On January 30th, the White House released a press release expanding upon President Obama’s mention of “precision medicine” in his State of the Union Address. Not surprisingly, the details are pretty much what we who are involved in various aspects of “personalized medicine” would expect – an emphasis on the use of genomic diagnostics to improve treatment selection – especially for cancer patients. The largest of the “Key Investments” listed would be to the NIH to develop what looks like the creation of a reference data base “through engaged participants and open, responsible data sharing.” The NCI would get $70 million to “identify genomic drivers in cancer” and develop more effective approaches to treatment.
Posts Tagged ‘biotechnology news’
Yesterday, Myriad announced it has settled the BRCA assay litigations that had been ongoing—and not going well– with Pathway Genomics, Invitae and Gene by Gene (and I assume….Ambry and Labcorp). Although I was just about at the brink of shouting “Stop The Madness” – the settlements mean that the IP community will not learn if Myriad had any patent-eligible claims in any of their assay patents. Would claims directed to mutations at specific positions of the BRCA1 or 2 genes have passed muster as that elusive “inventive concept” that both the Fed. Cir. and the S. Ct. extracted from Mayo as the standard by which to judge assays reciting abstract ideas or natural phenomena (which one is it?)?
You can read an article about the settlement on the GenomeWeb page by clicking here.
Arguing that human DNA is a natural product, the Children’s Hospital of Eastern Ontario (CHEO) has filed suit in Federal Court to invalidate patents claiming human DNA or diagnostic methods that use it. It has been reported that CHEO was threatened by a U.S. company holding Canadian patents on genes associated with long QT syndrome, an inherited heart rhythm disorder. Currently, the hospital sends samples to the U.S. for testing, at a cost of about $4500, but says it can perform the test for about half that amount in Canada.
Of course, this suit was inspired by the Myriad decision in which the U.S. Supreme Court held that isolated human genes or fragments thereof are unpatentable as “natural products,” but that cDNA is a patent-eligible product of human ingenuity. The Federal Circuit has twice held that methods involving comparing a patient’s BRCA DNA sequences with a reference DNA sequence to identify mutations in the patient’s DNA sequence are patent-ineligible as “abstract ideas.” However, assay claims with more detail about the mutations or the manipulative steps involved were before either court on appeal. In Mayo v. Prometheus, the Supreme Court held that a method for optimizing the dose of a known class of drugs by measuring the levels of a metabolite in the patient’s blood was patent-ineligible as an attempt to patent a “natural phenomenon.” It will be very interesting to see which, if any, of these tortuous legal trails the Canadian courts will follow.
This is a guest post from Hans Sauer, Deputy General Counsel, Intellectual Property for BIO.
“Recently, I set out to find real-world examples of recent rejections under the USPTO Guidance, to do my own sampling rather than rely on reported anecdotes. In just two hours of not very systematic searching, I was able to identify dozens of cases that have these new rejections, and I have attached some of the more interesting ones for you. [These can be found at the end of this post.] I focused mainly on applications with product claims, and pulled up method claims only incidentally.
“As expected, these new “product of nature” rejections go far beyond nucleic acid claims. Interesting examples include multipart vaccine preparations, industrial enzymes, organic crop protection products, a pharmaceutical composition and method of treatment involving an anticancer molecule from a marine sponge, and even a method for washing laundry. We’re also now seeing rejections of monoclonal antibody claims, which is something we were worried would happen. Perusing the attached rejections only takes a half hour; it’s a quick way to get an impression of what’s going on.”