Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA 2023 - WEB

HatchWaxman

Hatch-Waxman and BPCIA

3rd Annual Passport to Proficiency on the Essentials of October 10–26, 2023 (EST) | Virtual Series

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

2023 Co-Chairs

Li Feng Partner

Finnegan, Henderson, Farabow, Garrett & Dunner LLP

Your Hatch-Waxman Proficiency Series:

CALENDAR-ALT 3 weeks, 2x weekly

Clock 18 hours of interactive learning and professional development

Comments Dedicated questions and answer period each day

video 8 class recordings for future reference

L

File-Alt Substantive resource materials for your daily work

Certificate of completion and CLE credits

Rachel Pernic Waldron Partner Rakoczy Molino Mazzochi Siwik

LLP

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

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

Welcome 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 10 & 12

Regulatory Foundation

y Interplay of the FDA and PTO

y Pre-Commercialization Concerns

y Link between the FDA Approval and the Patent Process

y The Orange Book

WEEK TWO: October 17 & 19

Hatch-Waxman and BPCIA Framework

y The Hatch-Waxman Landscape

y Paragraph IV Disputes and Litigation

y Biosimilars: BPCIA and aBLA Overview

y Participating in the Patent Dance

y The Purple Book

WEEK THREE: October 24 & 26

Focus on Bioequivalence, Exclusivity, Extensions, and Exceptions

y Bioequivalence & Interchangeability

y 180-Day Exclusivity

y Non-Patent/ Regulatory Exclusivity

y Exploring the Safe Harbor

y Examining Patent Extensions

The Hatch-Waxman and BPCIA Proficiency Series is designed for new Associates and business executives for the life sciences industry

LAW FIRMS WITH PRACTICE GROUPS IN

y Life Sciences, Pharmaceuticals, and Biopharmaceuticals

y Intellectual Property and Patents

y Patent and IP Litigation

y Hatch-Waxman and BPCIA litigation

y Patents, Trademark & Copyright

PHARMACEUTICAL COMPANIES

y In-House Counsel

y Business Development Executives

y C-Suite Executives and Associate Executives

linkedin: Hatch-Waxman: Paragraph IV and PTAB Legal Professionals

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

DISTINGUISHED SPEAKER FACULTY

2023 CO-CHAIRS

Li Feng Partner

Finnegan, Henderson, Farabow, Garrett & Dunner LLP

A robust and balanced FDA/patent linkage system is critical to incentivizing innovation and facilitating access to lower cost medicine. The USPTO and FDA has recently announced collaboration initiatives to further this goal. I am excited to join industry experts and government representatives to provide this foundational course for anyone who is interested in practicing at the intersections of FDA and patent law.

SPEAKERS

David B. Abramowitz Partner

Locke Lord LLP

Alison Baldwin Partner Faegre Drinker Biddle & Reath LLP

Frederick Ball Partner

Duane Morris LLP

Brian Burgess Partner Goodwin Procter LLP

USER

Michael A. Davitz, M.D. J.D. Partner

Leason Ellis LLP

Lara E. FitzSimmons Partner

Rakoczy Molino Mazzochi Siwik LLP

David Frazier Partner Latham & Watkins LLP

John Goetz Principal Fish & Richardson P.C.

Emily Greb Partner Perkins Coie LLP

Rachel Pernic Waldron Partner

Rakoczy Molino Mazzochi Siwik LLP

The biopharmaceutical space is ever-changing, and yet a thorough understanding of Hatch-Waxman and the BPCIA—not to mention the interaction between the USPTO and FDA–is essential to anyone working in this area. I am thrilled to be a part of this immersive series, which explores a variety of litigation and regulatory issues, including the interplay between these key agencies. I very much look forward to hearing from industry experts, including skilled advocates from ‘both sides of the v.

Dov Grossman Partner Williams & Connolly LLP

Thomas Irving Senior Partner

The Marbury Law Group, PLLC

Daniel Klein Counsel Groombridge, Wu, Baughman & Stone LLP

Sara W. Koblitz Director Hyman, Phelps & McNamara PC

Fabian Koenigbauer Partner Ice Miller LLP

Daniel P. Margolis Partner Allen & Overy LLP

Jordan Markham Partner Steptoe & Johnson LLP

Christina Markus Partner King & Spalding LLP

Matthew Murphy Partner Axinn, Veltrop & Harkrider LLP

Kyle Musgrove Partner Parker Poe Adams & Bernstein LLP

Christopher Noyes Partner Wilmer Cutler Pickering Hale and Dorr LLP

Maureen Rurka Partner Winston & Strawn LLP

Keeto Sabharwal Partner Husch Blackwell LLP

Gary Veron Partner Hogan Lovells

Bryan Vogel Partner Robins Kaplan LLP

Rob Vrana Partner Young Conaway Stargatt & Taylor, LLP

April Weisbruch Partner

McDermott Will & Emery LLP

Andrea Weiss Jeffries Partner Jones Day

WEEK ONE | DAY ONE

Tuesday, October 10th, 2023

1:00 pm

Co-Chair Opening Remarks

Li Feng Partner

Finnegan, Henderson, Farabow, Garrett & Dunner LLP

Rachel Pernic Waldron Partner

Rakoczy Molino Mazzochi Siwik LLP

MOD 1

The USPTO

• Review of the organizational structure of the USPTO

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

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

» Agency and inventorship

• What is the USPTO’s jurisdiction in the patenting of drugs and biologics?

1:15 pm

Key Agencies Overview: Understanding the Jurisdiction and Interplay of the FDA and USPTO in the Patenting of Drugs and Biologics

GENERIC:

David B. Abramowitz Partner

Locke Lord LLP

Understanding the respective roles and interplay of the FDA and USPTO in the patenting and approval of drugs and biological products:

FDA

• FDA overview and organization

» Department of Health and Human Services and the Commissioner

» The 5 FDA Centers and the Office of Regulatory Affairs and their functions

• CDER (Drug) and CBER (Biologic) overview

• Defining the scope of the FDA’s jurisdiction with respect to drugs and biologics

• Examining how the FDA exercises its jurisdiction:

» Rule making

» Product decisions

» Enforcement

» Informal mechanisms

• Reviewing the laws that the FDA enforces relative to the patenting of drug and biological products

» Food Drug & Cosmetic Act

» Prescription Drug Marketing Act

» Public Health Services Act

• Defining drugs and biologics

» Hatch-Waxman Act

» Other applicable laws

• Labeling: when is a drug a drug and not a biologic

• Working with the FDA

» Administrative Procedures Act

» formal and informal dispute resolution mechanisms

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

• Patent Reform Legislation

• Trademarks vis-à-vis drugs and biologics

2:45 pm

Identifying and Comprehending PreCommercialization Concerns Relative to Small Molecules and Biologics

GENERIC:

Michael A. Davitz, M.D. J.D. Partner Leason Ellis LLP

The current pre-commercialization landscape:

• Reviewing the types of products that pharmaceutical, biotechnology and biopharmaceutical companies seeking to develop now

• 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 will change 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

Questions and Answers

Thursday, October 12th, 2023

1:00 pm

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

BRAND: Alison Baldwin Partner

Faegre Drinker Biddle & Reath LLP

GENERIC: Sara W. Koblitz

Director

Hyman, Phelps & McNamara PC

Rx Drugs (new drugs)

• Identifying the application process for the approval of a new drug, i.e., small molecule, new chemical entities, etc.

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

• INDA (Investigational New Drug Application)

» How does it differ from an NDA?

• Accelerated approvals

» Defining eligibility criteria for accelerated approval and priority reviews

» 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?

• Why is it a “license,” rather than an “approved application”?

2:15 PM Break

2:30 pm

Small and Large Molecule Drug Patents and Other Related IP Protections and Mechanisms

BRAND: Thomas

Irving Senior Partner

The Marbury Law Group, PLLC

Patent Protections for Drug and Biologics

• Summarizing the patenting process for drugs and biologics

• 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

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

• Reviewing the 271(e)(1) “safe harbor” provision

• Distinguishing the patenting process for drugs from that of biologics

Trademark, Trade Name, and Trade Dress Protections

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

• Roles of the USPTO and FDA in the drug naming process

• Identifying the PTO 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: Andrea Weiss Jeffries Partner Jones Day

GENERIC: Emily Greb Partner Perkins Coie LLP

• 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

• 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

Questions and Answers

5:00 pm

Co-Chair Closing Remarks and Week One Adjourns

WEEK TWO | DAY ONE

Tuesday,

October 17th, 2023

1:00 pm

Co-Chair Opening Remarks

1:15 pm

The Hatch-Waxman Landscape: ANDAs, and Exclusivities

BRAND: Daniel Klein Counsel

Groombridge, Wu, Baughman & Stone LLP

GENERIC: Frederick Ball Partner Duane Morris 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

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

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

» Understanding the role of the Orange Book in the drug approval process

» Listings, de-listings and use codes

• Market exclusivities and protection

• Identifying the different types of exclusivities

» Regulatory exclusivity (FDA)/(data) exclusivity

ƒ NCE (new chemical entity)

» 5 years data exclusivity

ƒ Indication (new indication or use)

» 3 years marketing exclusivity

ƒ NDF (new dosage formulation)

ƒ ODE (orphan drug exclusivity)

ƒ PED (pediatric exclusivity)

2:45 PM Break

3:00 pm

Paragraph IV Disputes and Litigation

BRAND: Dov Grossman Partner Williams & Connolly LLP

GENERIC: Keeto Sabharwal Partner Husch Blackwell

• Exploring the ANDA Paragraph IV Certification, and response to Notice Letters

• Pre-suit considerations

» Initial pleadings

» Multiple ANDA filers

» Declaratory judgments

• Typical Paragraph IV litigation scenarios -hypotheticals

» 30-month stay; patent extensions; ANDA filer exclusivity (180 day)

• Preparing for parallel litigation before the PTAB

» IPR overview

• Hot buttons in Hatch-Waxman litigation

» Settlements

» Damages

» Double-patenting

4:30 pm

Questions and Answers

5:00 PM Day One Adjourns

Media Partners

linkedin: Hatch-Waxman: Paragraph IV and PTAB Legal Professionals

WEEK TWO | DAY TWO

Thursday, October 19th, 2023 MOD 4

1:00 pm

Biosimilars: The BPCIA, aBLA Overview

BRAND:

Daniel P. Margolis

Partner

Allen & Overy LLP

GENERIC: Bryan Vogel Partner

Robins Kaplan 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:

April Weisbruch

Partner

McDermott Will & Emery LLP

GENERIC:

Kyle Musgrovez Partner

Parker Poe Adams & Bernstein LLP

Virtual Sponsorship Opportunities

• 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

3:45 pm

The Purple Book

USER

BRAND: Maureen Rurka Partner Winston & Strawn LLP

G ENERIC: Gary Veron Partner Hogan Lovells

• What is the purple 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

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WEEK THREE | DAY ONE

Tuessday, October 24th, 2023

1:00 pm

Co-Chair Opening Remarks

1:15 pm

In-Depth Drill-Down on Bioequivalence, “Same Active Ingredient”, and Interchangeability

BRAND: Christina Markus Partner King & Spalding LLP

GENERIC: Jordan Markham

Partner Steptoe & Johnson LLP

• Defining bioequivalence in drugs and biologics

» Drugs v. biologics

• What an ANDA-filer must demonstrate for bioequivalence?

» Bioequivalence and dosage form – oral tablet/capsule, injection, nasal sprays, topical, nasal sprays

• How does bioequivalence relate to patents?

» 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

ƒ Infringement, copying (non-obviousness)

2:30 pm

An In-Depth Look at 180- Day Exclusivity

BRAND: Christopher Noyes

Partner WilmerHale

GENERIC: Brian Burgess Partner Goodwin Procter LLP

• Understanding 180-day generic market exclusivity under the Hatch-Waxman Act

» What are the qualifying criteria for exclusivity?

• 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

• 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: John Goetz

Principal Fish & Richardson P.C.

GENERIC: Lara E. FitzSimmons

Partner Rakoczy Molino Mazzochi Siwik LLP

• Understanding which drug products are eligible for regulatory exclusivity

» Small biologics v. biologics

• The different modes and methods of regulatory exclusivity (non-patent)

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

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

» NDF (new dosage formulation)

» ODE (orphan drug exclusivity)

» PED (pediatric exclusivity)

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

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

• When are each of these methods sought?

• Using trade dress as means of exclusivity

4:30 pm

Questions and Answers

5:00 PM Day One Adjourns

October 26th, 2023

1:00 pm

Assessing Patent Protections Afforded Under the Safe Harbor

BRAND: David Frazier Partner

Latham & Watkins LLP

GENERIC: Rob Vrana Partner Young Conaway Stargatt & Taylor, 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:

» Basic R&D

» New product screening

» Optimization

» Pre-clinical testing

» Post-approval testing

2:15 PM Break

2:30 pm

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

BRAND:

Fabian Koenigbauer Partner Ice Miller LLP

GENERIC: Matthew Murphy Partner

Axinn, Veltrop & Harkrider 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

• Important benchmarks in the drug’s development and patent timelines

• Eligibility for patent term extension

• Regulatory review period determinations

• How to calculate the patent term restored

» Respective roles of the FDA and USPTO in granting patent extensions

» Third-party challenges — “diligence”

• Patent term extensions outside the U.S.

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

» Strategies for:

ƒ Diligence in prosecution by the patent applicant

ƒ 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

Question and Answer Wild Card

4:45 pm

Co-Chair Final Comments and Bootcamp Adjourns

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