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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.

Rx IP Update - April 2017

by Smart & Biggar on

Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more

Novartis’ Gilenya Patent Invalidated as Obvious

On April 12, 2017, the Federal Circuit affirmed the determination by the US Patent and Trademark Office (USPTO), Patent Trial and Appeal Board (Board) that the claims of U.S. Patent No. 8,324,283 (“the ’283 patent”) were...more

Rules of the Drone. The New FAA Drone Rules For Your Construction Site

About ten years ago, I visited a college friend in Simi Valley, California. He graduated Purdue with an Aeronautical Engineering degree and had left Indiana to work for a company developing unmanned aircraft for the military....more

Analogous Analysis: A Survey of Recent PTAB Decisions Establishing Subject Matter Patent Eligibility

In 2014, the U.S. Supreme Court established the current framework for determining patent-eligible subject matter in Alice. The Alice framework is a two-part test, with step one requiring a determination regarding whether a...more

No Nexus For Novartis Gilenya Patent

by Foley & Lardner LLP on

In Novartis AG v. Torrent Pharmaceuticals Ltd., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) invalidating all claims of U.S. Patent 8,324,283, which is one of four Orange...more

Health Update - April 2017

CMS Issues Self-Referral Disclosure Protocol for Stark Law Violations - On March 28, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a new voluntary self-referral disclosure protocol (SRDP) for disclosing...more

How Will the Trump Administration Impact Healthcare Litigation?

Editor's Note: In a dramatic conclusion to the heated debate surrounding the American Health Care Act (AHCA), the bill was withdrawn after it became clear that House leadership did not have enough votes to pass it. There is...more

FDA Advisory Committee to Hold Public Meeting on Hospira’s Proposed Epogen/Procrit Biosimilar

by Goodwin on

The FDA recently announced that the Oncologic Drugs Advisory Committee will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer...more

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

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