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Intellectual Property Science, Computers & Technology Antitrust & Trade Regulation

Read Intellectual Property Law updates, alerts, news, and legal analysis from leading lawyers and law firms:

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

USTR Publishes Initiation of Section 301 Investigation into China's Practices Related to Technology Transfer, Intellectual...

by Brinks Gilson & Lione on

On Thursday, August 24, the United States Trade Representative published formal initiation of the awaited Section 301 investigation under the Trade Act of 1974 to determine whether acts, policies and practices of the...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

California Federal Court Finds CUTSA Preemption on Unfair Competition Claim in Uber Row

by Seyfarth Shaw LLP on

Uber’s ongoing battle with Waymo in the Northern District of California federal court over technology used in self-driving cars provided another significant decision concerning the broad scope of trade secret preemption under...more

Coherus Implements Restructuring Plan Following Complete Response Letter For Its Pegfilgrastim Biosimilar

by Goodwin on

As we reported here on June 12, 2017, Coherus BioSciences received a complete response letter (“CRL”) from the FDA for its biologics license application for its pegfiltrastim (Neulasta®) biosimilar. On June 21, 2017, in a...more

FDA Works to Increase Competition Under Commissioner’s Drug Competition Action Plan

by Latham & Watkins LLP on

Agency works to speed approvals and improve access to generic prescription drugs. In recent weeks, the US Food and Drug Administration (FDA or the Agency) has taken a series of steps — under FDA Commissioner Scott...more

FDA accepts Celltrion/Teva BLA for biosimilar of Rituxan®

by Goodwin on

Celltrion and Teva announced today that the FDA has accepted for standard review their BLA for CT-P10 and that regulatory action is expected in the first quarter of 2018. CT-P10 is a proposed biosimilar to Rituxan®...more

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

One-E-Way, Inc. v. ITC, Fed. Cir. Case 2016-2105 (June 12, 2017) - A divided panel reverses a determination of indefiniteness by the ITC, ruling that under Nautilus, the claim language, in combination with the...more

European Commission Sets its Sights on Allegedly Excessive Drug Prices

by Jones Day on

In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more

Advertising Law - June 2017

Recipients of FTC Influencer Letters Revealed - The Federal Trade Commission took on some big-name celebrities and companies when it sent warning letters to influencers and marketers about the need to comply with the...more

Dietary Supplement & Cosmetics Legal Bulletin | June 2017

LEGISLATION, REGULATIONS & STANDARDS - FTC Warns Companies and Social Media Influencers on Sponsorship Disclosure - The Federal Trade Commission (FTC) sent 90 letters to companies and social media influencers...more

Coherus Responds to Apotex Citizen Petition Seeking Heightened Regulatory Requirements For Biosimilar Competition

by Goodwin on

We previously reported that Apotex filed a Citizen’s Petition requesting that FDA require biosimilar applicants to conduct comparative clinical efficacy studies in at least one intended patient population, rather than...more

Socially Aware: The Social Media Law Update Volume 8, Issue 2

Welcome to the newest edition of Socially Aware, our Burton Awardwinning guide to the law and business of social media. In this edition, we explore the threat to U.S. jobs posed by rapid advances in emerging technologies;...more

The Future of “Single Use Restrictions” in Jeopardy

by Knobbe Martens on

In 1992, the United States Court of Appeals for the Federal Circuit held that manufacturers of patented medical devices can use the patent laws to enforce single-use restrictions on medical devices. Mallinckrodt, Inc. v....more

[Webinar] Pharmaceutical Life Cycle Management: Updates on Navigating the IP, FDA and Antitrust Terrain - April 5th, 12:00pm EST

by BakerHostetler on

There’s been a sea change in the political climate. The regulatory forecast is still uncertain, and pharmaceutical evolution continues to develop....more

Second Circuit Declares That, to Survive Motions to Dismiss, Antitrust Allegations Require Factual Support for All “Necessary...

Last Wednesday, the Second Circuit Court of Appeals partially vacated the judgment of the district court in In re Actos End-Payor Antitrust Litigation. In doing so, the Second Circuit allowed only plaintiffs’ claims that...more

Updated Antitrust Guidelines for IP Licensing Address New Laws, Omit Some Key Areas

by Perkins Coie on

In 1995, the U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) (collectively, the Agencies) published guidelines that delineated how and when the Agencies would evaluate intellectual property licensing...more

Advertising Law - February 2017 #2

Uber’s Earnings, Financing Claims Crash Into FTC - For exaggerating claims about earnings potential and automobile financing, Uber has agreed to pay $20 million in a deal with the Federal Trade Commission. According...more

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