News & Analysis as of

Sandoz

Federal Circuit Finds Velcade Patent Not Obvious Under Lead Compound Analysis

by Foley & Lardner LLP on

In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court...more

Federal Circuit Thoroughly Reverses District Court Findings of Velcade® Patent Obviousness

On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

The Circuit issued only one precedential patent case this week, reversing a determination of obviousness as to a Millennium Pharmaceutical patent covering its blockbuster cancer drug Velcade®, thus extending the life of...more

Sandoz Files Two Petitions for IPR of Two AbbVie Patents Related to Humira

by Goodwin on

Sandoz has filed a petition for inter partes review of AbbVie’s U.S. Patent No. 8,802,100 (IPR2017-01823), which claims stable formulations of an anti-TNFa antibody identified in the petition as Humira® (adalimumab). Sandoz...more

The Federal Court Reverses a Hindsight Reconstruction of An Important Pharmaceutical Invention

by BakerHostetler on

In Millennium Pharmaceuticals v. Sandoz, the Federal Circuit reversed the district court’s holding of obviousness of certain claims of Millennium-owned U.S. Patent No. 6,713,446 (the ‘446 patent), finding that the district...more

Millennium Pharm. v. Sandoz, Inc. – Revenge of the Chemical Judges

In the 2003 panel decision in Schering Corp. v. Geneva Pharm., Inc., the panel rejected “the contention that inherent anticipation requires recognition [of the claim element not found] in the prior art.” The claims were...more

You Can Dance If You Want To

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

Millennium Pharmaceuticals, Inc. v. Sandoz Inc. (Fed. Cir. 2017)

In multiple ANDA litigations against multiple defendants, Millennium Pharmaceuticals, Inc. had several of its asserted claims held invalid for obviousness at the district court. The Federal Circuit reversed these decisions...more

Sandoz Inc. v Amgen Inc.

by Hodgson Russ LLP on

Artificial patent infringement occurs when certain types of approval applications are submitted to the U.S. Food And Drug Administration (the “FDA”). The U.S. Supreme Court recently considered a situation in which an...more

Supreme Court Decision Allows Faster Marketing of Biosimilars

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

by 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

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

by 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

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 Affords Greater Leeway to Biosimilars in the 'Patent Dance'

by Pepper Hamilton LLP on

In a recent ruling, the U.S. Supreme Court clarified what happens when biosimilar applicants do not follow the regulatory framework for disputes with reference product sponsors — a process known as the “patent dance.” Since...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

European commission approves Sandoz’s Rixathon® (rituximab)

by Goodwin on

Sandoz announced today that it has received approval for the use of Rixathon® in Europe. Rixathon® is a biosimilar version of Roche’s MabThera® (rituximab) and is approved for use in all the same indications, including...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

Supreme Court Issues Highly Anticipated Decision Interpreting the Biologics Price Competition and Innovation Act

On June 12, the Supreme Court decided Sandoz Inc. v. Amgen Inc., the first case under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) to reach the high court. The BPCIA establishes a regulatory pathway for...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

Supreme Court Decides Amgen v. Sandoz: Patent Dance Cannot Be Enforced by Federal Injunction, Notice of Commercial Marketing Can...

On June 12, 2017, the Supreme Court decided Amgen v. Sandoz, the landmark case about the meaning of the Biologics Price Competition and Innovation Act (BPCIA). First, the Supreme Court held that no federal injunction is...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 Decision Largely Favors Biosimilar Applicants

by Foley & Lardner LLP on

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

Sandoz Inc. v. Amgen Inc. (2017)

On June 12, 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...more

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