About the Course
Introduction
This CLE course will provide guidance to patent counsel on product-by-process claims. The panel will discuss the advantages and disadvantages of this type of claim as well as the challenges of these claims. The panel will examine recent treatment by the courts and the PTAB and offer best practices for product-by-process claims.
Description
At least for infringement, product-by-process claims use process information to define a product according to the en banc Federal Circuit decision in Abbott Lab. v. Sandoz Inc. (2009). For patentability, however, the process limitations are not considered. See MPEP 2113 and 2173.05(p). This sets up a most interesting asymmetry in the law.
This type of product-by-process claim format can provide patent protection to new products that are otherwise incapable of structural characterization, or at least for purposes of proving infringement. Whether use of the product-by-process format is warranted in any particular case will depend, in a highly factual manner, upon the balance between the benefits and the practical disadvantages of the format, in light of the unique circumstances of each case. A
Product-by-process claims are construed differently depending on whether the claim is being analyzed by the USPTO, including in AIA post-grant proceedings, or the courts. In proceedings before the USPTO, product-by-process claims are interpreted as not limited by the process steps recited in the claims, because product-by-process claims define a product rather than a process. The principle is an accommodation to the burden that product-by-process claims place upon the USPTO. Before the courts, however, as clarified by the en banc Federal Circuit decision in Abbott Lab. v. Sandoz Inc., process terms in product-by-process claims serve as limitations in determining infringement. The Federal Circuit and the PTAB have provided some guidance on the patentability of these interesting, asymmetric claims.
Listen as our authoritative panel of patent attorneys examines product-by-process patent claims and their treatment both before the USPTO, including AIA post-grant proceedings, and the courts. The panel will discuss the advantages and disadvantages of this type of claim as well as the challenges of these claims. The panel will examine recent decisions and offer best practices for product-by-process claims.
Presented By
Ms. Burgy focuses on opinion work, client counseling, patent prosecution and management, and litigation in the chemical, pharmaceutical, and biotechnology arts. She counsels her clients on a diverse range of patent issues. She assists clients on single-patent issues as well as complex matters involving multiple patents and applications requiring ongoing advice on patent portfolio strategy and development, with an eye towards litigation. She has assisted clients in the early stages of development through due diligence and patent portfolio analysis.
Mr. Irving has more than 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. Mr. Irving has served as lead counsel in many patent interferences.
Ms. Murphy focuses on developing patent filing and prosecution strategies tailored to clients’ worldwide business goals. She works with a wide range of clients, including small biotech startup companies, research foundations, and large publicly traded biotechnology and pharmaceutical companies. Ms. Murphy prepares new patent applications, prosecutes U.S. and foreign applications, and represents appellants in ex parte appeals before the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO). She has also led clients through numerous reissue applications, inter partes and ex parte reexamination applications, and supplemental examination proceedings. Ms. Murphy’s extensive client counseling practice includes providing patentability, freedom-to-operate, infringement, and validity opinions. In addition, she represents petitioners and patent owners in inter partes review (IPR) and post grant review (PGR) proceedings before the PTAB. She has substantial experience in a wide variety of life sciences technologies, including antibodies and antibody drug conjugates; antiretrovirals and anticancer agents; biologics; blood clotting factors; cell signaling and signal transduction; diagnostic markers and detection assays; drug formulations; gene delivery systems, including AAV; gene editing technologies, including CRISPR; immunooncology; lipid nanoparticles; microbiome analysis and probiotics; nucleic acid modifications; peptide synthesis and protein purification; single-cell and single-molecule analysis; small molecule drugs; and vaccines.
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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Date + Time
- event
Thursday, December 28, 2023
- schedule
1:00 p.m. ET./10:00 a.m. PT
- Product-by-process claims
- Advantages
- Disadvantages
- Challenges
- Court treatment
- USPTO treatment
- Best practices
The panel will review these and other key issues:
- What lessons can be learned from recent court treatment of product-by-process claims?
- What steps should counsel take when pursuing product-by-process claims?
- What steps should counsel take when addressing infringement of such claims?
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