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Washington Amends its State Data Breach Notification Law

On April 13, the Washington State Senate unanimously passed an amendment to the state’s data breach notification law. The amendment, which was requested by Washington Attorney General Bob Ferguson, and which we discussed in...more

FDA Increasing Scrutiny of Cosmetic Marketing Claims, New Agency Warnings Suggest

In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food,...more

FDA, CMS Form Interagency Task Force on LDT Quality Requirements

FDA and CMS have announced that they are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs) -- tests intended for clinical use and designed,...more

Otsuka Files Amended Complaint and Motion for TRO/PI for Abilify®, Pointing to Congressional Intent to Argue Broad Exclusivity

As discussed in our April 13, 2015 blog, Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”) had until April 15, 2015...more

Telemedicine Providers Need to Keep Up with State Laws

Tech-savvy health care providers and tech-savvy patients in California can be grateful for California’s policies regarding telehealth practices. Consider the turmoil in Texas: telehealth practitioners who want to treat...more

Wrap-Up of Federal and State Chemical Regulatory Developments April 2015

EAB Reverses Epic Penalty In Elementis Case, But Affirms EPA's "Continuing" TSCA Section 8(e) Interpretation: On March 13, 2015, the U.S. Environmental Protection Agency (EPA) Environmental Appeals Board (EAB) reversed the...more

FTC Settles with Technology Company for Allegedly Misleading Consumers about Refunds

On April 7, the FTC announced a proposed settlement of an administrative complaint alleging that a web hosting provider violated the Federal Trade Commission Act. According to the press release, the company offered web...more

Section 337’s Potential for Defending Biologics Market Share Against Biosimilars

Enforcement of biologic patents at the United States International Trade Commission under Section 337 provides certainty and tactical advantages to patent holders that are unavailable in district court under the BPCIA. For...more

Otsuka’s Pediatric Labeling Dispute Seeks to Expand Orphan Drug Exclusivity

On April 13, 2015, the U.S. District Court for the District of Maryland issued an Order granting Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America...more

This Changes Everything: The FCC Open Internet Report and Order on Remand, Declaratory Ruling, and Order

I. Not Your Father’s Broadband - The Federal Communications Commission (FCC) on March 12, 2015, released a new template for future regulation of a basket of mass market retail services it has named “broadband Internet...more

Amgen Receives No Help from the FDA -- A Biosimilar Update

Near the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and...more

New Precedent Decision Revoking an Approved H-1B Work Visa Petition Poses Dire Consequences for the Consulting Industry

On April 9, 2015, the Administrative Appeals Office (AAO) of the U.S. Citizenship and Immigration Service (CIS) issued a precedent decision affirming the California Service Center (CSC) Director's revocation of an H-1B...more

Generic Drug Manufacturers to be Investigated by HHS for Recent Price Hikes

On April 13, 2015, the Inspector General (IG) of the Department of Health and Human Services announced in a letter to Senator Bernard Sanders (I. VT), that it would investigate recent price hikes for generic drugs. Generic...more

SEC Secures Victory on Fraud Allegations Against Technology Executive

The US District Court for the District of Columbia took the unusual step of granting summary judgment against a technology company executive who the Securities and Exchange Commission accused of various violations of the...more

Stricter Standing for Inter Partes Review?

Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject...more

FCC Imposes Record Penalty for Data Breach

On Wednesday, April 8, the Federal Communications Commission (FCC) entered a consent decree and levied a $25 million civil penalty against AT&T to settle a data breach that exposed the information of nearly 280,000 customers....more

Also In The News - Health Headlines - April 2015

Guidance Issued on Payment for Biosimilars – On March 30, 2015, CMS released three guidance documents detailing the policies that will govern FDA-approved biosimilars under the Medicare Part B and Part D benefits, and how...more

H-1B Updates - (1) New Petition Required When Work Location Changes and (2) USCIS Ran Lottery for Fiscal Year 2016 on April 13

Changing years of established policy, the Administrative Appeals Office (AAO) ruled in a precedent decision on April 9, 2015 that the beneficiary of an H-1B petition working in the United States cannot change geographical...more

Google’s Pole Attachment Rights in California on Hold for Now

The California Public Utilities CPUC (CPUC) released a Proposed Decision on February 20, 2015 denying a petition by Google Fiber Inc. (Google) to modify the CPUC’s Video Service Provider Decision or DIVCA Order. Google’s...more

Toxic Tort and Environmental Litigation: Toxic Substances Control Act - Reform at Last? (4/15)

Efforts to reform the Toxic Substances Control Act (TSCA), 15 U.S.C. § 2601 et seq., have been underway for several years, but to date, none have succeeded in modifying how this often criticized law regulates chemicals in...more

Montana And Wyoming Revise Data Breach Notification Laws

The states of Montana and Wyoming recently updated their data breach notification statutes. The revisions include updates to the states’ definitions of personal information subject to breach notification provisions, among...more

FFIEC’s Seven Cybersecurity Priorities for 2015

While others were waiting for spring to arrive, community bank officers and directors were waiting for the Federal Financial Institutions Examination Council (FFIEC) to provide additional guidance on its cybersecurity...more

Navigating Protective Order and Prosecution Bar Issues in BPCIA Litigation

Protective orders preventing litigation counsel from participating in the prosecution of litigation-related patents are commonplace. The Biologics Price Competition and Innovation Act (“BPCIA”), for example, provides a...more

Alert: FCC Continues Aggressive Action on Data Breaches

As noted in previous alerts, the FCC has dramatically increased its enforcement of data security practices and breaches resulting from what the FCC considers to be inadequate security measures. ...more

Alternatives to the H-1B Visa: A New L-1B Adjudication Standard?

As expected, the United States Citizenship and Immigration Services (USCIS) announced that it has met the FY2016 H-1B cap during the first week of the new filing season. Over the next few weeks, many employers who filed H-1B...more

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