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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.

Due Diligence: Calculating the Regulatory Review Period for Patent Term Extension

by Pepper Hamilton LLP on

This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more

FDA Advisory Committee Recommends Approval of Pfizer’s EPOGEN®/PROCRIT® Biosimilar

by Goodwin on

As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer,...more

Ex Parte Hafner Provides Clarity in Assessing Patent Subject Matter Eligibility for Software Patents

In Ex Parte Hafner, the U.S. Patent and Trademark Office Patent Trial and Appeal Board (the “Board”) reversed the Examiner’s rejection that claims directed to an energy transaction plan were subject-matter ineligible. Ex...more

Why Design Patents Are Surviving Post-Grant Challenges

As of January 2017, the institution rate for Patent Trial and Appeal Board trials involving design patents was 37 percent. That is significantly lower than every other technology area and makes design patents the only...more

The D.C. Court of Appeals Just Scrapped the Drone Registry and May Have Also Turned Homeowners Insurers into Aviation Insurers

Model-aircraft hobbyist John Taylor didn’t want to register his model aircraft with the FAA pursuant to the newly created drone registry. So he took on the FAA, challenging new regulations aimed at unmanned aircraft...more

Amazon’s Air-Traffic Control System for Package Delivery Drones

Amazon announced this week that its development of an air-traffic control system for its package delivery drones (and other commercial drones flying in the national airspace) has taken off –pun intended. This air-traffic...more

A Simple Case of Statutory Interpretation: The FAA Lacks Authority to Require Model Aircraft Operators to Register

by Morrison & Foerster LLP on

On Friday, May 19, 2017, a federal appellate court struck down an integral part of the FAA’s attempt to safely monitor and integrate small unmanned aerial systems (“sUAS”) into the national airspace. The D.C. Circuit found...more

What Rights Will I Lose if I Pitch My Invention to Investors Before I File a Patent Application?

by Ward and Smith, P.A. on

Did you know that the individual often credited with popularizing karaoke did not reap the financial rewards of his invention to the extent possible? It's true—Japanese musician Daisuke Inoue invented karaoke in Kobe, Japan...more

EDTX Interprets Federal Circuit Precedent Narrowly, Recommends Applying §315 Estoppel Broadly

by Jones Day on

In Biscotti Inc. v. Microsoft Corp., Magistrate Judge Payne recommended that estoppel under §315(e) apply broadly against Microsoft in an upcoming patent infringement trial scheduled for early June 2017. No....more

PTAB Invalidates Patent for Blockbuster Drug HUMIRA®

The PTAB issued a Final Written Decision in Coherus BioSciences Inc. v. AbbVie Biotechnology Ltd., IPR2016-00172 (P.T.A.B. May 16, 2017) finding claims 1-5 of U.S. Patent No. 8,889,135 (“the ‘135 patent”) unpatentable....more

Materials Available for May 25, 2017 ODAC Meeting Regarding Hospira’s Epoetin Alfa Biosimilar Application

by Goodwin on

As we previously reported, the FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit®...more

Part I: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017. Innovators, biosimilar makers, patients, healthcare providers and other...more

Recreational UAS Registration Rule Struck Down

by Varnum LLP on

On Friday, May 19, 2017, the D.C. Circuit Court of Appeals struck down FAA’s registration rule for recreational unmanned aerial system (drone) users, also called model aircraft....more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Mylan v. Aurobindo the Circuit affirms the grant of a preliminary injunction based upon the infringement of one of the three patents in suit. However, the panel reverses the injunction as to the other two patents based on...more

Update on Biosimilar Approvals and Pending Applications in Europe and the U.S.

Approvals of biosimilar products in Europe continue to outpace those in the United States. 28 biosimilars are currently approved in Europe and five in the U.S. In 2017, the European Medical Agency has approved six...more

Registration Rule Decision Invites Congress to Expand FAA Authority Over Hobby Drones (Or Not)

On May 19, 2017, the U.S. Court of Appeals for the D.C. Circuit issued a ruling vacating the Federal Aviation Administration's "Registration Rule," which required owners of small unmanned aircraft ("drones") operated for...more

BREAKING: U.S. Court of Appeals for the DC Circuit Strikes Down FAA Drone Registration Rule for Hobbyist

by Hogan Lovells on

In a ruling issued last Friday, the the U.S. Court of Appeals for the District of Columbia Circuit vacated the FAA’s Registration Rule for small unmanned aircraft systems (UAS or drones) that are operated for recreational...more

Magistrate Judge Recommends IPR Estoppel Bar of Prior Art References

A magistrate judge in the Eastern District of Texas recommended in Biscotti, Inc. v. Microsoft Corp., No. 2:13-CV-01015, DI 191 (E.D. Tex. May 11, 2017) that Microsoft should be estopped from asserting invalidity grounds that...more

Secondary Considerations Carry The Day

by Jones Day on

We have previously reported (on February 1, on March 1, and on March 30) how patent owners have seen a mixed bag of results in trying to convince PTAB panels that secondary considerations of non-obviousness were sufficient to...more

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

by Pepper Hamilton LLP on

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

by Hogan Lovells on

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of 21–2. Please see full...more

How Will the Appointment of a Special Counsel Affect the Administration's Regulatory Agenda?

by Mark Mansour on

The news of the the appointment of Robert Mueller as special counsel to be investigate the Russia-Trump connection rocked Washington. The immediate concern was how the White House would surmount the distraction and where all...more

Amgen Sues Coherus Under BPCIA After Completing Patent Dance

On May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S....more

Updated Drone Statistics in the Commercial Industry

The commercial drone market is booming. While estimates certainly vary, many research firms say that the worldwide market value will rise from $2 billion today to over $10 million within the next 10 years. Similar to the GPS...more

FAA Drone/Human Collision Analysis Study Helpful for Drone Insurance

by Rumberger Kirk & Caldwell on

The FAA recently published the results of a study that was designed to evaluate the risks of serious injury to a pedestrian resulting from a drone collision. ...more

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