On October 24, 2017, the FDA announced new steps that it is taking to promote beneficial medical device innovation.

The FDA recently approved Abbott’s FreeStyle Libre Flash Glucose Monitoring System.  According to Bloomberg, this device marks the first continuous glucose monitoring system that adults can use that does not…

The FDA recently cleared the first medical device accessory for the Apple Watch — AliveCor’s KardiaBand.  According to AliveCor, the Kardiaband is a mobile, real-time electrocardiogram (EKG) reader that can record an EKG within 30 seconds and display the results on the Apple Watch or iPhone.  In conjunction with the KardiaBand, AliveCor is introducing “SmartRhythm, a new feature within the Kardia app for the Apple Watch.” 

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices.  The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices currently on the market that are manufactured using 3D printers.  Importantly, many of these devices can be tailored to fit a specific patient’s anatomy.  For example, the FDA has reviewed 3D-printed knee replacements and implants for facial reconstruction.

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices.  The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices currently on the market that are manufactured using 3D printers.  Importantly, many of these devices can be tailored to fit a specific patient’s anatomy.  For example, the FDA has reviewed 3D-printed knee replacements and implants for facial reconstruction

Before Moore, Plager, and Stoll.  Appeal from the United States District Court for the Southern District of Florida.

Summary: In challenging compliance with the marking requirement of § 287(a), an accused infringer need only identify the unmarked products sold or licensed by the patentee that it believes are covered by the patents in suit, at which point the burden shifts to the patentee to show that the identified products do not practice the patented invention.

Before Wallach, Chen, and Stoll.  Appeal from the United States District Court for the District of Delaware.

Summary: Even if a patentee’s initial complaint was reasonable, the patentee can be liable for attorney fees under 35 U.S.C. § 285 if it does not reassess the merits of its case in view of new controlling law.  

In a recent development with the ongoing complex litigation involving Janssen Biotech’s arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar,[1] Celltrion’s partner Pfizer has filed a suit against Janssen’s parent company Johnson & Johnson (J&J) in the Eastern District of Pennsylvania alleging that through anticompetitive pricing and exclusionary contracts with insurers and hospitals, J&J sought to preserve a monopoly over its sale of Remicade.[2]

On November 16, 2017, the USPTO issued new procedures (“Standard Operating Procedure 9”) for governing cases remanded from the Federal Circuit. These procedures are applicable to all decisions remanded from the Federal Circuit to the PTAB, including decisions resulting from IPR, PGR and CBM trials as well as ex parte appeals and reexamination proceedings.  

On November 6^th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD)[1].  The FDA approved Zelboraf under Priority Review, Breakthrough Therapy, and Orphan Drug designations for the ECD indication.