In June, academic researchers and clinical laboratories seeking to make a mark in the emerging fields of molecular diagnostics and personalized medicine were buoyed by the long-awaited ruling of the U.S. Supreme Court in the case of Association for Molecular Pathology (AMP) v. Myriad Genetics Inc., (2013).
Preliminary guidance from the U.S. Patent and Trademark Office defined the immediately actionable implication of the court’s ruling:
“As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Ex - aminers should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 USC 101.”
Experts say that additional litigation will eventually establish the undefined parameters of the Myriad ruling, including how much a genetic sequence must be changed before it is no longer considered a naturally occurring substance—and is therefore eligible for patenting. “The Myriad case was all about whether the subject matter was eligible to be patented,” says David C. Berry, JD, professor and director of the graduate program in intellectual property law at the Thomas M. Cooley Law School, Auburn Hills, MI. “The next wave will likely be to challenge cDNA patents on the grounds that they are obvious.”
But, in the meantime, the ruling has fulfilled the plaintiffs’ objective of removing gene patents as an obstacle to competition in the molecular diagnostics marketplace. “The Myriad ruling probably opens the door wide enough for companies to enter the field and seek to create competing businesses,” says James J. Mullen III, PhD, JD, managing partner in the San Diego office of Morrison & Foerster.
With Myriad’s gene patents invalidated, a number of labs immediately announced that they would begin offering testing services for BRCA gene mutations, the lucrative breast and ovarian cancer test at the center of the Myriad controversy.
Personalized medicine activists may hope that the Myriad ruling will also bring about greater participation from commercial in vitro diagnostics (IVD) manufacturers already active in the field of molecular diagnostics. Exploiting novel high-throughput sequencing technologies, for instance, “We may see companies produce multi-gene next-generation testing kits that include BRCA 1 and BRCA 2,” says Roger D. Klein, MD, JD, a molecular pathologist at the Cleveland Clinic and chair of the AMP professional relations committee.
“It’s uncertain what affect the Myriad ruling will have on companies seeking to develop commercially marketed tests cleared or approved by FDA,” says Mullen. “However, FDA has indicated that it would like to see more drugs come to market with companion diagnostics that can guide patient selection and dosing. That’s a powerful incentive for manufacturers and developers to work toward meeting this need.”
It is unclear whether commercial test manufacturers will be able to benefit from the Myriad decision. For IVD companies, gene patent obstacles have always been overshadowed by concerns over high regulatory hurdles, low reimbursement rates, limited demand for some tests, and the privacy of genetic information.
The complexity and ongoing importance of such obstacles awaiting would-be molecular diagnostics businesses were underscored at the beginning of July, in comments submitted by the Personalized Medicine Coalition on the 2013 gapfill payment amounts proposed by the Centers for Medicare and Medicaid Services for its Clinical Laboratory Fee Schedule. According to the coalition, inadequate reimbursement inhibits collaborations among drug and diagnostic companies, discourages investment, triggers job losses, and, ultimately, limits patient access to personalized medicine.
In the Myriad ruling, the U.S. Supreme Court set patent policy on a new footing with broad implications for the future of molecular diagnostics and personalized medicine. But to break the logjam that has long inhibited growth in the field, the leaders of molecular diagnostics companies will need to build more effective alliances with organizations that share a vision for the future of personalized medicine.
Unfortunately, the high court’s Myriad ruling won’t offer much help on that score.
Steve Halasey is vice president for programs at the Institute for Health Technology Studies (InHealth), a 501(c)3 research and educational foundation measuring the value of medical technology innovation. Washington, DC. He has more than 20 years of communications and editorial experience with publications informing industry executives, researchers, and investors in the medical device industry.