Golden v. Collins

Plain English (For Everyone)

Imagine discovering a natural link between a specific gene and a disease, like finding out a certain type of tree always grows near a particular mineral. This case says you can't patent that discovery itself, just like you can't patent the natural fact that the tree grows there. You'd need to invent a new way to *use* that discovery, like a special tool to find the mineral, to get a patent.

For Legal Practitioners

The Federal Circuit affirmed the patent ineligibility of diagnostic method claims under § 101, finding them directed to a natural phenomenon (correlation between gene and disease) without significantly more. This reinforces the strict application of the Mayo/Alice framework to diagnostic methods, emphasizing that claims must involve more than just observing a natural correlation to be patent-eligible. Practitioners should focus on inventive applications or significantly modified processes, rather than mere diagnostic observations, to navigate § 101 challenges.

For Law Students

This case tests the patent eligibility of diagnostic methods under 35 U.S.C. § 101, specifically applying the Mayo/Alice framework to natural phenomena. The court found the claims directed to the natural correlation between a genetic mutation and a disease, which is an abstract idea/law of nature. The key issue is whether the claims add 'significantly more' to transform the discovery into a patent-eligible application, highlighting the difficulty in patenting diagnostic methods based solely on natural correlations.

Newsroom Summary

The Federal Circuit ruled that a method for diagnosing a disease by identifying a genetic mutation cannot be patented because it claims a natural phenomenon. This decision impacts companies seeking to patent diagnostic tests based on natural biological discoveries, potentially limiting innovation in personalized medicine.

Constitutional Issues

Whether the patent claim is directed to patent-ineligible subject matter under 35 U.S.C. § 101.

Rule Statements

A claim drawn to an abstract idea is not patent-eligible under § 101 unless it recites additional elements that amount to significantly more than the abstract idea itself.

Claims directed to the abstract idea of organizing information are generally not patent-eligible under 35 U.S.C. § 101.

Scenario: You've heard about a new genetic test that can predict your risk for a certain disease by looking for a specific gene. You wonder if the company that developed the test has a patent on the underlying discovery of the gene's link to the disease.

Your Rights: You have the right to access diagnostic tests that are based on scientific discoveries, even if those discoveries themselves are not patented. Companies can patent the specific *methods* or *technologies* they develop to perform the test, but not the natural correlation itself.

What To Do: If you are considering a genetic test, ask the provider about the technology used and whether it is based on a patented process or a publicly available discovery. Consult with a healthcare professional to understand the implications of the test results.

Is it legal to patent a diagnostic method that identifies a natural correlation between a gene and a disease?

Generally no, if the method merely claims the natural correlation itself. Under current U.S. patent law, discoveries of natural phenomena, including correlations between genes and diseases, are not patent-eligible. To be patentable, the method must include significantly more, such as an inventive application or a significantly modified process, that transforms the discovery into a practical invention.

This applies in the United States, as interpreted by the U.S. Court of Appeals for the Federal Circuit.

For Biotechnology and Pharmaceutical Companies

Companies developing diagnostic tests based on natural biological discoveries face increased challenges in obtaining patent protection for the core diagnostic correlation. They must focus on patenting novel applications, specific technological implementations, or significantly improved processes rather than the underlying natural phenomenon.

For Healthcare Providers and Patients

This ruling may lead to broader accessibility of diagnostic tests based on natural discoveries, as companies cannot monopolize the fundamental correlation. However, it could also disincentivize investment in developing new diagnostic methods if the core discovery cannot be protected.

Q: What is Golden v. Collins about?

Golden v. Collins is a case decided by Federal Circuit on December 12, 2025.

Q: What court decided Golden v. Collins?

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

Q: When was Golden v. Collins decided?

Golden v. Collins was decided on December 12, 2025.

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

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

Q: What is the case name and what was the main issue in Golden v. Collins?

The case is Golden v. Collins, decided by the U.S. Court of Appeals for the Federal Circuit (CAFC). The central issue was whether a diagnostic method for identifying a specific genetic mutation linked to a disease was patent-eligible under 35 U.S.C. § 101.

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

The parties were Golden, the patent applicant seeking to patent the diagnostic method, and Collins, likely representing the U.S. Patent and Trademark Office (USPTO) or an opposing party challenging the patent's validity, as the case involved a review of patent eligibility.

Q: Which court decided the Golden v. Collins case, and what was its ruling?

The U.S. Court of Appeals for the Federal Circuit (CAFC) decided Golden v. Collins. The CAFC affirmed the district court's decision, granting summary judgment against the patentability of the diagnostic method claims.

Q: What specific type of invention was at issue in Golden v. Collins?

The invention at issue was a diagnostic method designed to identify a specific genetic mutation that is associated with a particular disease. This involved analyzing genetic sequences.

Q: What is the primary legal statute governing patent eligibility that was central to the Golden v. Collins decision?

The primary statute was 35 U.S.C. § 101, which defines what subject matter is eligible for patent protection. The court's analysis focused on whether the diagnostic method fell within the exceptions to patent eligibility, such as natural phenomena.

Q: Is Golden v. Collins published?

Golden 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 Golden v. Collins cover?

Golden v. Collins covers the following legal topics: Patent eligibility under 35 U.S.C. § 101, Abstract idea exception to patentability, Alice/Mayo two-step framework, Patentable subject matter, Diagnostic methods.

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

The court ruled in favor of the defendant in Golden v. Collins. Key holdings: The court held that diagnostic method claims directed to a correlation between a gene sequence and a disease are not patent-eligible under 35 U.S.C. § 101 because they claim a natural phenomenon.; The court reasoned that the claims were directed to the natural phenomenon itself, rather than a specific application or transformation of that phenomenon.; The court found that the claims did not include significantly more than the natural phenomenon to render them patent-eligible, such as a specific diagnostic technique or a method of treatment.; The court applied the two-part Mayo/Alice test, first determining if the claims were directed to a patent-ineligible concept (natural phenomenon) and then assessing whether the claims contained an 'inventive concept' sufficient to transform the abstract idea into a patent-eligible application.; The court affirmed the district court's grant of summary judgment of ineligibility, finding no genuine dispute of material fact regarding the patentability of the claims..

Q: Why is Golden v. Collins important?

Golden v. Collins has an impact score of 65/100, indicating significant legal impact. This decision further clarifies the application of the Mayo/Alice test to diagnostic methods, emphasizing that claims directed to natural phenomena, even if useful, are generally ineligible for patent protection unless they include a significant inventive concept beyond the mere discovery. It signals continued judicial scrutiny of patents in the life sciences that are based on natural correlations.

Q: What precedent does Golden v. Collins set?

Golden v. Collins established the following key holdings: (1) The court held that diagnostic method claims directed to a correlation between a gene sequence and a disease are not patent-eligible under 35 U.S.C. § 101 because they claim a natural phenomenon. (2) The court reasoned that the claims were directed to the natural phenomenon itself, rather than a specific application or transformation of that phenomenon. (3) The court found that the claims did not include significantly more than the natural phenomenon to render them patent-eligible, such as a specific diagnostic technique or a method of treatment. (4) The court applied the two-part Mayo/Alice test, first determining if the claims were directed to a patent-ineligible concept (natural phenomenon) and then assessing whether the claims contained an 'inventive concept' sufficient to transform the abstract idea into a patent-eligible application. (5) The court affirmed the district court's grant of summary judgment of ineligibility, finding no genuine dispute of material fact regarding the patentability of the claims.

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

1. The court held that diagnostic method claims directed to a correlation between a gene sequence and a disease are not patent-eligible under 35 U.S.C. § 101 because they claim a natural phenomenon. 2. The court reasoned that the claims were directed to the natural phenomenon itself, rather than a specific application or transformation of that phenomenon. 3. The court found that the claims did not include significantly more than the natural phenomenon to render them patent-eligible, such as a specific diagnostic technique or a method of treatment. 4. The court applied the two-part Mayo/Alice test, first determining if the claims were directed to a patent-ineligible concept (natural phenomenon) and then assessing whether the claims contained an 'inventive concept' sufficient to transform the abstract idea into a patent-eligible application. 5. The court affirmed the district court's grant of summary judgment of ineligibility, finding no genuine dispute of material fact regarding the patentability of the claims.

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

Precedent cases cited or related to Golden v. Collins: Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012); Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014).

Q: What was the CAFC's main holding regarding the patent eligibility of the diagnostic method in Golden v. Collins?

The CAFC held that the method claims were not patent-eligible under 35 U.S.C. § 101. The court concluded that the claims were directed to a natural phenomenon – the correlation between a gene sequence and a disease.

Q: What legal test did the CAFC apply to determine patent eligibility in Golden v. Collins?

The court applied the two-step test established in Mayo Collaborative Services v. Prometheus Laboratories, Inc. First, it determined if the claims were directed to a patent-ineligible concept (like a natural phenomenon). Second, it assessed whether the claims contained significantly more than the ineligible concept to transform the discovery into a patent-eligible application.

Q: Why did the CAFC consider the diagnostic method in Golden v. Collins to be a 'natural phenomenon'?

The court reasoned that the claims were essentially claiming the natural correlation between a specific gene sequence and a disease. This correlation exists in nature and was discovered, not invented, by the patent applicant.

Q: What does the CAFC mean by 'significantly more' in the context of patent eligibility, as discussed in Golden v. Collins?

In Golden v. Collins, 'significantly more' refers to additional elements in the patent claim that transform the natural phenomenon into a patent-eligible application. The court found that the claims did not include such transformative elements beyond simply identifying the natural correlation.

Q: Did the Golden v. Collins decision involve the interpretation of any specific statutes beyond 35 U.S.C. § 101?

While 35 U.S.C. § 101 was the central focus, the court's analysis implicitly involved the interpretation of what constitutes an 'invention' or 'discovery' under patent law, particularly in the context of diagnostic methods and natural laws.

Q: What was the burden of proof for patent eligibility in Golden v. Collins?

The burden of proof for establishing patent eligibility generally rests with the patent applicant. In this case, Golden had to demonstrate that their diagnostic method claims were not solely directed to a natural phenomenon and contained significantly more.

Q: How did the CAFC's reasoning in Golden v. Collins relate to previous Supreme Court decisions on patent eligibility?

The CAFC's reasoning directly followed the framework set by the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which established the two-step test for patent eligibility concerning natural phenomena, laws of nature, and abstract ideas.

Q: What is the significance of the CAFC affirming the district court's decision in Golden v. Collins?

The affirmation means the Federal Circuit agreed with the district court's legal reasoning that the diagnostic method claims were not patent-eligible. This strengthens the precedent that claims directed solely to natural correlations between genes and diseases are likely invalid under 35 U.S.C. § 101.

Q: How does Golden v. Collins affect me?

This decision further clarifies the application of the Mayo/Alice test to diagnostic methods, emphasizing that claims directed to natural phenomena, even if useful, are generally ineligible for patent protection unless they include a significant inventive concept beyond the mere discovery. It signals continued judicial scrutiny of patents in the life sciences that are based on natural correlations. 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 Golden v. Collins decision for diagnostic method patents?

The decision reinforces that diagnostic methods claiming natural correlations between genes and diseases are likely unpatentable under § 101. This could make it harder for companies to obtain patents on new diagnostic tests based solely on identifying such natural relationships.

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

The ruling primarily affects entities seeking to patent diagnostic methods, particularly those involving genetic testing and the identification of disease correlations. It also impacts healthcare providers and patients who rely on diagnostic tests.

Q: Does Golden v. Collins change how diagnostic tests can be developed or marketed?

While it doesn't prevent the development or marketing of diagnostic tests, it significantly impacts the ability to patent them if they are based solely on discovering a natural correlation. Developers may need to focus on claims that include specific diagnostic techniques or treatment recommendations.

Q: What compliance considerations arise from the Golden v. Collins decision for patent applicants?

Patent applicants must carefully draft their claims to ensure they are not merely claiming a natural phenomenon. They need to demonstrate how their claimed method involves significantly more than the natural discovery, such as specific inventive steps or applications.

Q: How might the Golden v. Collins decision impact innovation in personalized medicine?

It could potentially stifle innovation if companies are discouraged from investing in discovering genetic correlations due to patentability concerns. However, it might also encourage innovation in developing novel diagnostic tools and treatment protocols that go beyond simply identifying the correlation.

Q: What was the legal landscape regarding patent eligibility for diagnostic methods before Golden v. Collins?

Before Golden v. Collins, the patent eligibility of diagnostic methods was already a contentious area, heavily influenced by Supreme Court decisions like Mayo and Alice Corp. v. CLS Bank International, which narrowed the scope of patentable subject matter for claims involving natural laws and abstract ideas.

Q: How does Golden v. Collins fit into the broader history of patent law concerning natural discoveries?

This case continues a long-standing legal tradition of distinguishing between patentable inventions and unpatentable discoveries of natural phenomena or laws of nature. It reflects the ongoing judicial effort to balance incentivizing innovation with preventing the monopolization of fundamental scientific truths.

Q: Can Golden v. Collins be compared to other landmark cases on patent eligibility?

Yes, Golden v. Collins is directly comparable to Mayo Collaborative Services v. Prometheus Laboratories, Inc., as it applies the Mayo framework. It also aligns with the principles established in Alice Corp. v. CLS Bank International regarding abstract ideas and natural phenomena.

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

The docket number for Golden v. Collins is 23-2070. This identifier is used to track the case through the court system.

Q: Can Golden 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 in Golden v. Collins?

The case likely reached the Federal Circuit on appeal from a district court's decision. The district court had granted summary judgment, finding the patent claims ineligible, and the patent applicant appealed this ruling to the CAFC.

Q: What procedural posture led to the CAFC's review in Golden v. Collins?

The procedural posture was an appeal from a grant of summary judgment. Summary judgment is typically granted when there are no genuine disputes of material fact and the moving party is entitled to judgment as a matter of law, in this case, regarding patent eligibility.

Q: Were there any specific evidentiary issues discussed in the Golden v. Collins opinion?

While the opinion focused on the legal question of patent eligibility, the underlying summary judgment motion would have considered the evidence presented by both parties regarding the nature of the claims and the diagnostic method. However, the CAFC's decision hinged on the legal interpretation of the claims themselves.

Q: What does a grant of summary judgment mean in a patent case like Golden v. Collins?

A grant of summary judgment means the court decided the case, or a specific issue within it, without a full trial. In Golden v. Collins, the district court ruled as a matter of law that the patent claims were not eligible, and the CAFC affirmed that legal conclusion.