Dr. Ravi Dhar & Nikhil Dhar on Intellectual Property. Part I- Understanding Patents in Detail

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Dr. Ravi Dhar & Nikhil Dhar on Intellectual Property Part-I: Patents ([email protected]) ([email protected]) April 19, 2014 RD_ND_Patents_2014 1

Transcript of Dr. Ravi Dhar & Nikhil Dhar on Intellectual Property. Part I- Understanding Patents in Detail

Dr. Ravi Dhar & Nikhil Dhar on Intellectual Property

Part-I: Patents

([email protected]) ([email protected])

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ACKNOWLEDGEMENTS

DBT/ BIRAC/ NII/ US Embassy/ IPO/ USPTO/ EPO/ WIPO/ JPO/

Boston University,USA/ NIH, USA/ MIHR, UK/ Various websites & Journals/ Skyquestt Consulting Pvt. Limited, India/Colleagues

&

(Indian Patent Act: http://www.patentoffice.nic.in/ipr/patent/patAct1970-3-99.html)

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Intellectual Property

• Patents

• Trademarks

• Copyrights

• Protection of Plant Varieties

• Geographical Indicators

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Sections • Definition?

• Specifics of a Patent

• Components of writing a Patent

• What is Novelty?

• What is Non-obviousness?

• What is Utility?

• What is Obviousness?

• What are Claims

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Terms PCT National Phase

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Patents (General)

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What is a Patent?

Legal protection on an act of Intellect (i.e.,

inventions like drugs, vaccines, bio-markers,

medical devices, an industrial designs etc.) that

confers the creator of an invention the sole

right to make, use and sell invention for a set

period of time” Thus it restricts any other person to repeat the effort

unnecessarily.

Innovations may be tangible or intangible

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Legal Protection of Inventions & Business!!

Scientific Investigations

Innovations (Legal protection=Patent)

Product

Industry/ Business

Service to people

Royalties

Pump back some money for investigations

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Reward

Famous Quotes about Innovations

“No one asks you to throw Mozart out of the window. Keep Mozart. Cherish

him. Keep Moses too, and Buddha and Lao Tzu and Christ. Keep them in your

heart. But make room for the others, the coming ones, the ones who are

already scratching on the window-panes”

- Henry Miller (1891-1980) American author.

"I never perfected an invention that I did not think about in terms of the service

it might give others... I find out what the world needs, then I proceed to invent."

- Thomas Edison

"We were young, but we had good advice and good ideas and lots of

enthusiasm"

- Bill Gates, founder of Microsoft Corporation

"Our success has really been based on partnerships from the very beginning.“

- Bill Gates

(Accomodation + Need + Enthusiasm + Partnerships)

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Characteristics of a Patent

Novelty : Something new & non-existent in prior art

(previously existing knowledge)

Non-obvious/

Inventive Step : An idea is non-obvious if it would not be discovered by one of

``ordinary skill in the art'' when the idea was needed

Utility : Usefulness of an invention

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Story of Axel Patent

Revenue generated US $ 700 million

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Functional Definition

“A grant made by government that confers the creator

of an invention the sole right to make, use and sell

invention for a set period of time”

Thus it restricts any other person to repeat the effort

unnecessarily.

Innovations may be tangible or intangible

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“Patent protection does not result in owning the invention by the

inventor but protects, others from repeating the effort which has

already been made”

“ Patent System Adds fuel to interest to the fire of the genius” - Abraham Lincoln

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Patents

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Patents are exclusive property rights for intangible

creations of the human mind

Patents exist only in laws of sovereign states

Patents can be enforced only to the extend that

application has been made

Patents are granted covering the territory of an

individual state

Patent rights are limited in duration

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This could be boring; no variety

Patent : An Open Letter Document

Derived from Latin litterae patentes

An official document by which certain privileges, rights, ranks

or titles were conferred or publicly announced

They carried the seal of sovereign grantor on the inside, rather

than being closed by a seal on the exterior

The openness was in no way connected with disclosure of an

Invention – this happened much later in 1331 onwards for

skilled artisans from abroad.

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Why Patent ?

Avoid Repetitions

Monetary Compulsion

To Inflate Ego

Protect interest of country

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Reasons for Patenting (contd.)

Opportunity to license or sell the invention

Strong market position

Increase in negotiating power

Exclusive rights

Higher returns on investments

Positive image for your enterprise

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Types of Patents

Invention any new technical solution relating to a product, a process or

improvement thereof.

Utility Model any new technical solution relating to the shape, the structure,

or their combination, of a product, which is fit for practical use.

Design any new design of the shape, the pattern or their combination,

or the combination of the color with shape or pattern, of a

product, which creates an aesthetic feeling and is fit for

industrial application.

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Characteristics of Patents

Novelty

Inventive Step (=non-obviousness)

Industrial Application (=utility)

A patent has a life of 20 years

It has to be renewed periodically by payment of money

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Characteristics of Patents (expand)

(Hypothetical)

Novelty : A Flying Car/ A Spray Formulation of Anti-biotic

Inventive Step : No visible blades used for flying/ Absorption of

Antibiotic against rotavirus through skin

Utility : For rapid movement in cities/ Curing Flu

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Patent Related Terminology

Novelty

Prior Art

Non-Obviousness (inventive step)

Utility

Claims & Disclosure

Search

Fee & Annuity

Examination Report

Gazette

Patent document

(Important: go through http://www.stn-international.de/training_center/patents/pat_term.pdf)

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Patent Drafting

• India

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Components in Drafting a Patent

Field of Invention

Background of Invention

Object of Invention/ (Problem-Solution Approach)

Summary of Invention

Detailed Description

Description of Drawings

Experimental Procedures

Results

Claims

Abstract (RD/NII/2008)

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Expansion of the components

Field of Invention = Title

Background of Invention** = Why, how, what is known

Object of Invention = e.g., To develop a efficient pain killer

Summary of Invention = Summary

Detailed Description = Expand

Description of Drawings = On separate sheets

Experimental Procedures = Detailed one

Results = As you discuss in a publication;

mention utility

Claims = Leave this for Attorney

Abstract = Brief Summary

(**Object of Invention as in Indian patents = Disclosure as in USA)

(RD/NII/2008)

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Patents (contd.)

Novelty : Something new & non-existent in prior art

(previously existing knowledge)

Non-obvious/

Inventive Step : An idea is non-obvious if it would not be discovered by one of

``ordinary skill in the art'' when the idea was needed

Utility : Usefulness of an invention

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Definitions:

Novelty : matter described in application has not been

published or discussed before in India or abroad

Inventive Step: the invention is not obvious to a person

skilled in Art in the light of prior publication/knowledge/

document

Utility/ Industrial Application: it should be used in industry

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PRIOR ART

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What can be Prior Art?

Any Publication related to invention

Any material available to public

Oral Disclosure

Hence Filing date of Patent/ Invention is essential

Enablement: A document must enable an average skilled person to

practice the invention claimed

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Prior Art Issues (Take Precautions!!!)

Do not discuss your scientific findings having a technology

component/ invention in a public meeting, in a

pharmaceutical company meet, in press or other electronic

media

In-house presentations within the scientific organization/

NII/THSTI/RCB or places which gives funding e.g., DBT is o.k.

Technology part should be discussed in a non-disclosure

manner/format

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Prior Art Issues

Breadth of Claims

Nature of Invention

State of Prior Art

Level of Skill in Art

Level of Predictability

Amount of Direction/Guidance in Specification

Presence/Absence of Working examples

Quantity of Experimentation Needed or Expected

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Prior Art

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Why search Patent information? Avoid duplication of R&D work

Identify specific new ideas and technical solutions, products or

processes

Identify the state-of-the-art in a specific technological field in order to

be aware of the latest development

Assess and evaluate specific technology and to identify possible

licensors

Identify alternative technology and its sources

Locate of sources of know-how in a specific field of technology or in a

given country

Improvement of an existing product or process

Development of new technical solutions, products or processes

Identify existing or prospective industrial property rights (validity,

ownership, ...), particularly to avoid infringement actions

Assess novelty and patentability of own developments with a view of

applying for a domestic or foreign industrial property right

Monitor activities of competitors both within the country and abroad

Identify a market niche or to discover new trends in technology or

product development at an early stage.

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DIFFERENT TYPES

OF

PATENT SEARCHES

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1. What is the patent search?

2. Kinds of patent search

3. Exercises

4. Key Concepts in searching

• What do we search

• The process of patent search

5. Creating & Refining Search Queries

6. Databases to retrieve the Technology Information

• Patent database

• Non-Patent Databases

7. How to use patent databases

8. Exercise

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What is Patent Search

To retrieve information to answer specific questions

To search and analyze relevant patents in product development step or

Prior to patent application process to make sure the patentability of invention

To get current technology information and future trend of specific technology

area

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Kinds of Patent Search

Patentability Search

Freedom-To-Operate Search

Validity/Invalidity search

State-of-the Art search

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• Is a given invention (claimed in a patent application) patentable?

Patentability Search

• Do patent rights exist on which a given product risks infringing?

Freedom-To-Operate Search

• Is a given patent valid?

Validity/Invalidity Search

• Which technologies exist in a given field of technology?

• Who is active in a given field of technology?

State-of-the Art Search

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Patentability Search/Novelty Search

1. Done to identify patents and non-patent literature

2. Recommended to be done before writing and

filing the patent specification, and therefore,

3. Sometimes called a pre-application search

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A clearance search which concentrates on

uncovering enforceable patents that may act

as “roadblocks” to commercialization of a

product or service

Uses

Guide product design decisions.

Identify patents that may need to be licensed

Freedom-To-Operate Search (FTO)

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Validity/Invalidity Search

1. Search is done to invalid some claims of a particular

patent

2. The search can provide some prior art references that

disclose claims that are infringed by the subject

disclosure

1. Determine the enforceability of patents owned by you

2. Prepare an opposition/invalidity procedure against

others’ patents

3. Prepare a defence against lawsuits claiming

infringement of others’ patents

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State-of-the-Art Search

1. Search is executed in order to determine existing solutions

and potential competitors within a given technological field

2. The search includes not only patent documents but also

non patent literature

1. Plan R&D activities more efficiently

2. Decide whether to enter a market

3. Determine which areas are not sufficiently covered by

existing players

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Concepts in Searching

What we search

Any Relevant Information

In any type and part of

document

From

any place

From

any time period

Technology Information

Patent

Scientific and Technical

information

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Scholarly publications:

• Handbooks, textbooks, encyclopaedias, journals, dissertations,

conference proceedings, technical reports

Industry/trade publications:

• Industry reviews, disclosure publications

Newspapers

Websites

•Technology blogs, researchers’ websites

Scientific and technical information

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Process of Patent Search

Purpose of search

Scope of search Data

Extraction

Selection of keywords

Preparation of search queries

Searching

and

Reviewing

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Constructing a keyword search

What is known about the invention?

Problems to be solved

Solution proposed for this problem

• Features of the solution

• Functions of the solution

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Creating and Refining Search Queries

1. Truncation or Wildcard operators

These type of operators stand for an unspecified number of characters in a queries

Wildcard Meaning Use in Patent

collections

Example

? (Question

Mark)

Represent to exactly

one character

Left, right, and

internal use

supported

“t?re” will pick up

“tyre” and “tire”)

* (Asterisk) Represent to unlimited

number of characters

Left and/or right,

internal

“File*” will pick

up file or files

etc.

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2. Proximity operators

Proximity operators search:

• Based on the distance by number of terms separating two keywords, and

• Also find words in the same paragraph

Operators Meaning Example

SAME Terms must be in the same paragraph, in

any order

ADJ Terms should be next to each other and in

order specified

NEAR Terms should be next to each other and in

any order

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3. Boolean Operators

Major Boolean operators are AND, NOT, and OR which can be used in all collections

Operators Meaning Example

AND Two term must exist

OR Any one term or two terms

must exist

NOT A term following “NOT” must

be excluded

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Databases to retrieve the Technology information

Free Patent databases

US Patent and TradeMark Office (USPTO)

URL: www.uspto.gov

Espacenet

URL: www.ep.espacenet.com

WIPO (World Intellectual Property Organization)

URL: http://patentscope.wipo.int/search/en/search.jsf

Patent Lens

URL: http://www.patentlens.net/patentlens/quick.html

Freepatents online

URL: www.freepatentsonline.com

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For Chemical structure searches

• PubChem

• ChemSpider

For Sequence search

• Patent Lens

• PubMed

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Paid Patent Databases

• Thomson Innovation

URL: https://www.thomsoninnovation.com/login

• Questel Orbit

URL: www.orbit.com

• STN

URL: http://www.stn-international.de/index.php?id=123

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Non-Patent Databases

Google scholar

Scirus

DeLCON

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Obviousness

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Obviousness

• Obviousness, means that “a person having ordinary skill in the art” would not know how to solve the problem at which the invention is directed by using exactly the same mechanism.

• The obviousness standard prevents the patenting of relatively insignificant differences between the invention and the prior art

• The invention must provide one or more new and unexpected (surprising) results

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Obviousness (contd)

• Prior art can be combined in an obviousness determination, that is, more than one reference can be cited by the examiner as showing different features of the invention which, taken together, render the invention obvious

• Obviousness is inherently a subjective determination, as the examiner cannot be, or know the mind of, the hypothetical “one skilled in the art.”

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Non-obvious to Whom? • A patent will NOT be issued if a person having ordinary skill in

the field of the invention would consider the invention obvious at the time of creation

• The law considers a person having ordinary skill in the art to be

a worker in the field of the invention who: – Has ordinary skill – Is totally knowledgeable about all the prior art in his or her

field

• Pure Fantasy, but no other realistic way to determine non-obviousness – The PTO creates a hypothetical person and tries to weigh

the obviousness of the invention against the knowledge this hypothetical person would possess

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Examples of Obviousness** • Non-obvious: Slight Physical Changes – Dramatic Result

– Sometimes, a very slight change in chemical entity, or shape, slope, size, material can produce a patentable invention that operates entirely differently and produces totally unexpected results (e.g., hCG + M.w as anti-cancer vaccine??)

• Non-obvious: New Use Inventions

– Do not involve any physical change to old invention – Must be different use of known product or process and produce new,

unexpected results ( e.g., aspirin which is a pain killer now used as anti-diabetic??)

• Obvious: Different Element, Similar Function

– Courts have held that substituting a different, but similarly functioning, element for one of the elements in a known combination creates a novel invention but an obvious one.

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“If we posed the problem to 100 people skilled in the

art, would all 100 have to come up with the solution

that appears in the patent? Would 90 be enough? 50?

10? 1? More complex --- and quite germane (=related)

to what I regard as a central problem of how patents

are granted and enforced --- is the question of what

happens if the 100 people come up with 10 or 100

different solutions, all or most of which are at least as

good as the patented idea, and yet few, if any are

exactly that idea”.

How obvious is ``obvious''?

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Obviousness

35 U.S.C. § 103 (a)

“A patent may not be obtained though the invention is not

identically disclosed or described as set forth in section 102 of

this title, if the differences between the subject matter

sought to be patented and the prior art are such that

the subject matter as a whole would have been obvious at

the time the invention was made to a person having

ordinary skill in the art to which the said subject matter

pertains”

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Non-obviousness : The Relevant Prior Art

Two classes of Prior Art for Non-obviousness

•Common general knowledge

•Enhanced knowledge

•Hidden or imputed knowledge

•Prior application

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Issues on Obviousness

[Nature September 2009 “Obvious to whom?

Issue of non-coated tablet]

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The approach consists in:

identifying the closest prior art, the most relevant prior art;

determining the objective technical problem, that is,

determining, in the view of the closest prior art, the technical

problem which the claimed invention addresses and

successfully solves; and

examining whether or not the claimed solution to the objective

technical problem is obvious for the skilled person in view of

the state of the art in general.

CLAIMS

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Claims Claims are the parts of a patent which define the

boundaries (2,3,4) of patent protection

Patent claims are the legal basis for patent

protection

They form a protective boundary line around your

patent that lets others know when they are infringing

on your rights

The limits of this line are defined by the words and

phrasing of your claims

1

3

4

2

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Claims

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(*Pwil-2 Protein widely expressed in tumors)

*

Claims

Scope of claim:

Each claim should have only one meaning which can be either

broad or narrow, but not both at the same time.

In general a narrow claim specifies more details than a broader

claim.

Having many claims, where each one is a different scope allows

you to have legal title to several aspects of your invention.

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Claims

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Characteristics of Claims Be Clear

Your claim must be clear so that you do not cause the reader to

speculate about the claim. If you find yourself using words such as

"thin", "strong", "a major part", "such as", "when required", then you

are probably not being clear enough. These words force the reader

to make a subjective judgment, not an objective observation.

Be Complete

Each claim should be complete, so that it covers the inventive

feature and enough elements around it to put the invention in the

proper context.

Be Supported

The claims have to be supported by the description. This means that

all the characteristics of your invention that form part of the claims

must be fully explained in the description. In addition, any terms you

use in the claims must be either found in the description or clearly

inferred from the description.

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Structure of Claims (1) A claim is a single sentence composed of three parts:-

the introductory phrase

the body of the claim

and the link that joins the two

The introductory phrase identifies the category of the invention and

sometimes the purpose for example, a machine for waxing paper, or a

drug composition.

(2) The body of the claim is the specific legal description of the exact

invention which is being protected.

The linking consists of words and phrases such as:

which comprises

including

consisting of

consisting essentially of Note that the linking word or phrase describes how the body of the claim relates to the

introductory phrase. The linking words are also important in assessing the scope of the claim

as they can be restrictive or permissive in nature.

Example, "A drug injecting device" is the introductory phrase, "comprising" is

the linking word, and the rest of the claim is the body.

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Classification

WIPO International Patent Classification has eight sections:

• SECTION A – HUMAN NECESSITIES

• SECTION B – PERFORMING OPERATIONS; TRANSPORTING

• SECTION C – CHEMISTRY; METALLURGY

• SECTION D – TEXTILES; PAPER

• SECTION E – FIXED CONSTRUCTIONS

• SECTION F – MECHANICAL ENGINEERING; LIGHTING; HEATING;

WEAPONS; BLASTING

• SECTION G – PHYSICS

• SECTION H – ELECTRICITY

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Patent Search/Prior Art Search

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Patent Search Strategy

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Free On-line Patent Databases

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Charged on-line databases

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General Search for Beginners

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Advanced Search

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Search Results

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Clustering

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Patent Families

Each patent issuing authority/country may have

different regulations for the same patent filed

elsewhere

A group of patent equivalents make up a patent

family

Members of closely related patent family have

common priority number & date

The online database will have a single record only

(http://www.stn-international.de/training_center/ patents/patentfamily.pdf)

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“Basic Patent” The first family member identified for abstracting & indexing into database It has no legal meaning The basic for one-database producer may not be basic for another producer

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Patent Family & Timeline

US

Application

PRIORITY

JP

Application

Patent Family

GB

Application

GB

Granted Patent

US

Application

(Pre-grant)

US

Granted

Patent

JP

Application

GB

Application

0 ?? 18 12

Priority

filing

Additional

filings Published applications Published granted patents

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Patent Family- (contd.)

Complexity arises due to:-

a) Divisional applications: if results are too broad for

the patent, and it is split

into one or more to claim

different inventions

b) Continuation : results from second or subsequent

application being filed while the

original one is pending

c) Continuation-in-part : a result of second or subsequent

application being filed, which

includes new material, while the

original is pending

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Terminology Application A document consisting of the specification of the invention and an oath in which the inventor declares that he believes himself to be the original and first inventor of the subject matter in the application Claims Brief descriptions, in legal terms, of the subject matter which the applicant regards as his invention Continuation In the U.S., a later application claiming the same invention filed while the original application is pending. The original filing date is used for determination of prior art Continuation-in-part In the U.S., a second application for the same invention, usually to introduce improvements not covered in the original application. The original filing date is used for prior art

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Terminologies Defensive Publication Publication of the details of an invention in the Official Gazette or in the other publications to prevent others from obtaining a patent on the invention. Design patent A type of patent issued in the U.S. for inventive designs of a purely ornamental or aesthetic nature. Designated states In application filed at the European Patent Office or the World Intellectual Property Organization, the courtiers in which the invention will be protected. Division In the U.S., an additional application derived from an earlier application that claims two or more inventions, as determined by the patent examiner. The original date is used for determination of prior art.

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Terminologies (contd)

Equivalents All the patent publication within a patent family relating to a specific invention. Granted patent A legal document giving an inventor the right to exclude others from making, using, or selling the invention according to the laws governing patents in a country. Kind codes Codes indicating the stage of the published patent document, e.g., unexamined application, examined application, granted patent.

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Terminologies (contd)

Patent family

What was previously known in a given area of technology that lead to

the development of an invention.

Priority application

The application with the earliest date, when an inventor files for a

patent in more than one country.

Reassignment

The assignee transfers ownership of patent right to another party.

Reissued patent In the U.S., the result of an application by the patent owner to make corrections in the specifications or claims of the patent. A new patent

number is assigned, but the original expiration date is maintained.

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Terminologies (contd)

Unexamined application

In some countries, the first publication level for a patent

document in which application has not undergone full

examination for novelty and non-obviousness.

Utility model

In Japan and Germany legal protection for minor

inventions that do not necessarily meet the novelty or

non-obviousness criteria of regular patents.

April 19, 2014 RD_ND_Patents_2014 115

Patent Specifications

They are dynamic documents and often modified to

meet requirements of each jurisdiction (=country or

area)

This could disentitle an inventor his/her specific

contribution e.g., method of medical treatment claims

is valid in the USA but not in India or Europe or New

Zealand

April 19, 2014 RD_ND_Patents_2014 116

April 19, 2014 RD_ND_Patents_2014 117

Patent Rules

Patent Reforms Act – 2007 (U.S.A.)

On April 18, 2007, bipartisan legislators in both the Senate and House of

Representatives introduced sweeping patent reform measures in legislation

termed the Patent Reform Act of 2007. The reform measures include

modifying some of the following provisions:

First-to-file rights and elimination of interference proceedings;

Reform to make it easier to file a patent application without the inventor's

cooperation;

Limitation of damages to only the economic value of the improvement as

compared to the prior-art;

Specific limitations on when damages may be trebled for willfulness;

Post-grant opposition proceedings with a reduction in the litigation

estoppel (A bar preventing one from making allegations or a denial that contradicts what one has

previously stated as truth) effect;

Limitations on patent venue;

Authority to the PTO director to create further regulations.

Although couched in terms of the importance of patents and patent

quality. The thrust of many of the measures are clearly directed at

"limiting litigation abuses." Although a detailed analysis has not been

completed, the two versions appear virtually identical.

April 19, 2014 RD_ND_Patents_2014 118

5/25 of USA : A New Patent Rule

“First to invent System”

USPTO:

New Patent Application can have 5 independent claims &

25 total claims (effective date November 1, 2007) {on hold ?}

This rule is being slapped to improve quality of Patents

USPTO believes that many applicants abuse current

examination process by filing too many applications with

related inventions

April 19, 2014 RD_ND_Patents_2014 119

Why search patent information? Avoid duplication of R&D work

Identify specific new ideas and technical solutions, products or

processes

Identify the state-of-the-art in a specific technological field in order to

be aware of the latest development

Assess and evaluate specific technology and to identify possible

licensors

Identify alternative technology and its sources

Locate of sources of know-how in a specific field of technology or in a

given country

Improvement of an existing product or process

Development of new technical solutions, products or processes

Identify existing or prospective industrial property rights (validity,

ownership, ...), particularly to avoid infringement actions

Assess novelty and patentability of own developments with a view of

applying for a domestic or foreign industrial property right

Monitor activities of competitors both within the country and abroad

Identify a market niche or to discover new trends in technology or

product development at an early stage.

April 19, 2014 RD_ND_Patents_2014 120

Who are the main user groups of patent

information?

Industry, and in particular R&D intensive industry

Research and development institutions

Governmental authorities

Small and medium-size enterprises

Individual inventors

Professionals in the field of industrial property, e.g.,

administrators of technical libraries, patent agents, researchers,

producers of data banks

Educational institutions and university students

April 19, 2014 RD_ND_Patents_2014 121

What is the scope of ``an art''?

(Sort of background of an invention; example Computer Application)

“All computer science? A topic roughly equivalent to one course

at the undergraduate level? The subject of a PhD thesis? One

important criterion is that we must consider people actually

practicing the art, not those thinking about the art. Thus, an

academic researcher may not be a good, or even acceptable,

model for a person of ordinary skill in the art. Apparently, a better

model would be a person with a BS degree in Computer Science

who writes code for a living. In some cases, e.g., a patent

involving locking algorithms for database systems, we might

take the proper model to be someone who had had an

appropriate MS-level course, database systems in this example”.

April 19, 2014 RD_ND_Patents_2014 122

Explanation of scope of art

http://www.iusmentis.com/patents/claims

April 19, 2014 RD_ND_Patents_2014 123

Patent Application Information Retrieval

(PAIR) A system that displays information regarding patent

application status. There is both a Public and Private side to PAIR. “ Public PAIR ” only displays issued or published

application status.

To access Public PAIR, you need only have a patent, application, or publication number that you wish to

search.

“Private PAIR” is the Patent Application Information Retrieval

system developed to provide secure access for customers who want

to view current patent application status electronically via the

Internet. Private PAIR provides secure real-time access to pending application status

and history using digital certificates issued from the USPTO's Public Key Infrastructure.

To access Private PAIR, you must be a registered patent

attorney/agent, an Independent Inventor, or a person granted limited

recognition, have a customer number, have a digital PKI certificate to secure the transmission of the application to the USPTO.

April 19, 2014 RD_ND_Patents_2014 124

What is PAIR (SOPs) #Date Content description3205-14-2001Mail Notice of Allowance3105-14-

2001Notice of Allowance Data Verification Completed3005-14-2001Notice of

Allowability2910-06-2000Case Docketed to Examiner in GAU2809-27-2000Mail

BPAI Decision on Appeal - Reversed2709-27-2000BPAI Decision - Examiner

Reversed2610-25-1999Mail Miscellaneous Communication to Applicant2510-25-

1999Miscellaneous Communication to Applicant - No Action Count2407-16-

1999Remand to the Examiner by BPAI2302-21-1997Mail Reply Brief Noted by

Examiner2202-21-1997Reply Brief Noted by Examiner2112-26-1996Date

Forwarded to Examiner2012-18-1996Reply Brief Filed1911-13-1996Mail

Examiner's Answer1810-28-1996Examiner's Answer to Appeal Brief1707-17-

1996Date Forwarded to Examiner1607-12-1996Appeal Brief Filed1507-12-

1996Request for Extension of Time - Granted1404-15-1996Notice of Appeal

Filed1303-27-1996Mail Advisory Action (PTOL - 303)1203-26-1996Advisory

Action (PTOL-303)1103-13-1996Date Forwarded to Examiner1003-11-

1996Amendment after Final Rejection901-16-1996Mail Final Rejection (PTOL -

326)801-11-1996Final Rejection710-19-1995Date Forwarded to Examiner609-22-

1995Response after Non-Final Action509-22-1995Request for Extension of Time

- Granted404-20-1995Mail Non-Final Rejection304-03-1995Non-Final

Rejection202-03-1995Case Docketed to Examiner in GAU101-26-1995Application

Captured on Microfilm

April 19, 2014 RD_ND_Patents_2014 125

Events • Amendment

• Non-final rejection

• Final rejection

• Appeal brief

• Appeal to the Board of Patent Appeals and Interferences (BPAI)

April 19, 2014 RD_ND_Patents_2014 126

Example : A Method for Diagnosing Cancer

Bibliographic data Description Claims Mosaics Original Document INPADOC legal status

Publication number :WO2006066826 (A1)(patent of invention)

Publication date :2006-06-29

Inventor(s) :NAYERNIA KARIM [DE];ENGEL WOLFGANG [DE]

Applicant(s) :GEORG AUGUST UNI GOETTINGEN [DE];

NAYERNIA KARIM [DE];ENGEL WOLFGANG [DE]

Classification: - international: C12Q1/68; C12Q1/68;

Application number : WO2005EP13600 20051216 2006-06-29

Priority number(s) :EP20040030123 20041220

(Source: esp@cenet database — WIPO - esp@cenet)

April 19, 2014 RD_ND_Patents_2014 127

April 19, 2014 RD_ND_Patents_2014 128

Claims

April 19, 2014 RD_ND_Patents_2014 129

(*Pwil-2 Protein widely expressed in tumors)

*

April 19, 2014 RD_ND_Patents_2014 130

(Based on Indian Application: 466/DEL/IN of 2/3/2005: “Novel Nucleotide Sequences”)

Search Report

“Patent protection does not result in owning the invention by the

inventor but protects, others from repeating the effort which has

already been made”

“ Patent System Adds fuel to interest to the fire of the genius” - Abraham Lincoln

April 19, 2014 RD_ND_Patents_2014 131

Gene Patenting

April 19, 2014 RD_ND_Patents_2014 132

Gene Patenting

View # 1 on Claims (In Favour):

Gene is DNA of Defined and Specific Function

Gene is Isolated due to Human Technical Intervention

Hence a Gene should be Afforded Legal Protection (US Code Section 35 (100-101)

View # 2 on Claims (In Opposition):

Genes are discoveries and not inventions and should not

be owned by any individual or organization

Genes are discoveries & not inventions & hence not new

Gene isolation and cloning is well established and a person

skilled in art can fish it out.

April 19, 2014 RD_ND_Patents_2014 133

April 19, 2014 RD_ND_Patents_2014 134

??

Under New Laws; gene patenting now

requires mention of utility as a very

Important attribute

April 19, 2014 RD_ND_Patents_2014 135

Players who Generate Patents

Key Players in Patenting

Inventors / PIs/ Scientists / An individual-s

An Organization/s where the inventor works

Funding agency

The Patent Office

April 19, 2014 RD_ND_Patents_2014 136

Patent Office

Sell Technology/ Technology Transfer

Inventor/ PI

Upscale Technology

Funding Agency

Organization

Commercialize the

product

Earn Royalty

Share Royalty

April 19, 2014 RD_ND_Patents_2014 137

**

April 19, 2014 RD_ND_Patents_2014 138

Historical

Thomas Jefferson,U.S. Patent Act of 1793 & Firsts in Patenting! Thomas Jefferson was the first Patent Examiner

In 1790, the cost to obtain a patent was between $4 and $5.

The first U.S. patent was granted on July 31, 1790, to Samuel Hopkins of Pittsford, for an

improvement in "the making of Pot ash and Pearl ash by a new Apparatus and Process."

Mary Kies of Killingly, Conn., was the first women to obtain a patent. In 1809 she received

a patent for a way to weave "straw with silk or thread."

Chester Carlson was a patent agent who tired of having to make multiple copies of patent

applications using the only duplication method available at the time: carbon paper. In

1959 he came up with a new copying system and took it to IBM for evaluation. The

"experts" at IBM determined potential sales to be only 5,000 units because people

wouldn’t want to use a bulky machine when they had carbon paper. Carlson’s invention

was the xerography process, the company founded on the system is Xerox.

Abraham Lincoln, congressman from Illinois, received Patent No. 6,469 for "A Device for

Buoying Vessels over Shoals." The idea of the invention was that if a ship ran aground in

shallow waters, the bellows would be filled with air, and the vessel, thus buoyed, would

float clear. The model Lincoln whittled can be seen at the Smithsonian's National Museum

in Washington.

Mark Twain (Samuel L. Clemens) received Patent No. 121,992 for "An Improvement in

Adjustable and Detachable Straps for Garments." He later received two more patents:

one for a self-pasting scrapbook and one for a game to help players remember important

historical dates.

April 19, 2014 RD_ND_Patents_2014 139

First Patent on Genetically Modified Organism

DIAMOND v. CHAKRABARTY,

447 U.S. 303 (1980)

DIAMOND, COMMISSIONER OF PATENTS AND TRADEMARKS

versus

CHAKRABARTY.

CERTIORARI TO THE U.S. COURT OF CUSTOMS AND PATENT APPEALS.

No. 79-136.

Argued March 17, 1980.

Decided June 16, 1980.

(Respondent filed a patent application relating to his invention of a human-made, genetically

engineered bacterium capable of breaking down crude oil, a property which is possessed by

no naturally occurring bacteria)

April 19, 2014 RD_ND_Patents_2014 140

Patent Laws

Each country has it’s own set of laws

April 19, 2014 RD_ND_Patents_2014 141

Compulsions for framing laws

a) Domestic/ Regional (political or otherwise)

b) International Obligations : International pulls & pressures (TRIPs)

c) Financial/ Regional/ local etc

April 19, 2014 RD_ND_Patents_2014 142

What is Patentable ?

USA : “Anything under the Sun” “First to invent”

Europe : Discoveries, scientific theories & math. Models, aesthetic

creations, presentation of information, inventions contrary to “order

public” & those contrary to morality, plant & animal varieties,

production of plants and animals

India : Go to (http://www.patentoffice.nic.in/ipr/patent/patents_filing.pdf)

[Note: EPO, Japan, India “ First to File”]

April 19, 2014 RD_ND_Patents_2014 143

What is not Patentable in India !

Frivolous claims contrary to well-established natural laws

Anything contrary to law or morality, or injurious to public

health

Mere arrangement or rearrangement or duplication of known

devices, each functioning independently of one another in a

known way

A method or process of testing the process of manufacture

for rendering the machine, apparatus or other equipment more

efficient or for the improvement or restoration of the existing

machine, apparatus or other equipment or for the improvement

or control of manufacture

A method of agriculture or horticulture

April 19, 2014 RD_ND_Patents_2014 144

What is not Patentable in India? (contd.)

Inventions related to atomic energy

Computer software

Aesthetic creations

Discoveries, scientific theories, mathematical methods

Schemes, rules or methods for performing mental acts playing

games or doing business (business methods)

Presentation of information

Methods of treating humans or animals through surgery, or

therapeutical diagnostics

Animals and plants, and biological methods for rearing/growing

them (however, microorganism is patentable in India)

Products made by chemical synthesis foods, medicines

Process patents for drugs (reverse engineering) but when novel,

permitted

April 19, 2014 RD_ND_Patents_2014 145

Controversial Cases on Patents in India?

Case Study:

Initiatives for Medicine, Access & Knowledge (I-MAK)(A US Based

Non-Profit Organization)

Vs

Abbott Laboratories, U.K.

“Heat Stable forms of a medicine named Aluvia, in Tablet form

(formulation of Kaletra : an HIV Drug-pre; 1995 Drug) should not

be Patented as per pre-1995 Indian Patent Laws according to

Section 3 (d)” [Article 3 (d) allows serious modifications but not the frivolous ones]

(TOI: 25/08/2007)

April 19, 2014 RD_ND_Patents_2014 146

Controversial Cases on Patents in

Australian Patent Office? 2008: Australia's patent office admitted to being "uncomfortable" about

granting a patent to a group from Seoul National University Industry Foundation

that includes the disgraced researcher Woo-Suk Hwang as one of the inventors.

The patent application is for a stem cell line, which the group of 18

researchers claimed was produced by a procedure known as somatic cell nuclear

transfer but has since been revealed to have been created by parthenogenesis (the

development of an embryo in the absence of fertilization).

Although the application made false claims about the method used to

create the stem cell line, this did not alter the status of the product: "it is generally

accepted that the line of stem cells exists and is a new invention. But it is now

generally accepted that they were not derived by somatic cell nuclear transfer but

by another process called parthenogenesis."

"The Patents Act requires IP Australia to be satisfied that there is an

invention [...] that [has] not been discovered before. The new line of stem cells is

such an invention."

Nature Medicine: 14(12), December, 2008 April 19, 2014 RD_ND_Patents_2014 147

April 19, 2014 RD_ND_Patents_2014 148

Some Statistics

April 19, 2014 RD_ND_Patents_2014 149

http://www.wipo.int/ipstats/en/wipi/index.html

http://www.wipo.int/export/sites/www/ipstats/e

n/wipi/pdf/941_2011_section_a.pdf

April 19, 2014 RD_ND_Patents_2014 150

Share of Patent Offices in total patent

applications (Source: WIPO Statistics Database, October 2011)

(1995)

United States of America : 21.8%; China : 1.8%

Japan : 35.2%; Korea : 7.5%

European Patent Office : 5.8%; Others : 28.0%

(2010)

United States of America : 24.8%; China : 19.8%

Japan : 17.4%; Korea : 8.6%

European Patent Office : 7.6%; Others : 21.8%

April 19, 2014 RD_ND_Patents_2014 151

Application data availability IP type Estimated world totals based on Data available for Data coverage

Patents 135 offices 88 offices 97%

Utility models 60 offices 46 offices 99%

Trademarks 169 offices 115 offices 87%

Industrial designs 130 offices 104 offices 96%

Information about Patent Offices Worldwide (RD: 12/11/2012)

(Worldwide 7.3 million patents)

Country/ region # Employees # of Patent

Examiners

Total filings

in 2004

Total filings

in 2010

Remarks

EPO$ 6500 3500 181000 1,30,000 Heavy backlog

USPTO$ 7300 3000 250000 5,00,000 Heavy backlog

JPO$$ (Japan) 2651 1358 400000 3,50,000 Very slow in

assessment

SIPO$$S, * (China) 4400 2000 100000 3,80,000 Joined IPR regime

recently; gearing up

KIPO* (Korea) 1517 728 160000 1,50,000 No backlog; outsource

jobs

IPO$$$$, * (India) 200 135 17500 40,000 Heavy backlog; Need

more staff;

modernized

Latin America ? ? ? ? Setting up with help

of EPO

Africa Setting up with help

of EPO

Note : Trilateral Offices being planned between China, Korea & India

April 19, 2014 RD_ND_Patents_2014 152

Patents in Force World Wide as in 2010

EPO : 8.3%

USA : 32%

Japan : 22%

China : 24%

Korea : 9.6%

India : 2.5%

April 19, 2014 RD_ND_Patents_2014 153

[Title “Chimeric gene constructs for generation of

fluorescent transgenic ornamental fish”:

US Patent Application No. :

20040143864 dated July 22, 2004]

GloFish®™

International Patent Filings – 2008-2013

S. No. Country Patent Filed - 2008

1. Japan 28,774

2. Germany 18,428

3. Republic of Korea 7,908

4. France 6,867

5. China 6,089

6. United Kingdom 5,517

7 Netherlands 4,349

8. Sweden 4,114

9. Switzerland 3,832

10. Canada 2,966

11. Italy 2,939

12. Finland 2,119

13. Australia 2,028

14. Israel 1,882

15 Republic of Korea 7,908

16. India 766

17. Singapore 578

18. Brazil 451

19. South Africa 382

20. Turkey 367

21. Mexico 210

22. Malaysia 177

April 19, 2014 RD_ND_Patents_2014 154

Patents in Force in India

Action 1999-2000 2002-03 2004-05 2005-06 2006-07

Application

filed 4824 11,466 17,466 24,415 28,882

Application

Examined 2824 9538 14,813 11,569 14,119

Patents

Granted 1881 1379 1911 4320 7359

April 19, 2014 RD_ND_Patents_2014 155

(Source: Indian Patent Office)

Indian Patent Office as International

Search Authority

The Indian Patent Office has now designated as the

International Searching Authority (ISA) and International

Preliminary Examining Authority (IPEA) by the World

Intellectual Property Organization (WIPO) which consists of

more than 170 member countries.

The recognition of India as an ISA and IPEA puts India in a

coveted league of only 15 nations and organizations currently

recognized at a global level.

April 19, 2014 RD_ND_Patents_2014 156

April 19, 2014 RD_ND_Patents_2014 157

Please see World IP Today:-

http://science.thomsonreuters.com/press/pdf/tl/WIPTPatent07.pdf

April 19, 2014 RD_ND_Patents_2014 158

April 19, 2014 RD_ND_Patents_2014 159

Source : WIPO

April 19, 2014 RD_ND_Patents_2014 160

April 19, 2014 RD_ND_Patents_2014 161

April 19, 2014 RD_ND_Patents_2014 162

GM Crops

Drugs Going Off Patent Regime

April 19, 2014 RD_ND_Patents_2014 163

Total : US $ 10 b

(http://mediwire.skyscape.com/main/Default.aspx?P=Content&ArticleID=317333)

April 19, 2014 RD_ND_Patents_2014 164

(http://mediwire.skyscape.com/main/Default.aspx?P=Content&ArticleID=317333)

Total: US $ 9.7 billion

Number of drugs with patents expiring in 2000-04 (Grouped by treatment category)

Treatment category 2000 2001 2002 2003

1. Cancer and cancer related treatments 5 6 4 2

2. Anti-infective treatments 2 6 2 3

3. Central nervous system treatments 6 2 2 5

4. Cardiovascular/cerebro-vascular

treatments 13 13 6 17

5. Respiratory treatments 5 3 4 5

6. Endocrine, nutritional,

metabolic and immunity treatments 3 2 2 3

7. Topical treatments 5 1 3 7

8. Hormonal treatments 1 4 1 5

9. Musculo-skeletal and

connective tissue treatments 1 0 1 0

10. AIDS and AIDS related treatments 2 2 0 1

11. Analgesic treatments 1 5 5 1

12. Digestive system treatments 5 1 5 0

13. Blood disorder treatments http://www.biospectrumindia.com/content/BioBsiness/10511112.asp

0 0 0 0

April 19, 2014 RD_ND_Patents_2014 165

Mode of Drug Action

April 19, 2014 RD_ND_Patents_2014 166

Certain drugs work by interacting with receptors, special sites on the surface of body cells.

Drugs may bind to a specific receptor, possibly preventing naturally occurring chemicals

from binding to the receptor. In so doing, if a drug enhances cell activity, it is called an

agonist; if it blocks cell activity, it is called an antagonist.

Sale of Pharmaceutical Products for Lifestyle

Diseases in India (Jan-Dec 2007)

S.

No.

Segment Value in

Rs. Crore

%growth in

value

% growth

in volume

1. Cough & Cold 1020.23 5.78 2.13

2. Diabetes 437.73 39.33 27.75

3. Cardio-Vascular

(cholesterol lowering drugs)

304.19 35.09 31.25

4. Cefixime Oral Sol

(anti-infective)

295.10 9.46 9.19

5. Cephalo Comb Injection (surgery) 286.23 36.46 35.44

6. Conv. Iron Liquid 284.73 9.11 7.19

7. Ciprofloxacin Oral Solids (strong anti-

biotic)

274.50 -2.14 -3.24

8. Calcium Oral Solids 262.41 16.73 10.49

9. Diclo.comb.oral Solid (pain killer) 231.72 11.08 10.67

(Total : Rs. 3396.84 )

(Source: ORG; TOI – 17.03.2008) April 19, 2014 RD_ND_Patents_2014 167

Drug Price Competition and Patent

Term Restoration Act (U.S.A.)

Statutory and Regulatory Citations

The patent term restoration statute can be found at 35 U.S.C.ß 156

et seq. PTO published its regulations on March 24, 1987. These

regulations can be found at 37 C.F.R. Part 1. FDA published its

regulations on March 7, 1988. These regulations can be found at 21

C.F.R. Part 60. FDA published a Memorandum of Understanding

governing information exchanges and cooperation between the two

agencies in the May 12, 1987 Federal Register (52 Fed. Reg. 17,830).

April 19, 2014 RD_ND_Patents_2014 168

Gazette of India: Patents

= Federal Register in USA

April 19, 2014 RD_ND_Patents_2014 169

Ever-greening of Patents

April 19, 2014 RD_ND_Patents_2014 170

Drug Price Competition and Patent

Term Restoration Act (U.S.A.) Eligibility Assistance on Applications

To obtain patent term extension, an application must satisfy certain eligibility

criteria, including:

(1) the patent has not expired, (2) the patent has never been extended, (3) the

application is submitted by the patent owner or its agent, (4) the product has

been subject to a regulatory review period with FDA or USDA before its

commercial marketing or use, and (5) the permission for commercial marketing

or use represents the first permitted commercial marketing or use of the

product under the provision of law under which the regulatory review occurred

(but for products produced using recombinant DNA technology, excluding

animal drug products, the product can be the first permitted commercial

marketing or use of a product produced under that technology), or if the

product is a veterinary drug product, the product cannot be claimed in any

other patent which has been extended and, if previously approved for use in

non-food producing animals, must not have received patent term extension for

that use.

April 19, 2014 RD_ND_Patents_2014 171

Ever greening of Patents

“Evergreening, in one common form, occurs when the brand-

name manufacturer literally “stockpiles” patent protection by

obtaining separate 20-year patents on multiple attributes of a

single product. These patents can cover everything from

aspects of the manufacturing process to tablet color, or even a

chemical produced by the body when the drug is ingested and

metabolized by the patient”

Primary uses

Processes and intermediates

Bulk forms

Simple formulations

Composition of matter

April 19, 2014 RD_ND_Patents_2014 172

Ever greening of Patents (contd.)

Expansive numbers of uses

Methods of treatment

Mechanism of action

Packaging

Delivery profiles

Dosing regimen

Dosing range

Dosing route

Combinations

Screening Methods

Chemistry Methods

Biological Target

Field of use

April 19, 2014 RD_ND_Patents_2014 173

Patent Landscaping

April 19, 2014 RD_ND_Patents_2014 174

Patent Landscaping

April 19, 2014 RD_ND_Patents_2014 175

Freedom-to-operate search (FTO)

April 19, 2014 176 RD_ND_Patents_2014

Freedom-To-Operate Search (FTO)

A clearance search which concentrates on

uncovering enforceable patents that may act

as “roadblocks” to commercialization of a

product or service

Uses

Guide product design decisions.

Identify patents that may need to be licensed

April 19, 2014 177 RD_ND_Patents_2014

WHAT WE

SEARCH FOR

FTO

Existing claims of patents

currently in force (existing

“active” claims)

Subject matter that may appear

in claims of patents entering (or

re-entering) into force in the

future (future “active” claims)

April 19, 2014 178 RD_ND_Patents_2014

WHERE WE

SEARCH FOR

FUTURE ACTIVE

CLAIMS

Document Types

• Claims in patent applications

• Claims in patents lapsed or withdrawn reinstatement

• Description in patent applications amended claims

• Description in patents amended claims

April 19, 2014 179 RD_ND_Patents_2014

Remember

IP rights are specific to

different jurisdictions, a

FTO analysis should

relate to particular

countries or regions

where you want to

operate

April 19, 2014 180 RD_ND_Patents_2014

STRATEGIES

FOR

OBTAINING

FREEDOM TO OPERATE

(FTO)

April 19, 2014 181 RD_ND_Patents_2014

In-licensing

• Taking a written authorization from the patent holder to use the

patented technology for specified period of time in a specified

markets

Cross-licensing

• When two companies exchange licenses in order to be able to

use certain patents owned by the other party.

Inventing around

• Guiding research or making changes to the product or process to

avoid infringement on the patent(s) owned by others

Patent pools

• Where two or more companies practicing related technologies put

their patents in a pool to establish a clearinghouse for patent rights

April 19, 2014 182 RD_ND_Patents_2014

Patent Landscaping Process (1)

Patent landscapes are used to:

Gain competitive insight

Identify gaps and clusters in technology

Assess self portfolios vis-à-vis competition

Develop future R&D strategies

Identify new application areas of existing patents

Develop a licensing strategy

Develop new products and improve existing products

Determine commercial value of patents

Identify fundamental invention vis-à-vis improvements

Monitor patent activity in particular geographic

markets

NII/P&OTT/RD/2008 April 19, 2014 RD_ND_Patents_2014 183

Patent Landscaping Process (2)

Part A (Overview) Scan all patents of interest from Patent websites

Screen Patents of Interest

Map Patents

It is the visualized expression of total patent analysis results to understand

patent information effectively. Patent Map is produced by gathering related

patent information of a target technology field & analyzing these data by

different criteria and presenting results by using graphical tools. However,

the type of patent map is created depends upon the question that is trying

to be answered. Patent Maps allow us to identify acquisition target, patent

cross licensing targets, future competitive treats & potential of licensing in

and out.

Thus Patent Maps allow us to track, monitor, discover, spot, assess, guard

and see patent activities in a certain area.

Freedom to Operate

Mitigate

April 19, 2014 RD_ND_Patents_2014 184

Patent Landscaping Process (3)

Part B (Basic Information) Define Scope

Perform Search

Map Trends

Analyze Patents

Select Patents of Interest

Design Around

Investigate Owners

Mitigate Infringement

Display Results

Part C (Watch Competition) Understand Competitors IP

Identify Trends in Competitors IP

Identify Unprotected Areas

Avoid Infringement

Part D (Seek Strategic Positions) Licensing Agreements

Patents

Joint Ventures

April 19, 2014 RD_ND_Patents_2014 185

Patent Pools

April 19, 2014 RD_ND_Patents_2014 186

Patent pool for neglected diseases Pharmaceutical giant GlaxoSmithKline (GSK) will share the patented

knowledge it uses to develop medicines for neglected tropical diseases (NTDs)

— including malaria and tuberculosis — with other drugs companies,

governments and non-governmental organizations.

Andrew Witty, GSK's chief executive, proposed the voluntary 'patent pool' in a

12 February speech, and called on other drugs firms to open up access to

intellectual property relevant to NTDs.

Starting this year, Witty announced, GSK will also cap its prices for patented

medicines in poor countries at 25% of what it charges in developed countries.

It will also reinvest 20% of the profit it makes from selling medicines in poor

nations into health-care infrastructure projects in those countries.

Source: Nature News Published online 18 February 2009 | Nature 457, 949 (2009) | doi:10.1038/457949e

News in Brief

April 19, 2014 RD_ND_Patents_2014 187

Patent Pooling

A patent pool is a consortium of at least two companies

agreeing to cross-license patents relating to a particular

technology.

The creation of a patent pool can save patentees and

licensees time and money, and, in case of blocking

patents, it may also be the only reasonable method for

making the invention available to the public.

(Note: Competition law issues are usually important when a large

consortium is formed. Patent pooling has recently become a hotly

debated field)

April 19, 2014 RD_ND_Patents_2014 188

Patent Pooling

Identify relevant parties

Gain agreement between parties (e.g., need to access many Patents)

Letter of intent

Independent evaluation of Patents

Develop operating model

Regulatory authority approval

Sign full agreement

Go live

April 19, 2014 RD_ND_Patents_2014 189

Patent Pooling for HIV/AIDS drugs

WHO efforts (UNITAID)

Air Tax etc

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Patents & Economy

Patents Generate Economy

Examples:

India : (http://www.nistads.res.in/contents/patent/11-Chapter-3.pdf)

USA : NIH : 20,000 technologies/2000 generate $$

“AXLE” shuttle vector example

BU : 2000 technologies/ 15 generate US $100m

April 19, 2014 RD_ND_Patents_2014 194

Generation Money by IPR: an example

(Money Loss by USA in India due to lack of protection of IPR in 2000)

Motion pictures 80%

Sound Recordings and Musical Compositions 40%

Computer Programs: Business Applications 76%

Computer Programs: Entertainment Software 82%

Books (US$22 million) Not Available

Motion pictures 7.3%

Sound Recordings and Musical Compositions

24.5%

Software 292.8%

Books 21.0%

April 19, 2014 RD_ND_Patents_2014 195

Patents and Recession

Yes, it has affected filing and technology transfer

April 19, 2014 RD_ND_Patents_2014 196

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Patents generate revenue: do you agree ?

Only 5-12% of patents get commercially exploited!

April 19, 2014 RD_ND_Patents_2014 198

Patenting leads to business & need

uniform International rules for Trading

World Trade Organization

World Intellectual Property Organization

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Share of Patent Offices in total patent

applications (Source: WIPO Statistics Database, October 2011)

(1995)

United States of America : 21.8%; China : 1.8%

Japan : 35.2%; Korea : 7.5%

European Patent Office : 5.8%; Others : 28.0%

(2010)

United States of America : 24.8%; China : 19.8%

Japan : 17.4%; Korea : 8.6%

European Patent Office : 7.6%; Others : 21.8%

Patent Offices fall under:

Ministry of Commerce and Industry

Department of Industrial Policy and

Promotion

Controller General of Patents Designs and

Trade Marks (INDIA)

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April 19, 2014 RD_ND_Patents_2014 201

CONTROLLER GENERAL OF PATENTS, DESIGNS

AND TRADEMARKS

(CGPDTM)

T M REGISTRY

DESIGN OFFICE

G.I. REGISTRY

Head Office KOLKATA

Branch DELHI

Branch CHENNAI

Branch MUMBAI

Head Office MUMBAI

DELHI

KOLKATA

CHENNAI

A’BAD

P.I.S. Nagpur

KOLKATA

PATENT OFFICE

CHENNAI

(Source : Indian Patent Office)

April 19, 2014 RD_ND_Patents_2014 202

April 19, 2014 RD_ND_Patents_2014 203

HISTORY OF INDIAN PATENT SYSTEM 1856 THE ACT VI OF 1856 ON PROTECTION OF INVENTIONS BASED ON THE BRITISH PATENT LAW OF 1852. CERTAIN EXCLUSIVE

PRIVILEGES GRANTED TO INVENTORS OF NEW MANUFACTURERS FOR A PERIOD OF 14 YEARS.

1859 THE ACT MODIFIED AS ACT XV; PATENT MONOPOLIES CALLED EXCLUSIVE PRIVILEGES (MAKING. SELLING AND USING

INVENTIONS IN INDIA AND AUTHORIZING OTHERS TO DO SO FOR 14 YEARS FROM DATE OF FILING SPECIFICATION).

1872 THE PATENTS & DESIGNS PROTECTION ACT.

1883 THE PROTECTION OF INVENTIONS ACT.

1888 CONSOLIDATED AS THE INVENTIONS & DESIGNS ACT.

1911 THE INDIAN PATENTS & DESIGNS ACT.

PATENT ACT - 1970

1972 THE PATENTS ACT (ACT 39 OF 1970) CAME INTO FORCE ON 20TH APRIL 1972.

1999 ON MARCH 26, 1999 PATENTS (AMENDMENT) ACT, (1999) CAME INTO FORCE FROM 01-01-1995.

2002 THE PATENTS (AMENDMENT) ACT 2002 CAME INTO FORCE FROM 2OTH MAY 2003; modified in 2005

April 19, 2014 RD_ND_Patents_2014 204 (source : http://www.patentoffice.nic.in/ipr/patent/history.htm)

Department of Industrial Policy &

Promotion (DIPP) is the nodal

Department in the Government of India

for all matters concerning WIPO.

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Patent Activity in India

PSUs : 12%

MNCs : 28%

Indian Private Industry : 60%

April 19, 2014 RD_ND_Patents_2014 206

?

?

Patent filing process (India)

Filing :

Complete Specifications

Examination

Allowance

Issuance

Maintenance

Refusal/ Appeal !!

Publication Opposition

If yes, go to

Revise

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April 19, 2014 RD_ND_Patents_2014 208

April 19, 2014 RD_ND_Patents_2014 209

Patent Filing Documents

&

Drafting

Patent Filing Documents (INDIA)

(Form 1): Application form in triplicate

(Form 2): Provisional or complete specification in triplicate. If the

provisional specification is filed it must be followed by complete

specification within 12 months (15 months with extension)

Drawing in triplicate (if necessary)

Abstract of the invention (in triplicate)

Information and undertaking listing the number, filing date and

current status of each foreign patent application in duplicate

(Form 3): Priority document (if priority date is claimed)

(Form 5): Declaration of inventorship where provisional

specification is followed by complete specification or in case of PCT

convention application

Power of attorney (if filed through Patent Agent)

Fee in cash/by local cheque/by demand draft in favor of Controller of

Patents)

April 19, 2014 RD_ND_Patents_2014 210

Drafting of Claims (1)

1. Interview the inventor

2. Inventor knows best about his invention

3. Record Interview on Camera, if possible

4. Demand sketches

5. While evaluating invention, first of all draft broadest claims

6. The broadest claim is a claim that is narrower only at the point of

novelty than any prior art reference one is aware of

7. Once a point of novelty is in mind, decide on the type of claim

(product- new or improved compound or composition of matter) /

method of use/ process of manufacture, reconsider/ revise the

claims

8. While interpreting claims, consider other claims in the patent with

patent differentiation in mind

9. Ask the following: is the claim too broad or too narrow or

problematic

10.Consider how claims affect each other

11.When in doubt, ask inventor to again explain it

April 19, 2014 RD_ND_Patents_2014 211

Drafting of Claims (2)

Statutory Provisions — Basic Principles: The Statute

Omnibus Claims

Statutory Classes

Claim Forms and Formats: Placement After Specification

Numbering and Order

Preamble

Transition from Preamble to Body

Body of the Claim

Format and Punctuation

Dependent Claims

Independent Claims

Multiple Dependent Claims

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Drafting of Claims (3)

Fees Payable for Claims

Apparatus or Machine Claims: Elements of These

Claims

Order of Elements

Tying Elements Together

“Whereby” and “Means” Clauses

Method or Process Claims: Elements of Method

Claims

April 19, 2014 RD_ND_Patents_2014 213

Drafting of Claims (4)

Order of Steps

Article of Manufacture Claims: Product-by-Process Claims

Design Claims

Plant Patent Claims

Composition of Matter Claims — Chemical Cases: “Markush”

Expressions

Special Claims for Chemical Cases

New Use Claims

Jepson-Type Claims

Generic and Species Claims of Varying Scope:

Claiming Different Classes of Invention in One

Patent

Non-art Rejections: Duplicate Claiming

April 19, 2014 RD_ND_Patents_2014 214

Drafting of Claims (5)

Undue Multiplicity

Old Combination; Over-claiming

Aggregation

Printed Matter

Incomplete

Vague and Indefinite

Prolixity

New Matter

Claiming Biotechnology Inventions

Thoughts on Claim Drafting: Review of Some Basics

April 19, 2014 RD_ND_Patents_2014 215

How to file a Patent (ABROAD)

Direct Route for National Phase:

Seek permission from IPO, India ; 6-months time period

PCT Route:

Uniform examination agency

18-32 months

Go to National Phase e.g., USA, Europe, Singapore, China

Role of Patent Attorney & deficiencies in India?

April 19, 2014 RD_ND_Patents_2014 216

Strategy

1

The traditional way to apply for a patent is to file a standard Patent Application

(now called a non-provisional) with the PTO without a prior art search. This

way can sometimes be a roll-of-the-dice approach. Without a search of

relevant art, one cannot develop a proper strategy for applying for a patent.

While it may be one of the cheapest strategies, there is a chance that the

cost of filing could have been avoided. However, if your idea is truly one of

a kind, this could be the best approach.

Strategy

2

A variation on Strategy 1 is to perform a patentability search prior to filing the

non-provisional application. While no search can generate a 100% of the

relevant art or prevent a rejection by the PTO, a search can help determine

what is out there and shape the best strategy for prosecution.

Strategy

3

The newest and possibly the most attractive strategy is to file a Provisional

Patent Application. This is a great tool for inventors. When you invent

something, you generally have 1 year to file an application with the PTO, or

lose the right to do so. A provisional application allows you to file the

disclosure of your invention with the office, establish a priority date and

gives you another year to file your non-provisional application. This

strategy also gives you a year to determine if there is a market for your

invention while employing the title 'Patent Pending' on your invention.

April 19, 2014 RD_ND_Patents_2014 217

Patent Prosecution Strategy

Form No. Section and rule Title

1 2 3

1.

1.A

Sections 5(2), 7, 54, 135 and rule 39

Section 7(1A); rule 20(1)

Application for grant of a patent. Application for grant of patent on an application corresponding to

an International application under PCT.

2. Section 10; rule 13 Provisional/Complete Specification.

3. Section 8 and rule 12. Statement and undertaking.

4. Sections 8(2), 9(1), 25(1), 28(4), 43(3), 53(3) and rules 12(4),

13(6), 24(5), 56(1), 73(3) or 130.

Request for extension for time.

5. Section 10(6) and rule 13(6). Declaration as inventorship.

6. Sections 20(1), 20(4), 20(5) and rules 34(1), 35 or 36. Claim or request regarding any change in applicant for patent.

7. Section 25 and rule 55. Notice of opposition to grant of a patent.

8. Sections 28(2), 28(3) or 28(4) and rules 66, 67, 68. Request or claim regarding mention of inventor as such in a patent.

9. Section 43 and rule 73(1). Request for sealing of a patent.

10. Section 44 and rule 75. Application for amendment of patent.

11. Sections 51(1), 51(2) and rules 76, 77. Application for direction of the controller.

12. Section 52(2) and rule 79. Request for grant of patent.

13. Section 57 and rule 81(1). Application for amendment of the application for patent/complete

specification.

14. Sections 57(4), 61(1), 63(3), 78(5) and 87(2) and rules 49(1),

52(3), 81(3)(b), 85(1), 87(2), 98(1), 101(3) or 124 and

also section 87 (2) as modified by section 24C.

Notice of opposition to amendment/restoration/surrender of patent/grant of compulsory licence or revision of terms

thereof or to a correction of clerical errors.

15. Section 60 and rule 84. Application for restoration of patents.

16. Section 68 and rule 89. Application for registration of a document.

17. Sections 69(1) or 69(2) and rules 90(1) and 90(2) Application for registration of title/interest in a patent or share in it or registration of any document purporting to affect

proprietorship of the patent. April 19, 2014 RD_ND_Patents_2014 218

18. Sections 84(1), 91 or 92(1) and rules 47, 96 and also sections

84 and 92 as modified by section 24C.

Application for compulsory licence.

19. Section 11B and Rule 24(1). Request for examination of application for patent.

20. Section 85(1) and rules 47, 96, and also section 85(1) as

modified by section 24C.

Application for revocation of a patent or exclusive marketing right.

21. Section 88(4) and rules 51, 100 and also section 88(4) as

modified by section 24C.

Application for revision of terms and conditions of licence.

22. Section 94 and rule 102(1) and also section 94 as modified

by section 24C.

Request for termination of compulsory licence.

23. Rules 109 and 112. Application for registration of Patent Agent.

24. Section 130 (2) and rule 117. Application for the restoration of the name in the register of Patent

Agents.

25. Sections 77(1)(f), 77(1)(g) and rules 130(1) or 130(2). Application for review/setting aside controller’s decision/order.

26. Sections 127, 132 and rule 135. Form of authorisation of a Patent Agent/or any person in a matter

or proceeding under the Act.

27. Section 24A and rule 40. Application for grant of exclusive marketing rights.

28. Rule 46. Form for the grant of exclusive marketing rights.

29. Section 146(2) and rule 131(1) Statement regarding the working of the Patented invention.

30. Section 39 Request for permission for making patent application outside India

April 19, 2014 RD_ND_Patents_2014 219

Documents Needed to File an Application

Application for grant of patent in Form 1;

Form 2 accompanied by two copies of the complete patent

specification;

Two sets of the drawing figures, if any, one set of which should

be in thick A-4 size white sheets;

Duly stamped power of attorney in Form 26 authorizing the agent;

Declaration of the inventorship signed by the applicant in Form 5;

Priority documents, if any, if not in English, English translation

thereof;

The Statement and Undertaking regarding corresponding foreign

filings in Form 3; and

Proof for the applicant’s right to apply for patent.

To obtain a lodgment date, what is required is:

The Specification;

Name and address of the applicant;

Name(s) and addresse(s) of the Inventor(s); and

The priority details. April 19, 2014 RD_ND_Patents_2014 220

Patent Prosecution in India

Application

Applicant

Publication

Representation

Examination

Grant

Opposition

Renewal

April 19, 2014 RD_ND_Patents_2014 221

April 19, 2014 RD_ND_Patents_2014 222

Patent Filing Process

In

Patent Offices

Patent filing process (EPO)

Filing

Search

Request for Examination

Substantive Examination

Announcement of Grant

Publication of Patent

Maintenance

If opposed : revocation

Refusal

Withdrawal

Publication

April 19, 2014 RD_ND_Patents_2014 223

Patent filing process (USPTO)

Filing

Examination

Notice of Allowance

Patent Issuance

Maintenance

Opposition / Interference

Office action/ rejection/

abandonment

Patent withdrawal

April 19, 2014 RD_ND_Patents_2014 224

Patent Application Process in U.S.A. Contact a Law Firm

Study Law Firm Brochure

Study Schedule of Fee

Fix a Meeting with Attorney to discuss: Invention, Patent

application process and Fee arrangements

Conduct Patentability Search and Opinion

Preparations for filling of Patent Application

Prepare an Information disclosure Statement

Attend to the Notice to file missing parts

Notice to comply with Sequence rules

Office action and response to office action (amendment)

Notice of allowance

Final rejection

Amendment after rejection

Appeal

Continuation application

Abandon the Application

April 19, 2014 RD_ND_Patents_2014 225

Patent Application Process in U.S.A.

Extension applications

Continuation

Divisional

Continuation-in-part

Reissue

Continued Prosecution Application

April 19, 2014 RD_ND_Patents_2014 226

PCT

April 19, 2014 RD_ND_Patents_2014 227

Patent Cooperation Treaty

“The Patent Cooperation Treaty (PCT) of 1970 is an international patent

law treaty. It provides a unified procedure for filing patent applications to

protect inventions in each of its Contracting States – 137 countries. A

patent application filed under the PCT is called an international

application or PCT application.

A Patent Cooperative Treaty (PCT) patent application is a means to delay

filing in individual foreign countries for up to 30 months from the U.S.

filing. The PCT patent application does not mature into a patent. Rather,

an application must still be filled in each individual country”.

[List of PCT countries:

http://www.wipo.int/pct/guide/en/gdvol1/annexes/annexa/ax_a.pdf]

April 19, 2014 RD_ND_Patents_2014 228

Documents for filing Patents PCT Route

By PCT Route:

Complete Specification

Drawings (if any)

Priority Documents

Abstract

International Search Report

International Preliminary Examination Report

WIPO Publication

Power of Attorney

April 19, 2014 RD_ND_Patents_2014 229

PCT Filing Procedure

File PCT application in

Indian Patent Office

Ask for International

Preliminary

Examination Report

Choose

National Phase Countries e.g., USA, UK,

China, Japan, Singapore

1st written opinion issued;

If favorable

Publication of PCT after 18 months

from the priority date by WIPO

Response to written opinion

(Modify/ delete/ improve claims)

Local Patent Laws applicable

April 19, 2014 RD_ND_Patents_2014 230

University US federal funding for life sciences research (1998-2001) $ billion

Biotechnology patents granted by the USPTO (1998-2001)

Biotechnology applications submitted to the USPTO (1998-2001)

Disclosed technology transfer deals with biotechnology firms (1998-2002)

University of California system (Oakland, CA, USA)

2.97

757

330

23

University of Texas (Austin, TX, USA)

1.39 202 71 10

Johns Hopkins University (Baltimore, MD, USA)

1.19 258 107 13

Washington University (St. Louis, MO, USA)

1.04 125 37 3

University of Pennsylvania (Philadelphia, PA, USA)

0.98 138 50 4

Harvard University (Cambridge, MA, USA)

0.79 127 42 9

Stanford University (Stanford, CA, USA)

0.74 137 60 14

Columbia University (New York, NY, USA)

0.70 141 37 1

Cornell University (Ithaca, NY, USA)

0.50 136 49 0

Massachusetts Institute of Technology (Cambridge, MA, USA)

0.20 81 32 13

Rockefeller University (New York, NY, USA)

0.18 154 56 5

(Sources: National Science Foundation, US Patent and Trademark Office (USPTO), Recombinant Capital)

April 19, 2014 RD_ND_Patents_2014 231

April 19, 2014 RD_ND_Patents_2014 232

April 19, 2014 RD_ND_Patents_2014 233 (http://www.wipo.int/ipstats/en/statistics/patents/patent_report_2006.html)

April 19, 2014 RD_ND_Patents_2014 234

April 19, 2014 RD_ND_Patents_2014 235

Indian Patent Office

April 19, 2014 RD_ND_Patents_2014 236

April 19, 2014 RD_ND_Patents_2014 237

Patent Applications related

To Micro-organisms

Deposit at IMTECH,

Chandigarh

Patent Search Databases Free Databases

http://www.patentoffice.nic.in/

http://pat2pdt.org

http://www.uspto.gov/

http://www.epo.org/

http://www.jpo.go.jp/

http://www.ipo.gov.uk/

http://www.ipos.gov.sg/main/index.html

Restricted but Free Databases RaDius (US Federal Govt. Site)

USPTO private PAIR System

April 19, 2014 RD_ND_Patents_2014 238

Patent Search Databases (contd.)

Subscription/Paid Databases

Thomson Innovation

Delphoin (www.delphion.com)

MicroPatent (www.micropatent.com)

Dialog (www.dialog.com)

PatentCafe (www.patentcafe.com) Big Patents India (http://india.bigpatents.org/)

April 19, 2014 RD_ND_Patents_2014 239

Organization of Patent Offices

April 19, 2014 RD_ND_Patents_2014 240

April 19, 2014 RD_ND_Patents_2014 241

Organization of European Patent Office

April 19, 2014 RD_ND_Patents_2014 242

April 19, 2014 RD_ND_Patents_2014 243

April 19, 2014 RD_ND_Patents_2014 244

Various Components of IP-Activities

April 19, 2014 RD_ND_Patents_2014 245

April 19, 2014 RD_ND_Patents_2014 246

April 19, 2014 RD_ND_Patents_2014 247

Thank You & Good Luck

ACKNOWLEDGEMENTS Several websites; DBT/ BIRAC/ NII/ US Embassy/ IPO/ USPTO/ EPO/ WIPO/ JPO/

Boston University,USA/ NIH, USA/ MIHR, UK/ Various websites & Journals

&

(Indian Patent Act: http://www.patentoffice.nic.in/ipr/patent/patAct1970-3-99.html)

April 19, 2014 RD_ND_Patents_2014 248