Amgen

News & Analysis as of

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

Business News Digest – April 2013

In this issue: - Finders May Pose Risk in Private Capital Raising - NIST Holds First Workshop on Executive Order Cybersecurity Framework - NIST Issues Request for Information, Begins Developing...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

Supreme Court Update: Two Securities Law Decisions This Week, and Another to Come

The United States Supreme Court has taken a keen interest in the securities arena this current term, agreeing to hear at least three cases (of only approximately 70 in total). This week, the Supreme Court announced decisions...more

Materiality Can Wait, Says the Supreme Court in Amgen

The following post is reprinted with permission from Paul Karlsgodt’s blog, www.classactionblawg.com. The Supreme Court has issued its opinion in one of the most highly anticipated class action-related cases on the...more

First Take on Amgen Decision: Supreme Court “Basically” Endorses Status Quo

The Supreme Court released its anxiously awaited decision in Amgen Inc. v. Connecticut Retirement Plans yesterday. On the face of the decision, it was a loss for defendants in that case, and for companies everywhere that are...more

Supreme Court Holds That Securities Fraud Plaintiffs Do Not Have to Prove Materiality to Certify a Class

The Supreme Court issued a much-anticipated decision today in Amgen Inc. v. Connecticut Retirement Plans and Trust Funds, No. 11-1085, 568 U.S. __ (2013), affirming the Ninth Circuit and holding that securities class action...more

Legal Alert: Supreme Court Decides Materiality Need Not Be Demonstrated for Class Certification

This morning the United States Supreme Court affirmed class certification in Amgen, Inc. v. Connecticut Retirement Plans and Trust Funds , a securities fraud case. The question presented was whether plaintiffs seeking class...more

U.S. Supreme Court Rejects Need to Prove Materiality at Class-Certification Stage in Securities Class Actions

The U.S. Supreme Court ruled on February 27, 2013 that a plaintiff need not prove materiality as a prerequisite to obtaining class certification in a securities class action. The Court's ruling in Amgen Inc. v. Connecticut...more

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