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September 2016 Update on Significant DOT, FAA and Other Federal Agencies’ Aviation-Related Regulatory Actions

This edition of the Cozen O’Connor Aviation Regulatory Update discusses DOT’s selection of carriers to operate U.S.-Havana and U.S.-Tokyo (Haneda) air services, the FAA’s implementation of its small unmanned aircraft...more

Integrating Drones into Your Business

Drones are becoming increasingly important for business of all types and sizes. There are already many applications of drones for businesses, but many more will certainly arise over the next few years....more

BREAKING NEWS: FDA Expected to Approve Amgen’s Humira Biosimilar Today

According to a report this morning from Seeking Alpha, FDA is expected to approve Amgen’s application for a biosimilar version of AbbVie’s Humira (adalimumab) today. If approved, it will be the first biosimilar adalimumab...more

Administration’s Biotechnology Working Group Updates Coordinated Framework & Unveils National Strategy

After launching with an ambitious agenda fourteen months ago, last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks. The Working Group has proposed an Update to...more

Federal Circuit Overturns PTAB Denial of Motion to Amend Claims in IPR Proceeding

Veritas Technologies LLC v. Veeam Software Corp., No. 2015-1894 (Fed. Cir. Aug. 30, 2016). On recurring controversy in AIA trials is the difficulty patent owners face meeting the PTAB’s strict requirements for amending...more

Four Years of IPRs: Lessons from Proceedings for the Cabilly II Patent

It has been four years since the first inter partes review proceedings were filed in the United States. The first IPR petition, filed on September 16, 2012 (the first day IPRs became available), made it all the way to the...more

CMS's Payment Suspensions Wreak Havoc: Understanding the Risks

CMS payment suspensions can cripple any provider's or supplier's operations. Yet, CMS has the authority to impose a payment suspension upon the mere existence of "reliable information" that an overpayment or fraud may exist....more

FDA Announces Upcoming Public Meeting on Its Recommendations for Reauthorizing the Biosimilar User Fee Act

Today FDA announced that it will hold a public meeting on October 20, 2016 to discuss its proposed recommendations for the reauthorization of the Biosimilar User Fee Act, which permits FDA to collect fees and use them for the...more

Congress Releases Unclassified Summary on Snowden/NSA Leak

On September 15, 2016, the House of Representatives’ Intelligence Committee released its summary findings of a two-year investigation concerning the unauthorized disclosures made by former National Security Agency (NSA)...more

Privacy Implications of the Federal Aviation Administration’s New Drone Rule

A new era in the field of aviation began on August 29, 2016, when the Federal Aviation Administration’s (FAA’s) long-awaited commercial drone rule went into effect. The new rule, formally known as Part 107, broadly authorizes...more

New Tool for Companies Seeking Qualified Drone Pilots

As more and more drones enter the skies, more and more companies are seeking qualified drone pilots to operate Unmanned Aircraft Systems (UAS) for their business. Skyward, a drone operations management platform, has now...more

Is there a Way to Monetize Commercial Drone Data?

By the end of the year, it is estimated that there will be about 600,000 commercial drones operating in the United States. U.S. Transportation Secretary, Anthony Foxx says, “We are in one of the most dramatic periods of...more

Off-Label Promotion —To Speak or Not To Speak?

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more

FDA Call For Comments on Off-Label Communications

The FDA has announced a 2-day public hearing related to communications by manufacturers, packers, and distributors, regarding, in part, drugs licensed as biological products. There will be a particular focus on communications...more

USPTO Cancer Immunotherapy Pilot Program

In July 2016, the USPTO launched the Cancer Immunotherapy Pilot Program to provide a fast-track review for cancer immunotherapy-related patent applications without the need for applicants to pay a petition fee. Under this...more

US Biosimilar Pathway Update

Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved. Zarxio, a...more

PTAB Grants Patent Owner Motion to Request Certificate of Correction

Addressing the requirements for correcting a mistake in a patent undergoing inter partes review, the Patent Trial and Appeal Board (PTAB or Board) granted the patent owner’s motion requesting authorization to file a...more

Final Drone Rule and Potential Privacy Implications For Operators

Well, the Federal Aviation Administration’s (FAA) Part 107 commercial drone regulations are in full swing this week and without the inclusion of specific privacy standards, there are still concerns about privacy-related drone...more

PTAB Reversed Based on Non-Analogous Art Theory

Although In re Natural Alternatives LLC (Fed. Cir. August 31, 2016) is not an IPR appeal, it should be of interest to those who care about IPRs and PGRs because it reflects a successful appeal from the Patent Trial & Appeal...more

PTAB Life Sciences Report - August 2016

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Illumina, Inc. v. Scripps Research Institute - PTAB Petition: IPR2016-01619; filed...more

Despite PTAB “Sweet Talk” Federal Circuit Reverses Invalidity Of Deicing Patent

The Federal Circuit reversed a Patent Trial and Appeal Board (PTAB) invalidity decision last week that had found a patent for a molasses-based, road deicing agent obvious over earlier patents on sugar-related inventions. The...more

Health Alert (Australia) August 29, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 23 August 2016 - Secretary, Department of Health (as successor to the Secretary, Department of Social Services) v DLW...more

Roadmap to Software Patent Eligibility

Recent Federal Circuit cases provide direction on how to satisfy the PTO or the federal courts that software is eligible for a patent. Some key points include: - New ways of organizing data - New connections between...more

Enbrel Biosimilar Approved in US But Enjoined For Now

On August 30 FDA approved Sandoz Inc.’s biosimilar of Enbrel (etanercept), Amgen Inc.’s blockbuster biologic for treatment of moderate to severe rheumatoid arthritis and a number of other autoimmune conditions. The...more

New USPTO Subject Matter Eligibility Guidance Following CellzDirect and Sequenom

On July 14, 2016, the U.S. Patent and Trademark Office issued new subject matter eligibility guidance for life science claims following a ruling by the Federal Circuit in Rapid Litigation Management v. CellzDirect, No....more

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