After DNA Patent Ruling, Availability of Genetic Tests Could Broaden

The ruling in effect ends a nearly two-decade monopoly by Myriad Genetics, the company at the center of the case.

“It levels the playing field; we can all go out and compete,” said Sherri Bale, managing director of GeneDx, a testing company, which plans to offer a test for breast cancer risk. “This is going to make a lot more genetic tests available, especially for rare diseases.”

Just how many other tests are affected is a bit unclear. Experts say there are not that many tests offered exclusively by one company because of patents.

But some other patents, like those on bacterial genes that might be useful in producing enzymes or biofuel, might also now be in jeopardy.

Still, biotechnology industry officials and patent lawyers said on Thursday that the decision should have little effect on the pharmaceutical industry and on developers of genetically engineered crops. That is partly because while the court held that isolated DNA could not be patented because it is a natural product, it did allow patenting of a more synthetic form of DNA that is more commercially valuable.

“The Supreme Court got it exactly right,” said Eric Lander, the president of the Broad Institute, a genetic research center affiliated with Harvard and M.I.T. “It’s a great decision for patients, it’s a great decision for science, and I think it’s a great decision for the biotechnology industry.”

It is not necessarily a great decision for Myriad Genetics, which held the patents on the two genes, called BRCA1 and BRCA2, at issue in the case.

Women with certain mutations in either of these genes have an extraordinarily high risk of developing breast or ovarian cancer. The actress Angelina Jolie, who has one of those mutations, recently had both breasts removed to sharply reduce the risk of getting cancer.

Myriad, which charges about $4,000 for a complete analysis of the two genes, had used its patents to keep others from offering such tests.

The company, based in Salt Lake City, said it did not anticipate any impact on its business from the decision, which it said affected only a small number of its patent claims.

“We have 24 patents, more than 500 patent claims, the vast majority of which are still valid and enforceable,” Richard Marsh, Myriad’s general counsel, said in an interview.

But the groups that sued Myriad and some testing laboratories said the patents that were invalidated were the main barriers to competition.

Besides GeneDx, which is a subsidiary of Bio-Reference Laboratories, others that said that they would offer testing of the BRCA genes include Ambry Genetics; the University of Washington; Montefiore Medical Center and Quest Diagnostics, the nation’s largest clinical laboratory company.

Mr. Marsh declined to say whether Myriad would try to enforce its remaining patents against any of these companies.

Robert Cook-Deegan, a research professor at Duke University’s Institute for Genome Sciences and Policy who has closely studied gene patenting, said he doubted that would happen.

“I think there might be some blustering or saber rattling, but I would be really surprised if they sue anybody for patent infringement for a diagnostic test,” he said.

Myriad’s stock initially shot up 10 percent after the court’s opinion was issued, but it then retreated as investors realized that competition would indeed be coming for BRCA testing, which accounted for about $132 million of Myriad’s $156 million in revenue in the most recent quarter. Myriad shares ended the day at $32.01, down 5.63 percent.

The company, however, had also faced other challenges from the rapid improvement and declining costs of gene sequencing.

“Many academic labs, including our own, will soon be offering panel tests for dozens, or even hundreds of genes, for the same price Myriad historically charged for just two genes,” said Dr. Kenneth Offit, chief of the clinical genetics service at Memorial Sloan-Kettering Cancer Center.

Myriad itself has announced plans to phase out its BRCA gene tests by the middle of 2015 and replace them with a test that will analyze 25 genes that contribute to the risk of breast cancer and several other types of cancer. The price is expected to be similar to what the BRCA analysis costs now.

Also becoming more practical is whole genome sequencing. Some experts had feared that having numerous patents on individual genes would impede the ability to sequence and analyze a person’s entire genome, though others doubted that. In any case, that threat is now removed.

Some experts say that other genetic tests that are exclusively controlled by a patent holder include the test for spinal muscular atrophy and the test for an inherited form of deafness.

Dr. Bale of GeneDx said the deafness gene also caused a skin disease. Her company is allowed to test for mutations that cause the skin disease, but if it discovers a mutation for hearing loss, it cannot tell the doctor. Instead, a new blood sample has to be drawn and sent to Athena Diagnostics, which controls the testing for the deafness gene. Dr. Bale said the court’s decision should eliminate the need for that arrangement.

It is often said that patents cover 4,000 human genes, or about 20 percent of all human genes, meaning the decision could have a large impact.

But many of these patents were obtained in the genomics gold rush of the late 1990s and are either close to expiring or have been allowed to lapse for not being useful.

Moreover, said Christopher M. Holman, a biotechnology patent expert at the University of Missouri-Kansas City School of Law, many of the gene patents are actually patents on complementary DNA, or cDNA, which is essentially a gene with extraneous parts removed. The Supreme Court said cDNA was eligible for patenting because it was not naturally occurring.

Complementary DNA is commercially valuable because it is generally used to genetically engineer a cell, a plant or an animal.

Still, the Supreme Court ruling could have some broader effects — on bacterial genes, for example. An analysis in Nature Biotechnology in May concluded that more than 8,000 genes might be at risk in the Myriad decision, less than half of which were human genes.

It is also possible that the decision could make it hard to patent things other than genes that are isolated from natural products, like drugs derived from microorganisms or plants.

Patents on human genes are “almost yesterday’s I.P.” said Hans Sauer, deputy general counsel for the Biotechnology Industry Organization, a trade group, using the abbreviation for intellectual property. But inability to patent bacterial genes could slow innovation, he said.

“Paradoxically enough,” he said, “the case bites harder in areas that have the least to do with human genes.”

Article source: http://www.nytimes.com/2013/06/14/business/after-dna-patent-ruling-availability-of-genetic-tests-could-broaden.html?partner=rss&emc=rss