Citation- Mayo Collaborative Services v Prometheus Laboratories, Inc. 566 U.S. 66 (2012)

Court– Supreme Court of the United States

Date of decision– March 20, 2012

Judges– J. Roberts, J. Scalia, J. Kennedy, J. Thomas, J. Ginsburg, J. Breyer, J. Alita, J. Sotomayor, and J. Kagan

Introduction

It is a landmark judgment in the history of determining patentability of an invention. Justice Stephen J. Breyer gave the unanimous verdict by 9-0 in favour of the petitioner, Mayo clinic. This case reaffirmed the criteria of examination of the claims of patent eligibility, particularly in the scientific and medical domain.

Facts

Prometheus Laboratories (the respondent) held exclusive patent rights related to the diagnostic test that determines the dose of thiopurine drugs to treat autoimmune diseases like Crohn’s disease. The claimed patents were concerned with levels of metabolites present in a patient’s blood and the dosage required by the patient for the drug to be effective. Mayo (the petitioner) bought these diagnostic test kits and used them for some time. Later in 2004, they declared their own diagnostic tests with slightly higher levels of metabolites. Prometheus filed a patent infringement suit against them in the District Court.

The District Court delivered the judgment in favour of Mayo, stating that the patents are claiming exclusive rights over a natural phenomenon, that is, the connection between the metabolite levels of thiopurine drug and efficiency or inefficiency of the dosage. Hence, tests/processes were not eligible to be granted patent. 

The US Court of Appeals for the Federal Circuit reversed the judgment of the District Court. They found the processes to be patentable because the processes have specified steps and they passed the “machine or transformation test”’ of the Federal Circuit. 

Mayo then filed a petition for certiorari. The petition was granted by the SC and the judgment was remanded for reconsideration before the Federal Circuit in light of Bilski case. However, they maintained their decision. Mayo filed a petition for certiorari again, which was granted by the SC.

Issues

1. Whether adding a conventional step such as “administering a drug,” to the statements of the natural correlations is enough to allow the patent claims to qualify as patent-eligible processes under 35 U.S.C. section 101?

Judgment

The US Supreme Court reversed the decision of the Federal circuit. The SC unanimously held that the Prometheus’ process of diagnostic test is not eligible for patent under section 101 as it essentially claims only the existing laws of nature. Consequently, the patent claims were declared invalid.

Reasoning

Section 101 of the Patent Act, 35 U.S.C. discusses patentable inventions. It read as: “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 therefore, subject to the conditions and requirements of this title.”

In the present case, the court emphasized that the ‘alleged discovery’ of the correlation between levels of thiopurine metabolites in the blood of a patient and the changing efficacy of the dosage is widely known among the medical professionals and researchers. The hon’ble court argued that adding mere conventional steps in natural laws of correlations alone is not enough to make the concerned process into a patent-eligible process. The conventional steps here refer to the administration of a drug and thereafter measuring its levels, which is not an inventive concept at all. Thus, it cannot make the natural laws a patentable process. The court further supported this reasoning through the cases of Parker v. Flook and Bilski v. Kappos. 

Moreover, the SC reiterated that patent protection is a double-edged sword. On the one hand, it guarantees exclusive rights and financial rewards that promote innovation and creativity. While, on the other hand, if not carefully thought through, the same exclusivity can hinder the use of information that could lead to new inventions in the future.

Critique

There seems to be concurrence with the decision and reasoning of the Supreme Court that mere application of existing laws of nature without any inventive concept is not eligible for grant of patent. The present case effectively covers a natural law, without establishing a novel concept or application. These fundamental laws and principles are “the basic tools of scientific and technological work.” If the court grants patents to such discoveries, then it is effectively restricting the use of these patented processes, consequently endangering future innovation and discoveries.

Therefore, the court strengthened the evaluation standards by rightly excluding the mere application of natural laws and abstract ideas from patent eligibility. The decision maintained a harmony between promoting innovation and protecting use of basic principles by the public.

Impact

The instant case is critical in shaping the patent law of the US, especially when concerned with laws of nature, scientific principles, and medical inventions. The Supreme Court ruling has a broader impact in the following ways:

1. It encourages innovation and discoveries in the field of science and medicine by preventing monopolies over basic tools and principles.
2. It clarified the patentability criteria in case of laws of nature by rightfully interpreting the provision given under section 101 of the Patent Act. 
3. It established a strong judicial precedent for the future cases related to abstract ideas or such processes for determining patent eligibility.

Conclusion

To conclude, the decision in the present case protects the virtue of scientific discoveries by making sure that the laws of nature remain free from the clutches of patent monopolies. It promotes research, innovation, and development of new technology. 

References

1. Oyez, “Mayo Collaborative Services v. Prometheus Laboratories, Inc.,” available at: www.oyez.org/cases/2011/10-1150  (Last visited 30 April 2025).
2. Justia, “Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012),” available at: https://supreme.justia.com/cases/federal/us/566/66/ (Last visited 30 April 2025).
3. 437 U.S. 584 (1978).
4. Aayushi Gupta, “Patent-eligible matter after Mayo v. Prometheus case in the US,” available at: https://blog.ipleaders.in/patent-eligible-matter-mayo-v-prometheus-case-us/ (Last visited 30 April 2025).
5. 561 U.S. 593 (2010).
6. Title 35 U.S.C. § 101.