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News & Analysis as of

Alert - Biologics Price Competition and Innovation Act (BPCIA) Developments

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

One More Hurdle Cleared – Amgen’s Preliminary Injunction Motion for Filgrastim is Denied

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

Order in Amgen v. Sandoz Provides First Judicial Interpretations of the BPCIA Patent Dispute Resolution Provisions

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

FDA Approves First US Biosimilar but Court Action Could Delay Market Entry

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

Sandoz Inc. v. Amgen Inc.,

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

"No Clinically Meaningful Differences": The First Accepted Biosimilar Application Has Been Recommend for FDA Approval

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

ODAC Committee Votes to License Sandoz’s Zarxio®

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

Federal Circuit’s Sandoz v. Amgen Decision Forecloses Early Declaratory Judgment Suits by Biosimilars Applicants

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

Federal Circuit Rules Against Patent Declaratory Judgment Actions Before Biosimilar Application Is Filed

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

Sandoz Inc. v. Amgen Inc. (Fed. Cir. 2014)

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

Court Report -- Part II: November 2014

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

Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars Challenge the Applicability of the BPCIA’s Exchange Provisions...

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

Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures

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

Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures

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

Court Report - October 2014 #5

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: 10 Years On - Lord Hoffmann

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

Amgen Poised to Enter Biosimilars Market

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

Ninth Circuit Holds On 23(f) Appeal That District Court Abused Its Discretion By Weighing The Merits In Denying Certification

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

Stay Off My Turf! How to Protect Field of Use in a Biotechnology License Agreement

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

U.S. Supreme Court to Reconsider "Fraud-on-the-Market" Presumption in Securities Fraud Class Actions

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

Will Securities Fraud Class Actions Fade Into History?

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

Recent Ruling Clarifies Patent Litigation Timing Under Biosimilars Act

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

Not So Basic Supreme Court to Revisit the Fraud-­on-­the Market Presumption of Reliance

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

No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Action Before Biosimilars Application Is Filed

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

Sandoz v. Amgen: Interpretation of the Biosimilar Act Results in Dismissal for Lack of Subject Matter Jurisdiction for Declaratory...

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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