Gene Patents and the Myriad patent case reveal the confusion that often occurs when you mix science, law, politics, and emotion. This article provides a digest of a series of blog posts on Biotech-Now that address common myths in the gene patent debate.
Myth 1: Your Genes are Patented
Fact: It is not possible to patent your genes
The term “gene patent” is a misnomer, because genes as they exist in the body cannot be patented. Because a naturally-occurring gene – even a newly-discovered one – cannot be patented, patents don’t provide ownership rights over our genes, and nobody can infringe a patent by having a certain gene, or by passing it on to their children.
For more on what actually is patented read Debunking the Myth: Your Genes are Patented
Myth 2: ‘Gene Patents’ are not necessary for health care innovation.
Patents on DNA preparations or sequences are often the first patents upon which a later technology platform or portfolio is built. These patents are often in-licensed from universities by small start-up companies for the purpose of additional R&D, evidencing that the public/non-profit university sector cannot bear alone the cost of development of these inventions into useful products.
It is precisely these types of early-stage companies that hold roughly 2/3 of the future clinical pipeline for patients, and are developing novel DNA-based approaches to dealing with environmental contamination, climate change, renewable energy, and more sustainable agriculture. Without these basic patents, these early-stage companies will not be able to attract the necessary funding for further R&D and to ultimately develop an approvable product based off of the original DNA-based invention.
For more relevant facts read ‘Gene Patents’ are not necessary for health care innovation.
Myth 3: ‘Gene Patents’ Stifle Research?
1. The Federal Trade Commission has concluded that concerns that strong biotechnology patent protection would obstruct commercialization have yet to materialize. Indeed, the FTC recently concluded that concern that patenting upstream technology, or “research tools,” would actually obstruct commercialization of new products and hinder follow-on innovation in biotechnology “has yet to materialize.”
2. In 2007, David Adelman from the University of Arizona and Kathryn DeAngelis from Piper Rudnick published a detailed study of more than 52,000 biotechnology patents found “few tangible signs of patent thickets that define the anti-commons.”
For more evidence that ‘gene patents’ do not stifle research read ‘Gene Patents’ Stifle Research?
Myth 4: Banning Gene Patents Will Promote Innovation?
Patents on isolated DNA molecules have featured prominently in innovative biotechnology success stories:
Amgen holds claims to isolated DNA molecules encoding the human protein erythropoietin. Amgen’s pioneering work with EPO-encoding DNA radically changed anemia treatment worldwide.
Chiron’s cloning of the HCV genome led to its patenting of certain HCV genes. Its HCV patent estate attracted the investment dollars and license revenues that made possible dramatic changes in how the world’s blood supply is tested. By screening for HCV nucleic acids, the incidence of contracting Hepatitis C during a blood transfusion dropped from an alarming 1 in 25 chance to near zero.
A decision that isolated DNA molecules are patent-ineligible would have far-reaching negative consequences for approximately 50,000 issued DNA patents both from past reliance and forward-looking perspectives. Some innovative technologies directly affected would be:
i. U.S. Patent No. 7,341,750 has claims directed to a compound isolated from the bark of Ginkgo biloba that has useful anti-platelet activity and thus may prove to be an important medicine in vascular diseases.
ii. U.S. Patent No. 7,307,057 has claims directed to an antibiotic isolated from a particular microorganism that has shown to be effective against even some of the most dangerous multi-drug resistant bacteria in existence today.
iii. United States Patent 7384953 claims a new highly-purified preparation of rapamycin (sirolimus), an immunosuppressant and antifungal compound discovered in a ground fungus on Easter Island, and first patented in purified form in 1975 (U.S. 3,929,992, now expired), available in the United States under the trade name Rapamune®;
For more biotechnology innovation that would be affected by a ‘gene patent’ ban read Banning Gene Patents Will Promote Innovation?
Myth 5: Myriad Genetics’ actions justify a ban on gene patents?
The following information was provided by Myriad’s General Counsel during his presentation on the subject during a recent BIO IP conference:
In order to develop and then ensure the widest possible distribution of the Myriad BRCA diagnostic test, Myriad needed to make the initial discovery, educate the medical community on the values of personalized medicine (the BRCA test), convince insurance companies to cover the test, and educate the patient community. All of these activities took significant investment. Investors will not make that investment without a patent. Discovery of a gene mutation alone will not get patients access to a test.
Myriad spent $500 million dollars in the first 10 years but did not fully recoup its investment and make its first dollar of profit until 2005. It filed for the patent in 1994 and it was issued in 1997.
The following information comes from U.S. District Court Judge Sweet’s Opinion:
To compete with Dr. Francis Collins’ team and their substantial grant from NIH, Dr. Skolnick and a local venture capital group formed Myriad and Myriad received $5 million in funding in 1992, $8 million in 1993, and $9 million in 1994.
According to one analysis, the NIH contributed only 1/3 of the funding for the identification of BRCA1. That means that 2/3 of the funding for identification came from other sources like private investors.
90% of the tests Myriad performs are covered by insurance at more than 90% of the test cost.
For more facts read Myriad Genetics’ actions justify a ban on gene patents?