On May 24, 2024, member states of the World Intellectual Property Organization (WIPO) adopted a new treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge that was over 20 years in the making. Genetic resources, which can include medicinal plants, agriculture crops and animal breeds, cannot themselves be claimed as intellectual property. However, inventions developed using genetic resources can be protected, usually through patents. The stated goals of the treaty include enhancing the efficacy, transparency, and quality of the patent system and preventing patents from being granted erroneously for inventions that are not novel or inventive with regard to genetic resources and traditional knowledge.
On Friday, June 21, 2024, the FDA updated its Patent Listing Dispute List to indicate that the ten pharmaceutical companies who had received warning letters from the FTC in April did not make changes to their patent listings in the FDA’s catalog in view of the warning letters.
Press releases report that Boston Scientific (BSX) has entered an agreement to acquire medical device developer Silk Road Medical in a deal totaling $1.16 billion.
AMARIN PHARMA, INC. v. HIKMA PHARMACEUTICALS USA INC.
Before Moore, Lourie, and Albright. Appeal from the United States District Court for the District of Delaware.
Summary: The totality of the complaint’s allegations must be considered when assessing whether induced patent infringement was sufficiently pleaded.
BETEIRO, LLC v. DRAFTKINGS INC
Before Dyk, Prost, and Stark. Appeal from the United States District Court for the District of New Jersey.
Summary: Recitations of a computer-implemented method can be an abstract idea and non-eligible under 35 U.S.C. § 101 if the claims recite result-focused functional language that is analogous to longstanding “real-world” activities and do not improve technology.
In this episode of the Knobbe IP+ podcast, Knobbe Martens partner Jared Bunker speaks with guest David A. Gauntlett, principal of Gauntlett & Associates, on how businesses may use insurance policies…
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.
