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Administrative Agency Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

Litigation Misconduct Helps Render a Patent Unenforceable

by Knobbe Martens on

In March 2014, Regeneron Pharmaceuticals, Inc. sued Merus B.V. for allegedly infringing U.S. Patent No. 8,502,018 (“the ’018 Patent"). The ’018 Patent generally relates to using vectors to modify genes and chromosomal loci...more

Too Much or Too Little: FDA Requests Comments on New Strategy Regarding Risk Information in DTC Ads

by Hogan Lovells on

On August 21, 2017, FDA solicited comments in the Federal Register on a new potential approach regarding communicating risk information in direct-to-consumer (DTC) broadcast ads for prescription drugs and biologics that...more

Athena Automation IPR Decision Rejecting Equitable Defense of Assignor Estoppel in IPR Proceedings Designated Precedential by the...

by Fish & Richardson on

On August 2, 2017, the Patent Trial and Appeal Board (PTAB) designated Section II.A. of the Institution Decision in Athena Automation Ltd. v. Husky Injection Molding Systems Ltd., IPR2013-00290, Paper 18 (PTAB Oct. 25, 2013)...more

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of...

by Ladas & Parry LLP on

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more

Digital Health Companies May Find a Faster Path to Market Under the FDA's Digital Health Plan

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the...more

DJI Reports Enhanced Data Privacy for its Drones

We posted last week about the U.S. Army issuing a memorandum banning the use of DJI drones due to security concerns, but now, this week DJI reports that it is developing a new local data mode that stops internet traffic to...more

All You Need to Know About Flying Your Drone During the Solar Eclipse

Next week, on August 21, a solar eclipse (or the alignment of the sun, moon and earth) will take place for the first time in 38 years. The last time this cosmic event occurred, there were no battery-powered...more

Hospira Finds Mixed Results in Instituting IPRs Against Genentech Patents for Herceptin®

by Knobbe Martens on

Hospira (owned by Pfizer) filed five IPR petitions against Genentech patents that Genentech asserted were directed to Herpceptin® (trastuzumab). The PTAB has now instituted IPRs in three of the five petitions and denied the...more

Patent Term Extension Considerations for BioPharma Patents

Time spent on securing marketing approval for regulated products, such as pharmaceuticals, medical devices and agrochemicals effectively shortens the term of patent protection during which an innovator can recover its...more

FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

by Knobbe Martens on

The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone...more

Global Patent Prosecution Newsletter - August 2017

Worldwide Patent Term Extension Provisions - Mechanisms to recover patent term lost during regulatory approval are available in many countries throughout the world. The August 2017 issue of Sterne Kessler’s Global Patent...more

PTO Designates Precedential its Athena Automation Decision on Assignor Estoppel in IPR

by Finnegan – AIA Blog on

The PTAB designated as precedential its Institution Decision in Athena Automation Ltd. v. Husky Injection Moldings Systems Ltd., IPR2013-00290, Paper No. 18 (Oct. 25, 2013). According to the Patent Office’s message announcing...more

New FAA Waiver Issued to CNN Will Help Expand Commercial Drone Operations Over People

by Hogan Lovells on

Drones are the future of transportation and information technology. Recent innovations have transformed what used to be considered toys into powerful tools that provide substantial safety and efficiency benefits to commercial...more

U.S. Army Issues Memorandum Banning Use of DJI Products Due to Cybersecurity Issues

Last week, the U.S. Army issued a memorandum discontinuing the use of DJI drone products due to cybersecurity concerns. The memorandum said, “Due to increased awareness of cyber vulnerabilities associated with DJI products,...more

Federal Circuit Criticizes PTAB for Failing to Properly Weigh Objective Evidence of Non-Obviousness

by Pepper Hamilton LLP on

The Federal Circuit Court of Appeals again vacated a Patent Trial and Appeal Board (PTAB) panel decision for failing to properly evaluate “objective evidence of non-obviousness” and remanded the case for determinations...more

Testing a Patent Claim against an Abstract Idea, in Response to 35 USC §101 Rejection

USPTO (United States Patent and Trademark Office) rejection of a patent claim, alleging the claim is not significantly more than an abstract idea under 35 USC §101, is a frequent and often frustrating occurrence during patent...more

Do the Waive – FDA Implements Informed Consent Waivers for Minimal Risk Studies

by Hogan Lovells on

On July 25, 2017, FDA issued a guidance document describing under what circumstances IRBs may now approve consent procedures that waive or alter some or all of the elements of informed consent as set forth in FDA’s informed...more

FDA’s Software Pre-Cert Program: More Details Revealed

by Hogan Lovells on

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert) program, the Agency held an August 1, 2017,...more

Genentech to Defend 3 of 4 Herceptin® Patents Challenged by Hospira

by Jones Day on

At least 19 IPRs have been filed against seven of Genentech’s patents covering its blockbuster antibody drug Herceptin® (trastuzumab). On July 27, 2017, the PTAB instituted IPRs filed by Hospira, Inc. (a subsidiary of Pfizer)...more

Minnesota Patent Litigation Wrap-Up – July 2017

by Fish & Richardson on

This post continues our monthly summary of patent litigation in the District of Minnesota, including short summaries of substantive orders issued in pending cases. In July 2017, there were three notable decisions for...more

When It Comes to Domestic Industry’s Economic Prong, Numbers Speak Louder Than Words

by Orrick - IP Landscape on

Initial Determination on Violation of Section 337 and Recommended Determination on Remedy and Bond, Certain Radio Frequency Identification (“RFID”) Products and Components Thereof, ITC Inv. No. 337-TA-979 (June 22, 2017) (ALJ...more

A Review of the OMB Guidelines Issued to Federal Agencies for Reporting Requirements to Congress That Redefined What Constitutes a...

by Nossaman LLP on

With the growing threat of cyberattacks, we thought it would be worthwhile to discuss a late 2016 change in reporting requirements for federal agencies that have suffered a data breach. The Office of Management and Budget’s...more

Contraband Drone Crashes Near Prison in Washington State

Recently, a drone carrying 16 individual bags of marijuana, cell phones and chargers, two bags of tobacco, and 31 oxycodone pills crashed into the ground near the Washington State Prison yard....more

FDA and FTC Solicit Consumer Complaints About Dietary Supplement Marketing

by Pepper Hamilton LLP on

The Food and Drug Administration and the Federal Trade Commission have jointly requested that consumers report dietary supplements that “didn’t work as promised” or that are marketed with “unbelievable” claims. Consumers may...more

CAFC Finds Another PTAB Claim Construction Unreasonable and Again Reverses an Invalidity Holding

by Pepper Hamilton LLP on

In an inter partes review (IPR) proceeding, the meaning of terms used in challenged claims of an unexpired patent are given their broadest reasonable interpretation in light of the claim language and the specification. The...more

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