October 15 – 16, 2024
Hyatt Regency McCormick Place, Chicago, IL
The Hatch-Waxman Practitioners Think Tank on
Paragraph IV Disputes
The ANDA Litigation Strategy Symposium for Brand Name and Generics
Co-Chairs
Aaron F. Barkoff, Ph.D.
Associate Vice President –General Patent Counsel, IP Litigation
Eli Lilly, and Company
April E. Weisbruch
Partner
McDermott Will & Emery LLP
Kevin Zive Vice President, General Counsel, and Head of Global Intellectual Property Apotex Inc.
In-House Insights from:
• PhRMA
• BIO
• AbbVie
• BMS
• Eli Lilly
• Fresenius Kabi
• Hetero
• Jazz
• Meitheal
• Merck
Supporting Sponsor
Special Presentation by U.S. Magistrate Judges
Hon. Tonianne J. Bongiovanni
U.S. M.J. District of New Jersey
USPTO PTAB
Hon. Christopher J. Burke
U.S. M.J. District of Delaware
Hon. Sherry R. Fallon
U.S. M.J. District of Delaware
Hon. Jacqueline Bonilla
Deputy Chief Administrative Patent Judge; Senior Legal Advisor, Under Secretary of Commerce for Intellectual Property and Director USPTO
Key Program Highlights Include:
Check Spotlight on Chevron Overturned in Loper V. Raimondo
Check §112 Think Tank
Check Drill down on the Use of Clinical Trials as Prior Art
Associate Sponsors
FTC
Tim Kamal-Grayson Attorney, Healthcare Division Bureau of Competition, FTC
Check Focus on Patent Rights and Supply Chain Dynamics
Check Fireside Chat Future FDA Activity Affecting Small Molecules
Premium Exhibitor Conference Sponsor
Small molecule drugs are under attack.
The rules of the Hatch-Waxman litigation playbook are changing once again. Both brand and generic pharmaceutical manufacturers will need to assess patent portfolios and formulate strategies through a very different lens. In addition to patent expiration dates and invalidity challenges, they must now take into account the implementation of the Inflation Reduction Act, proposed use of the Bayh Doyle Act, and recent calls for the delisting of Orange Book patents by the FTC and in the District Courts. In short, this trifecta attack on small molecule patents cannot be ignored.
Obviousness Type Double Patenting and the Petition for Cert. in In re Cellect
Moreover, the petition for cert. in In re Cellect, and continued focus on fine-tuning claim strategies following Amgen v. Sanofi has added new layers of complexity to the offensive plays and defensive moves traditionally associated with the IP litigation landscape and pharmaceutical patent endgame.
…And then in a landmark ruling the Supreme Court overturned Chevron. A move the Biden Administration had previously warned could cause “convulsive shock” to the US legal system.
American Conference Institute (ACI) is pleased to announce that the 10th Anniversary The Hatch-Waxman Practitioners Think Tank on Paragraph IV Disputes will return to Chicago on October 15 – 16, 2024 to address these concerns and more, and with consideration for the competing interests of brand and generics.
We invite you to join our esteemed faculty of industry decision-makers and counsel, for analysis of some of the most significant Hatch-Waxman cases and practical insights that will help inform future business decisions and legal strategies in this intense political environment.
Enhanced Learning with Early Riser Roundtables and Focused Discussions:
CHEVRON-RIGHT A Breakfast with ACI’s Hatch Waxman Advisory Board (Closed Door)
CHEVRON-RIGHT Discussion on DEI Leadership for Pharmaceutical Patent Practitioners
Patent attorneys and litigators (in-house & law firms) who represent:
• Brand name pharmaceutical companies
• Generic pharmaceutical companies
• Biopharmaceutical companies
EARN CLE/ ETHICS CREDITS
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.
ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board. ACI certifies this activity has been approved for CLE credit by the State Bar of California.
ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.
For more information on ACI’s CLE process, visit: www.AmericanConference.com/Accreditation/CLE
Speaker Faculty
Distinguished Chairs
Aaron F. Barkoff, Ph.D.
Associate Vice President – General Patent Counsel, IP Litigation Eli Lilly and Company
April E. Weisbruch
Partner
McDermott Will & Emery LLP
Kevin Zive
Vice President, General Counsel, and Head of Global Intellectual Property
Apotex Inc.
Members of the Judiciary
Hon. Tonianne J. Bongiovanni
Magistrate Judge
United States District Court, District of New Jersey
Hon. Christopher J. Burke
Magistrate Judge
United States District Court, District of Delaware
Hon. Sherry R. Fallon
Magistrate Judge
United States District Court, District of Delaware
USPTO Patent Trial and Appeal Board
Hon. Jacqueline Bonilla
Deputy Chief Administrative Patent Judge; Senior Legal Advisor, Under Secretary of Commerce for Intellectual Property and Director USPTO
Government Representatives
Tim Kamal-Grayson Attorney Federal Trade Commission (FTC)
Brad Watts
Vice President, Global Innovation Policy Center US Chamber of Commerce
Trade Associations
David Korn
Vice President, Intellectual Property (IP) and Law PhRMA
Hans Sauer, Ph.D., J.D.
Deputy General Counsel, Vice President, Intellectual Property Biotechnology Innovation Organization
In-House Counsel
James Cekola
Corporate Counsel, IP
Jazz Pharmaceuticals
Ryan M. Daniel
Vice President, Associate General Counsel, Corporate and Business
Transactions
Fresenius Kabi USA, LLC
Laura DeMoor
Senior Counsel
Baxter Healthcare
Guy Donatiello
Principal Odyssey Pharmaceuticals Consulting (Former SVP, IP, Endo Pharmaceuticals)
Melissa El Menaouar
Senior IP Counsel Sumitomo Pharma
Linda Friedlieb
Vice President,
Intellectual Property Litigation AbbVie
Roy Issac
Senior IP Counsel
Bristol Myers Squibb
Mary J. Morry Counsel, IP Litigation
Merck Sharp & Dohme LLC
Vijay Nasare
Vice President, Intellectual Property and Portfolio Management Hetero
Cynthia Sun Director, Legal Counsel
Meitheal Pharmaceuticals Inc.
Law Firm Counsel
John Abramic Partner
Steptoe LLP
John T. Bennett Partner
A&O Shearman
Jeremy Cobb Partner
Arnold & Porter LLP
Jenna Rea Deneault Partner
Groombridge, Wu, Baughman & Stone LLP
Tasha Francis Gerasimow Partner Kirkland & Ellis LLP
Bradley C. Graveline Partner
Sheppard Mullin, Richter & Hampton LLP
Colleen Tracy James Partner
Cahill Gordon & Reindel LLP
Kurt R. Karst
Director
Hyman, Phelps & McNamara PC
Josephine Kim Director
Sterne, Kessler, Goldstein & Fox P.L.L.C.
Maarika L. Kimbrell Partner
Morgan Lewis & Bockius LLP
Ha Kung Partner
Venable LLP
Chad Landmon Partner Polsinelli
Michael E. McCabe, Jr. Managing Partner McCabe Ali LLP
Alejandro Menchaca Shareholder
MacAndrews, Held & Malloy, Ltd.
Mercedes Meyer Partner
Banner Witcoff
Don Mizerk Partner
Husch Blackwell LLP
Gregory A. Morris Partner
O'Melveny & Myers LLP
Brian Nolan Partner
Mayer Brown
Kevin E. Noonan Partner
McDonnell Boehnen Hulbert & Berghoff LLP
Kevin Prussia Partner
WilmerHale
Rich Ruzich Partner
Taft
Ellen Scordino Partner
DLA Piper
Emer Simic Partner
Neal, Geber & Eisenberg LLP
Steven H. Sklar Partner
Leydig, Voit & Mayer, Ltd
Shashank Upadhye Partner
Upadhye Tang LLP
Ruud van der Velden Partner
Hogan Lovells International LLP
Jason Winchester Partner
Jones Day
Vanessa Yen Partner
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
ACI’s Hatch-Waxman Series Advisory Board
American Conference Institute’s Hatch-Waxman Series Advisory board was created as a part of ACI’s ongoing effort to provide industry leading content and a world-renowned speaker faculty. The board is composed of a selection of all-in-house advisers, including Chief IP and very senior IP/Patent counsel from the leading brand name and generic pharmaceutical companies in the country and in some cases the world. This ‘inner circle’ counsels ACI on the impact of litigation trends and emerging topics.
Ryan M. Daniel
AGC, Corporate and Business Transactions Fresenius Kabi USA, LLC
Laura DeMoor Senior Counsel Baxter Healthcare
Stephanie Donahue
Head of Global Patent Litigation, Global Intellectual Property Department, Legal, Ethics & Business Integrity Sanofi
Serena Farquharson-Torres
Executive Director, Assistant General Counsel Bristol Myers Squibb
Linda Friedlieb
Vice President, Intellectual Property Litigation AbbVie
Colin Heitzmann Vice President, IP and Business Development Daiichi Sankyo, Inc.
Stephen R. Auten
Partner, Chair of Pharmaceutical & Life Sciences Litigation
Taft Stettinius & Hollister LLP
(Former Vice President, IP, Sandoz, Inc.)
Guy Donatiello
Senior Vice President, Intellectual Property Endo Pharmaceuticals
Jenny Johnson Vice President, IP Endo Pharmaceuticals
Staci Julie
SVP and Chief IP Counsel Teva Pharmaceuticals
Neema Kumar
Vice President, IP, North America Sandoz
James P. Leeds
Assistant General Patent Counsel Eli Lilly & Company
Mary Morry Counsel, IP Litigation Merck & Company
Jeffrey N. Myers, Ph.D.
Vice President & Assistant General Counsel Pfizer Inc
Aaron Pereira
Senior Director of Patents Ferring Pharmaceuticals
Emeritus Members
George W. Johnston Counsel
Gibbons P.C.
(Former Vice President & Chief Patent Counsel, Hoffmann-La Roche)
Honorable Kathleen M. O’Malley (Ret.) Of Counsel
Sullivan & Cromwell LLP
(Former United States Circuit Judge, U.S. Court of Appeals for the Federal Circuit)
Brian Stone
Associate General Counsel Global Legal-Regulatory Viatris
Lars P. Taavola
VP, Chief IP Counsel & General Counsel, Specialty Generics Mallinckrodt Pharmaceuticals
Andrea D. Tiglio
Executive Director, Assistant General Counsel, Intellectual Property
Jazz Pharmaceuticals
Maryll W. Toufanian
Senior Vice President, Regulatory Strategy and Government Affairs Amneal Pharmaceuticals
Kevin Zive
Vice President, General Counsel, and Head of Global Intellectual Property Apotex Inc.
Honorable Teresa Rea Consultant
Rea Consulting LLC
(Former Acting Director of the USPTO)
Shashank Upadhye Partner
Upadhye Tang LLP
(Former Vice President – Global Intellectual Property, Apotex, Inc.)
Peter Waibel
Head, US Patent Litigation
Novartis Pharmaceuticals Corporation
Day One | Tuesday, October 15, 2024
7:00 Registration and Networking Breakfast
7:30
Breakfast with the Chicago Chapter of ACI’s Hatch Waxman Advisory Board
Connect over coffee and a light breakfast at this pre-conference think tank for in house counsel. This closed-door meeting will be by invitation only. Led by members of ACI’s Hatch-Waxman Advisory Board, and senior counsel from leading brand and generic pharmaceutical companies, this breakfast presents a unique opportunity to benchmark with other in-house legal teams and fine-tune strategies on the 3Cs. Attendance is limited to 15 in-house counsel attendees. To apply: [Details to come]
Topics to be discussed include:
• “Cost”, will offer insights on the monitoring of legal spend and balancing a budget
• “Competency”, will provide best practices for overcoming talent limitations with demonstrable advice
• “Communication”, will engage attendees in the art of communicating value and fostering collaboration between corporate legal counsel and outside
8:30 Opening Remarks from the Co-Chairs
Aaron F. Barkoff, Ph.D.
Associate Vice President –General Patent Counsel, IP Litigation Eli Lilly and Company
April E. Weisbruch Partner McDermott Will & Emery LLP
8:45 State of the Union on Small Molecule Patents
Ryan M. Daniel
Vice President, Associate General Counsel, Corporate and Business Transactions
Fresenius Kabi USA, LLC
Laura DeMoor
Senior Counsel
Baxter Healthcare
Kevin Zive
Vice President, General Counsel, and Head of Global Intellectual Property
Apotex Inc.
Kevin Zive Vice President, General Counsel, and Head of Global Intellectual Property Apotex Inc.
In recognition of the 40th Anniversary of the Hatch Waxman Act, this session will analyze the current state of play for small molecule patents, Paragraph IV litigation, and pending political threats to industry. Panelists will examine shifts in the small molecule market. This will be followed by a discussion on the levers and tools being used by the Biden Administration to lower drug prices. Delve into the strategic pre-suit considerations and anticipate the future use of these methods after the November 2024 election.
Part I: Special Focus on Loper Bright Enterprises v. Raimondo
• Analyzing how the Loper Bright decision will affect federal agencies and the application of statutes impacting the life sciences industry
» FDA » FTC
» USPTO
• Anticipating future litigation challenging federal agency interpretations of statutes
• Devising IP strategies in a landscape where federal agencies are no longer shielded by the Chevron Deference Doctrine
Part II: IRA, Orange Book Delistings, Bayh Doyle Act
• Analyzing trends in small molecule patent filings and Paragraph IV litigation
• Assessing the extent to which innovator companies are shifting the focus of the business to biologics/biosimilars
• Scaling the next ledge of the patent cliff with market erosion expected through 2030
• Pending legislation influencing pharmaceutical patent rights
» PREVAIL » PERA » BIOSECURE Act
• Understanding how the presidential invocation of Bayh Doyle march in rights, FTC’s delisting strategy and IRA form a trifecta attack on pharmaceutical patents
» Assessing what this means for the future of Hatch Waxman
• Monitoring ongoing legal challenges over the constitutionality of the Inflation Reduction Act
• Assessing the potential impact of drug pricing negotiations under the IRA on IP patent litigation
» Negotiating settlements prior to the IRA process
• Evaluating the impact on innovation and the pursuit of additional orphan indications
• Examining draft guidance on prerequisites to exercise March-in rights on “high-priced” federally funded drugs
MODERATOR:
Mercedes Meyer Partner
Banner Witcoff
David Korn
Vice President, Intellectual Property (IP) and Law PhRMA
Hans Sauer, Ph.D., J.D. Deputy General Counsel, Vice President, Intellectual Property
Biotechnology Innovation Organization
Brad Watts
Vice President, Global Innovation Policy Center US Chamber of Commerce
10:15 Morning Coffee and Networking Break
10:45
Assessing Patent Portfolios Post In Re Cellect: Insights on Obviousness Type Double Patenting, PTA and Terminal Disclaimers
Cellect has filed a petition for certiorari with the Supreme Court following a district court decision that held that statutory patent term adjustment could be invalidated on ODP grounds through earlier expiring patents. The petition for en banc rehearing was denied. The Supreme Court will now consider whether to grapple with the question of the ODP doctrine and its ability to override the congressional guarantee of PTA. This session will parse the Cellect case, and the implications for patent portfolios moving forward.
• Analyzing the impact of the Federal Circuit’s holding in recent Hatch-Waxman cases
» Comparing Allergan case to In re Cellect
• Using the In re Cellect decision to audit patent portfolios for ODP concerns
• Navigating loss of exclusivity for a product
• Devising strategies in drafting claims for first filed and subsequent continuation applications to avoid OTDP concerns
• Adapting approaches to patent prosecution and litigation
Special Focus on §103
Emer Simic Partner
Neal, Geber & Eisenberg LLP
James Cekola
Corporate Counsel, IP
Jazz Pharmaceuticals
Ellen Scordino Partner
DLA Piper
11:45 Examining the Use of Clinical Trials as Prior Art: How to Thread the Needle on Protecting IP and Mandated Disclosures
Innovators are flagging concerns over clinical trials being used against them as prior art in the district courts and IPR. In Salix Pharms., Ltd. V. Norwich Pharms. Inc., the federal circuit upheld a district court decision to invalidate method of treatment claims for obviousness, making it an important time to discuss best practices for managing disclosures and protecting IP.
• Distinguishing between publication of clinical trials and how that creates publication-based-prior-art; and whether the clinical trial itself is public-use-prior-art
• Determining whether patient confidentiality and other confidentiality agreements amongst clinical investigators eliminates the public use prong of prior art
• Examining how generics are using clinical trial summaries as evidence of obviousness to challenge patents through IPR and the district courts
• Understanding how patent examiners view clinical trials published on ClinicalTrials.gov
• Reconciling IP protection with FDA disclosure rules for clinical trials
• Devising filing strategies to maximize patent term while managing risk of invalidation
» Considerations for dosing regimen patents
• Reviewing the Federal circuit’s analysis of:
• Janssen v. Teva, Salix v. Norwich Pharms. Inc., Vanda Pharms.Inc. v. Teva Pharms. USA inc.
John T. Bennett Partner
A&O Shearman
Kevin Prussia Partner
WilmerHale
Bradley C. Graveline Partner
Sheppard Mullin, Richter & Hampton LLP
1:30 Musings from Chief IP Counsel and General Counsel: A Roundtable Discussion on In House Strategy for the Current Pharmaceutical IP Landscape
This panel will delve into the inner workings of two vitally important in-house legal functions and the importance of the relationship between the two. Join Chief IP Counsel and General Counsel from both brand and generic manufacturers for a discussion on how they work together to enforce IP, develop strategy, and navigate an increasingly unpredictable political landscape, alongside Hatch-Waxman concerns. Panelists will also share dos, don’ts, and other key considerations for outside counsel.
• Exploring the critical relationship between General Counsel and Chief IP Counsel: brand and generic perspectives
» Identifying in house criteria for selecting outside counsel
» Understanding how to provide value to in house and build better relationships
» Overcoming litigation funding challenges
In-house best practices for managing budgets in different litigation scenarios
Exploring alternative fee arrangements
» Examining brand and generic considerations for Hatch-Waxman settlements
MODERATOR: Guy Donatiello Principal, Odyssey Pharmaceuticals Consulting (Former SVP, IP, Endo Pharmaceuticals)
Mary J. Morry Counsel, IP Litigation Merck Sharp & Dohme LLC
Cynthia Sun Director, Legal Counsel
Meitheal Pharmaceuticals Inc.
2:15 §112 Think Tank: Brand Name and Generic Perspectives on Patent Claim Strategies and Enablement
• Analyzing how the district courts are applying directives from the Supreme Court ruling on Amgen v. Sanofi
• Developing strategies to make use of the full scope of the invention without creating exposure
• Generic insights on how this influences future patents being targeted under PIV
• Satisfying the enablement standard
• Determining whether to use functional claiming in view of the Supreme Court ruling
» Recent USPTO guidance on means plus function claiming
• Navigating the interplay between written description and enablement when drafting claims
Roy Issac Senior IP Counsel
Bristol Myers Squibb
Steven H. Sklar Partner Leydig, Voit & Mayer, Ltd
3:00 European Perspectives on Claims Drafting and Plausibility and its Impacts on Hatch-Waxman Strategies in the US
Less than a year after the U.S. Supreme Court Decision on Amgen v. Sanofi, comes a similar result at the UPC. The Munich Central Division ruled that Amgen's patent for a cholesterol lowering drug is not valid, marking a successful challenge for both Sanofi and Regeneron. This session will offer a continuation of our conversation §112 concerns and how to approach written description and enablement in other jurisdictions. Hold the UPC’s analysis up against the US Supreme Court decision and reconcile strategies for global portfolios.
• Comparing the UPC decision with the U.S. Supreme Court’s findings
• Examining the concept of plausibility vis-a-vis enablement
• Understanding how the UPC’s final ruling may affect your global small molecule patent strategies
» Brand and generic outlook
3:30 Afternoon Networking and Refreshment Break
Ruud van der Velden Partner Hogan Lovells International LLP
Special Panel Presentation
3:45 Magistrate Judges on the Present Paragraph IV Litigation Landscape: Analysis of Filing
Trends, Settlements and Timings
Hon. Tonianne J. Bongiovanni
Magistrate Judge
United States District Court, District of New Jersey
Hon. Christopher J. Burke
Magistrate Judge
United States District Court, District of Delaware
Hon. Sherry R. Fallon
Magistrate Judge
United States District Court, District of Delaware
In this special presentation, a distinguished panel of Magistrate Judges will offer perspectives on Paragraph IV litigation dockets as well as decisionmaking practices. This ‘views from the bench’ panel will provide practical insights for both patent holders and patent challengers.
4:45
Patent Rights and Supply Chain Dynamics: Understanding How Developments in India May Affect Hatch-Waxman
India is the world’s generic drug capital, and no stranger to the US Hatch Waxman schematic. This session will address how changes in IP law as well as supply chain dynamics in the developing world and API procurement are matters of concern, not only for generics, but for brands as well.
• Assessing the potential for US brand companies to seek injunctive relief in Indian Courts to block the manufacture/export of ANDA products to the USA
• Examining how recent changes to the MADE In America Act may now permit Indian companies to make constituent or whole products in India that can be sold to the US government
• Analyzing the impact of FDA inspections on the manufacture and export to the US market
• Forecasting potential post-election action on pharmaceutical API and the manufacturing of pharmaceutical products
• Using litigation in India and other jurisdictions to inform US strategies
5:30 Cocktail Reception
Shashank Upadhye Partner
Upadhye Tang LLP
Vijay Nasare
Vice President, Intellectual Property and Portfolio Management Hetero
Global Sponsorship Opportunities
With conferences in the United States, Canada, Latin America and Europe, the C5 Group of Companies: American Conference Institute, Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world. Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us at: SponsorInfo@AmericanConference.com
Day 2| Wednesday, October 16, 2024
7:15 Registration Opens and Breakfast Served
8:00 Co-Chairs Opening Remarks
Aaron F. Barkoff, Ph.D. Associate Vice President –General Patent Counsel, IP Litigation Eli Lilly and Company
April E. Weisbruch Partner McDermott Will & Emery LLP
Zive Vice President, General Counsel, and Head of Global Intellectual Property Apotex Inc.
8:15 Advancing DEI in the IP Life Sciences Legal Landscape
DEI is fast becoming a key priority for in house legal teams as well as many law firms —especially in the realm of IP – where the gender gap is still significant. Creating more opportunities for women in STEM and promoting diversity in the life sciences is a critical step towards building an inclusive industry, that benefits from diverse perspectives.
It is an important time to come together to discuss what DEI success looks like for different organizations, the value it brings to teams, and the ways in which in house and outside counsel can work together to move the dial on DEI together in this current climate.
MODERATOR:
Jenna Rea Deneault Partner
Groombridge, Wu, Baughman & Stone LLP
Colleen Tracy James Partner Cahill
Spotlight on Antitrust and FTC Enforcement
Linda Friedlieb Vice President, Intellectual Property Litigation AbbVie
Josephine Kim Director Sterne, Kessler, Goldstein & Fox P.L.L.C.
9:15 PART 1: Orange Book Patent War Room: Devising a Strategy to Defend Your Patents from Government Delisting Attempts
In November 2023 and April 2024, FTC collectively challenged more than 300 Orange Book patents as “improper” or “inaccurate” listings. The FTC has also stated that it may initiate further investigations of unfair competition under section 5 of the FTC act. In this session we will explore defensive moves to protect your patent from delisting. We will also examine the generics perspective on this matter.
• Overview of recent FTC scrutiny of Orange Book patents, Amicus Curiae, and congressional activity
• Identifying the type of patents the FTC had flagged as “improperly” listed
Kevin E. Noonan Partner McDonnell Boehnen Hulbert & Berghoff LLP
» Evaluating portfolios in view of FTC activity and anticipating what patents could be targeted next by the FTC
• Determining what steps to take after receiving an FTC notice letter to delist a patent
» Assessing the consequences of withdrawing, amending the patent listing, or leaving it unchanged
• Preparing for potential litigation stemming from the FTC’s calls to delist certain patents
• Anticipating how the FTC may make good on its warning to invoke FTC Act and what offensive and defensive moves industry may use considering this warning
• Assessing FDA guidance on complying with Orange Book listing requirements
» Strengthening due diligence to avoid FTC scrutiny
• Preparing for delisting as a strategy in the district courts following the decision in the Teva v. Amneal case
10:00 PART II: Round-up on Reverse Payment Settlements: Do’s, Don’t and Other Key Takeaways from Antitrust Litigation and Third-Party Payor
• Tracking trends in anti-competitive settlements between brand and generics, agency actions and third-party payor lawsuits
• Calculating the potential damages associated with settlements if deemed anti-competitive
• Examining related state antitrust ligation litigation concerning
» Examining recent jury trials in California
Tim Kamal-Grayson Attorney Federal Trade Commission (FTC)
Don Mizerk Partner Husch Blackwell LLP
Lawsuits
Tasha Francis Gerasimow Partner Kirkland & Ellis LLP
Kevin
10:30 Morning Coffee Break
10:45 Fireside Chat on the
Future of the FDA: Regulatory Initiatives, and Agency Developments for Hatch Waxman Practitioners to Watch
Staying abreast of the latest FDA developments enables Hatch Waxman practitioners to navigate the regulatory process efficiently and put a strategic plan in place for future litigation. This session will examine new FDA initiatives and notable developments with implications for both brand and generics.
Key areas of focus:
• Unpacking new and impending regulatory developments with implications for pharmaceutical patents
• Interpreting FDA guidance on Orange Book patent listings following FTC’s use of the Patent Dispute Process
• Monitoring progress on collaborative initiatives between the FDA and USPTO
• Reviewing recent legislative proposals
• Examining how recent challenges to the Chevron framework could impact future rulemaking and FDA litigation
• Reviewing current FDA litigation
» United Therapeutics v. FDA, Jazz v. FDA; Neurelis v. FDA
» Endo/Par v. FDA
• Addressing trade secret disclosure concerns when the FDA provides recommendations to ANDA applicants derived from the NDA application process
11:45 In
Chad Landmon Partner Polsinelli
Maarika L. Kimbrell Partner
Morgan Lewis & Bockius LLP
MODERATOR:
Kurt R. Karst Director
Hyman, Phelps & McNamara PC
Conversation with the PTAB: Preparing for Proposed Changes to Practices, Policies and Procedures
Join the PTAB for a conversation focused on:
• Analyzing IPR utilization trends for patent validity challenges by generics
» Assessing if this route is being taken prior to filing ANDAs, adjunct to litigation
• Examining the potential impact of proposed PTAB reforms:
» Discretionary denials
» Defining parallel and serial petition practices
» Termination and settlement agreements
12:30 Lunch Break
1:30 Skinny Labeling and Induced Infringement Revisited: Analyzing the Latest in Section viii Carveout Cases
• Exploring assessment of the label in recent cases to determine what is sufficient or not to prove infringement
• Analyzing takeaways from recent decisions on induced infringement
» Amarin Pharmaceuticals, Inc. v. Hikma Pharmaceuticals USA Inc.
• Examining the Federal Circuit’s opinion on Salix v. Norwich
» Assessing the use of post-trial ANDA amendments to carve out an infringing use
Hon. Jacqueline Bonilla Deputy Chief Administrative Patent Judge; Senior Legal Advisor, Under Secretary of Commerce for Intellectual Property and Director USPTO
INTERVIEWED BY: Gregory A. Morris Partner O'Melveny & Myers LLP
Alejandro Menchaca Shareholder MacAndrews, Held & Malloy, Ltd.
Melissa El Menaouar Senior IP Counsel Sumitomo Pharma
MODERATOR: Ha Kung Partner Venable LLP
Jason Winchester Partner Jones Day
2:30 Risky Business: At-Risk Launch Scenarios from Both the Brand and Generic Point of View
• Brand and generic perspectives on how At-Risk Launch strategies
» Generic perspectives on the cost benefit analysis for an at-risk launch
Assessing timing
Calculating potential damages
TRO considerations
» Brand perspectives on strategies to prevent and respond to an at-risk launch scenario 3:15
Networking and Refreshment Break
3:30 Anticipating the Impact of AI on Drug Discovery and Future Hatch- Waxman Litigation
• Exploring current and future opportunities to leverage AI in life sciences and IP and understanding how this may influence Hatch-Waxman litigation
» Drug discovery
» Patent prosecution
» E-discovery
• Examining how in house counsel and outside firms using AI in Paragraph IV litigation
• Identifying the risks of using publicly available AI for inventorship
• Complying with USPTO rules when using AI
• Drafting legal submissions for the PTAB
• Determining the level of human involvement required for an AI assisted invention to be patentable
» Anticipating where future litigation on AI assisted inventorship could arise and potential defenses
4:15 Ethics for the Hatch Waxman Practitioner: A Scenario Based Discussion on Conduct, Communication and the Conundrums that Can Arise
• Exchanging tips for patent prosecutors and litigators
» Listing prior art in the patent specification and in the information disclose statement
» Determining whether you need to identify prior art in the specification generically or specifically and in addition to the IDS
• Avoiding imputed conflicts of interest with future clients through the client interviews
» Examining key steps to take when a client reaches out
• Navigating disclosures in the joint representation of clients
• Reviewing the Practical aspects of the Attorney Client Privilege and Work Product Doctrine
» Defining and comparing ACP and WPD
» Exploring how this differs in different jurisdictions e.g. India, EU
5:15 Conference Concludes
Events
Venue Information
Hyatt Regency McCormick Place – Chicago 2233 South Martin Luther King Drive, Chicago, Illinois 60616 Phone: 1 312-567-1234
ACCOMMODATIONS
American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote "ACIN".
Please note that the guest room block cut-off date is September 27, 2024. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.
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Register and pay to lock in your early rate and be eligible for a full refund until October 1, 2024.
If you are unable to attend for any reason, you will have the following options:
y A full credit note for you, or a colleague to attend another event.
y A full refund.
All cancellations and changes must be submitted to CustomerService@AmericanConference.com by October 1, 2024.