By Ryan Abbott
While awaiting the torrent of academic commentary on this case that is no doubt forthcoming, for now I thought I’d highlight a few interesting aspects of today’s unanimous Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, 569 U. S. ____ (2013).
Briefly, this case concerned whether genes can be patented. The company Myriad Genetics held several patents related to two genes: BRCA1 and BRCA2. When mutations of these genes are present, it may indicate that a woman is at a high risk for getting breast or ovarian cancer. Myriad also held patents on a proprietary test to evaluate for the presence of BRCA gene mutations that costs over $3,000. This screening has been in the news recently due to Angelina Jolie’s decision to undergo preventive double mastectomy after testing positive for BRCA mutations.
In today’s case, Myriad’s patents were being challenged because they limited competition from other companies and researchers that could have independently tested for the same gene mutations. The outcome of this case has been critically anticipated for years because of its impact on patient access to medicines and funding medical research and development. Thousands of human genes have been patented in the U.S. over the past 30 years.
Before reaching the Supreme Court, a U.S. District judge in New York invalidated Myriad’s patents in 2010, ruling that genes were ineligible for patent protection as “products of nature.” However, the Court of Appeals for the Federal Circuit disagreed, holding that genes were eligible for patent protection because DNA isolated from the body is “markedly different” in chemical structure than DNA as it exists inside the body. The Supreme Court remanded the decision back to the Federal Circuit in light of its decision in Prometheus, and the Federal Circuit affirmed its decision that DNA was patent eligible.
Today, the Supreme Court held that a naturally occurring DNA segment is a product of nature and therefore not patent eligible merely because it has been isolated. However, in an apparent attempt at compromise, the Court did rule that complementary DNA (cDNA) is patent eligible because it is not naturally occurring. cDNA is DNA that specifically codes for amino acids. It is synthesized from naturally occurring messenger RNA (mRNA). Some retroviruses can also synthesize cDNA naturally.
Overall, this decision is a major victory for patient access. Myriad’s patents were keeping women from getting necessary screening. While this comes at the biotechnology industry’s expense, the effect on industry will be modest. Although naturally occurring DNA is longer patent eligible, patents are still possible for new applications of knowledge about genes such as new testing methods.
Today’s decision was not a surprise. The U.S. had been an international outlier in terms of granting these patents. In fact, Myriad’s stock price initially rose after the decision was released – likely because of widespread predictions that Myriad was going to lose across the board. Instead, Myriad can claim the Supreme Court’s decision to uphold patentability of cDNA was a partial victory. The company also notes they still have over 500 claims in 25 different patents related to their test for BRCA. Even leaving this aside, Myriad is going to do just fine. The company’s patents related to BRCA1 and BRCA2 were due to expire soon anyway. In the meantime, on the strength of these patents Myriad succeeded in transforming itself from a 1994 start-up to a publicly traded company employing about 1200 people in 2012 and grossing around $500 million annually.
The Court tried to draw a clear line between “naturally” occurring isolated DNA and “synthetically” created cDNA. Yet whether cDNA is meaningfully less natural than isolated DNA is questionable. The body essentially produces cDNA in the form of mRNA. Granted, a cDNA sequence is not naturally occurring, but the informational quality of the genetic code has not changed from the underlying RNA. The cDNA has a different chemical structure than mRNA to be sure, but in the same opinion the Court ruled a mere difference in chemical structure wasn’t enough to render isolated DNA patent eligible. What makes cDNA different?