The Myriad case will affect access to products on the basis of their patents. If the courts uphold Myriad’s gene patents, companies relying on patenting DNA sequences will be able to demand higher prices because of limited market competition. Conversely, if the courts invalidate Myriad’s gene patents, 50,000 DNA patents already issued may be at risk of being invalidated. Companies holding those patents will be unable to block competitors from entering the market, which will, in turn, result in price reductions.
The Myriad case will also have an impact on innovation. The ability of companies to patent their assets directly affects their ability to secure investment. Invalidating the nearly 50,000 DNA patents already issued will hurt the companies that hold them — in particular, early-stage companies looking to recruit investors. Without the market exclusivity afforded by patent protection, companies will struggle to support research and development, and many potentially life-saving technologies may never come to fruition.
Broad application of Mayo could have profound implications for biotechnology and other industries. Many claimed inventions could be found unpatentable under Section 101 if analyzed under the reasoning in Mayo. Even basic method-of-treatment claims could be rendered unpatentable because it could be argued that the effect of a compound on the body is a natural phenomenon, and that the application of medicines to patients needing treatment could be conventional under Mayo. Moreover, patents for isolated natural substances may be invalidated. U.S. Patent No. 7,341,750, for instance, is directed to a compound isolated from the bark of Ginkgo biloba, a type of tree. The isolated bark is believed to have useful antiplatelet activity and thus may be important in treating vascular diseases.
If neither the isolated DNA molecules nor the proteins that are encoded by them are patent-eligible, the development of vaccines and protein drugs using isolated DNA molecules may be affected. Gardasil, for example, is based on patented claims directed to an isolated human papillomavirus (HPV) envelope protein. Without patent protection for the HPV protein, the vaccine would likely not have been developed.
The suit against Myriad represents an opportunity to resolve the patent eligibility status of DNA sequences. Ultimately, it will have important implications for drug and diagnostics innovation.