October 25-26, 2022
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Agenda

Panels, times and speakers subject to change. Initial descriptions written by IPWatchdog. Will be updated by the panel to more specifically reflect the conversation that will be had by panelists.

Monday, Oct 24, 2022

6:30 PM ET

Speaker Dinner

Sponsorship available. Please see our sponsorship information.

IPWatchdog
Add to Calendar 10/24/2022 6:30 PM America/New_York Speaker Dinner

Sponsorship available. Please see our sponsorship information.

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Tuesday, Oct 25, 2022

8:00 AM ET

Add to Calendar 10/25/2022 8:00 AM America/New_York Registration & Breakfast

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9:00 AM ET

Welcome to Life Sciences 2022

Life sciences innovations have been under constant attack at the U.S. Patent and Trademark Office, in litigation, and in the court of popular opinion. We will explore the law, politics and business of life sciences in this two-day program. Join as we begin our journey at 9am ET in the new IPWatchdog Headquarters in Ashburn, Virginia.

Gene Quinn, IPWatchdog Gene Quinn
Stephanie Schonewald Stephanie Schonewald
Add to Calendar 10/25/2022 9:00 AM America/New_York Welcome to Life Sciences 2022

Life sciences innovations have been under constant attack at the U.S. Patent and Trademark Office, in litigation, and in the court of popular opinion. We will explore the law, politics and business of life sciences in this two-day program. Join as we begin our journey at 9am ET in the new IPWatchdog Headquarters in Ashburn, Virginia.

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9:30 AM ET

The Future of the Written Description Requirement

Dating back to The Telephone Cases, 126 U.S. 1 (1888), the Supreme Court has required enough description so that the invention is described with “sufficient clearness and precision to enable those skilled in the matter to understand what the process is…” And more recently, the Supreme Court reiterated that “Section 112 requires only a written description of the invention… in…

Henry Hadad Henry Hadad
Stephanie Schonewald Stephanie Schonewald
user icon of man in business suit Steven Tang
Hans Sauer
Add to Calendar 10/25/2022 9:30 AM America/New_York The Future of the Written Description Requirement

Dating back to The Telephone Cases, 126 U.S. 1 (1888), the Supreme Court has required enough description so that the invention is described with “sufficient clearness and precision to enable those skilled in the matter to understand what the process is…” And more recently, the Supreme Court reiterated that “Section 112 requires only a written description of the invention… in…

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10:30 AM ET

Networking

Break

Sponsorship available. Please see our sponsorship information.

IPWatchdog
Add to Calendar 10/25/2022 10:30 AM America/New_York Break

Sponsorship available. Please see our sponsorship information.

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11:00 AM ET

Patent Eligibility and the Life Sciences Industry– What Next?

With the Supreme Court recently refusing certiorari in American Axle, hope has been lost for a near-term patent eligibility fix that would help the life sciences industry. Was it foolish to be hopeful the Supreme Court would fix a Federal Circuit ruling that found a drive shaft to be patent ineligible because the operation of the drive shaft fundamentally relies on Hooke’s law?…

Laura Smalley
Thomas Stoll Thomas Stoll
Michael Cottler Mike Cottler
Chief Judge Paul Michel Hon. Paul R. Michel
Add to Calendar 10/25/2022 11:00 AM America/New_York Patent Eligibility and the Life Sciences Industry– What Next?

With the Supreme Court recently refusing certiorari in American Axle, hope has been lost for a near-term patent eligibility fix that would help the life sciences industry. Was it foolish to be hopeful the Supreme Court would fix a Federal Circuit ruling that found a drive shaft to be patent ineligible because the operation of the drive shaft fundamentally relies on Hooke’s law?…

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12:15 PM ET

Strategic Considerations for Life Sciences Claim Drafting

Over the past 80 years, about 40% of all FDA-approved pharmaceutical products have been in the form of pharmaceutical salts. The typical route for claiming such salts in patents involves claim cascades beginning with the ubiquitous “and pharmaceutically acceptable salts thereof” and often ends by naming the particular salt species of interest. Examples of such salts include sodium or hydrochloride…

Eyal Barash
Debora Plehn-Dujowich Debora Plehn-Dujowich
Add to Calendar 10/25/2022 12:15 PM America/New_York Strategic Considerations for Life Sciences Claim Drafting

Over the past 80 years, about 40% of all FDA-approved pharmaceutical products have been in the form of pharmaceutical salts. The typical route for claiming such salts in patents involves claim cascades beginning with the ubiquitous “and pharmaceutically acceptable salts thereof” and often ends by naming the particular salt species of interest. Examples of such salts include sodium or hydrochloride…

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1:15 PM ET

Lunch

Sponsorship available. Please see our sponsorship information.

IPWatchdog
Add to Calendar 10/25/2022 1:15 PM America/New_York Lunch

Sponsorship available. Please see our sponsorship information.

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2:15 PM ET

The Incentivizing of Pharmaceutical Innovations in the Biden Administration

President Biden has called for the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to work together to leverage their collective expertise to promoting innovation and competition, while working to reduce the cost of pharmaceutical drugs for the benefit of American families. On July 6, USPTO Director Kathi Vidal wrote on the Director’s Blog…

Doreen Trujillo Doreen Y. Trujillo
Drew Hirshfeld
Corey Salsberg Corey Salsberg
Sherry Knowles
Add to Calendar 10/25/2022 2:15 PM America/New_York The Incentivizing of Pharmaceutical Innovations in the Biden Administration

President Biden has called for the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to work together to leverage their collective expertise to promoting innovation and competition, while working to reduce the cost of pharmaceutical drugs for the benefit of American families. On July 6, USPTO Director Kathi Vidal wrote on the Director’s Blog…

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3:30 PM ET

Price Fixing and Antitrust Liability as a Mechanism to Control Drug Prices

The drug price fixing provisions of the Inflation Reduction Act of 2022 impose government price controls on certain innovative medicines. Under the provisions of the bill, drug companies would be virtually mandated to accept the government’s offered sale price on drugs captured within the legislation, otherwise they would be accessed a 95% excise tax on sales. The bill could jeopardize…

Kelly Anderson (GIPC) Kelly Anderson
Hon. Susan G. Braden
Mythili Markowski, Ph.D.
Add to Calendar 10/25/2022 3:30 PM America/New_York Price Fixing and Antitrust Liability as a Mechanism to Control Drug Prices

The drug price fixing provisions of the Inflation Reduction Act of 2022 impose government price controls on certain innovative medicines. Under the provisions of the bill, drug companies would be virtually mandated to accept the government’s offered sale price on drugs captured within the legislation, otherwise they would be accessed a 95% excise tax on sales. The bill could jeopardize…

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4:30 PM ET

Break

Sponsorship available. Please see our sponsorship information.

IPWatchdog
Add to Calendar 10/25/2022 4:30 PM America/New_York Break

Sponsorship available. Please see our sponsorship information.

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5:00 PM ET

Add to Calendar 10/25/2022 5:00 PM America/New_York Obtaining Investment for Life Sciences Companies: Best Practices for Securing Funding and Negotiating Term Sheets

Description forthcoming.

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6:00 PM ET

Reception

Join us for happy hour and networking at the conclusion of day 1.

IPWatchdog
Add to Calendar 10/25/2022 6:00 PM America/New_York Reception

Join us for happy hour and networking at the conclusion of day 1.

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Wednesday, Oct 26, 2022

8:00 AM ET

Add to Calendar 10/26/2022 8:00 AM America/New_York Registration & Breakfast

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9:00 AM ET

PTAB Trends: Where Does the PTAB Fit in for Life Sciences Companies

The primary focus of this panel will be a discussion of how post grant proceedings— both post grant review (PGR) and inter partes review (IPR)—  fit within the freedom to operate (FTO) and pre-litigation strategy of life science companies. We will begin the conversation with a discussion of recent trends at the PTAB in the life sciences area, and consider…

Sophie Wang Sophie F. Wang
Emily Johnson Emily Johnson
Phil Johnson
Todd Walters
Add to Calendar 10/26/2022 9:00 AM America/New_York PTAB Trends: Where Does the PTAB Fit in for Life Sciences Companies

The primary focus of this panel will be a discussion of how post grant proceedings— both post grant review (PGR) and inter partes review (IPR)—  fit within the freedom to operate (FTO) and pre-litigation strategy of life science companies. We will begin the conversation with a discussion of recent trends at the PTAB in the life sciences area, and consider…

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10:15 AM ET

Antibodies: The Challenges Facing Patent Applicants

This panel will discuss the short-term and long-term implications of the application of Abbvie, Amgen and similar cases for biopharma companies engaging in the development of therapeutics. The panel will also discuss the current state of the enablement and written description requirements.

Sharon Crane
Rachel Elsby, Ph.D.
Peter Choi Peter Choi
Michele Wales Michele Wales, Ph.D., JD
Add to Calendar 10/26/2022 10:15 AM America/New_York Antibodies: The Challenges Facing Patent Applicants

This panel will discuss the short-term and long-term implications of the application of Abbvie, Amgen and similar cases for biopharma companies engaging in the development of therapeutics. The panel will also discuss the current state of the enablement and written description requirements.

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11:15 AM ET

Networking

Break

Sponsorship available. Please see our sponsorship information.

IPWatchdog
Add to Calendar 10/26/2022 11:15 AM America/New_York Break

Sponsorship available. Please see our sponsorship information.

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11:45 AM ET

International Biopharma Enforcement: Protecting Your Assets Globally

Description forthcoming.

Otto Licks
Jamison Lynch Jamison Lynch
Brent R. Bellows, Ph.D.
Add to Calendar 10/26/2022 11:45 AM America/New_York International Biopharma Enforcement: Protecting Your Assets Globally

Description forthcoming.

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12:45 PM ET

Lunch

Sponsorship available. Please see our sponsorship information.

IPWatchdog
Add to Calendar 10/26/2022 12:45 PM America/New_York Lunch

Sponsorship available. Please see our sponsorship information.

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1:45 PM ET

Double Patenting, Double Trouble: Continuations, Terminal Disclaimers, and Interplay with PTA and PTE

The judicially created doctrine of obviousness-type double patenting (OTDP) is a complex body of law with very high stakes for the life sciences industry. A negative decision on OTDP can cost the patentee years of patent term on clinical assets, severely limit the ability of the patentee to monetize their patent portfolio, and even invalidate patents if careful control of…

Robert Sahr, Ph.D.
Craig Svoboda Craig Svoboda
Anthony Prosser, Ph.D. Anthony R. Prosser, Ph.D.
Add to Calendar 10/26/2022 1:45 PM America/New_York Double Patenting, Double Trouble: Continuations, Terminal Disclaimers, and Interplay with PTA and PTE

The judicially created doctrine of obviousness-type double patenting (OTDP) is a complex body of law with very high stakes for the life sciences industry. A negative decision on OTDP can cost the patentee years of patent term on clinical assets, severely limit the ability of the patentee to monetize their patent portfolio, and even invalidate patents if careful control of…

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3:00 PM ET

ANDA Litigation Strategies and Tactics

Description forthcoming.

Emer Simic Emer Simic
Add to Calendar 10/26/2022 3:00 PM America/New_York ANDA Litigation Strategies and Tactics

Description forthcoming.

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