Amgen

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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

Recent Supreme Court Rulings on Class Actions

The Supreme Court continued to focus on class action litigation during this term, handing down a number of significant rulings relating to jurisdiction, class certification, and arbitration of putative class claims. The many...more

Basic Is Anything But: Courts Continue to Wrangle with the Fraud-on-the-Market Presumption

It has been 25 years since the Supreme Court announced the fraud-on-the-market presumption of reliance in Basic Inc. v. Levinson, 485 U.S. 224 (1988). Yet many courts, including the Supreme Court itself, continue to struggle...more

Mintz Levin Health Care Qui Tam Update - Recent Developments and Unsealed Cases

Trends and Analysis: ..We have identified 20 health care-related qui tam cases unsealed in July 2013. About a quarter of those were filed in 2013. ..Among the cases unsealed in July, the government has declined to...more

Corporate and Financial Weekly Digest - July 26, 2013

In this issue: - District Court Rejects Challenge to SEC Conflict Minerals Rule - Mandatory Clearing of iTraxx CDS Indices for Category 2 Entities Began July 25 - CFTC Issues Extension of Time-Limited...more

"Business Cases in the US Supreme Court"

The U.S. Supreme Court recently closed its 2012 term with its usual headline-grabbing flurry of June decisions. Several of those decisions, as well as many more that received less publicity, will affect business interests. In...more

June 2013: Securities Litigation Update - Supreme Court Rejects the Need to Prove “Materiality” for Class Certification in...

Resolving a split among several circuits, the U.S. Supreme Court in Amgen Inc. v. Connecticut Retirement Plans & Trust Funds, 133 S.Ct. 1184 (2013), held that plaintiffs are not required to demonstrate that misrepresentations...more

Ninth Circuit Limits Key Defense in ERISA Stock Drop Cases

On June 4, 2013, the Ninth Circuit issued an opinion in Harris v. Amgen, reversing an order granting a motion to dismiss and reviving a class action ERISA lawsuit based on allegedly imprudent investments in company stock. In...more

Second Take on Amgen: Defense Arguments Largely Intact, Even in Overruled Circuits

In our post in the immediate wake of the Supreme Court’s decision in Amgen Inc. v. Connecticut Retirement Plans, we concluded that rather than being a new threat to the defense of securities class actions, Amgen basically...more

Life Sciences Companies Should Protect Themselves Against Increased Exposure to Costly Securities Fraud Lawsuits After Supreme...

What you need to know: The Supreme Court recently found that defendants in class action securities fraud lawsuits will not be able to challenge the materiality of allegedly fraudulent misstatements or omissions at the...more

Supreme Court Decides AMGEN – Allows Plaintiff Class to be Certified Without Separate Materiality Inquiry

On February 27, 2013, the Supreme Court handed down its decision in Amgen Inc. v. Connecticut Retirement Plans & Trust Funds, No. 11-1085 (U.S. Feb. 27, 2013). In a six to three decision, the Court held that plaintiffs...more

Plausible Allegations – Not Proof – Of Materiality All That’s Required For Class Certification in Securities Fraud Suits, Says...

In its ruling on February 27, in Amgen, Inc. v. Connecticut Retirement Plans & Trust Funds (No. 11-1085), the first of several highly anticipated class action decisions that impact securities class action litigation going...more

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