Implications for Personalized Medicine after Myriad

06/20/2013

On June 13, 2013, in the highly anticipated decision for Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court shed some light on the future of genetic patenting to companies and scientists working in the personalized medicine and genetics industry. The personalized medicine industry seeks to revolutionize patient care by using genetic sequencing and testing to predict disease likelihood, severity, progression, and/or treatment response. The Court unanimously held that although an isolated, naturally occurring DNA sequence is not patent eligible under 35 U.S.C. § 101 because it is a product of nature, a complementary DNA (cDNA) sequence is patent eligible because it constitutes “something new.” The ruling opens up the field of personalized medicine by allowing competitive research with isolated gene sequences while preserving the incentive for biotechnology companies to develop new genetic tests, genetic treatments, and manipulated DNA sequences.

The case involves Myriad’s patents on two human genes, BRCA1 and BRCA2, which Myriad isolated nearly two decades ago. Specific mutations in these genes are associated with a dramatically higher risk of breast and ovarian cancers. Because the patents enabled Myriad to block others from clinical research using the BRCA genes, Myriad has monopolized the genetic testing market for these mutations.

An Isolated Human Gene is not Patentable Because Nothing New is Created

Although Justice Thomas lauded Myriad for its “medical breakthrough” in identifying and isolating BRCA1 and BRCA2, he asserted that “[g]roundbreaking, innovative or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Noting that “[t]he location and order of the nucleotides existed in nature before Myriad found them,” and that Myriad did not “alter the genetic structure of DNA,” the Court concluded that “Myriad did not create anything.” The Court emphasized that a human gene does not become patent eligible merely because it has been isolated from the rest of the human genome, stating that although Myriad “found an important and useful gene, [] separating that gene from its surrounding genetic material is not an act of invention.”

Synthesized DNA is Patentable Because Something New is Created

In contrast to the non-creative act of merely locating and isolating a naturally occurring DNA sequence, the Court opined that Myriad did create something when it synthesized cDNA, which is a shortened segment of DNA that omits certain non-coding portions (“introns”) of the original DNA sequence. Notably, however, the act of removing the introns from the original DNA sequence is routinely performed as part of a natural cellular process.1 To the assertion that cDNA sequences were therefore also dictated by nature, Justice Thomas responded that while “[t]hat may be so, the lab technician undoubtedly creates something new when cDNA is made.”

The Court limited its holding to the patentability of cDNA under Section 101, explicitly stating that “[w]e express no opinion whether cDNA satisfies the other statutory requirements for patentability.” The Court accompanied this cautionary statement with a reference to a brief filed by the Obama administration, which noted that “given the prevailing level of knowledge in biotechnological fields, future patent applications directed to cDNAs and other synthesized DNA molecules may be rejected as obvious.” Thus, the possibility remains that future claims directed to cDNA may ultimately be denied patent protection.

Impact on Genetic Innovations and Personalized Medicine

The Court specifically refrained from considering the patentability of method claims for manipulating genes or of claims for new applications of DNA sequences. Myriad officials stressed how the Court upheld the patentability of lab-synthesized genetic sequences and scientific methods of testing for cancer susceptibility using genetic material. Myriad’s chief executive, Peter D. Meldrum, stated, “We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our test moving forward.” Thus, even in the potential absence of composition claims for DNA sequences (whether isolated or synthetically created), companies may gain patent protection for genetic innovations through method claims.

The ruling impacts thousands of patents that have been granted on isolated genes, and will likely have an immediate impact on the development of personalized medicine as rival companies enter the market of genetic testing involving patented genes. The new inability to patent isolated DNA sequences could create financial difficulties for biotechnology companies seeking investment for genetic research. However, the ability to freely research using previously isolated DNA sequences may speed developments in the personalized medicine arena. In addition, as more companies enter the personalized medicine market, competition may improve the quality of genetic testing and will likely drive down the costs of such testing. Several companies have already announced that they will begin offering genetic testing for breast cancer risk assessment. For example, mere hours after the ruling, DNATraits, a part of the Houston-based company Gene By Gene, Ltd., stated that it would offer the BRCA gene testing for under $1,000, less than one-third of Myriad’s current price.

The Court began its patentability analysis by highlighting that “patent protection strikes a delicate balance between creating ‘incentives that lead to creation, innovation, and discovery,’ and ‘imped[ing] the flow of information that might permit, indeed spur, invention’” (internal citations omitted). The Court’s holding maintains that balance by preventing patent-derived monopolization of isolated, naturally occurring genes while preserving patent protection for genetic innovations derived from these genes, such as artificially created DNA sequences and genetic testing methods in the growing field of personalized medicine.

For more information about the Myriad decision or any other health law questions, please contact any of the following attorneys:

Kenya S. Woodruff
214.651.5446
kenya.woodruff@haynesboone.com

Stephanie Sivinski
214.651.5078
stephanie.sivinski@haynesboone.com

 

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1 In particular, intracellular pre-RNA, which contains introns, transforms into messenger RNA, which does not. Scientists create cDNA by using messenger RNA, which already lacks introns, to synthesize cDNA.

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