Notice Requirements

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Competition News July-August 2016

The French Competition Authority severely punished the exclusivity practices put in place by company in a dominant position - On June 23, 2016, the French Competition Authority punished the Belgian group Umicore for...more

Chicago Minimum Wage Increased Again On July 1, 2016, And Updated Notice Must Be Given To Employees

As previously reported in The Fast Laner, the Chicago Minimum Wage Ordinance incrementally increases each on July 1 of each year until it reaches $13.00 per hour in 2019. Therefore, as a reminder, effective July 1, 2016,...more

Can FDA Implement The BPCIA As The CAFC Suggested?

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

Clarifications Regarding Trial Period by the French Supreme Court

With two decisions dated March 31 and April 15, 2016, the Employment Division of the French Supreme Court (“Cour de cassation”) clarified the legal framework applicable to trial periods. The Supreme Court explained how to...more

New PAGA Amendments Fail to Substantively Address Employers’ Concerns

Governor Brown recently approved Senate Bill No. 836, which amends the Private Attorneys General Act (“PAGA”) in a few minor technical ways, including new filing and notice requirements. Although employers had hoped for...more

Superior Court Dismisses Wrongful Death Claims Against Maricopa County Based On Plaintiff’s Untimely Notice Of Claim

Jones, Skelton & Hochuli Governmental and Appellate Group members John DiCaro and Jennifer Anderson recently obtained dismissal of a portion of a wrongful death lawsuit filed against Maricopa County. On January 22, 2014,...more

Colorado jumps into student data privacy protection with new privacy law

The recognized trend in data privacy is that those collecting or storing personally identifying information (“PII”) are required to safeguard and protect that information. The requirement to safeguard and protect data extends...more

Amgen v. Apotex: District Court Decides that the ’138 Patent is Not Invalid on Some Grounds; Enablement is Still an Open Issue

As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it...more

Defend Trade Secrets Act of 2016: What Does It Mean for Employers?

On May 11, 2016, President Obama signed the Defend Trade Secrets Act (DTSA) into law, creating a federal claim for misappropriation of trade secrets. Concerns with the difficulty of protecting trade secrets have grown as...more

General Motors: Protection Granted in Section 363 Sale Orders is Only as Good as the Notice Given

In a recent decision by the U.S. Court of Appeals for the Second Circuit in the General Motors case, the court held certain claimants were not afforded procedural due process with respect to the § 363 sale of General Motor...more

Fourth Circuit Says Failure to Advise Employee of Leave Reinstatement Interfered with FMLA Rights

The U.S. Supreme Court’s 2002 Ragsdale decision rejected Department of Labor regulations stating that failure to provide employees with notice of leave rights was a per se violation of the Family and Medical Leave Act....more

The Commercial Marketing Provisions of the Biologics Act are Mandatory

In Amgen Inc. v. Apotex Inc., [2016-1308] (July 5, 2016), the Federal Circuit affirmed a preliminary injunction against Apotex from entering the market until 180 days after giving Amgen Notice after receiving its FDA license....more

Biosimilar “Patent Dance” Does Not Permit Sidestepping of 180-Day Notice

On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) unanimously ruled in Amgen v. Apotex that biosimilar makers must provide brand-name rivals with a 180-day notice only after receipt of...more

Privacy Shield Finalized - How Everyone Can Take Advantage of the New European Data Transfer Framework

The EU Data Protection Directive 95/46/EC (the “Directive”) creates the legal framework for national data-protection laws in each EU Member State. The Directive states that personal data may only be transferred to countries...more

New Colorado Laws Grant Employees Access to Personnel Files, Right to Pregnancy Accommodations

The Colorado General Assembly ended the 2016 session by passing significant employment legislation. In June 2016, Colorado Governor John Hickenlooper signed into law House Bill 16-1432, granting employees access to personnel...more

CFPB Issues Proposed Revisions to GLBA Annual Privacy Notice Requirement

Earlier this month, the Consumer Financial Services Bureau issued its proposed rule amending the Gramm-Leach-Bliley Act’s annual privacy notice requirement set forth in Regulation P....more

Seven Tips for Food & Beverage Transactions in the Middle East

Parties purchasing Middle East-based companies operating in the retail and wholesale food and beverage sector with a focus on companies in Saudi Arabia and the United Arab Emirates (“UAE”) are facing some common issues....more

Amgen Inc. v. Apotex Inc. (Fed. Cir. 2016)

Last year, the Federal Circuit described the Biologics Price Competition and Innovation Act ("BPCIA") as "a riddle wrapped in a mystery inside of an enigma" in the Amgen v. Sandoz case. Nevertheless, one of the provisions of...more

Employer Wellness Programs: ADA, ACA, and HIPAA Compliance

Employer wellness programs are a subject of much interest to employers and receive considerable scrutiny from the EEOC and Department of Labor. Employers want to lower their health care costs by improving the health of...more

Federal Circuit Backs Amgen on Key Provision of Biosimilars Statute

The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more

Federal Circuit Requires 180 Day Notice For All Biosimilars, Even After Patent Dance

In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics...more

Hospira to Court: Amgen v. Apotex does not address the specific question raised by Hospira’s Motion to Dismiss in Amgen v. Hospira

The Federal Circuit's July 5, 2016 opinion in Amgen v. Apotex is already being picked up and analyzed in other BPCIA litigation: in Amgen v. Hospira, Hospira has submitted the Federal Circuit’s opinion to the District Court...more

Amgen v. Apotex: Analysis of the Fed. Cir. Opinion

As we posted on July 5, 2016, the Federal Circuit has issued its decision in Amgen v. Apotex, affirming the district court’s (S.D. Fla, J. Cohn) order preliminarily enjoining Apotex from launching its biosimilar version of...more

Recovering Possession of Abandoned Residential Property

The headline news from the Housing and Planning Act 2016 (the ‘Housing and Planning Act’) makes it look as though there is a good new solution to enable residential landlords to get their property back in their control when...more

Federal Circuit Invites FDA's Early Licensure of Biosimilars to Encourage Pre-Launch Resolution of Patent Disputes

In its July 5, 2016 decision in Amgen v. Apotex, the Federal Circuit interpreted the Biologics Price Competition and Innovation Act (BPCIA) for the second time. The Court reiterated that the BPCIA requires a biosimilar...more

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