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?

YES!!

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Post-Grant: Number of Filings (2/24/15)

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Post-Grant: Overall Technology Breakdown

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Post-Grant: Petition Dispositions (2/24/15)

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Who is Filing?

Generics

• Accord Healthcare

• Amneal• Apotex• Aurobindo• Breckenridge• Impax• Mylan

• Par• Perrigo• Ranbaxy• Roxanne• Sandoz• Sun• Torrent

Non- Generics

• BioDeliverySciences

• Eli Lilly• Endo• Galderma• MonoSol Rx

• Phigenix• Purdue• Shire• St Jude

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Who has been Targeted?

AllerganAlza

Alcon PharmaBrigham and Women's

HospitalBTG International

Choongwae Pharma. Corp.Cubist

DepomedEli LillyEndo

GenentechGilead

Grifols SAHelsinn Healthcare SA

ImmunogenJazz Pharma

LifeScanKyoto University

MayoMerck

MonoSol RX, LLCMyriad Genetics

NovartisReckitt BenckiserRoche Palo Alto

Senju Pharma. Co., Ltd

SupernusUCLA Med. Ctr.

Univ. of MichiganUniv. of Utah

VertexViiv HealthcareWyeth (Pfizer)

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IPR vs District Court

IPR Timing

IPR Written Decision - 18 months CAFC Decision - 18 months

DCT Timing

TrialFact Discovery Expert Discovery

18 months 4 months

30 months to End of Stay/Typical Written Decision

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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

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Thank You!

Dorothy WhelanFish & RichardsonPrincipalwhelan@fr.com

Chad ShearFish & RichardsonPrincipalshear@fr.com

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Leslie RobbinsCoherus BioSciencesVice President, Intellectual Propertylrobbins@coherus.com

Contact Fish & Richardson

Download the presentation and access other valuable materials at www.fishlifesciences.com

Contact us with your questions and comments.

Robin Chance Senior Marketing Manager Fish & Richardsonchance@fr.com; +1-612-766-2023

© Copyright 2015 Fish & Richardson P.C. These materials may be considered advertising for legal services under the laws and rules of professional conduct. The materials contained in this presentation has been gathered by the lawyers at Fish & Richardson P.C. for informational purposes only and is not intended to be legal advice. Transmission is not intended to create and receipt does not establish an attorney-client relationship. Legal advice of any nature should be sought from legal counsel. For more information about Fish & Richardson P.C. and our practices, please visit www.fr.com