SCOTUS Rules on Gene Patents

The Supreme Court ruled last week that genes cannot be patented, but cDNA can be. This blog post provides some background on the case, ASSOCIATION FOR MOLECULAR PATHOLOGY ET AL.v. MYRIAD GENETICS, INC ET AL. Myriad identified and isolated two genes that are associated with high risk for breast cancer, BRCA1 and BRCA2, and sought patents for the isolated genes. The case hinged largely on a debate over the relation of patents to progress. The Association for Molecular Pathology and the American Civil Liberties Union argued that granting exclusive claims to genes would stymie further research, limiting what scientists unaffiliated with Myriad would be able to do. On the other hand, such exclusivity incentivizes research and development, the costs of which could be otherwise untenable.

"There have been mixed reactions, everything from 'Armageddon!' to 'meh,'" says Dr. John Murray. Dr. Murray has a PhD in genetics and practices intellectual property law at the NY firm Tannenbaum Helpern Syracuse & Hirschtritt. "I think the truth is somewhere in the middle."

Based on the arguments, the ruling matched what observers expected. It overturns thirty years of patent office decisions in which gene claims were granted, and concern has been expressed that thousands of prior patents might now be endangered. However, points out Daniel Fischer in this Forbes article, many of those patents are old and near expiration.

Dr. Murray elaborates,

"The stuff about it being a disaster for biotech is just overwrought. We're in a post-Human Genome Project and Encode Project world. In the early 90s, you could just ride out into the frontier of the human genome, stake your claim, and they'd give you a patent on it. How many biotech companies are dedicating their resources to isolating individual human genes now? I would guess none or very few, because at this point it's mostly already been done. Now it's more about developing ways of using these genes, diagnostic techniques, or ways of manipulating the DNA. To get a patent, you have to be able to demonstrate that your invention is non-obvious. But when it comes to isolated gene sequences, these days I can just go on my computer and get those, so it's not at all non-obvious. The kind of research this might have killed has already been done."

The Court was careful to explicitly circumscribe the impact of the ruling. The Opinion states, 

"It is important to note what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent...Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes...Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered."

The compromise seems unlikely to devastate biotech companies. While some companies will take a hit, says Dr. Murray, it won't be a fatal one. "Any smart biotech company, including Myriad, will have claims on their 'killer apps' every which way from Sunday. Moving forward, there will be a real premium in drafting methods claims, identifying what you're doing differently from other people."

Unless you work for a biotech company with an ossified business model, the most depressing element of this case might be the lack of scientific understanding on display throughout the case. According to Justice Thomas, cDNA is patentable because "the lab technician unquestionably creates something new when cDNA is made." Dr. Murray calls the ruling "scientifically and intellectually incoherent." The debated claims cover the information expressed in the exons. "When exons are separated from introns naturally, it's unpatentable. If the information is separated in a lab to make cDNA, it's mysteriously patentable, even though it's the same information. So you could certainly apply better science, which the Court didn't do. They were clearly just trying to make sure they didn't blow up the biotech industry by invalidating cDNA," says Dr. Murray.

Dalila Argaez Wendlandt, a partner with Ropes & Gray, points out that DNA/cDNA distinction could allow for technical loopholes. "What if you took that same cDNA sequence and added non-functional introns?" she asks in Fisher's piece.

Dr. Steven Salzberg, Professor of Medicine and Biostatistics at the Institute of Genetic Medicine at the Johns Hopkins University School of Medicine, highlights some of the Court's basic errors in this article. "It's troubling that the highest court in the land can't get even the basic facts of molecular biology right when writing a decision that has such fundamental importance to genetic testing, the biotechnology industry, and health care," he says.

On the plus side, screening for the BRCA genes is likely to become much more affordable, says John Wilbanks, chief commons officer at Sage Bionetworks, in this Wired article. "By making that data free, there is a lot of room for public good and public and private innovation."

Disclaimer: The views and opinions expressed in the articles on nyas.org are those of the author(s) and do not necessarily reflect the views or opinions of the New York Academy of Sciences.