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Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding…more

Advertising Law - July 2015

Try, Try Again: Lawmakers Reintroduce Do Not Track Kids Act - A group of federal lawmakers reintroduced the Do Not Track Kids Act, a bill to amend the Children’s Online Privacy Protection Act (COPPA), with some changes since its…more

No Innovator Liability: National Drug Code Saves the Day

This is a quick-hit post as we head into the Independence Day holiday weekend. The Southern District of West Virginia’s order this week in McNair v. Johnson & Johnson, No. 2:14-17463, 2015 WL 3935787 (S.D. W. Va. June 26, 2015)…more

EU Litigation Update - June 2015

Recognition and Enforcement of Arbitral Awards in Russia: Recent Developments. Recent decisions concerning the enforcement of international arbitration awards in Russian courts have yielded mixed results. Russian courts have limited…more

Neighbors’ Noise Complaints Trigger EIR

Keep Our Mountains Quiet v. County of Santa Clara - Why It Matters: The Sixth District Court of Appeal affirmed the trial court’s holding that preparation of an EIR was required for the approval of a use permit to allow wedding…more

CMS Releases ESRD PPS Proposed Rule

On June 26, 2015, CMS released a Proposed Rule to increase payments by 0.3% for end-stage renal disease (ESRD) care providers in 2016 under the ESRD Prospective Payment System (PPS) for renal dialysis services. CMS estimates that the…more

(UK) New Rules for Residential Landlords in Wales

Residential landlords of properties in Wales need to be aware of the extra regulatory burden that applies to them and particularly because breach could be a criminal offence. The Welsh Assembly has added an additional layer of…more

Only Basic Functions of a Processor Avoid Need for Disclosed Algorithm - EON Corp. IP Holdings LLC v. AT&T Mobility LLC

Addressing the question of what corresponding structure must be disclosed to support a means-plus-function claim element, the U.S. Court of Appeals for the Federal Circuit upheld a district court finding that eight computer-implemented…more

Seventh Circuit Limits Construction Lender’s Use of Title Insurance Policy to Cover Construction Liens Created by Lender’s Cutoff of Funding

In a recent decision written by Judge Sykes, affirming a decision from the Western District of Wisconsin, in an issue governed by Wisconsin law, the Seventh Circuit ruled that a title insurer has no duty to indemnify a construction…more

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding…more

No Induced Infringement Where Off-Label Use of a Drug Is Not “Inevitable” - Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp.

Finding that a drug label’s language did not rise to the level of “active encouragement” that would induce doctors to infringe, the U.S. Court of Appeals for the Federal Circuit upheld the district court’s denial of a preliminary…more

Insurance Recovery Law - July 2015

In the Context of a Bad Faith Claim, Insurer’s Defense That Coverage Denial Was Reasonable Put at Issue Otherwise Protected Attorney-Client and Work Product Communications - Why it matters: Recognizing the “conflicting policy…more

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