February 16, 2021 | The intellectual property landscape for diagnostics can seem fraught with confusion. Tom Cowan, a partner at Knobbe Martens tackled some of the most common questions about IP issues that diagnostics companies are likely to face in 2021.
Cowan is a partner in the San Diego, Calif. office of Knobbe Martens and serves clients worldwide in medical, mechanical, and aerospace technologies. He counsels clients on overall IP strategy, prosecutes patents and trademarks, conducts pre-litigation enforcement of IP rights, negotiates licenses, and conducts offensive and defensive diligence such as patentability and infringement studies. He holds a master’s degree in biomedical engineering.
Cowan shared his thoughts with Diagnostics World.
What types of U.S. intellectual property (IP) protection are available for diagnostic technologies?
Tom Cowan: Diagnostic inventions may be protected in the U.S. with utility patents, which protect functional aspects of diagnostic methods and devices. Utility patent protection allows the patent owner to exclude others from using the method, or making or selling the device, for a period of 20 years.
However, given recent hurdles to patenting purely diagnostic methods, strategy will continue to be important with utility patents in 2021. Any of a variety of subject matter necessary to accomplish the diagnostic method may have a patent opportunity. For example, specialized test kits, chemical reagents, sample collection or processing technologies, or other peripheral technologies, can sometimes effectively block the competition even in the absence of patent protection on the diagnostic method per se.
Another option is trade secret protection, especially if your diagnostic is not easily reverse-engineered. Trade secrets include information having commercial value by virtue of their secrecy. Reasonable measures must be taken to keep the invention secret, such as using confidentiality agreements and security protocols.
Design patents protect the ornamental, non-functional features of your device. And trademarks protect phrases or logos that identify the source of origin of goods or services.
Can COVID-related diagnostics be legally protected in the U.S.?
Yes. The U.S. Patent & Trademark Office (USPTO) has issued utility patents in 2020 related specifically to detection of COVID. The USPTO currently shows about 30 issued patents and about 150 filed patent applications at least mentioning COVID, although not all necessarily relate to diagnostics.
However, we are yet to see how these patents hold up under judicial or administrative challenges. One concern is the “eligibility” requirement. The courts have recently applied enhanced scrutiny in this regard to diagnostic patents, which will most likely continue into 2021.
What are the benefits and risks of pursuing U.S. patent protection for diagnostics?
One big risk is, as mentioned, the enhanced judicial scrutiny of diagnostic patents regarding “eligible” subject matter. “Eligibility” is a threshold requirement, in addition to the other patentability requirements, such as novelty and non-obviousness. In the U.S., certain inventions are not eligible for patent protection, including laws of nature, natural phenomena, and abstract ideas. The exclusion against laws of nature was significantly expanded by the U.S. Supreme Court in 2012 in Mayo v. Prometheus, in which a patent related to a method of diagnosis and treatment was found ineligible and which created a serious obstacle to patenting diagnostics.
For example, the courts have since struck down patents related to determining fetal characteristics by examining paternally inherited cell-free fetal DNA in the mother’s blood, to detecting coding region alleles of a multi-allelic genetic locus, to detecting Mycobacterium tuberculosis, and to assessing risk of atherosclerotic cardiovascular disease by correlating myeloperoxidase in a patient to that of a control group. Most recently, in 2020, the courts struck down a patent related to methods for diagnosing neurotransmission or developmental disorders related to muscle-specific tyrosine kinase. So this issue is likely to continue into 2021 and beyond.
However, there is some cause for hope. The courts in 2020 also found a patent eligible that related to determining fetal characteristics based on analysis of maternal blood, where the scope of protection was directed to the preparation of samples used in the process. Further, the courts in 2020 found eligibility of a patent related to measuring a patient’s metabolic activity and providing a specific dose range of medication.
There is also potential legislative activity to watch for in 2021. A bill was proposed by two senators in 2019 to reform patent eligibility law. One co-sponsor of that bill reiterated publicly in 2020 that Congress should fix the eligibility issue regarding diagnostic methods. With the new administration, it will be interesting to see if this sentiment gains traction with other legislators.
What are the main considerations for U.S. patent strategy with diagnostics?
Three big issues include ownership, patentability, and risk of infringement. To ensure ownership, you want to make sure you have proper assignments from employees to the company, otherwise you face difficulty enforcing your patents. “Patentability” includes the eligibility issue, but it also includes ensuring your patents are new and non-obvious and provide strong, layered protection, for example with patents covering different statutory categories (processes, devices, systems, etc.). The third category relates to uncovering third-party patents that may present roadblocks to making and selling your own inventions. Keep in mind your own patents don’t give you the right to practice your invention, only the right to exclude others from doing so. So an infringement risk analysis can be very important.
At what stage of the development of a diagnostic should a company begin to think about IP protection in the U.S.?
Generally, you want to have IP counsel involved sooner rather than later. Inventorship doesn’t require a prototype, but rather only the conception of a complete and definite idea of the diagnostic method. And as soon as there is an inventor, there are ownership issues to address. Further, the U.S. is a first-to-file patent system, so filing sooner rather than later is generally recommended, especially if you plan on pursuing patent protection outside the U.S.
Can diagnostics be patented in Europe?
Yes, but with certain, specific exceptions. Generally, a method of diagnosis is not patentable in Europe if it is carried out on the human or animal body and includes all of the procedural steps for making a medical diagnosis, including data collection, data comparison to standard values, finding a standard deviation, and attribution of any deviation to a diagnosis. A method that avoids any of these steps is likely to be patent eligible.