Often those with terminal illnesses wish to try new experimental therapies. Now they can if they are willing to accept the risks. On May 30, 2018, President Trump signed into law the Right to Try Act.[1] The Act allows eligible patients to receive drugs that are not FDA-approved but have passed phase I clinical trials. For a patient to be eligible, he or she must be diagnosed with a life-threatening disease or condition, exhausted all other treatment options including being unable to participate in a clinical trial, and give informed consent.
The ITC has issued a series of new rules applying to all Section 337 investigations instituted after June 7, 2018. Although the overall impact of these new rules is not yet known, attorneys will find the following four changes of particular interest.
On June 1, 2018 the U.S. Patent and Trademark Office designated a Board order in Western Digital Corporation v. SPEX Technologies, Inc. as informative on the issue of Motions to Amend during an IPR. At the same time, the USPTO de-designated two previously designated orders concerning Motions to Amend. The Western Digital order provides eight separate areas of guidance for the parties in the event the patent owner elects to file a Motion to Amend. Some of the information may be familiar to IPR practitioners because of overlap with the de-designated orders, but the Western Digital order importantly incorporates new guidance from recent cases and Board practice. Thus, IPR litigants should be aware of several important practice changes reflected in the order.
The market for medical device connectivity is projected to reach about $2.6 billion by the year 2023, according to a report published in April 2018 by several publishers. The report states that the connectivity market for 2018 is expected to be about $940 million. This equates to a compound annual growth rate (CAGR) from 2018 to 2023 of 23.2%
Before Prost, Newman, Mayer, Lourie, Dyk, Moore, O’Malley, Reyna, Wallach, Taranto, Chen, Hughes, and Stoll. Petition for panel rehearing and rehearing en banc.
On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the FDA, this is the first approved artificial iris. The approval was granted to Clinical Research Consultants, Inc., and the device is marketed and developed by HumanOptics AG.
Before PROST, Wallach, and Taranto. Appeal from the Southern District of Indiana.
Summary: In determining whether a party’s actions were “exceptional” under Octane Fitness, the District Court properly considered the totality of the evidence, including clear notice of the prevailing party’s invalidity position and litigation conduct.
Before Taranto, Plager, and Chen. Appeal from the Patent Trials and Appeals Board.
Summary: In determining whether materials distributed at meetings or conferences are reasonably accessible to the public, the Board must consider numerous factors, not just the exclusive nature and expertise of a group.
Until the cloning of Dolly the sheep in 1996 by scientists at the Roslin Institute, the idea of cloning a mammal, let alone a human being, was an idea relegated…
Cyberdyne, a Japan-based robotics technology company, recently announced its collaboration with Brooks Rehabilitation and the Brooks Cybernic Treatment Center to bring its Hybrid Assistive Limb (HAL®) exoskeleton to the U.S. market.
