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Freedom to Operate Opinion

Freedom to Operate Opinion . Vandana Mamidanna. Overview. Right to use Country-wise analysis Not a static single point activity Changes in IP Landscape Changes in Product . Pre- FTO. Identify Current Product Characteristics

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Freedom to Operate Opinion

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  1. Freedom to Operate Opinion VandanaMamidanna

  2. Overview • Right to use • Country-wise analysis • Not a static single point activity • Changes in IP Landscape • Changes in Product

  3. Pre- FTO • Identify Current Product Characteristics • Identify Any Proposed/Projected Changes To Be Made To The Product • Is The Product Only For The Local Market Or International • Determine Level Of Interest In Product And Next Key Decision Points • Before Further Significant Investment (Time/Cost), Initiate Patent FTO Search And Analysis

  4. Initial Search • Develop expertise/ Use an Expert • Extent of search • Age of the product • Target Market/Markets • Consider Local searches • Refine the search

  5. Analysis of Search Results • Identify Patent Series Of Possible Concern • Review Status (Pending, Granted, Abandoned, Next Action Due) • Check Original And Latest Claims Where Identified Patent Applications Are Pending For Relevance . Check Claims Of Granted Patents For Relevance • Discuss Patent Claims Of Concern With Scientists To Determine If Concerns Are Resolvable By Workaround Activities

  6. Analysis of Search Results • If Decision Is To Monitor Pending Claims Of Concern, Introduce A Regular Review Process With Appropriate Reminders • Consider Possible Invalidity Grounds For Problem Patents – Review Cited Art, Conduct Invalidity Search And Analysis • Retain Outside Counsel, If Appropriate, And Develop Invalidity Attacks • Manage FTO issues

  7. Freedom to Operate – Process Flow Search Analysis 1 Analysis 2 • # Records • Abstracts • Countries • Remove duplicates • < Records • Abstracts • Countries of interest • << Records • Claims • Countries of interest • Issued? Infringement Assessment Input High Value Database(s) √ OK TRACK LITIGATE STOP LICENSE [Repeat over time] • Assess: • Claims • (esp issued) • Countries • Assess: • Claims (esp issued) • Countries Advice • Keywords • Substructure • Generic scope Invalidity/ Workaround

  8. Mitigate FTO Issues • Utilise in-house and partners’ knowledge of area • Conduct formal FTO reviews (stage-gate) • Update periodically – new published applications daily • Patent your inventions (and/or defensive publication) • Don’t rely on prior user defence to infringement

  9. Mitigate FTO Issues • Track relevant pending applications • Intervene as necessary (e.g. 3rd party observations) • Publish to “throw off the scent” • DON’T ignore relevant valid patents • Injunctions, enhanced damages, “Bolar” limitations, dealbreaker

  10. Managing FTO Issues • Consider workarounds • Re-formulation • Off-shoring • Develop bargaining chips • Patent in 3rd party space • Solidify your own IP position

  11. Managing FTO Issues • License – earlier the better • Look for a win-win • Litigate – courts, patent offices (oppose/re-examine), ITC, standing issues • Stop

  12. Thank You vandana@thinkipstrategy.com

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