Prostate cancer and patenting genes

Prostate cancer is the most prevalent form of cancer among males, but at present there is no standard test for the disease. It is no wonder, then, that researchers at Johns Hopkins University and several other major universities across the country have been working diligently over the past twenty years to discover the gene underlying this predominant cancer. In an article published in the New England Journal of Medicine, researchers reported their findings on the HOXB13 gene.

Scientists determined that the HOXB13 gene variant is linked to a higher risk of developing hereditary prostate cancer, especially among younger men. This gene, in its unmutated form, directs the development of the prostate. In the study, consisting of over five thousand men, 1.4% of the participants had the mutation. Those men having the mutation were also far more likely to have one or more first-degree relatives with the disease.

In light of recent legal and legislative hot topics, one might wonder whether the HOXB13 gene will go the way of the BRCA1/2 genes, which predicts susceptibility to breast and ovarian cancers. The Supreme Court is currently deciding whether to grant certiorari for the controversial Associated Molecular Pathology v. Myriad Genetics case respecting these genes. The district court for the Southern District of New York initially invalidated the patents Myriad Genetics held on these genes, finding human DNA, even when isolated and purified, to be unpatentable subject matter. The Federal Circuit reversed this decision.

Among the arguments before the Supreme Court for reversing the Federal Circuit’s decision are those pertaining to the public’s access to diagnostic tests. Myriad currently holds a monopoly on tests identifying the BRCA1/2 gene mutation, charging patients at least $3,000 each for the screening. The exams rarely qualify for insurance coverage, and Myriad’s monopoly precludes patients from seeking a second opinion. In view of these limitations, many feel that allowing gene patents, at least in the form in which they currently stand, unfairly limits public access to critical health information.

If the scientists behind the HOXB13 discovery also choose to seek a patent covering the gene and its coinciding tests, men may face the same challenges many women are fighting now. Prostate cancer, like breast and ovarian cancer, is treatable if caught early enough, but can be life threatening if it goes undetected. It is imperative, therefore, that the public is given readily available and financeable access to tests predicting future susceptibility to these cancers so that they can take the appropriate precautionary actions. By the same token, such life changing choices as hysterectomies, mastectomies and castrations must be made only after careful consideration of all available information, which most people would agree involves at least a second, if not third and fourth, opinion.

This is speculative, of course, depending both on the Supreme Court’s decisions, first whether to grant certiorari, and next whether to uphold the Federal Circuit’s decision. But given the time and effort put into the search for the HOXB13 gene, it is not beyond the realm of possibility that the scientists behind this discovery would seek to protect and financially benefit from their breakthrough.