News & Analysis as of

Amarin

Proskauer - Life Sciences

Skinny Labels May Not Be Dead: Delaware District Court Distinguishes GSK, Dismisses Induced Infringement Claim

In one of the first district court opinions applying the Federal Circuit’s recent GSK decision on induced infringement in the context of label carve-outs, Judge Richard Andrews in the District of Delaware held that plaintiff...more

Robins Kaplan LLP

Amarin Pharma, Inc. v. Hikma Pharms. USA Inc.

Robins Kaplan LLP on

Case Name: Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. CV 20-1630-RGA-JLH, 2021 WL 3396199 (D. Del. Aug. 3, 2021) (Hall, J.) - Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S. Patents Nos. 9,700,537...more

Haug Partners LLP

Objective Indicia of Nonobviousness – Considered as Part of a “Totality of the Evidence” Approach or a “Prima Facie Framework”?

Haug Partners LLP on

On February 11, 2021, Amarin Pharma, Inc. (“Amarin”) filed a petition for a writ of certiorari with the Supreme Court seeking reversal of the Federal Circuit’s decision to affirm a finding that Amarin’s patents are invalid as...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2020)

On September 3rd, the Federal Circuit affirmed under Rule 36 the decision by the District Court of Nevada (Du, J.) in March that the claims asserted by Amarin Pharma against West-Ward Pharmaceuticals International Ltd., Hikma...more

Robins Kaplan LLP

Amarin Pharma, Inc. v. Hikma Pharms USA Inc.

Robins Kaplan LLP on

Case Name: Amarin Pharma, Inc. v. Hikma Pharms USA Inc., No. 16-cv-02525, 2020 WL 1517568 (D. Nev. March 30, 2020) (Du, J.)....more

Robins Kaplan LLP

Amarin Pharma, Inc. v. West-Ward Pharms. Int’l Ltd.

Robins Kaplan LLP on

SUMMARY JUDGMENT OF NO CONTRIBUTORY INFRINGEMENT GRANTED BUT DENIED WITH RESPECT TO INDUCED INFRINGEMENT. Case Name: Amarin Pharma, Inc. v. West-Ward Pharms. Int’l Ltd., No. 2:16-cv-02525-MMD-NJK, 2019 U.S. Dist. LEXIS...more

Pillsbury Winthrop Shaw Pittman LLP

Despite Amarin, ITC May Be Right Prescription For Pharma

Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amarin Pharma, Inc. v. ITC (Fed. Cir. 2019)

The International Trade Commission, although having limited jurisdiction, can be a very powerful ally to U.S. industries facing foreign competition. The Commission's power to interdict importation of infringing articles can...more

Patrick Malone & Associates P.C. | DC Injury...

Big Pharma shows off its big gall with risky products and dubious practices

Big Pharma is a broad commercial sector with many diverse enterprises large and small, but they keep showing they’re united in their giant gall when it comes to their unacceptable products and practices, as timely news...more

Womble Bond Dickinson

FDA Seeks to Provide Greater Insight on Off-Label Promotions of Pharmaceuticals

Womble Bond Dickinson on

The US Food & Drug Administration (FDA) serves as the gatekeeper between pharmaceutical companies and the public they serve, including governing how medications are promoted and advertised. Pharmaceutical companies want to go...more

Hogan Lovells

Hogan Lovells ITC Section 337 Monthly Highlights

Hogan Lovells on

The latest news round-up from our Hogan Lovells ITC Section 337 practice, including a new section featuring "tips from the bench" by former ITC Judge Theodore (Ted) R. Essex. ...more

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

Troutman Pepper

FDA Is Evolving on Qualifications for 'New Chemical Entity'

Troutman Pepper on

The prior approval of a drug containing an active ingredient of the innovator drug is not necessarily a death knell for NCE exclusivity. Originally published in the Intellectual Property and Life Sciences sections of...more

Mintz - Health Care Viewpoints

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

Searcy Denney Scarola Barnhart & Shipley

Amarin Pharma Comes Out on Top in Federal Case Involving Freedom of Speech

The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional...more

Robins Kaplan LLP

Amarin Pharma, Inc. v. Apotex, Inc.

Robins Kaplan LLP on

Case Name: Amarin Pharma, Inc. v. Apotex, Inc., Civil Action No. 14-2250 (MLC), 2016 U.S. Dist. LEXIS 7555 (D.N.J. Jan 22, 2016) (Cooper, J.)... Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S....more

Jackson Walker

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs: Part Two

Jackson Walker on

The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more

Patrick Malone & Associates P.C. | DC Injury...

Will Big Pharma’s free speech rights trump FDA, regulatory safety?

Recent developments in the law may have opened a new path for drug makers to exercise corporate free speech rights in ways that don’t look healthy for consumers. The case that concerns health watchdogs started when...more

Foley Hoag LLP

FDA and Amarin Pharma Reach Milestone Settlement Allowing Off-Label Drug Promotion

Foley Hoag LLP on

A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more

Arnall Golden Gregory LLP

Fight the Good Fight Every Moment: Do Recent First Amendment Court Developments Deal a Blow to the Government?

In the last month, the Food and Drug Administration has suffered setbacks relating to off-label promotion oversight. In both cases, one involving a pharmaceutical company and the other a medical device firm and its Chief...more

Latham & Watkins LLP

Amarin Settles Off-Label Promotion Case Against the FDA

Latham & Watkins LLP on

The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion. On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more

Mintz - Health Care Viewpoints

Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing

On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to...more

Foley & Lardner LLP

Amarin Pharma Settles First Amendment Claims Against FDA: Potential Implications

Foley & Lardner LLP on

Irish drug company Amarin Pharma, Inc. (Amarin) and the U.S. Food and Drug Administration (FDA) agreed, on March 8, 2016, to settle claims that FDA regulations barring Amarin from making “truthful” and “non-misleading”...more

Morgan Lewis

FDA and Amarin Reach Settlement on First Amendment and Off-Label Statements

Morgan Lewis on

FDA agrees to allow truthful and non-misleading off-label promotion. On March 8, the US District Court for the Southern District of New York approved settlement terms in connection with Amarin Pharma, Inc., et al. v....more

King & Spalding

Amarin and FDA Reach Settlement Agreement in Off-Label Speech/First Amendment Case

King & Spalding on

On March 8, 2016, Amarin Pharmaceuticals, Inc. (“Amarin”) and the Food and Drug Administration (“FDA” or the “Agency”) reached a settlement agreement in a closely followed case involving Amarin’s First Amendment rights to...more

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