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Do-Gooders Won’t Take “No” For An Answer

About a month ago we posted an article on the dismissal of Consumer Watchdog’s appeal at the Court of Appeals for the Federal Circuit following a loss at the USPTO in an inter partes reexamination. Consumer Watchdog, Inc. had...more

European Companies Appeal ECHA Titanium Dioxide Decision

The European Chemicals Agency (ECHA) published on November 3, 2014, an announcement of appeal of a June 17, 2014, contested decision following a compliance check of the Registration, Evaluation, Authorization and Restriction...more

D.C. Circuit Rejects FDA’s Claim of Inherent Authority to Reclassify a Device by Rescinding a 510(k) Substantial Equivalence Order

On September 26, 2014, the D.C. Circuit issued an opinion holding that the Food and Drug Administration (“FDA”) failed to follow the appropriate statutory procedure for reclassifying a device when the Agency relied on its...more

Beyond Borders: The Power to Block the International Flow of Digital Files

With the advance of digital technology, courts are being forced to deal with the legal ramifications beyond the borders of the United States. In a previous post, we discussed the potential impact of the decision in Motorola...more

Health Alert (Australia) - October 20, 2014

In This Issue: Judgements, Legislation, and Reports. Excerpt from Judgments: Commonwealth - 15 October 2014 - Gray v Richards [2014] HCA 40 - In 2003, a 10-year-old girl...more

Hospira, Inc. v. Burwell

Nature of the Case and Issue(s) Presented: Precedex is commonly used as a sedative. Specifically, the FDA has approved Precedex for two uses: (i) sedation of initially intubated and mechanically ventilated patients during...more

New Challenge to 340B Rule Regarding Orphan Drugs

On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint (the October 9 Complaint) against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services...more

IP Newsflash - October 2014 #2

Patents to a “Specific Technological Process” Fall on the Pleadings as Abstract Ideas - On September 22, 2014, Judge George H. Wu (C.D. Cal.) ruled on the pleadings that two Planet Blue patents relating to “the idea of...more

Sham-Wow! Antitrust Liability May Attach to Sham Administrative Petitions

Addressing whether the “sham” exception to Noerr-Pennington immunity is limited to sham litigation in courts, the U.S. Court of Appeals for the Federal Circuit vacated a lower court’s summary judgment of no antitrust...more

Court Finds FDA Explanation of Knee Implant Reversal Lame

The FDA had approved the mesh—called the Collagen Scaffold—in December 2008. But after the change in administrations the following month, the agency decided that the approval process had been flawed and had been the focus of...more

Judge Dismisses FDA Spying Case But Not Because It’s Innocent

Earlier this week a federal judge dismissed a lawsuit by six former and current FDA scientists who allege that the FDA retaliated and spied on them for blowing the whistle on FDA approval of medical devices that put cancer...more

Scripts Newsletter - October 2014

In this issue: - Health Care Decisions — Who Decides? - Medical Software Licensing — Tips from the Trenches - An Ounce of Prevention — The Importance of Periodic Corporate Audits - ACA -...more

The SAB Enters the “Waters of the United States” Fray: Guess Which Side the Scientists Support

The Science Advisory Board has now provided its advice to EPA and the ACOE concerning their proposed rule clarifying the definition of “waters of the United States” under the Clean Water Act. In a brief letter that can only...more

Drug-Device Apple Cart Upset Again

On September 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act)....more

New draft regulation on resolution of disputes between electronic communication operators

The Italian Communication Authority (AGCOM) published a new consultation on a draft regulation relating to the resolution of disputes between electronic communication operators....more

California Federal District Court Grants Partial Dismissal to Suit Alleging Violations of the Endangered Species Act

Earlier this month, a federal district court in California partially granted motions to dismiss a second amended complaint filed by the Center for Biological Diversity and the Pesticide Action Network alleging that the...more

Court Allows ESA Claims Involving Oversight of Pesticides to Move Forward

In Center for Biological Diversity v. Environmental Protection Agency, No. 11-cv-00293-JCS, plaintiffs alleged that the Environmental Protection Agency (EPA) violated section 7 of the Endangered Species Act by failing to...more

Federal Circuit Finds That FDA Citizen Petition Could Give Rise to Antitrust Liability

In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge...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

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

HHS Says It Has Authority to Issue Interpretive Guidance on Contested 340B Orphan Drug Rule Despite Court Order Vacating Final...

According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more

Scientists Weigh In On Biogenic Carbon Accounting Debate

On June 19, 2014, over 90 scientists sent a letter to EPA urging the Agency to move forward under its Tailoring Rule by "1) moving beyond the flawed assumption that bioenergy is inherently carbon neutral; 2) rejecting the...more

Supreme Court Reinforces Need for Robust Adverse Event Reporting Process

On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more

Recent Court Decision May Impact 340B Drug Pricing Program "Mega-Reg"

A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not...more

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