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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.

St. Jude Medical On Hot Seat for Cybersecurity Flaws in Home Monitoring System

The Food and Drug Administration (FDA) recently issued a warning letter to St. Jude Medical, alleging that it failed to properly investigate issues with the batteries in its defibrillator implants and for failing to fix the...more

Breaking News: FDA Approves Samsung Bioepis’s Biosimilar of REMICADE®

by Goodwin on

Today, FDA approved Samsung Bioepis’s aBLA for RENFLEXIS® (infliximab-abda), a biosimilar of Janssen’s REMICADE®. According to the approved prescribing information, RENFLEXIS® is indicated for the treatment of Crohn’s...more

Congressional Committees Propose Restructuring of User Fees in Draft Language

by Morgan Lewis on

The draft language reauthorizes FDA’s authority to assess user fees and proposes fee restructuring and increases. On April 14, the health committees for both the US Senate and the US House of Representatives released a...more

Top unmanned aircraft systems developments in 2017 for ADG companies

by Hogan Lovells on

Aerospace, defense, and government services (ADG) companies are not new to game-changing technology innovations. It is therefore no surprise that a number of ADG companies are early investors in unmanned aircraft systems...more

Pharmaceutical Compound Nonobvious Absent Evidence Suggesting Specific Modification to Prior Art Compound

by Jones Day on

The PTAB issued a final written decision in IPR2016-00204, upholding the validity of claims 1–13 of Patent RE38,551 E (“the ’551 patent”), which covers the antiepileptic drug VIMPAT® (lacosamide)....more

Fed Circ Affirms Conflicting Invalidity Determinations from District Court and PTAB

by Jones Day on

As we have previously discussed on this blog, when considering an issue of patentability such as definiteness under section 112, the PTAB and a district court may properly reach opposite conclusions. In Tinnus Enterprises LLC...more

"Strategies for Litigants in Patent Infringement Cases Using Motions to Dismiss Post-Alice"

Nearly three years have passed since the U.S. Supreme Court's decision on patent eligibility in Alice Corp. Pty. Ltd. v. CLS Bank Int'l. The decision, which ushered in an unprecedented wave of cases invalidating...more

Federal Circuit Affirms PTAB’s Obviousness Holding for Novartis’s Dementia Drug Patents

The Federal Circuit affirmed the PTAB’s final written decisions holding that claims directed to Novartis’s dementia drug compositions containing Exelon were obvious in Novartis AG v. Noven Pharm. Inc., No. 2016-1679 (Fed....more

Your Business Drone Crashed... What Do You Do?

by Rumberger Kirk & Caldwell on

Understanding FAA & NTSB Drone Accident Reporting Requirements - When a corporate drone crashes, it can be one of the worst-case scenarios for owners who rely on UAS technology to conduct a wide-array of business...more

US Comptroller of the Currency Discusses Fintech

by Shearman & Sterling LLP on

US Comptroller of the Currency Thomas Curry provided remarks describing actions the OCC has taken to meet the needs of all types of consumers, businesses and communities in the US. Specifically, he described a new department...more

FDA Cleared First DTC Genetic Tests for Health Risks

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

Federal Circuit Affirms Obviousness of Novartis’s Patent for Multiple Sclerosis Drug

The Federal Circuit affirmed the PTAB’s final written decision holding that claims directed to Novartis’s multiple sclerosis drug Gilenya were obvious in Novartis AG v. Torrent Pharmaceuticals. Ltd., No. 2016-1352 (Fed. Cir....more

FAA Publishes Notice to Airman Restricting UAS Flights Over 133 Military Facilities

On April 7, 2017, the Federal Aviation Administration (FAA) published a Notice to Airmen (Notice) that becomes effective on April 14, 2017. The Notice prohibits the operation of unmanned aircraft systems (UAS) over 133...more

The Importance of Aligning Your Regulatory and IP Strategies

by Mark Mansour on

One of the least discussed but potentially most important part of the drug and device approval process is the smooth functioning of the IP and the regulatory strategies. It is natural to focus first on the IP issues,...more

FDA Delays Effective Date of Amended Regulations Affecting "Intended Use" Definition

by Jones Day on

One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses,'" would have taken...more

FAA to Release New UAS Airspace Maps

The Federal Aviation Administration (FAA) plans to release a set of unmanned aircraft systems (UAS) facility maps on April 27, 2017. These maps will help drone operators improve their Part 107 airspace authorization requests,...more

Just Because the Board Didn’t Say It, Doesn’t Mean that the Board Didn’t Think It

In Novartis AG v. Torrent Pharmaceuticals Limited, [2016-1352] (April 12, 2017), the Federal Circuit affirmed the PTAB’s determination that the challenged claims of U.S. Patent No. 8,324,283, and Novartis’ proposed substitute...more

Evidence of Priority to Provisional Application and that Prior Art Was Not Work of Another Defeated Obviousness Challenge in IPR

The Patent Trial and Appeal Board (the “Board”) issued a final written decision determining that the Coalition for Affordable Drugs (ADROCA), LLC (“Petitioner”) failed to prove unpatentable claims 1-52 of U.S. Patent No....more

Federal Circuit Limits Claim to Single Embodiment Because Only Enabling Description Provided in the Patent

On April 6, 2017, the Federal Circuit reversed-in-part and affirmed-in-part the district court’s judgment of infringement and summary judgment for non-infringement of The Medicines Company’s (“MedCo”) patents-in-suit. See The...more

PTAB Not Bound By Prior Court Decisions Upholding Exelon Patents

by Foley & Lardner LLP on

In Novartis v. Noven Pharmaceuticals, Inc., the Federal Circuit affirmed the USPTO Patent Trial and Appeal Board (PTAB) decisions invalidating certain claims of two Orange Book-listed Exelon patents. This decision has...more

Sky full of drones – Germany opens up for new drone opportunities as it introduces its new UAS Regulation

by Hogan Lovells on

Germany has introduced a new “Regulation for the Operation of Unmanned Aircraft Systems” (“Drone-Regulation“). On 7 April 2017, the new Drone-Regulation entered into force adapting national legislation to the risk-based...more

FDA authorizes first direct-to-consumer genetic test panel for predisposition to Alzheimer's disease and other serious disorders

by DLA Piper on

The FDA has announced its decision to grant a de novo application submitted by 23andMe for the company's direct-to-consumer (DTC) Personal Genome Service Genetic Health Risk ("GHR") tests. The GHR test panel currently...more

FAA Announces Release of UAS Facility Maps for Drone Operators

by Rumberger Kirk & Caldwell on

The Federal Aviation Administration has just announced that it will release its first set of UAS (Unmanned Aircraft Systems) facility maps on April 27, 2017, which can be found at: http://www.faa.gov/uas. Once published,...more

ITC Opens the Door Wider To Non -Practicing Entities

by Dickinson Wright on

In a recent ruling, the International Trade Commission permitted a non-practicing entity to rely on the activities of its licensee to establish the “economic industry” prong of the domestic industry requirement. In...more

Sense-and-Avoid Software Tests Successfully in Recent Drone Flights

The Federal Aviation Administration (FAA), Northrop Grumman, and Aviation & Communication & Surveillance Systems (ACSS) recently announced a series of successful drone flights testing sense-and-avoid systems. One of the key...more

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