Obviousness, 35 U.S.C. 271(e)(4)(A) and Application of Federal Rule of Civil Procedure 60(b) in the Pharma Space
A live 90-minute premium CLE video webinar with interactive Q&A
This CLE webinar will guide patent counsel on obviousness issues and the implications of the Federal Circuit's recent decisions. The panel will discuss the obviousness analysis and offer best practices for a patent owner to present claims to assist in navigating obviousness and for a generic manufacturer to surf the waves of Section 271(e)(4)(A).
Outline
- Salix Pharm. v. Norwich Pharm. (Fed. Cir. Apr. 11, 2024)
- Janssen Pharm. v. Teva Pharm. (Fed. Cir. Apr. 1, 2024)
- Obviousness analysis
- Section 271(e)(4)(A)
- Best practices, particularly in drafting and obtaining U.S. pharm patent claims that should be enforceable
Benefits
The panel will review these and other important issues:
- How have recent Federal Circuit decisions impacted the application of the obviousness standard?
- What impact will the interpretation of Section 271(e)(4)(A) have on generics?
- What strategies should patentees and petitioners employ to prevail on obviousness assertions at the Federal Circuit?
Faculty
Joanna T. Brougher, Esq., MPH
Owner & Principal
BioPharma Law Group
Ms. Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of... | Read More
Ms. Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of biotechnology, pharmaceuticals and medical devices, including patentability opinions, due diligence, patent drafting, domestic and foreign patent prosecution, development and management of patent portfolios, and general client counseling during all phases of a product’s lifecycle, from concept to commercialization.
Her patent experience covers a variety of complex and innovative inventions involving small molecule drugs, biologics, cell-based technologies, compositions, drug formulations and drug delivery systems, immunotherapeutics, medical devices, diagnostic tests, nanotechnology, and immunology, particularly vaccines and antibodies. Ms. Brougher also has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act.
Thomas L. Irving
Partner
The Marbury Law Group
Mr. Irving has 47 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,... | Read More
Mr. Irving has 47 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. He has served as lead counsel in many patent interferences.
CloseMichelle E. O'Brien
Partner
The Marbury Law Group
Ms. O’Brien has more than 20 years of experience representing domestic and foreign clients of all sizes in... | Read More
Ms. O’Brien has more than 20 years of experience representing domestic and foreign clients of all sizes in patent procurement, litigation, and client counseling, with a particular emphasis on chemical, biochemical, and pharmaceutical technologies. Exemplary areas of her technical expertise include polymer chemistry; ceramics; glass; food chemistry; cosmetics; paper products; adhesives; and pharmaceutical products, including new chemical entities and formulations and novel solid forms, including polymorphs, cocrystals, and amorphous forms of compounds.
CloseBrit Perla, Ph.D.
Senior Patent Agent
Arcus Biosciences
Dr. Perla is a Senior Patent Agent at Arcus Biosciences, a clinical-stage, global biopharmaceutical company with the... | Read More
Dr. Perla is a Senior Patent Agent at Arcus Biosciences, a clinical-stage, global biopharmaceutical company with the goal of developing best-in-class molecules and combination therapies for people with cancer. At Arcus, Dr. Perla supports small molecule discovery and clinical stage programs. Prior to joining Arcus Biosciences, she was a Patent Agent at Haley Guiliano LLP where she supported pharmaceutical and consumer product-based companies. She earned her Ph.D. in Chemistry from the University of Notre Dame.
CloseEarly Discount (through 05/24/24)
Cannot Attend June 10?
Early Discount (through 05/24/24)
You may pre-order a recording to listen at your convenience. Recordings are available 48 hours after the webinar. Strafford will process CLE credit for one person on each recording. All formats include course handouts.