Abolishing gene patents will deter, not promote, innovation, as the patent eligibility of isolated DNA molecules provides incentives necessary for development of life-enhancing diagnostics and therapeutics.
- R&D to identify genes, their sequences, genetic variations, and their disease correlation is very costly.
- Claims like those of the patents at issue in the Myriad Genetics lawsuit have been a key foundation supporting the massive investment of time and capital that is necessary to bring life-enhancing DNA-based diagnostics and therapeutics to the public.
- “Investors believe that in order for the biotechnology sector to succeed, it is critical that biotechnology firms be able to obtain and enforce strong patents. Biotechnology companies, particularly those that have yet to put a product on the market, must rely on substantial investment funding in order to survive.”
- 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 both from past reliance and forward-looking perspectives.
- Most obviously, invalidating the approximately 50,000 issued DNA patents could cripple or derail many, particularly early-stage, biotech companies that are on track to make important innovations.
- Abolition of DNA patents would shake investor confidence with net results of severely impeding research, development and innovation.
- In addition to undermining the viability of the U.S. biotechnology industry, a determination that isolated nucleic acids are patent-ineligible subject matter would put at risk the validity of a whole host of patents on isolated natural substances of great medical, industrial, and agricultural value. For example:
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®;
iv. U.S. Patent No. 5,820,870 claims an isolated human papillomavirus envelope (HPV) protein that forms the basis for the Gardasil® cervical cancer vaccine, which was first approved in the United States in 2009 and is effective in preventing the most common forms of HPV-associated cervical cancer in young women;
v. Another affected area would be new life-saving vaccines and protein drugs made using isolated DNA molecules that would no longer be patent protectable (e.g., EPO). If neither isolated DNA molecules coding for proteins nor the proteins themselves are patent-eligible subject matter, private enterprise incentives to discover and develop such life-saving therapies would be greatly diminished.
vi. Industrial enzymes derived from patent-protected isolated DNA molecules would be at similar risk.
vii. Genetic tests based on patent-protected isolated DNA molecules would share the same fate.
Taking the arguments of DNA patent opponents to their natural conclusion would result in a long list of medically important inventions like these losing patent-eligibility.