Case Summary
**Case Summary: Mayo Foundation v. Iancu**
**Docket Number:** 15427014
**Court:** United States Court of Appeals for the Federal Circuit
**Decided:** 2019
**Background:**
Mayo Foundation for Medical Education and Research, along with other associated parties, was involved in a legal dispute with Andrei Iancu, the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO). The case revolved around the patentability of certain diagnostic methods related to personalized medicine, particularly concerning how the assessments of these methods aligned with statutory eligibility criteria under U.S. patent law.
**Legal Issues:**
The key issue before the court was whether the claims made by Mayo Foundation in its patent application were eligible for patent protection under 35 U.S.C. § 101. This section outlines what constitutes a patentable invention and specifies that laws of nature, natural phenomena, and abstract ideas are not patentable.
**Arguments:**
Mayo Foundation argued that their inventions provided significant advancements in medical diagnostics and should be granted patent protection. They contended that their claims did more than simply apply a law of nature—they involved specific and practical applications in the field of medicine.
On the other hand, Iancu and the USPTO maintained that the claims were grounded in natural laws and that the methods were not sufficiently transformative to qualify as patentable inventions. They emphasized that simply discovering a natural relationship should not lead to patent eligibility.
**Court Ruling:**
The Federal Circuit ruled in favor of Iancu, affirming the USPTO’s rejection of Mayo's patent claims. The court found that the claims at issue were directed to a law of nature and did not contain the necessary additional inventive concept to make them eligible for patent protection under the established legal standards following the Supreme Court’s decision in *Mayo Collaborative Services v. Prometheus Laboratories, Inc.*
**Impact:**
This decision reinforced the principles established in prior case law regarding the limitations on patentability of methods that rely on natural correlations. It had significant implications for patent law related to biotechnological and medical diagnostics, highlighting the challenges faced by inventors in this field when seeking to obtain patent protection for innovations that leverage natural laws.
**Conclusion:**
Mayo Foundation v. Iancu serves as a critical reference in the ongoing dialogue surrounding the intersection of patent law and biomedical innovation. The case underscored the importance of demonstrating a sufficient inventive step beyond merely applying scientific principles to achieve patent eligibility. This ruling may influence future patent applications and the strategies employed by organizations in the biomedical sector.