DR. RAVI DHAR ON “FREEDOM TO

OPERATE (FTO) IN INTELLECTUAL

PROPERTY”

Ravi Dhar, Ph.D., f-STEM

in.linkedin.com/pub/ravi-dhar/18/71b/895

(Email: rdhar_in@yahoo.com)

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1 RD_FTO_2016

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Acknowledgements

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2

Various Web sites, Relevant Journals like

Nature, Current Opinions in Biotechnology etc

Colleagues (Dr. Vinita Jindal of BIRAC)

Times of India

Mentors

NII, BIRAC, BU

Freedom to Operate (FTO)

“FTO is the ability to capitalize on an

invention, without challenges from other

parties (inventors, companies).

Obviously the inventor/s take extra care

not to use any other products or processes that

have been previously patented by others.”

Preferably, one should ensure FTO

screening before applying for a patent

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A word of caution Inventions are time & resource consuming

processes in which numerous raw materials,

chemical reactions, techniques & processes are

used by several investigators.

During the course of this journey one needs to:

a) Record all materials, tools & processes

used

b) Identify & study any potentially existing

exclusivity claims on each & every

ingredient used

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S. No. R&D Steps FTO Bottlenecks

1. Discovery & Technology Use of in-vitro & in-vivo

disease models

2. Manufacturing Lead identification & pre-

clinical development

3. Selection of indications &

dosage

Selection of host system,

isolation & purification of

active substance,

improving yield, scaling up

& full scale production

Each of the above R&D steps has thousands of small steps, respective inputs, processes

& outputs, which need to be carefully recorded. To claim FTO for a product before

commercial application, all information is subject to IP screening for claimed invention

(RD_2016)

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Obstacles should always be removed using

available legal channels in all cases.

No word of mouth agreements please

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This is complex & in order to

circumvent or remove obstacles on

FTOs, one may:-

1) Pay to remove the obstacle

2) Exchange a technology with other party

3) Invent around

4) Share patents

5) Share confidential information for mutual

benefit

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1) Pay to remove obstacle to FTO:

Request competing patent holder to sell or license the patent

(many times big mergers or acquisitions take place

like this)

2) Exchange a Technology e.g., a patent holder may have technology to fast screen

thousands of molecules, while as others may hold animal or cell

disease models, (or)

exchange technologies for drastically improving yields

3) Patent sharing Several R&D labs come up with complimentary ideas for

enhancing or accelerating process of gene sequencing or data

generation (www.molecularpartners.com)

4) Share confidential information for benefit of both

parties

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Example: Biopharmaceutical R&D: 1) Discovery & technology

2) Identification of candidate molecule

3) Manufacturing

4) Selection of indications & dosages

5) Validation of target product profile

6) Compilation of regulatory dossier

7) Regulatory submission

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Technology to boost old drugs with

Hydrogen (Times of India, P-15, Sept. 19, 2016)

Deuteration: Medicines with Deuterium (heavy hydrogen) for

Treatment of Huntington’s Disease by Teva Pharmaceutical Industries

Limited, Isreal

Deuterium “is armored hydrogen, tougher & more difficult for

enzymes to break down, so it sticks in body for longer duration”

Original deuterium drugs produced by Vertex Pharmaceuticals Inc,

e.g., for treatment of Cystic Fibrosis (SD-809) (tetrabenazine

compounds)

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2015:

Patents for treatment of Huntington’s Disease with

Concert Pharma + Auspex Pharmaceuticals Inc.

Companies acquired by Teva for 3.5 Bn US $

Concert Pharma has IPR in USA

Concert Pharma believes it has “Freedom to Operate (FTO)”

in USA – so can use the technology for drug production

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Competing Pharma companies like Valeant Pharmaceutical

International Inc

&

Those who designed Tetrabenzine drug SD-809 (drug marketed

under brand Name Xenazine ( byH. Lundbeck A/S) have not

contested against Teva

Why?

1) Either Teva has FTO

2) Or, May be Teva acquires the related Technologies or

Companies

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Search Strategy

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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1. Kinds of patent search

2. Key Concepts in searching

• What do we search

• The process of patent search

3. Creating & Refining Search Queries

4. Databases

• Patent database

• Non-Patent Databases

5. Drafting of Specification

6. Filing

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Why do we Search?

To retrieve information which is required to answer specific questions

How we Search?

What do we Search?

Identify Keywords or write the Key string

Any document or information related to questions

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Why do we search patents?

o Is a given invention patentable?

o Do the patent rights already exist for a given

product/process?

o Is a given patent valid?

o Which technologies exist in a given field of

technology?

o Who is active in a given field of technology?

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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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TYPES OF PATENT SEARCH

Novelty/Patentability Search

Freedom-To-Operate

/Clearance /Infringement

Search

Validity/Invalidity Search

State-of-the Art search

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PATENTABILITY SEARCH

Also known as Novelty Search which helps to determine the

Novelty of the invention

Done to identify Patents and Non-Patent literature

To find out if the similar or identical invention that has been

patented by someone else

Recommended to be done before writing and filing patent

specification, hence known as Pre-application search

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Novelty

An invention shall not be considered new if it forms part of a prior art

Prior Art

All related information available to the public anywhere in the world,

before the filing date or the priority date of the application claiming the

invention

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FREEDOM-TO-OPERATE SEARCH (FTO)

A clearance search to find out enforceable patents which may act

as “roadblocks” for commercialization of a product or service

Search of active/enforced patents, pending published patent applications

within a particular country or region where we wish to operate or market

What we target???

o Existing claims of patents currently in force

Existing “active claims”

o Subject matter that may appear in claims of patents

entering (or re-entering) into force in the future

Future “active claims”

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STATE-OF-THE-ART SEARCH

Helps to plan R&D activities more efficiently

Determine which areas are not sufficiently covered by existing

players

Search is executed to determine existing solutions

To find out potential competitors within a given technological

field

Search includes not only patent documents but also non-patent

literature

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VALIDITY/INVALIDITY SEARCHES

Purpose of the search either -

• To validate the enforceability of a patent's claims; or

• To invalidate one or more claims of a patent

Exhaustive prior art search conducted after patent issuance

Sources of Prior Art for a Patent Invalidity Search

• Patents, Published patent applications

• Non-patent literature such as journals, books, academic work,

internet publications

• Also includes physical embodiments of products and evidence of

sale or public use

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Patent Databases Free Patent databases

US Patent and TradeMark Office (USPTO)

URL: www.uspto.gov

EPO-Espacenet

URL: www.ep.espacenet.com

WIPO (World Intellectual Property Organization) Patentscope

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

Patent Lens

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

Free Patents online

URL: www.freepatentsonline.com

Google Patents

URL: http://www.google.com/?tbm=pts

Indian Patent Office

URL: http://ipindiaservices.gov.in/patentsearch/search/index.aspx

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Thank you