The healthcare IT market, comprising electronic medical records, diagnostic systems and medical devices, is expected to top $100 billion this year. But this growth is tempered by an often hostile landscape for patenting, especially surrounding patent eligibility under Section 101 of the United States Patent Act.
Navigating these rules means treading a precarious path, where the difference separating a successful claim strategy from one doomed to failure may only be a few small steps. US Supreme Court decisions have raised substantial uncertainty around whether certain inventions are abstract ideas, laws of nature, or natural phenomenon, or contain sufficient additional elements to be patent eligible. Three recent Federal Circuit decisions, along with new updates from the USPTO, offer guidance on which steps to take in patenting healthcare IT-related inventions.
Rapid Litigation Management v. CellzDirect. The patent at issue claims a method of preparing frozen liver cells that can be thawed and re-frozen while remaining viable. The lower court found the patent essentially claimed the “natural law” that some such cells can survive multiple freeze-thaw cycles. The Federal Circuit disagreed, holding that the claimed process was not an “abstract mental process,” but instead a production method: “[The inventors] employed their natural discovery to create a new and improved way of preserving [liver cells] for later use.”
The court’s willingness to accept methods of producing materials leveraging natural phenomena as patent eligible may signal relief for healthcare companies looking for ways to monetize intellectual property. For example, a diagnostic device may be patentable if it collects samples in a unique way or retains them for an unusual period of time.
BASCOM Global Internet Services, Inc. v. AT&T Mobility LLC. The Federal Circuit held that software designed to filter Internet content is eligible for patent protection when the patent disclosed computerized solutions to specific problems in the art. The court acknowledged that filtering content is itself an abstract idea. However, the claims at issue do not “preempt all ways of filtering content on the Internet; rather, they recite a specific, discrete implementation of the abstract idea of filtering content.” The court held that “…an inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.” Thus, combinations of known elements that solve existing problems in the art may become patent eligible even when the individual steps involved are not, offering a path forward to patenting for applications of known IT to the healthcare context. For example, a system that reads data from connected devices to drive clinical decisions may be patentable if the manner in which the data is analyzed or displayed is sufficiently unconventional.
Enfish v. Microsoft Corporation. Enfish’s patents on a “self-referential” database were held invalid by a trial court as being directed to the abstract idea of "organizing information using tabular formats." The Federal Circuit disagreed, holding the claims are patent eligible because they are focused on a “specific improvement to the way computers operate.” The court carefully noted that the claims were not directed to all databases, but only an “improvement over existing databases because it increased flexibility, led to faster search times, and required less memory.”
Enfish suggests that narrowly drawn claims are more likely to pass patent eligibility muster than broader ones, sound advice for patenting algorithm-intensive inventions in the healthcare field. For example, a database which provides population-based data to guide wellness-enhancing activities may be patentable if the combination of analytical steps are narrowly drawn to particular steps leading to definable outcomes.
USPTO provides direction
In an updated publication called “Guidance to Patent Examiners” issued in May 2016, the USPTO overviews its test for patent eligibility. For more details, visit this page.
Steps to patentability
The recent Federal Circuit decisions and USPTO guidance suggest that inventions relating to abstract ideas, laws of nature, and natural phenomena may become patent eligible if applied in narrowly defined real-world terms, especially involving combinations of elements (subject to other patent laws requiring inventions to be novel and non-obvious) which lead to below-referenced outcomes or results. For healthcare technologies such as electronic medical records, diagnostic systems and medical devices, steps to patentability may include:
- For natural materials, approaches which alter their properties in an unexpected fashion
- For algorithms, defining multiple sets of data which, in combination, lead to an unexpected or unusual result and
- In general, tightly focusing patent claims on particular steps which lead to specific practical outcomes.