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Supreme Court of the United States › BPCIA

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 -
Kramer Levin Naftalis & Frankel LLP

BPCIA Survives Challenge to the Affordable Care Act at Supreme Court

Kramer Levin Naftalis & Frankel LLP on

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

Morrison & Foerster LLP - Federal Circuitry

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

Morrison & Foerster LLP - Federal Circuitry on

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

Patterson Belknap Webb & Tyler LLP

Future of Biosimilars at Issue in Latest Supreme Court Affordable Care Act Case

Patterson Belknap Webb & Tyler LLP on

On Tuesday, November 10, 2020, the Supreme Court heard oral argument in California v. Texas, a challenge to the Affordable Care Act (the “ACA”) brought by Republican Attorneys General and the Trump Administration. ...more

Hogan Lovells

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

Hogan Lovells on

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

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for October 2018?

Morrison & Foerster LLP on

This month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation settlements and perhaps the end of a long-running Mylan venue dispute in Delaware....more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for September 2018?

Morrison & Foerster LLP on

This month we highlight the possibility that the Supreme Court will consider the standard for adequacy of written description and a Federal Circuit exposition on the relationship between “blocking patents” and objective...more

Morrison & Foerster LLP

Hatch-Waxman and BPCIA Developments in June 2018

Morrison & Foerster LLP on

This month, we highlight significant developments in June 2018, including a Supreme Court decision regarding the PTAB, a federal court affirmation in Impax Laboratories Inc. v. Lannett Holdings Inc., and new legislation...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Stories of 2017: #5 to #9

McDonnell Boehnen Hulbert & Berghoff LLP on

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

Jones Day

Federal Circuit Rules BPCIA Preempts State Law

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

Mintz - Intellectual Property Viewpoints

Federal Circuit Rules that BPCIA Preempts State Law Biosimilars Claims

Mintz - Intellectual Property Viewpoints on

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP on

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

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...

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

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

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

You Can Dance If You Want To

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

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

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

Global Patent Prosecution Newsletter - July 2017

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

Biosimilars Around the World - Last month’s Supreme Court ruling in Sandoz v. Amgen brought greater certainty to both biosimilar applicants and originators in the United States. The July 2017 issue of Sterne Kessler’s...more

Robinson+Cole Health Law Diagnosis

Supreme Court Decision Allows Faster Marketing of Biosimilars

Robinson+Cole Health Law Diagnosis on

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

Hogan Lovells

ITC Section 337 – Quarterly Highlights

Hogan Lovells on

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

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

BakerHostetler

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

BakerHostetler on

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP on

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

Jones Day

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

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

McDermott Will & Emery

Supreme Court Analyzes Key Provisions of Biologics Price Competition and Innovation Act of 2009

McDermott Will & Emery on

In a unanimous decision, the United States Supreme Court has clarified certain portions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), concluding (1) that biosimilar makers do not have to wait for...more

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

McGuireWoods LLP

Supreme Court Interprets BPCIA Provisions Relating to the ‘Patent Dance’

McGuireWoods LLP on

On June 12, 2017, the U.S. Supreme Court interpreted two provisions of the Biologics Price Competition & Innovation Act (BPCIA) relating to patent infringement suits. The Court held that, under the BPCIA, (1) a biologic...more

Weintraub Tobin

U.S. Supreme Court Allows Early Notice For Biosimilars

Weintraub Tobin on

In SANDOZ INC. v. AMGEN INC. et al., the United States Supreme Court in a unanimous opinion ruled that biosimilar makers can give their required 180-day statutory notice of sales before their products win approval by the...more

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