I am excited to announce the publication of the Intellectual Property Owner (IPO)’s white paper on “Software and Medical Device Guidance: A Global Perspective.”

The paper was authored by the IPO’s Software and Medical Device Subcommittee, which I had the honor and pleasure of leading in 2022. The Subcommittee reports to the IPO’s Software Committee. Continue Reading Announcing IPO white paper on a Global Perspective on Software and Medical Device Guidance 

PatentNext Summary: The life sciences and healthcare fields produce big data, which Artificial Intelligence (AI) tools can use to train AI models to assist doctors, patients, researchers, and other stakeholders in various ways. In the intellectual property (IP) space, there has been explosive growth in this area, with AI-based patent filings addressing trending areas, including disease identification and diagnosis, drug discovery, personalized medicine, and clinical trials, among others. These trends are expected to continue though challenges remain, such as the balance between the need for health-related data to train AI models and privacy and ethical concerns in using such data.Continue Reading The Intersection of Artificial Intelligence (AI), Life Sciences, Healthcare, and Intellectual Property (IP)

PatentNext Summary: Artificial Intelligence (AI) typically involves certain common aspects such as training data and AI models trained from that training data. Nonetheless, a recent Patent Trial and Appeal Board (PTAB) decision found that it is not always obvious to combine these common aspects to render an AI-based medical device invention unpatentable.Continue Reading PTAB finds Artificial Intelligence (AI) Medical Device Patent not so Obvious

PatentNext Summary: Software-based medical devices that focus on “data processing” can be patented. However, a patent practitioner should exercise care when drafting such claims. Otherwise, patent eligibility issues can arise. This article demonstrates countervailing Federal Circuit decisions that reached opposite patent eligibility conclusions for a pair of “data processing” medical device patents asserted by Cardionet, LLC against Infobionic, Inc.

The below article provides additional details. This article forms the second part of a multi-part series. The first part, focusing on patent-eligible software-based medical devices (i.e., “particular machines” and those having “underlying improvements”), may be found here: Patenting Software-based Medical Devices (Part 1).Continue Reading Patenting Software-based Medical Devices (Part 2)

PatentNext Summary: The development of modern medical devices increasingly includes the use of software for performing sophisticated diagnostic or treatment-related functions. In fact, the U.S. Food and Drug Administration (FDA) now defines specific categories of software-based medical devices that include “Software as a Medical Device (SaMD)” and “Software in a Medical Device (SiMD).” In a similar way, courts review patents directed to software-based medical devices across several categories, which include inventions having “particular machines” (e.g., SiMD) and inventions purely involving software only (e.g., SaMD).

Continue Reading Patenting Software-based Medical Devices (Part 1)