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FDA Issues Final Guidance on Benefit-Risk Factors to Consider in Medical Device Product Availability, Compliance, and Enforcement...

On December 27, 2016, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement...more

Patent Challengers Must Show Harm to Appeal Final PTAB Decisions

Last week, the Federal Circuit for the first time addressed the legal standard for demonstrating standing in an appeal from a final agency decision, such as an inter partes review (IPR) decision. Phigenix, Inc. v. ...more

FAA Issued Notice Advising Public of RTCA Drone Advisory Committee Second Meeting for Jan 31

The Federal Aviation Administration has issued a notice advising the public of the RTCA Drone Advisory Committee’s second public meeting, which is scheduled to take place on January 31, 2017 in Reno, Nevada. The FAA has...more

FDA Takes Action in the Last Days of the Obama Administration to Clarify Some of Its Views on Off-Label Communications

In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more

SkyPan and FAA Settle UAS Enforcement Cases

SkyPan International, Inc. (SkyPan), based in Chicago, and the Federal Aviation Administration (FAA) agreed upon a comprehensive settlement to resolve the enforcement cases where the FAA alleged that the SkyPan operated...more

Seattle Jury Convicts Man of Reckless Endangerment for Drone Operation

A Seattle Municipal Court jury convicted a man of reckless endangerment for losing control of his drone at the Gay Pride Parade in Seattle in 2015. The jury deliberated for approximately two hours and reached a unanimous...more

Federal Circuit Requires Standing to Appeal PTAB’s Final Decisions

Although arguably foreshadowed, some may be surprised to learn that a party with the right to challenge the validity of a patent at the United States Patent and Trademark Office (“USPTO”) may not have the right to appeal an...more

L.A. County Sheriff’s Department Begins Use of UAS for Dangerous, Hostile and Life-Saving Operations

The Los Angeles County Sheriff’s Department’s (LASD) use of unmanned aircraft systems (UAS or drones) has been approved by the Federal Aviation Administration (FAA) for “dangerous, hostile and life-saving operations.” LASD...more

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ? Intent, But Knowledge Certainly Can Be One Element in Establishing the...

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

No Stay Pending IPR in Brewing Patent Dispute

District court patent defendants often request a parallel inter partes review (“IPR”) proceeding at the U.S. Patent Office to challenge the validity of the patent at issue. As such IPR proceedings have the potential to kill...more

FDA Issued Draft Guidance on Interchangeability

Today, the FDA announced the availability of a draft guidance on biosimilar interchangeability, entitled “Considerations in Demonstrating Interchangeability With a Reference Product,” which is currently available on FDA’s...more

Federal Circuit Requires Standing To Appeal An IPR Decision

In the case of Phygenix, Inc. v. ImmunoGen, Inc., the Court of Appeals for the Federal Circuit (CAFC) held that the petitioner (Phygenix) that had unsuccessfully challenged certain claims of ImmunoGen’s U.S. Patent No....more

FDA Finalizes Guidance on Postmarket Management of Medical Device Cybersecurity

On December 28, 2016, the Food and Drug Administration (FDA) issued final guidance on the postmarket management of cybersecurity in medical devices. The guidance outlines nonbinding recommendations on how device manufacturers...more

A Family Victory! Victory! Just Not for Little Caesars

The United States Patent and Trademark Office, Trademark Trial and Appeal Board (the “Board”) modified its treatment of the “family of trademarks” doctrine in the recent case In re LC Trademarks, Inc., Serial No. 85890412...more

FAA Updates the Public on Drones with “A Story of Revolution and Evolution”

At the CES Unmanned Systems conference in Las Vegas last week, Administrator of the Federal Aviation Administration (FAA), Michael Huerta, provided the public with an update on the state of our unmanned aircraft systems (UAS)...more

CBM Review Standard

Whether a patent qualifies for a CBM review has been a moving target. Early decisions held that the claims do not need to be directed to a “financial product or service,” since a reference in the specification to a financial...more

Covered Business Methods Patents — Not So Broad!

The Federal Circuit Court of Appeals has reminded the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office in no uncertain terms that covered business method review has limits. In Unwired Planet, LLC v....more

Update on the Drone Flights-Over-People Rule

The Federal Aviation Administration (FAA) continues to work on its proposed rule which would allow the operation of unmanned aircraft systems (UAS), or drones, over people, expected (hopefully) to be released before the end...more

Federal Circuit Narrows Patent Eligibility for CBM Review

In the recently decided Unwired Planet, LLC v. Google, Inc. case, the Federal Circuit significantly narrowed the eligibility standards for covered business method (CBM) patent review. Prior to the decision in Unwired Planet,...more

WCAG 2.0 AA Is the New Accessibility Standard for Federal Agency Websites

Seyfarth synopsis: The federal government has adopted the Web Content Accessibility Guidelines 2.0 Levels A and AA as its accessibility standard for federal agency websites, making it very likely that the Department of...more

Overview of Recent FAA Remarks on UAS/Drone Integration into the National Airspace

On January 6, 2017, Federal Aviation Administration (“FAA”) Administrator Michael Huerta, delivered a speech at the Consumer Electronics Show (CES), a global consumer electronics and technology tradeshow in Las Vegas, Nevada,...more

RxIP Update - 2016 Year in Review

The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights. 1. Substantive patent law developments - Utility and...more

Keeping Up with the Drones(es)

For the U.K., Amazon drone delivery has left the realm of fantasy and become a reality. On December 14, Amazon announced that it successfully completed its first delivery using an automated drone in Cambridge in the U.K. (In...more

Full Federal Circuit to Review Appeals of PTAB Time-Bar Decisions

The hottest recent decisions from the Federal Circuit have centered on post-grant proceedings at the Patent Trial and Appeal Board (PTAB). One such issue involves when the PTAB is immune from appellate review of decisions it...more

Federal Circuit to Reconsider Appealability of Time-Bar Determinations in Institution Decisions

On January 4, 2017, the Federal Circuit agreed to reconsider en banc a panel decision in Wi-Fi One, LLC v. Broadcom Corp., 837 F.3d 1329 (Fed. Cir. 2016), which held that a patent owner cannot appeal a determination by the...more

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