Académique Documents
Professionnel Documents
Culture Documents
Freedom to Operate
Search
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
Freedom to Operate
Search
WHO SHOULD CARRY OUT FTO
SEARCH
In-house IP Counsel of Companies before
starting work for a Product
Attorney
Freedom to Operate
Search
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
Freedom to Operate
Search
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.
Freedom to Operate
Search
METHODOLOGY FOR FTO
OPINION
Step 1: Identify the Country where you intend to launch your product or
use your invention.
Step 4: Know the Law, Doctrines and Case laws of the country w.r.t.
infringement
Freedom to Operate
Search
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.
Freedom to Operate
Search
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;
Freedom to Operate
Search
Step 3: Identify the search engines.
Freedom to Operate
Search
Step 5: Collate relevant patents
1. Granted & Active Patents
2. Under Prosecution Patent Applications
3. WIPO application which may enter national phase
Freedom to Operate
Search
Step 6: Prepare FTO opinion.
Product Name
Product/process details for which FTO is being prepared
Closest competitor/s Product details
Freedom to Operate
Search
Step 6: Prepare FTO opinion.
Claim 5
Freedom to Operate
Search
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
Freedom to Operate
Search
Claim analysis
Bifurcate the claim in maximum possible elements. Each
analyze infringement
Freedom to Operate
Search
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.
Freedom to Operate
Search
Claim analysis
other pharmaceutical Diluent, filler, lubricant, glidant, binder and the other pharmaceutical
excipeints like. excipeints
Freedom to Operate
Search
Step 6: FTO Opinion: No infringement
issue
Go Ahead
Freedom to Operate
Search
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
Freedom to Operate
Search
Step 6: FTO Opinion : Infringement
issues
Option 3
Search Invalidation Grounds of the hindering Patent: Validity
Search
Freedom to Operate
Search
Step 6: FTO Opinion : Infringement
issues
Option 4:
Freedom to Operate
Search
Thanks..
Freedom to Operate
Search