News & Analysis as of September 20, 2024

Supreme Court of the United States › Biologics

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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 -

Supreme Court to Address What it Means to Have an Enabling Disclosure

BakerHostetler on 11/8/2022

The Supreme Court has granted Amgen’s Petition for a Writ of Certiorari, agreeing to address what it means to provide an enabling disclosure. In particular, Amgen asked the Court to address...more

BPCIA Survives Challenge to the Affordable Care Act at Supreme Court

Kramer Levin Naftalis & Frankel LLP on 6/17/2021

On June 17, 2021, the Supreme Court of the United States issued its decision in California et al. v. Texas et al. (No. 19-840), upholding the Affordable Care Act (ACA). A bloc of U.S. states, led by Texas, and two individuals...more

Healthcare, Biologics, and Severability: Will the ACA—and the BPCIA—Survive the Latest Challenge?

Morrison & Foerster LLP - Federal Circuitry on 11/18/2020

The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) is looking alive and well after last week’s Supreme Court oral argument on the Affordable Care Act (“ACA”). If you didn’t realize the BPCIA was at issue...more

Trump administration reversal would take away FDA’s authority to approve biosimilars

Hogan Lovells on 7/15/2020

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

Federal Circuit Rules that BPCIA Preempts State Law Biosimilars Claims

Mintz - Intellectual Property Viewpoints on 12/19/2017

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

Federal Circuit Clarifies Probative Value of Patent Dance Statements

Jones Day on 11/29/2017

The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more

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

Ladas & Parry LLP on 8/21/2017

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

Supreme Court Decision Allows Faster Marketing of Biosimilars

Robinson+Cole Health Law Diagnosis on 7/3/2017

On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to...more

ITC Section 337 – Quarterly Highlights

Hogan Lovells on 6/30/2017

SCOTUS Narrows Opportunity For ITC Section 337 Jurisdiction Over Imported Biosimilars Based On 180-Day Notice Provision - In Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1357-58 (Fed. Cir. 2015), the Federal Circuit held that...more

The Supreme Court Delivers a Win for Biosimilar Manufacturers in Sandoz v. Amgen

BakerHostetler on 6/29/2017

On June 12, 2017, the Supreme Court issued a unanimous opinion in Sandoz v. Amgen, interpreting key provisions of the Biologics Price Competition and Innovation Act (BPCIA) in favor of biosimilar manufacturers...more

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

McDonnell Boehnen Hulbert & Berghoff LLP on 6/27/2017

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

Jones Day on 6/26/2017

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

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

Mintz - Health Care Viewpoints on 6/16/2017

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

Mintz - Intellectual Property Viewpoints on 6/14/2017

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

Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

Snell & Wilmer on 6/14/2017

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

Jackson Walker on 6/14/2017

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

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 6/13/2017

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 Decision Largely Favors Biosimilar Applicants

Foley & Lardner LLP on 6/13/2017

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

Industry Perspectives On The Biosimilar Patent Dance

Foley & Lardner LLP on 6/12/2017

The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more

Practical Issues for the Pharmaceutical and Biopharmaceutical Industry in the Wake of TC Heartland

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 5/24/2017

The US Supreme Court this week held that the broad venue provision of 28 U.S.C. § 1391(c) does not apply to patent law—at least, when the defendant is a domestic entity. This decision arises after years of judicial...more

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

Jones Day on 5/15/2017

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

Supreme Court Grants Certiorari in Amgen v. Sandoz

Knobbe Martens on 2/4/2017

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

Biosimilars: Supreme Court Grants Certiorari in Amgen v. Sandoz

Fenwick & West Life Sciences Group on 1/23/2017

On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its decision on the parties’ certiorari petitions in order to consider the...more

Supreme Court to Consider Biologics Price Competition and Innovation Act

Kramer Levin Naftalis & Frankel LLP on 1/18/2017

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

Patterson Belknap Webb & Tyler LLP on 1/18/2017

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

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Supreme Court of the United States › Biologics

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