By Clark A.D. Wilson, Senior Counsel, Merchant & Gould
Most medical device and diagnostics innovation is based largely on some understanding of the fundamental laws of nature with respect to biology. However, while most medical device patents describe tangible products or diagnostic methods, laws of nature, natural phenomena, and abstract ideas are not patentable. This guideline, examined by the U.S. Supreme Court in three recent patent cases — Mayo Collaborative Services v. Prometheus Laboratories, Inc.,1 Association for Molecular Pathology v. Myriad Genetics, Inc.,2 and Alice Corporation Pty, Ltd. v. CLS Bank International et al.3 — has led to widespread and ongoing discussion among the patent community.
Between the short period of June 19, 2014 (i.e., publication date of the Alice opinion) and Jan. 13, 2015, courts have applied the above reasoning to invalidate more than 70 percent of previously granted patent claims that were raised for review in litigation.4 Invalidation activity has been equally heavy-handed through the U.S. Patent and Trademark Office’s (USPTO) new inter partes review procedure, used for subsequent consideration of issued patent claims based on newly identified information. The general consensus is that these percentages are so high because the low-hanging fruit (i.e., the most obviously invalid) claimed inventions were questioned first. A recent drop in the volume of new actions filed to question patent validity, based on the above reasoning, certainly supports the hypothesis that the bad patents were culled and the good ones have survived. As with many aspects of law, only time will tell.
The good news for medical device and diagnostics innovators is that the vast majority, if not nearly all, of the claimed inventions that have been questioned and invalidated so far were directed to business and software applications. Nevertheless, medical device and diagnostics patent owners and innovators need to understand the law to refine and clarify their strategies for intellectual property (IP) protection going forward. With this in mind, actions by the courts and USPTO in response to the above cases have provided some level of predictability and instruction for those continuing to innovate in the medical device and diagnostics space.
As a result, they are worthy of further analysis.
The law specifically states that “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”5 The last part of this language broadly introduces the concept of exceptions to what is patentable. Previously discussed patent exceptions have included a new mineral discovered in the earth, a new plant discovered in the wild, Einstein’s theory of relativity, and Newton’s theory of gravity. More specifically, the U.S. Supreme Court has explained that “phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.”6 Restricting these concepts from patent protection, it is hypothesized, ensures continued innovation by keeping the building blocks of science open and available for all.
However, the U.S. Supreme Court has recognized that “while a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure (or process) created with the aid of the knowledge of scientific truth may be.”7 Specifically, in the Alice Corp. opinion, the court explained that patent law distinguishes between the “building blocks of human ingenuity and those that integrate the building blocks into something more.” Accordingly, the U.S Supreme Court, and then the USPTO,8 compiled years of discussion on the subject and presented a somewhat structured roadmap for determining whether an invention claimed in a patent or patent application is eligible subject matter under patent law. Subsequently, U.S. patent attorneys, patent examiners, and courts alike have adopted and applied this new structure. While the wrinkles still are being ironed out of this new regime, it remains the current standard for patentable subject matter eligibility and warrants explanation.
The first step suggested in the eligibility analysis is a review of the claimed invention to determine if it is directed to a “statutory category” (i.e., process, machine, article of manufacture, or composition of matter), because abstract ideas are not patentable. The USPTO has explained that “directed to” means that the concept is recited in a patent claim. If the claimed invention is not directed to one of those statutory categories, then it is not patentable and the analysis is over. Fortunately, if the patent is drafted correctly, most medical device and diagnostics inventions qualify as a process, a machine, an article of manufacture, or a composition of matter. For example, a patent-eligible process could be a method to monitor blood sugar levels using a wearable device. An example machine could be a stent, while an example article of manufacture could be a spinal implant. An example composition of matter could be a polymer for making contact lenses.
However, even if a claimed invention is directed to one of these statutory categories, further review may determine that it also is directed to one of the patent ineligible concepts. In such cases, further analysis is needed to determine if there is an inventive concept that transforms the invention into “something significantly more” than a patent on the ineligible concept itself. Essentially, each claimed element is considered individually and as an ordered combination to search for such an inventive concept. There is no black-and-white formula for what qualifies as “something significantly more,” but to transform an unpatentable exception into a patent-eligible invention, more is required than simply “applying” this exception. Some examples of “something significantly more” include improving another technology or technical field; application to a particular machine; transforming an article to a different state or thing; or adding a limitation that is not well understood, routine, and conventional in the field.
Each claimed invention will have its own elements, thus requiring individual consideration on a case-by-case basis. Although few patents for medical device and diagnostics technology have been formally questioned in the courts or by the USPTO, there are some cases involving similar technology that offer valuable analysis.
In PerkinElmer, Inc. v. Intema Limited,9 the U.S. Court of Appeals for the Federal Circuit — the federal court created to decide patent-related cases — considered patents for analytical screening methods to estimate the risk of fetal Down’s syndrome, using markers from both the first and second trimesters of pregnancy to determine the risk. For example, one of the patent’s claims required two “measuring” steps: a screening marker from the first trimester of pregnancy is observed, then a marker from the second trimester is observed. The patent application explained that the risk of Down’s syndrome is calculated by comparing both screening marker measurements with known statistical information. An additional claim in the patent included a third step, in between the two “measuring” steps, in which the risk of Down’s syndrome is calculated based on the first measurement. The second measurement would be taken only if this first risk was below a predetermined level. In each claim, no action beyond the comparison was required.
The PerkinElmer court concluded that the claims, while reciting a statutory process, were directed to the abstract idea of a mental process comparing data that has been gathered. The relationship between the screening marker levels and the risk of fetal Down’s syndrome also was determined to be directed to a law of nature because “an increased risk of Down’s syndrome producing certain analytical results is a natural process, an eternal truth that exists in principle apart from any human action.”
Having determined that these claims were directed to abstract ideas and laws of nature, the PerkinElmer court then evaluated whether the claimed steps added “something significantly more” to make then patent eligible. The court explained that the “measuring” steps simply instructed users to measure the screening markers through whatever known method they desired. Such purely conventional or obvious presolution activity was deemed insufficient to make these steps patent eligible. Regarding the “determining” step, the PerkinElmer court similarly reasoned that the statistical information was well-understood and conventional, and not the product of any new method for calculating or determining risk. For these reasons, the court concluded that the patent completed its steps through “conventional and obvious extra-solution activity that cannot save the claims.”
From this example, it is clear that this patent may have been patent-eligible if any one of the steps in the process was not well-known, routine, or conventional. Thus, medical device and diagnostics innovators should achieve patent eligibility by developing new and previously unknown ways of completing steps.
In another case, the USPTO applied reasoning and analysis from PerkinElmer to conclude that a claimed invention10 describing a method to rapidly determine the milk production capacity of a nursing mother was not patentable subject matter. This claimed invention specifically recited “administering an expression protocol to a mother comprising predicted amounts that the interval of expression can be extended without compromising the volume of milk produced, wherein said volume of milk produced is determined based on an average yield of milk per pumping session.”
The USPTO reasoned that “while human action (measuring and calculating the amount of milk expressed in several pumping sessions) is required to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action.” Specifically, mammary tissue produces milk through entirely intrinsic and natural processes. Since the “administering” step simply informed a woman of optimal intervals at which to pump milk, and such time interval determination already was well-known prior to the patent application, the USPTO concluded that the patent claim did no more than tell a doctor to explain natural law to nursing mothers. As a result, this claimed invention was not deemed patent-eligible.
However, this patent application had a second patent claim, also detailing a method to determine the milk production capacity of a nursing mother, and this latter claim was deemed patent eligible. The steps in this second patent claim described “measuring, via a breastpump, the volume of milk produced in the last three pumping sessions” and “administering, via a breastpump, an expression protocol.” As a result, although it is clear that this second claim was directed to a law of nature (i.e., milk production), it offered “something significantly more” (i.e., use of a breastpump) to make it patent eligible. Thus, including something tangible (e.g., a machine) into a diagnostic process that otherwise is directed to an abstract idea or a law of nature may add enough to make it patent eligible.
Finally, even when a tangible machine is being described, a claimed invention’s patent eligibility may be undermined by the language used to describe it. The USPTO considered a patent application11 that described a catheter (i.e., a machine) with “an embryo in the distal portion.” Importantly, the catheter design itself was deemed patent eligible. But, the USPTO explained that the claim positively recited a combination of the catheter and the embryo, which is a naturally occurring and patent-ineligible part of the human body. Even though the patent claim included the catheter, the USPTO explained that “simply pairing in combination patent-ineligible subject matter with patent-eligible subject matter” does not make the overall claim patentable. The USPTO suggested that the claim might have been patent-eligible had it recited that the distal portion of the catheter is “adapted to receive/hold an embryo.” This example language does not positively claim the embryo, thus it does not seek to protect something that is naturally occurring.
Accordingly, while medical devices and diagnostics have not been widely questioned for patent eligibility, it still is important to view new innovation through the lens of the above discussion. Take care to consider whether a new innovation, or an existing patent, would survive such analysis. If the innovation is likely directed to one of the exceptions described above, consider how to add a limitation that offers something significantly more to the patent claim.
About The Author
Clark A.D. Wilson is a patent attorney and senior counsel in the Atlanta office of the intellectual property (IP) law firm Merchant & Gould, PC. He also is the current chair of the IP Section of the Atlanta Bar Association. For over a decade, Wilson’s practice has involved patent application preparation and prosecution, new invention analysis, freedom-to-operate and non-infringement analysis, and licensing. Much of Wilson’s experience has involved working with medical device innovators, from multinational corporations to entrepreneurs. In fact, prior to his present firm, Wilson worked as a corporate patent attorney for a market-leading medical device manufacturer.
In addition to law school, Wilson holds a master’s degree in bioengineering from the University of Maryland. He is board certified in IP law by the Florida Bar Association and is 10/10 rated by the Avvo attorney rating service. Since 2013, Wilson has been named a “Rising Star” in IP by Georgia SuperLawyers. Wilson has been a guest lecturer at the Georgia Tech Master of Biomedical Innovation and Design program, and is a frequent speaker at national medical device IP conferences. He can be contacted at email@example.com.