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Sandoz Was Disinvited to the Patent Dance: The Federal Circuit's First Interpretation of the BPCIA Will Have to Wait

Since the 1984 enactment of the Drug Price Competition and Patent Term Restoration Act, Hatch-Waxman litigation has dominated the sphere of life-sciences patent litigation. The battle between proprietary and generic...more

Federal Circuit’s Sandoz v. Amgen Decision Forecloses Early Declaratory Judgment Suits by Biosimilars Applicants

On December 5, in the closely watched Sandoz v. Amgen case, the Federal Circuit held that a biosimilars applicant cannot use the Declaratory Judgment Act to challenge a reference product sponsor's patent prior to filing a...more

Federal Circuit Rules Against Patent Declaratory Judgment Actions Before Biosimilar Application Is Filed

On December 5, 2014, the Federal Circuit issued its opinion in Sandoz Inc. v. Amgen Inc. et al. In a unanimous panel opinion (Judges Dyk, Taranto and Chen), the Court held that clinical trials initiated to support a possible...more

Food Litigation Newsletter - October 2014 #2

In This Issue: - RECENT SIGNIFICANT DEVELOPMENTS AND RULINGS ..Court rules that ‘Kosher’ suit poses religious question; dismisses with prejudice ..Settlement terms approved in stevia sweetener...more

California District Court Finds Threat of Future Harm Sufficient to Confer Article III Standing in Data Breach Action

In a departure from the mounting body of case law finding that the “increased risk of future harm” is insufficient to confer Article III standing on victims of a data breach, the U.S. District Court for the Northern District...more

States Have the Right to Protect Businesses Against NPEs

State of Vermont v. MPHJ Technology Investments, LLC; In re MPHJ Technology Investments, LLC - Addressing the issue of state efforts to reign in non-practicing entities, the U.S. Court of Appeals for the Federal...more

Mylan Pharms., Inc. v. FDA (N.D.W.V.)

Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more

PissedConsumer.com SLAPPs Back

From the land of Wayne Newton and Brittney Spears comes news of an interesting lawsuit implicating the Nevada anti-SLAPP statute. Techdirt.com explains that the lawsuit, Opinion Corporation d/b/a PissedConsumer.com v. Nevada...more

Judicial Efficiencies and Economy Support Bifurcation of Liability and Damages at Trial

Endo Pharmaceuticals, Inc. v. Actavis, Inc., et al. Case Number: 1:12-cv-08985-TPG (Dkt.55) - Endo brought suit against Actavis, as well as over a dozen other pharmaceutical manufacturers, for allegedly...more

Health Data Breach Victims Have Standing to Sue Says WV Supreme Court

The most common defense against class actions for data breach has itself been breached in a ruling last week by the West Virginia Supreme Court....more

Complaint Filed Against HHS Alleges Medicare LCDs Deprive Beneficiaries of Necessary Clinical Laboratory Services

On April 18, 2014, California Clinical Laboratory Association (“CCLA”) and “Jane Doe” (collectively, “Plaintiffs”) filed a lawsuit against HHS for equitable relief in the United States District Court for the District of...more

Federal Circuit Review - StoneEagle, Vederi, and Ancora Technologies (April 2014)

Inventor Cannot Use Declaratory Judgment Jurisdiction - In StoneEagle Services, Inc. v. Gillman, Appeal No. 13-1248, the Federal Circuit vacated a declaratory judgment and remanded with instructions to dismiss based on...more

University of Pittsburgh v. Varian Medical Systems, Inc. (Fed. Cir. 2014)

The Federal Circuit used its decision that the District Court erred in certain of its claim construction determinations to reverse a jury award of greater than $100 million, but left intact large portions of the District...more

Once Again, Clapper Defeats Data Breach Class Action

Article III standing has once again proved to be an insurmountable hurdle for data breach class action plaintiffs whose personal information hasn’t been misused. In Galaria v. Nationwide Mutual Insurance Co., an Ohio federal...more

False Claim Act: 2013 Year in Review

Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more

Parameters of CDA Immunity Being Tested by Appeals Court in Jones v. Dirty World Entertainment

The U.S. Court of Appeals for the Sixth Circuit is currently hearing an appeal of a district court decision, which if upheld would have enormous ramifications for freedom of speech and the online service provider safe harbor...more

HHS States That It Will Issue Guidance On HIPAA Regulation For Prescription Refill Reminders

On September 11, 2013, HHS stated in a joint motion filed in the case of Adheris, Inc. v. Sebelius, No. 1:13-cv-1342 (D.D.C.), that it plans to issue guidance on a HIPAA regulation related to prescription drug refill...more

HIPAA Marketing Rules Prompt First Amendment Challenge

In what is believed to be the first legal challenge to the HIPAA Omnibus Rule (the “Rule”), a vendor of prescription drug adherence services is seeking an injunction to block certain provisions of the Rule related to drug...more

Class Action Plaintiffs Lack Standing under Clapper to Sue Barnes & Noble for Credit Card Data Breach

Relying heavily on the Supreme Court’s recent Clapper decision, a federal court dismissed a class action lawsuit arising out of a “skimming” data breach against Barnes & Noble (BN)....more

Amici Submit Brief in Support of Ambry Genetics and Gene by Gene

Last week, the American Civil Liberties Union (ACLU), ACLU of Utah Foundation, Inc., Public Patent Foundation (PUBPAT), Association for Molecular Pathology (AMP), Breast Cancer Action, and AARP submitted an amici curiae brief...more

What You Should Know About Electronic Subscriptions and Copyright Law: A Best Practices Guide

Increasingly, printed matter is being made available via the Internet in electronic form, and both publishers and readers alike are starting to prefer an online format over the printed hardcopy format. One example is...more

IP Update, Vol. 16, No. 6, June 2013

Patents / Patent Eligible Subject Matter - Supreme Court to Myriad: Isolated DNA Sequences Are Not Patent-Eligible Subject Matter -- AMP et al. v. Myriad Genetics, Inc.: In a 9–0 decision the Supreme...more

Federal District Court Allows Data Breach Class Action to Proceed Based On Risk Of Future Harm

On October 11, the U.S. District Court for the Southern District of California held that the plaintiffs in a consolidated data breach class action have plead sufficient harm to satisfy Article III’s injury-in-fact requirement...more

Eleventh Circuit Reverses Dismissal of Data Breach Class Action Involving Stolen Laptops

Addressing a purported class action filed after laptops containing health care patients’ private data were stolen, the Eleventh Circuit recently issued one of its more consumer-friendly class action decisions, Resnick v....more

Supreme Court Grants Enhanced Access to Justice for Victims of Cyberbullies

On September 27, 2012, the Supreme Court of Canada released its decision in AB v Bragg Communications Inc., an important constitutional case at the intersection of defamation law and children’s rights. A.B., the...more

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