Personalized medicine is especially intriguing, as a problem with most drugs are the potential side effects. From a naive perspective, administering drugs may appear to be a trial and error process: take this for two weeks and come back with a follow up visit. If you have any side effects, contact me immediately. Wouldn't it be nice if a drug had the effect it was meant to have without the possibility of side effects?
The technology of artificial intelligence (AI) has taken off over the past 10 years, due to a combination of the growth of data and storage space in the Internet (Cloud), and rapid development in computer hardware that can handle large AI models. The faster CPUs, as well as algorithms being adopted to run on graphics processing units (GPUs), have all come together.
Due to this expanding usage of AI in products and services, it would seem that personalized medicine would be included in that mix. A recent report by WIPO showed that life sciences and medicine are among the highest growth areas for Generative AI (report: WIPO: Patent Landscape Report - Generative Artificial Intelligence (GenAI) 2023).
The multi-disciplinary nature of computer-related inventions for molecular biology can face issues from both worlds. Section 101 issues are prevalent in both disciplines and Section 112 disclosure issues are important considerations especially in the chemical art.
Personalized medicine falls under this multi-disciplinary situation. Legal issues of patenting in personalized medicine are discussed in an article, Anusuya Das, “PATENTABILITY CHALLENGES IN PERSONALIZED MEDICINE: A FORK IN THE ROAD,” Indiana Law Review, 2023.
Patentability issues of molecular biology struggle with diagnostics vs. therapeutics. The Supreme Court invalidated a patent for a method of optimizing a drug-based treatment by measuring serum drug metabolite level in a patient in Mayo Collaborative Services v. Prometheus Laboratories, Inc. In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, the invention was based on the discovery that certain genetic differences could indicate if a patient was an effective metabolizer of iloperidone, a drug used to treat schizophrenia. The court reasoned that the main difference between Mayo and Vanda was that the claim in Mayo was not directed to a particular disease treatment.
A recent case of Athena Diagnostics, Inc. v. Mayo Collaborative Services addressed an issue of whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter, when the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed. The Federal Circuit Court held that claiming a natural cause of an ailment and well-known means of observing it is not eligible for patenting because such a claim in effect only encompasses the natural law itself.
Subsequently, firms have a great incentive to increase their emphasis on combination products that pair a diagnostic with a device or drug, or both. These incentives are likely to be skewed towards those diagnostics that enhance profits on therapeutics. The following are a couple of examples where the claims avoid diagnostics as a main inventive concept.
US Patent Publication 2023/0115171 is for drug discovery and recites,
“A system for generating customizable molecular structures for drug discovery, wherein the system comprises a processor communicably coupled to a memory, the processor configured to execute: a deep neural network based molecular encoding model, wherein the processor receives input datasets of drug-like molecules from private and public databases…”
US Patent Publication 2019/0043610 particularly relates to personalized medicine, and recites,
“A computer-implemented method for providing an individual with a personal therapeutic treatment plan for treating a disorder, delay, or impairment…”
Regarding section 112 issues, the Supreme Court has held that a claim that included an entire genus of antibodies that perform specific functions was not enabled by the identification of 26 exemplary antibodies that perform the functions.
Personalized medicine involves creating treatments and drugs based on an individual's genetic, environmental, and lifestyle factors. Subsequently, although personalized medicine weighs heavily on genetics, other factors of an individual have an impact on personalized medicine.
The ability to generate insights and patterns from vast quantities of patient data may spark more personalized treatments. Subsequently, artificial intelligence may provide insights for patentability of personalized medicine.
In the case of patenting of artificial intelligence, the specification should describe the types of data that can be used to train the neural network, and in particular describe the input features. The input features should be specific, not generic data types. For example, if the patient's age is an essential input feature, the description should not broadly indicate that the input may be patient information.
Given the patentable aspects of artificial intelligence, it may be possible to obtain patent protection for a medical diagnosis without relying solely on naturally occurring genetic information. Claims to this multi-disciplinary technology can alleviate being characterized as a natural law and/or an abstract idea.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
