Background
Ferring B.V. owned a patent on a desmopressin pharmaceutical formulation used to treat bedwetting and diabetes insipidus. Ferring licensed the patent exclusively to Aventis Pharmaceuticals. Barr Laboratories filed an ANDA seeking approval to market a generic version. When Ferring and Aventis sued for patent infringement, Barr raised the defense that the patent was unenforceable for inequitable conduct committed during prosecution.
The inequitable conduct arose from a pattern in the prosecution record. During prosecution, the examiner had rejected the patent claims as obvious over prior art and had specifically expressed concern that Ferring’s own declarations might be biased. The examiner requested declarations from scientists who were not inventors and who could speak independently about the patentability of the invention. Ferring submitted five declarations from scientists with significant financial and professional relationships with Ferring and Aventis — including consulting agreements, research grants, and contractual arrangements — none of which were disclosed to the patent office. Barr argued these undisclosed affiliations constituted inequitable conduct.
The Court’s Holding
The Federal Circuit affirmed summary judgment of unenforceability in an opinion by Judge Dyk, with Judge Newman dissenting. On materiality, the court held that the undisclosed relationships between the declarants and Ferring were highly material. The declarations had been pivotal in overcoming the examiner’s rejections, and the examiner had specifically requested independent declarations precisely because of expressed concerns about bias. When an examiner explicitly flags concern about bias and requests unbiased evidence, the affiliations of those who provide that evidence are directly relevant to the examiner’s evaluation — making them material to patentability.
On intent to deceive, the court applied the inference standard that had developed in Federal Circuit inequitable conduct law: where a party knowingly withholds material information and offers no credible explanation for the omission, intent to deceive may be inferred. The prosecution agent knew about the declarants’ relationships with Ferring, knew or should have known those relationships were material given the examiner’s expressed concerns, and offered no credible explanation for the failure to disclose them. Four of the five declarants had undisclosed ties to Ferring, creating a false appearance of broad, independent scientific consensus supporting patentability.
Judge Newman dissented, arguing that the majority’s approach to inferring deceptive intent was too expansive and that failure to disclose affiliations should not automatically yield an inequitable conduct finding without stronger direct evidence of intent to deceive.
Key Takeaways
- When a patent examiner specifically requests independent, unbiased declarations to overcome a rejection, the declarants’ financial and professional relationships with the patent applicant are highly material to the examiner’s evaluation and must be disclosed.
- Intent to deceive in inequitable conduct analysis may be inferred when an applicant knowingly withholds material information and offers no credible explanation — the inference is stronger when the omissions are systematic or affect multiple declarations.
- Submitting declarations from scientists with undisclosed consulting or financial ties to the patent owner creates serious inequitable conduct risk, particularly where the examiner has specifically sought independent evidence.
- Inequitable conduct resulting in unenforceability can render a patent unenforceable against all infringers, not just the party who raised the defense — making the duty of candor a matter of critical commercial importance.
- This case represents the pre-Therasense era’s expansive inequitable conduct doctrine; the Federal Circuit’s 2011 en banc decision in Therasense v. Becton Dickinson later raised the bars for both materiality and intent, limiting cases like Ferring.
Why It Matters
Ferring v. Barr Laboratories is a significant case in the development of Federal Circuit inequitable conduct law, particularly in the pharmaceutical context where declarations from academic scientists play a central role in overcoming obviousness rejections. The pharmaceutical industry routinely seeks declarations from researchers with existing relationships to the sponsor — relationships that, if undisclosed, create exactly the kind of misleading impression of independent validation that the duty of candor is designed to prevent.
This case sits at a historically important moment in inequitable conduct law. In the years before Therasense, courts applied a relatively low bar for finding both materiality and deceptive intent, leading to what critics called an epidemic of inequitable conduct allegations in patent litigation. The Federal Circuit’s later en banc correction in Therasense significantly narrowed both elements, requiring but-for materiality for most cases and demanding evidence of specific intent rather than an inference from knowing nondisclosure. Understanding Ferring helps practitioners appreciate how far the inequitable conduct doctrine has been pulled back and what the current law requires in comparison to the pre-Therasense standard.