A federal court ruling in New York that genes may not be patented, if ultimately upheld by the U.S. Supreme Court, could irreparably harm the behemoth biotechnology industry that relies on patents to protect the results of its costly research.
The decision in Association for Molecular Pathology vs. United States Patent and Trademark Office comes in the wake of 40,000 patents already issued on 20 percent of all human genes.
The case didn't go to trial: A summary judgment for the plaintiffs was granted on the gene patents at issue.
The knee-jerk reaction might be to say it's good the case was decided before the villain who wants to own the very material that determines what we are could have its day in court. It seems almost intuitive that our genes should not be owned by anyone other than ourselves.
It's not that simple.
The plaintiffs, the Association for Molecular Pathology, a not-for-profit genomics research advancement society, several medical colleges, doctors and patients sued Myriad Genetics, a biopharmaceutical company in a multibillion-dollar industry and associated with the University of Utah Research Park in Salt Lake City and the directors of the University of Utah Research Foundation.
Plaintiffs sought a ruling to declare the patents on genes related to breast and ovarian cancer -- patents held by Myriad -- to be invalid and unenforceable, and to prevent defendants from enforcing the patents. The medical establishment maintained federal patent law doesn't allow genes to be patented, and said with Myriad's inappropriate lock on the genes, it can't meet its ethical obligations to effectively help women who need testing.
They also sued the United States Patent and Trademark Office, arguing gene patents violate Article 1, Section 8 of the U.S. Constitution and Title 35, Section 101 of the U.S. Code, which give Congress the power to issue patents. The American Civil Liberties Union, which represented the plaintiffs, said patenting genes limits research and the free flow of information, thus violating the First Amendment.
Myriad is the only laboratory where the BRCA-1 and -2 screenings for breast and ovarian cancer may be performed comprehensively. There is no opportunity for a complete second opinion elsewhere.
Research scientists and physicians say they are frustrated because they can't do further research on the genes or on other genes where the BRCA-related DNA may be intertwined: Myriad slaps them with cease-and-desist orders.
Further, some of their patients (of whom the women named as plaintiffs are examples) whose insurance doesn't cover the test, can't have the test done because of its cost: $3,200. Many doctors say they can have a simple blood test done for $300.
Myriad said genes may lawfully be patented, arguing once removed from the body and isolated, the DNA is different-in-kind from products of nature found in the body and is, therefore, a patentable organism.
Myriad also said the language of the federal patent code indicates Congress intended patentability to be construed broadly. Without the ability to patent genes, venture capital would no longer be invested in genetic research and scientific progress in medicine would be slowed significantly. Patents reward the economic risks of research.
The company pointed out patents expire (Myriad's patents-at-issue will end in 2018), after which the knowledge and data -- which originally had been paid for by those willing to invest in such a risky business -- ends up in the public domain.
The trial court found for the plaintiffs primarily on the basis the isolated DNA is not "markedly different" from a product of nature.
The district court declined to speak on the constitutional issues, following the established rule that courts should not reach unnecessary constitutional decisions, leaving the constitutional issue open to future litigation.
The trial court evaded Myriad's argument that the reward of a patent provides an incentive for investors in research. It said that whether patents affect BRCA-1 or -2 testing is a factual dispute.
But will the defendants take up the court's implicit challenge to appeal the summary judgment and most likely land this case back in court? Will they bring this scientifically complicated and controversial issue before a trier of fact? A judge in the role of fact-finder likely would be more sympathetic to such defendants than a jury; plaintiffs undoubtedly would opt for the jury.
There is, however, too much at stake for Myriad not to appeal, and the company said immediately after the decision March 29 it would do so. Myriad stated in a brief that disallowing gene-related patents would "scuttle the biotechnology industry."
It is on the constitutional issues, which would be brought up by plaintiffs as counter arguments to Myriad's appeal, that the case would reach the Supreme Court. But if the suit is brought back to trial, in part, under the ACLU's First Amendment banner that gene patents stymie the free flow of information, the very concept of protecting inventions through patents would be challenged. After all, don't all enforced patents, by definition, preclude such an exchange of information for a limited -- albeit long -- time?
Although the high court doesn't often accept patent cases, commentators on both sides overwhelmingly say they believe it would take this one and, regardless of the outcome, it will be a landmark decision.