In a decision that could roil the biotech industry working to gain a foothold in Palm Beach County and the Treasure Coast, a federal judge has ruled that genes can't be patented.

The American Civil Liberties Union and the Public Patent Foundation won — at least temporarily— a suit against Myriad Genetics, a Salt Lake City-based company that holds seven patents related to genes that can mutate and cause breast cancer. If the ruling stands, it would topple the biotech industry's decades-long tradition of using patents to protect promising discoveries from rivals.

"If the appellate courts uphold the decision, it could really hurt the biotech industry," said Stanley Kim, a patent attorney and biotech entrepreneur in Wellington. "If Myriad had never gotten those patents, their competitors could have come in and just copycatted what they were doing."

But Kim isn't too worried yet. Myriad Genetics plans to appeal Monday's ruling by U.S. District Court Judge Robert W. Sweet, and Kim said the chances the ruling will stand are "pretty slim."

The debate pits the two sides of the biotech industry — the altruistic side that seeks cures for diseases against the profit-minded part that rewards entrepreneurs and scientists who take drugs to market.

The ACLU and the Public Patent Foundation argue that genes, as products of nature, fall outside the realm of things that can be patented. The patents, they say, stifle research and innovation and limit options for consumers.

"The human genome, like the structure of blood, air or water, was discovered, not created," said Chris Hansen, an ACLU staff lawyer. "There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas."

Sweet agreed with that argument, writing in his 152-page decision that the patents were "improperly granted" because they involved a "law of nature."

The debate over whether genes can be patented is an esoteric one, but it has very practical consequences. Myriad sells a test costing more than $3,000 that looks for mutations in two genes to determine if a woman is at risk of getting breast cancer or ovarian cancer. Plaintiffs in the case said Myriad's patent-protected monopoly on the test keeps prices high and prevents women from getting a second test from another laboratory.

One of the individual plaintiffs in the suit, Genae Girard, who has breast cancer and has been tested for ovarian cancer, applauded the decision as "a big turning point for all women in the country that may have breast cancer that runs in their family."

But biotech entrepreneurs say patents on genes have been a tried-and-true way of repaying entrepreneurs who develop drugs. About 20 percent of human genes have been patented, and multibillion-dollar industries have been built atop the intellectual property rights that the patents grant.

"If you want safe, effective drugs, it costs a lot of money to prove that things are safe and effective," said Joe Collard, head of CURNA, a Jupiter biotech firm.

While Collard said he was still deciphering Monday's ruling, he said looser patent protections could help the biotech industry by making it easier for companies to develop products based on once-patented genes. "It's one ruling," Collard said. "All these rulings can cut both ways. It could in some sense make it easier for us, and it could in some sense make it harder for us."

Mark Emalfarb, head of Jupiter-based biotech firm Dyadic International, likewise stressed the financial realities that have driven the biotech industry's use of patents.

"In the end, it's about creating shareholder value in addition to benefiting mankind," Emalfarb said.

Bryan Roberts, a prominent Silicon Valley venture capitalist, said the decision could push more work aimed at discovering genes and diagnostic tests to universities.

"The government is going to become the funder for content discovery because it's going to be very hard to justify it outside of academia," he said.

But John Ball, executive vice president of the American Society for Clinical Pathology, one of the plaintiffs in the case, called the decision a boon for consumers.

"It's good for patients and patient care, it's good for science and scientists," he said. "It really opens up things."

The New York Times contributed to this story.

Contact:
Jeff Ostrowski
Palm Beach Post Staff Writer