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 27TRIPS – Article 27Patentable Subject Matter1. 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 27TRIPS – Article 27Patentable 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 STEPNon-obvious to a person “Skilled in the

Art”

Must have INDUSTRIAL APPLICATIONMust be UsefulMust 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

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

Non- living 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 PublicationOR

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

Publication after 18 months

Pre Grant Opposition /Representation by any person.

Request for examination

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

Prior art search

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.)

National + Convention Country

National + US + EU

Only PCT

National + PCT

Any or all 142 States

Any or all 142 States

(With permission)

(With permission)

INTELLECTUAL PROPERTY RIGHTS INTELLECTUAL PROPERTY RIGHTS ARE TERRITORIALARE TERRITORIAL

Provisional Application

Complete Application

Convention Application

Application for Patent of Addition (CIP)

Cognate Application

Divisional Application

PCT International Application

PCT National Phase Application

1. Inventive Step & Sec 3

2. Pre & Post grant opposition

3. Revocation through IPAB

4. Counter-claim for revocation in an

infringement suit.

(Balance against unfair monopoly)

COMPULSORY LICENSINGCOMPULSORY LICENSINGGOVERNMENT USEGOVERNMENT USE

RIGHTSExclusive 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.

OBLIGATION/EXEMPTIONS

Disclosure of the inventionExemption 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.

quid pro quo

CBD

CONVENTION ON BIODIVERSITY

UPOV

Plant Varieties Protection Act

Data Exclusivity

GNAs

Sources

Incremental Innovations

Need-based Solutions

Intensive Research

Disruptive inventions

Serendipity

NCE/NME API Product Patent 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)

Famotidine

Tiotidine