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

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Passport to Proficiency on the Essentials of

Hatch-Waxman and BPCIA A comprehensive series for life sciences lawyers and executives on the fundamentals as well as the intricacies of Hatch-Waxman and BPCIA litigation and regulation.

CALENDAR-ALT October 5–21, 2021 (EST)

Your Hatch-Waxman Proficiency Series will give you:

CALENDAR-ALT

3 weeks of 2x weekly in-depth instruction

Clock

18 hours of interactive learning for professional development

Comments Dedicated questions and answer period each day video 6 class recordings for future reference File-Alt

Substantive resource materials for your daily work Certificate of completion and CLE credits

Virtual Series

Join leading IP and regulatory counsel for in-depth training on: y The interplay of the PTO and FDA in the patenting of drugs and biologics y The essentials of the FDA approval process and its link to biopharma patents y Hatch-Waxman and BPCIA protocols, including: » Orange Book vs Purple Book » Bioequivalency » Exclusivities

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

y Paragraph IV litigation and the BPCIA patent dance y The “ins and outs” of patent term extension y The rules and exceptions of the safe harbor

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 biopharmaceutical arena.

W

elcome to ACI’s Hatch-Waxman and BPCIA Proficiency Series, a virtual three-week program designed to provide new lawyers and executives for the life sciences industry with a solid foundation for understanding the essentials as well as the intricacies of HatchWaxman 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.

A thorough understanding of Hatch-Waxman and the BPCIA is essential to anyone working in the biopharmaceutical area. This series, presenting virtually on our new 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. This program will lay the necessary foundation to understand the dynamics of the applicable patent life cycles for biopharmaceutical 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 5 & 7

WEEK TWO: October 12 & 14

WEEK THREE: October 19 & 21

Regulatory Foundation

Hatch-Waxman and BPCIA Framework

Focus on Bioequivalence, Exclusivity, Extensions, and Exceptions

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

y y y y y

y y y y y

The Hatch-Waxman Landscape Paragraph IV Disputes and Litigation Biosimilars: BPCIA and aBLA Overview Participating in the Patent Dance The Purple Book

Bioequivalence & Interchangeability 180-Day Exclusivity Non-Patent/ Regulatory Exclusivity Exploring the Safe Harbor 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

PHARMACEUTICAL COMPANIES y In-House Counsel y Business Development Executives y C-Suite Executives and Associate Executives

y Patents, Trademark & Copyright

2 | #HatchWaxman #BPCIA

twitter: @ACI_Pharma linkedin: ACI’s Hatch-Waxman Series

Practical Benefits of Attending this Series:

Distinguished Speaker Faculty CO-CHAIRS: Anne Shea Gaza Partner Young Conaway Stargatt & Taylor, LLP (Wilmington, DE) Gregory A. Morris, Ph.D Leader, Life Sciences Intellectual Property Litigation Practice Group Honigman LLP (Chicago, IL)

SPEAKER FACULTY: David B. Abramowitz Partner Locke Lord LLP (Chicago, IL) Christopher M. Bruno Partner McDermott Will & Emery (Washington, DC) Quintin Cassady Attorney, Former Vice President and General Counsel Galderma Laboratories (Fort Worth, TX) Scott A. Cunning Partner Parker Poe Adams & Bernstein, LLP (Washington, DC) Krista Hessler Carver Partner Covington & Burling LLP (Washington, DC) Bindu Donovan Partner Desmarais LLP (New York, NY) Lara E. Fitzsimmons Partner Rakoczy Molino Mazzochi Siwik LLP (Chicago, IL)

James Matthew Gould Counsel Ratner Prestia (Philadelphia, PA) Vishal C. Gupta Partner Steptoe & Johnson LLP (New York, NY) Jeffrey Alan Hovden Partner Robins Kaplan LLP (New York, NY) April Abele Isaacson Partner Kilpatrick Townsend & Stockton LLP (San Fransisco, CA) Omar Jabri Senior Director, Global Generic IP Apotex (Toronto, ON) Sara Koblitz Counsel Hyman, Phelps & McNamara, P.C. (Washington, DC) Fabian M. Koenigbauer Counsel Baker & Hostetler LLP (Washington, DC) Susan Krumplitsch Partner DLA Piper (Palo Alto CA) Rich Kurz Partner Haug Partners (New York, NY) Chad A. Landmon Partner Axinn, Veltrop & Harkrider LLP (Hartford, CT)

AmericanConference.com/Hatch-Waxman • 888 224 2480

Wan-Shon Lo Partner Morgan, Lewis & Bockius LLP (Chicago, IL) Aaron Lukas Ph.D. Member Cozen O’Connor (Washington, DC) Stephen B. Maebius Partner Foley & Lardner LLP (Washington, DC)

ĉ UNDERSTAND the interplay of the PTO and FDA in the patenting of drugs and biologics ĉ LEARN about the approval process for drugs and biologics and their connection to the patent process ĉ DEVELOP an in-depth and practical knowledge of Hatch-Waxman protocols, including: » Differences between NDAs, ANDAs, BLAs, aBLAs

Seth A. Mailhot Partner Husch Blackwell LLP (Washington, DC)

» The Orange Book vs. The Purple Book

Leslie-Anne Maxwell, Ph.D. Partner and Chair of the Pharmaceutical Patent Practice Cantor Colburn LLP (Hartford, CT)

» The Safe Harbor

Daniel M. Silver Partner McCarter & English, LLP (Wilmington, DE) Jeffrey D. Smyth Partner Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Palo Alto, CA) Alexander Varond Partner Goodwin Procter LLP (Washington, DC)

» 180 Exclusivity » Bioequivalency ĉ COMPREHEND the framework of Hatch-Waxman Paragraph IV litigation and BPCIA patent dance ĉ MAKE SENSE of the relationship between patent and non-patent exclusivity ĉ EXAMINE patent extensions including restorations and adjustments ĉ NAVIGATE the rules and exceptions of the safe harbor

Media Partners

Gary L. Veron Partner Hogan Lovells US LLP (Washington, DC) Jovial Wong Partner Winston & Strawn LLP (Washington, DC) Part of ACI’s PROFICIENCY SERIES

WEEK ONE | DAY ONE | Tuesday, October 5, 2021 (est) The PTO

1:00

Co-Chairs’ Opening Remarks

• Review of the organizational structure of the PTO

Anne Shea Gaza Partner Young Conaway Stargatt & Taylor, LLP

Gregory A. Morris, Ph.D Leader, Life Sciences Intellectual Property Litigation Practice Group Honigman LLP

1:15

Key Agencies Overview: Understanding the Jurisdiction and Interplay of the FDA and PTO in the Patenting of Drugs and Biologics James Matthew Gould Counsel Ratner Prestia

Seth A. Mailhot Partner Husch Blackwell LLP

• Patents: overview of drug and biological products that may be patented • Who may apply for a patent?

• What are the requirements for patentability?

• Trademark vis-à-vis drugs and biologics 2:30

Break

2:45

Identifying and Comprehending Pre-Commercialization Concerns Relative to Small Molecules and Biologics Chad A. Landmon Partner Axinn, Veltrop & Harkrider LLP

• Understanding the respective roles and interplay of the FDA and PTO in the patenting and approval of drugs and biological products

The current pre-commercialization landscape:

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

» 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

• 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 the evolving U.S. healthcare system: • 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

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

3:45

• Working with the FDA

Questions and Answers

» Administrative Procedures Act » Formal and informal dispute resolution mechanisms

4 | #HatchWaxman #BPCIA

Alexander Varond Partner Goodwin Procter LLP

4:15

Day One Adjourns

twitter: @ACI_Pharma linkedin: ACI’s Hatch-Waxman Series

WEEK ONE | DAY TWO | Thursday, October 7, 2021 (est) 1:00

Co-Chairs’ Opening Remarks 1:05

Exploring the Link Between the FDA Approval Process and the Patenting of Drugs and Biologics Krista Hessler Carver Partner Covington & Burling LLP 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) aka “IND” » How does it differ from an NDA? • Accelerated approvals 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?

2:15

Aaron Lukas Ph.D. Member Cozen O’Connor » 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

» Which products require BLAs instead of NDAs? • Why is it a “license,” rather than an “approved application”?

Break

2:30

Small and Large Molecule Drug Patents and Other Related IP Protections and Mechanisms Quintin Cassady Attorney, Former Vice President and General Counsel Galderma Laboratories Stephen B. Maebius Partner Foley & Lardner LLP

Daniel M. Silver Partner McCarter & English, LLP

Patent Protections for Drug and Biologics • Summarizing the patenting process for drugs and biologics

AmericanConference.com/Hatch-Waxman • 888 224 2480

• 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

The Orange Book: Listings, De-Listings, and Other Matters of Interest Vishal C. Gupta Partner Steptoe & Johnson LLP

Gary L. Veron Partner Hogan Lovells US 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 » Metabolites; polymorphs; intermediates » Product-by-process claims » Patents on unapproved uses 4:30

Questions and Answers 5:00

Co-Chairs’ Closing Remarks and Week One Adjourns Part of ACI’s PROFICIENCY SERIES

WEEK TWO | DAY ONE | Tuesday, October 12, 2021 (est) 1:00

2:45

Co-Chairs’ Opening Remarks

3:00

1:15

Paragraph IV Disputes and Litigation

The Hatch-Waxman Landscape: ANDAs, Economics, and Exclusivities

Bindu Donovan Partner Desmarais LLP

Sara Koblitz Counsel Hyman, Phelps & McNamara, P.C. Gregory A. Morris, Ph.D Leader, Life Sciences Intellectual Property Litigation Practice Group Honigman LLP

Break

Anne Shea Gaza Partner Young Conaway Stargatt & Taylor, LLP • Exploring the ANDA Paragraph IV Certification, and response to Notice Letters • Pre-suit considerations

• Overview of Hatch-Waxman Act and reforms

» Initial pleadings

• Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes

» Multiple ANDA filers

» 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

» 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

• 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) » 3 years marketing exclusivity

4:30

Questions and Answers 5:00

Day One Adjourns

NDF (new dosage formulation) ODE (orphan drug exclusivity) PED (pediatric exclusivity)

6 | #HatchWaxman #BPCIA

twitter: @ACI_Pharma linkedin: ACI’s Hatch-Waxman Series

WEEK TWO | DAY TWO | Thursday, October 14, 2021 (est) 1:00

3:45

Co-Chairs’ Opening Remarks

The Purple Book Leslie-Anne Maxwell, Ph.D. Partner and Chair of the Pharmaceutical Patent Practice Cantor Colburn LLP

1:05

Biosimilars: The BPCIA and aBLA Overview Susan Krumplitsch Partner DLA Piper

Jovial Wong 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”

Jeffrey D. Smyth Partner Finnegan, Henderson, Farabow, Garrett & Dunner LLP

• 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’

• FDA rulemaking and guidance relative to biosimilars

• Evaluating how new requirements of including patent information will impact the ‘patent dance’

• Other points for consideration: substitution, naming, patents, and additional nuances

• Appreciating the differences in the Orange Book and Purple Book listing

• The Purple Book

• Addressing how new information requirements will affect business strategies

• Examining biosimilar exclusivities 2:30

4:15

Questions and Answers

Break

2:45

4:45

“Shall We Dance”—Weighing the Pros and Cons of Participating in the BPCIA Patent Dance

Co-Chairs’ Closing Remarks and Week Two Adjourns

Christopher M. Bruno Partner McDermott Will & Emery

Scott A. Cunning Partner Parker Poe Adams & Bernstein, LLP

About us:

• 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

AmericanConference.com/Hatch-Waxman • 888 224 2480

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Part of ACI’s PROFICIENCY SERIES

WEEK THREE | DAY ONE | Tuesday, October 19, 2021 (est) • Exploring the interplay between the 30-month stay and 180-day exclusivity

1:00

Co-Chairs’ Opening Remarks

• Forfeiture provisions: identifying circumstances under which exclusivity is forfeited » Other circumstances that may trigger the loss of 180-day exclusivity

1:15

In-Depth Drill-Down on Bioequivalence, “Same Active Ingredient”, and Interchangeability Jeffrey Alan Hovden Partner Robins Kaplan LLP

Omar Jabri Senior Director, Global Generic IP Apotex

• 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

Comprehending the Intricacies of Non-Patent/Regulatory Exclusivity David B. Abramowitz Partner Locke Lord 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?

Fabian M. Koenigbauer Counsel Baker & Hostetler LLP

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

» Patenting of bioequivalence characteristics—extended-release drug products

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

» Bioequivalence v. Doctrine of Equivalents—what is the difference?

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

» Arguments about bioequivalence raised in Paragraph IV patent litigation

» NDF (new dosage formulation) » ODE (orphan drug exclusivity)

Infringement, copying (non-obviousness) 2:15

» PED (pediatric exclusivity)

Break

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

2:30

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

An In-Depth Look at 180-Day Exclusivity

• When are each of these methods sought?

Lara E. Fitzsimmons Partner Rakoczy Molino Mazzochi Siwik LLP • Understanding 180-day generic market exclusivity under the Hatch-Waxman Act » What are the qualifying criteria for exclusivity?

• Using trade dress as means of exclusivity 4:30

Questions and Answers 5:00

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 • 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?

8 | #HatchWaxman #BPCIA

twitter: @ACI_Pharma linkedin: ACI’s Hatch-Waxman Series

WEEK THREE | DAY TWO | Thursday, October 21, 2021 (est) • Patent term extensions outside the U.S.

1:00

Co-Chairs’ Opening Remarks

• Examining patent term adjustment due to delays in prosecution before the USPTO » Strategies for:

1:05

Diligence in prosecution by the patent applicant

Assessing Patent Protections Afforded Under the Safe Harbor Rich Kurz Partner Haug Partners

Wan-Shon Lo Partner Morgan, Lewis & Bockius LLP

• Exploring the safe harbor of the Hatch-Waxman Act 35 USC § 271(e)(1)

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.,

• Understanding the safe harbor’s scope of protection for otherwise infringing activities

» Maintaining patent position for second-generation products

• Examining the safe harbor protections afforded to research tool patents

» Approaches taken by pharmaceutical companies in obtaining second-generation patents

• Identifying safe harbor protections relative to:

» Enforcement of second-generation patents

» Basic R&D » New product screening

4:00

» Optimization

Question and Answer Wild Card

» Pre-clinical testing » Post-approval testing 2:15

Break

4:45

Co-Chairs’ Final Comments and Proficiency Series Adjourns

2:30

Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration April Abele Isaacson Partner Kilpatrick Townsend & Stockton 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

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• Regulatory review period determinations • How to calculate the patent term restored » Respective roles of the FDA and PTO in granting patent extensions » Third-party challenges — “diligence”

AmericanConference.com/Hatch-Waxman • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

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