Gene Patent Myths

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:

1. 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.
2. 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:

1. 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.
2. 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.
3. 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?