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Preliminary Injunctions Biologics

American Conference Institute (ACI)

[Event] Pharma & Biotech Patent Litigation Conference in Europe - May 29th - 30th, Amsterdam, Netherlands

Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more

WilmerHale

PTAB/USPTO Update - September 2021

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USPTO Leadership - ..Drew Hirshfeld is still performing the functions and duties of Director. The Biden Administration has not made an announcement as to who will be nominated to become the next Director. ...more

Kramer Levin Naftalis & Frankel LLP

Biosimilars in 2020: What’s Ahead

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...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

Mintz - Health Care Viewpoints

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

Mintz - Intellectual Property Viewpoints

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

Jackson Walker

SCOTUS Simplifies Market Entry Process for Biosimilar Products

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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

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

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

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

Robins Kaplan LLP

When Time is Money

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As the Biologics market is predicted to be a $250 billion market in the next few years, it is not surprising that parties embroiled in biosimilar litigation go to the mat. Both Apotex and Sandoz filed cert petitions this year...more

Mintz - Health Care Viewpoints

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

McDermott Will & Emery

BPCIA 180-Day Notice of Intent to Market a Biosimilar Is Required, Enforceable by Injunction

In an opinion that details many intricacies of both the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and related portions of the Patent Act, the US Court of Appeals for the Federal Circuit affirmed a...more

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

Federal Circuit Backs Amgen on Key Provision of Biosimilars Statute

The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more

Foley Hoag LLP

Federal Circuit Invites FDA's Early Licensure of Biosimilars to Encourage Pre-Launch Resolution of Patent Disputes

Foley Hoag LLP on

In its July 5, 2016 decision in Amgen v. Apotex, the Federal Circuit interpreted the Biologics Price Competition and Innovation Act (BPCIA) for the second time. The Court reiterated that the BPCIA requires a biosimilar...more

Knobbe Martens

Federal Circuit Rules on Biosimilar Notice Requirement

Knobbe Martens on

Biosimilar Applicants Must Provide Notice of Commercial Launch: What You Need To Know - Case Background - In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more

WilmerHale

Federal Circuit Patent Updates - July 2016

WilmerHale on

Amgen Inc. v. Apotex Inc. (No. 2016-1308, 7/5/16) (Wallach, Bryson, Taranto) - July 5, 2016 12:05 PM - Taranto, J. In a suit under the Biologics Price Competition and Innovation Act, affirming the grant of a...more

Mintz - Health Care Viewpoints

6-Month Notice from a Biosimilar Sponsor Always Required — Says Federal Circuit

Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new...more

Patterson Belknap Webb & Tyler LLP

Both Parties Seek En Banc Intervention in Amgen v. Sandoz

Last month, a divided panel of the Federal Circuit issued a split decision in Amgen v. Sandoz (summary; opinion). Amgen (in which Patterson Belknap represented one of the amici supporting Amgen) is the court’s first decision...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Issues Its First Decision Interpreting BPCIA

The courts must “say what the law is,” even when that law, as Judge Lourie described the BPCIA, is “a riddle wrapped in a mystery inside an enigma.” Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23,...more

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

One More Hurdle Cleared – Amgen’s Preliminary Injunction Motion for Filgrastim is Denied

On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more

Goodwin

Order in Amgen v. Sandoz Provides First Judicial Interpretations of the BPCIA Patent Dispute Resolution Provisions

Goodwin on

On March 19, 2015, the District Court for Northern District of California (Judge Seeborg), issued an order providing one of the first judicial interpretations of the patent dispute resolution provisions laid out in subsection...more

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