The content of this presentation is for educational purposes only and does not necessarily reflect the opinions of Fish & Richardson or the companies represented by the speakers at this event, and is also not intended to address every court or case situation. Impact of IPR in Hatch-Waxman and Biologics Strategies Presented By: Leslie Robbins, Dorothy Whelan, and Chad Shear
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The content of this presentation is for educational purposes only and does not necessarily reflect the opinions of Fish & Richardson or the companies represented by the speakers at this event, and is also not intended to address every court or case situation.
Impact of IPR in Hatch-Waxman and Biologics StrategiesPresented By: Leslie Robbins, Dorothy Whelan, and Chad Shear
What is Post-Grant?
• USPTO mechanisms for testing patentability• Designed as cost-effective and speedy alternatives to
litigation• Three primary flavors:
1 – IPR (Inter Partes Review)2 – PGR (Post Grant Review)3 – CBM (Transitional Program for Covered Business Method Patents)
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Proceeding When Does It Apply? Legal standard Grounds (Prior Art)
Estoppel?
PGR: Post-grant review(9 month window)
-First available on Sept. 16, 2012-Applies only to patents having a claim with a priority date on or after March 16, 2013
More likely than not that at least 1 claim is unpatentable
Any invalidity ground Raised or reasonably could have raised
IPR: Inter partesreview(after PGR)
-First available on Sept. 16, 2012-Applies to all patents-Must file within 1 year of being served with infringement complaint
Reasonable likelihood that petitioner would prevail on at least 1 claim
PatentsPublished patent appsPrinted publications
Raised or reasonably could have raised
CBM: Covered Business Method
-First available on Sept. 16, 2012-Applies to all patents related to “financial services” but excludes “technological inventions”
-More likely than not that at least 1 claim is unpatentable-Petitioner sued or “charged with infringement”
Any invalidity ground Narrow: Raised(USPTO and Civil) or reasonably could have raised (USPTO)
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Features
• Claim construction: Broadest reasonable interpretation• Burden of proof: Preponderance of the evidence• Limited discovery• Limited ability to amend claims• Fast relative to reexamination and district court litigation• Estoppel• Can be settled
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Background - Timeline
Early post-grant webinars speak to the timeline in detail:http://fishpostgrant.com/webinars-2012/http://fishpostgrant.com/webinars-2013/
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Post-Grant
Are defendants and license targets using Post-Grant?
• fishpostgrant.com• Details on each proceeding, timelines, links to searchable versions of relevant rules• 24+ hours of webinars on post-grant topics (audio and video)• News alerts, case summaries, case studies/testimonials• Listing of stays relating to IPR
• Fish Post-Grant App• Available for iPhone and Android through their respective app
stores• Details at fishpostgrant.com/app
• USPTO Sites:• AIA Main: http://www.uspto.gov/aia_implementation/index.jsp• Inter Partes: http://www.uspto.gov/aia_implementation/bpai.jsp