Life After Cellect: Potential Pitfalls and Arguments to Navigate Through the Invalidity/Unpatentability/Loss of PTA Minefields
Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Patent
- event Date
Thursday, December 12, 2024
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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.
Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new patent applications, prosecutes U.S. and foreign applications, and represents applicants at appeals and oral hearings before the PTAB. She has experience in prosecuting inter partes and ex partes reexamination applications, reissue applications, and patent term extension applications for approved pharmaceuticals, including obtaining supplemental protection certificates in Europe.
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.
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.
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.
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.
- 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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