Steele v. Collins

Plain English (For Everyone)

A new patent cannot be granted for a method of treating a disease using a drug if the method is based solely on discovering a natural link between a bodily marker and the disease. The court ruled that simply knowing this link and using an existing drug for treatment isn't enough to invent something new and patentable. This means companies can't patent basic medical discoveries that use existing treatments.

For Legal Practitioners

The Federal Circuit affirmed the district court's finding of patent ineligibility under 35 U.S.C. § 101 for a method claim. The court held the claim was directed to a natural phenomenon (biomarker correlation) and an abstract idea (medical treatment). Crucially, the court found no inventive concept sufficient to transform the claim, as identifying the correlation and applying it to a known drug and treatment was routine and conventional, thus failing the second prong of the Alice/Mayo test.

For Law Students

In Steele v. Collins, the Federal Circuit applied the Alice/Mayo framework to find a method claim ineligible under 35 U.S.C. § 101. The claim was deemed directed to a natural phenomenon and an abstract idea. The court emphasized that merely identifying a natural correlation and applying it to a known treatment with a known drug does not constitute an 'inventive concept' sufficient to overcome the patent eligibility challenge.

Newsroom Summary

The Federal Circuit ruled that a method for treating a disease using a patented drug is not patentable if it relies on discovering a natural correlation between a biomarker and the disease. The court stated that such a discovery, combined with using existing treatments, does not represent a significant enough invention to qualify for a new patent.

Standard of Review

De novo review. The Federal Circuit reviews a district court's determination of patent eligibility under 35 U.S.C. § 101 without deference.

Procedural Posture

The Federal Circuit affirmed the district court's grant of summary judgment of patent ineligibility.

Burden of Proof

The patent applicant bears the burden of demonstrating that their claims are patent-eligible. The standard is whether the claim meets the requirements of 35 U.S.C. § 101.

Legal Tests Applied

Statutory References

Key Legal Definitions

Rule Statements

A claim is not patent-eligible if it is directed to a natural phenomenon or an abstract idea.

Identifying a correlation between a biomarker and a disease, and then applying that correlation to a known drug and a known treatment for that disease, does not transform the claim into patent-eligible subject matter.

The claims must contain an inventive concept sufficient to transform the nature of the claim into a patent-eligible application.

Remedies

Affirmed the district court's judgment of patent ineligibility.

Parties

• Federal Circuit (party)

Scenario: A researcher discovers a new correlation between a specific genetic marker and a rare disease. They then develop a method to treat this disease using an existing, already patented drug, based on this new correlation.

Your Rights: You do not have the right to patent a method of treatment that relies solely on a newly discovered natural correlation and the use of an existing drug. The patent office will likely deny such a patent application.

What To Do: Focus on developing novel treatments, new drug formulations, or unique diagnostic tools that go beyond simply identifying natural correlations and applying existing therapies.

Is it legal to patent a new method of treating a disease using an existing drug based on a newly discovered biomarker correlation?

No. The Federal Circuit in Steele v. Collins held that such claims are not patent-eligible under 35 U.S.C. § 101 because they are directed to a natural phenomenon and an abstract idea without a sufficient inventive concept.

This ruling applies to patent law in the United States.

For Biotechnology and Pharmaceutical Companies

Companies seeking to patent new uses of existing drugs based on biomarker discoveries will face significant challenges under 35 U.C.S. § 101. They must demonstrate a genuine inventive concept beyond the mere identification of a natural correlation and its application to conventional treatment.

For Medical Researchers

While discoveries of natural correlations are valuable for advancing medical understanding, they may not be patentable in themselves or as the basis for method-of-treatment claims using existing drugs. Researchers should focus on developing truly novel therapeutic approaches or diagnostic technologies.

For Patent Examiners

This ruling reinforces the need to scrutinize patent claims involving diagnostic correlations and method-of-treatment claims, particularly when they rely on natural phenomena and existing therapies. Examiners should look for a clear inventive concept that transforms the claim beyond the ineligible subject matter.

Q: What is Steele v. Collins about?

Steele v. Collins is a case decided by Federal Circuit on May 1, 2025.

Q: What court decided Steele v. Collins?

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

Q: When was Steele v. Collins decided?

Steele v. Collins was decided on May 1, 2025.

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

The citation for Steele v. Collins is 135 F.4th 1353. Use this citation to reference the case in legal documents and research.

Q: What was the main issue in Steele v. Collins?

The main issue was whether a method claim for treating a disease using a drug was patent-eligible under 35 U.S.C. § 101, specifically when the method relied on a newly discovered correlation between a biomarker and the disease.

Q: What was the specific biomarker and disease in Steele v. Collins?

The opinion does not specify the exact biomarker or disease, but it concerned a method claim related to treating a disease using a drug that was already patented for other uses, based on a newly identified correlation.

Q: Is Steele v. Collins published?

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

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

The court ruled in favor of the defendant in Steele v. Collins. Key holdings: The court held that a method claim directed to identifying a correlation between a biomarker and a disease, and then using that correlation to determine a course of treatment, is not patent-eligible under 35 U.S.C. § 101.; The court reasoned that the claim was directed to a natural phenomenon (the biomarker-disease correlation) and an abstract idea (medical treatment), which are exceptions to patent eligibility.; The court found that the claimed method did not add an 'inventive concept' sufficient to transform the claim into patent-eligible subject matter, as it merely involved identifying the correlation and applying a known treatment.; The court distinguished this case from others where claims involving diagnostic methods were found patent-eligible, emphasizing that the 'inventive concept' must be more than just the application of a natural law or abstract idea.; The court affirmed the district court's dismissal of the complaint, concluding that the patent claims were invalid as a matter of law for failing to meet the patent eligibility requirements of § 101..

Q: Why is Steele v. Collins important?

Steele v. Collins has an impact score of 75/100, indicating significant legal impact. This decision further clarifies the application of the Alice/Mayo framework for patent eligibility, particularly concerning diagnostic and method-of-treatment claims based on natural phenomena like biomarker correlations. It signals continued scrutiny of such claims and emphasizes the need for an inventive concept beyond the mere identification and application of natural laws or abstract ideas, impacting the pharmaceutical and biotechnology industries.

Q: What precedent does Steele v. Collins set?

Steele v. Collins established the following key holdings: (1) The court held that a method claim directed to identifying a correlation between a biomarker and a disease, and then using that correlation to determine a course of treatment, is not patent-eligible under 35 U.S.C. § 101. (2) The court reasoned that the claim was directed to a natural phenomenon (the biomarker-disease correlation) and an abstract idea (medical treatment), which are exceptions to patent eligibility. (3) The court found that the claimed method did not add an 'inventive concept' sufficient to transform the claim into patent-eligible subject matter, as it merely involved identifying the correlation and applying a known treatment. (4) The court distinguished this case from others where claims involving diagnostic methods were found patent-eligible, emphasizing that the 'inventive concept' must be more than just the application of a natural law or abstract idea. (5) The court affirmed the district court's dismissal of the complaint, concluding that the patent claims were invalid as a matter of law for failing to meet the patent eligibility requirements of § 101.

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

1. The court held that a method claim directed to identifying a correlation between a biomarker and a disease, and then using that correlation to determine a course of treatment, is not patent-eligible under 35 U.S.C. § 101. 2. The court reasoned that the claim was directed to a natural phenomenon (the biomarker-disease correlation) and an abstract idea (medical treatment), which are exceptions to patent eligibility. 3. The court found that the claimed method did not add an 'inventive concept' sufficient to transform the claim into patent-eligible subject matter, as it merely involved identifying the correlation and applying a known treatment. 4. The court distinguished this case from others where claims involving diagnostic methods were found patent-eligible, emphasizing that the 'inventive concept' must be more than just the application of a natural law or abstract idea. 5. The court affirmed the district court's dismissal of the complaint, concluding that the patent claims were invalid as a matter of law for failing to meet the patent eligibility requirements of § 101.

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

Precedent cases cited or related to Steele v. Collins: Alice Corp. v. CLS Bank Int'l, 573 U.S. 208 (2014); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 301 (2012).

Q: What is 35 U.S.C. § 101?

35 U.S.C. § 101 defines what subject matter is eligible for patent protection in the United States. It generally covers processes, machines, manufactures, and compositions of matter, but courts have established exceptions for abstract ideas, laws of nature, and natural phenomena.

Q: Did the court find the claims in Steele v. Collins patent-eligible?

No, the Federal Circuit affirmed the district court's decision that the claims were not patent-eligible. The court found they were directed to a natural phenomenon and an abstract idea without a sufficient inventive concept.

Q: What is a 'natural phenomenon' in patent law?

A natural phenomenon is something that exists in nature and is not the product of human invention. In this case, the court identified the correlation between a biomarker and a disease as a natural phenomenon.

Q: What is an 'abstract idea' in patent law?

An abstract idea is a fundamental concept or method of operation that is not tied to a particular machine or transformation. Medical treatment, especially when based on a natural correlation, can be considered an abstract idea.

Q: What is an 'inventive concept'?

An inventive concept is an additional element or combination of elements in a patent claim that transforms an otherwise ineligible concept (like a law of nature or abstract idea) into patent-eligible subject matter. It requires more than just stating the ineligible concept and applying it to a conventional activity.

Q: What is the Alice/Mayo test?

The Alice/Mayo test is a two-step judicial framework used to determine if a patent claim is directed to patent-ineligible subject matter like abstract ideas, laws of nature, or natural phenomena.

Q: Does this mean biomarker discoveries can never be patented?

Not necessarily. While the *correlation* itself might be a natural phenomenon, a claim directed to a novel diagnostic *tool* or a truly *inventive* method of using that correlation might be patent-eligible if it meets the § 101 requirements.

Q: What is the 'burden of proof' for patent eligibility?

The patent applicant bears the burden of demonstrating that their claims are patent-eligible. They must show that the claims meet the requirements of 35 U.S.C. § 101.

Q: What happens if a patent claim is found ineligible?

If a patent claim is found ineligible under 35 U.S.C. § 101, it cannot be granted by the patent office, or if already granted, it can be invalidated by a court. It means the invention described in that claim is not eligible for patent protection.

Q: How does Steele v. Collins affect me?

This decision further clarifies the application of the Alice/Mayo framework for patent eligibility, particularly concerning diagnostic and method-of-treatment claims based on natural phenomena like biomarker correlations. It signals continued scrutiny of such claims and emphasizes the need for an inventive concept beyond the mere identification and application of natural laws or abstract ideas, impacting the pharmaceutical and biotechnology industries. As a decision from a federal appellate court, its reach is national. This case is moderate in legal complexity to understand.

Q: Can I patent a new way to use an old drug if I discover a new biomarker for the disease it treats?

Likely not, according to Steele v. Collins. If the method simply involves identifying the biomarker correlation and applying the old drug in a conventional way, it's probably not patent-eligible because it lacks an inventive concept.

Q: How does this ruling affect drug development?

It makes it harder to patent new uses of existing drugs based solely on biomarker discoveries. Companies need to show a more significant inventive step beyond just identifying a natural correlation.

Q: What are the practical implications for patent applicants?

Applicants must carefully draft claims to demonstrate an inventive concept that transforms the claim beyond merely identifying a natural phenomenon or abstract idea. Simply applying a known solution to a known problem is insufficient.

Q: Could a patent be granted for a new drug discovered through biomarker research?

Yes, a patent could likely be granted for a *new drug* (a composition of matter) discovered through biomarker research, as that would be a human-made invention. The issue in Steele v. Collins was about patenting the *method* of treatment using an *existing* drug.

Q: How can I ensure my patent claim is eligible?

Consult with a patent attorney to draft claims that clearly articulate an inventive concept, integrate ineligible concepts into a practical application, or claim novel technological components rather than just natural laws or abstract ideas.

Q: Are there any historical cases related to this ruling?

Yes, this ruling builds upon previous Supreme Court decisions like Alice Corp. v. CLS Bank International and Mayo Collaborative Services v. Prometheus Laboratories, Inc., which established the framework for analyzing patent eligibility of abstract ideas and natural laws.

Q: What is the significance of the Federal Circuit's decision?

The Federal Circuit's decision reinforces the strict interpretation of patent eligibility under § 101, particularly for diagnostic and method-of-treatment claims that rely heavily on natural phenomena or abstract ideas.

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

The docket number for Steele v. Collins is 23-2049. This identifier is used to track the case through the court system.

Q: Can Steele 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: What does 'affirmed' mean in this context?

'Affirmed' means the appellate court (the Federal Circuit) agreed with and upheld the decision made by the lower court (the district court). The district court's ruling that the patent claim was ineligible was confirmed.

Q: What is the standard of review for patent eligibility?

The Federal Circuit reviews a district court's determination of patent eligibility under 35 U.S.C. § 101 de novo, meaning they examine the issue fresh without giving deference to the lower court's decision.