US DOJ weighs in on battle over gene patents

US DOJ weighs in on battle over gene patents

Ivy Tsui is a JD candidate at Osgoode Hall Law School

The U.S. Department of Justice (“DOJ”) filed an amicus brief to support the ACLU and the PUBPAT in a lawsuit challenging Myriad Genetics’ patents on the BRCA1 and BRCA2 genes. Previously on IPilogue, Dan Whalen covered some of the social policy issues raised by gene patents. In this post, I will discuss the science that is behind some of the legal arguments in the amicus brief and the potential impact on scientific research if gene patents were invalidated.

In the brief, the US DOJ argues that unaltered DNA should not be patented because the DNA has “merely been isolated from the human body”. It distinguishes such naturally occurring DNA sequences from genetically-engineered cDNA sequences, vectors, recombinant plasmids, and chimeric proteins, all of which are patentable. It further argues that the process of isolation does not transform a “product of nature” to “man-made invention”. It also compares isolated DNA to extracted mined coal, reasoning that because such coal is not patentable, isolated DNA should not be patentable as well.

With the advent of high-throughput sequencing technologies, the human genome can be sequenced at an unprecedented rate without offering any discoveries on the functions of the genes. If the mere knowledge of a DNA sequence is accepted as patentable, it would pose several potential dangers to the scientific community, including introducing monopolies of gene patents to large genome sequencing centres, inhibiting downstream therapeutic development, and undermining the quality of scientific results.

It is important for the USPTO to ensure that gene patentability guidelines differentiate patentability of DNA sequences based on their utility. A naturally occurring or mutated DNA sequence may contain sufficient utility for patent granting if the scientist can discover its association with prognostic or diagnostic assessments. For example, a mutation that contributes to an increased risk of disease is a “discovery” and not “isolating what has always existed in nature”. Myriad’s BRCA gene patent, which forms the BRACAnalysis diagnostic test, is aimed at evaluating susceptibility to hereditary breast and ovarian cancer.

However, it is inappropriate for the DOJ to compare isolated genes to mined coals. The haploid human genome contains over 3 billion DNA nucleotides which encode over 20,000 protein-coding genes. Nucleotides, the building block of a gene, might be comparable to coals. Each gene carries specific functions, and different variants could exist for each gene, which could also contribute to diseases differently. An example of this is the CFTR gene that is involved in cystic fibrosis, where several patents were issued for testing different mutations in the CFTR gene.

There are compelling reasons for concluding that gene patents provide an incentive for investment in biotechnology.  The Myriad (MYGN) BRACAnalysis diagnostic test drove revenue up in the first quarter of fiscal 2011 by 7.2% to $80.7 million from $75.3 million one year ago. Technology transfer offices are locally set up at university research institutions to facilitate academic researchers in the commercialization process. It is now widely accepted that if research results are to be translated from the bench-side to bedside, patenting is an imperative process to attract commercial interests for the investment in costly, and often lengthy, clinical trials.

One might argue that the government’s position is “contrary to the longstanding practice” of gene patents. “If adopted, the Department of Justice’s position would undermine US global leadership and investment in the life sciences,” said Jim Greenwood, president and chief executive of the Biotechnology Industry Organization, as reported in Nature News. Also, if the USPTO enacts such a new gene patent policy, it could potentially invalidate more than 2,000 gene patents that have been approved.

It is important to realize that the DOJ is simply invalidating patents that pertain to naturally occurring DNA sequences alone. The narrowing of patentability could be beneficial to the community by encouraging intellectual scientific research rather than promoting a rat race of genome sequencing. However, the DOJ’s brief is unclear whether natural DNA sequences that contain risk assessment utility would also be invalidated.

Stanford law professor Hank Greely also raises several interesting questions in his blog regarding this case: “I wonder what it means for organic chemicals that exist (or might exist? or probably exist?) in nature but are produced in pure form for the first time. And I wonder what it means for Myriad’s genetic tests – could they still have a patent on the process of comparing a person’s DNA to the wild type (and known variants) of the BRCA 1 and 2 sequence even if they didn’t have a composition of matter patent on that sequence?”