News & Analysis as of

Declaratory Judgments Supreme Court of the United States

2017 Supreme Court and Precedential Patent Cases From the Federal Circuit, With Some Significant Cases from 2016

Arbitration - Waymo v. Uber Technologies, 870 F.3d 1342 (Fed. Cir. 2017) - Waymo sued Uber and others for trade secret misappropriation and patent infringement. Uber contends that Waymo should be compelled to...more

SCOTUS: Supreme Court Lifts Biosimilars by Allowing Early Commercial Marketing Notice

The Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) for the approval of biosimilar drugs. On...more

Supreme Court: Biosimilar Applicants May Provide Commercial Marketing Notice Before FDA Approval

by Jones Day on

On June 12, 2017, the U.S. Supreme Court decided two important questions under the Biologics Price Competition and Innovation Act ("BPCIA"), which provides an abbreviated pathway for the approval of generic biologics: (i) the...more

Supreme Court overturns the Federal Circuit, granting more flexibility to biosimilar makers

by Thompson Coburn LLP on

In a unanimous opinion, the United States Supreme Court again reversed the Federal Circuit in Sandoz Inc. v. Amgen Inc., interpreting the meaning of key provisions of the Biologics Price Competition and Innovation Act of...more

SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more

Amgen v. Sandoz: The Supreme Court’s First Biosimilars Ruling

In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195...more

You Don’t Have to Dance the Patent Dance (Except Maybe in California)

Supreme Court Decides BPCIA “Patent Dance” Questions - The 2009 Biologics Price Competition & Innovation Act (BPCIA) provides an orderly process for manufacturers of generic biological drugs (called “biosimilars”) to...more

Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

by Snell & Wilmer on

On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more

SCOTUS Simplifies Market Entry Process for Biosimilar Products

by Jackson Walker on

Yesterday’s unanimous ruling by the U.S. Supreme Court in Sandoz v. Amgen injects much needed certainty into a difficult statute and streamlines the process for biosimilar products to enter the marketplace following FDA...more

The Patent Dance Is Optional

In Sandoz Inc. v. Amgen Inc., the Supreme Court brought greater certainty to two key issues relating to the “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA). First, the Court held that where a...more

Supreme Court Decides Sandoz, Inc. v. Amgen, Inc.

by Faegre Baker Daniels on

On June 12, 2017, the Supreme Court decided Sandoz, Inc. v. Amgen, Inc., Nos. 15-1039, 15-1195, in which it held that (a) a manufacturer of a licensed biological product cannot obtain federal injunctive relief to enforce 42...more

Summaries of All Supreme Court and Precedential Federal Circuit Patent Cases Decided Since Jun. 1, 2016

This paper is based on reports on precedential patent cases decided by the Federal Circuit distributed by Peter Heuser on a weekly basis. Please see full publication below for more information....more

Supreme Court Hears Oral Arguments in Sandoz Inc. v. Amgen

by Jones Day on

On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more

United States Supreme Court Upholds Campaign Ad Disclosure Requirement

by Snell & Wilmer on

In its recent four-word decision (“The judgment is affirmed.”) Independence Institute v. Federal Election Commission, the U.S. Supreme Court upheld a campaign finance law requirement that donors backing certain campaign ads...more

Supreme Court Grants Certiorari in Amgen v. Sandoz

by Knobbe Martens on

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

Supreme Court Will Judge Biosimilar Patent Dance

by Foley & Lardner LLP on

The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more

Supreme Court to Consider Biologics Price Competition and Innovation Act

On Friday, Jan. 13, the Supreme Court granted the appellant’s petition and the respondent’s cross-petition for a writ of certiorari in Sandoz Inc. v. Amgen Inc. This is the first time the Court will construe the Biologics...more

Supreme Court Grants Cert in Amgen v. Sandoz

On January 13, 2017, the Supreme Court granted Sandoz’s petition for certiorari and Amgen’s cross-petition in Amgen v. Sandoz, case nos. 15-1039 and 15-1195. The two cases were consolidated, and an hour was allotted for oral...more

Supreme Court rules on state energy incentives

by PretiFlaherty on

The U.S. Supreme Court has released its ruling on a case affecting how states may provide incentives for electric power generation. In Hughes v. Talen Energy Marketing, LLC, the Court upheld a lower court's ruling...more

Pennsylvania Federal Court Strikes Down Ordinance Banning Disposal of Wastewater as Unconstitutional

by Reed Smith on

In Pennsylvania General Energy Co. L.L.C. v. Grant Township, Magistrate Judge Susan P. Baxter of the United States District Court for the Western District of Pennsylvania, in an unpublished opinion, held that several...more

A Royalty By Any Other Name: Post-Expiration Payments After Kimble v. Marvel

by Foley & Lardner LLP on

Patent holders and accused infringers will need to continue being creative in drafting license agreements after the Supreme Court’s recent decision in Kimble v. Marvel, No. 13-720, 2015 U.S. Dist. LEXIS 4067, at *6 (June 22,...more

Don’t Get Personal

by Orrick - IP Landscape on

Xilinx, Inc. v. Papst Licensing GMBH & Co. KG (Judge Lucy Koh) (July 9, 2015) - The Supreme Court’s 2014 ruling in Daimler v. Bauman raised the bar to establish personal jurisdiction over a defendant. Daimler has made it...more

Myriad Throws in the Towel

In the aftermath of the Supreme Court's decision in AMP v. Myriad Genetics in 2013, Myriad (paradoxically to those either not paying attention or who over interpreted the scope of the Court's holding in its opinion) filed...more

Challenge to Patent Validity by a Licensee

by Ladas & Parry LLP on

The United States Supreme Court has issued a decision which some commentators believe may increase the risk that patent licensees will challenge the validity of patents under which they are licensed....more

Losing The Home-Team Advantage – The Supreme Court’s Narrowing of the Doctrine of General Personal Jurisdiction and its Impact on...

by McCarter & English, LLP on

A recent Supreme Court opinion in a non-patent case, Daimler AG v. Bauman, likely will have a far-reaching impact on the prevalence of patent declaratory judgment actions. In the past, an accused patent infringer often could...more

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