Download 2021 Brochure
Flip through our 2021 conference brochure and discover what’s new this year.

VIEW FULL PROGRAM

Day 1 - Wednesday, July 21, 2021

10:00
Co-Chairs Opening Remarks
10:15
Redefining Your Global Patent Prosecution Strategy for 2021: Addressing the Top Challenges Companies are Currently Facing in Securing Patent Ownership in the U.S., Europe and China
11:15
Gauging the Continued Impact of the Novel Coronavirus Across the Global IP Market: Compulsory Licensing and March-In Rights in the Age of COVID-19
12:00
Break
12:15
Keynote Address:
12:45
PTAB Year in Review: Examining the Latest PTAB Developments Impacting Patent Prosecution and Litigation, Key Federal Circuit Cases Involving the PTAB in the Last Year and an Update on Arthrex
2:00
1:1 Networking
2:15
Lunch Break
3:00
Determining the Future Landscape of §101: Will We Ever Have Clarity on Patent Subject Matter Eligibility?
4:00
Afternoon Break
4:15
Written Description and Enablement in Antibody Patent Claims: International Perspectives on Establishing the Scope of Antibody Claims and Incorporating the Latest Developments into Your Patent Prosecution Strategy
5:00

INTERACTIVE SESSION

Life Sciences Litigator Think Tank: “What I Wish the Patent Prosecutor Would Have Done”
6:00
Conference Adjourns

Day 2 - Thursday, July 22, 2021

10:00
Co-Chairs’ Opening Remarks and Recap of Day One
10:15
Examining the Recent Resurgence of Doctrine of Equivalents: Weighing the Effects of the Latest DoE Decisions on Patent Prosecution and Litigation Strategies in the U.S., Europe and Asia
11:15
Morning Break
11:30
Patent Term Extension Developments in the U.S. and Europe: Examining the Implications of Biogen v. Banner and Deciphering Europe’s SVC Manufacturing Waiver
12:15
1:1 Networking
12:30
Lunch Break
1:15

A Focus on Method of Treatment / Second Medical Use Patents

Exploring Effective Strategies for Obtaining Method of Treatment/Second Medical Use Patents, Personalized Medicine Patents and Dosage Regimen Patents
2:15

INTERACTIVE CASE STUDY

Evaluating the Consequence of a Skinny Label: Implications of GSK v. Teva
3:00
Afternoon Break
3:30
Navigating the Current Obviousness Landscape: Integrating the Latest Developments in Obviousness-Type Double Patenting and Inherency into Your Patent Prosecution Approach
4:15

Live Polling

Interactive Ethics Lab: Overcoming Common Challenges and Ethical Dilemmas in Patent Prosecution
5:15
Conference Concludes

Day 1 - Wednesday, July 21, 2021

10:00
Co-Chairs Opening Remarks

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

Duane Marks
Assistant General Patent Counsel
Eli Lilly and Company

10:15
Redefining Your Global Patent Prosecution Strategy for 2021: Addressing the Top Challenges Companies are Currently Facing in Securing Patent Ownership in the U.S., Europe and China

Mythili Markowski
Senior Patent Attorney
Novartis

Catherine McCarty
Partner
Goodwin Procter LLP

Bert Oosting
Partner
Hogan Lovells International LLP (Amsterdam, NE)

Tune in as a panel of leading patent attorneys from both sides of the Atlantic provide key strategies for protecting your IP and minimizing risk when filing patents internationally.  Engage in a unique opportunity to examine vital considerations for patent prosecution at both the USPTO and European Patent Office, and for overcoming the latest challenges to patent procurement both in the U.S. and abroad.  Topics of discussion will include:

  • Comparing and contrasting the standards of patentability and related issues in the US and Europe
  • Developing strategies to achieving patent protection in the U.S., Europe and China within one-year time frame
  • Discussing the most cost-effective processes in patent applications in the U.S and abroad
  • How do patent assignments affect ownership and patent prosecution rights in the U.S. vs. the EU?

11:15
Gauging the Continued Impact of the Novel Coronavirus Across the Global IP Market: Compulsory Licensing and March-In Rights in the Age of COVID-19

Meaghan Richmond
Assistant General Counsel
AstraZeneca

Kevin Noonan
Partner
McDonnell Boehnen Hulbert & Berghoff LLP

  • Assessing how the search for a Covid-19 cure has affected drug development and patent prosecution
  • Examining the measures being undertaken by patent offices around the world with regard to Covid-19 related patents and how they will impact patent prosecution and examination
  • Exploring the potential impact that government use provisions and Bayh-Dole “march in rights” will have 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

12:00
Break
12:15
Keynote Address:

Andrew Faile
Acting Commissioner for Patents
U.S. Patent and Trademark Office (USPTO)

12:45
PTAB Year in Review: Examining the Latest PTAB Developments Impacting Patent Prosecution and Litigation, Key Federal Circuit Cases Involving the PTAB in the Last Year and an Update on Arthrex

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

Abeona Therapeutics Inc.

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

U.S. Patent and Trademark Office
(Invited)

Update on Arthrex & Discretionary Denials

  • Examining the current status of Arthrex: the latest developments in the Supreme Court’s review of the constitutionality of APJ appointments
  • Assessing the continued surge of discretionary denials of PTAB trials, and new incidences of forums foreclosing PTAB challenges altogether
  • Analyzing developments in Apple, Google, Cisco and Intel’s litigation with the PTAB challenging it’s IPR discretionary denial precedent — how may developments in this litigation impact similar rulings in the life sciences arena?

Latest PTAB Developments Impacting Prosecution and Litigation

  • Exploring the latest PTAB statistics in the life sciences arena, as well as recently designated precedential decisions
  • Analyzing the implications of new PTAB rules and pilot programs (e.g. the Fast Track Appeals pilot)
  • Examining how the newly clarified standard for indefiniteness is being applied in AIA post-grant proceedings
  • Assessing the latest trends in PTAB motion to amend practice: how many patent proprietors are successfully amending their claims and what are the outcomes of those amendments?
  • How is the PTAB ruling on inherency determinations in contentious proceedings? What kind of data and evidence needs to be shown to establish it?

2:00
1:1 Networking
2:15
Lunch Break
3:00
Determining the Future Landscape of §101: Will We Ever Have Clarity on Patent Subject Matter Eligibility?

Donna Meuth
Associate General Counsel, Intellectual Property
Eisai

Cara Coburn
Associate General Counsel, Patent Law
Genentech

Thomas J. Kowalski
Partner
Duane Morris LLP

Amir Naini
Senior Counsel
Proskauer Rose LLP

The Supreme Court has yet to solve or provide clarity on §101, leaving only confusion resulting from decisions from the last decade.  This session will explore topics including:

  • Understanding how SC guidance in Am. Axle & Manufacturing could impact how patent prosecutors draft their future claims
  • Anticipating whether the court will finally provide clarity on 101
  • How can biotech companies best protect their diagnostic inventions in the current 101 environment absent a clear roadmap set forth by the court?  How could Supreme Court intervention in Illumina change this going forward?
  • Assessing the most recent 101 cases applying the Supreme Court’s Alice/Mayo tests before the Federal Circuit – what are we extrapolating from these decisions absent clear guidance from the Supreme Court?
  • Examining the trend of using §101 as a substitute for §112 in policing broad claims: are we missing out on opportunities to further develop the case law on §112?
  • Developing best practices for drafting patent claims within the current 101 landscape to avoid unpatentable subject matter findings
  • Examining the Federal Circuit’s treatment and application of the USPTO’s recent patent eligibility (PEG) guidance

4:00
Afternoon Break
4:15
Written Description and Enablement in Antibody Patent Claims: International Perspectives on Establishing the Scope of Antibody Claims and Incorporating the Latest Developments into Your Patent Prosecution Strategy

Duane Marks
Assistant General Patent Counsel
Eli Lilly and Company

Kristel Schorr
Partner
Foley & Lardner LLP

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

Bird & Bird (Munich, Germany)

  • How has the recent Federal Circuit decision in Amgen v Sanofi (Fed. Cir. 2021) raised the enablement bar for antibody patents and what will the implications be going forward?
  • Creative strategies for claiming monoclonal antibodies in order to secure the broadest claim possible from the patent office
  • Establishing the scope of claims for obtaining antibody patents at the USPTO, EPO, and JPO: what can be found as valid and enforceable antibody patent in the US vs. EU vs. Japan?

5:00

INTERACTIVE SESSION

Life Sciences Litigator Think Tank: “What I Wish the Patent Prosecutor Would Have Done”

Katie Nolan-Stevaux
Assistant General Counsel, Litigation
Genentech

Poopak (Paki) Banky
IP Litigation Counsel
Novartis

Filko Prugo
Partner
Chair, Life Sciences IP Litigation

Ropes & Gray LLP

Siegmund (“Sige”) Gutman
Partner
Chair, Life Sciences Patent Practice

Proskauer Rose LLP

This unique session will feature a panel of patent litigators who will share personal accounts of challenges they have faced in IPRs and litigation and reflect on what they wished the prosecutor of the patent would have done in the early stages to prevent or mitigate the issues that developed down the road. The panelists will talk through scenarios where a more favorable outcome could have been achieved in litigation had the prosecutor changed certain language in the claim, argued something differently during prosecution, or even built the portfolio in a different way overall.

Attendees will then have the opportunity to come on camera at the end of the session to meet the speakers face-to-face, share their own personal insights and ask questions of our panelists.

6:00
Conference Adjourns

Day 2 - Thursday, July 22, 2021

10:00
Co-Chairs’ Opening Remarks and Recap of Day One
10:15
Examining the Recent Resurgence of Doctrine of Equivalents: Weighing the Effects of the Latest DoE Decisions on Patent Prosecution and Litigation Strategies in the U.S., Europe and Asia

Wanda French-Brown
Partner
Loeb & Loeb LLP

Sharon Walker, Ph.D.
Director Legal
Translate Bio

Guido Pontremoli

Guido Pontremoli, Ph.D.
Global IP Head
Corp. Intellectual Property-Patents

Chiesi Farmaceutici S.p.A (Parma, Italy)

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

Across global jurisdictions, the extent of protection afforded by a patent is defined by the claims as read literally – or, under the Doctrine of Equivalents.  In the U.S., the courts seem to recently be taking a more expansive view on the application of DoE in finding patent infringement.  Meanwhile, across Europe, each jurisdiction has its own infringement test, making it difficult to predict the outcomes of infringement proceedings based on DOE.  This session will consider the current status of the Doctrine of Equivalents in the U.S. and across Europe, as well as the latest DoE developments in Japan.

  • Understanding the practical implications of the latest DoE case law developments in the U.S.
  • Examining the impact of Eagle Pharmaceuticals v. Slayback Pharma (Fed. Cir. 2020) on the future use of the disclosure-dedication doctrine
  • How can you draft a claim so you can get the broadest interpretation of Doctrine of Equivalents in a subsequent litigation?
  • Analyzing biologics under the Doctrine of Equivalents: How is the DoE being applied for small molecules vs. biologics? 
  • Comparing and contrasting the latest DoE decisions in the UK, Netherlands, Germany, France and Japan
  • Developing best practices for drafting patents to ensure DoE claims are covered for UK courts

11:15
Morning Break
11:30
Patent Term Extension Developments in the U.S. and Europe: Examining the Implications of Biogen v. Banner and Deciphering Europe’s SVC Manufacturing Waiver

Charlotte Jacobsen
Partner
Ropes & Gray LLP

Rachel Mumby
Partner
Bristows LLP (London, UK)

  • Understanding how the Federal Circuit’s decision in Biogen Int’l GmbH v. Banner Life Scis. LLC (Fe. Cir. 2020) may influence the future application of patent term extensions in the U.S.
  • Taking a closer look at Europe’s Supplementary Protection Certificate Waiver: this legislation provides a patent term extension during which European generic and biosimilar manufacturers can continue to produce protected medicines for export or stockpiling.  Examining pressing questions including:
    • How is the waiver going to be used and what will the response to using the waiver be?
    • What requirements and qualifications need to be met to use the waiver?
    • What is the scope of the waiver?  What acts are specifically excepted from patent infringement?
    • Who can use the waiver?
    • What partner activities are exempt from infringement?
    • What will the points of attack be?

12:15
1:1 Networking
12:30
Lunch Break
1:15

A Focus on Method of Treatment / Second Medical Use Patents

Exploring Effective Strategies for Obtaining Method of Treatment/Second Medical Use Patents, Personalized Medicine Patents and Dosage Regimen Patents

Jenny Papatolis Johnson
Intellectual Property Executive Director
Endo Pharmaceuticals

Felicity E. Groth
Partner
BakerHostetler

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

While method of treatment/second medical use patents, personalized medicine patents and dosage regimen patents are all very valuable to a patent portfolio, they often prove to be difficult to obtain as they are viewed rather harshly by global patent offices.  Further, what you must show to obtain such patents differs across global jurisdictions, adding additional challenges to a company’s pursuit of them.  This panel will examine topics including:

  • What are the key challenges and hurdles being faced in obtaining these types of patents?
  • What strategies can be employed to help succeed in procuring such patents?
  • Analyzing different approaches you can take to writing these claims which may yield success in the US and abroad
  • What do you have to show in the US, EU, Japan and China in order to obtain Second Medical Use, Personalized Medicine and Dosage Regimen patents?

2:15

INTERACTIVE CASE STUDY

Evaluating the Consequence of a Skinny Label: Implications of GSK v. Teva

Sarah Hooson
Counsel, Patents
Merck

James M. Gould
Counsel
RatnerPrestia

Jim Czaban
Partner
Loeb & Loeb LLP

This panel will analyze GSK v. Teva – a case which epitomizes the major challenges that can arise with method of treatment/second medical use patents.  Following the recent decision of the US Court of Appeals to vacate its prior finding that Teva induced infringement, both brand and generic drug manufacturers are currently awaiting an outcome which will have a profound impact on the future use of skinny label carve outs.  Topics of discussion will include:

  • Understanding the role of skinny labeling in the FDA’s regulation of innovative and generic drug products
  • Understanding the significant implications of the Federal Circuit striking down label carve outs
  • Reconciling whether launching with a skinny label that carves out infringing methods violates a patented method of use
  • What impact will GSK v. Teva have on prosecution strategies and tactics for drafting claim language and label language?
  • Examining the impact on future drug development and FDA regulatory strategies
  • Incorporating skinny labeling considerations into your patent prosecution strategy in light of GSK v. Teva
    • When to start thinking about these issues in the early stages of planning your patent protection

3:00
Afternoon Break
3:30
Navigating the Current Obviousness Landscape: Integrating the Latest Developments in Obviousness-Type Double Patenting and Inherency into Your Patent Prosecution Approach

Laura Wine
Associate General Counsel, Intellectual Property
Arena Pharmaceuticals, Inc.

Tina Dorr, Ph.D.
Partner
Cantor Colburn LLP

Kathleen Kahler Fonda
Senior Legal Advisor, Office of Patent Legal Administration
U.S. Patent and Trademark Office (USPTO)

  • Analyzing the latest obviousness-type double patenting case law developments in the U.S.
  • Examining the implications of Immunex v. Sandoz (Fed. Cir. 2020) on the standard for determining common ownership in applying ODP
  • What is the status of current legislation being proposed around ODP?
  • Developing strategies for avoiding and overcoming obviousness-type double patenting rejections
  • Inherency and Obviousness: comparing and contrasting international standards and strategies for prior art requirements
  • Examining when previously unstated elements can be used to determine obviousness
  • Examining functional limits on claims which you attack with inherency

4:15

Live Polling

Interactive Ethics Lab: Overcoming Common Challenges and Ethical Dilemmas in Patent Prosecution

Test your ethical skills with a series of anonymous polling questions on sensitive hypothetical scenarios. Discover how your approach to tackling ethical dilemmas in patent prosecution compares to your peers and benefit from a practical discussion of the polling results and important takeaways for your practice.

5:15
Conference Concludes