14 Mar
  • By tbm2421
  • Cause in Africa

OFA Testing Labs & Patents

Another comment we often hear from callers is that “OFA likes” a particular lab and we take test results only from that lab because we like them. OFA doesn’t have a preference for any one lab over another—we’re happy to do business with all of them. The reason OFA accepts results only from one lab for a particular test is because that lab (or university, etc.) holds the patent on that test, and is the only lab that has a legal right to use the test, unless they license rights to another lab.

Actually patents have been issued in the United States since President George Washington signed a bill that created the U.S. patent system in 1790. The patent system was designed to give an inventor (and later researchers) the sole legal right to profit from his discovery or invention.

Back to the modern day: as one example, researchers at Washington State University found the mutation of the multi-drug resistant gene (MDR1), developed the MDR1 test and subsequently obtained the patent for the test. The university has allowed labs in Canada and Australia a license for the MDR1 test, but no labs in the U.S. Because the MDR1 test is patent protected, OFA only accepts results for the MRD1 test from Washington State, HealthGene in Canada, and ASP Genetics and Genetic Technologies in Australia, all three of which obtained a license to use the test with permission from Washington State.

In a scenario with the opposite result, researchers at the University of Missouri and the Broad Institute of MIT/Harvard discovered the gene mutation for Degenerative Myelopathy. Neither MU or the Broad Institute pursued a patent for the DM test, so it is not patent protected and OFA is able to accept DM test results from numerous labs.

Until last week, Optigen held the patent for four tests: PRA-prcd, Collie eye anomaly (CEA) and congenital sationary night blindness (CSNB) and retinal dysplasia/oculoskeletal dysplasia (RD/OSD). Labs in Australia were issued licenses to perform these tests but no U.S. facilities were legally allowed to perform the test; thus OFA only accepted results from Optigen and the licensed labs. On Friday, March 11, 2016, Optigen granted “an exclusive sub-license” to Paw Print Genetics, allowing that lab to also perform these tests, and OFA will now accept test results from Paw Prints for these tests.

So there you have it!