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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

Federal Circuit Patent Updates - June 2017

by WilmerHale on

Nexlearn, LLC v. Allen Interactions, Inc. (No. 2016-2107, -2221, 6/19/17) (Moore, Schall, Hughes) Moore, J. Affirming dismissal due to lack of personal jurisdiction....more

Supreme Court Holds Voluntary Dismissal With Prejudice Does Not Constitute An Appealable "Final Decision" That Would Allow The...

by Shearman & Sterling LLP on

On June 12, 2017, the United States Supreme Court, in an opinion authored by Justice Ginsburg, held that “[f]ederal courts of appeals lack jurisdiction under [28 U.S.C.] § 1291 to review an order denying class certification...more

Federal Circuit Reverses Fee Award in Case Tagged as Exceptional

While the Supreme Court’s decisions in Octane Fitness, LLC v. ICON Health & Fitness, Inc. and Highmark Inc. v. Allcare Health Management System, Inc. significantly relaxed the standard for awarding attorney fees under 35...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 Confirms Plaintiffs Cannot Manufacture Appellate Jurisdiction Over Class Certification Denials

by King & Spalding on

On June 12, 2017, the Supreme Court issued its decision in Microsoft Corp. v. Baker. Baker resolves a Circuit split concerning whether a plaintiff, after losing a class certification battle, can effectively manufacture...more

US Supreme Court: class action plaintiffs cannot voluntarily dismiss claims in effort to appeal denial of class certification

by DLA Piper on

In a significant victory for class action defendants, whose success often depends on whether a class is certified, the US Supreme Court has ruled that federal courts of appeals lack jurisdiction under 28 USC §1291 to review...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

SCOTUS Simplifies Market Entry Process for Biosimilar Products

by Jackson Walker on

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

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

Yet another Target settlement highlights data breach costs

by Thompson Coburn LLP on

In what appears to be the closing act of the saga that is the Target data breach, on May 23 the retailer announced it had reached a settlement agreement with a coalition of 47 states’ attorneys general. Pursuant to the...more

The 4th U.S. Circuit Court of Appeals Maintains Nationwide Preliminary Injunction Blocking the Trump Administration's Revised...

by Seyfarth Shaw LLP on

Seyfarth Synopsis: On May 25, 2017, the U.S. Court of Appeals for the 4th Circuit ruled that President Trump’s travel ban should remain on hold, upholding a preliminary injunction issued in March 2017 by a lower court....more

For Patent Infringement, Sold Property Is All Yours

by Strasburger & Price, LLP on

When do patent rights end? If you buy a patented invention, is it your property in the same way that you can do with a pair of pants as you please after purchasing it? ...more

The Latest in the Epipen Medicaid Drug Rebate Saga – Where Are We Now?

The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by...more

Court Questions Applicability of Function Way Result Test In Chemical Cases

by Foley & Lardner LLP on

In Mylan Institutional LLC v. Aurobindo Pharma Ltd., the Federal Circuit reviewed a preliminary injunction based in part on a finding of likelihood of success in establishing infringement under the doctrine of equivalents....more

Summaries of All Supreme Court and Precedential Federal Circuit Patent Cases Decided Since Jun. 1, 2016

This paper is based on reports on precedential patent cases decided by the Federal Circuit distributed by Peter Heuser on a weekly basis. Please see full publication below for more information....more

Recent Guidance from the Federal Circuit on the Doctrine of Equivalents in Cases Involving Chemical Compositions

by Foley & Lardner LLP on

In Mylan Institutional LLC, et al. v. Aurobindo Pharma Ltd., et al., Case No. 2017-1645, the Federal Circuit affirmed the district court’s grant of a preliminary injunction as to one of three patents-in-suit, while finding...more

Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazadone drug submission

by Smart & Biggar on

On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that Apotex failed to mitigate the damage it incurred as the result of Health Canada’s misfeasance in public office and negligence in its...more

Function/Way/Result Test Causes Headaches in Chemical Cases; Substitute Insubstantial Differences Test

In Mylan Institutional LLC v. Aurobindo Pharma Ltd., [2017-1645] (May 19, 2017), the Federal Circuit affirmed the grant of a preliminary injunction against the infringement of U.S. Patent 9,353,050 on a triarylmethane dye...more

A New Employment Law Frontier: Illinois' Biometric Information Privacy Act

by Holland & Knight LLP on

An emerging area of the law has become the focal point in a new class action lawsuit pending in the U.S. District Court for the Northern District of Illinois. In Baron v. Roundy's Supermarkets, Inc., et al. (No....more

Federal Circuit’s Primer on Equivalence Infringement of Chemical Process Patents

by Foley & Lardner LLP on

In an appeal characterized as “unusual,” the Federal Circuit affirmed the grant of a preliminary injunction, holding it likely that plaintiff patent holder would succeed on the merits its claim of infringement of a patent...more

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