Myriad Genetics Finally Gives Up Its Gene Patent Fight... Just As The Patent Office Opens The Doors Up To More Gene Patents

For many years, we've been covering the story of Myriad Genetics, the biotech company that has a test for the BRCA1 and BRCA2 genes (often an indicator of a higher risk for breast cancer). The company argued that because of its patent on those genes, no one else could test for those genes. Back in 2013, the Supreme Court did the right thing and finally rejected the concept of gene patents, despite years of the USPTO granting such patents. As the court noted, allowing gene patents created a perverse situation in which a single company could have the exclusive right to isolate a person's own genes -- and that's just not right.

But Myriad Genetics did not give up easily. Just a month after the Supreme Court ruling it sued a bunch of competitors over a different set of gene patents, insisting that the Supreme Court had really only struck down the two in question. Those lawsuits did not go well, as Myriad lost again and again. At this point, it's only choice was to go back to the Supreme Court, where it was obviously going to get a pretty big smackdown -- so Myriad has now admitted that it will not pursue an appeal effectively ending this latest round of cases (after costing those other testing centers tons of money to defend themselves).

As the ACLU notes, this news is great, but there's also some bad news. Just as Myriad is finally coming to terms with what the Supreme Court actually said a year and a half ago, the US Patent and Trademark is quietly opening the door back up to gene patents:

In response to severe criticism by industry groups, patentholders, and patent attorneys, the Patent Office issued new guidance in December that watered down the standard for determining whether something is an unpatentable product of nature. It said that differences in structure or function could allow companies to patent things based in nature. Under this test, if a surgeon removed a kidney from one's body in order to transplant it, the surgeon could argue that she should be able to patent it because it no longer has the same structure as in the body since its blood vessels were cut. The kidney, of course, would be intended to function just as it has prior to being removed in the body that receives it.

The Supreme Court has long rejected this view. For example, in 1931 the court said that a fruit treated with a preservative in its rind could not be patented, because while it has a different structure, its uses are still the same - to be eaten. The applicant could have sought a patent on a new preservative it developed, but not on the fruit itself.

In other words, the ugly head of gene patents may be about to come back alive, despite the Supreme Court killing it off a couple years ago. However, there's still a chance the USPTO will reconsider:

The public has an opportunity to weigh in on this latest guidance. The Patent Office is seeking comments until March 16. In its next revision of the guidance, the Patent Office must require differences in both structure and function when assessing patent applications. Otherwise, the public will bear the consequences when another company, like Myriad, wields its exclusive rights on nature to stall medical and scientific advancement.

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