The article surveys twenty years’ worth of motion to dismiss decisions in federal securities class actions brought against clinical-stage biotech companies and concludes that, contrary to conventional wisdom, these cases are dismissed more often than securities cases brought against other types of companies. The authors discuss their methodology and findings, identify relevant trends, and offer tips to help biotech companies and their insurers avoid and successfully defend against securities suits.
In this decision, the First Circuit denies the federal government's emergency request to stay a district court preliminary injunction blocking implementation of the new 340B Rebate Model Pilot Program. That program would have allowed participating drug manufacturers to stop giving safety-net hospitals the traditional upfront 340B discount on certain drugs and instead charge wholesale prices first, with the hospitals receiving rebates later. The hospitals argued that this abrupt shift threatened severe financial harm and violated the Administrative Procedure Act (APA). The First Circuit held that the government had not made the "strong showing" required for a stay pending appeal, especially on the likelihood of success on the merits. The court agreed with the district court that the administrative record previewed by the government was remarkably thin and did not show that the agency had seriously considered the hospitals' substantial reliance interests in the longstanding upfront-discount regime. Because agencies changing established policy must account for serious reliance interests and other important aspects of the problem, the apparent failure to do so strongly supported the hospitals' APA challenge. The court also rejected the government's effort to rely on a declaration from a federal official to supply reasons for the program after the fact. It treated that declaration as an impermissible post hoc rationalization rather than a permissible elaboration of reasons already found in the record. On irreparable harm, the court emphasized evidence that many safety-net hospitals had minimal cash reserves and could face major losses, service cuts, or even closure under the rebate model. Because the injunction merely preserved the decades-old status quo and the government itself showed little irreparable harm from delay, the stay was denied.
Functional features play a crucial role in securing robust patent protection for antibody inventions and have been the focus of extensive case law from the European Patent Office’s Technical Boards of Appeal. This article analyzes key patterns and emerging trends within this case law, explores their application in examination practice, and provides a comparative perspective on recent jurisprudence from the Unified Patent Court. A particular focus is on the EPO’s concerning shift towards demanding structural predictability in the context of functional features.
In this decision, the Federal Circuit reverses a district court ruling that had held REGENXBIO's asserted patent claims ineligible under 35 U.S.C. & sect; 101 as directed to a patent ineligible natural phenomenon. The patent concerned cultured host cells containing a recombinant nucleic acid molecule encoding an adeno-associated virus (AAV) capsid protein sequence together with a heterologous non-AAV sequence. REGENXBIO accused Sarepta of infringing through its use of AAV-based technology in a Duchenne muscular dystrophy gene therapy product. The district court had concluded that the claims merely combined natural products and therefore resembled the unpatentable mixture in Funk Brothers. The Federal Circuit disagreed, framing the core question under Chakrabarty and Myria as whether the claimed composition had markedly different characteristics from anything found in nature and possessed the potential for significant utility. It emphasized that the claimed host cells were undisputedly human-made and could not exist in nature because they required a recombinant nucleic acid molecule created through human intervention by splicing genetic material from different sources. That feature made the claims more like the genetically engineered bacterium in Chakrabarty and the cDNA in Myriad than the natural products at issue in Funk Brothers, Myriad's isolated DNA claims, or ChromaDex. The Federal Circuit rejected the district court's focus on whether the individual natural components had themselves been altered. The proper inquiry, it said, was whether the claimed composition as a whole was nonnatural. Because the claimed host cells contained a recombinant molecule that was itself markedly different from anything occurring in nature, the claims were not directed to a natural phenomenon. Having resolved the case at step one of the Alice/Mayo framework, the court deemed it unnecessary to reach step two and remanded for further proceedings.
In this decision, the Federal Circuit reverses a district court's judgment as a matter of law, holding Teva's asserted headache-treatment claims invalid for lack of written description and enablement under 35 U.S.C. & sect; 112. The patent claims methods of treating headache by administering a humanized anti-Calcitonin Gene-Related Peptide (CGRP) antagonist antibody. A jury had found that Lilly willfully infringed and failed to prove invalidity, but the district court set that verdict aside. The Federal Circuit reinstated the jury's position. The court emphasized that, on review of judgment as a matter of law, it had to view the evidence in the light most favorable to the jury's verdict and determine only whether a reasonable jury could have rejected Lilly's invalidity case. It concluded that substantial evidence supported findings that anti-CGRP antagonist antibodies were already well known in the prior art, methods for making them were known, and antibody humanization was routine by the patent's 2006 priority date. The specification disclosed one humanized antibody, several murine antibodies, and prior-art humanization methods. Just as important, the record supported the view that a skilled artisan would understand that all humanized anti-CGRP antagonist antibodies would work for the claimed purpose of treating headache. Relying on precedent distinguishing claims to a known genus used in a different invention from claims to the genus itself, the court held that the patents were not claiming the antibodies as such, but their use in a treatment method. That distinction also defeated Lilly's enablement challenge. Unlike cases such as Amgen and Idenix, the claims did not require Teva to enable the entire universe of antibodies as compositions; the relevant invention was the treatment method.
Non-invasive brain-computer interfaces are rapidly integrating into daily life in a consumer-oriented form, withthe focus of risks shifting from physiological safety to mental integrity. The low entry threshold brought by non-invasiveness has enabled the generalization of neural monitoring on a large scale, the weakening of signals hasled to algorithmic dependence, and continuous monitoring due to daily wear has transformed the risk form fromone-time exposure to persistent infiltration. During the entire data lifecycle, the collection phase faces thedilemma of the validity of informed consent, the processing phase harbors risks of algorithmic black boxes andcognitive manipulation, and the circulation phase encounters structural tensions of purpose evasion. To addressthese challenges, on one hand, legal regulations must establish exclusive control rights for individuals over neu-ral data and prohibit the commercial utilization of cognitive states. On the other hand, a regulatory system cen-tered on dual-layer protection of collection and inference must be constructed, and differentiated rules must beset for scenarios such as education, workplace, and judiciary to safeguard the bottom line of mental integrity,which is the fundamental aspect of being human.
The rapid advancement of artificial intelligence (AI) has enabled machines to autonomously generate technical solutions, thereby challenging the foundational assumptions of patent law. In this context, can AI-generated inventions be protected by patent law? There is a great controversy in the global academic community about this issue. One side advocates for protection, while the other opposes. There are two main reasons for the above controversy. First, scholars have different opinions on the subject of who completed the AI-generated inventions: Is it a person or a machine that completed such invention? Second, there is controversy over whether AI-generated inventions need to be incentivized. In the face of these controversies, it should be noted that humans play a core role in the creation of AI-generated inventions, and there is a need for incentives for AI-generated inventions. Therefore, it should be affirmed that AI-generated inventions can be protected by patent law. However, this does not mean that all AI-generated inventions can be protected by patent law: only when sufficient human intervention requirements are met can the invention be protected.
The processing of digital medical data (DMD) raises significant legal and ethical challenges. The rapid development of artificial Intelligence (AI) has tremendously influenced the processing of DMD. However, AI may also give rise to concerns about patient privacy breaches and data security risks. China emphasizes the legal and ethical considerations for processing DMD. In this article, we focus upon the parameters of DMD in the context of China's legal framework and identify related applications of DMD. We explore the legal issues involving processing DMD in China: (1) individual control right/informed consent, (2) institutional obligations, (3) security impact assessment, and (4) secondary use compliance. We also find ethical issues involving processing DMD in China, involving (1) group bias and other data flaws and (2) privacy risks. Building on the above analysis, we propose legal and ethical "toolboxes" for regulating processing DMD in China. In the legal toolbox, there are four tools, including (1) optimizing individual permit and authorization, (2) creating three types of obligations, (3) promoting responsible and explainable security impact assessment, and (4) identifying public interest standards. In the ethical toolbox, there are two tools, including (1) paying particular attention to handling specific groups' DMD and (2) enhancing accountability of handling DMD.
