Administrative Agency International Trade Science, Computers & Technology

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UK’s First Ever Right To Be Forgotten Enforcement : Google In The Firing Line Again

The UK’s Information Commissioner’s Office (ICO) has made what appears to be its first “right to be forgotten” enforcement action against Google Inc. The ICO issued the notice on 18 August 2015, ordering Google to remove nine...more

Federal Circuit Upholds ITC Interpretation of § 337 to Cover Induced Infringement

Suprema, Inc. and Mentalix Inc. v. Int’l Trade Comm’n, Case No. 12-1170 (Fed. Cir. Aug. 10, 2015) (Reyna, J.) (O’Malley, Proust, Lourie, and Dyk JJ., dissenting). By way of background, appellee Suprema manufactures...more

EC JRC Publishes Options for the Review of the EC Nanomaterial Definition

The European Commission (EC) Joint Research Center (JRC) announced on July 10, 2015, the publication of its third report in its review of the EC recommendation on the definition of a nanomaterial. The report is the last in a...more

Proposed Rule to Subject Certain Cybersecurity Items to Greater Export Restrictions

The U.S. Department of Commerce Bureau of Industry and Security (BIS) recently published a proposed rule enhancing controls on certain cybersecurity items under the Export Administration Regulations (EAR). Specifically, the...more

Patent Opposition System - 2014 revision to Japan’s Patent Act introduces new method for challenging patent validity in an...

The 2014 revision of the Japanese Patent Act created an Opposition System to provide a simpler procedure for third parties to challenge patent validity and amended the scope of the existing Invalidation Trial System. This...more

United States and Canada Release Regulatory Partnership Statements

On May 28, 2015, several United States and Canadian regulatory agencies announced the release of Regulatory Partnership Statements (RPS) and updated annual Work Plans outlining the framework for how these agencies will...more

A Sea Change for IPRs? -- Part II

Yesterday, we reported on the inter partes review (IPR)-specific provisions of the Managers Amendment to the PATENT ACT bil, which was passed last week by the Senate Judiciary Committee (see also "Senate Judiciary Committee...more

Quantify Versus Quality Determines Domestic Industry - Lelo Inc. v. International Trade Commission

The U.S. Court of Appeals for the Federal Circuit reversed a finding by the U.S. International Trade Commission (ITC) of a violation of § 337, concluding that the Commission’s use of a qualitative analysis could not meet the...more

Patent Infringement in the Digital Age: How a Dispute About Tooth Aligners Led to a Fight About the ITC’s Jurisdiction over...

The International Trade Commission (“ITC”) is an “independent nonpartisan agency that investigates and reports to the President and Congress on matters concerning import trade, tariffs and trade agreements.” Shewmaker v....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

OFAC on Bitcoin—Learning Before Actively Regulating

Before a government agency issues regulations implementing a new law—or applies existing regulations to a new technology—it has to do some groundwork. The agency will interpret its authorizing legislation and executive...more

Recently Finalized FDA Guidance Indicates Some Flexibility for Biosimilars

Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more

OIG Report: FDA Has Made Progress on Oversight/Inspections of Manufacturers of Generic Drugs

Yesterday the OIG posted a report entitled “FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs” in response to a Congressional request expressing concerns about the safety and quality of...more

New Changes to U.S. Design Patent Law

American-based companies seeking protection for industrial designs will soon be encountering significant changes. On May 13, 2015, the United States will become a contracting party to the Geneva Act of the Hague Agreement...more

PTO Revival Rulings Are Not Subject to Collateral Attacks by Third Parties - Exela Pharma Sciences, LLC v. Lee

Addressing whether third parties have the right to challenge a patent revival ruling by the U.S. Patent and Trademark Office (PTO) under the Administrative Procedure Act (APA), the U.S. Court of Appeals for the Federal...more

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data

The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices. In view of the...more

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the Agency’s acceptance of medical device clinical data from studies conducted...more

Senju Pharm. Co., Ltd. v. Metrics, Inc.

Case Name: Senju Pharm. Co., Ltd. v. Metrics, Inc., Civ. No. 14-3962-JBS/KMW, 2015 U.S. Dist. LEXIS 41504 (D.N.J. Mar. 31, 2015) (Simandle, J.) ....more

FCC Enters Into $25 Million Settlement Following Cell Phone Carrier Data Breach

On April 8, the Federal Communications Commission (FCC) announced a $25 million settlement with an international telecommunications carrier concerning the unauthorized release of the personal information of nearly 280,000...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

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

Assuring Regulatory Compliance Doesn’t Get Lost in Translation

With the expansion of large multinational corporations into developing countries such as Russia, Brazil, India, Mexico and China, a proliferation of global regulatory enforcement actions, including anti-bribery and...more

Canada Issues First Penalties Under Anti-Spam Law

CRTC imposes over US$900,000 in fines against two companies, reminding U.S.- and foreign-based businesses about possible liability under Canada’s Anti-Spam Law - This month marks the issuance of the first two enforcement...more

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part Two of Two

On the second day of the 11th Annual Legal Affairs Forum held by the European Generic and Biosimilar Medicines Association, additional exclusivity and intellectual property concerns were covered, including key case updates...more

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