What is the Future of Gene Patents – Another Left Curve Added by Technology Advances
Posted Oct 10 2009 10:01pm
This is something else from the old methodologies of doing business and it’s not going away any time soon, but are there lines crossed when curing disease gets in the way of a company maintaining and not sharing a patent? This really pretty much opens that discussion. In working with today’s complicated algorithms for both creating drugs and genomics markers, a lot of work can be cut to the chaise if the availability of some already proven and functioning code is not having to be written from the ground up. With patent protection and no availability, this is what we have today with one company in the driver’s seat collecting their royalties.
Also, the one company collecting the money though may have spent millions of dollars on their research and it is only fair that there be compensation in that area as well, so there’s the flip side of this. In this area of patents, we are not talking about the machines that do the sequencing as they are a combination of a machine and software, although they have their battles amongst themselves, its the Intellectual Property of the algorithms that identify the markers. This is a huge amount of data and time to isolate and find the mysteries locked in our DNA. The sequencing companies are sometimes battling themselves and a related link on such a story can be found below and there’s more.
The BRACAnalysis test to establish hereditary genetic risk for breast and ovarian cancer is held by a company by the name of Myriad and they do all the testing. Recently I posted about the additional rules and regulations for this test being increased by United HealthCare, due to the cost, and when only one company does the testing, well they somewhat have a lock on the business and everyone goes to them. What if this technology could be expanded upon for additional information and potential cures? It’s just like everything else in healthcare with the demand to bring down pricing with having one source only, something the drug companies too are very well aware of, see this example of Teva suing Merck over the question of their patent with the drug Singulair.
So what is in a patent anymore? How long and does the issuing of a patent hold up progress for disease cures? If the rewards vanish or are much smaller, would this hinder progress? This is a tough one here as there could probably be a little give and take from both sides, perhaps the length of the patent would be shorter, or pay for the use of the patented technology and the related algorithms. The old patent procedure just isn’t what it used to be and the economy is a big source of pressure for revisions and there’s not enough money and time to be spent in court trying to determine this anymore. The longer items from science are held up in court, the longer it takes for cures to be created. You do see drug companies that license other pharma companies to sell their drugs, so perhaps this is not a bad idea to begin licensing the algorithmic technology for starters. BD
NEW YORK (GenomeWeb News) – The Department of Health and Human Services committee charged with advising the agency on genetics policy has recommended in a new draft report making gene patents exempt from infringement liability — a move that would allow researchers and clinics to use and offer genetic information and genetic tests even on genes that are patented.
If implemented, such policies could make it difficult or impossible for holders of patents on some genes and genetic testing technology to sue others using those genes.
The recommendations in the report are not final and are being discussed at a meeting taking place in Washington, DC, today and tomorrow. The task force is expected to issue a final report by the end of the year.
The practice of exclusive licensing through a sole provider also causes problems when it is combined with a multi-payer healthcare system and "often results in patient access problems," the report states."Sole providers fail to secure coverage from some major payers, including out-of-state Medicaid programs," which makes it difficult for some patients to get genetic testing covered.
The suit was filed against Myriad Genetics, the US Patent and Trademark Office, and the University of Utah Research Foundation, which holds the patents to the BRCA1 and BRCA2 genes. The research foundation exclusively licensed the rights to perform diagnostic tests on the genes to Myriad, which provides genetic testing for ovarian and breast cancer.