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FTC Case Against LabMD Dismissed Due to Lack of Harm

This past Friday the 13th was not a lucky day for the Federal Trade Commission (FTC). An Administrative Law Judge (ALJ) dismissed the FTC’s data security enforcement proceeding against LabMD on the grounds that the FTC failed...more

ALJ Dismisses FTC’s Data Security Suit Against LabMD for Failure to Prove ‘Substantial Injury’ to Consumers

In a landmark decision, an administrative law judge dismissed the FTC’s long-running data security lawsuit against Atlanta-based cancer screening laboratory, LabMD Inc., following an alleged data breach. Chief Administrative...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

Corporate Investigations & White Collar Defense - October 2015

"Wherefore Art Thou Due Process?" Part III - Why it matters: It is time for another installment in our continuing "Wherefore Art Thou Due Process?" coverage into the ongoing constitutional challenges to the SEC's...more

Department of Homeland Security Regulation Benefitting STEM Employers Thrown into Question

A federal district judge recently issued a 37-page decision vacating a 2008 Department of Homeland Security (DHS) regulation that has helped thousands of U.S. companies hire and retain foreign students holding U.S. degrees in...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

ITC Section 337 Update – October 2015

ITC Proposes Extensive Changes To Rules For Adjudicating Section 337 Investigations – On September 24, 2015, the Commission published a Notice of Proposed Rulemaking in the Federal Register announcing proposed changes to its...more

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

ITC Section 337 Update – September 2015

Judge MaryJoan McNamara Appointed New Administrative Law Judge at U.S. International Trade Commission – On August 17, 2015, the ITC issued a news release announcing that Judge MaryJoan McNamara has been appointed as an ALJ....more

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more

Life Sciences Companies and Free %$&*@# Speech

Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has...more

Federal Circuit Upholds ITC Interpretation of § 337 to Cover Induced Infringement

Suprema, Inc. and Mentalix Inc. v. Int’l Trade Comm’n, Case No. 12-1170 (Fed. Cir. Aug. 10, 2015) (Reyna, J.) (O’Malley, Proust, Lourie, and Dyk JJ., dissenting). By way of background, appellee Suprema manufactures...more

Federal Court Rules on OPT Extension

On Wednesday, August 12, 2015, the US District Court for the District of Columbia ruled that the US Department of Homeland Security (“DHS”) did not follow required procedures when it promulgated regulations allowing for...more

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

What Comes Next In Amarin Pharm v. FDA?

The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug...more

Bass Opposes Sanctions and Defends His Actions at the PTAB

On July 28, 2015, Celgene filed a motion for sanctions in IPR Nos. 2015-01092 and 2015-01103, proceedings challenging the validity of Celgene patents covering Thalomid®, Revlimid® and Pomalyst®. Celgene specifically...more

Amarin Wins Truthful Off-Label Speech Challenge

On August 7, Citing the First Amendment, a Southern District of New York court ruled that FDA cannot limit a manufacturer’s “truthful and non-misleading speech promoting off-label use” of a drug and evaluated specific...more

Amgen Inc. v. Sandoz Inc. Federal Circuit Decision on BPCIA

On July 21, 2015, the United States Court of Appeals for the Federal Circuit issued its decision in Amgen Inc. v. Sandoz Inc., interpreting key provisions in the Biologics Price Competition and Innovation Act (“BPCIA”). In a...more

NGOs File Suit Regarding Inert Ingredients’ Disclosure

On June 24, 2015, in the United States District Court for the Northern District of California, the Center for Environmental Health, Beyond Pesticides, and Physicians for Social Responsibility (Plaintiffs) sued the U.S....more

NGOs Challenge Nanosilva’s Conditional Registration

On July 27, 2015, two petitions for review of the U.S. Environmental Protection Agency’s (EPA) second conditional registration of a nanosilver pesticide product were filed in the U.S. Court of Appeals for the Ninth Circuit....more

Biotech-specific Subject Matter Eligibility Materials Delayed

Pursuant to the Notice published in the Federal Register today, the U.S. Patent and Trademark Office provided additional materials related to the Office's interpretation of what does (and what does not) satisfy the subject...more

Companies Appeal ECHA’s Requests for Information Concerning Nanoforms

The cases all concern silicic acid, aluminum sodium salt. The contested decisions were adopted December 17, 2014, following a compliance check under the dossier evaluation procedure of the submitted registration. In each...more

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

Federal Circuit Finds Biosimilar Patent Dispute Resolution Procedures Optional

In Amgen v. Sandoz, a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that appears to favor biosimilar applicants...more

Submission of Supplemental Evidence in an IPR May Be Submitted After the Due Date - International Business Machines Corp. v....

Addressing the circumstances for submitting supplemental evidence in an inter partes review (IPR), the Patent Trial and Appeal Board (PTAB or Board) allowed the petitioner to submit a responsive declaration after the due date...more

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