California biotechnology companies are drawn to the outcome of a case recently debated in the U.S. Supreme Court. Justices are considering whether a business that offers predictive cancer testing can retain a patent for a pair of gene sequences, DNA segments that determine heredity.
Justices debated Myriad Genetics’ intellectual property rights to hold on to a patent sanctioned by the U.S. Patent and Trademark Office. The company argues the patent led to the development of a vital medical test for women, whose genetic makeup shows ovarian and breast cancer susceptibility.
The other side of the argument comes from scientists who say their medical research is limited by Myriad’s patent lock. Breast cancer patients are also plaintiffs in the court battle championed by the Public Patent Foundation and The American Civil Liberties Union. Patients contend Myriad holds an unfair monopoly on expensive predictive cancer testing that obstructs alternate diagnostic opinions.
The lawsuit was filed in 2009 claiming Myriad had no right to patent a natural product – human genetic material. A federal circuit court sided with Myriad with the contention that the company’s invention was “new and useful.”
Several Supreme Court justices seemed to agree “products of nature” were off limits to patentability. A justice stated that Myriad could secure a patent for the way it uses gene sequences, but should not have an exclusive claim to the “underlying substance” of DNA segments.
Another justice used simpler term. He stated Myriad could not patent a “snip” of human DNA any more a researcher could claim exclusivity for another natural product like a plant leaf. The U.S. patent office has a 30-year history of granting isolated living cell patents, which seems to conflict with the justices’ arguments.
California intellectual property attorneys are anxious to learn what justices will decide in June. A ruling in either direction would have considerable implications for intellectual property clients in the scientific business community.
Source: latimes.com, “Supreme Court critical of patents on human genes,” David G. Savage, April 15, 2013