On Friday, June 26, 2015 Amgen Inc. filed IPR petitions (IPR2015-01514 and IPR2015-01517) against two Humira (adalimumab) patents owned by AbbVie Inc., in an effort to clear the way for…
On Friday, June 26, 2015 Amgen Inc. filed IPR petitions (IPR2015-01514 and IPR2015-01517) against two Humira (adalimumab) patents owned by AbbVie Inc., in an effort to clear the way for…
The Federal Circuit recently received additional briefing on the bond issue from the parties in Amgen v. Sandoz, which remains under advisement. Our earlier posts on Amgen, which can be…
AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose three labeling requirements on biosimilar applicants. “Biosimilars are not generic drugs and should not be labeled like…
We joined a packed courtroom at the Federal Circuit Court of Appeals yesterday to observe oral arguments in the Amgen v. Sandoz appeal. Judge Newman, Judge Lourie, and Judge Chen…
Amgen appealed the district court order on March 25, 2015, and sought an expedited briefing schedule and an injunction to delay the launch of Sandoz’s Zarxio product while the Court…
As discussed in our introductory post, the BPCIA lays out a series of steps to resolve patent disputes involving biosimilars. According to these steps, once a biosimilar applicant receives…
Below we provide a short introduction to the world of biologics and the BPCIA. For a more comprehensive guide on biosimilars, check out Goodwin Procter’s Biosimilars: A Guide to Regulatory…
District Court Litigation Amgen Complaint Sandoz Answer Amgen Answer to Counterclaims and Affirmative Defenses Amgen Motion for Partial Judgment on Pleadings Amgen Motion for Preliminary…