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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The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017.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

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

Our report includes discussions of six of the precedential cases decided in the past week and will include the other three cases in next week’s report. In Aylus v. Apple, the panel finds prosecution disclaimer in a...more

Key Trends In Pharmaceutical IPRs Filed By Generic Petitioners

by Foley & Lardner LLP on

We reviewed a sub-group of two hundred and four (204) IPRs filed by generic drug companies against pharmaceutical patents to assess PTAB outcomes and key trends in dealing with this technology field. The survey captured IPR...more

New FAA-Commissioned Report on Unmanned Aircraft Systems (UAS) Human Collision Hazards May Support Broader Approval for UAS...

by Hogan Lovells on

Part 107, the rule broadly authorizing commercial UAS (drone) operations, was an important step forward for the commercial UAS industry. However, Part 107 limited operations in important ways. One significant limitation...more

Federal Circuit Maintains Pre-AIA Interpretation of the On-Sale Bar for Public Sales

by Brinks Gilson & Lione on

In Helsinn Healthcare S.A., v. Teva Pharm. USA, Inc., the Federal Circuit recently held that, despite changes to the statutory language of § 102 under the Leahy-Smith America Invents Act (“AIA”), the Court’s pre-AIA...more

New EASA Consultation: Are Drone Pilots Heading for a Period of Regulatory Turbulence?

by Hogan Lovells on

On 12 May 2017 the European Aviation Safety Agency (“EASA“) opened a consultation into sweeping new regulations on the operation of unmanned aircraft systems (“UAS” or drones) in European airspace. Individuals and companies...more

China FDA Calls for Comments on Key Policy Proposals

by Ropes & Gray LLP on

On May 11-12, 2017, the China FDA (CFDA) issued four new draft policies for public comments, proposing further reforms in the current drug and medical device regulatory regime. The four draft policies aim to accelerate the...more

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