The Evolving World of Biosimilars -
Amgen, Inc. v. Sandoz, Inc.
Addressing two new issues in the Biologics Price Competition and Innovation Act (BPCIA), the Northern District of California issued an order, on...more
On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more
On March 19, 2015, the District Court for Northern District of California (Judge Seeborg), issued an order providing one of the first judicial interpretations of the patent dispute resolution provisions laid out in subsection...more
On March 6, 2015, the U.S. FDA announced that it had approved Zarxio, making Sandoz the first company ever to obtain approval of a biosimilar product in the U.S. The FDA deemed Zarxio to be biosimilar to Amgen’s Neupogen...more
Case Name: Sandoz Inc. v. Amgen Inc., No. 2014-1693, 2014 U.S. App. LEXIS 22903 (Fed. Cir. Dec. 5, 2014) (Circuit Judges Dyk, Taranto, and Chen presiding; Opinion by Taranto, J.) (appeal from N.D. Cal, Chesney, J.) (A...more
Last week, at their January 7, 2015 meeting, the FDA's Oncologic Drugs Advisory Committee ("ODAC") recommended the approval of Sandoz's biosimilar filgrastim application to market a version of Amgen's NEUPOGEN® biologic drug....more
As noted in our previous client alert, FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act, Sandoz Inc. (“Sandoz”) filed the first biosimilar application under the Biologics...more
On December 5, in the closely watched Sandoz v. Amgen case, the Federal Circuit held that a biosimilars applicant cannot use the Declaratory Judgment Act to challenge a reference product sponsor's patent prior to filing a...more
On December 5, 2014, the Federal Circuit issued its opinion in Sandoz Inc. v. Amgen Inc. et al. In a unanimous panel opinion (Judges Dyk, Taranto and Chen), the Court held that clinical trials initiated to support a possible...more
Last year, Sandoz filed a declaratory judgment action against Amgen and Roche related to its etanercept biosimilar drug product, which it developed to compete with Amgen's Enbrel® TNF inhibitor. Specifically, Enbrel® is a...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Par Pharmaceutical, Inc. v. Glaxosmithkline LLC et al. 2:14-cv-06627; filed November 19, 2014 in the Eastern District of...more
In our blog post of November 18, 2013 (“No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Before Biosimilars Application is Filed”), we discussed the decision of the U.S. District Court for the Northern...more
Amgen, Inc. (“Amgen”) has brought the discussion of the procedure for biosimilar applications from the courts to the FDA by filing a Citizen Petition (Docket No. FDA-2014-P-1771) on October 29, 2014 (“Petition”) requesting...more
There has been a lot of curiosity within the biologics industry regarding how the “patent dance” procedures of the Biologics Price Competition and Innovation Act (“BPCIA”) would operate. This interest was piqued in July 2014...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases
Amgen Inc. v. Sanofi et al. 1:14-cv-01349; filed October 28, 2014 in the District Court of Delaware.
• Plaintiff: ...more
Kirin-Amgen Inc v Transkaryotic Therapies Inc (No.2), the long-awaited case in which the applicability of a purposive approach to construction of patent claims was considered in light of the Patents Act 1977 and the EPC,...more
As reported in Fierce Biotech earlier today, Amgen announced the results of a Phase III clinical trial of its biosimilar drug (designated ABP 501) for moderate-to-sever plaque psoriasis conducted in comparison with adalimumab...more
After granting the plaintiffs’ Rule 23(f) petition, the Ninth Circuit reversed a denial of class certification, finding that the district court had improperly weighed the merits of the plaintiffs’ Rule 23(a)(2) commonality...more
To protect a licensor’s rights, a key element of a biotech license is the licensor’s right to restrict the scope of the license by limiting the field of use, often to a particular disease area. But the license agreement only...more
On November 15, 2013, the U.S. Supreme Court announced that it would revisit the "fraud-on-the-market" presumption that it adopted 25 years ago, which substantially expanded securities fraud class actions. The appeal in which...more
The U.S. Supreme Court’s grant of certiorari in Halliburton Co. v. Erica P. John Fund, No. 13-317, suggests a dramatic change in private securities litigation is possible. On November 15, 2013, the Court accepted...more
The first court decision interpreting the Biosimilars Act has arrived, with a federal district court in California finding that a biosimilar application must be filed with the FDA before patent litigation can be initiated....more
Parties to pending securities fraud class actions may adjust litigation strategies, even before the Court revisits Basic’s presumption of investor reliance.
On Friday, November 15, 2013, the Supreme Court granted...more
The United States District Court for the Northern District of California ruled November 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price...more
On November 11, 2013, the U.S. District Court for the Northern District of California in Sandoz, Inc. v. Amgen, Inc. and Hoffman-La Roche, Inc., Docket No. C-13-2904, made the first-ever judicial interpretation of the...more
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