Introduction

The landmark Supreme Court case, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., 569 U.S. 576 (2013), addressed the critical issue of patent eligibility concerning human genes. The dispute arose when Myriad Genetics, Inc., obtained patents for the isolated BRCA1 and BRCA2 genes, mutations of which significantly increase the risk of breast and ovarian cancer. Petitioners, including researchers, doctors, and advocacy groups, challenged the validity of these patents, arguing that they encompassed naturally occurring genetic material, which should remain free from patent restrictions.

Summary of the Judgment

The U.S. Supreme Court held that naturally occurring DNA segments cannot be patented merely because they have been isolated from the human genome. However, the Court ruled that cDNA (complementary DNA), which is synthetically created and does not occur naturally, is patent eligible. Specifically, the decision invalidated Myriad's patents on isolated BRCA1 and BRCA2 genes as products of nature but upheld the patents on cDNA variants. This distinction underscores the Court's stance on the boundaries of patent law concerning natural phenomena and human ingenuity.

Analysis

Precedents Cited

The Court's decision in Myriad heavily relied on prior cases that delineate the scope of patentable subject matter:

• DIAMOND v. CHAKRABARTY, 447 U.S. 303 (1980): Recognized that genetically modified organisms are patentable because they exhibit markedly different characteristics from their natural counterparts.
• Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012): Established that applications of natural laws must include additional inventive elements to qualify for patent protection.
• Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948): Highlighted that discoveries of natural phenomena are not patentable merely through identification or isolation.

These precedents guided the Court in assessing whether Myriad's patents claimed something beyond the natural gene sequences.

Legal Reasoning

The Court applied the framework established in Mayo to determine patent eligibility under 35 U.S.C. §101. The central question was whether the patented DNA sequences were products of nature or possessed sufficient inventive characteristics to qualify as patent-eligible material.

For the naturally occurring isolated DNA, the Court concluded that merely isolating a gene does not transform it into a patentable invention. The genetic information encoded in BRCA1 and BRCA2 exists in nature, and isolating these genes does not alter their fundamental structure. Therefore, such isolated DNA segments are not eligible for patents as they are products of nature.

Conversely, cDNA is deemed patent eligible because it is not naturally occurring. cDNA is synthetically created by removing introns from a messenger RNA template, resulting in a DNA sequence that does not exist in nature. This synthetic alteration introduces enough human ingenuity to qualify cDNA for patent protection.

Impact

The Myriad decision has profound implications for the biotechnology and pharmaceutical industries. Key impacts include:

• Research and Development: By excluding naturally occurring genes from patent protection, the decision fosters open research and reduces barriers for scientists studying genetic material.
• Diagnostic Testing: Companies can develop and offer genetic tests without the risk of infringing on patents for natural genes, potentially lowering costs and increasing accessibility.
• Innovation Incentives: While the decision removes certain patent protections, it reinforces the importance of synthetic modifications and novel applications, encouraging innovation in creating new, non-naturally occurring genetic materials.
• Legal Precedent: Establishing a clear distinction between natural phenomena and human-made inventions provides a framework for future patent eligibility cases involving biological materials.

Complex Concepts Simplified

• Isolated DNA: DNA that has been separated from its natural environment in the genome. However, its sequence remains identical to how it exists in nature.
• cDNA (Complementary DNA): Synthetic DNA created from messenger RNA by removing introns, resulting in a sequence that does not naturally occur in the genome.
• Products of Nature: Natural phenomena or substances found in nature, which are not eligible for patents unless significantly altered through human intervention.
• 35 U.S.C. §101: A section of U.S. patent law that defines what constitutes patent-eligible subject matter.
• Patent Eligibility: The criteria that determine whether an invention qualifies for patent protection, focusing on novelty, non-obviousness, and usefulness.

Conclusion

The Supreme Court's ruling in Myriad Genetics v. Association for Molecular Pathology marks a pivotal moment in patent law, particularly concerning genetic material. By delineating the boundaries between naturally occurring genes and synthetically created cDNA, the decision promotes a balanced approach that protects human innovation while keeping fundamental natural phenomena in the public domain. This balance is crucial for fostering continued advancements in biotechnology and ensuring that essential genetic information remains accessible for research and medical purposes.

Moving forward, the distinction established in Myriad will guide the evaluation of future patent claims involving biological materials, emphasizing the necessity of human ingenuity in transforming natural substances into patentable inventions.