Source: https://www.americanconference.com/paragraph-iv-disputes-3/agenda/
Timestamp: 2020-01-27 01:25:11
Document Index: 218683111

Matched Legal Cases: ['§101', '§112', '§112', '§101', '§101', '§ 112']

The Present State of Paragraph IV Litigation and Its Impact on the Pharmaceutical Industry: Legal Analyses and Business Prognoses
Addressing the Impact of a Uniform Claims Construction Standard: Panacea or Peril?
Helsinn v. Teva
The Supreme Court Weighs in on the On- Sale Bar and the State of Secret Prior Art
The Costs and the Consequences of Determining Venue Post-TC Heartland
Day One Afternoon Tracks A, B or C
Subject Matter Patentability and Written Description Reconsidered: Understanding the New §101 and §112 Conundrum
The Great Debate with District Judges
Latest FDA Initiatives Affecting Generic Drug Access and Pricing
Day Two Morning Tracks D, E or F
THE PTAB LIVE!
The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Challenges
Obviousness Case Study
Assessing Secondary Considerations in Light of Blocking Patents Post-Acorda
“Skinny Labeling” Revisited
The Evolving Induced Infringement Analysis
The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena
Working Group on Biosimilars for the Hatch-Waxman Practitioner
May 1, 2019 8:30am – 12:00pm
May 1, 2019 1:00pm – 4:30pm
Pearl T.L. Siew
Senior Vice President and Head, Intellectual Property
Investigating the most popular districts, filing trends, settlements and timings
Examining how judicial shortages in key districts are impacting ANDA litigation and venue selection
Understanding how this is influencing PTAB filings
Analyzing the connection between recent Paragraph IV filings and the speed of ANDA approvals
Studying IPR outcomes of Orange Book patents and appreciating the correlation with District Court litigation
Exploring when settlement is considered as a favorable outcome in an IPR and its consequences for related District Court litigation
Understanding how ANDA litigation outcomes affect business forecasts in this next era of the patent cliff
Appreciating how Paragraph IV outcomes impact business decisions from, R&D to licensing, to M&A activity and beyond
Akin Gump Strauss Hauer & Feld LLP (New York, NY)
Analyzing how the PTAB’s adoption of the Phillips standard is impacting Hatch-Waxman practice
Investigating the effect that a narrower claim construction standard will have on patentability rulings in both forums as well as the Federal Circuit
Developing new strategies for parallel proceedings in the District Courts and PTAB in view of a single standard
Weighing the future of parallel proceedings in view of a single standard adoption
Understanding the impact that the uniform standard will have on efficiency and cost of litigation
Honorable Kathleen M. O’Malley
United States Court of Appeals for the Federal Circuit (Washington, DC)
District of Delaware (Wilmington, DE)
Join us for a conversation with Judge O’Malley as she will provides exceptional insights into working at the Appellate Court tasked with reviewing the country’s patent cases.
Colman Ragan
VP & General Counsel, North America IP Litigation
Winston & Strawn LLP (Washington, DC)
On January 22, 2019, the Court released its opinion in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc., (Supreme Court No. No. 17-1229). This panel will explore the current state of on-sale bar jurisprudence as they engage in a lively point-counterpoint discussion in view of the monumental decision.
Reviewing the Supreme Court’s opinion and it its nuances relative to how a secret sale constitutes prior art
Understanding the Court’s interpretation of how the AIA altered the on-sale bar
Assessing whether prior art patents and printed publications will continue to play a central role in patent invalidations in a post-Helsinn world in light of the Court’s decision
Deciding whether an inventor’s sale of an invention to a third party that is required to keep the invention confidential qualifies as prior art for the purposes of determining patentability
Analyzing whether the phrase “available to the public” implies a distinct restraint on issuance or if it adjusts the two prior limitations that appear before it
Honigman LLP (Chicago, IL)
Senior Patent Counsel – Global IP, Head of Patent Litigation
At the time of this conference it will be nearly two years since the Supreme Court issued its ground-breaking decision on venue and jurisdiction in TC Heartland. However, confusion remains as to how the district courts and litigants should interpret the meaning of “where the defendant has committed acts of infringement and has a regular and established place of business.” As such, many district courts are allowing limited discovery to find the right place to file suit. This panel will explore the benefits, costs and consequences of this remaining and unsettled question.
Knowing when to seek discovery related to venue and jurisdiction in order to defeat a motion to dismiss based on improper venue under TC Heartland
Assessing the impact of TC Heartland on litigation costs for both plaintiffs and defendants relative to additional venue discovery
The Business of Pharmaceutical Patent Litigation: A Global Approach
Track Moderator: George Johnston Counsel Intellectual Property, Gibbons P.C.(Newark, NJ)
The Practice of Pharmaceutical Patent Litigation: Part I
Track Moderator: Shashank Upadhye Partner Amin Talati Upadhye (Chicago, IL)
The Hatch-Waxman Series Advisory Board on “The Three C’s”
Track Moderator: Pearl T.L. Siew Senior Vice President and Head, Intellectual Property Eagle Pharmaceuticals, Inc.
Director, Legal Counsel, IP
Gerald J. Flattmann Jr.
King & Spalding (New York, NY)
Akin Gump Strauss Hauer & Feld LLP (Philadelphia, PA)
Exploring the §112 and §101 nexus illustrated in recent ANDA cases
Understanding how the Federal Circuit’s decision in Affinity Labs of Texas, LLC v. Amazon.com, Inc., may impact Paragraph IV litigation
Examining the resurgence of 101 applicability in an ANDA setting
Drafting claims to avoid §101 roadblocks relative to pharmaceutical patent applications
Reviewing court-determined “adequate written descriptions” under § 112
Understanding the standard for determining the adequacy of the “written description” of the invention under this recent jurisprudence and how it applies in a Hatch-Waxman setting
Reviewing precedent where substantial evidence supports claims of adequate written description
Analyzing whether the true test of written description requirement is based on enablement versus possession
Norther District of Illinois (Chicago, IL)
Honorable Renee M. Bumb
Honorable Stanley R. Chesler
District of New Jersey (Newark, NJ)
Deputy Center Director, Regulatory Policy
Maryll Toufanian
Director Office of Generic Drug Policy, CDER
U.S. Food & Drug Administration (Silver Spring, MD)
Analyzing the status and findings of the FDA’s internal working group on Generic Competition
A Town Hall with the Magistrate Judges
Track Moderator: Honorable Mary Pat Thynge Chief Magistrate Judge District of Delaware (Wilmington, DE)(Newark, NJ)
The Practice of Pharmaceutical Patent Litigation: Part II
Track Moderator: Guy Donatiello Senior Vice President, Intellectual Property Endo Pharmaceuticals
New Developments in Market Access and Exclusivities
Track Moderator: Hon. Teresa Rea Partner Crowell & Moring LLP
(Former Acting Under Secretary of Commerce for IP and Former Acting Director of the U.S. Patent and Trademark Office) (Washington, DC)
Acting Director, Bureau of Competition
Vice Chief, Administrative
Honorable Michelle N. Ankenbrand
Honorable Rama G. Elluru
Surveying notable pharmaceutical patent wins and losses
Reviewing IPR, PGR and CBM filings involving pharmaceutical patents
Sterne Kessler Goldstein & Fox (Washington, DC)
Reviewing the expanding doctrine of blocking patents relative to secondary considerations
Exploring the difficulty of presenting evidence of “negative acts”
Considering which party bears the burden of proving the effect of the putative blocking patent
Determining how much proof is required to overcome the “solid premise of diminished incentive” when a blocking patent is invoked?
Analyzing how the Acorda decision effects the obviousness analysis
U.S. General Counsel and Global Head of IP
Examining precedent where Courts have found inducement to exist when there is an element of inevitability resulting in infringement
Surveying decisions on infringement based on drug labels for support of execution of the infringing acts
Identifying strategic considerations of labeling language based on this new jurisprudence
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (Boston, MA)
Marck Rachlin
GSK (King of Prussia, PA)
This session will identify common ethical dilemmas in Hatch-Waxman litigation and help you incorporate practices to avoid them. Points of discussion will include:
Establishing standards for determining when attorneys/firms should be disqualified based on conflict
Determining who is a client based on actual representation
Considering joint defense arrangements in the Hatch-Waxman setting and possible ethical predicaments
(Registration begins at 8:00 AM – Breakfast will be served) The Supreme Court delivered its groundbreaking decision in Sandoz Inc. v. Amgen Inc. in June of 2017, memorializing the first time the Court analyzed the Biologics Price Competition and Innovation Act (BPCIA) for the approval of biosimilar drugs. When discussing the BPCIA, the Court noted that it was a “a carefully calibrated scheme for preparing to adjudicate, and then adjudicating, claims of infringement” related to biosimilar applications, and granted more flexibility to biosimilar companies and filers of abbreviated biologics license applications. This intimate and interactive working group will examine the core components of the Court’s decision, and provide an analysis of biosimilar case law in the progeny that followed. Further, we will explore the approvalprocess and other key points of regulation for the benefit of Hatch-Waxman practitioners. Points of discussion will include:
An introduction to biologic drugs, biosimilars, the Biologics Price Competition and Innovation Act (BPCIA) abbreviated approval pathway, and statutory language
Discussing the FDA Draft Guidance documents on biosimilar product development
Making predictions for the future of biotech patents and biosimilar product development in the U.S.
Reviewing BPCIA cases at the Federal Circuit and District Court levels
(Registration begins at 12:30 PM) Parallel litigation in the District Court and PTAB in a Hatch-Waxman setting has become standard practice and adds to the “no-holds barred” atmosphere of this high stakes type of litigation. The art of navigating proceedings between to these two forums has been described as akin to walking a tightrope. In navigating these dual forums, even the most seasoned of litigators has a new appreciation for the intricacies of parallel litigation. They are developing best practices and also becoming aware of certain things to avoid in these procedures. In this interactive session, we will illustrate the “ins and outs” of IPR practice and appearing in dual proceedings in both the District Court and PTAB.