In 2013, the US Supreme Court unanimouslyannulled patents on two human genes - BRCA1 and BRCA2 - related to breast and ovarian cancer. Judge Clarence Thomas wrote that the isolated DNA "is a product of nature and is not subject to patenting." This historic decision invalidated patents owned by Myriad Genetics, the defendant in a 2009 lawsuit filed by dozens of patients. Because of this, more than a dozen companies today can tell you what your BRCA genes say about the risk of getting cancer.
But now Washington lawmakers are weighingA new proposal that overturns this landmark decision and other recent rulings that created judicial exemptions from federal patent law. It discusses the notion that natural phenomena, observations of the laws of nature and abstract ideas cannot be patented. This legal precedent includes a major victory for the software industry against the plague of patent trolls. If successful, this bill could turn the genetic resources of the world into commercial ownership, forcing scientists to conduct basic research under the constant threat of legal risks.
Patented genes
Bipartisan bill issued in the pastBy month, Senators Tom Tillis and Chris Koons, amends several sections of the statute on patent law and adds a provision that invalidates the Supreme Court’s exceptions to it. Critics of these decisions say they leave the United States inconsistent and overly strict with patent law, which is detrimental to innovation. At the same time, technological competitors, particularly China, are accelerating. Proponents of the current legal doctrine fear that reform will bring the United States back to a time when it was possible to stick intellectual property rights to anything from the DNA sequence to the act of scanning and sending a file with a single mouse click.
In the proposed patent reform billfaced the biomedical and pharmaceutical industry and the Internet giants of Silicon Valley. Now the senators will listen to the concerns of both parties and proceed to a compromise in the form of a final bill that could be submitted to the Senate later this summer.
“If I were the CEO of the company intechnology and software, I’d like to maintain the status quo because it provides certainty, ”says Tillis. “Unfortunately, this happens only with a part of our current innovative economy. I fear for the US economy as a whole. "
Forty-five experts will speakamong them are professors of law, former judges, former heads of patent and trade bureaus, representatives of pharmaceutical and diagnostic companies, associations representing Amazon, Facebook, Google and Microsoft.
Lawmakers note that their billin fact, does not revive the powers of companies to patenting human genes or other fundamental scientific discoveries. "I want to be clear in one thing," said Kun on Tuesday. "Our proposal does not change the law, allowing it to patent the gene that exists in the human body."
However, there is one provision in this case, due to which different interpretations breed.
"They do not say: well, now you can patent natural phenomena, ”says one of the critics of the bill. “They say that it can be difficult to define what an abstract idea is, what the law of nature is and what we mean when we say“ natural phenomena ”. The new bill creates a legal test for patent examiners, who should define these things instead of referring to the precedents of the Supreme Court.
New legal test includes updateddefinition of the term "useful." To be eligible for a patent, discovery or invention, a discovery or invention must now have a clearly identifiable benefit made possible only by human intervention. And all this should fit into the "technological area", which, according to experts, will create a safe zone for purely scientific research. These new conditions should keep human genes and other "laws of nature" inaccessible to patent owners.
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