Federal Circuit Ruling In Myriad Genetics: Genes Are Patentable

Federal Circuit Ruling In Myriad Genetics: Genes Are Patentable

Danny Titolo is a JD candidate at Osgoode Hall Law School.

The Court of Appeals for the Federal Circuit recently overturned a Southern District of New York court’s decision by ruling that genes can be patented. The Federal Circuit decided that DNA isolated from the body was patent-eligible since it is “markedly different” from the DNA that exists naturally in chromosomes. This means that once DNA is isolated it is no longer a product of nature, hence, eligible for a patent.

The Federal Circuit ruled that Myriad Genetics is entitled to two human gene patents which are used as potential predictors for breast and ovarian cancer in women. The genes in question are BRCA1 and BRCA2. The American Civil Liberties Union (ACLU) is challenging the BRCA patents held by Myriad Genetics on the grounds that they inhibit scientists from conducting the research that is necessary to produce better cancer treatments. 

Myriad Genetics feels that protection of their BRCA patents is necessary to ensure that the substantial time and money that has been invested in developing these tests is not wasted. The Southern District of New York court did not agree and originally overturned some of the BRCA patents on the grounds that isolated DNA is the same as DNA found in nature and not eligible for patent protection.

Although this case will likely be appealed and potentially reach the Supreme Court, the decision does have possible consequences. It permits Myriad Genetics to exclude others from researching the BRCA patented genes. This will ultimately allow them to monopolize the market for the genetic testing of hereditary breast and ovarian cancer.    

The Federal Circuit ultimately ruled in favour of Myriad Genetics allowing their BRCA patents to remain almost intact. The majority made four main rulings:

  1. The District Court did have jurisdiction in this case
  2. The District Court erred in ruling that Myriad’s claims directed to isolated DNA were invalid
  3. Myriad’s claims directed to comparing or analyzing gene sequences were invalid
  4. The District Court erred in ruling that Myriad’s claims directed to screening potential cancer therapeutics via changes in cell growth rates were invalid

The fourth ruling was a reversing of the District Court decision that analyzing whether genes have mutations that could increase the risk of cancer was not patentable since it involved “patent-ineligible abstract mental steps.”

The ruling also goes against arguments made by the Obama administration last year that isolated DNA should not be patented. Although this decision may not be looked at favourably by many Democrats, the biotechnology industry certainly thinks otherwise. Since thousands of genes have already been patented, this decision will encourage the practice of gene patenting and potentially encourage innovation through competition.

The ethical and moral issues that revolve around patenting genes are not a recent phenomenon and have been discussed for a number of years. Not only do critics feel that patenting genes is unethical, they also feel that patents will create monopolies which will ultimately drive-up the cost of testing. The test for breast cancer screening that once cost $1,000 now costs $3,000 simply because Myriad Genetics owns the patents and can charge higher prices.

The majority opinion, given by Judge Lourie, was that the isolation of DNA created a new and unique chemical entity. Since it is different from the DNA in the body, it is not a product of nature.

Although the decision does favour Myriad Genetics, the 2-1 split decision does not make it very convincing and it could potentially be overturned on appeal. It was clear that the judges could not agree amongst themselves on whether pieces of the human genome are patentable. 

The plaintiffs are currently considering whether or not to ask the appellate court to rehear the patenting aspects of the case or to appeal to the Supreme Court.