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Relying on Irrelevant Factors to Award Attorneys’ Fees Is a Red Flag

Before Moore, Lourie, and Albright.  Appeal from the United States District Court for the District of Colorado. Summary: Awarding attorneys’ fees may be an abuse of discretion if the court relies on factors that should be...more

Responding to Preliminary Guidance Is the Core Purpose of the MTA Pilot Program

Before Dyk, Prost, and Stark. Appeal from the Patent Trial and Appeal Board. Summary: Because the PTAB’s MTA Pilot Program’s core purpose is to allow patent owners to address errors or deficiencies in motions to amend, the...more

Reliably Determining Reasonable Royalty Rates From Lump-Sum Licenses

Summary:  License agreements containing a lump-sum payment “based on” a royalty rate may provide reliable evidence of a reasonable royalty rate for the licensed patent. EcoFactor sued Google for patent infringement over...more

Jury Instructions Must Describe All Relevant Objective Indicia of Non-obviousness

INLINE PLASTICS CORP V. LACERTA GROUP, LLC - Before Taranto, Chen, and Hughes.  Appeal from the United States District Court for the District of Massachusetts....more

Being Known Is Not Enough

VIRTEK VISION INTERNATIONAL ULC, v. ASSEMBLY GUIDANCE SYSTEMS, INC., DBA ALIGNED VISION - Before Moore, Hughes, and Stark.  Appeal from the Patent Trial and Appeal Board (“Board”)....more

A Terminal Disclaimer Is Not an Escape Hatch

IN RE CELLECT, LLC - Before Lourie, Dyk, and Reyna. Appeal from the Patent Trial and Appeal Board. Summary: Obviousness-type double patenting analyses for patents with Patent Term Adjustments are based on the...more

Evidence of Commercial Success and the Prior Art

YITA LLC V. MACNEIL IP LLC - Before Taranto, Chen, and Stoll.  Appeal from the Patent Trial and Appeal Board. Summary: Evidence of commercial success that relates entirely to an individual claim element that was...more

Who Bears the Burden of Proof for IPR Estoppel?

IRONBURG INVENTIONS LTD. v. VALVE CORP. Before Lourie, Clevenger, and Stark.  Appeal from the United States District Court for the Western District of Washington. Summary: The patentee has the burden of proving that...more

Factual Disputes Preclude Grant of Summary Judgment of Improper Inventorship

Plastipak Packaging, Inc. v. Premium Waters, Inc. Before Newman, Stoll, and Stark. Appeal from the United States District Court for the Western District of Wisconsin. Summary: An overwhelming amount of evidence in favor of...more

Claim Directed to Specific, Hardware-Based Data Structure That Enables Technological Improvement Is Eligible Under § 101

ADASA INC. v. AVERY DENNISON CORPORATION - Before Moore, Hughes and Stark.  Appeal from the United States District Court for the District of Oregon. Summary: A claim directed to a specific, hardware-based data...more

FDA Expresses Priorities for Clinical Trial Efficiency, Artificial Intelligence

The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials...more

Wisconsin Alumni Research Foundation v. Apple, Inc.

Federal Circuit Summary - Before Prost, Bryson, and O’Malley. Appeal from the United States District Court for the Western District of Wisconsin. Summary: (1) To uphold a jury verdict of infringement, evidence must...more

Seizure-Detecting Smart Watch Given FDA Approval

The FDA has recently approved Embrace, a smart watch designed to monitor epileptic patients for seizures, according to a press release. According to the press release, the device uses machine learning to monitor patients for...more

Polaris Industries, Inc. v. Arctic Cat, Inc.

Federal Circuit Summaries - Before Lourie, O’Malley, and Hughes. Appeal from the Patent Trial and Appeal Board. Summary: Evaluation of “teaching away” requires consideration of whether a reference “criticize[s],...more

Recall Highlights Medical Device Cybersecurity Issues

On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or...more

FDA to Create New Digital Health Unit

The FDA has announced that it will create a new unit responsible for overseeing digital health products. According to Bakul Patel, the Associate Center Director for Digital Health at FDA, the agency is working to define...more

Medical Device Manufacturers’ Duty to Warn Expands

The Washington State Supreme Court recently released its decision in Taylor v. Intuitive Surgical, Inc. where it held that Washington law requires medical device manufacturers to warn hospitals that purchase their products of...more

ICU Medical Buys Hospira Infusion Systems From Pfizer

ICU Medical and Pfizer have reached an agreement to transfer ownership of Hospira Infusion Systems to ICU Medical, according to a joint press release on October 6....more

10/26/2016  /  Acquisitions , Hospira , Medical Devices , Pfizer

FDA Approves First MRI-Guided Ultrasound Device to Treat Essential Tremor

The FDA recently approved INSIGHTEC’s Premarket Approval (“PMA”) application for ExAblate Neuro, a device designed to treat essential tremor. Essential tremor is the most common kind of tremor; it commonly affects the hands,...more

7/14/2016  /  FDA Approval , Medical Devices

FDA Medical Device Quality Inspections Drop in 2015

The U.S. Food & Drug Administration (FDA) has released statistics showing that it inspected fewer medical device manufacturers in 2015 than in 2014....more

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