The U.S. Supreme Court will finally take up the legality of gene patents Monday morning, when it hears oral arguments in the four-year-old legal wrangle over the patenting of breast cancer susceptibility genes BRCA 1 and 2.
At issue is the validity of the seven patents issued to Myriad Genetics for BRCA 1 and 2 by the U.S. Patent and Trademark Office (USPTO). In 2009, 20 medical associations and individual doctors led by the Association for Molecular Pathology (AMP) and assisted by the American Civil Liberties Union (ACLU) and Public Patent Foundation (PUBPAT) sued Myriad and USPTO over the patents, as well as Myriad’s method for analyzing sequences of those genes for mutations associated with breast cancer.
AMP and co-plaintiffs argue that the patents on BRCA 1 and 2 are unconstitutional and invalid, contending that human genes are unpatentable under Section 101 of Title 35 of the U.S. Code because they are “products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.”
Myriad counters that patent protection is needed for companies to justify the millions of dollars spent creating diagnostics like its BRACAnalysis® test, which took more than 17 years and $500 million to develop. Myriad also says a Supreme Court decision against the company would discourage large-scale biotech innovation, and that the issue should be decided by Congress rather than the courts.
In 2010, the U.S. District Court for the Southern District of New York sided with AMP, ACLU and PUBPAT in denying patent eligibility for Myriad’s method claims directed to comparing or analyzing DNA sequences using the genes. While that part of the decision was upheld by a divided U.S. Court of Appeals for the Federal Circuit (CAFC), a 2-1 majority sided with Myriad in overturning two other parts of the district court decision.
CAFC found the BRCA 1 and 2 genes represented “a non-naturally occurring composition of matter,” and thus were patentable under Section 101. The appellate majority also upheld Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells.
Today, the Supreme Court is only taking up the first of three questions it asked both sides in the case to answer in written briefs: Whether CAFC applied court precedents correctly in 2011 and last August when it concluded the BRCA gene patents were defined and isolated by human inventors, and thus were “product[s] of human ingenuity ‘having a distinctive name, character [and] use.’”
“If the Supreme Court revisits section 101 and patentability, it may go further than gene patents, since the court’s decision could affect anything that could be isolated from the body and then be used in a particular way,” Lisa A. Haile J.D., Ph.D., a partner with DLA Piper U.S. and co-chair of its global life sciences practice, told GEN. “Potentially, any sort of what would have been a naturally occurring product is going to be affected.
The obvious examples of such naturally occurring products, Dr. Haile said, would be genes and proteins. But proteins also include antibodies, which are still natural occurring whether they are made recombinantly or isolated from the body. Also vulnerable, she added, are patents for chimeric antibodies and humanized antibodies, which are still basically identical to what is in the body whether they are either isolated from the body, or made in the lab.
If there’s any comfort to biopharma companies under that scenario, Dr. Haile added, it is that many gene patents are either already expired or close to expiring.
“An adverse decision on the patentability of genes may not have the impact on the industry that some have predicted,” she said.