Impact of IPR in Hatch-Waxman and Biologics Strategies Presented By: Leslie Robbins, Dorothy Whelan, and Chad Shear 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.
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) 2
Proceeding When Does It Apply? Legal standard Grounds (Prior Art) PGR: Postgrant 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 Estoppel? Raised or reasonably could have raised IPR: Inter partes review (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 Patents Published patent apps Printed 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) 3
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 4
Background - Timeline Early post-grant webinars speak to the timeline in detail: http://fishpostgrant.com/webinars-2012/ http://fishpostgrant.com/webinars-2013/ 5
Post-Grant Are defendants and license targets using Post-Grant? YES!! 6
Post-Grant: Number of Filings (2/24/15) 7
Post-Grant: Overall Technology Breakdown 8
Post-Grant: Petition Dispositions (2/24/15) 9
Who is Filing? Generics Non- Generics Accord Healthcare Amneal Apotex Aurobindo Breckenridge Impax Mylan Par Perrigo Ranbaxy Roxanne Sandoz Sun Torrent BioDelivery Sciences Eli Lilly Endo Galderma MonoSol Rx Phigenix Purdue Shire St Jude 10
Who has been Targeted? Allergan Alza Alcon Pharma Brigham and Women's Hospital BTG International Choongwae Pharma. Corp. Cubist Depomed Eli Lilly Endo Genentech Gilead Grifols SA Helsinn Healthcare SA Immunogen Jazz Pharma LifeScan Kyoto University Mayo Merck MonoSol RX, LLC Myriad Genetics Novartis Reckitt Benckiser Roche Palo Alto Senju Pharma. Co., Ltd Supernus UCLA Med. Ctr. Univ. of Michigan Univ. of Utah Vertex Viiv Healthcare Wyeth (Pfizer) 11
IPR vs District Court IPR Timing IPR Written Decision - 18 months CAFC Decision - 18 months DCT Timing 18 months 4 months Fact Discovery Expert Discovery Trial 30 months to End of Stay/Typical Written Decision 12
Resources General Info 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 13
Thank You! Leslie Robbins Coherus BioSciences Vice President, Intellectual Property lrobbins@coherus.com Dorothy Whelan Fish & Richardson Principal whelan@fr.com Chad Shear Fish & Richardson Principal shear@fr.com 14
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