Pre-Conference Workshop

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

Aug 2020

Speakers

Deborah Lu
Partner
Duane Morris (New York, NY)

Adrian Bradley
Partner
Cleveland Scott York (Thames Valley Reading, UK)

Day 1

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
Discretionary Denials at the PTAB
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

9:00
Co-Chairs’ Opening Remarks and Recap of Day One
9:15
Recent Developments Regarding License Agreements and Compulsory Licensing in the Life Sciences
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 litigation in Developing Countries
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

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
Vice President, Chief IP Counsel
Akebia Therapeutics (Cambridge, MA)

Rachel Mumby
Senior Associate
Bristows LLP (London, UK)

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 Jacobsen
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
Discretionary Denials at the PTAB

Gabrielle E. Higgins
Partner
Ropes & Gray LLP (San Francisco, CA)

Peter Waibel
Head US Patent Litigation
Novartis Pharmaceuticals Corporation (East Hanover, NJ)

In this session, we will examine the PTAB’s precedential decisions regarding discretionary denials under 35 U.S.C. §§ 325(d) and 314(a) and factors to consider when developing litigation strategy.

  • Understanding PTAB 2020 statistics on institution and discretionary denials
  • Evaluating recent “informative” decisions regarding discretionary denials under 35 U.S.C. § 314(a) and their influence on litigation decisions
  • Apple Inv. v. Fintiv, Inc., IPR2020-00019, Pap. 11 (P.T.A.B. Mar. 20, 2020)
  • Sand Revolution II v. Continental Intermodal Group – Trucking, IPR2019-01393, Pap. 24 (P.T.A.B. Jun. 16, 2020)

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 Waddell
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)

Dr. Sebastian Höpfner
Partner
German and European Patent and Trademark Attorney

Bird & Bird (Munich, Germany)

  • 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

9:00
Co-Chairs’ Opening Remarks and Recap of Day One
9:15
Recent Developments Regarding License Agreements and Compulsory Licensing in the Life Sciences

James M. Gould
Counsel and Co-Chair – Pharmaceutical, Biopharma and Life Sciences
Ratner Prestia (Philadelphia, PA)
(Former Legal Director — IP Litigation at Merck & Co)

Brendan M. O’Malley
Vice President, Head of Legal & IP
Corporate Secretary

Abeona Therapeutics Inc (New York, NY)

Dorothy R. Auth Ph.D.
Partner
Cadwalader, Wickersham & Taft LLP (New York, NY)

Applying the “All Substantial Rights” Test: Standing and Obviousness-Type Double Patenting

  • Lone Star v. Nanya Technology (Fed. Cir. 2019): the “all substantial rights” test in the context of standing to sue for patent infringement
    • May a licensee who lacks “all substantial rights” in a patent still have standing to sue for patent infringement and involuntarily join the patentee?
  • Immunex v. Sandoz (Fed. Cir. 2020): importing the “all substantial rights” test into the OTDP analysis
    • Is a licensee who is granted “all substantial rights” under a patent a “patentee” for purposes of the common ownership analysis?

Compulsory Licensing and March-In Rights in the Age of COVID-19

  • Exploring the potential impact of 28 U.S.C. § 1498(a) “government-use provisions” and Bayh-Dole “march-in rights” on life science companies developing pharmaceuticals and medical devices to address the current COVID-19 pandemic
  • Exploration of applicable compulsory licensing laws around the world:
    • Canada
    • Europe
    • Asia
    • South America

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

Klaas Bisschop
Partner
Hogan Lovells (Amsterdam, NE)

John D. Livingstone
Partner
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Atlanta, GA)

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 litigation in Developing Countries
Roberto Rodrigues

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

  • Defining social contracting and assessing the obligations of social contracting that can impact a life sciences patent litigation strategy
  • Questioning whether social contracting of patent portfolios should be proactive or imposed upon a life sciences company
  • Exploring how the patents will be viewed in courts and how preliminary injunctions rights would be balanced?

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

Robin Ellis
Partner
Reddie & Grose GmbH

Roberto Ribeiro
Partner
Daniel Law (Sao Paolo, Brazil)

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 2020

Deborah Lu
Partner
Duane Morris (New York, NY)

Adrian Bradley
Partner
Cleveland Scott York (Thames Valley Reading, UK)

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?