Wright v. Collins

Plain English (For Everyone)

Imagine you discover a new way to find a disease marker in your blood. This case says you can't patent the basic discovery of that marker or how to measure it if it's a natural process. The court decided that simply detecting something natural, like a tumor marker in your blood, isn't enough to get a patent unless you add a truly inventive step beyond just the natural discovery itself.

For Legal Practitioners

The Federal Circuit affirmed PTAB's § 101 rejection, holding that claims directed to detecting and quantifying ctDNA, a natural phenomenon, were ineligible. The court found that the recited detection and quantification steps did not provide an inventive concept sufficient to transform the claim into patent-eligible subject matter. This reinforces the PTAB's stringent approach to natural phenomenon rejections and highlights the need for claims to articulate a significantly inventive application beyond merely observing or measuring a natural occurrence.

For Law Students

This case tests the boundaries of patent eligibility under 35 U.S.C. § 101, specifically concerning natural phenomena. The court found that claims directed to detecting and quantifying ctDNA, a naturally occurring substance, were ineligible because the method steps did not add an 'inventive concept.' This decision fits within the broader doctrine of patenting natural phenomena and abstract ideas, emphasizing that claims must involve significantly more than the natural phenomenon itself to be patentable.

Newsroom Summary

A federal appeals court ruled that a method for detecting cancer DNA in blood cannot be patented because it claims a natural phenomenon. This decision impacts medical researchers and companies developing diagnostic tests, potentially limiting patent protection for discoveries based on natural biological processes.

Constitutional Issues

Patent validityPatent infringement

Rule Statements

"The construction of a patent claim is a question of law, reviewed de novo."

"The specification is always highly relevant in the interpretation of claim language."

Scenario: You are a patient undergoing cancer treatment and your doctor uses a new blood test to monitor the effectiveness of your treatment by measuring naturally occurring tumor DNA. You later learn the company that developed the test is suing others for using similar methods.

Your Rights: You have the right to understand that discoveries of natural phenomena, like the presence and measurement of tumor DNA, are generally not patentable. If a company claims they have a patent on such a basic discovery, this ruling suggests it may be invalid.

What To Do: If you are involved in a dispute over such a patent, consult with an attorney specializing in intellectual property law. They can advise you on the patent's validity based on rulings like Wright v. Collins and your specific situation.

Is it legal to patent a method for detecting naturally occurring substances in the human body, like cancer markers?

It depends. While you can't patent the natural substance itself or the mere observation of it, you might be able to patent a method if it involves a significantly inventive application or technological improvement beyond simply detecting the natural phenomenon. This ruling suggests that basic detection and quantification methods of natural phenomena are likely not patent-eligible.

This ruling applies to patent law in the United States.

For Biotechnology and diagnostic test developers

Companies developing diagnostic tests based on detecting natural biological markers may face challenges in obtaining broad patent protection for their methods. They will need to ensure their claims include specific, inventive steps that go beyond merely identifying or quantifying the natural phenomenon to be patent-eligible.

For Medical researchers

Researchers may find it easier to operate without fear of infringing patents on fundamental discoveries related to natural biological processes. However, patenting their own novel diagnostic methods might require demonstrating a more significant inventive leap beyond the natural discovery.

Q: What is Wright v. Collins about?

Wright v. Collins is a case decided by Federal Circuit on October 28, 2025.

Q: What court decided Wright v. Collins?

Wright v. Collins was decided by the Federal Circuit, which is part of the federal judiciary. This is a federal appellate court.

Q: When was Wright v. Collins decided?

Wright v. Collins was decided on October 28, 2025.

Q: What is the citation for Wright v. Collins?

The citation for Wright v. Collins is . Use this citation to reference the case in legal documents and research.

Q: What is the case Wright v. Collins about?

The case Wright v. Collins, decided by the U.S. Court of Appeals for the Federal Circuit (CAFC), concerns the patentability of a method for detecting and quantifying circulating tumor DNA (ctDNA) in blood samples. The core issue was whether the claims were eligible for patent protection under 35 U.S.C. § 101, which excludes laws of nature, natural phenomena, and abstract ideas.

Q: Who were the parties involved in Wright v. Collins?

The parties in Wright v. Collins were the patent applicant, represented by Wright, and the U.S. Patent and Trademark Office (USPTO), whose decision was reviewed by the Patent Trial and Appeal Board (PTAB). The Federal Circuit reviewed the PTAB's decision regarding the patent eligibility of the claims.

Q: Which court decided Wright v. Collins?

The case Wright v. Collins was decided by the United States Court of Appeals for the Federal Circuit (CAFC). This court has exclusive jurisdiction over appeals from decisions of the U.S. Patent Trial and Appeal Board (PTAB) in patent-related matters.

Q: What was the specific invention at issue in Wright v. Collins?

The invention at issue in Wright v. Collins involved a method for detecting and quantifying circulating tumor DNA (ctDNA) in blood samples. The claims focused on the process of identifying and measuring the concentration of this naturally occurring substance found in the bloodstream.

Q: When was the Wright v. Collins decision issued?

The specific date of the Wright v. Collins decision by the Federal Circuit is not provided in the summary, but it was a review of a Patent Trial and Appeal Board (PTAB) decision concerning patent eligibility under 35 U.S.C. § 101.

Q: Is Wright v. Collins published?

Wright v. Collins is a published, precedential opinion. Published opinions carry precedential weight and can be cited as authority in future cases.

Q: What topics does Wright v. Collins cover?

Wright v. Collins covers the following legal topics: Patent law indefiniteness, Patent claim construction, Specification's role in claim interpretation, Therapeutically effective amount in patent claims, 35 U.S.C. § 112(b).

Q: What was the ruling in Wright v. Collins?

The court ruled in favor of the defendant in Wright v. Collins. Key holdings: The court held that claims directed to detecting and quantifying ctDNA are directed to a natural phenomenon, specifically the presence and concentration of ctDNA in a patient's blood.; The court reasoned that the method claims, which involve detecting and quantifying ctDNA, do not add an 'inventive concept' sufficient to transform the claim into patent-eligible subject matter under Alice/Mayo.; The court found that the recited steps of detecting and quantifying ctDNA were routine and conventional, not amounting to significantly more than the natural phenomenon itself.; The court affirmed the PTAB's determination that the claims were invalid for failing to meet the requirements of 35 U.S.C. § 101.; The court rejected the patentee's argument that the claims were directed to a practical application of the natural phenomenon, finding the application was not sufficiently inventive..

Q: Why is Wright v. Collins important?

Wright v. Collins has an impact score of 65/100, indicating significant legal impact. This decision further clarifies the application of 35 U.S.C. § 101 to diagnostic methods involving natural phenomena, particularly in the rapidly evolving field of biotechnology. It signals that claims focused on identifying natural correlations, even if clinically significant, will face significant hurdles if they do not include a sufficiently inventive step beyond the natural phenomenon itself. Researchers and companies in the diagnostics space should carefully craft their claims to focus on inventive applications rather than mere detection of natural occurrences.

Q: What precedent does Wright v. Collins set?

Wright v. Collins established the following key holdings: (1) The court held that claims directed to detecting and quantifying ctDNA are directed to a natural phenomenon, specifically the presence and concentration of ctDNA in a patient's blood. (2) The court reasoned that the method claims, which involve detecting and quantifying ctDNA, do not add an 'inventive concept' sufficient to transform the claim into patent-eligible subject matter under Alice/Mayo. (3) The court found that the recited steps of detecting and quantifying ctDNA were routine and conventional, not amounting to significantly more than the natural phenomenon itself. (4) The court affirmed the PTAB's determination that the claims were invalid for failing to meet the requirements of 35 U.S.C. § 101. (5) The court rejected the patentee's argument that the claims were directed to a practical application of the natural phenomenon, finding the application was not sufficiently inventive.

Q: What are the key holdings in Wright v. Collins?

1. The court held that claims directed to detecting and quantifying ctDNA are directed to a natural phenomenon, specifically the presence and concentration of ctDNA in a patient's blood. 2. The court reasoned that the method claims, which involve detecting and quantifying ctDNA, do not add an 'inventive concept' sufficient to transform the claim into patent-eligible subject matter under Alice/Mayo. 3. The court found that the recited steps of detecting and quantifying ctDNA were routine and conventional, not amounting to significantly more than the natural phenomenon itself. 4. The court affirmed the PTAB's determination that the claims were invalid for failing to meet the requirements of 35 U.S.C. § 101. 5. The court rejected the patentee's argument that the claims were directed to a practical application of the natural phenomenon, finding the application was not sufficiently inventive.

Q: What cases are related to Wright v. Collins?

Precedent cases cited or related to Wright v. Collins: Alice Corp. v. CLS Bank Int'l, 573 U.S. 208 (2014); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).

Q: What was the main legal question in Wright v. Collins?

The main legal question in Wright v. Collins was whether the claims directed to a method for detecting and quantifying ctDNA in blood samples were patent-eligible under 35 U.S.C. § 101. Specifically, the court had to determine if the claims were directed to a natural phenomenon or an abstract idea.

Q: What was the Federal Circuit's holding in Wright v. Collins?

The Federal Circuit held that the claims in Wright v. Collins were not patent-eligible under 35 U.S.C. § 101. The court affirmed the PTAB's decision, finding that the claims were directed to the natural phenomenon of ctDNA presence and concentration.

Q: Why did the court in Wright v. Collins find the claims unpatentable?

The court found the claims unpatentable because they were directed to a natural phenomenon – the presence and concentration of ctDNA in blood. The court determined that the recited steps of detecting and quantifying ctDNA did not add an 'inventive concept' sufficient to transform the claim into something significantly more than the natural phenomenon itself.

Q: What legal standard did the court apply in Wright v. Collins?

The court applied the two-step framework established in Alice Corp. v. CLS Bank International for analyzing patent eligibility under 35 U.S.C. § 101. This framework first asks if the claim is directed to a patent-ineligible concept (like a law of nature or abstract idea), and if so, whether the claim recites additional elements that amount to 'significantly more' than the ineligible concept.

Q: Did the court consider the detection and quantification steps to be inventive in Wright v. Collins?

No, the court in Wright v. Collins concluded that the steps of detecting and quantifying ctDNA did not add enough inventive concept to make the claims patent-eligible. These steps were seen as merely conventional or routine ways of observing the natural phenomenon, not transforming it into a patentable application.

Q: What does 35 U.S.C. § 101 state regarding patent eligibility?

35 U.S.C. § 101 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. However, the Supreme Court has interpreted this statute to exclude from patent eligibility laws of nature, natural phenomena, and abstract ideas.

Q: How does Wright v. Collins relate to the patenting of diagnostic methods?

Wright v. Collins highlights the challenges in patenting diagnostic methods that rely on detecting natural phenomena, such as biomarkers like ctDNA. The decision suggests that simply detecting or quantifying a natural substance may not be enough to confer patent eligibility if the method doesn't add a significantly inventive step beyond observing the natural phenomenon.

Q: What is 'circulating tumor DNA' (ctDNA)?

Circulating tumor DNA (ctDNA) refers to fragments of DNA that are released from tumor cells into the bloodstream. Detecting and quantifying ctDNA is a significant area of research for cancer diagnosis, monitoring treatment response, and detecting recurrence, as it can provide insights into the presence and characteristics of a tumor.

Q: What is the 'inventive concept' requirement in patent law?

The 'inventive concept' requirement, particularly relevant under the Alice/Mayo framework for § 101, refers to elements in a patent claim that transform a patent-ineligible concept (like a law of nature) into a patent-eligible application. These elements must be more than merely conventional or routine activities applied to the ineligible concept.

Q: How does Wright v. Collins affect me?

This decision further clarifies the application of 35 U.S.C. § 101 to diagnostic methods involving natural phenomena, particularly in the rapidly evolving field of biotechnology. It signals that claims focused on identifying natural correlations, even if clinically significant, will face significant hurdles if they do not include a sufficiently inventive step beyond the natural phenomenon itself. Researchers and companies in the diagnostics space should carefully craft their claims to focus on inventive applications rather than mere detection of natural occurrences. As a decision from a federal appellate court, its reach is national. This case is moderate in legal complexity to understand.

Q: What are the practical implications of the Wright v. Collins decision?

The practical implication of Wright v. Collins is that companies and researchers developing diagnostic tests based on detecting natural substances, like ctDNA, may face difficulties in obtaining patent protection for their methods. This could impact investment in and commercialization of such technologies if patent exclusivity is uncertain.

Q: Who is most affected by the Wright v. Collins ruling?

The ruling in Wright v. Collins primarily affects entities involved in developing and commercializing diagnostic tests, particularly those focused on molecular diagnostics and cancer detection. This includes biotechnology companies, diagnostic laboratories, and academic researchers seeking to patent their inventions.

Q: Does Wright v. Collins prevent all patents on diagnostic methods?

No, Wright v. Collins does not prevent all patents on diagnostic methods. The decision focuses on claims that are directed to natural phenomena without adding a sufficient inventive concept. Methods that integrate the natural phenomenon with a specific, inventive technological application or process may still be patent-eligible.

Q: What changes might companies need to make in response to Wright v. Collins?

Companies developing diagnostic tests may need to re-evaluate their patent strategies. They might focus on claiming specific technological improvements in detection or quantification, or novel applications of the detected information, rather than just the detection of the natural phenomenon itself, to satisfy the 'inventive concept' requirement.

Q: How might Wright v. Collins affect the cost or availability of diagnostic tests?

If patent protection becomes harder to obtain for certain diagnostic methods, it could potentially lead to increased competition and, in some cases, lower costs for consumers. However, it could also disincentivize innovation if companies are less willing to invest in developing new tests without the prospect of patent exclusivity.

Q: How does Wright v. Collins fit into the history of patent eligibility challenges?

Wright v. Collins is part of a long line of cases, including Mayo Collaborative Services v. Prometheus Laboratories and Alice Corp. v. CLS Bank, that have grappled with the patent eligibility of diagnostic methods and life science innovations. These cases reflect a judicial trend of scrutinizing patents that claim natural phenomena or abstract ideas.

Q: What legal precedent did the court consider in Wright v. Collins?

The court in Wright v. Collins relied heavily on the Supreme Court's decisions in Mayo Collaborative Services v. Prometheus Laboratories and Alice Corp. v. CLS Bank International. These cases established the framework for determining patent eligibility for claims involving natural phenomena and abstract ideas.

Q: How has the interpretation of 35 U.S.C. § 101 evolved regarding natural phenomena?

The interpretation of 35 U.S.C. § 101 has evolved to place significant limitations on patenting natural phenomena. Early interpretations were broader, but landmark cases like Diamond v. Chakrabarty, Diamond v. Diehr, Mayo, and Alice have progressively narrowed the scope, emphasizing that laws of nature and natural phenomena themselves are not patentable, only their practical applications.

Q: What was the docket number in Wright v. Collins?

The docket number for Wright v. Collins is 25-1502. This identifier is used to track the case through the court system.

Q: Can Wright v. Collins be appealed?

Potentially — decisions from federal appellate courts can be appealed to the Supreme Court of the United States via a petition for certiorari, though the Court accepts very few cases.

Q: How did the case reach the Federal Circuit?

The case reached the Federal Circuit through an appeal from a decision by the Patent Trial and Appeal Board (PTAB). The PTAB had determined that the patent claims were not eligible for patenting under 35 U.S.C. § 101, and the applicant, Wright, appealed this decision to the CAFC, which has jurisdiction over such patent appeals.

Q: What was the procedural posture of Wright v. Collins?

The procedural posture of Wright v. Collins was an appeal from a final decision of the Patent Trial and Appeal Board (PTAB). The PTAB had issued a decision finding the patent claims invalid for lack of patent eligibility under 35 U.S.C. § 101, and the Federal Circuit reviewed that decision.

Q: Did the Federal Circuit make any new rulings on patent law in Wright v. Collins?

While Wright v. Collins affirmed existing precedent, it applied the established Alice/Mayo framework to a specific method for detecting ctDNA. The ruling reinforces the application of the § 101 analysis to diagnostic methods involving natural phenomena, clarifying how the 'inventive concept' is assessed in such cases.