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
6:00 PM ET
Sponsorship available. Please see our sponsorship information.
,Tuesday, Oct 25, 2022
8:00 AM ET
Registration & Breakfast
IPWatchdog
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
Stephanie Schonewald
Arthur Daemmrich
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.
,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
Stephanie Schonewald
Steven Tang
Hans Sauer
Brian Cocca
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…
,10:30 AM ET
Sponsorship available. Please see our sponsorship information.
,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
Mike Cottler
Hon. Paul R. Michel
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?…
,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
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…
,1:15 PM ET
Sponsorship available. Please see our sponsorship information.
,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 Y. Trujillo
Drew Hirshfeld
Corey Salsberg
Sherry Knowles
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…
,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
Hon. Susan G. Braden
Mythili Markowski, Ph.D.
Gene Quinn
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…
,4:30 PM ET
Sponsorship available. Please see our sponsorship information.
,5:00 PM ET
Obtaining Investment for Life Sciences Companies: Best Practices for Securing Funding and Negotiating Term Sheets
Description forthcoming.
Cecilia Vega
Joshua Harris
Megan Lyman
Jessica Alfano
Lauren Huizenga
Description forthcoming.
,6:30 PM ET
Join us for happy hour and networking at the conclusion of day 1.
,Wednesday, Oct 26, 2022
8:00 AM ET
Registration & Breakfast
IPWatchdog
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 F. Wang
Emily Johnson
Philip S. Johnson
Todd Walters
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…
,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
Michele Wales, Ph.D., JD
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.
,11:15 AM ET
Sponsorship available. Please see our sponsorship information.
,11:45 AM ET
International Biopharma Enforcement: Protecting Your Assets Globally
Description forthcoming.
Otto Licks
Jamison Lynch
Brent R. Bellows, Ph.D.
Corey Salsberg
Description forthcoming.
,12:45 PM ET
Sponsorship available. Please see our sponsorship information.
,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
Anthony R. Prosser, Ph.D.
Mary C. Till
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…
,3:00 PM ET
Strategic Considerations for Generics and Brands in Light of GSK v. Teva
Under the Hatch-Waxman Act, so-called “Section VIII carveout” also known as a skinny label, are intended to give generic drug companies protection from patent infringement liability as long as the uses the ANDA applicant lists are not covered by the innovator’s patents. GSK v. Teva arguably altered the skinny label landscape and unquestionably illustrates that the stakes could not be higher, even…
Emer Simic
Douglas J. Bucklin, Ph.D.
Melissa Brand
Luke Shannon
Under the Hatch-Waxman Act, so-called “Section VIII carveout” also known as a skinny label, are intended to give generic drug companies protection from patent infringement liability as long as the uses the ANDA applicant lists are not covered by the innovator’s patents. GSK v. Teva arguably altered the skinny label landscape and unquestionably illustrates that the stakes could not be higher, even…
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