Serena Nath is an IPilogue Writer and a 2L JD candidate at Osgoode Hall Law School.
Controversy and uncertainty in the field of patent eligibility have resulted in decade-long fights over what can be patented and what cannot be, especially regarding diagnostic tests. There is currently a congressional push to let drug companies patent diagnostic tests in the United States. This push comes from Senator Thom Tills. On August 2, 2022, Senator Tills introduced Bill S.4734, titled the Patent Eligibility Restoration Act of 2022, which, in part, aims to change currently existing US federal patent law regarding patent eligibility for different classes of inventions.
History of Patenting Diagnostic Methods
The bill was largely motivated by several Supreme Court rulings over the past decade, which have created exceptions to patent eligibility in biotechnology and pharmaceuticals. Traditionally, an inventor can gain patent protection for their invention if it is novel, non-obvious, and has utility. However, in 2012, the court in Mayo Collaborative Clinics v Prometheus (2012) ruled that diagnostic tests that reflect naturally occurring biological phenomena cannot be patented because one cannot have a monopoly on a relationship based on natural principles. This ruling was then reaffirmed later in 2013. This exception in the eligibility of diagnostic tests led to widespread confusion regarding patent eligibility. In particular, the chief judge of the US’s top patent court, Kimberly A. Moore, has commented saying that Federal Circuit judges are now unsure of how to apply the patent eligibility provision. Additionally, these exceptions have led to patents being rejected in the United States but approved in other jurisdictions with similar patent laws, such as Europe, thus discouraging biotech companies from investing in diagnostic methods. In response, Bill S.4734 is being presented to address this confusion and increase innovation in the United States via more specific patent eligibility standards that are likely to expand the ability to patent modified genes and pharmaceutical processes, including diagnostic methods.
The Debate over S. 4734
This proposed bill has drawn much debate. On the one hand, many groups, such as the American Civil Liberties Union, have expressed concern that this bill will allow pharmaceutical companies to take advantage of this expanded patent eligibility by creating monopolies over essential diagnostic methods resulting in decreased access to these methods and overall harm to the health of Americans. However, other groups, such as the Council of Innovation Promotion, argue that the bill will increase investment into diagnostic research, which decreased significantly after the Mayo decision. These groups point to the pharmaceutical industry’s response to COVID-19, arguing that patents were the basis for creating the vaccines.
If the bill can clarify patent eligibility in the US, it may be worth pursuing further. However, I also question the idea that patent eligibility is the driving force behind biotech innovation. The Invention-Induced Theory, argued by proponents for S.4734, posits that patents are an incentive for inventors and that absent patents, there will be no inventions. However, this theory fails to account for inventions induced by the market, scientific curiosity, accident, or ego. Additionally, studies have shown that patents are not a significant driver of most innovations. Thus, there may be a better way to both reward biotech companies for their creation of diagnostic methods and prevent harmful monopolies over essential lifesaving inventions.
Regardless of which side of this debate you fall on, it is still being determined if S. 4734 will be further explored. When this bill was introduced in August 2022, the Tillis planned to hold hearings focused on this legislation if the Republicans took the senate in the November midterm elections. However, with the Democrats retaining control of the senate, the future of this matter remains uncertain.
I was curious about how Canada has treated this issue and it seems that we follow a similar logic. The CIPO posted examples of patented subject matter analysis (https://ised-isde.canada.ca/site/canadian-intellectual-property-office/en/patents/patent-notices/examples-patentable-subject-matter-analysis) which is mainly centered around computer-implemented inventions but also includes this example related to diagnostic tests:
A method of diagnosing whether a human subject is at risk for developing cancer, comprising:
a. ([measuring the level of X in a biological sample] vs [receiving a report summarizing the level of X in a
sample]) from the subject; and
b. comparing said level to the level of a non-cancerous reference sample, wherein an increase in the level of
X relative to said reference indicates the subject is at risk for cancer.
CIPO indicates that a patent measuring the level of X is patentable while a process that takes as an input the measurement of X is not patentable, on the grounds that in the latter (unpatentable) claim the “data about the level of X is not provided by an element that physically measures the level. Instead, data about the level of X is provided by an element involving receiving a report summarizing the subject’s level of X…In order to be found patentable, the actual invention must have physical existence or manifest a discernible physical effect or change.”
I can see why this would lead to confusion. Hopefully it gets clarified a bit – if not from this bill, then as we figure out how to deal with other non-physical inventions. I also agree that the role of patents in the biotech space might be overstated – there seems to be plenty of motivation in the innovation sector to develop these types of technologies already and introducing patent protection might end up as more of a hindrance for the start-up/mid-size innovators.