Two Sides of the Diagnostic Coin
“Because information about gene sequences is so fundamental to understanding the cause, progression, and treatment of disease, patent holders can essentially gain ownership of disease understanding and management through patents,” Mary Steele Williams, executive director of the Association for Molecular Pathology (AMP), told GEN.
“Gene patents serve as a disincentive to innovation, because they deny patients access to vital genetic information that cannot be ‘invented around.’ The threat of litigation for infringing on these patents has created a chilling effect as clinical laboratories and manufacturers of exciting new technologies are reluctant to develop new, improved, and less costly tests that could directly benefit patients.”
A patent attorney whose clients include genetic test developers counters that without the patents, molecular test developers are unlikely to invest the time and money needed to create the screening instruments that doctors and patients need. “If you remove the patent system, the question is, would this test even exist?” David S. Resnick, co-leader of the patents practice group at the law firm Nixon Peabody, told GEN.
“The companies need to recoup their investment and need to profit,” Resnik continued. “The United States doesn’t quite have socialized medicine yet. We’re still in a system where people make an investment, with the expectation that they’re going to make money from it.”
But that sense of ownership by entities whose intellectual property renders them the sole provider of testing around a particular gene sequence or gene-disease association results in them having little incentive to invest in improving their test, according to Williams: “The potential impact on the public health is huge.”
Advocates of independent second-opinion genetic tests have also linked patent eligibility with the high cost of tests and medicines. Developers of diagnostics argue back that the cost issue reflects more the expense of lengthening FDA reviews and the reluctance of insurers to cover expenses of molecular diagnostic tests.
Resnick noted that decisions on patent eligibility should be based on patent law rather than judgments about the value of IP. Section 101, for example, defines as patentable inventions: “Any new and useful process, machine, manufacture, or composition of matter or any new and useful improvement thereof.”
“Who is going to be the arbiter of Section 101? It’s going to be a patent examiner,” Resnick said. “If the examiner sees that the claims are all mental steps, or do not satisfy the machine-or-transformation test, or someone’s trying to patent a human being, then the examiner can give a Section 101 rejection. But to have the examiner be the one who says, ‘this test really is going to hurt society because it’s going to prevent people from getting this test or raise its cost,’ that’s not the job of the Patent Office.”
Do you believe the U.S. can develop a system to protect innovator diagnostic firms but also safeguard those offering confirming tests against patent infringement?