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Supreme Court of the United States › Preemption › Patents

The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary... more +
The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary with only a limited number of cases granted review each term.  The Court is comprised of one chief justice and eight associate justices, who are nominated by the President and confirmed by the Senate to hold lifetime positions. less -
Jones Day

Federal Circuit Rules BPCIA Preempts State Law

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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

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2017) -- One Last Dance . . .

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Last June, in Sandoz Inc. v. Amgen Inc., the Supreme Court handed down its interpretation of the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of biosimilar drugs. As we reported at the time, the...more

Foley & Lardner LLP

Does Amgen Have Viable State Law Claims Against Sandoz Arising From The Zarxio Biosimilar Patent Dispute?

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In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the...more

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

The Patent Dance Is Optional

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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

Foley & Lardner LLP

Supreme Court Decision Largely Favors Biosimilar Applicants

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The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues...more

Fenwick & West LLP

USPTO's Patent Subject Matter Eligibility Roundtable on Dec. 5, 2015

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On December 5, 2016 the USPTO will hold its second Patent Subject Matter Eligibility Roundtable to discuss issues in patent eligibility. The USPTO published a list of eighteen questions in anticipation of the event, dealing...more

McDermott Will & Emery

ANDA Update - October 2015

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Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

McDonnell Boehnen Hulbert & Berghoff LLP

Natera Responds to Sequenom's Petition for Rehearing En Banc

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Last week, Appellee Natera, Inc. filed its response to the petition for rehearing en banc filed by Appellants Sequenom, Inc. and Sequenom Center for Molecular Medicine, LLC in August (see "Sequenom Requests Rehearing En...more

Fenwick & West LLP

Overview of Comments on the USPTO's July 2015 Update to the Interim Examination Guidance

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In late July, the USPTO issued its July 2015 Update to the 2014 Interim Section 101 Patent Eligibility Guidance (IEG). The July 2015 Update addresses a number of the issues and concerns raised in the public comments to the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: NYIPLA

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Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more

Patterson Belknap Webb & Tyler LLP

Strong Support for Sequenom’s Petition for Rehearing En Banc

Patterson Belknap Webb & Tyler LLP on

In Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015), a Federal Circuit panel held that Sequenom Inc.’s prenatal diagnosis patent claims patent ineligible subject matter under the two-step test of Mayo...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: IPO

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Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more

Burns & Levinson LLP

One Year After Alice

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It has been more than a year since the Supreme Court issued its decision in Alice Corp. Pty, Ltd. v. CLS Bank International, 134 S. Ct. 2347 (2014). Although a number of software patents have been invalidated for reciting...more

McDonnell Boehnen Hulbert & Berghoff LLP

July 2015 Update on Subject Matter Eligibility

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On July 30, 2015, the U.S. Patent and Trademark Office updated its subject matter eligibility guidance ("Eligibility Update"). This update provides recommendations and resources for examiners in addition to those in the...more

Foley & Lardner LLP

USPTO Issues July 2015 Updated Guidance on Subject Matter Eligibility Analysis

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On July 30, 2015, the United States Patent and Trademark Office (USPTO) issued updated guidance regarding subject matter eligibility analysis to address six major themes from comments received in response to the 2014 Interim...more

Fenwick & West LLP

The One Year Anniversary: The Aftermath of #AliceStorm

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It's been one year since the Supreme Court's decision in Alice Corp. v. CLS Bank. On its face the opinion was relatively conservative, cautioning courts to "tread carefully" before invalidating patents, and emphasizing that...more

Fenwick & West LLP

The Day the Exception Swallowed the Rule: Is Any Software Patent Eligible After Ultramercial III?

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The Supreme Court has consistently cautioned that the judicial exceptions to patent eligibility need to be carefully applied: At the same time, we tread carefully in construing this exclusionary principle lest it...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Business Cases in the US Supreme Court"

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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

McDonnell Boehnen Hulbert & Berghoff LLP

Is Lack of Preemption the Key for the Supreme Court to Decide in Myriad's Favor?

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The U.S. Supreme Court will hear arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. on April15th, and the parties and their different cadres of amici have submitted briefs of varying degrees of...more

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