Human genes can be patented. That issue was settled years ago. Or so many experts thought.
The U.S. Patent and Trademark Office (USPTO) began issuing patents on human genes in 1982. Since then, the agency has granted 3,000-5,000 such patents, covering more than one-fifth of all human genes. The agency has issued, in addition, 47,000 patents on inventions involving human genetic material.
Only one company in the U.S. can legally test for these gene mutations. That company is Myriad Genetics Inc., a medical services firm based in Salt Lake City, which has patented the BRCA1 and BRCA2 genes. More specifically, the company has patented the purified forms of these genes, which are required for both scientific research and medical tests.
Myriad has used these patents to prevent any other organization from performing BRCA1/2 gene tests. And the company has parlayed its monopoly on the tests into a nice revenue stream. In 2008, Myriad's revenues from these tests were $222 million, while costs were just $32 million.
Because this was merely a district court decision, the ramifications will be limited, according to many experts. Financiers may become more skittish about investing in biotech firms, fearing that biotech innovations may not be protected by patent law.