Introduction

In the landmark case Association for Molecular Pathology et al. v. Myriad Genetics, Inc. (133 S.Ct. 2107, 2013), the United States Supreme Court addressed the contentious issue of gene patenting. The case centered around Myriad Genetics' patents on the BRCA1 and BRCA2 genes, mutations of which significantly elevate the risk of breast and ovarian cancer. Petitioners, including medical professionals and advocacy groups, challenged the validity of these patents, arguing that genes are natural phenomena and thus should not be patentable under 35 U.S.C. § 101. This commentary delves into the Court's comprehensive analysis, the precedents cited, the legal reasoning employed, and the far-reaching impact of the Judgment on biotechnology and patent law.

Summary of the Judgment

The Supreme Court held that naturally occurring DNA segments, even when isolated, are not patent eligible under 35 U.S.C. § 101 because they are products of nature. However, the Court distinguished complementary DNA (cDNA), which is synthetically created in the laboratory, as patent eligible since it does not occur naturally. Consequently, while Myriad's patents on isolated BRCA1 and BRCA2 genes were invalidated, patents on cDNA were upheld. This decision affirmed the lower court's ruling in part and reversed it in part, thereby clarifying the scope of patentable genetic material.

Analysis

Precedents Cited

The Court extensively referenced several key precedents to frame its analysis:

• DIAMOND v. CHAKRABARTY (447 U.S. 303, 1980): This case established that genetically modified organisms could be patented, provided they were markedly different from their natural counterparts.
• Mayo Collaborative Services v. Prometheus Laboratories, Inc. (566 U.S. 66, 2012): This decision reinforced the principle that laws of nature, natural phenomena, and abstract ideas are not patentable, even if applied in a novel way.
• Funk Brothers Seed Co. v. Kalo Inoculant Co. (333 U.S. 127, 1948): Here, the Court held that a mere discovery of natural microorganisms without altering their characteristics did not warrant patent protection.
• J.E.M. Ag Supply, Inc. v. Pioneer Hi–Bred Int'l, Inc. (534 U.S. 124, 2001): This case dealt with the patent eligibility of plant breeds, emphasizing that patentability requires a determined invention beyond natural phenomena.

Legal Reasoning

The Court's reasoning hinged on distinguishing between naturally occurring genetic material and human-made modifications. It emphasized that merely isolating a gene does not transform it into patent-eligible subject matter, as the underlying genetic information remains a product of nature. The Court underscored that patent law aims to promote innovation without inhibiting access to fundamental tools of scientific work.

In contrast, cDNA, created by removing introns (non-coding regions) from mRNA, does not naturally occur and thus qualifies as new and useful under § 101. This synthetic alteration alters the molecule's structure, aligning it with the criteria set in DIAMOND v. CHAKRABARTY.

Impact

The Judgment has profound implications for the biotechnology industry and the broader patent landscape:

• Patent Eligibility: Clarifies that naturally occurring genes cannot be patented, limiting the scope of biotechnology patents and preventing monopolies on genetic information.
• Research and Innovation: Facilitates broader access to genetic research by removing legal barriers associated with gene patents, potentially accelerating scientific discovery and medical advancements.
• Medical Testing: Enhances competition in genetic testing services, which can lead to reduced costs and increased accessibility for patients.
• Legal Precedent: Sets a legal standard for evaluating other naturally occurring substances and their eligibility for patent protection.

Complex Concepts Simplified

35 U.S.C. § 101

This section of the United States Code defines what constitutes patent-eligible subject matter. It allows patents for new and useful inventions or discoveries but explicitly excludes laws of nature, natural phenomena, and abstract ideas.

Complementary DNA (cDNA)

cDNA is a synthetic version of DNA that differs from naturally occurring DNA by excluding introns, resulting in a molecule that is not found in nature. This alteration makes cDNA eligible for patent protection as it is considered a product of human ingenuity.

Product of Nature Exception

A legal doctrine that prohibits the patenting of natural phenomena, including naturally occurring substances, even if isolated. The rationale is to ensure that fundamental tools of scientific inquiry remain accessible to all.

Conclusion

The Supreme Court's decision in Myriad Genetics v. AMP marks a pivotal moment in patent law, particularly concerning biotechnology. By delineating the boundaries between naturally occurring genetic material and synthetically created DNA, the Court has struck a balance between fostering innovation and preventing monopolistic control over fundamental biological information. This landmark ruling not only reshapes the landscape of genetic research and medical testing but also sets a clear precedent for future cases involving the patentability of natural substances. As the biotechnology field continues to evolve, the principles established in this Judgment will serve as a foundational reference for determining the eligibility of new discoveries and inventions.