Pre-Conference Workshop

Workshop — Master Class on Drafting Life Sciences Patent Applications In the U.S., Europe, and Asia

Aug 4, 2020 1:30pm – 5:00pm

Speakers

Deborah Lu
Partner
Duane Morris (New York, NY)

Day 1 - Wednesday, August 5, 2020

8:45
Virtual Conference Log-In
9:00
Co-Chairs’ Opening Remarks
9:15
PTAB Keynote Address
10:00
Morning Break
10:20
Focus on Small Molecules: Harnessing the Power of Written Description and Enablement to Strengthen Patent Protection in the U.S. – Europe – China
11:20
Written Description and Enablement in Antibody Arts: How Has the Scope of Claim Shifted in the U.S., Europe, and Japan?
12:15
Debating the PTAB Appointments Controversy
1:00
Lunch Break
2:00
Section 101: Exploring the Realities of the New USPTO Guidance
3:20
Afternoon Break
3:40
Navigating the Evolving Obviousness-Type Double Patenting Landscape
4:30
Inherency and Obviousness: Anticipating What’s Next Around the World
5:30
Conference Adjourns to Day Two

Day 2 - Thursday, August 6, 2020

9:00
Co-Chairs’ Opening Remarks and Recap of Day One
9:15
Comparing and Contrasting Licensing Agreements in U.S. and Europe
10:30
Morning Break
11:00
Doctrine of Equivalents Analysis: Understanding How the Latest DoE Decisions Will Impact Future of Trends in Patent Law Protection in the U.S., Europe and Asia
12:00
Lunch Break
1:00
Social Contracting: Understanding Its Impact on Patent Portfolio Design
1:45
Afternoon Break
2:15
Exploring the Future of Patent Protection Through Artificial Intelligence
3:00
Ethical Obligations in Prosecution
4:00
Conference Concludes

Day 1 - Wednesday, August 5, 2020

8:45
Virtual Conference Log-In
9:00
Co-Chairs’ Opening Remarks

Dr. Leslie Fischer
Principal Patent Attorney
Sandoz (Princeton, NJ)

Duane Marks
Assistant General Patent Counsel
Eli Lilly (Indianapolis, IN)

9:15
PTAB Keynote Address

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

U.S. Patent and Trademark Office
(Invited)

10:00
Morning Break
10:20
Focus on Small Molecules: Harnessing the Power of Written Description and Enablement to Strengthen Patent Protection in the U.S. – Europe – China

Henry Gu
Head of Intellectual Property
Akebia Therapeutics (Cambridge, MA)

Written Description
  • Understanding how Idenix Pharmaceuticals LLC v. Gilead Sciences Inc. (Fed. Cir. 2019) has shifted focus on the written description requirements from large molecule antibodies to small molecules
  • Interpreting the latest understanding of a broad claim
  • Determining how much a patentee need to disclose for a broad claim
  • Analyzing the latest tests required to satisfy a claimed function per MorphoSys AG v. Janssen Biotech Inc C.A. No. 16-221-LPS. (D. Del.)
  • Defining “undetermined quantity” in Amgen Inc. v. Sanofi SA relative to whether product can be functionality claimed
  • Assessing when a function claim is allowed Enablement
  • Analysing the latest case law on small molecule and biologic patents for enablement requirements
  • Understanding the EPO’s requirements for inventive step and sufficiency for patent application
  • Comparing and contrasting enablement requirements in the U.S., Europe, and China
Enablement
  • Analysing the latest case law on small molecule and biologic patents for enablement requirements
  • Understanding the EPO’s requirements for inventive step and sufficiency for patent application
  • Comparing and contrasting enablement requirements in the U.S., Europe, and China

11:20
Written Description and Enablement in Antibody Arts: How Has the Scope of Claim Shifted in the U.S., Europe, and Japan?

Charlotte Jacobson
Partner
Ropes & Gray (New York, NY)

Nicola Dagg
Partner
Kirkland & Ellis (London, UK)

Takanori Abe
Managing Partner
Abe & Partners (Osaka, Japan)

Heather Boussios
Assistant General Counsel – IP
Aptevo Therapeutics (Seattle, WA)

  • Understanding the state of 35 U.S.C. §112(a) on the requirement of adequate written description of an antibody at the Federal Circuit
  • Comparing the difference in law between EPO and Federal Circuit for antibodies patent law
Enforcement Challenges
  • Establishing the scope of claims for obtaining antibody patent at the USPTO and EPO
  • What can be found as valid and enforceable antibody patent?
European Updates
  • Review of recent leading cases in Europe on sufficiency of antibody or biotechnology patents
  • The “golden thread”: is the claim commensurate with the technical contribution?
  • Striking the right legal and policy balance between effective protection for the patentee and room for further innovation in relation to an antibody or a biotech platform invention

12:15
Debating the PTAB Appointments Controversy

The recent case of Arthrex, Inc. v. Smith & Nephew, Inc. caused a significant rift in the life sciences patent community. The Federal Circuit, in an opinion authored by Judge Moore, ruled that the current statutory scheme for appointing Administrative Patent Judges (APJs) to the Patent Trial and Appeal Board (PTAB) violates the Appointments Clause of the U.S. Constitution. In this fireside chat, attendees will examine the constitutional questions surrounding the appointments debate.

  • Understanding the constitutional questions related to PTAB judges’ appointments
  • Anticipating and assessing the Supreme Court’s views on the current status of the legitimacy of PTAB judges
  • Evaluating whether already approved patents as well as PTAB rulings can be invalidated as a result of the appointments controversy

1:00
Lunch Break
2:00
Section 101: Exploring the Realities of the New USPTO Guidance

June Cohan
Legal Advisor, Office of Patent Legal Administration
U.S. Patent and Trademark Office (Alexandria, VA)

Duane Marks
Assistant General Patent Counsel
Eli Lilly (Indianapolis, IN)

Kevin E. Noonan, Ph. D.
Partner
McDonnell Boehnen Hulbert & Berghoff LLP (Chicago, IL)

Mark Waddle
Co-Chair, Life Sciences; Chair, Patent Litigation & Counseling
Loeb & Loeb LLP (New York, NY)

  • Analysing the new requirements indicated in the new patent eligibility (PEG) guidance
  • Understanding how the new tests set out in the new patent eligibility guidance can apply to the life sciences industry with regard to:
    • Products
    • Methods
  • Analysing the updated new patent eligibility guidance in conjunction with:
    • Whether a claim recites a judicial exception
    • Whether a judicial exception is integrated into a practical application
    • How to consider a prima facie case and the role of evidence concerning eligibility rejections
  • Evaluating the benefits of life sciences examples that have been incorporated into the new patent eligibility guidance
  • Determining the new patent eligibility guidance relating to Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, No. 2016-2707

3:20
Afternoon Break
3:40
Navigating the Evolving Obviousness-Type Double Patenting Landscape

Christina Schwarz
Partner
Venable LLP (New York, NY)

Marina Volin
VP, General Counsel and Corporate Secretary
Amring Pharmaceuticals (Berwyn, PA)

  • Analysing the latest obviousness-type double patenting case law in the U.S.
  • Determining the latest requirements relative to the rules of obviousness-type double patenting
  • Understanding how obviousness-type double patenting is being processed in conjunction with PTA and PTE
    • How this may impact the overall patent portfolio
  • Assessing the industry’s thoughts and strategies on obviousness-type double patenting
  • Discovering which other countries have obviousness-type double patent law scenarios and determining their limitations

4:30
Inherency and Obviousness: Anticipating What’s Next Around the World

Filko Prugo
Partner
Ropes & Gray (New York, NY)

Forrester Liddle
Senior Director,
Head of Intellectual Property

Jounce Therapeutics (Cambridge, MA)

Moderator:

Paki Banky
IP Litigation Counsel
Sandoz (Princeton, NJ)

  • Determining the differences in obviousness rejection and prior art
  • Examining when previously unstated elements can be used to determine obviousness
  • Comparing and contrasting international standards and strategies for prior art requirements
  • Discovering China’s inherency obligations to prior art
  • Understand obviousness before a European Patent Office
  • Assessing obviousness considerations before a national court
  • Determining how to best apply Federal Circuit two standards for determining obviousness
    • Pharmaceutical patent claims directed to specific compounds
    • Pharmaceutical patent are directed to pharmaceutical formulations

5:30
Conference Adjourns to Day Two

Day 2 - Thursday, August 6, 2020

9:00
Co-Chairs’ Opening Remarks and Recap of Day One
9:15
Comparing and Contrasting Licensing Agreements in U.S. and Europe

James M. Gould
Counsel
Ratner Prestia (Philadelphia, PA)

Brendan M. O’Malley
Vice President, Chief IP Counsel
Abeona Therapeutics Inc (New York, NY)

Moderator:

George Johnston
Counsel
Gibbons P.C. (Newark, NJ)
Former Vice President & Chief Patent Counsel, Hoffman-LaRoche

Due to the steep costs associated with research and development alongside the relatively limited patent lifespan, licencing agreements require high degrees of due diligence to minimise risks when entering into a partnership.

Forum Selection Clauses: Dodocase VR, Inc. v. MerchSource, LLC
  • Assessing whether a forum selection clause in the licence agreement can impact the ability to pursue a validity challenge being held at the IPR or PGR
Licensee and Patentee Communication: Immunex Corp. v. Sandoz Inc.
  • Analyzing the latest interpretations of attorney-client privilege
  • Contrasting the legal interpretation between business communication vs. attorney and client privileged communication
  • Determining the differences between U.S. and European perspective on Attorney-Client privilege
Bayh-Dole Act Amendments and Government Paid Up Licence to UseAn Invention
  • Determining the uncertainties posed to a pharmaceutical company regarding the Bayh-Dole Act
  • Understanding the due diligence requirements by a pharmaceutical company before entering a research agreement with a university
    • How to calculate associated risks
    • Indemnification
Licencing Agreement Enforcement in the U.S. and Europe
  • Developing best practices in enforcing licencing agreements between larger and smaller biopharmaceutical companies and universities when each party has a different set of ideas relating to
    • Ownership
    • Enforcement
    • Joint inventions

10:30
Morning Break
11:00
Doctrine of Equivalents Analysis: Understanding How the Latest DoE Decisions Will Impact Future of Trends in Patent Law Protection in the U.S., Europe and Asia

Bert Oosting
Partner
Hogan Lovells (Amsterdam, NE)

U.S.
  • Understanding the practical implications of recent developments affecting the evolution of the DOE doctrine
    • Analysing the most current parameters courts will adopt to determine the types of amendments made during the prosecution of a patent application which would later preclude the patentee from applying the doctrine of equivalents in a patent infringement litigation
    • Examining current “foreseeability” tests adopted by Federal Circuit and District Courts
  • Analysing the consequences when a patentee cannot prove literal infringement?
  • Exploring the impact of the tangential exception to prosecution history estoppel in Eli Lilly and Co. v. Hospira, Inc.
Europe
  • Comparing the latest DOE case decisions in the UK, Netherlands and Germany
    • Regen Lab SA v Estar Medical Ltd & Ors [2019] EWHC
    • Eli Lilly & Ors v Genentech [2019] EWHC 387
  • Understanding how to extend the scope of protection for a patent relative to DoE
  • Assessing whether there are similarities between each jurisdiction and whether this relief can be adapted in other jurisdictions
  • Dissecting the details and the differences between the UK and Netherlands Courts’ e DoE interpretations in Eli Lilly v Fresenius Kabi
  • Developing best practices for drafting patents to ensure DOE claims are covered for UK courts
    • Understanding how specific wording can be construed as infringement and taking the necessary steps to avoid this scenario
    • Exploring the knock-on effect of UK DOE decisions on European court rulings and their impact on U.S. Pharmaceutical Companies
Japan
  • Determining DOE requirements in Japan set in IP High Court En Banc Decision (2016) Case No. 2015 (Ne) 10080 “Maxacalcitol Case”
    • Assessing when is a patent infringement considered by the courts
    • How to decide the essential part of a claim?
    • Understanding determination for broad and narrow equivalence
  • Comparing and contrasting the differences in scope of claim between Japan and the U.S.

12:00
Lunch Break
1:00
Social Contracting: Understanding Its Impact on Patent Portfolio Design
Roberto Rodrigues

Roberto Rodrigues
Attorney at Law
Licks Attorney (Rio de Janerio, BR)

  • Assessing the types of social contracting obligations that can impact a life sciences patent portfolio
    • Short- and long-term impact
  • Discovering what elements of social contracting life sciences companies will have to implement into patents portfolio to mesh with the direction of politicians, millennials investors
    • What does this mean for IP portfolios?
    • How to utilise and enforce this
    • What will happen to product listing and licensing?
  • Questioning whether social contracting into patent portfolios should be proactive or imposed upon a life sciences company?
  • Exploring the possibilities of how the patent will be viewed in court and law once social contracting is implemented?

1:45
Afternoon Break
2:15
Exploring the Future of Patent Protection Through Artificial Intelligence

Robin Ellis
Partner
Reddie & Grose GmbH

Invention
  • Understanding how AI may impact patent law in the U.S. and Europe
  • Exploring questions of AI-related inventorship
    • Who will be considered as the owner of the patent? AI or Human operator?
    • What are the consequences if AI creates data leading to IP protection?
    • How is inventive step considered through AI assistance?
  • When considering the design different applications for healthcare products, will there be a global standard on AI patents?
Infringement
  • Discovering how AI can infringe on protected patent processes
  • Determining where an infringement can take place in a decision-making process assisted by AI

3:00
Ethical Obligations in Prosecution

Tom Kowlaski
Partner
Duane Morris (New York, NY)

USPTO Director Iancu recently indicated that a significant number of patent applications are failing to fulfill their legal and ethical obligations to file accurately and in good faith. Thus, resulting in improper submissions and bad faith behaviour. This ethical obligation session will address challenges when completing patent application to ensure you are achieving the correct standard.

4:00
Conference Concludes

Workshop — Master Class on Drafting Life Sciences Patent Applications In the U.S., Europe, and Asia

Aug 4, 2020 1:30pm – 5:00pm

Deborah Lu
Partner
Duane Morris (New York, NY)

What is it about?

Drafting patents claims in the life sciences sphere is complex and requires the right amount of substance to ensure their success. Questions surrounding life sciences patentable subject matter in the United States as well as Europe are becoming increasingly difficult to navigate. This workshop will help cut through the complexity and offer solutions for successful patenting strategies as well as global commercialization in the life sciences sector.

Points of discussion will include:

  • Review of patent drafting, and the application process for drugs and biologics around the world
  • Understanding different patent offices’ interpretation for a patentable claim relative to the life sciences arena
  • Drafting claims for protection across different jurisdictions for drugs and biologics
  • Discussing latest case law in relevant jurisdictions and interpreting their results
  • Developing drafting strategies for effectively conveying that the life sciences invention meets the patentable subject matter tests in different international jurisdictions
  • Best practices when applying for patents in the U.S. | Europe | Asia
  • Understanding the variety of options available to maximise the scope of protection
  • Understanding how life sciences patent drafting and application strategies vary from country to country and office to office for multinational companies
  • Examining the corporate in-house process for drafting claims
  • Finding solutions to common drafting dilemmas in the life sciences sphere, e.g., the Abraxis case?