Original Program Agenda
This live, in-person program originally took place on October 16-18, 2023 at IPWatchdog
Studios in Ashburn, VA.
To watch the replay videos for this program, scheduled for November 20, 21, 27, & 28,
click the Register for Panel Replays button above to register.
Panel descriptions and speakers for each panel can be found in the Agenda below.
Monday, Oct 16, 2023
3:00 PM ET
Fixing the U.S. Patent System to Realign Biopharm Incentives
There is little doubt that the way intellectual property is viewed and protected has transformed over the last 18 years, at least in the eyes of those who strategically appreciate both the importance and limitations of rights available today. The patent system our government has created over the last decade incentivizes stealing patent rights rather than engaging in an arm…
Sherry Knowles
Gene Quinn
There is little doubt that the way intellectual property is viewed and protected has transformed over the last 18 years, at least in the eyes of those who strategically appreciate both the importance and limitations of rights available today. The patent system our government has created over the last decade incentivizes stealing patent rights rather than engaging in an arm…
,3:30 PM ET
Myths & Misconceptions: Setting the Record Straight on IP in the Pharma Sector
Last year Senator Thom Tillis (R-NC) wrote to the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to voice his concerns over “sources that are often cited to advance the false narrative that patent protections are to blame for high drug prices.” As Senator Tillis’ letter would go on to conclude, policymaking in this critical…
Hon. Paul R. Michel
Sharon Reiche
Hans Sauer
Brad Watts
Last year Senator Thom Tillis (R-NC) wrote to the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to voice his concerns over “sources that are often cited to advance the false narrative that patent protections are to blame for high drug prices.” As Senator Tillis’ letter would go on to conclude, policymaking in this critical…
,5:00 PM ET
Jeopardizing Drug Development with Bad Policy: How to Properly Incentivize Biopharma to Get What We Need
It is no secret that the cost for prescription drugs is more than anyone wants to pay. But is the price of newly developed, FDA approved drugs really the result of patents, or a thicket of patents? While patents are often to blame for the cost of prescription drugs, the truth is far more complicated. Indeed, the FDA approval process…
Joseph Allen
Arthur Daemmrich
Emily Johnson
Corey Salsberg
It is no secret that the cost for prescription drugs is more than anyone wants to pay. But is the price of newly developed, FDA approved drugs really the result of patents, or a thicket of patents? While patents are often to blame for the cost of prescription drugs, the truth is far more complicated. Indeed, the FDA approval process…
,6:00 PM ET
Opening Reception & Dinner
Beer, wine, cocktails, hors’ d’ oeuvres, dinner and networking.
Beer, wine, cocktails, hors’ d’ oeuvres, dinner and networking.
,Tuesday, Oct 17, 2023
8:30 AM ET
9:15 AM ET
Patent Eligibility: Train or Light at the End of the Tunnel?
With the Supreme Court continually refusing certiorari on issued of patent eligibility it seems there is little hope for relief for life sciences companies in the courts. With the evolution of the law of patent eligibility we seem to be at a place where every invention that embodies, uses, reflects, rests upon or applies scientific laws is patent ineligible? Given…
Gene Quinn
Vincent Shier
With the Supreme Court continually refusing certiorari on issued of patent eligibility it seems there is little hope for relief for life sciences companies in the courts. With the evolution of the law of patent eligibility we seem to be at a place where every invention that embodies, uses, reflects, rests upon or applies scientific laws is patent ineligible? Given…
,9:45 AM ET
The Future of the Written Description for Life Sciences
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…
Eyal Barash
Anthony R. Prosser
Charles Steenburg
Robin A. Weatherhead
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…
,11:05 AM ET
The Future of Claim Drafting after Amgen: How Much Disclosure is Enough to Enable Claims?
The United States Supreme Court issued its decision in Amgen, Inc. v. Sanofi et al. The Court held, as many feared they would, that the 26 antibody examples and detailed instructions for generating additional antibodies within the genus—which covered some 400 pages and included a CD Rom of the x-ray crystallography coordinates of Amgen’s “anchor” (or lead) antibodies 21B12 (Repatha) and…
Benjamin Cappel
Sarah Fashena
Ben Pelletier
Sophie F. Wang
The United States Supreme Court issued its decision in Amgen, Inc. v. Sanofi et al. The Court held, as many feared they would, that the 26 antibody examples and detailed instructions for generating additional antibodies within the genus—which covered some 400 pages and included a CD Rom of the x-ray crystallography coordinates of Amgen’s “anchor” (or lead) antibodies 21B12 (Repatha) and…
,1:00 PM ET
Best Practices for Multi-Defendant Life Sciences Patent Litigation
The panel will address, among other things: How to share workload at various stages of litigation while also ensuring satisfactory representation of your client. How to find out about bombshells your co-defendants may have created (we have a war story here). Whether to share experts, related confidentiality issues if one expert sees multiple ANDAs and how to divvy witnesses at…
Joshua Harris
Brandon Helms
Philip S. Johnson
Stephanie Sivinski
The panel will address, among other things: How to share workload at various stages of litigation while also ensuring satisfactory representation of your client. How to find out about bombshells your co-defendants may have created (we have a war story here). Whether to share experts, related confidentiality issues if one expert sees multiple ANDAs and how to divvy witnesses at…
,2:20 PM ET
The CRISPR Patent Wars: Implication for Human Medical Use
Few current technologies bring as much hope and promise to biotech as CRISPR-CAS genome editing technology. The incredible discovery was first reported in 2012 by Emmanuelle Charpentier and Jennifer A. Doudna, landing them the Nobel Prize for Chemistry in 2020, and promises to revolutionize basic and applied science. Since the discovery 11 short year ago, the technology has been deployed…
Brent R. Bellows
Jeffrey E. Depp
Jennifer L. King
Alicia Russo
Few current technologies bring as much hope and promise to biotech as CRISPR-CAS genome editing technology. The incredible discovery was first reported in 2012 by Emmanuelle Charpentier and Jennifer A. Doudna, landing them the Nobel Prize for Chemistry in 2020, and promises to revolutionize basic and applied science. Since the discovery 11 short year ago, the technology has been deployed…
,3:40 PM ET
Double Patenting: Constitutionality, In re Cellect and the fate of PTA & PTE
Patent Term Adjustment (PTA) was designed to serve an important purpose – to compensate patentees for time lost during examination due to U.S. Patent and Trademark Office (USPTO) delays. But what is the effect of obviousness type double patenting (OTDP) on PTA and patent term extension (PTE)? In Novartis v. Breckenridge, the Federal Circuit upheld the validity of a patent…
Sherry Knowles
Robert Sahr
Vincent Shier
Doreen Y. Trujillo
Patent Term Adjustment (PTA) was designed to serve an important purpose – to compensate patentees for time lost during examination due to U.S. Patent and Trademark Office (USPTO) delays. But what is the effect of obviousness type double patenting (OTDP) on PTA and patent term extension (PTE)? In Novartis v. Breckenridge, the Federal Circuit upheld the validity of a patent…
,5:00 PM ET
Cancer Therapies and the Future: A Scientific and IP Perspective
Everyone likely knows someone whose life has been impacted by cancer, be it a parent, a sibling, or a friend. Thankfully, there is a robust infrastructure in place, both on the public side and on the private side, with countless foundations, hospitals and research companies and centers all supporting cancer research. But is the American intellectual property infrastructure maximally facilitating the…
Hilary J. Libka
Michael Ybarra
Daniel Young
Everyone likely knows someone whose life has been impacted by cancer, be it a parent, a sibling, or a friend. Thankfully, there is a robust infrastructure in place, both on the public side and on the private side, with countless foundations, hospitals and research companies and centers all supporting cancer research. But is the American intellectual property infrastructure maximally facilitating the…
,6:00 PM ET
Happy Hour Cocktail Reception
Beer, wine, cocktails, hors’ d’ oeuvres and networking.
Beer, wine, cocktails, hors’ d’ oeuvres and networking.
,Wednesday, Oct 18, 2023
9:00 AM ET
9:45 AM ET
Masterminding Multi-Forum Challenges
Bryana McGillycuddy
Gene Quinn
Stephanie Schonewald
Sophie F. Wang
10:15 AM ET
Competitor vs. Competitor Biopharma Patent Litigation: Current Trends and Best Practices
This panel will examine current trends and best practice in competitor vs. competitor biopharma patent litigation, including both Hatch-Waxman litigation and biosimilar litigation. Among the specific items to be discussed, the panel will address: (1) The effect of In re Cellect on the Hatch-Waxman industry; (2) How a patent owner and generic can settle an ANDA case while minimizing anti-trust…
W. Blake Coblentz
Philip S. Johnson
Bryana McGillycuddy
This panel will examine current trends and best practice in competitor vs. competitor biopharma patent litigation, including both Hatch-Waxman litigation and biosimilar litigation. Among the specific items to be discussed, the panel will address: (1) The effect of In re Cellect on the Hatch-Waxman industry; (2) How a patent owner and generic can settle an ANDA case while minimizing anti-trust…
,11:35 AM ET
Best Practices and Tips for Winning at the PTAB
The differences between PTAB and district court proceedings are many. Unlike most district court judges, the Administrative Patent Judges (APJs) consist of technically savvy engineers and scientists. As a result, what works in district court or on appeal to the Federal Circuit does not necessarily work while appearing at the PTAB. In district court, for example, successful attorneys often create…
Scott McKeown
Hon. Grace Karaffa Obermann
Stephanie Schonewald
The differences between PTAB and district court proceedings are many. Unlike most district court judges, the Administrative Patent Judges (APJs) consist of technically savvy engineers and scientists. As a result, what works in district court or on appeal to the Federal Circuit does not necessarily work while appearing at the PTAB. In district court, for example, successful attorneys often create…
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