Will Gene Patents Come Back from the Dead?

Almost exactly 16 years ago, a district court judge in New York City single-handedly changed the trajectory of the biotech field — most notably the path of genetic tests that are now broadly used to improve healthcare.

I was in Judge Robert Sweet’s courtroom in lower Manhattan when lawyers argued the Association for Molecular Pathology v. Myriad Genetics case, which ultimately wound up before the Supreme Court. Judge Sweet overturned years of nonsensical patent law when he determined that naturally occurring genes could not be patented. That was followed in 2013 by a unanimous decision from the Supreme Court justices agreeing with Sweet’s ruling.

Until then, it was common practice for companies to patent genes (human or otherwise). To protect those patents, they often went after academic scientists to prevent them from even conducting research on those genes. The practice stifled progress and prevented other laboratories — commercial, academic, or hospital — from being able to analyze genes patented by another organization. With zero market competition, tests could be prohibitively expensive. Patients who might have benefited from getting those genes tested were out of luck if they couldn’t afford the one and only test available.

All of that changed when gene patenting was finally — and mercifully — overturned. Now, academic scientists are free to research any gene they want, and the number of genetic tests on the market has exploded, with prices falling accordingly. It’s been a huge boon to the general public and to the biomedical community alike.

That’s why it is so hard to believe that legislators are actively trying to bring us back to the days of gene patents. Last year, a bipartisan group of four U.S. senators and representatives introduced the Patent Eligibility Restoration Act, which aims to whittle down the types of things that can’t be patented. While the bill specifies that unmodified human genes as they exist in nature would remain ineligible for patenting, it does not address the loophole that companies used for years to defend gene patents: in short, that any molecular lab work done to remove the gene from the body and analyze it almost automatically qualifies as going beyond what occurs naturally. It’s as if the law says you can’t patent the sun, but you can patent the reflection of the sun seen in a mirror.

The bill has been condemned by many clinical laboratory associations and other organizations in the biotech field. In a letter sent to the legislators who introduced the bill — that includes Thom Tillis (R-NC) and Chris Coons (D-DE) in the Senate and Kevin Kiley (R-CA) and Scott Peters (D-CA) in the House of Representatives — a group of more than 100 organizations argued that the change to patent law would ultimately harm patients. They pointed to the U.S. response to the COVID-19 pandemic to illustrate the point: “This awe-inspiring innovation could not have occurred in the United States if an entity had been allowed to patent the COVID-19 genome(s),” the letter stated. “We oppose any legislative effort that would allow patents on abstract ideas, laws of nature, or natural phenomena, which are the building blocks of innovation.”

The bill was also part of an advocacy update at the recent annual meeting of the American College of Medical Genetics and Genomics, in which speakers on a panel indicated with relief that it was not likely to advance in this particular session of Congress. (The ACMG was one of the organizations that signed onto the opposition letter noted above.) But the concerning legislation has already been introduced more than once; it will likely be back in the future.

I like to believe that legislators will eventually put a stake through the heart of gene patents once and for all. In the meantime, though, if you have strong feelings about the Patent Eligibility Restoration Act, I encourage you to reach out to your elected officials and let them know.