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Read Antitrust & Trade Regulation updates, alerts, news, and legal analysis from leading lawyers and law firms:

Non-Infringement of a Patent Also Not an Antitrust Injury

by McDermott Will & Emery on

Wading into the merging streams of antitrust and patents, the US Court of Appeals for the Ninth Circuit upheld dismissal of an antitrust suit where a jury verdict in a parallel case found no patent infringement. Cascades...more

Year in Review: The Top-Five U.S. Market Developments of 2017

by Goodwin on

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more

Federal Circuit Rules BPCIA Preempts State Law

by 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

Federal Circuit Finds Preemption Of State Law Penalty For Sitting Out Biosimilar Patent Dance

by Foley & Lardner LLP on

The Federal Circuit has issued its final decision in the biosimilar patent litigation between Amgen and Sandoz over the first product to be approved under the Biologics Price Competition and Innovation Act (BPCIA). Not...more

FDA Accepts Samsung Bioepis’ aBLA for Herceptin® Biosimilar

by Goodwin on

Yesterday, Samsung Bioepis announced that the FDA has accepted for review the company’s BLA under the 351(k) pathway for SB3, a biosimilar candidate referencing Genentech’s Herceptin® (trastuzumab). The press release states...more

Fresenius Kabi Announces Submission of Application for Biosimilar of Humira (Adalimumab)

by Goodwin on

Fresenius Kabi today announced it has submitted an application seeking marketing authorization for its biosimilar version of Humira® (adalimumab) in the EU. This is Fresenius Kabi’s first biosimilar regulatory filing....more

[Webinar] Anticipating When the FDA Will Treat Your Product as a Drug-Device Combination - January 17th, 11:00am CT

by Robins Kaplan LLP on

Wednesday, January 17, 2018, 11:00 A.M. CST -- The FDA considers a product a drug-device if it includes at least two of the following: a drug component, device component, or a biologic component. The FDA does not classify as...more

Federal Circuit Rules Out State-Law Remedies for Failure to Participate in the Biosimilars "Patent Dance"

by Perkins Coie on

On December 14, the Federal Circuit issued a decision that further clarifies the ground rules for disclosures of product information by manufacturers of biosimilar pharmaceutical products. In particular, the Federal Circuit...more

CJEU-Referral: SPCs for drug-device combinations?

by DLA Piper on

The German Federal Patent Court (FPC), in its decision of 18 July 2017, referred to the Court of Justice of the European Union (CJEU) the question whether and under which prerequisites the granting of a Supplementary...more

AD-ttorneys@law

by BakerHostetler on

The Digital Millennium Copyright Act (DMCA) includes a safe harbor provision that protects appropriately registered online service providers from potential secondary liability for the infringing acts of others. Ironically, in...more

The Latest Trends in Drug Monopolies

by Zelle LLP on

Brand-name pharmaceutical companies employ a variety of strategies to preserve and extend their branded drug products’ monopolies. Challenges by generic drug manufacturers and consumers to those efforts as allegedly...more

Indirect Purchasers Cannot Sue Qualcomm Under Federal Law, But State Law Claims Survive

A federal judge in California has refused to allow indirect purchasers of semiconductor chips—i.e., cell phone consumers—to bring claims against Qualcomm under federal antitrust law....more

Reverse-Payment Plaintiffs Mine Patent Litigation Record to Survive Summary Judgment

by Holland & Knight LLP on

We pointed out in a recent article that, based on recent decisions by the Courts of Appeals for the First and Third Circuits, private antitrust plaintiffs seeking damages from so-called “reverse-payment” settlement agreements...more

Senators and court complain of ‘anti-competitive’ transfer of patent rights to American Indian tribe

We have previously discussed antitrust implications of pharmaceutical companies’ efforts to maximize patent protection for their drugs. Consumers and generic drug makers, for instance, have alleged antitrust violations based...more

Federal Circuit Stay Order Demonstrates Value of Redesign as Defense in ITC Actions

by Jones Day on

The Federal Circuit has determined to partially stay an ITC exclusion order as it pertains to products redesigned after the remedial orders issued. We have previously posted about Certain Network Devices, Related Software and...more

THE LATEST: Integra Forced to Divest Neurosurgical Tools to Gain FTC Clearance

by McDermott Will & Emery on

WHAT HAPPENED - On February 14, 2017, Integra agreed to purchase Johnson & Johnson’s Codman neurosurgery business (excluding Codman’s neurovascular and drug deliver businesses) for $1.045 billion.... ...more

News from Abroad -- Mexican Antitrust Authority Study on Generic Drug Entry – Recommendations on Changes to Public Policy -- Part...

In the first three installments of this series, we've explained the general purpose of the study, and gone through the sections of patents, marketing authorizations and strategic behavior of the study published on August 9,...more

Third Circuit Holds No Sham Litigation or Unlawful Reverse Payment in Wellbutrin XL Litigation

The Third Circuit recently affirmed the grant of summary judgment to GlaxoSmithKline (“GSK”) in the nearly 10-year-old Wellbutrin XL Antitrust Litigation, which challenged the lawfulness of settlement agreements resolving...more

News from Abroad -- Mexican Antitrust Authority Study on Generic Drug Entry -- On Patents and Marketing Authorizations -- Part III

In the first and second installments of this series, we've explained the general purpose and the patents and marketing authorizations sections of the study published on August 9, 2017 by the Federal Commission for Economic...more

News from Abroad -- Mexican Antitrust Authority Study on Generic Drug Entry -- On Patents and Marketing Authorizations -- Part II

In the first installment of this series, we outlined the general contents of the study published on August 9, 2017 by the Federal Commission for Economic Competition, highlighting that the Antitrust authority is calling for...more

News from Abroad -- Mexican Antitrust Authority Issues Broad Study on Generic Drug Entry into Mexican Market -- Part I

Study Suggests Several Changes to Legislation on Patents, Marketing Authorizations, and Government Procurement - In July of 2016, the Federal Commission for Economic Competition announced a broad ranging study on the entry...more

Federal Circuit Review - July 2017

by 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

Lidoderm Plaintiffs Survive Class Certification in Pay-for-Delay Suit

by McDermott Will & Emery on

The US District Court for the Northern District of California certified classes of direct purchasers and end-payers in a pay-for-delay multidistrict litigation involving Lidoderm. In re Lidoderm Antitrust Litigation, Case No....more

Second Circuit Allows Class Action Suit Involving Diabetes Drug to Proceed

by McDermott Will & Emery on

Purchasers of Takeda Pharmaceuticals Company’s branded diabetes drug, ACTOS, filed an antitrust suit alleging that Takeda falsely described two patents to the US Food and Drug Association (FDA) and, as a result, delayed...more

The Effects of the Actavis Decision on Reverse Payment Settlement Agreements in ANDA cases -- Four Years After

In 2013, the U.S. Supreme Court rendered its decision in FTC v. Actavis, finding that although so-called reverse payment settlement agreements were not per se antitrust violations in cases brought against generic drug makers...more

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