Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Implications of 'Amgen v. Sanofi' On the State of Enablement Law
On Feb. 11, 2021, the Federal Circuit affirmed the district court's judgment as a matter of law (JMOL) that Amgen's asserted claims to genera of antibodies were invalid for lack of enablement. Amgen Inc. v. Sanofi, No. 2020-1074, 2021 WL 501114 (Fed. Cir. Feb. 11, 2021). The panel consisting of Chief Judge Prost and Judges Lourie and Hughes unanimously affirmed the District of Delaware's holding that undue experimentation would be required to practice the full scope of the claims-at-issue. Id.
Although this decision was highly fact-dependent, turning on the scope of particular antibody claims and the level of detail in the attendant specifications, its implications potentially stretch beyond the biotech space to the state of enablement law more generally. In particular and as further explained below, the decision appears to take steps to harmonize the prior cases that appropriately were guided by the Wands factors with the cases discussing the "full scope" of enablement that have engendered some confusion in the law.
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.