Freedom To Operate: A

Prerequisite From the

Commercialization Perspective

Dr. Nidhi Sandal

Scientist
DRDO Bhawan
nidhisandal@hqr.drdo.in
WHAT IS FREEDOM TO OPERATE?
"Freedom to operate", abbreviated "FTO", is the ability to
proceed with research, development and
commercialization of a product, without infringing valid
intellectual property rights of others.

FTO ensures that a product can be made, used, sold,

offered for sale, or exported, with a minimal risk of
infringing the unlicensed intellectual property rights (IPR)
or tangible property rights (TPR) of others.
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WHAT IS THE NEED FOR FTO?
If a company/individual is interested to know whether his conceptualized
work would infringe an already existing patent (patent application)
If a company wants to commercialize its product in a country

A company/individual must do the FTO analysis

well before launch to avoid the risk of litigation.

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EXCEPTIONS FOR FTO ANALYSIS
Bolar Provision:
Performing research and tests for preparing regulatory
approval, does not constitute infringement before the end
of patent term.
(Roche Products v. Bolar Pharmaceutical Fed. Cir. 1984)
Experimental Use
trying to make an improvement to the invention
testing

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WHO SHOULD CARRY OUT FTO
SEARCH
In-house IP Counsel of Companies before
starting work for a Product
Attorney

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WHAT TYPE OF PRIOR ART TO BE
SEARCHED FOR FTO?
1. Granted & Active Patents
2. Under Prosecution Patent Applications
3. WIPO application which may enter national phase

For FTO Non-Patent Literature search is not required.

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IMPORTANT FEATURES OF PATENTS
Patent protection is territorial i.e. country specific so is
Freedom To Operate
Patents have a limited duration.
Patents have limits of scope.

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 METHODOLOGY FOR FTO
OPINION
Step 1: Identify the Country where you intend to launch your product or
use your invention.

Step 2: Identify the keywords/classification/s that properly define your

invention/product.

Step 3: Identify the search engines.

Step 4: Know the Law, Doctrines and Case laws of the country w.r.t.
infringement

Step 5: Collate relevant patent documents

Step 6: Prepare FTO opinion.

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 Step 1: Identify the Country where you intend
to launch your product or use your invention.
Patents are territorial therefore FTO analysis is country
specific.
For same product in two different countries; two FTO
analysis of their respective patents is must.

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 Step 2: Identify the keywords that properly
define your invention/product.
1. Include all the features of the invention in Keywords and
classifications.
2. The keywords list must include broad and specific terms to
identify the invention.
3. Keywords must also include synonyms e.g for Bio-digester,
bioreactor should also be searched; for car, four wheelers;

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Step 3: Identify the search engines.

Official site search of the Countries Patent Office

www.uspto.gov
www-european-patent-office.org
www.wipo.int
www.brevets-patents.ic.gc.ca
www.ilpatsearch.justice.gov.il
www.ipo.gov.uk
www.patentoffice.nic.in
Commercially available data bases like
Scifinder
STN
Derwent
Dialogue
Delhpion
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Step 4: Know the Law, Doctrines and Case laws
of the country w.r.t. infringement
Statute: What constitutes infringement in a country is well defined in several
sections of Patent laws eg, in US, section 271, In India section 104-115 dictates
the rule.
Doctrines: Doctrine is a body of inter-related rules (usually of common law and
built over a long period of time) associated with a legal concept or principle.
E.g. In US Doctrine of Double Patenting; Doctrine of equivalents
Case laws:
Case law incorporates courts' decisions from individual cases and
encompasses courts' interpretations of statutes, constitutional provisions,
administrative regulations
Both presidential and non- presidential case laws of that country wherein
invalidation grounds have been discussed must be referred and known

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Step 5: Collate relevant patents
1. Granted & Active Patents
2. Under Prosecution Patent Applications
3. WIPO application which may enter national phase

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Step 6: Prepare FTO opinion.
Product Name
Product/process details for which FTO is being prepared
Closest competitor/s Product details

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Step 6: Prepare FTO opinion.

S. Patent/ Patent Priority Expiry Independe Analysis Remarks

No. Application Date Date nt Claims
Number

1 US 7,343,209 Jan 2, Jan 2, Claim 1.

2004 2024

Claim 5

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Step 6: Prepare FTO opinion.
Analyze your invention with each independent
claim for
Literal infringement
Infringement under Doctrine of equivalence
Indirect Infringement i.e inducement of infringement

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Claim analysis
Bifurcate the claim in maximum possible elements. Each

element defines the scope of the claim.

Read the description of each element from the specification

to understand the scope of element.

Now read your invention over the claim wherein you

broaden the claim to its maximum scope.

One must read prosecution history of the patent as well to

analyze infringement

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Claim analysis
Our invention: a tablet dosage form of Paracetamol containing HPMC
as a rate controlling polymer and other pharmaceutical excipeints
wherein the tablet controls the release of Paracetamol for 8 hrs.

Claim 1 of IN261234 patent is :

A pharmaceutical composition of paracetamol comprising rate
controlling polymer along with other pharmaceutical excipieints
wherein the said dosage form is capable of controlling the release of
Paracetamol for at least 12 hr.

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Claim analysis

Claimed invention Description in specification Our Invention

pharmaceutical pharmaceutical composition comprises tablet, Tablet composition of

composition of capsule, sachet, powder, suppository and the Paracetamol
Paracetamol like

comprising rate HPMC, HPC, ethyl cellulose, cetostearyl HPMC

controlling polymer alcohol, alginate, methyl cellulose, waxes,
methacrylates ant the like

other pharmaceutical Diluent, filler, lubricant, glidant, binder and the other pharmaceutical
excipeints like. excipeints

controlling the release Delailed description: the pharmaceutical 8 hr control release

of Paracetamol for at composition of the present invention controls
least 12 hr. the release of paracetamol for 10-12 hrs.
Background: pharmaceutical composition of
paracetamol with 8 hr control release are
described in several prior art

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Step 6: FTO Opinion: No infringement
issue

Go Ahead

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Step 6: FTO Opinion : Infringement
issues
Option 1:
Design around strategy; if this option is not feasible then

Option 2:
Purchase the patent or in-licensing.
Cross-licensing.
Compulsory licence regime

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Step 6: FTO Opinion : Infringement
issues
Option 3
Search Invalidation Grounds of the hindering Patent: Validity
Search

In case of a patent application, search the prior art to analyze

whether it would be granted of not.

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Step 6: FTO Opinion : Infringement
issues
Option 4:

Forget the Product for time being and wait till

the hindering patent expires.

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 Thanks..

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