FTO and Infringement Analysis An Approach and Strategy Vikram Pratap Singh Thakur Sunday, June 26, 2022 © 2010 BananaIP
May 27, 2015
April 12, 2023
FTO and Infringement AnalysisAn Approach and Strategy
Vikram Pratap Singh Thakur
© 2010 BananaIP
April 12, 2023 © 2010 BananaIP
Agenda
Infringement Types Defenses
FTO analysis Why Challenges Methodology
April 12, 2023 © 2010 BananaIP
Background
Rights Make Use Sell Offer for sale Import
Infringement
April 12, 2023 © 2010 BananaIP
Infringement factors
Term
Territorial
Claims
April 12, 2023 © 2010 BananaIP
Types
Direct infringement Literal infringement Doctrine of equivalence
Indirect infringement Induced infringement Contributory infringement
April 12, 2023 © 2010 BananaIP
Literal Infringement
Claim Construction
Intrinsic factors
Extrinsic factors
Comparison
Claim by claim - element by element
April 12, 2023 © 2010 BananaIP
Example 1
PATENT
“ What I claim is a gel composition for treatment of pain comprising;
2-10 % by weight Benzocaine in atleast in part as the free base; and
atleast one of propylene glycol and glycerine as a solvent. “
Infringing?
PRODUCT
“ A gel for treating neuropathies causing pain at a site by inducing analgesia. The gel is administered intradermally. The gel has 10 % by weight of Benzocaine and glycerine as solvent.“
April 12, 2023 © 2010 BananaIP
Example 2
PATENT
“ What I claim is a gel composition for treatment of pain comprising;
10 % by weight Benzocaine in atleast in part as the free base; and
propyl paraben.“
PRODUCT
“ A gel for treating neuropathies causing pain at a site by inducing analgesia. The gel is administered intradermally. The gel has 2-10 % by weight of Benzocaine and methyl paraben.“
April 12, 2023 © 2010 BananaIP
Doctrine of Equivalence
Equivalents of a claim Function Way Result
April 12, 2023 © 2010 BananaIP
Example 2
PATENT
“ What I claim is a gel composition for treatment of pain comprising;
10 % by weight Benzocaine in atleast in part as the free base; and
propyl paraben.“
PRODUCT
“ A gel for treating neuropathies causing pain at a site by inducing analgesia. The gel is administered intradermally. The gel has 2-10 % by weight of Benzocaine and methyl paraben.“
April 12, 2023 © 2010 BananaIP
Doctrine of equivalence …
Prosecution History Estoppel Eg.
a filtering process for the purification of a dye solution
Amendment by patentee (pH 6-9) Alleged infringing process (pH 5) Doctrine of equivalence ?
April 12, 2023 © 2010 BananaIP
Doctrine of equivalence …
Hilton Davis v. Warner Jenkinson case
Amendment during prosecution: purpose not related to patentability
demonstrated – court decides based on purpose
Patent holder unable to establish purpose – estoppel applies
April 12, 2023 © 2010 BananaIP
Prior art limitation to Doctrine of equivalence – Hilton Davis case eg.
PATENT
pH – 3-6
Hypothetical claim analysis test
PRIOR ART
pH – 10 and above
April 12, 2023 © 2010 BananaIP
Indirect Infringement
Induced Infringement
Contributory Infringement
April 12, 2023 © 2010 BananaIP
Example
Katrina, a graduate of IISc, develops a molecule for treating AIDS. She acquires a patent for the same and is also recognized as the inventor of the year by the Indian government. Teddy, a company based out of Bangalore sells an intermediate to the said molecule.
Katrina sues Teddy.
Infringement?
April 12, 2023 © 2010 BananaIP
Lalabhai v. Chimanlal
Process of treating dry fruits Comparison Sulphuric Acid - Washing Soda muriatic acid - Acetic acid Sulphur dioxide fumes under
pressure - Sulphur dioxide fumes without pressure
April 12, 2023 © 2010 BananaIP
Example
Dizer gets a patent on a drug for AIDS and a method for making the kit in USA, India and Bangladesh. Sachin decides to research further to come up with a process which will be cost-effective. He manufactures the patented product in his lab and is able to comes up with the improved cost effective process.
Is Sachin liable for patent infringement?
April 12, 2023 © 2010 BananaIP
Defenses
Patent Invalid Subject Matter Utility Novelty Non-obviousness Specification
April 12, 2023 © 2010 BananaIP
Defenses (cont…)
Government Use By or For
Research Exemptions Experiment Regulatory Approval
Parallel Imports Inequitable Conduct
April 12, 2023 © 2010 BananaIP
Importance & Challenges – FTO analysis
April 12, 2023 © 2010 BananaIP
FTO – stage
Launch product
Launch generic products
R&D focus
April 12, 2023 © 2010 BananaIP
Challenge
1 product – many patents
Eg. Temodar - TEMOZOLOMIDE
Patent No. Filing Date Priority Date
Estimated Expiry Date
5,260,291 October 18, 1991
Aug 24, 1981
Nov 9, 2010
6,987,108 February 21, 2003
Feb 22, 2002 Feb 22, 2022
April 12, 2023 © 2010 BananaIP
Challenge…
Patent term extension
Term extension accessibility Easily accessible - US, Europe Not easily accessible – Russia
Patent No.
Filing Date
Priority Date
Estimated Expiry Date
Expiry date (including extension)
5,260,291 October 18, 1991
Aug 24, 1981
Nov 9, 2010
Aug 11, 2013
6,987,108 February 21, 2003
Feb 22, 2002
Feb 22, 2022
Sep 8, 2023
April 12, 2023 © 2010 BananaIP
Challenge…
Renewal status
Renewal data accessibility Easily accessible - US, Europe Not easily accessible – Brazil, Mexico
April 12, 2023 © 2010 BananaIP
Challenge…
Difference in Law Regulatory procedure Patent act
Patent term date – priority or filing Priority – India Filing – Turkey, Russia
Change in law – term changes USA – June 8, 1995
April 12, 2023 © 2010 BananaIP
Challenge…
Access to databases
Language
Case Law
April 12, 2023 © 2010 BananaIP
Options
Multiple National attorneys
Carry out on own In house External counsels
April 12, 2023 © 2010 BananaIP
Commonly used Methodology
US, Europe, WIPO
Regulatory Search
Proprietary Database search
National country database search
Contact Local Attorney for details
April 12, 2023 © 2010 BananaIP
THANK YOU
www.bananaip.comwww.bananaip.com/sinapse-blog