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About the Course
Introduction
This CLE webinar will guide patent counsel on how to navigate the fallout of the Cellect decision, understanding the potential pitfalls that may be encountered and the arguments that can be made to circumvent those pitfalls.
Description
On Oct. 7, 2024, the Supreme Court declined to hear Cellect L.L.C. v. Vidal, in which the Federal Circuit had upheld PTAB's application of the judicially created doctrine of non-statutory obvious-type double patenting (ODP). The PTAB found, in a reexamination proceeding, that claims in four patents were unpatentable because they were not patentably distinct from claims in other patents in the same family. The decision clarified that in an ODP situation, patent term adjustments (PTA) are first calculated and then added to a normal patent expiration to obtain an expiration date for a challenged patent, after which ODP via an ODP reference is applied against the PTA-lengthened expiration date. In Cellect, all the challenged patents, under this methodology, were unpatentable over ODP reference patents.
Following Cellect, PTA may now result in a risk of invalidity/unpatentability giving defendants another option to achieve their objective of no liability for patent infringement. Furthermore, Cellect did not treat PTA the same as patent term extensions (PTE). In a patent with PTE, ODP is applied before PTE is added to the expiration date. Had Cellect applied PTA as it does PTE, none of the Cellect patents would have been declared unpatentable! Now that Cellect is final, patent counsel should take steps to mitigate the risk of ODP challenges.
The panel will discuss strategies designed to reduce the risk of Cellect's devastating result, such as drafting claims to elicit a restriction requirement, filing one or more divisionals to swim into the Safe Harbor of 35 U.S.C. § 121 and then staying there through consonance, and obtaining patents timely claiming the results of clinical trials, such as Phase 2B or Phase 3. Also, patent counsel should avoid the pitfall of admitting claims in different applications in a family are patentably indistinct (Cellect made such an admission, and it did not turn out well, as noted above), and making efforts to get the USPTO to consider other family patents that might be ODP reference (Cellect did not make any such efforts, and the Cellect court considered that to be a negative against Cellect).
Listen as our authoritative panel of patent attorneys reviews the Federal Circuit's decision in Cellect and what it means for PTA. The panel will offer guidance on how to navigate the fallout of the Cellect decision, understanding the potential pitfalls that may be encountered and the arguments that can be made to circumvent those pitfalls.
Presented By
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.
Ms. O’Brien has more than 25 years of experience representing both domestic and foreign clients of all sizes in the areas of patent procurement, litigation, and client counseling, with a particular emphasis on chemical, biochemical, and pharmaceutical technologies. Exemplary areas of Ms. O’Brien’s technical expertise include polymer chemistry; ceramics; glass; food chemistry; cosmetics; paper products; adhesives; and pharmaceutical products including new chemical entities and formulations, as well as novel solid forms including polymorphs, cocrystals, and amorphous forms of compounds. Ms. O’Brien’s expertise includes all aspects of preparing and prosecuting U.S. and foreign patent applications, such as patent drafting and prosecution, as well as more complex matters such as reissue and reexamination proceedings, appeals hearings, Post-Grant Reviews (PGR), and Inter Partes Reviews (IPR) before the Patent Trial and Appeal Board (PTAB). Her litigation expertise focuses on patent infringement cases including, for example, Hatch-Waxman litigation involving Abbreviated New Drug Applications, and includes all stages from pre-discovery through trial.
Ms. Zimmerman is a member of the Patent Group’s Life Sciences team. Her practice focuses on various aspects of patent prosecution, due diligence, and freedom to operate analysis, working primarily with clients in the life sciences, chemical, and food and beverage industries. Ms. Zimmerman has nearly a decade of experience in domestic and international patent prosecution. She also has significant experience providing strategic patent counseling to life sciences companies, universities, and research institutions, leveraging complex structures searches to guide them through key stages of drug development. In addition, Ms. Zimmerman has worked closely on several due diligence projects, which have successfully culminated in multi-million dollar license agreements. She regularly accepts pro bono patent cases from Georgia Pro Bono Assistance and Training for Entrepreneurs and New, Talented, Solo Inventors (PATENTS), and was named to the State Bar of Georgia’s 2021 Pro Bono Honor Roll. Ms. Zimmerman is a member of AUTM Eastern Region Planning Committee, where she assists in reviewing and selecting abstract submissions and in organizing the programming sessions for the organization’s regional meeting.
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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Live Online
On Demand
Date + Time
- event
Thursday, December 12, 2024
- schedule
1:00 p.m. ET./10:00 a.m. PT
- Cellect L.L.C. v. Vidal
- Implications for invalidity
- Implications for unpatentability
- Implications for PTA/PTE
- Strategies after Cellect
- Best practices in an effort to avoid having your cleint's patents "Cellected"
The panel will review these and other key issues:
- What are specific, best steps to avoid the untoward result in Cellect?
- What best practices should patent prosecutors adopt after Cellect?
- What best practices should plaintiffs in patent infringement matters consider in light of Cellect?
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