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Administrative Agency Civil Remedies Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

Global Patent Prosecution Newsletter - November 2017

An Update on Brazilian Patent Law – Emergency Backlog/Fast-Track Options and Enforcement Issues - We are delighted to have as contributors to the November Global Patent Prosecution newsletter, Ricardo Nunes and Andre...more

2017 Supreme Court and Precedential Patent Cases From the Federal Circuit, With Some Significant Cases from 2016

Arbitration - Waymo v. Uber Technologies, 870 F.3d 1342 (Fed. Cir. 2017) - Waymo sued Uber and others for trade secret misappropriation and patent infringement. Uber contends that Waymo should be compelled to...more

The Biosimilars Council Supports Sandoz’s Preemption Position in Federal Circuit Amicus Brief

by Goodwin on

Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit remand proceedings for Amgen v. Sandoz, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s...more

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

In Regeneron v. Merus, a divided panel affirms a determination of unenforceability for violation of the duty of disclosure. What is interesting about the case is that neither the district court nor the majority reviewed...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

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

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

In Mylan v. Aurobindo the Circuit affirms the grant of a preliminary injunction based upon the infringement of one of the three patents in suit. However, the panel reverses the injunction as to the other two patents based on...more

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

Our report includes discussions of six of the precedential cases decided in the past week and will include the other three cases in next week’s report. In Aylus v. Apple, the panel finds prosecution disclaimer in a...more

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

In Nichia the Circuit affirms the denial of a permanent injunction because Nichia failed to prove irreparable injury. In RecogniCorp the panel throws out as not being directed to patentable subject matter claims directed to...more

Rx IP Update - April 2017

by Smart & Biggar on

Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more

Janssen v. Celltrion, Damages: “Patent Dance” May Determine Availability of Lost Profits

On March 2, 2017, the United States District Court for the District of Massachusetts issued an order in Janssen v. Celltrion explaining that an accused patent infringer’s failure to fully engage in the Biologics Price...more

DJI Drone Manufacturer Hit with Class Action Lawsuit Over Firmware Update

Last week, a class action law suit was filed against leader in the drone industry, DJI Technology, Inc. (DJI), for an allegedly harmful firmware update that occurred in December 2015 that rendered certain commercial drones in...more

RxIP Update - 2016 Year in Review

by Smart & Biggar on

The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights. 1. Substantive patent law developments - Utility and...more

Basics of the BPCIA

by Womble Bond Dickinson on

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

Federal Circuit Review | September 2016

by Knobbe Martens on

Claims Directed to Monitoring and Analyzing Data Held to Be Invalid under § 101 - In Electric Power Group, LLC v. Alstom S.A., Appeal No. 2015-1778, the Federal Circuit upheld the district court’s grant of summary...more

Enbrel Biosimilar Approved in US But Enjoined For Now

On August 30 FDA approved Sandoz Inc.’s biosimilar of Enbrel (etanercept), Amgen Inc.’s blockbuster biologic for treatment of moderate to severe rheumatoid arthritis and a number of other autoimmune conditions. The...more

Apotex Files Petition for IPR On Amgen’s Neulasta Patent

by Goodwin on

On August 5, Apotex filed a petition for an IPR on Patent No. 8,952,138, owned by Amgen. The ’138 patent is the same patent that is being challenged in the District Court for the Southern District of Florida, in a case in...more

Federal Circuit Patent Updates - July 2016 #2

by WilmerHale on

WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more

Federal Circuit Patent Updates - June 2016

by WilmerHale on

Cuozzo Speed Technologies, LLC v. Lee (No. 2015-446, 6/20/16) (Roberts, Kennedy, Thomas, Ginsburg, Breyer, Alito, Sotomayor, Kagan) - June 20, 2016 12:49 PM - Breyer, J. Affirming Federal Circuit decision that the...more

Supreme Court Affirms USPTO’s Broadest Reasonable Construction Standard for IPRs

by Snell & Wilmer on

In Cuozzo Speed Technologies, LLC v. Lee, the Supreme Court unanimously affirmed the United States Patent and Trademark Office’s (“USPTO’s”) standard for construing patent claims in an inter partes review (“IPR”), a...more

Standing Alone – The Current Status of the BPCIA’s Notice of Commercial Marketing

In March 2015, the FDA approved the first biosimilar application, which was for a follow-on biologic drug of Amgen’s reference product NEUPOGEN® (filgrastim). Yet, before the applicant, Sandoz, could launch its biosimilar...more

Aerial trespass, privacy violations, and the drone slayer

John David Boggs’s drone was shot down out of the sky last summer when he flew it over another individual’s home. Bogg’s claims that he was flying his drone over Class G airspace –federal protected airspace. Bogg’s claims...more

Ropes & Gray Advises Pacira Pharmaceuticals in Reaching Landmark Settlement Agreement with FDA

by Ropes & Gray LLP on

A cross-disciplinary team of Ropes & Gray attorneys advised Pacira Pharmaceuticals on its December 14 settlement agreement with FDA. On behalf of Pacira, Ropes & Gray had filed suit against FDA in September 2015 in the U.S...more

Apotex Follows the BPCIA “Patent Dance” Again

The first biosimilar makers to file regulatory applications with FDA attempted to bypass all or a subset of the patent litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Apotex, the...more

Nearly Two Years After Dismissal of its Declaratory Judgment Action, FDA Accepts for Review Sandoz’s Application for a Biosimilar...

Sandoz Inc. announced on October 2, 2015 that FDA accepted its regulatory application for a proposed biosimilar of Amgen Inc.’s biologic arthritis drug Enbrel for review. The acceptance comes years after Sandoz attempted to...more

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