The United States District Court for the District of Delaware recently denied United Therapeutics Corporation‘s motion for a preliminary injunction. The motion sought to prevent Liquidia Technologies, Inc. from launching its YUTREPIA, which is used to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). YUTREPIA is an inhaled dry power formulation of treprostinil delivered through a palm-sized inhalation device.
BD (Becton, Dickinson and Company) has announced the acquisition of Edwards Lifesciences’ Critical Care product group for $4.2 billion. The acquisition follows Edwards’ previously announced plans to spin off Critical Care by the end of 2024 to focus on transcatheter/surgical therapies. BD has announced that the acquisition aims to enhance BD’s smart connected care solutions portfolio and advance its position in the monitoring technology sector.
On June 4, 2024, a panel of experts advising the Food and Drug Administration (FDA) on the use of the psychedelic midomafetamine (MDMA) for post-traumatic stress disorder (PTSD) voted 9-2 that MDMA in combination with talk therapy is not effective for treating PTSD, and 10-1 that the benefits of MDMA treatment do not outweigh its risks. The panel had reviewed Lykos Therapeutics ’s new drug application and associated clinical research related to treating PTSD using MDMA, also known by its street name ecstasy, in combination with talk therapy.
Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom. On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of intent for what could be a significant shift in policy: approval to market and sell medical devices based on prior approval from a comparable regulatory country (CRC). Medical devices approved under the new framework would be allowed into the UK market but would not receive the UK Conformity Assessed (UKCA) certification. Market availability would be determined based on the CRC approval.
ECOFACTOR, INC. V. GOOGLE LLC
Before Lourie, Prost, and Reyna. Appeal from the United States District Court of the Western District of Texas.
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.
In this episode of the Knobbe IP+ podcast, Knobbe Martens partner Mauricio Uribe speaks with World Intellectual Property Organization (WIPO) Legal Officer Oscar Alberto Suárez Bohorquez on the recently announced…
Speck v. Bates
Before Dyk, Bryson, and Stoll.
Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board.
Summary: Comparing pre-Section 135 bar date claims to amended post-bar date claims in an interference proceeding requires comparing the two sets of claims to determine if either set contains material limitations not found in the other—a “two-way test.”
LUCA MCDERMOTT CATENA GIFT TRUST v. FRUCTUOSO-HOBBS SL
Before Lourie, Reyna, and Chen.
Appeal from the United States Patent and Trademark Office, Trademark Trial and Appeal Board.
Summary: Parties that own minority shares in the trademark registrant, but do not separately use or possess an ownership right in the trademark, are not entitled to seek cancellation of third-party registrations based on likelihood of confusion.
Florida is more than just the home of alligators and presidential candidates. The state was recently ranked as the fourth largest “medical device state” in the U.S., after California, Minnesota, and Massachusetts. It was estimated to have the third largest “total medical technology employment, with nearly 24,000 jobs, and No. 7 in total revenue generated in the sector, with $6.09 billion.” Florida has also recently been recognized as having the nation’s “second-largest pharmaceuticals manufacturing industry” and “the fourth-largest biotech R&D industry.”
Quest Diagnostics recently announced a multi-faceted collaboration with PathAI to improve diagnoses in cancer and other diseases using AI pathology innovations.