The U.S. diagnostics industry is being strangled, and other life science inventions are being hobbled by, ill-conceived and contradictory patent policies. The USPTO director has signaled he wants to help, but only Congress has the power to fix the problem.
Compounding Congress’ slow pace are conflicts between the interests of the tech and biotech industries, which differ on how wide the boundaries of patentable subject matter should be.
The parties are being brought to the table by an ad hoc group that includes a former United States Patent and Trademark Office director and an influential retired federal judge, who are trying to push Congress to come up with a solution that helps life science companies without harming the tech industry.
The source of the confusion is Section 101 of the Patent Act, which creates a minimum threshold for patentable inventions. The problems were created by the Supreme Court’s interpretation of Section 101 and attempts to draw lines between discovery and invention.
"The law is in chaos through a series of Supreme Court decisions that cannot be read except as conflicting each other."
Since the 2012 Mayo Collaborative Sciences et al v. Prometheus Laboratories Inc. ruling raised questions about the patentability of diagnostic tests, it has become exceptionally difficult to get diagnostics claims issued. Those that do issue are rarely enforceable in court.
The fallout has affected investments in the space. “As a whole, the diagnostics industry has been practically destroyed by Section