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New Bill Threatens Section 101 of Patent Act, Puts Small Businesses at Risk

Section 101 of the Patent Act, first written in 1790, sets the boundary on what can be patented, and it has shielded small businesses from lawsuits built on overly broad patents. A newly proposed bill would loosen that boundary, potentially reopening the door to gene patents and other abstract claims the Supreme Court already ruled ineligible.

The brass and glass optics of a laboratory microscope

A proposed bill threatens to change Section 101 of the Patent Act in ways that could make it harder for small businesses and independent inventors to obtain and defend patent protection. Patent law has been central to American innovation since it was first used over 228 years ago, ensuring that the people responsible for an idea get credit for it. Here is what the bill would change and why it matters.

Patent law has been crucial to the U.S. since it was first used over 228 years ago. It ensures that the individual (or individuals) responsible for an idea or a product get the credit for their efforts.

The Patent Act, established in 1790, was the basis of trademark law and was responsible for the creation of the patent process as we know it today; unfortunately, one of its most important Sections is under attack by a new bill.

Section 101 pertains to Inventions patentable and reads as such in the Patent Act:

“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title [35 USCS Sects. 1 et seq.].”

This Section has played a major role in the successes of numerous small businesses throughout the years, who have been saved because the patents being used to sue them were thrown out under it. The current proposed bill would open the door for corporations to eviscerate such small businesses in a very specific way.

In 2013, a Utah company called Myriad Genetics was taken to court over their patents on the BRCA1 and BRCA2 genes, which are used to determine a person’s likelihood of developing breast and ovarian cancer. Because they owned these patents, they were able to monopolize testing; if you wanted to know if you possessed these genes, they could only be processed through Myriad’s labs, which quickly led to the financial success and expansion of the company in the 90s. The case made it all the way to the Supreme Court, who inevitably ruled that DNA is a product of nature and “is not patent eligible merely because it has been isolated.”

The new bill threatens to undo that ruling, opening up the door for human genome patents and other theoretical concepts (such as the patenting of business methods, fundamental scientific principles, and mathematical equations) to be owned exclusively by one company. Although dozens of people have spoken out against the bill, including the ACLU and 169 other civil rights, medical, and scientific groups, only time will tell what happens.

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Common questions

Frequently asked

What does Section 101 of the Patent Act actually protect?
Section 101 defines what type of invention is eligible for a patent in the first place, covering new and useful processes, machines, manufactures, or compositions of matter. Courts use it to throw out patents on things like naturally occurring genes or abstract ideas, which has protected small businesses from being sued over patents that never should have issued.
What did the Supreme Court rule in the Myriad Genetics case?
The Court ruled that isolating a naturally occurring gene, such as the BRCA1 and BRCA2 genes at issue in that case, does not make it patent eligible. The decision established that a product of nature stays unpatentable even after a company identifies and isolates it, which limited that company’s ability to monopolize genetic testing.
How could a change to Section 101 affect a small business?
Loosening Section 101 could allow patents on things like human genes, business methods, or mathematical formulas, the kind of broad claims that were previously thrown out under the existing standard. A small business could then face an infringement suit over territory that was never legitimately protected before the law changed.