Myriad Genetics Inc. has told a federal court that 30 years of experience has shown the U.S. practice of patenting of human genes to private companies has been richly beneficial for research, and it has improved patient access to medical information.
The Salt Lake City-based company makes those arguments as its gears up for a hearing in January in a lawsuit challenging the U.S. Patent and Trademark Office policy of patenting human genes.
The case has the potential of either affirming or overturning the decades-long practice that has led to patents related to thousands of genes. An adverse ruling could affect product research and marketing by numerous companies, such as Myriad, that aim to turn gene research into profits from diagnostic tests and disease treatments.
On Jan. 21, before U.S. District Judge Robert W. Sweet in New York, Myriad will ask that the lawsuit be dismissed. Opponents want Sweet to decide the case in their favor even before a trial takes place.
The lawsuit is being spearheaded by the American Civil Liberties Union. Aligned with it are various prominent medical and research groups, including the American Medical Association, American Society of Human Genetics and the American College of Obstetricians and Gynecologists.
Filed May 12 of last year, the suit disputes the granting of patents to the University of Utah that are associated with the so-called BRCA1 and BRCA2 genes. The U. licensed them some 15 years ago to Myriad Genetics, which was formed specifically to engage in gene research and create commercial medical products.
The two genes are associated with breast and ovarian cancer, and Myriad is selling tests that show whether a woman has a raised risk of those diseases.
The decision to sue Myriad over those particular genes -- instead of hundreds of others patented to various entities -- and the inclusion of breast and ovarian cancer victims as plaintiffs has given the lawsuit a particular emotional quality.
The ACLU and its allies argue the patents violate the U.S. Constitution, and federal law doesn't allow the patenting of products of nature.
"They also constitute patents on thought, knowledge and ideas in violation of the First Amendment," they argue in court documents. "Because they patent basic scientific principles, not inventions or discoveries, they have impeded rather than advanced science."
But Myriad Genetics, in asking Sweet to dismiss the case, points to a U.S. Supreme Court decision 30 years ago that said technology related to genes was eligible to be patented -- despite arguments that a "gruesome parade of horribles" would follow.
"Unlike 30 years ago, however, this court has the benefit of experience, and that experience dispels these fears as unfounded," Myriad told Sweet. "The BRCA patents have not stifled research -- in fact, Myriad has consistently promoted and subsidized research on the BRCA genes."
It said more than 18,000 scientists, including eight of those aligned against it in the lawsuit, have conducted research on the BRCA1 and BRCA2 genes and have published more than 7,000 papers on them.
Myriad has now gathered allies, such as the Biotechnology Industry Organization, a trade group, and the similar Genetic Alliance. The company also has gathered various statements from researchers who have said the patents have not hindered their efforts to study the two genes.
Myriad Genetics and the University of Utah have maintained a policy of not commenting on the pending lawsuit. The ACLU in New York did not return an e-mail seeking comment.