Agenda
** Panel videos are available to watch for any panel below showing a double asterisk after the title.
Monday, Oct 28, 2024
12:00 PM ET
REGISTRATION & LUNCH
We will have sandwiches and snacks available during registration, which will begin at 12 PM ET on Monday, October 28.
We will have sandwiches and snacks available during registration, which will begin at 12 PM ET on Monday, October 28.
,1:00 PM ET
The U.S. Biopharma Innovation Ecosystem: The Good, the Bad and the Ugly **
The biopharmaceutical innovation system—which brings novel, life-improving, and life-saving therapies from the researcher’s bench to a patient’s bedside—is a major engine powering health improvements, economic output, and wealth creation in the United States. But while the commercial and national security competition with China has brought policy attention to securing the semiconductor industry, the importance of sustaining a world-leading U.S. biopharmaceutical…
Jeffrey E. Depp
Sherry Knowles
Robert Sahr
The biopharmaceutical innovation system—which brings novel, life-improving, and life-saving therapies from the researcher’s bench to a patient’s bedside—is a major engine powering health improvements, economic output, and wealth creation in the United States. But while the commercial and national security competition with China has brought policy attention to securing the semiconductor industry, the importance of sustaining a world-leading U.S. biopharmaceutical…
,2:20 PM ET
The Drug Pricing Conundrum: Are Patents to Blame for High Drug Prices*
At a time when the Biden Administration is attempting to blame patents for everything relating to drug prices, patents on some of the most popular drugs the world has ever seen will soon be expiring. This panel will discuss the escalating debate over drug pricing, whether patents really are to blame for high drug prices, why the Biden Administration is threatening to “march-in“ to compel…
Ratib Ali
Hon. Paul R. Michel
Jon Putnam
Corey Salsberg
At a time when the Biden Administration is attempting to blame patents for everything relating to drug prices, patents on some of the most popular drugs the world has ever seen will soon be expiring. This panel will discuss the escalating debate over drug pricing, whether patents really are to blame for high drug prices, why the Biden Administration is threatening to “march-in“ to compel…
,3:40 PM ET
The CDMO Surge and Potential IP Landmines in Outsourcing**
Biotech and pharma companies are increasingly outsourcing to CROs, CMOs, and CDMOs across all stages, from discovery to commercialization. With the CDMO market projected to exceed $300 billion within the next decade, this strategy offers critical benefits in expertise, speed, and capacity. However, it also brings unique IP challenges, particularly the risk of triggering the on-sale bar when contractors are…
Melissa Brand
Gillian Fenton
Bryana McGillycuddy
Daniel Young
Biotech and pharma companies are increasingly outsourcing to CROs, CMOs, and CDMOs across all stages, from discovery to commercialization. With the CDMO market projected to exceed $300 billion within the next decade, this strategy offers critical benefits in expertise, speed, and capacity. However, it also brings unique IP challenges, particularly the risk of triggering the on-sale bar when contractors are…
,5:00 PM ET
How Emerging BioPharma Companies Navigate Innovation
Emerging biopharma is a segment of companies are responsible for a great deal of innovation, research and development within the life sciences sector. In fact, emerging biopharma has gradually taken over the R&D pipeline, producing two-thirds of all new drugs in 2022 according to one study. Emerging Biopharma companies are much smaller, more nimble and have a higher risk tolerance…
Brent R. Bellows, Ph.D.
Heather Champion Brady
Jennifer Burdman
Sage Mandel
Emerging biopharma is a segment of companies are responsible for a great deal of innovation, research and development within the life sciences sector. In fact, emerging biopharma has gradually taken over the R&D pipeline, producing two-thirds of all new drugs in 2022 according to one study. Emerging Biopharma companies are much smaller, more nimble and have a higher risk tolerance…
,6:00 PM ET
Topgolf Outing – Hosted by Choate and Wolf Greenfield
All guests of the IPWatchdog Life Sciences Masters 2024 program are invited to join us for a fun evening outing at Topgolf hosted by Choate and Wolf Greenfield. RSVPs will be required. Topgolf Address: 20356 Commonwealth Center Dr. Ashburn, VA 20147
All guests of the IPWatchdog Life Sciences Masters 2024 program are invited to join us for a fun evening outing at Topgolf hosted by Choate and Wolf Greenfield. RSVPs will be required. Topgolf Address: 20356 Commonwealth Center Dr. Ashburn, VA 20147
,Tuesday, Oct 29, 2024
9:00 AM ET
9:30 AM ET
The PTO Terminal Disclaimer Proposal: Updates, Preparations & Fighting Back**
The doctrine of obviousness-type double patenting has had a checkered and questionable history, not finding any support in the text of the Patent Act, which is why it is also known as “non-statutory double patenting.” Despite no statutory foundation, the doctrine of obviousness-type double patenting has become an increasingly complex body of law with very high stakes for the life…
Chris Israel
Sherry Knowles
Brad D. Pedersen
Brad Watts
The doctrine of obviousness-type double patenting has had a checkered and questionable history, not finding any support in the text of the Patent Act, which is why it is also known as “non-statutory double patenting.” Despite no statutory foundation, the doctrine of obviousness-type double patenting has become an increasingly complex body of law with very high stakes for the life…
,10:45 AM ET
Patent Term Adjustment After In re Cellect**
Patents are often filed on drug candidates long before the innovator receives FDA approval. As a result, the terminal portion of the patent’s life is the most valuable and important to ensure the innovator can see a return on their investment. Extra years, months, or even days of patent term can result in millions of dollars of revenue. Thus, the…
Robert Bahr
Jeffrey E. Depp
Anthony R. Prosser, Ph.D.
Patents are often filed on drug candidates long before the innovator receives FDA approval. As a result, the terminal portion of the patent’s life is the most valuable and important to ensure the innovator can see a return on their investment. Extra years, months, or even days of patent term can result in millions of dollars of revenue. Thus, the…
,11:40 AM ET
Unified Patent Court Update
Description forthcoming. Survey https://www.surveymonkey.com/r/UPC-Update
Tobias Wuttke
Description forthcoming. Survey https://www.surveymonkey.com/r/UPC-Update
,1:00 PM ET
Fixing PTE to Make Its ‘Product’ Fit for Biologics**
Patent Term Extension (PTE) under 35 U.S.C. 156 enables the owners of a patent that claims certain human drug products, medical device products, animal drug products, veterinary biological products to restore to the terms of those patents some of the time lost while awaiting premarket regulatory approvals. This right to PTE is the result of the Drug Price Competition and…
Robert Sahr
Meghann Teague
Mary C. Till
Patent Term Extension (PTE) under 35 U.S.C. 156 enables the owners of a patent that claims certain human drug products, medical device products, animal drug products, veterinary biological products to restore to the terms of those patents some of the time lost while awaiting premarket regulatory approvals. This right to PTE is the result of the Drug Price Competition and…
,2:20 PM ET
Using Salt Forms to Overcome Obviousness Type Double Patenting and the IRA
Pharmaceutical patents and patent strategies are under greater stress now than at any other time in modern history. The Inflation Reduction Act has for the first time in United States history has set prices for pharmaceutical products and case law and PTO policy have been creating roadblocks for protecting important new pharmaceutical products. What is a patent practitioner to do?…
Eyal Barash
Deborah Herzfeld
Gene Quinn
Pharmaceutical patents and patent strategies are under greater stress now than at any other time in modern history. The Inflation Reduction Act has for the first time in United States history has set prices for pharmaceutical products and case law and PTO policy have been creating roadblocks for protecting important new pharmaceutical products. What is a patent practitioner to do?…
,3:40 PM ET
The Unpredictable Arts Before the PTAB: 112 & Beyond**
Last year’s landmark decision in Amgen v. Sanofi emphasized that “the more a party claims, the broader the monopoly it demands, the more it must enable.” That is, particularly when claiming a broad genus of antibodies, the specification cannot be a research assignment to engage in trial and error as to the recited claim scope. Since the Supreme Court’s decision…
Tim Fink
Nicholas Matich
Scott McKeown
Stephen T. Schreiner
Last year’s landmark decision in Amgen v. Sanofi emphasized that “the more a party claims, the broader the monopoly it demands, the more it must enable.” That is, particularly when claiming a broad genus of antibodies, the specification cannot be a research assignment to engage in trial and error as to the recited claim scope. Since the Supreme Court’s decision…
,5:00 PM ET
In-House Counsel Perspective: What Keeps Us Awake at Night?
We have all been there, lying in bed when we are suddenly jolted awake in a cold sweat—was a response due and did I miss the deadline? Is the case abandoned? Did we pay maintenance fees on the right patent or did I transpose the number and the one patent that means the most has now fallen into the public domain? As…
Christian Bauer
Kady Bruce, Ph.D.
Patrick Kilbride
Kwame Mensah
We have all been there, lying in bed when we are suddenly jolted awake in a cold sweat—was a response due and did I miss the deadline? Is the case abandoned? Did we pay maintenance fees on the right patent or did I transpose the number and the one patent that means the most has now fallen into the public domain? As…
,6:00 PM ET
A Conversation with Judge Pauline Newman **
Please join us for a very special conversation with Hon. Pauline Newman, Circuit Judge on the United States Court of Appeals for the Federal Circuit.
Gene Quinn
Hon. Pauline Newman
Please join us for a very special conversation with Hon. Pauline Newman, Circuit Judge on the United States Court of Appeals for the Federal Circuit.
,6:30 PM ET
Wednesday, Oct 30, 2024
9:00 AM ET
9:30 AM ET
Obviousness and Life Sciences: Trends & Strategies for Success**
One of the more recent developments with respect to obviousness is the recent and increasing use of clinical trial evidence tied together with argument that it would have been reasonable to expect success. This puts the brands in a very difficult position because the inventor’s own work that is necessary in order to generate the invention is being used against…
Christopher Bruno
John Rearick, Ph.D.
Stephanie Schonewald
One of the more recent developments with respect to obviousness is the recent and increasing use of clinical trial evidence tied together with argument that it would have been reasonable to expect success. This puts the brands in a very difficult position because the inventor’s own work that is necessary in order to generate the invention is being used against…
,10:50 AM ET
The Role of Artificial Intelligence in Life Sciences**
Artificial intelligence (AI) is a rapidly growing sector of the life sciences industry, with broad-ranging applications in drug discovery, biotechnology, medical diagnosis, clinical trials, precision and personalized medicine and patient monitoring. This panel will discuss how AI is being used in the pharmaceutical industry to discover new drugs and ultimately bring them to the market quicker. The panel will also…
Patrick Kilbride
Diana Pankevich
Daniel Rudoy
Artificial intelligence (AI) is a rapidly growing sector of the life sciences industry, with broad-ranging applications in drug discovery, biotechnology, medical diagnosis, clinical trials, precision and personalized medicine and patient monitoring. This panel will discuss how AI is being used in the pharmaceutical industry to discover new drugs and ultimately bring them to the market quicker. The panel will also…
,12:10 PM ET
Fireside Chat with Walt Copan**
Dr. Walter Copan has been on the front lines in the technology transfer world throughout his career. Today he serves at Vice President of Research and Technology Transfer at the Colorado School of Mines. Prior to assuming this position he served as Under Secretary of Commerce and Director of NIST during the Trump Administration. Dr. Copan continues to be involved…
Dr. Walter Copan
Gene Quinn
Dr. Walter Copan has been on the front lines in the technology transfer world throughout his career. Today he serves at Vice President of Research and Technology Transfer at the Colorado School of Mines. Prior to assuming this position he served as Under Secretary of Commerce and Director of NIST during the Trump Administration. Dr. Copan continues to be involved…
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