Patent eligibility for healthcare IT applications
Healthcare IT, which includes electronic medical records, diagnostic systems and medical devices, makes up a market expected to top $100 billion by 2020, according to Grandview Research. But this growth has been tempered by an often hostile environment for patenting, especially under section 101 of the US Patent Act. Decisions of the Supreme Court in Mayo (diagnostic methods), Myriad (gene sequences) and Alice (software) have raised substantial uncertainty around whether certain inventions are an “abstract idea, law of nature, or natural phenomenon” (tending not to be patentable) or if, as claimed, the invention contains additional (potentially patentable) elements.
Navigating the rules in this space is like sailing without a map, where tacking slightly in one direction can spell success, and in another, failure. Failure for patentees in navigating Alice/Mayo/Myriad was a theme in patent eligibility cases until early 2016, when the tide began to turn, with one court calling the rise in ineligibility complaints a “fad” (Verint Systems v Red Box Recorders).
The US Patent and Trademark Office (USPTO) attempted to make sense of the shifting section 101 landscape by publishing a guidance for its patent examiners in May 2016. But in the year which followed, courts including the US Court of Appeals for the Federal Circuit began to find in favour of eligibility for technologies which often appeared to differ little from those previously found ineligible.
It’s therefore difficult to determine which inventions will pass muster under section 101 based only on their technological characteristics. Instead, the devil is in the details of how the patent claims are presented, making drafting allowable claims a challenge even for experienced patent practitioners.
The ground rules for evaluating whether a particular patent claim may succeed are listed below. The more affirmative answers presented, the more likely it is that a claim will be allowed:
1. Are a clear improvement and benefit to be realised from what is recited in the claim?
2. Is the invention as defined in the claim something new and useful?
3. Does the claim define a particular solution to a problem or a particular way to achieve a desired outcome?
Factor 3 in particular has been a highlight of several recent cases. In essence, it means that a patent claim which attempts to preempt all commercially feasible ways of practising an invention is likely to be seen as extending too far into the realm of abstract ideas. Of course, blocking competition is a goal for many who pursue patents, which may make the concept of limits unpalatable. But those who ignore the precept are most likely to fail under section 101 (although it should be noted that the lack of preemption does not itself confer patent eligibility).
Case studies
The preemption risk is illustrated by two 2016 cases involving diagnostic tests. In Rapid Litigation Management v CellzDirect, the patent at issue (US # 7,604,929) claims a method of preparing frozen liver cells that can be thawed and re-frozen while remaining viable. The lower court found that the patent effectively claimed the ‘natural law’ that says 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.”
A more stringent application of the Supreme Court rulings might not only compel a different outcome, but could also threaten the value of the patent system. According to Rapid Litigation Management: “The ‘929 patent claims are like thousands of others that recite processes to achieve a desired outcome, eg, methods of producing things, or methods of treating disease. That one way of describing the process is to describe the natural ability of the subject matter to undergo the process does not make the claim ‘directed to’ that natural ability.”
“The devil is in the details of how the patent claims are presented, making drafting allowable claims a challenge even for experienced patent practitioners.”
On the other hand, the breadth of the non-invasive prenatal testing patent claims in Ariosa Diagnostics v Sequenom ran foul of section 101. The Federal Circuit noted that the claims began by reciting a natural phenomenon (the state of a particular gene) and ended with another (a change to that gene). The intervening steps claimed were merely broadly defined conventional laboratory techniques. Those were considered to be neither new nor useful (with a nod to the Mayo decision, which states that transformation into a patent-eligible application requires “more than simply stating the law of nature while adding the words ‘apply it’”).
Moreover, the breadth of the claims could preempt others from using the only commercially viable way of evaluating the genes. In that respect, the court warned that patent claims should not prevent the use of the basic building blocks of technology—abstract ideas, naturally occurring phenomena, and natural laws. As such, in contrast to the result in Rapid Litigation Management, Sequenom’s relatively broad claims in Ariosa were held to be patent-ineligible.
Defining patent claims narrowly to avoid preemption of a field that leverages abstract ideas or natural phenomena also plays a part in computer-based healthcare technologies. An improvement in computer-related technology “is not limited to improvements in the operation of a computer or a computer network per se, but may also be claimed as a set of ‘rules’ (basically mathematical relationships) that improve computer-related technology by allowing computer performance of a function not previously performable by a computer”, according to a USPTO memorandum regarding section 101 in November 2016.
What is eligible?
The Federal Circuit has held that software programs designed to filter internet content, define databases or automate tasks can be eligible for patent protection under the Supreme Court rulings (see Federal Circuit decisions Bascom Global Internet Services v AT&T Mobility, Enfish v Microsoft and McRo v Bandai Namco Games America).
For example, the court in Bascom acknowledged that filtering internet content is itself an abstract idea. However, the claims did not “preempt all ways of filtering content on the internet; rather, they recited a specific, discrete implementation of the abstract idea of filtering content”. Similarly, Enfish’s claims were patent-eligible because they focused on a “specific improvement to the way computers operate”. And the claims in McRo were drawn not to all means of identifying “phenomes” (in a facial animation program), but to specific subsequences of phenomes.
In short, “an inventive concept in the non-conventional and non-generic arrangement of known, conventional pieces” (Bascom) which are “properly claimed” (McRo), preferably provide clear improved benefits over the prior art (Enfish) and do not block others from using the only commercially viable technology(Ariosa) may become patent-eligible even when the technology involves application of known IT or methods to the healthcare context.
The trend towards finding patent eligibility for properly claimed healthcare IT applications should therefore signal relief for companies looking for ways to monetise intellectual property in the space.
Stacy Taylor is of counsel and co-chair of the medical device practice at DLA Piper. She can be contacted at: stacy.taylor@dlapiper.com
