News & Analysis as of

Sandoz v Amgen

Fish & Richardson

Discovery Disputes Related to Manufacturing in BPCIA Litigation

by Fish & Richardson on

Many reference product sponsors (“RPSs”) of biologic products have sought extensive patent protection for their manufacturing processes, and RPSs commonly assert those patents against biosimilar manufacturers in Biologics...more

Ladas & Parry LLP

It’s 2018: The Impact Of IP Decisions From 2017

by Ladas & Parry LLP on

2017 saw a bumper crop of Supreme Court decisions on intellectual property matters around the world including eight by the United States Supreme Court, two by the Canadian Supreme Court, and two by the United Kingdom Supreme...more

Quinn Emanuel Urquhart & Sullivan, LLP

Business Litigation Report - February 2018

Defining Sexual Harassment: The State of the Law - Litigation involving sexual harassment, in a variety of forms, emerged as a recurring headline in 2017 and shows no sign of slowing in 2018. The increase in...more

Quinn Emanuel Urquhart & Sullivan, LLP

February 2018: Life Sciences Litigation Update

Amgen Inc. v. Sandoz Inc., No. 2015-1499, 2017 WL 6375146 (Fed. Cir. Dec. 14, 2017). This Federal Circuit decision is a remand from the June 2017 Supreme Court decision addressing the consequences when the proposed marketer...more

Fish & Richardson

Declaratory Judgment Litigation Brought by Biosimilar Manufacturers

by Fish & Richardson on

Courts have begun to shape the contours of the Biologics Price Competition and Innovation Act (“BPCIA”) and the progress of biosimilar litigation, but the use of declaratory judgment actions by biosimilar manufacturers...more

Fish & Richardson

Biosimilars 2017 Year in Review

by Fish & Richardson on

Since the passage of the Biologics Price Competition and Innovation Act (BPCIA), 2017 has been the most active year yet for drug manufacturers. Fish attorneys Tasha Francis, Jenny Shmuel, and Brianna Chamberlin addressed the...more

McDermott Will & Emery

No State Law Remedies for Failure to Comply with BPCIA Notice

by McDermott Will & Emery on

On remand from the Supreme Court of the United States, the US Court of Appeals for the Federal Circuit held that under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), state law claims and remedies are not...more

Robins Kaplan LLP

Allergan Sales, LLC v. Sandoz. Inc.

by Robins Kaplan LLP on

Case Name: Allergan Sales, LLC v. Sandoz. Inc., Nos. 2017-1499, 2017-1500, 2017-1558, 2017-1559, 2017 U.S. App. LEXIS 26312 (Fed. Cir. Dec. 22, 2017) (Circuit Judges Moore, Mayer, and Hughes presiding; Opinion by Hughes, J.)...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Stories of 2017: #5 to #9

After reflecting upon the events of the past twelve months, Patent Docs presents its 11th annual list of top patent stories. For 2017, we identified nineteen stories that were covered on Patent Docs last year that we believe...more

Goodwin

Year in Review: Top Five Legal Developments of 2017

by Goodwin on

Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more

Jones Day

Federal Circuit Rules BPCIA Preempts State Law

by Jones Day on

On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

Polsinelli

Biosimilars: Strategic Considerations for 2018

by Polsinelli on

2017 was an eventful year for biosimilars in the U.S. As the number of biosimilar filings increased, important legal and regulatory decisions changed the strategic landscape of the biosimilars market for both innovators and...more

Foley & Lardner LLP

Federal Circuit Finds Preemption Of State Law Penalty For Sitting Out Biosimilar Patent Dance

by Foley & Lardner LLP on

The Federal Circuit has issued its final decision in the biosimilar patent litigation between Amgen and Sandoz over the first product to be approved under the Biologics Price Competition and Innovation Act (BPCIA). Not...more

Fish & Richardson

Federal Circuit Simplifies BPCIA Disputes by Finding State Remedies Preempted

by Fish & Richardson on

The Amgen v. Sandoz battle continues to make new law regarding the Biologics Price Competition and Innovation Act (“BPCIA”), this time in a December 14th ruling from the Federal Circuit finding that “the BPCIA preempts state...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Rules that BPCIA Preempts State Law Biosimilars Claims

In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit: BPCIA Preempts State Law In Biosimilar Litigation

The Federal Circuit on Thursday issued an opinion in Amgen v. Sandoz holding that that the Biologics Price Competition and Innovation Act (BPCIA) preempts state-law claims that are based on a biosimilar applicant’s failure to...more

Goodwin

Federal Circuit Affirms Sandoz Win on Preemption Grounds

by Goodwin on

The Federal Circuit today ruled decisively in favor of Sandoz in the long-running battle with Amgen over whether state law can be used to compel a biosimilar applicant to participate in the BPCIA’s “patent dance.” The panel...more

Goodwin

The Biosimilars Council Supports Sandoz’s Preemption Position in Federal Circuit Amicus Brief

by Goodwin on

Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit remand proceedings for Amgen v. Sandoz, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s...more

Goodwin

Amgen v. Sandoz Appeal: Parties Submit Supplemental Briefing; Court Grants US Extension to File Amicus Brief

by Goodwin on

As we previously reported, following the Supreme Court’s June 12, 2017 decision in Sandoz v. Amgen, the Federal Circuit on July 26, 2017, issued an order recalling its October 23, 2015 mandate, reinstating the appeal, and...more

Ladas & Parry LLP

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of...

by Ladas & Parry LLP on

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more

Knobbe Martens

Federal Circuit Review - July 2017

by Knobbe Martens on

District Court Abused Discretion in Not Finding Case Exceptional - In Rothschild Connected Devices v. Guardian Protection Services, Appeal No. 2016-2521, the Federal Circuit held that a district court abused its discretion...more

Fish & Richardson

The Ramifications of Leaving the Patent Dance Floor

by Fish & Richardson on

While the Supreme Court held in Amgen v. Sandoz that biosimilar applicants cannot be forced with a federal injunction to provide a copy of their biosimilar application (aBLA) and manufacturing information to the reference...more

Fish & Richardson

The Amgen v. Sandoz Disclosure Disputes Continue

by Fish & Richardson on

A theme emerging in biosimilar litigation is when –and how much—discovery is available to reference product sponsors. The Supreme Court in Amgen v. Sandoz grappled with this issue in the spring, as it decided whether...more

Jones Day

Jones Day’s Review of Business-Related Cases in the Supreme Court’s October Term 2016

by Jones Day on

During what many have labeled a “quiet Term,” the U.S. Supreme Court, working with only eight justices for most of the session, still delivered at least 30 rulings of particular interest to business and industry. These...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

You Can Dance If You Want To

In borrowing a page from the '80s band "Men Without Hats," on June 12, 2017, the U.S. Supreme Court brought greater certainty for both biosimilar applicants and originator companies. In Sandoz Inc. v. Amgen Inc., the Supreme...more

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