Can I Patent Biomarkers? - An Analysis of Patent Eligibility in the US, EP, and China

Biomarkers play a pivotal role in modern medicine and research, helping to detect diseases early, monitor health conditions, and personalize treatments. However, given that many biomarkers are naturally occurring, patenting them is not straightforward. Here, I will explain the patent eligibility of biomarkers across three major jurisdictions—the United States, Europe, and China—to help inventors understand the challenges and strategies for protecting these valuable inventions.

What Is a Biomarker?

A biomarker is a measurable biological characteristic, such as a gene, protein, or metabolite, that indicates the presence or progression of a disease or the body’s response to treatment. Biomarkers are central to diagnostic tests, personalized medicine, and pharmaceutical research, making them highly valuable in the life sciences industry. However, because of their connection to natural biological processes, biomarkers face unique patenting challenges, particularly in the United States.

United States: Strict Limits on Patenting Biomarkers After Mayo/Myriad

In the U.S., patent eligibility for biomarkers is governed by 35 U.S.C. 101. The Supreme Court has interpreted the language in the statute to implicitly exclude laws of nature, natural phenomena, and abstract ideas. A series of Supreme Court cases in early 2010s, particularly Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012) and Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), have severely restricted the patentability of biomarkers.

In Mayo, the Court ruled that a method for optimizing drug dosage based on metabolite levels in the blood was unpatentable because it relied on a natural correlation. This decision significantly impacted the patentability of biomarker-based diagnostic methods, particularly if they rely solely on observing a natural relationship without additional inventive steps.

The Myriad case held that naturally occurring DNA sequences, even if isolated, are not patentable. Although synthetic DNA (cDNA, if different from their original DNA) was considered patentable, the ruling limited the patenting of naturally occurring biomarkers like genes and proteins, which form the basis of many diagnostic tests.

Strategies for Patenting Biomarkers in the United States

• Focus on Technical Elements: To overcome these limitations, it’s essential to emphasize any technical or methodological steps used in detecting or analyzing the biomarker. It can be hardware, software, operation, or methodology. For example, novel devices, improved sample preparation, or new analytical methods. Sometimes, you may need to add specific steps of subsequence treatment to the diagnostic method claim to avoid a 101 rejection (Vanda v. West-ward).

• Combination of Biomarkers: If your invention involves multiple biomarkers or novel combinations, consider drafting claims that emphasize how the combination improves diagnostic accuracy or specificity. For example, diagnosis based on a multitude of digital biomarkers.

• Synthetic or Engineered Variants: If possible, highlight synthetic forms of the biomarker or engineered proteins that are not naturally occurring. For instance, cDNA sequences that are not naturally occurring were still considered eligible under Myriad. However, keep in mind that you still need to show novelty and non-obviousness of these variants.

EPO: Different Approach to Biomarker Patentability

The European Patent Office (EPO) allows for broader patent eligibility for biomarkers than the U.S., although certain restrictions apply. Under the European Patent Convention (EPC), biomarker patents are assessed based on novelty, inventive step, and industrial applicability rather than patentable subject matter restrictions.

One advantage in the EPO is that, unlike in the U.S., isolated biomarkers can be patented in Europe if they are “isolated from their natural environment” and if their use or application is novel and inventive. You can also draft claims linking the biomarker to a specific, practical use, such as a treatment regimen or disease monitoring protocol.

It should be noted that the EPO typically does not allow claims directed to diagnostic methods performed on the human body for public policy reason. However, the EPO historically interpreted the statute narrowly. Therefore, in vitro diagnoses (IVD) are generally patentable in the EPO. If the biomarker detection process involves technical steps that do not diagnose a disease directly but provide important information for further testing or analysis, it can also be patentable.

Strategies for Patenting Biomarkers in Europe

• Patent the Biomarker with a Specific Use: the EPO often looks for technical effects of the claimed invention , therefore it is important to emphasize a practical application for the biomarker, such as using it to monitor disease progression or assess treatment efficacy.

• Technical Claims: In addition to the biomarker itself, you should also have claims directed to the technical parts of the diagnosis such as reagents or devices involved in the detection of the biomarker to have additional layers of protection.

• Alternative Method Claims: As noted earlier, methods aimed directly at diagnosing within the human body are not patentable under EPO guidelines. However, there are strategies to draft claims that circumvent this restriction. Consider crafting these alternative method claims to safeguard your diagnostic innovations.

• Diagnostic Kit: if the biomarker will be commercialized as a kit with other reagents, you should also consider pursuing diagnostic kit claims. Diagnostic kit claims are claims that relate to a combination of components sold as a kit or package. A kit claim can be an extreme valuable assets sometimes.

China: A Similar Approach to the EPO

In China, like the EPO, the China National Intellectual Property Administration (CNIPA) considers biomarkers patentable, provided they meet the requirements for novelty, inventiveness, and practical applicability.

Similar to the EPO, CNIPA allows patenting biomarkers if they are part of a technical solution with a specific purpose, that is, industrial applicability. However, according to Chinese Patent Law, Article 25.3, diagnostic methods that directly diagnose diseases are not patentable. However, instruments or apparatus for implementing diagnostic methods, or substances or materials used in the diagnosis, are patentable subject matter (the Guidelines for Patent Examination, Part II, Chapter 1, Section 4.3).

The strategy for patenting biomarkers in China is similar to the EPO as mentioned above.

In summary, due to the different standards of patent eligibility for the biomarkers used in diagnostics, the claims as well as the disclosure of the invention in the patent application should be tailored to meet the unique requirements for each jurisdiction. For example, pursuing narrow claims with certain limitations to overcome the 35 U.S.C. 101 hurdle in the United States while purusing broad claims in other jurisdictions such as Europe and China.