Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA 2022 - WEB

Hatch-Waxman and BPCIA

Vishal Gupta

Hatch-Waxman Proficiency Series

Litigation Partner,

of U.S. Life Sciences Practice Allen & Overy

counsel

Elizabeth Holland

Welcome 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 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.

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.

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

EXPERT INSTRUCTORS

2022 Co-Chairs

Vishal Gupta

Partner, Co-Chair of Life Sciences Practice Steptoe & Johnson LLP

Speakers

Michael J. Abernathy Partner

Morgan, Lewis & Bockius LLP

David B. Abramowitz Partner Locke Lord LLP

Alison J. Baldwin Partner

Faegre Drinker Biddle & Reath LLP

David I. Berl Partner Williams & Connolly LLP

David Bloch Partner GreenbergTraurig LLP

Anna Brook Partner Culhane Meadows PLLC

Robert Cerwinski Partner Gemini Law LLP

Brian Coggio Of Counsel Fish & Richardson

Scott Cunning Partner Parker Poe Adams & Bernstein LLP

Mark Deming Shareholder Polsinelli LLP

Hear from Our Co-Chairs!

NOW

Elizabeth Holland

IP Litigation Partner, Head of U.S. Life Sciences Practice Allen & Overy

Li Feng Partner

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Whitney Meier Howard Partner Venable LLP

Patrick C. Gallagher Partner Duane Morris LLP

Matthew M. Kamps Partner Husch Blackwell LLP

Sara W. Koblitz Director Hyman, Phelps & McNamara PC

Fabian Koenigbauer Partner Ice Miller

Susan Krumplitsch Partner

DLA Piper

Chad Landmon Partner

Axinn, Veltrop & Harkrider LLP

Adam P. Samansky Member

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Keri L. Schaubert Member Cozen O'Connor

Lance A. Soderstrom Partner

Katten Muchin Rosenman LLP

Eric Alan Stone Partner

Weiss, Rifkind, Wharton & Garrison LLP

Alexander J. Varond Partner Goodwin Procter LLP

Rachel Pernic Waldron Partner

Rakoczy, Molino, Mazzochi, Siwik LLP

Emily R. Whelan Partner

Wilmer Cutler Pickering Hale and Dorr LLP

Joshua A. Whitehill Partner Kasowitz Benson Torres LLP

Samantha G. Wilson Associate Young Conaway Stargatt & Taylor, LLP

Jason Winchester Partner Jones Day Vanessa Yen Partner King & Spalding LLP

1:00 pm

Co-Chair Opening Remarks

Vishal Gupta

Partner, Co-Chair of Life Sciences Practice

Steptoe & Johnson LLP

Elizabeth Holland

IP Litigation Partner, Head of U.S. Life Sciences Practice Allen & Overy

The PTO

• Review of the organizational structure of the PTO

• 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 PTO’s jurisdiction in the patenting of drugs and biologics?

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

• Patent Reform Legislation

1:15 pm

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

Adam P. Samansky

Member

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Patrick C. Gallagher Partner

Duane Morris LLP

• Understanding the respective roles and interplay of the FDA and PTO 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

• Trademarks vis-à-vis drugs and biologics

2:30 pm Break

2:45 pm

Identifying and Comprehending PreCommercialization Concerns Relative to Small Molecules and Biologics

Matthew M. Kamps Partner

Husch Blackwell LLP Chad Landmon Partner

Axinn, Veltrop & Harkrider 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

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

• Working with the FDA

» Administrative Procedures Act

» formal and informal dispute resolution mechanisms

» 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

1:00 pm

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

Alexander J. Varond Partner Goodwin Procter LLP

Keri L. Schaubert Member Cozen O'Connor

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

» 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

David I. Berl Partner Williams & Connolly LLP Anna Brook Partner Culhane Meadows 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

Li Feng Partner

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

David Bloch Partner

GreenbergTraurig 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

1:00 pm

Co-Chair Opening Remarks

1:15 pm

The Hatch-Waxman Landscape: ANDAs, and Exclusivities

Alison J. Baldwin Partner

Faegre Drinker Biddle & Reath LLP Lance A. Soderstrom Partner Katten Muchin Rosenman 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

Jason Winchester Partner Jones Day Rachel Pernic Waldron Partner

Rakoczy, Molino, Mazzochi, Siwik LLP

• 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

Elizabeth Holland, IP Litigation Partner, Head of U.S. Life Sciences Practice, Allen & Overy LLP

be very impressed with the quality of the content of ACI’s Proficiency Series, in no small part thanks to the fantastic teachers ACI engages!

1:00 pm

Biosimilars: The BPCIA, aBLA Overview

Vanessa Yen Partner King & Spalding LLP Joshua A. Whitehill Partner Kasowitz Benson Torres 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

Michael J. Abernathy Partner Morgan, Lewis & Bockius LLP Scott Cunning Partner Parker Poe Adams & Bernstein LLP

• 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

Robert Cerwinski Partner Gemini Law LLP Brian Coggio Of Counsel Fish & Richardson

• 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

Vishal Gupta, Co-Chair, Life Sciences Practice Steptoe & Johnson LLP

ACI’s Proficiency Series is an excellent primer on all essentials of Hatch-Waxman and BPICA practice. It is a great program for both in-house and outside counsel.

1:00 pm

Co-Chair Opening Remarks

1:15 pm

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

Whitney Meier Howard Partner

Venable LLP

Mark Deming Shareholder

Polsinelli 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)

2:15 pm Break

2:30 pm

An In-Depth Look at 180- Day Exclusivity

Susan Krumplitsch Partner DLA Piper Sara W. Koblitz Director Hyman, Phelps & McNamara PC

• 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

Fabian Koenigbauer Partner Ice Miller David B. Abramowitz Partner Locke Lord 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

1:00 pm

Assessing Patent Protections Afforded Under the Safe Harbor

Emily R. Whelan Partner

Wilmer Cutler Pickering Hale and Dorr LLP Samantha G. Wilson Associate 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

Eric Alan Stone Partner Weiss, Rifkind, Wharton & Garrison 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 PTO 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:

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

Question and Answer Wild Card

4:45 pm

Co-Chair Final Comments and Bootcamp Adjourns

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