4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - WEB

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HatchWaxman

4th Annual Passport to Proficiency on the Essentials of

SERIES

Hatch-Waxman and BPCIA October 8–24, 2024 | Virtual Series (EST)

A comprehensive series designed to provide lawyers and executives in the life sciences industry with the essentials and intricacies of Hatch-Waxman and BPCIA litigation and regulation, as well as a solid foundation for understanding the commercialization and pre-approval processes for drugs, biologics and biosimilars.

2024 Co-Chairs Fangli Chen, Ph.D. Partner Proskauer Rose LLP

Jason Murata Partner Axinn, Veltrop & Harkrider

Your Hatch-Waxman Proficiency Series:

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3 weeks, 2x weekly

18 hours of interactive learning and professional development

Dedicated questions and answer period each day

Recordings of all sessions for future reference

Substantive resource materials for your daily work

Certificate of completion and CLE credits

Join leading life sciences IP and regulatory counsel to help you understand: y Interplay of the USPTO and FDA in the patenting of drugs and biologics y Essentials of the FDA approval process and its link to pharma and biopharma patents

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y In-depth and practical knowledge of Hatch-Waxman and BPCIA protocols, including: » Orange Book vs Purple Book » Bioequivalency » Exclusivities

» Differences between NDAs, ANDAs, BLAs, aBLAs » The Safe Harbor

y Paragraph IV litigation and the BPCIA patent dance y ‘Ins and outs’ of patent term extension

REGISTER NOW AmericanConference.com/Hatch-Waxman • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the pharma, biotech, and biopharma arenas.

W

elcome to ACI’s Hatch-Waxman and BPCIA Proficiency Series, a three-week virtual proficiency series designed to provide new lawyers and executives in the life sciences industry with a solid foundation for understanding the essentials and intricacies of Hatch-Waxman and BPCIA litigation and regulation.

Everyone who works in the life sciences industry must be well versed in the regulatory components and IP subtleties that play such an integral role in the patenting of its products.

This series, presented virtually on our state of the art interactive platform, will provide an in-depth review of Hatch-Waxman and the BPCIA, as well as other IP basics relative to small molecules and biologics. Join our distinguished speaker faculty as they lay the necessary foundation to understand the dynamics of the applicable patent life cycles for pharma and biopharma products and business development plans.

Sessions will take place each Tuesday and Thursday afternoon in October for 3 weeks.

Here’s what you can expect will be covered each week: WEEK ONE: October 8 & 10

WEEK TWO: October 15 & 17

WEEK THREE: October 22 & 24

Regulatory Foundation

Hatch-Waxman and BPCIA Framework

Focus on Bioequivalence, Exclusivity, Extensions, and Exceptions

y Interplay of the FDA and PTO

y The Hatch-Waxman Landscape

y Bioequivalence & Interchangeability

y Pre-Commercialization Concerns

y Paragraph IV Disputes and Litigation

y 180-Day Exclusivity

y Link between the FDA Approval and the Patent Process

y Biosimilars: BPCIA and aBLA Overview

y Non-Patent/ Regulatory Exclusivity

y Participating in the Patent Dance

y Exploring the Safe Harbor

y The Purple Book

y Examining Patent Extensions

y The Orange Book

The Hatch-Waxman and BPCIA Proficiency Series is designed for new associates, junior partners, and business executives in the life sciences industry LAW FIRMS WITH PRACTICE GROUPS IN • Life Sciences, Pharmaceuticals, and Biopharmaceuticals

• Hatch-Waxman and BPCIA Litigation

• Follow-on Biologics and Biosimilars

• Regulatory and Commercialization

• Intellectual Property and Patent Prosecution

• Trademark & Copyright

• Patent and IP Litigation

• Life Sciences IP Antitrust

PHARMA AND BIOPHARMEUTICAL COMPANIES • C-Suite Executives and Associate Executives

• Business Development Executives and Managers

• In-House Counsel (IP, Regulatory, Corporate, Litigation)

2 | LINKEDIN Hatch-Waxman: Paragraph IV and PTAB Legal Professionals

DISTINGUISHED SPEAKER FACULTY 2024 CO-CHAIRS Brand:

Generic:

Fangli Chen, Ph.D. Partner Proskauer Rose LLP

Jason Murata Partner Axinn, Veltrop & Harkrider

Legal and business professionals who work in the life sciences industry must be well versed in the regulatory components and IP issues that play an integral role in the protection of companies’ products. I am excited to be a part of this immersive series, which explores a variety of patent and regulatory issues, including essentials and intricacies of Hatch-Waxman and BPCIA litigation and regulation. The Series is so comprehensive, it truly stands apart as the best option to train newer lawyers and in-house counsel and I look forward to overseeing the Series as Co-Chair this October.

Patent litigation continues to generate numerous consequential precedents that impact the strength and scope of patent rights covering pharmaceutical and biopharmaceutical innovations.

Further, legislators and regulators continue to increase their oversight of the pharmaceutical and biopharmaceutical industries.

This Series promises to cover the essentials of the litigation, regulatory, and business landscape relating to these industries to give attendees a proficiency with the fundamentals of patent prosecution, exclusivities, patent litigation, commercialization, and more. I’m proud to co-chair such a comprehensive Series, especially at a time where all attorneys increasingly need to have a holistic and multifaceted understanding of the legal and business aspects of these complex industries.

SPEAKERS Caleb Bates Principal Fish & Richardson P.C. Brianne Bharkhda Partner Covington & Burling LLP Naomi Birbach Partner Goodwin Procter LLP Thomas J. Campbell Jr. Partner Neal, Gerber & Eisenberg LLP Shannon K. Clark Partner Venable LLP Jason Conaty Counsel, Global Regulatory Hogan Lovells US LLP Bradford C. Frese Partner ArentFox Schiff Claire Fundakowski Partner Winston & Strawn LLP

Christopher M. Gallo Director Sterne, Kessler, Goldstein & Fox PLLC

Samuel T. Lockner Partner Carlson Caspers Vandenburgh & Lindquist, PA

Adam P. Samansky Member Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Tasha Francis Gerasimow, Ph.D. Partner Kirkland & Ellis LLP

Alejandro Menchaca Shareholder McAndrews, Held & Malloy, Ltd.

Andrew Wasson Partner Haug Partners LLP

Vishal Gupta Partner Steptoe LLP

Don J. Mizerk Partner Husch Blackwell LLP

Sandra Haberny, Ph.D Partner Quinn, Emanuel, Urquhart & Sullivan LLP

George O'Brien FDA Partner Mayer Brown

Abeba Habtemariam Partner Arnold & Porter LLP Daniel J. Klein Partner Groombridge, Wu, Baughman & Stone LLP Sara Koblitz Director Hyman, Phelps & McNamara P.C.

Matthew Piscitelli Attorney Foley Hoag LLP Tara M. Raghavan Partner Benesch Friedlander Coplan & Aronoff LLP Christy G. Rothwell, Ph.D. Partner FisherBroyles, LLP

REGISTER NOW AmericanConference.com/Hatch-Waxman • 888 224 2480

M. David Weingarten Partner Finnegan, Henderson, Farabow, Garrett & Dunner LLP April Weisbruch Partner McDermott Will & Emery LLP Joshua Whitehill Counsel Brown Rudnick LLP Samantha G. Wilson Partner Young Conaway Stargatt & Taylor, LLP Aviv Zalcenstein Partner Gemini Law LLP

Part of ACI’s PROFICIENCY SERIES

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WEEK ONE | DAY ONE Tuesday, October 8, 2024 (EST) The USPTO

1:00 pm

Co-Chair Opening Remarks

• Review of the organizational structure of the PTO

Brand:

• Patents: overview of drug and biological products that may be patented

Fangli Chen, Ph.D. Partner Proskauer Rose LLP

• Who may apply for a patent? What are the requirements for patentability?

Generic:

• What laws and regulations does the PTO enforce relative to the patenting of drugs and biologics?

» agency and inventorship • What is the PTO’s jurisdiction in the patenting of drugs and biologics?

Jason Murata Partner Axinn, Veltrop & Harkrider

• Patent Reform Legislation • Trademarks vis-à-vis drugs, biologics and biosimilars

1:15 pm

2:30 pm Break

Key Agencies Overview: Understanding the Jurisdiction and Interplay of the FDA and the USPTO in the Patenting of Drugs and Biologics Brand: Naomi Birbach Partner Goodwin Procter LLP

2:45 pm

Identifying and Comprehending Pre-Commercialization Concerns Relative to Small Molecules and Biologics Brand: Sandra Haberny, Ph.D Partner Quinn, Emanuel, Urquhart & Sullivan LLP

Generic: Adam P. Samansky Member Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Understanding the respective roles and interplay of the FDA and USPTO in the patenting and approval of drugs and biological products:

FDA

Generic: Christopher M. Gallo Director Sterne, Kessler, Goldstein & Fox PLLC The current pre-commercialization landscape: • Reviewing the types of products that pharmaceutical, biotechnology and biopharmaceutical companies seeking to develop now

• FDA overview and organization » Department of Health and Human Services and the Commissioner » The 6 FDA Centers and the Office of Regulatory Affairs and their functions • CDER (Drug), and CBER (e.g., Office of Therapeutic Biologics and Biosimilars, OTBB) in-depth review • Defining the scope of the FDA’s jurisdiction with respect to drugs, biologics and biosimilars • Examining how the FDA exercises its jurisdiction: » rule making

» enforcement

» product decisions

» informal mechanisms

• Reviewing the laws that the FDA enforces relative to the patenting of drug and biological products » Food Drug & Cosmetic Act

» Hatch-Waxman Act

» Prescription Drug Marketing Act

» Other applicable laws

» Public Health Services Act • Defining drugs and biologics • Labeling: when is a drug a drug and not a biologic • Working with the FDA » Administrative Procedures Act » Formal and informal dispute resolution mechanisms

• Identifying impediments – through patent or regulatory restraint — which prevent these companies from pursuing the development of the desired product • FDA hurdles that may not clear even if all patent and other IP hurdles are met • Techniques for analyzing the value the product adds to the company's portfolio, and methods for proving value • Assessing the competition and analyzing potential therapeutic interchange considerations

Considerations in light of Health Care Reform: • Understanding how the introduction of follow-on biologics and biosimilars has changed the commercial landscape • Examining the role of the Center for Medicare and Medicaid Services (CMS) in the approval process and its impact on R&D » The connection between CMS approval and commercial viability via government payor systems and rebates » Comparative effectiveness 3:45 pm

Questions and Answers 4:15 pm Day One Adjourns

4 | LINKEDIN Hatch-Waxman: Paragraph IV and PTAB Legal Professionals

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WEEK ONE | DAY TWO Thursday, October 10, 2024 (EST) 1:00 pm

• Patent Term Extension (“PTE”) / Patent Term Adjustment (“PTA”) synopsis

Exploring the Link between the FDA Approval Process and the Patenting of Drugs and Biologics

• Reviewing the 271(e)(1) “safe harbor” provision • Distinguishing the patenting process for drugs from that of biologics

Brand:

Trademark, Trade Name, and Trade Dress Protections

Thomas J. Campbell Jr. Partner Neal, Gerber & Eisenberg LLP

• Overview of selecting a brand name for a proposed drug product

Regulatory: Matthew Piscitelli Attorney Foley Hoag LLP Rx Drugs (new drugs) • Identifying the application process for the approval of a new drug, i.e., small molecule, new chemical entities, etc.

• Roles of the USPTO and FDA in the drug naming process • Identifying the USPTO and FDA clearances necessary for trade name/ trademark approval on your product • Understanding the importance of trade dress • How does the branding process work for your product 3:30 pm

The Orange Book: Listings, De- Listings and Other Matters of Interest Brand:

• NDA (New Drug Application): definition, contents and regulatory overview

M. David Weingarten Partner Finnegan, Henderson, Farabow, Garrett & Dunner LLP

• INDA (Investigational New Drug Application) aka “IND” » how does it differ from an NDA? • Accelerated approvals

Generic:

» defining eligibility criteria for accelerated approval and priority reviews

Bradford C. Frese Partner ArentFox Schiff

» what portions of approval submissions might FDA release and when?

• Using advisory committees in the approval process

Biologics • How does the approval process for a biologic differ from that of a drug?

• BLA (Biological Licensing Application): application and filing » how does a biologic differ from a drug? » which products require BLAs instead of NDAs? 2:15 pm Break 2:30 pm

Small and Large Molecule Drug Patents and Other Related IP Protections and Mechanisms Brand: Caleb Bates Principal Fish & Richardson P.C. Generic: Samuel T. Lockner Partner Carlson Caspers Vandenburgh & Lindquist, PA

• What is the Orange Book, what does it contain, and why is it orange? » FDA’s publication on Approved Drug Products with Therapeutic Equivalence Evaluations • Understanding the role of Orange Book listings in patent life cycle management and patent portfolio management • Exploring the continuing dilemma of which patents should be listed, delisted, and held in reserve • Examining the FDA’s position on not listing a patent • Understanding the FTC’s increased focus on listing and de-listing patents in the Orange Book • Overcoming challenges associated with listing patented information in the product label and indications discovered in clinical testing » incorporating long term patent listing strategies into label negotiations with FDA » the ongoing skinny labeling and carve – out conundrum • Assessing the scope of potential Orange Book listing controversies relative to: » device patents » product-by-process claims » metabolites; polymorphs; intermediates » patents on unapproved uses 4:30 pm

Patent Protections for Drug and Biologics

Questions and Answers

• Summarizing the patenting process for drugs and biologics

5:00 pm

• Strategies for building patent protection for drugs and biologics • Applying for and achieving extension of patent term for time spent in the drug approval process

Co-Chair Closing Remarks and Week One Adjourns

REGISTER NOW AmericanConference.com/Hatch-Waxman • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

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WEEK TWO | DAY ONE Tuesday, October 15, 2024 (EST) 1:00 pm

2:45 pm Break

Co-Chair Opening Remarks

3:00 pm

1:15 pm

Paragraph IV Disputes and Litigation

The Hatch-Waxman Landscape: ANDAs, and Exclusivities

Brand: Brianne Bharkhda Partner Covington & Burling LLP

Brand: Shannon K. Clark Partner Venable LLP

Generic: Don J. Mizerk Partner Husch Blackwell LLP

Generic: Samantha G. Wilson Partner Young Conaway Stargatt & Taylor, LLP • Overview of Hatch-Waxman and reforms • Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes » Reviewing fundamentals of applications

• Exploring the ANDA Paragraph IV Certification, and response to Notice Letters • Pre-suit considerations » Initial pleadings » Multiple ANDA filers » Declaratory judgments

• Examining ANDA Standards for approval and the concepts of sameness and bioequivalence

• Typical Paragraph IV litigation scenarios -hypotheticals

• Special considerations: local acting drugs, labeling carve outs and other nuances

• Preparing for parallel litigation before the PTAB

» Understanding the role of the Orange Book in the drug approval process » Listings, de-listings and use codes

» 30-month stay; patent extensions; ANDA filer exclusivity (180 day) » IPR overview • Hot buttons in Hatch-Waxman litigation » Settlements

• Market exclusivities and protection

» Damages

• Identifying the different types of exclusivities

» Double-patenting

» Regulatory exclusivity (FDA)/ (data) exclusivity NCE (new chemical entity) » 5 years data exclusivity indication (new indication or use)

4:30 pm

Questions and Answers 5:00 pm Day One Adjourns

» 3 years marketing exclusivity NDF (new dosage formulation) ODE (orphan drug exclusivity) PED (pediatric exclusivity)

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6 | LINKEDIN Hatch-Waxman: Paragraph IV and PTAB Legal Professionals

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WEEK TWO | DAY TWO Thursday, October 17, 2024 (EST) 1:00 pm

3:45 pm

Biosimilars: The BPCIA, aBLA Overview

The Purple Book

Brand:

Brand:

Abeba Habtemariam Partner Arnold & Porter LLP

April Weisbruch Partner McDermott Will & Emery

Generic:

Generic:

Aviv Zalcenstein Partner Gemini Law LLP

Claire Fundakowski Partner Winston & Strawn LLP

• Overview of biosimilar legislation and regulations, i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA) • Understanding the rationale for safety and efficacy concerns surrounding second generation biologics or aBLAs • Exploring the concepts of “biosimilarity” or “interchangeability” • FDA rulemaking and guidance relative to biosimilars • Other points for consideration: substitution, naming, patents, and additional nuances • The Purple Book • Examining biosimilar exclusivities 2:30 pm Break 2:45 pm

“Shall We Dance” — Weighing the Pros and Cons of Participating in the BPCIA Patent Dance Brand: Vishal Gupta Partner Steptoe LLP Biosimilar: Claire Fundakowski Partner Winston & Strawn LLP

• What is the book and what does it contain? » Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations • FDA’s interpretation of what is included in the list • Understand the obligations of Reference Product sponsors under Section 325 (“Biological Product Patent Transparency”), ‘The Purple Book Act’ • Evaluating how new requirements of including patent information will impact the ‘patent dance’ • Appreciating the differences in the Orange Book and Purple Book listing • Addressing how new information requirements will affect business strategies 4:15 pm

Questions and Answers 4:45 pm

Co-Chair Closing Remarks and Week Two Adjourns Media Partners

• Deciding when to provide notice of commercial marketing • Addressing contentions and controversies in the aBLA information exchange • Understanding how biosimilar applicants can command the stride of litigation under the BPCIA • Evaluating what is “manufacturing information” • Appreciating the limitations on declaratory judgment actions • Analyzing the biosimilar and innovator perspectives when deciding whether to dance

REGISTER NOW AmericanConference.com/Hatch-Waxman • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

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WEEK THREE | DAY ONE Tuessday, October 22, 2024 (EST) 1:00 pm

Co-Chair Opening Remarks 1:15 pm

In-Depth Drill-Down on Bioequivalence, “Same Active Ingredient”, and Interchangeability Brand: Jason Conaty Counsel, Global Regulatory Hogan Lovells US LLP Generic: Joshua Whitehill Counsel Brown Rudnick LLP • Defining bioequivalence in drugs and biologics

• Deciphering the FDA’s new interpretation of pre- and post- MMA 180 day exclusivity » what are the implications of this interpretation for products having ANDA’s filed prior to the enactment of the MMA? • Exploring the interplay between the 30-month stay and 180-day exclusivity • Forfeiture provisions: identifying circumstances under which exclusivity is forfeited » Other circumstances that may trigger the loss of 180-day exclusivity • When can the 180-day exclusivity period be transferred to another ANDA applicant?

• Evaluating when the 180-day exclusivity period can be relinquished, and exploring the consequences defining "shared exclusivity" 3:30 pm

Comprehending the Intricacies of Non-Patent/ Regulatory Exclusivity Brand:

» drugs v. biologics

George O'Brien FDA Partner Mayer Brown

• What an ANDA-filer must demonstrate for bioequivalence? » bioequivalence and dosage form – oral tablet/capsule, injection, nasal sprays, topical, nasal sprays

Generic:

• How does bioequivalence relate to patents?

Sara Koblitz Director Hyman, Phelps & McNamara P.C.

» patenting of bioequivalence characteristics – extended-release drug products » bioequivalence v. Doctrine of Equivalents – what is the difference? » arguments about bioequivalence raised in Paragraph IV patent litigation infringement, copying (non-obviousness)

• Understanding which drug products are eligible for regulatory exclusivity » small biologics v. biologics • The different modes and methods of regulatory exclusivity (non-patent)

2:15 pm Break

» NCE (new chemical entity): 5 years marketing exclusivity/5 years data exclusivity

2:30 pm

» indication (new indication or use): 3 years marketing exclusivity

An In-Depth Look at 180- Day Exclusivity

» NDF (new dosage formulation)

Brand:

» ODE (orphan drug exclusivity)

Andrew Wasson Partner Haug Partners LLP

» PED (pediatric exclusivity) • FD&C 505b2 (alternate pathway to ANDA) a/k/a paper NDA

Generic:

• When are each of these methods sought?

Alejandro Menchaca Shareholder McAndrews, Held & Malloy, Ltd. • Understanding 180-day generic market exclusivity under the HatchWaxman Act » what are the qualifying criteria for exclusivity?

• What role does the FDA play in regulating these modes of exclusivity?

• Using trade dress as means of exclusivity 4:30 pm

Questions and Answers 5:00 pm Day One Adjourns

• How can an ANDA applicant really determine who is "first-to-file" and win 180-day exclusivity?

• Identifying triggers for the running of the 180-day exclusivity period

8 | LINKEDIN Hatch-Waxman: Paragraph IV and PTAB Legal Professionals

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WEEK THREE | DAY TWO Thursday, October 24, 2024 (EST) 1:00 pm

• Patent term extensions outside the U.S.

Assessing Patent Protections Afforded Under the Safe Harbor

• Examining patent term adjustment due to delays in prosecution before the USPTO

Brand: Tasha Francis Gerasimow, Ph.D. Partner Kirkland & Ellis LLP Generic: Tara M. Raghavan Partner Benesch Friedlander Coplan & Aronoff LLP • Exploring the safe harbor of the Hatch-Waxman Act 35 USC § 271(e)(1) • Understanding the safe harbor’s scope of protection for otherwise infringing activities • Examining the safe harbor protections afforded to research tool patents • Identifying safe harbor protections relative to:

» strategies for: diligence in prosecution by the patent applicant calculating the adjustment period • Understanding the link between patent extensions and exclusivity » extensions obtained through FDA Pediatric Exclusivity and Orphan Drug Exclusivity • Obtaining patent coverage for pharmaceuticals through the use of second-generation patents, e.g., » maintaining patent position for second-generation products » approaches taken by pharmaceutical companies in obtaining second-generation patents » enforcement of second-generation patents 4:00 pm

» basic R&D

Question and Answer Wild Card

» new product screening

4:45 pm

» optimization » pre-clinical testing » post-approval testing

Co-Chair Final Comments and Proficiency Series Adjourns

2:15 pm Break 2:30 pm

Brand:

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.

Daniel J. Klein Partner Groombridge, Wu, Baughman & Stone LLP

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

Generic:

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration

Christy G. Rothwell, Ph.D. Partner FisherBroyles, LLP • Extension of patent term under 35 U.S.C. § 156 and 37 CFR 1.710 – 1.791 • Exploring the viability of extension applications to: » basic and combination compounds; secondary patents

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• Important benchmarks in the drug’s development and patent timelines • Eligibility for patent term extension • Regulatory review period determinations

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• How to calculate the patent term restored

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» respective roles of the FDA and PTO in granting patent extensions » third-party challenges — “diligence”

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