Administrative Agency Science, Computers & Technology

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Patent Safe Harbor Applies to Supplemental New Drug Applications

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for...more

FDA Addresses Compounding of Animal Drugs From Bulk Drug Substances

The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more

Congress Could Be Coming For Dietary Supplements Soon

The next chapter in the saga of New York State Attorney General Eric T. Schneiderman's investigation of the dietary supplements industry may take place on Capitol Hill. On April 2, Schneiderman and the state attorneys general...more

FTC sued by blogger to release data security guidelines

The Federal Trade Commission (FTC) was sued this week by Philip Reitinger, a fellow blogger and former Deputy Undersecretary of the Department of Homeland Security. He is now President of VisionSpear LLC, an information...more

TSCA Reform: Detailed Review of Representative Shimkus' Second Discussion Draft of TSCA Reform Legislation

On May 12, 2015, Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released a new (second) draft of the TSCA Modernization Act of 2015 (TMA2 DD). In April,...more

Must the "Maker" of a False Statement have "Ultimate Authority" over that Statement to be Subject to Liability for Securities...

This case involved a civil enforcement action by the Securities and Exchange Commission (SEC) against certain public relations companies and their principals, alleging violations of—among other things—Section 17(a) of the...more

Nearly Expired Is Not the Same as Expired: The Board Clarifies Claim Construction Standards for Inter Partes Review - Apple, Inc....

Addressing the standard to be applied for claim construction during inter partes review (IPR) proceedings, the U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal Board (PTAB or Board) declined to create an...more

Facts Govern Real Party-in-Interest Determinations - TRW Automotive US LLC v. Magna Electronics Inc.; Paramount Home Entertainment...

Addressing the real-party-in-interest (RPI) requirement of 35 U.S.C. § 312(a) in two separate proceedings, the U.S. Patent and Trademark Office (PTO) Patent Trial and Appeal Board (PTAB or Board) emphasized the fact-dependent...more

Department of Justice Settles Virtual Currency Enforcement Action

The US Attorney’s Office in the Northern District of California recently settled an enforcement action against Ripple Labs Inc., a Delaware corporation providing virtual currency exchange services. According to the settlement...more

A Gathering Storm in the Dietary Supplement World

This past February, the New York State Attorney General's office accused four major retailers of selling fraudulent and possibly dangerous herbal supplements and demanded that they remove the products from their shelves. The...more

ONC Releases Updated Guide to Privacy and Security of Electronic Health Information

The Office of the National Coordinator for Health Information Technology (“ONC”) of the U.S. Department of Health and Human Services (“HHS”) recently released Version 2.0 of the Guide to Privacy and Security of Electronic...more

Biogen MA, Inc. v. Japanese Foundation for Cancer Research (Fed. Cir. 2015)

The Federal Circuit affirmed a decision by the U.S. District Court for the District of Massachusetts that it lacked subject matter jurisdiction under 35 U.S.C. § 146 pursuant to changes in the statute provided by the...more

“Restriction Requirements” Series, Part 1: Considering Restrictions When Developing A Claim Filing Strategy

Welcome to the blog’s first post in a series about restriction requirements! This series will explore nuances in restriction requirement law and provide strategies for most effectively handling restriction requirements, both...more

Comingling of employee and patient data compromises employer’s HIPAA defense to employee’s claim of discharge for union activity

An administrative law judge (ALJ) of the National Labor Relations Board has concluded that a health care employer’s use of its medical records software to store employee contact information allowed an employee to access that...more

Justice to Target Corporations and C-Suite Executives in the Healthcare Industry

On Thursday, May 14, 2015, at a meeting of the American Bar Association’s Healthcare Fraud Section, Leslie Caldwell, the Assistant Attorney General for the Department of Justice (DOJ) Criminal Division, declared stamping out...more

Shifting Landscapes: Regulatory Challenges Stemming from Emerging Technologies

In the modern era, the world moves fast—aided by technology that is constantly evolving and changing our relationships with each other and with the world around us. Technological developments challenge state and local...more

US House of Representatives Holds Hearing on the .SUCKS New gTLD and ICANN Accountability and Stakeholder Trust

On May 13, 2015, the US House of Representatives Judiciary Committee's Subcommittee on Courts, Intellectual Property, and the Internet held a hearing on "Stakeholder Perspectives on ICANN: The .SUCKS Domain and Essential...more

FDA Issues Biosimilars Q&A Guidance Document

On May 13, the FDA released a draft question-and-answer guidance document, titled “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.” The...more

The DOJ’s Cyber Incident “Best Practices” Guidance

The Cybersecurity Unit of the U.S. Department of Justice released in April its “Best Practices for Victim Response and Reporting of Cyber Incidents,” which it says reflects “lessons learned by federal prosecutors while...more

Mobile Privacy Rules to Be Enforced Starting September 1, 2015

All businesses acting in the mobile ecosystem—including app developers, analytics companies, advertising networks, app platform providers, and providers of devices and related services—should be aware that the Digital...more

IPR Privity Analysis Includes Post-Complaint Period - VMWare, Inc. v. Good Technology Software, Inc.

Clarifying the privity requirement for inter partes review (IPR) petitions, the U.S. Patent and Trademark Office (PTO) Patent Trial and Appeal Board (PTAB or Board) explained that privity should be determined looking at the...more

May 2015 Immigration Alert

AAO Issues Precedent Decision Requiring Employers to File Amended Petitions When an H-1B Employee Changes Work Locations - On April 9, 2015, the Administrative Appeals Office (“AAO”) issued an important precedent...more

Filing Waiver of Service Triggers One-Year IPR Bar Date - The Brinkmann Corporation v. A&J Manufacturing

Addressing the issue of standing to present a petition, the Patent Trial and Appeal Board (PTAB or Board) granted institution of an inter partes review (IPR), finding that the petition filed within one year of filing waiver...more

Animal Compounding Guidance (Draft) for Use of Bulk Drug Substances Released by FDA Today

On May 18, 2015, FDA released new draft guidance on animal drug compounding from bulk drug substances. While FDA’s current statutory framework and regulations do not permit compounding of animal drugs from bulk drug...more

Mere Receipt of a Copy of the Complaint Does Not Invoke the One-Year Bar Rule - Petroleum Geo-Services, Inc. v. Westerngeco LLC

Addressing the meaning of “defendant” for purpose of the one-year bar rule, the U.S. Patent and Trademark Office (PTO) Patent Trial and Appeal Board (PTAB or Board) explained that being served with a third party subpoena in...more

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