We value your privacy
We use cookies to analyze site traffic and improve your experience. See our Privacy Policy.
Clinical Trials
0
0 active
Approvals
3
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
No trial phase data available
No trial data available
FDA
Food and Drug Administration
- The Federal Circuit affirmed that Rubicon's generic baclofen label does not induce patent infringement because it only optionally permits refrigerated storage while clearly instructing room temperature storage. - The court distinguished between drug labels that require infringing use versus those that merely permit it as an option, with only the former constituting induced infringement. - The ruling establishes that optional instruction language in drug labels, even if covered by a patent, may not result in induced infringement liability for generic manufacturers. - Brand companies are advised to seek FDA labeling that requires specific instructions rather than merely presenting options to maintain patent protection against generic competition.
