The U.S. Supreme Court made winners out of both sides in the closely watched case over the patenting of isolated human genetic sequences—including diagnostics developers and the broader biotech industry, which had feared the worst.
True, the high court gave 20 medical associations and individual doctors led by the Association for Molecular Pathology (AMP) a key victory in overturning Myriad Genetics’ seven patents related to its discovery of the precise location and sequence of breast cancer susceptibility genes BRCA 1 and 2.
But in their unanimous decision, the justices also held that companies can patent composite DNA (cDNA) and other synthetic genetic material not meeting the “product of nature” exemption from patentability under 35 U.S.C. § 101.
“cDNA is the commercially most important form of DNA used in biotechnology. [Thursday’s] decision offers urgently needed certainty for research-driven companies that rely on cDNA patents for investment in innovation,” declared the Biotechnology Industry Organization (BIO) in a statement that also criticized the court for upending Myriad’s BRCA 1 and 2 patents.
Four lawyers who represent diagnostic and biotech clients said test developers will still be able to protect their inventions through increased use of method patents and patents for new applications of gene knowledge.
“The implications for this decision may not be as far reaching in the biopharma industry as some have speculated,” Lisa A. Haile Ph.D., J.D., a partner with DLA Piper U.S. and co-chair of its global life sciences practice, said in a statement.
For one thing, Dr. Haile noted, most patentees with gene patents have claims that include cDNA, claims that will remain valid. And science has come a long way from when Myriad patented the BRCA genes, given the rise of synthetic biology.
“Most diseases, and therefore therapies, are based on much more than just gene sequences,” she said. “So while the decision will impact certain gene-based diagnostics directly, the biotech industry will not likely be significantly altered.”
Agreeing is Paul M. Rivard, J.D., an attorney with Banner & Witcoff: “With the shift in research away from the use of whole genes, I don’t expect the decision will be too detrimental to the biotech industry.”
“It will be interesting to see whether and how the decision is applied to other inventions involving purification of naturally occurring materials where the isolation imparts new properties to the material,” Rivard told GEN.
Tim Worrall, a partner in Dorsey & Whitney, told GEN the decision will prompt many test developers to rethink how they make patent claims. They should strive, he said, to protect their IP without keeping their technologies to themselves.
“You’ll have to be much more nuanced in your patent strategy,” Worrall said. “You will need very specific claims that are directed to specific nuanced aspects of the technology, and methods. Some companies are deciding that they want to keep everything proprietary and not tell anyone. Whether or not you can have a diagnostic test that does that, I think is questionable.”
AMP and co-plaintiffs—assisted by the American Civil Liberties Union (ACLU) and Public Patent Foundation—successfully argued that Myriad’s patents were invalid because human genes are unpatentable “products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought” under Section 101.
BRCA 1 and BRCA 2 are among some 4,000 genes protected by patents. “The ruling will certainly impact a large number of issued patents—in particular, claims that encompass both cDNA and naturally occurring DNA are most vulnerable,” Michael J. Belliveau, Ph.D., J.D., a partner in Clark & Elbing, told GEN.
With the U.S. Patent and Trademark Office (USPTO) unlikely to overturn existing claims, challenges to existing patents will likely arise case-by-case—for example, if competitors seek access to a rival company’s patented diagnostic technique using isolated DNA.
“I don’t know if this is going to trigger a large number of lawsuits,” Dr. Belliveau said. “If you’re the patent owner and you know that you have a patent that likely isn’t going to withstand scrutiny, you would just give permission to the competitor to use the technology.”
With more companies set to offer genetic tests as a result, the price of existing genetic diagnostic tests can be expected to fall short-term. Myriad’s BRACAnalysis test costs $3,340. Pathway Genomics said in August will launch its own BRCA test "at a substantially lower cost than the competition" as part of its Hereditary Cancer DNA Insight(SM) test, which will also be competitively priced, spokesperson Terri Somers told GEN. Pathway is but one firm making such claims related to BRCA1/2 testing.