Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Duty of Candor and Good Faith With the USPTO Covers Non-Inventors and Non-Practitioners
The Federal Circuit decision in Belcher Pharm. v. Hospira, Inc., 11 F.4th 1345 (Fed. Cir. 2021), confirms important details regarding the duty of candor and good faith when interacting with the United States Patent & Trademark Office (USPTO). For example, withholding information that is material to the patentability of a pending claim of a patent application during prosecution can cause a resultant patent to be found unenforceable. In view of the Belcher decision, the USPTO released a Notice on July 29, 2022 that provides additional guidance on the duty of candor and good faith. Practitioners and non-practitioners that are associated with the examination of patents and patent applications should be vigilant about information that may be material to patentability to avoid having an issued patent be deemed unenforceable.
Federal Circuit Decision
The decision concerns Belcher's U.S. Patent No. 9,283,197, which discloses an injectable liquid formulation having a concentration of 1.0 – 1.06 mg/mL of L-epinephrine, a pH between 2.8 and 3.3, and certain specified percentages of degradation products. Id. at 1347–1350. The subject matter of the '197 patent also was submitted in a New Drug Application (NDA) to the Federal Drug Administration (FDA). Id. The information and arguments submitted to the FDA were different than the information and arguments presented to the USPTO. Based on this difference, the Federal Circuit determined that the '197 patent was unenforceable because Belcher engaged in inequitable conduct by intentionally and deceptively withholding material information from the USPTO during prosecution of the '197 patent, where such material information was disclosed to the FDA. Id. at 1354.
This premium content is locked for Entertainment Law & Finance subscribers only
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
- Stay current on the latest information, rulings, regulations, and trends
- Includes practical, must-have information on copyrights, royalties, AI, and more
- Tap into expert guidance from top entertainment lawyers and experts
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
New York's Latest Cybersecurity Commitment
On Aug. 9, 2023, Gov. Kathy Hochul introduced New York's inaugural comprehensive cybersecurity strategy. In sum, the plan aims to update government networks, bolster county-level digital defenses, and regulate critical infrastructure.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
How AI Has Affected PR
When we consider how the use of AI affects legal PR and communications, we have to look at it as an industrywide global phenomenon. A recent online conference provided an overview of the latest AI trends in public relations, and specifically, the impact of AI on communications. Here are some of the key points and takeaways from several of the speakers, who provided current best practices, tips, concerns and case studies.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.