Amgen

News & Analysis as of

Amgen v. Sandoz: Sandoz’s Opposition to Amgen’s Conditional Cross-Petition for Certiorari

As we covered in a previous post, following the Federal Circuit’s decision in Amgen v. Sandoz, Sandoz filed a petition for a writ of certiorari asking the Supreme Court to review the Federal Circuit’s interpretation of the...more

Analysis of Amgen’s complaint against Sandoz in pegfilgrastim litigation

As we reported earlier, Amgen recently filed suit under the BPCIA against Sandoz and Lek Pharmaceuticals in the Northern District of California. Amgen alleges that Sandoz’s submission of an aBLA for its pegfilgrastim product...more

Amgen And Sandoz Do The Biosimilar Patent Dance Over Neulasta

Amgen Inc. has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Sandoz Inc. seeking approval of a biosimilar version of Neulasta® infringes...more

Amgen Sues Sandoz Over Biosimilar Version of NEULASTA® (pegfilgrastim)

Yesterday, Amgen filed suit in an action for patent infringement arising under the Biologics Price Competition and Innovation Act of 2009 (“the BPCIA”), following Sandoz’s submission of an abbreviated Biologics License...more

Amgen v. Hospira: Court Considers Issues Regarding the Scope of Discovery and the RPS’s Ability to Assert Additional Patents in...

In a recent hearing held in Amgen v. Hospira, the parties offered arguments on some novel issues relating to litigation under the BPCIA, particularly: - ..Whether a reference product sponsor (“RPS”) can compel a...more

Amgen Hedges Its Bets With Cross-Petition For Certiorari Of Biosimilar Decision

Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a...more

Update on Enbrel Biosimilar and Related US Litigation

Amgen’s Enbrel (etanercept), a blockbuster biologic treatment for a number of autoimmune diseases, including rheumatoid arthritis and psoriasis, has been an attractive target for biosimilar makers. Sandoz, the maker of...more

SCOTUS v. the Ninth Circuit on Failure to Enforce ERISA Stock-Drop Pleading Standard

In a terse per curiam opinion, the U.S. Supreme Court in Amgen Inc. v. Harris, No. 15-278 (U.S. Jan. 25, 2016), made clear that it expects lower courts to faithfully apply the pleading requirements for “stock-drop” cases...more

Amgen files Declaratory Judgment Action against Sandoz over NEULASTA® Biosimilar

Last Friday, Amgen filed a declaratory judgment action in the District Court for New Jersey against Sandoz, in the latest iteration of biosimilar litigation between the parties (see complaint). Amgen's and Sandoz's actions...more

Amgen Launches Enbrel Biosimilar Patent Litigation

Although Sandoz’ application for FDA approval to market a biosimilar version of ENBREL® (etanercept) has yet to be approved, Amgen has brought suit under the Patent Act and Biologics Price Competition and Innovation Act...more

Does the "Notice of Commercial Marketing" Provision in the BPCIA Stand Alone? -- Amgen v. Apotex Case Preview

According to the Federal Circuit website, the appeal from the Amgen Inc. v. Apotex Inc. case will be argued on April 4, 2016 in Courtroom 402. This case is an appeal from a decision by Judge Cohn of the Southern District of...more

Employee Benefits Developments - February 2016

IRS Issues Guidance Regarding Application of ACA Fee to Expatriate Health Plans. Section 9010 of the Affordable Care Act (ACA) imposes an annual fee on covered entities engaged in the business of providing health insurance...more

Court Report - February 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Actavis Laboratories UT, Inc. v. Par Pharmaceutical, Inc. 1:15-cv-00886; filed October 2, 2015 in the District Court of...more

Plausible sheep v. meritless goats: Supreme Court reinforces duty of care and prudence for retirement plans with employer stock...

The United States Supreme Court reaffirmed in Amgen v. Harris the pleading standards to be applied by the federal courts in reviewing a claim alleging breach of fiduciary duty in connection with an employer stock fund when...more

Sandoz Asks Supreme Court To Reverse Biosimilar Decision

On February 16, 2016, Sandoz, Inc. filed a petition for writ of certiorari to the Supreme Court, asking the Court to overturn the Federal Circuit decision that interpreted the “patent dance” provisions of the Biologics Price...more

Montanile, Amgen, Tackett & Moen: Four Important Employee Benefits Cases to Kick Off 2016

The year 2016 has only just started, and we have already seen several important court decisions related to employee benefit plans and the Employee Retirement Income Security Act of 1974, as amended (ERISA). This Client Alert...more

High Court helps employers avoid frivolous 401(k) stock-drop suits

Prior to 2014, most courts had recognized an unwritten presumption that favored having a company’s 401(k) plan invest in the publicly traded stock of the employer. However, in mid-2014 the Supreme Court struck down that...more

FDA Panel Shows Strong Support for a Remicade Biosimilar

The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more

First Monoclonal Antibody Biosimilar in U.S. Gets One Step Closer to FDA Approval

On February 9, 2016, the FDA’s Arthritis Advisory Committee voted 21-3 to recommend that CT-P13, Celltrion’s proposed biosimilar of Janssen Biotech, Inc.’s Remicade® (infliximab) be approved for all indications — including,...more

Celltrion's Proposed REMICADE® Biosimilar Recommended for Approval

On February 10, 2016, the FDA's Arthritis Advisory Committee recommended approval of biologics license application ("BLA") 125544 submitted by Celltrion, Inc. for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s...more

Court Report - February 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Astellas Pharma Inc. et al. v. Apotex Inc. et al. 1:15-cv-00857; filed September 22, 2015 in the District Court of...more

PTAB Denies Amgen’s IPR in Win for AbbVie – Article “Suggests a High Degree of Unpredictability” in the Art at Time of Invention

The Patent Trial and Appeal Board recently denied institution of Amgen’s inter partes review against an AbbVie patent covering HUMIRA® (currently, the best-selling drug in the world). ...more

U.S. Supreme Court Clarifies the Scope of ERISA Fiduciary Obligations in Recent Stock Drop Decision

In recent years, plaintiffs’ lawyers have brought numerous ERISA breach of fiduciary duty lawsuits against employers that offer employer stock funds in their 401(k) plans. These lawsuits are typically brought on behalf of...more

Supreme Court Revisits Stock Drop Fiduciary Standards

In Amgen v. Harris, the Supreme Court for the second time considered whether the plan participants sufficiently stated a claim against the plan fiduciaries for breach of fiduciary duty under ERISA by continuing to provide...more

The Supreme Court Meant What It Said On Employer Stock Funds

On January 25, 2016, in Amgen, Inc. v. Harris, 2016 WL 280886, the Supreme Court sent a strong message to the lower courts, plaintiffs and ERISA fiduciaries that pleading standards for breach of fiduciary duty prudence claims...more

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