Patently Obvious

Assuming you are a medical researcher working for a biotech company looking for a cure for breast cancer. Your company knows that to create an effective cure, it would be necessary to isolate and identify genes that would reflect a predisposition to such cancer, a process inquiry that would take years and require the expenditure of millions of dollars. Assume that your company elects to bite the bullet, spend the money, resulting in a discovery of that precise gene sequence, now identified as “Breast Cancer Susceptibility Genes 1 and 2” (or as they are effectively known in the biotech world, BRCA1 and BRCA2). Naturally, with all this effort, your company files a patent, that governmentally-permitted monopoly that allows inventors to enjoy the fruits of their efforts.

Now assume you are a thirty-year-old woman (or friends with or married to such a wondrous woman) with a very strong family history of breast cancer. You want someone to tell you if you have BRCA 1 and/or 2 so you can take appropriate steps. But, you are told, there is a company that controls anything linked to those two genes and without their consent, you cannot find out or you have to pay some serious dough to have the right to find out about your own body, well beyond the mere costs of the procedure. There’s no special process involved, other than pre-existing gene tracking procedures that can work for any targeted gene, just the mere existence of that DNA-aggregation, the identity of which was discovered by a purported patent holder. It’s your body!

With millions of dollars invested in highly-specialized technology plus highly-paid researchers holding serious academic credentials required to ferret out so many of nature’s mysteries, what is the incentive to do needed research if you can never patent your work to get paid back? But if all someone is doing is discovering a fact of nature that is there regardless of the researcher’s work, is a patent really viable? That’s the issue that was recently decided (unless a more senior court, probably the Supreme Court, decides differently) in a federal district court in New York in Association for Molecular Pathology vs. U.S. Patent and Trademark Office. In an opinion released on March 29^th, the court ruled against the patenting company, Myriad Genetics (and other defendants) and invalidated the underlying patents for several reasons: 1. There is a legal prohibition against patenting the products of nature and 2. Under patent case law, there was no “machine or transformation” steps inherent in the discovery. The researchers just found out something that already existed. The biotech companies, however, are definitely appealing the decision.

Will this decision hold? Will it apply only to small efforts regarding just a few isolated DNA/genetic efforts and not to greater “mapping” efforts? Time will tell, but the arena of genetic mapping has an interesting history that antedates the above decision. Some medical problems are so massive and obviously impossible to solve that they invite a massive collaboration effort, often spurred on by the government. So was the case of the DNA-focused Human Genome Project, begun in 1990 led by James Watson at the U.S. National Institutes of Health, with the goal of identifying all of the individual genes that make up the human species. Battles over the right to patent such discoveries by individual contributors increased the complexity of the task, even though a completed research project was essential to enable the future of medical research.

By the mid-1990s, about 20% of gene research was covered by private patents (would they how muster after the above ruling?). In 1995, one holder of many of these patents, Merck Pharmaceuticals, realized the magnitude of the blockage that such private research meant for the entire process and released 15,000 human gene sequences to the general public through its Merck Gene Index. In 1999, a non-profit consortium of eleven pharmaceutical companies opened up collaboration to create “a public biological blueprint for all human life.” By 2003, the basics of the entire genome had been identified, and in 2006, the significance of the Human Genome Project reached a new plateau as the sequence for the last unmapped human chromosome was published. With this profoundly complex body of knowledge, the pharmaceutical and academic worlds were empowered to develop an entirely new body of medical solutions for the benefit of all of us. Or maybe patent law might stop the process?

I’m Peter Dekom, and it’s getting really complicated out there!