Science, Computers & Technology Health Civil Procedure

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The E-Cigarettes Industry Fights Back Challenging the FDA in Federal Court

Days after the publication of the Food and Drug Administration’s controversial final rule regarding e-cigarettes (and other nicotine-delivering products), a company called Nicopure Labs LLC filed a lawsuit challenging it in...more

Intermedix data breach class action case dismissed

We previously reported that Intermedix was sued in a class action lawsuit regarding the data breach involving millions of patient records....more

Superior Court of Pennsylvania Denies Data Breach Class Certification

In an encouraging development for data breach defendants, the Superior Court of Pennsylvania recently affirmed a trial court decision rejecting class certification in a suit filed against two Medicare programs for losing a...more

Prohibition on Pharmacy Inducements Beyond College of Pharmacists’ Authority

In Sobeys West Inc v. Alberta College of Pharmacists, 2016 ABQB 232, the Alberta Court of Queen’s Bench held that amendments to the College of Pharmacists’ Codes of Ethics and Standards of Practice prohibiting inducements to...more

Fourth Circuit Affirms Insurance Coverage for Cyber Claim Under CGL Policy

In a decision issued April 11, the Fourth Circuit added to a small but growing body of case law across the country finding coverage for cyber claims under traditional general liability insurance policies. In Travelers...more

USPTO Issues Subject Matter Eligibility Update

On May 5, 2016, the USPTO published a Memorandum to the Patent Examining Corps titled “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection.” The...more

Class Certification Improper in Data Breach Case, PA Appellate Court Finds

The Pennsylvania Superior Court has affirmed a trial court's decision denying class certification in a data breach case against two health plans, reversing its own earlier ruling in the same case that the plaintiff did not...more

Patents-In Suit In ANDA Trial Are Non-Obvious

A 6-day bench trial was held from April 6-14, 2015. After trial, the court entered stipulations and orders regarding infringement of certain claims of the ‘178 and ‘206 patents. The court rejected defendant’s claim that the...more

Failure to Disclose Best Pricing: Pharmaceutical Companies Settle FCA Claims for $784 Million

The Department of Justice announced late last month that pharmaceutical manufacturers Wyeth and Pfizer would pay $784 million to resolve a False Claims Act investigation and qui tam lawsuit arising from Wyeth’s failure to...more

The Writing's on the Wall: Wise Pharma Companies Will Heed FDA Warning in New Draft Guidance on Data Integrity cGMPs

FDA is again shining a spotlight on data integrity violations, announcing in a new draft Guidance for Industry: Data Integrity and Compliance with CGMP that it was “troubl[ed]” by the growing number of such violations that...more

Supreme Court Denies Petition to Review Expanded Theory of Joint Infringement

On Monday the Supreme Court denied certiorari in Limelight Networks Inc. v. Akamai Technologies Inc. et al, Case No. 15-993. Limelight had petitioned the Court in January, urging for review of the Federal Circuit’s en banc...more

Court Report - April 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Teva Pharmaceuticals USA Inc. et al. v. Biocon Ltd. et al. 1:16-cv-00278; filed April 19, 2015 in the District Court of...more

Epic Verdict in Trade Secrets Case

Last week, a federal jury in Wisconsin awarded almost $1 billion to Epic Systems Corporation in its trade secrets case against Indian consulting company Tata Consulting Services, Ltd., and its American unit, Tata America...more

Not a Check-the-Box Exercise: Failure to Have Signed BAA Results in Substantial Fine

A group practice that was the victim of a silver-harvesting scam has agreed to pay the U.S. Department of Health and Human Services (“HHS”) $750,000 to settle charges that it released protected health information (“PHI”) of...more

Sequenom v. Ariosa Diagnostics: A Supreme Court Petition that Requests Clarification on the Patent Eligibility of Diagnostic...

UUnder the Patent Act, one can patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Common exceptions to what can be patented include laws of nature,...more

Ex-Husband's Revenge Leads to HHS Trophy

Patient care is not confined to a single office or exam room, or a single physician or other provider. Caring for patients these days now includes complex coordination among physicians, nurse, technicians, staff, management,...more

Appeals Court Confirms that HITECH Violations Do Not Violate FCA

In an important recent decision, the Sixth Circuit Court of Appeals confirmed that a qui tam relator's claim that her former husband improperly accessed electronic protected health information (e-PHI) of her and her relatives...more

Summary Judgment for Defendants in FCA Action: No Admissible Evidence of False Claims

How much is “enough?” Will we have enough money to retire someday? Did the Drug and Device Law College Sophomore study enough for her computer science midterm? Is there enough salt in the matzo ball soup? In the realm of...more

21st Century Oncology data breach litigation update

We previously reported that 21st Century Oncology suffered a data breach affecting 2.2 million patients and has been sued in at least two class action lawsuits following notification to the patient....more

Sixth Circuit Affirms Dismissal of FCA Claim Based on Health Data Breaches

The U.S. Court of Appeals for the Sixth Circuit recently affirmed the dismissal of a False Claims Act (FCA) case premised on protected health data breaches. In United States ex rel. Sheldon v. Kettering Health Network, the...more

Alert: FTC Challenges "No-AG" Agreement as Illegal Reverse Payment

On March 30 the US Federal Trade Commission filed suit in federal court alleging that settlements of patent litigation in the pharmaceutical industry in which a pioneer firm agrees not to market an "authorized generic"...more

Reformulated OxyContin Patents Invalid - Purdue Pharma L.P., et al. v. Epic Pharma, LLC, et al.

Addressing product-by-process limitations and inherent anticipation issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s ruling that the asserted claims of Purdue Pharma’s patents covering...more

Class action suit filed against 21st Century Oncology for data breach

We previously reported that 21st Century Oncology had suffered a data breach and notified 2.2 million patients that it had been the victim of a hacking that exposed the names, Social Security numbers, physicians’ names,...more

Olympus to Pay $632.2 Million to Resolve Allegations of Kickbacks

Olympus Corporation of the Americas, the United States’ largest distributor of endoscopes and related medical equipment, recently agreed to pay $623.2 million to resolve criminal charges and civil claims, according to a...more

Federal Circuit Upholds Home Field Advantage in Generic Drug Cases

Under United States law, the holder of a patent on a brand-name, FDA-approved drug can bring suit for patent infringement against a generic drug manufacturer even before the generic manufacturer brings the drug to market....more

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