Obvious-Type Double Patenting and PTEs: Defeating ODP Rejections and Avoiding Terminal Disclaimers
Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
- work Practice Area
Patent
- event Date
Tuesday, June 21, 2022
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
This CLE course will guide IP counsel in understanding double patenting. The panel will analyze recent court treatment, offer best practices to defeat double patenting rejections and avoid terminal disclaimers, and provide specific language to consider if a terminal disclaimer must be filed.
Dr. MacAlpine practices patent procurement, due diligence investigations, opinion work, and client counseling, primarily in the chemical and pharmaceutical areas. She has extensive experience in handling patent matters before the U.S. Patent and Trademark Office (USPTO), including post-grant proceedings specifically IPRs, appeals, and oral hearings at the PTAB; drafting and prosecution of patent applications; reissue and reexamination proceedings; and interferences.
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. Stuart is a patent attorney with 15 years experience prosecuting and litigating patents, and providing strategic IP counseling with emphasis in pharmaceuticals and life sciences. Her current practice includes supporting programs in all stages of development from early stage R&D and throughout product life cycle, including drafting and prosecuting global patent portfolios, advising on freedom to operate and diligence matters, supporting global regulatory filings, providing contract support, and developing global IP strategies.
Obviousness-type double patenting (ODP) is not statutory and is intended to prevent an inventor from improperly extending a patent's life by having two patents on the same invention. ODP may arise between pending applications, between a patent and one or more pending applications, and between multiple patents, even if not owned by the same party.
In December 2018, the Federal Circuit brought some clarity to ODP in the context of pre-Uruguay Round Agreements Act (URAA) and URAA patents and applications. In Novartis AG v. Ezra Ventures LLC, the court held that (PTE) granted under 35 U.S.C. Section 156. Recently Judge Shipp cited Ezra in Amgen, Inc. v. Sandoz Inc., 2021 U.S. Dist. LEXIS 224304 (D. NJ Sept. 20, 2021), for the same principle: "these statutorily authorized time extensions do not cause a patent to be invalid for obviousness-type double patenting ('ODP'). ODP is a 'judicially created doctrine intended to prevent improper timewise extension of the patent right.' ... A difference in expiration dates between two patents that arises solely from a statutorily authorized time extension, such as a patent-term adjustment pursuant to 35 U.S.C. § 154(b) or a patent-term extension pursuant to 35 U.S.C. § 156, cannot be the basis for an application of ODP." Id. at *84-85.
In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., the court clarified that Gilead Sciences Inc. v. Natco Pharma Ltd. (Fed. Cir. 2014) (that a later-issued but earlier-expiring patent could invalidate an earlier-issuing but later-expiring patent for ODP) only applies to post-URAA patents.
In Breckenridge and Ezra, involving a pre-URAA patent and a post-URAA patent, the Federal Circuit cabined Gilead to circumstances where both the patent and the asserted reference patent are URAA. Importantly, the Federal Circuit definitively stated that ODP could not invalidate a validly obtained PTE.
Instead of a terminal disclaimer, arguments of separate patentability are an option. Arguments for separate patentability may arise in a genus-species context (such as in UCB, Inc. v. Accord Healthcare, Inc., 890 F.3d 1313 (Fed. Cir. 2018)) or may be supported by carefully presented real world objective evidence of patentability, such as commercial success, long-felt need, and failure of others.
Listen as our authoritative panel of patent attorneys examines ODP, including the impact of Breckenridge and Ezra and other recent decisions. The panel will offer best practices to defeat ODP rejections and avoid terminal disclaimers.
- Recent court treatment
- Implications of the recent decisions on ODP practice
- Best practices
- Defeating ODP rejections
- Avoiding terminal disclaimers
The panel will review these and other key issues:
- What is the scope of double patenting? How do the two recent Federal Circuit decisions impact the scope?
- What are the steps to defeat double patenting rejections?
- What are best practices to avoid terminal disclaimers?
- How can practitioners craft terminal disclaimers with an eye towards patent litigation?
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