The rug has been pulled out from under key patent rights of diagnostic companies and research institutions. A series of US court decisions have invalidated patent claims for diagnostic inventions as allegedly merely claiming a law of nature1.
The Canadian Patent Office is also now potentially scrutinizing diagnostic method claims more closely, even though there is no Canadian court decision on diagnostics, only computer inventions2.
Diagnostic patent rights have been used to protect inventions made after intensive and expensive R&D. They include diagnostic inventions for everything from heart disease to cancer. If you catch these conditions early, they are more likely to be treatable. If not, hopefully drugs and lifestyle changes can compensate for the lack of early diagnosis. Growing trends, such as personalized medicine and new drugs with companion diagnostics are further integrating diagnostics with treatment. Developing new diagnostics makes perfect sense to help improve quality of life, treatment outcomes and cost-savings.
Patent protection provides a limited period of exclusivity to sell an invention before it becomes public domain. Without the exclusivity period, the innovative company that invested in developing a successful diagnostic test can be wiped out financially by the competitor that copies the test and can sell it cheaper because it has no R&D costs to recoup (other than the cost of copying someone else's homework). The copyists that don't invent anything would reap the benefits, nobody would invest in the innovative company, and that could be the end of the innovative company. Immediate copying would, at a minimum, remove incentives for the innovative company to do further work to improve and test its product. The patent system was created to avoid this outcome by providing the time-limited exclusivity period. The patent system doesn't just prevent competitive disadvantage to the inventor but it also encourages further innovation by the innovative company. The company can use its patent rights to generate revenue to grow its business and R&D, create more jobs, develop more diagnostics and test more patients. The patent rights provide certainty that helps attract further investment. The knowledge of how the test works must be disclosed in the patent so that others can see it and improve upon it - other R&D companies can then benefit in using that knowledge to help speed up the discovery of their own diagnostics.
If a diagnostic test invention was a really only a mere law of nature then we would not need laboratories run by skilled scientists in order to do diagnostic tests. Diagnostic tests are the application of lab tests to detect a person's natural or unnatural condition.
Courts, the US Patent Office and companies are now engaged in an awkward, resource-wasting dance, trying to figure out whether a particular invention, or patent claim style is a law of nature. Really, it should not matter if a diagnostic patent embodies a law of nature or not. That is an issue of legal theory. If a diagnostic method patent claim cannot be written in a way that it is not construed as a law of nature (patent attorneys are feverishly working on their patent claims strategies), then there is a problem with the patent system or the court decisions that needs to be fixed by legislation.
Developing new diagnostics tests is critical and should be strongly incentivized. The diagnostics industry is important on many levels and should be encouraged to grow by having some measure of patent protection. The legislature should urgently take into consideration the views of the diagnostics industry, healthcare providers and patients and come to a balanced solution to each side's concern. Give the companies that invent great things a reasonable measure of patent protection, and let them focus on doing what they do best, inventing, without the concern that their patents will fall.
Footnotes
1 Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 12-398; Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 10-1150; Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)2 On June 29, 2015, CIPO released a brief Patent Notice to Examiners regarding examination of medical diagnostic methods ("Examination Practice Respecting Medical Diagnostic Methods – PN 2015-02").
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