Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

The Intellectual Property StrategistFeaturesIntellectual PropertyPatent Licensing and TransactionsPatent Litigation

Duty of Candor and Good Faith With the USPTO Covers Non-Inventors and Non-Practitioners

By George Chen, Cory Smith and Ryan Fitzpatrick
October 01, 2022

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

  • 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

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
Bankruptcy Sales: Finding a Diamond In the Rough Image

There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.

Coverage Issues Stemming from Dry Cleaner Contamination Suits Image

In recent years, there has been a growing number of dry cleaners claiming to be "organic," "green," or "eco-friendly." While that may be true with respect to some, many dry cleaners continue to use a cleaning method involving the use of a solvent called perchloroethylene, commonly known as perc. And, there seems to be an increasing number of lawsuits stemming from environmental problems associated with historic dry cleaning operations utilizing this chemical.

Removing Restrictive Covenants In New York Image

In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?

Blockchain Domains: New Developments for Brand Owners Image

Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.

Major Differences In UK, U.S. Copyright Laws Image

This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.