Search Team

Search by Last Name
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z

Articles

Caraco Brings New Challenges for Drafting Use Codes

April 17, 2013

Articles

Caraco Brings New Challenges for Drafting Use Codes

April 17, 2013

Back to News Listing
Caraco Brings New Challenges for Drafting Use Codes

Caraco Brings New Challenges for Drafting Use Codes

This article appeared in Pharmaceutical Compliance Monitor, April 17, 2013, and is reproduced with permission.

Ever since the U.S. Supreme Court ruled in Caraco v. Novo Nordisk, 132 S.Ct. 1670 (2012) that Orange Book use codes are unlawful if they preclude generic marketing of non-infringing uses of a pioneer drug, patent attorneys have been walking a fine line. If they draft use codes that are too narrow, generics might easily carve them out and go quickly to market with an AB (full substitution) rating. But if they are too broad, the pioneer runs the risk of being accused of unlawfully restraining generic competition. In the wake of Caraco, patent attorneys face many new challenges trying to match the language of patent claims with the FDA-approved uses that appear on the drug label.

Orange Book use codes essentially serve one purpose – to tell the U.S. Food and Drug Administration (FDA) what language to remove from the pioneer label so that a generic will not induce infringement of the listed patent. As long as the generic drug is not marketed for the carved out use and is no less safe or effective than the pioneer drug for all remaining uses on the label, the FDA will approve the carve out and generics will escape lengthy (and costly) patent litigation.

Please read “Caraco Brings New Challenges for Drafting Use Codes” for more information.

If you have any questions about this article or would like to discuss this topic further, please contact your Fish & Richardson attorney or the author:

Attorney Terry Mahn on Drafting Use Codes Terry G. Mahn
Principal
Washington, DC
202-626-6421
mahn@fr.com

 

Stay current with Fish Sign up for our Newsletter