United States: Implications Of The U.S. Supreme Court’s "Myriad" Decision On Human Gene Patents And Other Biotechnology Inventions

On June 13, 2013, the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., U.S., No. 12-398¹, provided a long awaited answer to the question, "are human genes patentable?" The court unanimously held that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring."²The judgment both affirmed and reversed in part the Federal Circuit's more patentee-friendly opinion in Association for Molecular Pathology v. U.S. Patent & Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011), which held that claims to isolated genetic material, including cDNA as well as segments of naturally occurring DNA, are patent eligible because the isolated material is in a chemical form distinct from that naturally occurring in nature.

The case involves patent applications filed by Myriad about 17 years ago. At the time, Myriad made a medical breakthrough in cancer research by identifying and isolating two human genes (BRCA1 and BRCA2), and determining that mutations in these genes correlate to elevated risk for breast and ovarian cancer. This information enabled Myriad to develop medical tests for assessing susceptibility to these forms of cancer. Myriad was awarded a series of patents based on its discoveries. Claims directed to genetic sequences, in the form of DNA and cDNA³, were specifically at issue in this case. It is noteworthy that other claims in the patents (e.g., claims to cloning vectors, host cells, oligonucleotide primers, and associated methods and kits), were not challenged by the petitioners.

The Supreme Court's Opinion

Justice Thomas, writing for the court, explained that the Supreme Court has historically limited patent eligible subject matter under 35 U.S.C. § 101 to exclude laws of nature, natural phenomena, and abstract ideas. These categories serve to protect the "basic tools of scientific and technological work." However, the court also recognized that, to some extent, all inventions involve laws of nature, natural phenomena, and abstract ideas. In light of this tension, the court stated that there is a "delicate balance" inherent in patent protection between, on the one hand, incentives that lead to creation, invention, and discovery and, on the other, impeding the flow of information in a manner that thwarts such progress.

Turning to the claims at issue, the court held that naturally occurring DNA sequences are not rendered patent eligible simply because they have been isolated. Even though Myriad discovered an "important and useful gene," the court noted that "separating that gene from its surrounding genetic material is not an act of invention." Furthermore, because the genetic sequence, i.e., the location and order of nucleotides, and genetic structure of DNA are products of nature, the gene sequences themselves were held not to be "new... composition[s] of matter" under § 101. The court did, however, provide guidance for patent eligible claims, indicating that the claims would have defined patent eligible subject matter if directed to non-naturally occurring aspects of the chemical structure. One interpretation of this could be that human genes that have been modified beyond mere "isolation" may meet the requirements of 35 U.S.C. § 101 (e.g., by purification, chemical alteration, and/or combination with other materials).

In support of this view, the court held that cDNA is patent eligible under 35 U.S.C. § 101 because it is not a product of nature. The court explained that, unlike naturally occurring, isolated DNA segments, cDNA is synthesized by lab technicians and lacks introns, making it distinct from the naturally-occurring genomic DNA from which it is derived. While the court squarely stated that cDNA meets the § 101 threshold, it left open the question of whether cDNA satisfies other statutory requirements of patentability, e.g., 35 U.S.C. §§ 102, 103, and 112.

Potential Implications of the Myriad Decision

While the Myriad decision creates clarity regarding the lack of patentability of isolated gene sequences, it also creates significant uncertainty for other classes of naturally occurring isolated biomolecules often critical to the biotechnology industry, such as additional nucleotide forms (e.g., antisense, interfering RNA), carbohydrates, lipids, and proteins (e.g., antibodies, and specifically human antibodies). In this regard, patent claims are often directed to isolated forms of these types of biomolecules and the court's decision in Myriad suggests that such claims may now need to be viewed under a more stringent 35 U.S.C. § 101 standard.

Although the patentability of certain isolated biomolecules will be in question following this decision, patentees will be able to protect commercially relevant aspects of their inventions using language that more clearly distinguishes their inventions from naturally occurring molecules. Moreover, the Myriad court's decision makes clear that method claims utilizing the isolated gene sequence or claims directed to applications of the isolated gene sequence still could be patent eligible subject matter. Finally, the biotech industry must remain mindful of not only patentability issues raised by this decision, but also enforceability/validity of their patents and, most importantly, the commercial value/exclusivity afforded by their patents.

The U.S. Patent & Trademark Office (USPTO) readily embraced the court's guidance and disseminated a memorandum to the patent examining corps on the same day as the opinion.⁴ The memo provides initial guidance to patent examiners on procedures for addressing nucleic acid-related patent claims. Thus, the USPTO's application of the Myriad decision on patent prosecution should provide the biotech industry with additional clarity regarding the scope of its impact on future patents. Undoubtedly however, the ramifications of this decision will not be fully appreciated until many of these issues have been further tested in the courts.

Footnotes

[1] __ S. Ct. __, 2013 WL 2631062 (June 13, 2013).

[2] Justice Antonin Scalia wrote a brief concurrence. He joined the judgment, and all of its opinion except for portions describing molecular biology.

[3] Briefly, the DNA (deoxyribonucleic acid) claims refer to isolated sequences of naturally occurring genetic material in the form of chemically-joined nucleotides. The DNA sequence includes regions of nucleotides that encode for amino acids, "exons," and regions of nucleotides that do not encode for amino acids, "introns." The DNA sequence is "isolated" by breaking the chemical bonds that connect the DNA sequence to the rest of an individual's genome. The cDNA (complimentary DNA) claims refer to shorter sequences of genetic material that lack introns, are synthetically generated, and not found in nature.

[4] Memorandum from Andrew H. Hirshfeld, Deputy Comm'r for Patent Examination Policy, to Patent Examining Corps, (June 13, 2013), available at http://www.uspto.gov/patents/law/exam/myriad_20130613.pdf.

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