A presentation on FTO and Infringement Analysis

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


Background

Rights Make Use Sell Offer for sale Import

Infringement


Infringement factors

Term

Territorial

Claims


Types

Direct infringement Literal infringement Doctrine of equivalence

Indirect infringement Induced infringement Contributory infringement


Literal Infringement

Claim Construction

Intrinsic factors

Extrinsic factors

Comparison

Claim by claim - element by element


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.“


Example 2

PATENT


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.“


Doctrine of Equivalence

Equivalents of a claim Function Way Result


Example 2

PATENT


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.“


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 ?


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


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


Indirect Infringement

Induced Infringement

Contributory Infringement


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?


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


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?


Defenses

Patent Invalid Subject Matter Utility Novelty Non-obviousness Specification


Defenses (cont…)

Government Use By or For

Research Exemptions Experiment Regulatory Approval

Parallel Imports Inequitable Conduct


Importance & Challenges – FTO analysis


FTO – stage

Launch product

Launch generic products

R&D focus


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


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


Challenge…

Renewal status

Renewal data accessibility Easily accessible - US, Europe Not easily accessible – Brazil, Mexico


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


Challenge…

Access to databases

Language

Case Law


Options

Multiple National attorneys

Carry out on own In house External counsels


Commonly used Methodology

US, Europe, WIPO

Regulatory Search

Proprietary Database search

National country database search

Contact Local Attorney for details


THANK YOU

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A presentation on FTO and Infringement Analysis

Law

Transcript of A presentation on FTO and Infringement Analysis