Paragraph IV Disputes

Regional Breakfast Briefing

China Strategy Session: An Inside Look at the Reformations to the Patent Law of the People’s Republic of China Relative for the Hatch-Waxman Practitioner

Amy Feng
Managing and Founding Partner
Wu, Feng & Zhang

Hong Ai
Partner
ZY Partners

Modifications by China’s National People’s Congress (NPC) to its country’s patent laws which go into effect on June 1st will considerably change its legal structure for pharmaceutical patents. The regulation, endorsed by China’s National Medical Products Administration (NMPA), protects pharmaceutical patent rights, and fosters competition by establishing a Hatch-Waxman-style arrangement for both brands and generics. This session will cover the most relevant updates to the law and everything the U.S. Hatch- Waxman practitioner needs to know, including:

• The Chinese patent linkage system
• The 12-month exclusivity period
• Extensions of patent terms
• The good faith requirement
• Enhanced damages, and more

Opening Remarks from Co-Chairs

Rekha Hanu
Vice President, Associate General Counsel Chief IP Counsel
Akorn, Inc.

Andrea Hutchison
Senior Associate General Counsel, IP Litigation
Gilead Sciences

Virtual Town Hall

Patents, Prices, and Politics: Legislative, Administrative and Geopolitical Developments Impacting the Pharmaceutical Industry

Ryan M. Daniel
Chief Patent Counsel Region North America
Fresenius Kabi USA, LLC

Shashank Upadhye
Partner
Upadhye Tang LLP

Evan Diamond
Partner
King & Spalding LLP

Omar Jabri
Senior Director, Global Intellectual Property
Apotex Inc.

Moderator:

John J. Molenda
Partner
Steptoe & Johnson LLP

The original intent of the Hatch-Waxman Act was to provide an abbreviated approval pathway for generic drugs and to maintain patent integrity for innovator products. In the 36 years since its enactment, prized generics have become more elusive, bringing into focus the political debate between patents and price which the law sought to address. This panel, in town hall fashion, will take questions as it explores such matters as:

• Analyzing recent federal and state executive actions and legislative initiatives, with a focus on their potential impact on the pharmaceutical industry
• Orange Book Transparency Act
• “Buy America” policies and executive orders
• California’s A824 patent settlement law and related federal and state legislative initiatives
• Potential amendments to the Hatch-Waxman Act, and more
• Navigating state laws governing transparency in drug pricing
• Evaluating the factors impacting the pharmaceutical global supply chain
• Understanding the impact on pharma of patent enforcement trends in ex-U.S. jurisdictions, as well as ongoing international developments at the WTO

Audience Polling

GSK v. Teva: What’s the Skinny on Carve Outs?

James P. Leeds
Assistant General Patent Counsel
Eli Lilly & Company (Indianapolis, IN)

Donna Meuth
Associate General Counsel, IP
Eisai

Jeffrey A. Marx
Partner
Rakoczy Molino Mazzochi Siwik LLP

Bruce M. Wexler
Partner and Global Co-Chair, Intellectual Property
Paul Hastings LLP

David L. Anstaett
Partner
Perkins Coie LLP

In October of 2020, the Federal Circuit held that Teva induced the infringement of a GSK patent and reinstated a $235 million verdict in favor of GSK. Teva subsequently filed a petition for en banc, reiterating the dissent from the Chief Judge Prost thereby claiming that the majority, in effect, invalidated the relevant section of the Hatch-Waxman Act that permits skinny labeling. Presently, both brand and generic drug manufacturers await an outcome which likely will merit Supreme Court review.

• Understanding the profound implications of the Federal Circuit striking down label carve outs
• Examining the Federal Circuit’s rationale regarding a skinny label launch
• Analyzing Chief Judge Prost’s dissent
• Reconciling whether launching with a skinny label that carves out infringing methods violates a patented method of use
• Making sense of the inconsistencies in the language from FDA approved indication, the patent language in the claim, and the language in the use code
• Mitigating inducement charges via internal training
• Balancing competing interests in promoting innovation v. permitting generic drugs market entry
• Understanding second medical use patents and carve out strategies
• Clarifying the patentability of further medical use inventions
• Assessing the legal and regulatory implications of second use patents
• Market access implications?
• Determining whether post-filing evidence is admissible to show insufficient disclosure of further medical use

Networking Break

Spotlight on Delaware: Fireside Chat with Chief Judge Stark and Judge Noreika

Honorable Leonard P. Stark
Chief Judge
United States District Court, District of Delaware

Honorable Maryellen Noreika
Chief Judge
United States District Court, District of Delaware

Moderator:

Meg Fasulo
Partner
Bartlit Beck LLP

1:1 Networking

Lunch Break

Diversity, Inclusion, Incorporation: How to Manage and Maintain a Diverse Pharmaceutical IP Team

Steven M. Coyle
Partner, Pharmaceutical Patent Practice Co-Chair, Litigation Co-Chair
Cantor Colburn LLP

Huong T. Nguyen
General Counsel
Fosun Pharma USA Inc.

Elizabeth S. Weiswasser
Partner
Weil, Gotshal & Manges LLP

Vanessa Yen
Partner
King & Spalding LLP

• Increasing awareness among pharmaceutical IP practitioners about underrepresented racial and ethnic groups in the patent bar
• Championing their representation in the pharmaceutical IP work force
• Advocating for diverse and young attorneys appearing in the court room
• Supporting STEM initiatives
• Reviewing data showing the benefits of a diverse workforce
• Accelerating the advancement of a more diverse pharmaceutical IP community via mentoring and networking
• Understanding what specific evidence of diversity pharmaceutical companies and IP departments, are seeking from their law firm counterparts
• Implementing organizational changes that promote diversity
• How clients can seek out partnerships with firms that promote:
• Utilizing NAMWOLF lists
• Abiding by the Mansfield Declaration
• Using a DuPont Legal Model
• Identifying best practices for evaluating your outside firm’s efforts in promoting diversity
• Reviewing firm statistics on women, minorities, sexual orientation, etc.
• Sharing data-driven strategies to address current diversity challenges in STEM

Audience Polling

You Can’t Go Home Again…Or Can You? Establishing Venue in PIV Litigation Post-Valeant v. Mylan

Aziz Burgy
Partner
Axinn, Veltrop & Harkrider LLP

Derek Johnson
Associate General Counsel, IP
Baxter International Inc.

Irena Royzman
Partner
Kramer Levin Naftalis & Frankel LLP

Jeanna M. Wacker
Partner
Kirkland & Ellis LLP

Moderator:

Gregory A. Morris, Ph.D.
Partner
Honigman LLP

In building on the Supreme Court’s decision in TC Heartland, the Federal Circuit in Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., held that “acts of infringement” under 28 U.S.C. § 1400(b) occur “only in districts where actions related to the submission of the ANDA occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.” This panel will help provide clarity as practitioners from both branded and generic drug companies revisit the present and anticipated state of the venue quandary.

• Reviewing the latest precedent regarding venue determination in pharmaceutical patent infringement cases
• Determining where a corporate defendant be sued
• Options for foreign defendants
• Outlining the impact of safe harbor provisions on venue determinations
• Which activities must be excluded from a venue determination?
• Whether the analyzing, compiling, and submitting of information in the ANDA or NDA that can be considered?
• Devising strategies for deciding where you should file your case to avoid a motion to transfer
• Developing new approaches for moving to transfer for improper venue in the wake of Valeant v. Mylan
• Weighing the chances for success or defeat of a venue transfer motion

BREAKOUT SESSIONS (CHOOSE A OR B)

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
Optimizing Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
Structuring Settlements and Antitrust Considerations for the PIV Litigator

Track A

Matt Becker
Partner
Axinn, Veltrop & Harkrider LLP

Colin Heitzmann
Senior Corporate Attorney Senior Director, IP Group Leader
Otsuka Pharmaceutical Companies

Kevin Zive
Vice President – Global Intellectual Property and Legal Affairs
Apotex Inc. (Toronto, CA)

Deepro R. Mukerjee
Partner and Co-Chair, Patent Litigation
Katten Muchin Rosenman LLP

Track B

Honorable Tonianne J. Bongiovanni
Magistrate Judge
United States District Court, District of New Jersey

Henry Gu
Vice President, Head of Intellectual Property
Morphic Therapeutics

Jeffrey R. Gargano
Partner
Morgan, Lewis & Bockius LLP

Arlene Lee Chow
Partner
Latham & Watkins LLP

A | Optimizing Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

• Considering the critical factors when selecting products for development:
• IP constraints and Freedom to Operate
• Development costs
• Market forces
• The potential long-term impact the coronavirus could have on supply chain disruption
• Considering license deals to save litigation spend and remain within budget
• Strengthening your launch strategy
• Examining the value of licensing deals and structures
• Establishing best practices for cost reduction to enhance predictability for cash flow purposes
• What kind of case management does a client expect with a low budget when there is no settlement?
• Evaluating the impact of the conservation of resources on future investment in research and development

B | Structuring Settlements and Antitrust Considerations for the PIV Litigator

• Analyzing the implications of the In re Humira antitrust decision
• Whether patent holders may lawfully obtain and enforce patents against alleged infringers and protects their ability to settle
• Interpreting Judge Newman’s dissent in Takeda Pharms. U.S.A., Inc. v. Mylan Pharms (Fed. Cir. 2020)
• Examining California “Pay for Delay” Law A824
• Developing timelines for business and legal milestones relatives to terms of the settlement
• Understanding the application of antitrust law’s “rule of reason” to pharmaceutical patent settlements
• Investigating recent judicial efforts to promote settlements
• Understanding the limits of judicial settlement authority
• Evaluating the dissemination of settlement-oriented innovation

BREAKOUT SESSIONS (CHOOSE A OR B)

A | The Economics and Economy of Drug Patents with ACI’s Hatch-Waxman Series Advisory Board Members
The Repurposing and Repositioning of Small Molecule Drugs: Strategies for Re-Innovation and Overcoming Related IP Conundrums

B | The Practice of Hatch-Waxman Litigation: PIV on Trial
I’m here Live – I’m Not a Cat: Gracefully and Effectively Navigating Remote Hearings, Trials, Depositions, and Discovery

Track A

Mary J. Morry
Counsel, IP Litigation Merck Office of the General Counsel
Merck Sharp & Dohme Corp

Lars Taavola
VP, Chief Intellectual Property Counsel
Mallinckrodt Pharmaceuticals

Track B

Honorable Christopher J. Burke
Magistrate Judge
District of Delaware

Eric W. Dittmann
Partner and Global Vice-Chair, Intellectual Property
Paul Hastings LLP

Anne Shea Gaza
Partner
Young Conaway Stargatt & Taylor, LLP

Wanda D. French-Brown
Partner
Loeb & Loeb LLP

Track A | The Repurposing and Repositioning of Small Molecule Drugs: Strategies for Re-Innovation and Overcoming Related IP Conundrums

With the COVID-19 pandemic came the international race to identify therapeutic treatments, cures, and vaccines. Under immense pressure to deliver, drug companies across the globe have shown a restored interest in the repurposing of existing drugs, such as remdesivir and dexamethasone that were effective against corona-like viruses.

While the repurposing of existing therapies can be crucial for delivering novel treatments to the population, in turn it raises myriad of pharmaceutical intellectual property questions — this session will address the underlying controversies and challenges posed by these questions.

• Analyzing the types of exclusivities available for repurposed drugs
• Outlining whether patent or regulatory based
• Orphan drug exclusivity
• Three-year data exclusivity

B | I’m here Live – I’m Not a Cat: Gracefully and Effectively Navigating Remote Hearings, Trials, Depositions, and Discovery

To stop the spread of the coronavirus, courts around the country pivoted to video conferences or telephonic proceedings. Like the Hatch-Waxman Act itself, practicing virtually comes with a unique set of obstacles. Attend this breakout session and replenish your toolkit in view of these unprecedented circumstances, with a special focus on:

• Hearings and trial practice
• Depositions
• Discovery planning and scheduling
• Privilege and confidentiality considerations
• Motions to compel
• Document requests

Faculty-Attendee Roundtables

New for this year — through a feature on our virtual platform, take advantage of the opportunity to meet our speakers in smaller group settings, ask targeted questions, receive real time answers, and share your own thoughts on pressure points and challenges.

Conference Adjourns to Day Two

Regional Breakfast Briefing

Pharmaceutical Patent Litigation in the EU: A New Look at Bolar Exemptions and Recent Critical Developments Impacting Pharmaceutical Patent Litigation

Dominic Adair
Partner
Bristows LLP

Bert Oosting
Partner
Hogan Lovells

Sara Burghart
Lead IP Litigation Counsel
Global Litigation & Launch – Global IP
Sandoz International GmbH

This regional assembly will bring you up-to-speed on the most significant developments from the last 12 months — including important, practical takeaways that will help prepare you to successfully manage European pharmaceutical IP litigations. Topics of discussion will include:

• Named for the United States Supreme Court case, Roche v. Bolar, the Bolar Exemption is a research safe harbor allowing for the exemption of necessary data related to the regulatory approval process. This exemption was adopted into the Hatch-Waxman Act in the United States and later implemented in several EU countries
• Understanding which medical products are available for Bolar exemptions
• Determining whether a company is free to market and sell generic versions of patented pharmaceuticals under the Bolar exemption
• Examining life cycle strategies and filing divisionals
• Developing best practices for managing and winning global patent litigation disputes
• Coordinating strategies and assessing the role of early decisions in key countries
• Detailing the role of experts, claim construction standards, rationalizing potentially inconsistent positions that may need to be taken in different countries
• Determining whether anti-trust issues still have a role on the European stage
• Leveraging the substantive and procedural nuances between the U.S. and Europe When and where to bring infringement suits in various global jurisdictions

Main Conference Resumes | Opening Remarks from Co-Chairs and Recap of Day One

Rekha Hanu
Vice President, Associate General Counsel Chief IP Counsel
Akorn, Inc.

Andrea Hutchison
Senior Associate General Counsel, IP Litigation
Gilead Sciences

Key Agency Briefing for the Hatch-Waxman Practitioner

Challenges and Opportunities in an Evolving Landscape Featuring USPTO, FDA and FTC

Beckey Egeland
Attorney, Health Care Division
Federal Trade Commission

Maryll Toufanian
Director, Office of Generic Drug Policy
United States Food and Drug Administration

Moderator:

David B. Abramowitz
Partner
Locke Lord LLP

Please join us for this highly anticipated briefing with representation from the three key agencies governing Hatch-Waxman Litigation — USPTO, FDA and FTC, and they contemplate legal, regulatory and policy changes under the Biden Administration.

Audience Polling

Definitely, Maybe: Determining Patentable Subject Matter and the Future of Section 101

Karen E. Brown
SVP, IP and Legal Affairs
Obsidian Therapeutics, Inc.

Guy Donatiello
SVP Intellectual Property
Endo Pharmaceuticals

Dr. D.J. Jonathan Loeb, Ph.D.
Partner
Dechert LLP

Kaveh V. Saba
Partner
Maddox Edwards, PLLC

Moderator:

Matthew A. Pearson
Partner
Akin Gump Strauss Hauer & Feld LLP

In recent years, competing interests have kept the reformation of patentable subject matter eligibility under 35 U.S.C. 101 from getting before the Congress. A frustrated federal judiciary went so far to invoke Supreme Court intervention. In Am. Axle & Manufacturing, Inc. v. Neapco Holdings LLC (Fed. Cir. 2020), Judge Moore in dissent, reiterated the Federal Circuit’s request for guidance in 101 jurisprudence and emphasized the need for the Supreme Court to grant certiorari in a 101 case to resolve the “bitter divide” in the application of §101. This session will review the most impactful cases from the last 12 months, including:

• Reviewing recent District Court cases tackling 101 at the motion to dismiss and summary judgment stages
• Taking stock of the recent 101 cases applying the Supreme Court’s Alice/Mayo tests before the Federal Circuit
• Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, Inc. (Fed. Cir. 2020)
• Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)
• Deciding whether a new application of an abstract idea is abstract
• Analyzing when courts will conclude that any claim at issue is deemed invalid as claiming ineligible subject matter
• Whether there was direction to a natural phenomenon

View from the Bench

All Rise! District Court Judges Address Brand and Generic Concerns

The Honorable Alan D. Albright
District Judge
United States District Court​, Western District of Texas​

Honorable Mitchell S. Goldberg
District Judge
United States District Court
Eastern District of Pennsylvania
(Visiting Judge, District of Delaware)

Moderator:

Paul J. Molino
Managing Partner
Rakoczy Molino Mazzochi Siwik LLP

Co-Moderator

Gerald Flattmann
Partner
King & Spalding LLP

1:1 Networking

Lunch Break

A Study in Stats, Status, Standing, and Sustainability: The PTAB Year in Review

Honorable Jacqueline Wright Bonilla
Vice Chief, Administrative Patent Judge
USPTO Patent Trial and Appeal Board

Michael P. Kahn
Partner
Akin Gump Strauss Hauer & Feld LLP

Liane M. Peterson
Partner
Foley & Lardner LLP

• Assessing the latest developments on the PTAB’s expanded use of discretionary denials of petitions
• Analyzing how the Supreme Court in Thryv, Inc. v. Click-to-Call Technologies, LP, et al. (Supreme Court 2020) expanded the powers of the PTAB through its ruling that the time bar cannot be appealed
• Anticipating the impact of the Supreme Court’s review of the Federal Circuit’s denial of rehearing in Arthrex Inc. v. Smith & Nephew (Fed. Cir. 2020) and predicting what the decision will mean for the PTAB under the Appointments clause as well as the status of invalidated patents under past proceedings
• Determining whether APJs are “principal officers” or “inferior officers”
• Reviewing the Federal Circuit’s decision in Network-1 Technologies, Inc. v. Hewlett-Packard Co., (Fed. Cir. Sept. 24, 2020) that limited the scope of IPR estoppel and vacated claim construction based on expert testimony
• Interpreting the new claim amendment process
• Taking stock of the number of small vs. large molecule cases in IPRs and PGRs
• Examining the nexus between injury and standing to appeal an IPR
• Argentum v. Novartis (Fed. Cir. 2020)

Mock Argument | Audience Polling

Debating the Applicability of the Doctrine of Assignor Estoppel: What Every Hatch-Waxman Practitioner Needs to Know About the Anticipated SCOTUS Decision in Hologic v. Minerva

Alan B. Clement
Partner
Locke Lord LLP

Noah M. Leibowitz
Partner
Dechert LLP

Bill Ward
Partner
Boies, Schiller & Flexner LLP

Last year, in Hologic, Inc. v. Minerva Surgical, Inc. the Federal Circuit held that the doctrine of assignor estoppel does not prevent an assignor from lodging a validity challenge of an assigned patent in an IPR proceeding. The doctrine precludes inventors from assigning a patent to someone and then challenging the validity of the patent. In reviewing the Federal Court’s decision, The Supreme Court will decide whether a defendant in a patent infringement action who assigned a patent or is in privity with an assignor of the patent, may have a defense of invalidity heard on the merits. Join us for an intriguing debate where panelists will make both arguments to understand the salient repercussions of this anticipated decision on Hatch-Waxman practice.

• Argument I: The doctrine should be abolished
• Argument II: The doctrine’s scope should be expanded to cover proceedings before the PTAB
• At time of press, the doctrine is only relevant in litigations before the Federal Courts

Ethics Lab | Audience Polling

The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena

Mark E. Waddell
Partner
Loeb & Loeb LLP

Vishal Gupta
Partner
Steptoe & Johnson LLP

Aaron F. Barkoff
Shareholder
McAndrews, Held & Malloy, Ltd.

This session will identify common ethical dilemmas in Hatch-Waxman litigation and help you incorporate practices to avoid them. Points of discussion will include:

• Drafting conflicts of interest waivers, whether actual or potential
• Identifying hidden dangers in joint defense arrangements
• What happens if the clients do not agree or a dispute between them arises?
• Do all parties have to seek new counsel?
• Analyzing the requirements for pleadings, whether in the complaint, the answer, or the counterclaim
• Interpreting Rule 11 and other standards

Conference Concludes