On August 23, 2018, Dthera Sciences announced that the Food and Drug Administration granted Breakthrough Therapy designation to its Alzheimer’s disease therapeutic device. According to the FDA, Breakthrough Therapy designation is intended to help patients have more timely access to breakthrough technologies that provide treatment for diseases for which no approved treatment exists or which offer significant advantages over existing treatments. A therapy that receives Breakthrough Therapy designation will be reviewed within 60 days of receipt.
Blockchain is a technological innovation underlying cryptocurrencies like Bitcoin. Given the importance of cryptocurrencies not only for buying and selling goods and services, but also as funding and investment vehicles, the underlying blockchain technology is obviously of interest in the fintech space.
Boston Scientific recently announced an agreement to acquire privately-held VENITI, Inc. for $160 million. According to the press release, VENITI submitted a pre-market approval application with the U.S. Food and Drug Administration in June 2018 for the VICI stent system for treating obstructive venous disease. The VICI stent system received CE Mark approval in 2013.
On July 18, 2018 the well-known luxury goods company, Cartier International AG and Cartier, a division of Richemont North America Inc. (collectively, “Cartier” or “Plaintiffs”) filed suit in the United States District Court for the Southern District of New York against Wholesale Jewelry, Inc. d/b/a Diamond Source (“Defendant”). Plaintiffs’ claims include federal counterfeiting, trademark and trade dress infringement, unfair competition, dilution, and similar claims of trademark infringement and unfair competition under New York common law.
The United States Patent and Trademark Office (USPTO) published an update to the AIA Trial Practice Guide (‘‘Trial Practice Guide’’) in August 2018 to revise guidance on practices before the Patent Trial and Appeal Board (‘‘Board’’). The original Trial Practice Guide was published in 2012 at the same time as the promulgation of AIA Trial Rules. The Trial Practice Guide contains informative material of standard practices in front of the Board, and outlines procedures during AIA trials. The recent update incorporates the Board’s current practices and changes in applicable regulations.
Before Prost, Wallach, and Hughes. Appeal from the Trademark Trial and Appeal Board.
Summary: TTAB did not abuse its discretion by (1) refusing to consider factual assertions made in a brief, where no evidence was introduced supporting the assertions, and (2) refusing to consider a procedurally improper reply brief.
Before Reyna, Taranto, and Chen. Appeal from the Patent Trial and Appeal Board.
Summary: The Board must consider arguments in an IPR petitioner’s reply, where the arguments expressly follow from the petition, do not rely on new references or rationales, and are necessary to address an issue that arose after institution.
Before Dyk, Reyna, and Stoll. Appeal from the Patent Trial and Appeal Board.
Summary: A two-dimensional drawing of a three-dimensional object may meet the enablement and definiteness requirements for a design patent.
Before Lourie, Dyk, and Taranto. Appeal from the Patent Trial and Appeal Board.
Summary: The section 315(b) time-bar for IPRs applies even when the underlying complaint alleging infringement has been voluntarily dismissed without prejudice.
Research supporting the role of the microbiome in human, animal, and plant health continues to grow at a staggering rate. While the wave of new health technologies emerging from this research rises, companies working in the microbiome space have had to confront a number of unique, interlinked technical, intellectual property, and regulatory issues that threaten to derail this extraordinarily promising area of development.
