US District Judge Rules Gene Patents Invalid

shriphani writes "A US judge has ruled that Myriad Genetics' breast cancer gene patent is invalid. Hopefully this will go a long way in ensuring that patents on genes do not stand in the way of research. From the article: 'Patents on genes associated with hereditary breast and ovarian cancer are invalid, ruled a New York federal court today. The precedent-setting ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes.'"

Comments

Don't forget GMOs

[JumboMessiah]

Gene patents are also big in the agriculture industry. And they actively sue to keep it that way.

Re:Conversely

[NFN_NLN]

However, most research and medical breakthroughs come from publicly funded money, research, and institutions. They only find their way into the corporate portfolio latter.

[citation needed]

http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml

Completed in 2003, the Human Genome Project (HGP) was a 13-year project coordinated by the U.S. Department of Energy and the National Institutes of Health.

  Project goals were to

        * identify all the approximately 20,000-25,000 genes in human DNA,
        * determine the sequences of the 3 billion chemical base pairs that make up human DNA,
        * store this information in databases, ...

Re:Conversely

[besalope]

The drug formulas can still patented.

The judge just invalidated corporate patents that restricted others from working on trying to cure problems from "patented" genes without paying royalties.

Re:Conversely

[reverseengineer]

The real issue, in my opinion, with these patents is that Myriad tries to make the information of the gene sequence essential to any detection method for that gene. Take a look at Myriad's patent for the breast cancer-related gene BRCA2. Right at the beginning, "Specifically, the present invention relates to methods and materials used to isolate and detect a human breast cancer predisposing gene (BRCA2), some mutant alleles of which cause susceptibility to cancer, in particular breast cancer. More specifically, the invention relates to germline mutations in the BRCA2 gene and their use in the diagnosis of predisposition to breast cancer." So at first glance, you might think that this patent refers to a diagnostic test for BRCA2, which seems to be an acceptable place for a patent for many people. After all, DNA sequences are just molecules, and there are any number of non-contentious patented tests for biological molecules already- think of glucose test strips, for instance. Manufacturers have found ways to patent various advances in testing for blood glucose without actually asserting a patent on glucose itself.

However, when you test for something like glucose, the test result is going to be a concentration. When you talk about performing a test for BRCA2-based cancer susceptibility, you don't just need to "detect" BRCA2, but be able to isolate it and determine whether it differs from the wild-type BRCA2. So Myriad had the idea that in their patent claims they could define their "methods and materials" to be both the likely molecular bio technique intermediates, and also the molecules that are the theoretical outcomes of any BRCA2 test.

Paraphrasing some of their claims: -We claim the isolated normal BRCA2 sequence, and any isolated subset of that sequence comprised of at least 15 contiguous nucleotides.
-We claim the isolated major mutant sequence of BRCA2 known to be involved in susceptibility to cancer, and any isolated subset of that sequence comprised of at least 15 contiguous nucleotides.
-We claim nearly 40 different variants of the major mutant sequence.
-We claim any sort of cloning vector, expression vector, recombinant cell line, or PCR primer involving an at least 15 contiguous nucleotide stretch of any of the above sequences.

So Myriad was trying to claim that the invention was a diagnostic method, just that any molecule corresponding to the nucleotide sequences they claimed were an intrinsic part of the "method." What's interesting about the "15 contiguous nucleotides" mention that keeps cropping up is that BRCA2 is over 11000 nucleotides long, producing a protein 3400 amino acids long, such that Myriad laid claim to tiny fragments of the gene which would have had no BRCA2 function on their own.