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
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
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
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.
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)
A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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