Agenda
Panel times and speakers subject to change.
Monday, Oct 16, 2023
2:00 PM ET
Welcome
Sherry Knowles
Gene Quinn
Stephanie Schonewald
Vincent Shier
2:40 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 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 can…
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 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 can…
,4:00 PM ET
USPTO-FDA Collaboration– Shortsighted or Visionary?
On July 9, 2021, President Biden signed Executive Order (EO) 14036 on “Promoting Competition in the American Economy.” In this Executive Order, President Biden stated that “too often, patent and other laws have been misused to inhibit or delay—for years and even decades—competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” To advance the Biden Administration’s vision…
On July 9, 2021, President Biden signed Executive Order (EO) 14036 on “Promoting Competition in the American Economy.” In this Executive Order, President Biden stated that “too often, patent and other laws have been misused to inhibit or delay—for years and even decades—competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” To advance the Biden Administration’s vision…
,6:20 PM ET
Opening Reception
Beer, wine, cocktails, hors’ d’ oeuvres and networking.
Beer, wine, cocktails, hors’ d’ oeuvres and networking.
,Tuesday, Oct 17, 2023
8:00 AM ET
9:00 AM ET
Welcome
Sherry Knowles
Gene Quinn
Vincent Shier
Stephanie Schonewald
9:40 AM ET
The Future of Biopharma Claim Drafting after Amgen
The United States Supreme Court is soon poised to decide the fate of the enablement requirement in Amgen v. Sanofi. Is it proper to inject the traditional enablement requirement with concepts up until now associated with undue experimentation? In other words, does the mere fact that it takes time and routine effort to make and use antibodies not explicitly disclosed…
Emily Johnson
Sophie F. Wang
The United States Supreme Court is soon poised to decide the fate of the enablement requirement in Amgen v. Sanofi. Is it proper to inject the traditional enablement requirement with concepts up until now associated with undue experimentation? In other words, does the mere fact that it takes time and routine effort to make and use antibodies not explicitly disclosed…
,11:00 AM ET
Double Patenting: 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 was it 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 having…
Sherry Knowles
Vincent Shier
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 was it 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 having…
,1:00 PM ET
Pharmaceutically Obvious: Winning on 103 in Examination, at the PTAB and in District Court
Obviousness is a question of law based on underlying factual inquiries. That is easy to say, but reliably determining what is or is not obvious and, therefore, is or is not patentable, is a difficult matter. Not only is obviousness unevenly applied between Art Units within the United States Patent and Trademark Office (USPTO), but obviousness is also applied quiet differently between…
Obviousness is a question of law based on underlying factual inquiries. That is easy to say, but reliably determining what is or is not obvious and, therefore, is or is not patentable, is a difficult matter. Not only is obviousness unevenly applied between Art Units within the United States Patent and Trademark Office (USPTO), but obviousness is also applied quiet differently between…
,2:20 PM ET
Best Practices for Multi-Defendant Biopharma Patent Litigation
The panel will address, among other things: 1. How to share workload at various stages of litigation while also ensuring satisfactory representation of your client. 2. How to find out about bombshells your co0defendants may have created (we have a war story here) 3. Whether to share experts, and related confidentiality issues if one expert sees multiple ANDAs 4. How…
Meredith Addy
The panel will address, among other things: 1. How to share workload at various stages of litigation while also ensuring satisfactory representation of your client. 2. How to find out about bombshells your co0defendants may have created (we have a war story here) 3. Whether to share experts, and related confidentiality issues if one expert sees multiple ANDAs 4. How…
,3:40 PM 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…
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…
,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
Colin Sandercock
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
Cocktail Reception
Beer, wine, cocktails, hors’ d’ oeuvres and networking.
Beer, wine, cocktails, hors’ d’ oeuvres and networking.
,Wednesday, Oct 18, 2023
8:00 AM ET
9:00 AM ET
Welcome
Sherry Knowles
Gene Quinn
Vincent Shier
Stephanie Schonewald
9:40 AM ET
ANDA Litigation: Current Trends and Best Practices
In the United States, for a new drug to receive market approval, a New Drug Application, known as an NDA, must be submitted to the FDA. To lessen the burden on generics, Hatch-Waxman allows generic manufacturers to submit Abbreviated New Drug Applications, known as ANDAs, which allows the generic manufacturer to piggyback on the research data in the NDA, which…
W. Blake Coblentz
In the United States, for a new drug to receive market approval, a New Drug Application, known as an NDA, must be submitted to the FDA. To lessen the burden on generics, Hatch-Waxman allows generic manufacturers to submit Abbreviated New Drug Applications, known as ANDAs, which allows the generic manufacturer to piggyback on the research data in the NDA, which…
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