Although the Myriad Genetics BRCA gene class-action lawsuit has a long way to go in appeals, and will certainly not be resolved until 2012 at the earliest, so far the outcome is still promising. (This is despite the fact that Myriad’s lawyers are now trying to get the case dropped on a technical basis, that the class suing, breast cancer patients who want the right to get a second opinion on their genetic test, has no standing [who else they believe would have standing is unclear]). Last November, the federal Department of Justice overruled current Patent Office policy by filing a brief taking the position that unmodified genes are products of nature, and therefore unpatentable. Although it would have been much more helpful if the Clinton administration had been paying attention and determined common-sense patent law before the gene-rush was fully on, the government and appeals court should resist all claims that the lawsuit should lose because of disruption to the biotech industry. Clearly patent law was misapplied because early on in the genomics era, no special interest group was paying attention to this issue because gene-identification was such a new technology, and there was no counterweight to biotech firms’ claims. But just because policy for years benefited biotech corporations at the expense of individuals doesn’t make it right. Even now, the implications of current patent law are only beginning to be understood by the general public; our current president may only be paying attention to the absurdity of a company owning your genes because of his own experience watching his mother have to worry about her ability to pay her medical bills as she lay dying of cancer.
Companies who own your genes are profiting off government research. Although the arguments in this case seem to be hinging on unreasonable current patent law, there is an important point to be made here (and in most other cases): that the majority of the time and money locating these genes was spent by university researchers using grant money from the National Institutes of Health – that is, taxpayer money.
Right now, taxpayer-funded research labs all over the country are doing the basic research that will lead to the prevention and treatment of all sorts of diseases. In a couple of local examples in my home state, NIH-funded labs at my own town’s tiny regional campus, the University of Montana Western, are studying the mechanisms by which biological agents cause lyme disease and yeast infections. Researchers in a lab at the University of Montana in Missoula are studying intensively binding properties of DNA in the telomeres of cancer cells, which will ultimately allow highly targeted chemotherapy rather than the whole-body chemotherapy carpet-bombing that is now typical.
Companies like Myriad Genetics would not exist in the first place without the foundation laid by taxpayer-funded research. This is research that biotech companies have no interest in doing, for several reasons. First, research at this level will not be quickly translatable to a profitable product; it will take years to apply what is learned in these labs to therapeutics, and a business will have a hard time finding investors for a long slog of basic research that may or may not pan out for profit in a decade or more (which is one big reason why taxpayer-funded research is so critical). Second, and perhaps more important, is that biotech companies are only interested in the first place in medical advances that will turn a profit (another big reason we need NIH). So, research that could greatly reduce the cost of cancer treatment, for example, is not in biotech/pharmaceutical business best interest, so they will never do it. Although this is a tangential point to the argument against patenting genes, it is here to illustrate the absurdity of the argument made by biotech companies that if unmodified genes are unpatentable, then life-saving research will come crashing to a halt, because no one would possibly do biomedical research without the chance to profit from it. News flash for the biotech industry: the great majority of research that leads to medical advances occurs on campuses and uses taxpayer money, and is led by science geeks that just love to figure stuff like this out, and have never made a dime on any patent related to their work. (For example, we finally are getting some taxpayer-funded research on chemotherapy drugs that is identifying which patients they actually are helping, something that drug companies would really rather not know because it will reduce their profits.) Ironically, in practice we have the opposite effect: by blocking out research on particular sequences, biotech companies are slowing down research because the academic science geeks who want to study them, can’t.
Changing patent law is more likely to develop more research avenues than close them off. The “death of research” argument made by the defendants in this case is absurd because the government’s amicus brief leaves plenty of room for biotech companies to make plenty of money. It takes the quite reasonable position that specific technological processes, modified genes, and the like satisfy the requirement that to be patent-eligible as human inventions. This is by no means a “slippery-slope” argument; it is simple to distinguish the mere sequencing of existing genes from a gene product that does not exist in nature. The only place there could be rational argument in patent law is in how much a gene needs to be altered to be considered a “human invention,” and this argument is irrelevant to this case, because the BRCA genes existed for millennia before Myriad cranked up its sequencing machines. If the judges (or justices, as it is likely this case will reach the Supreme Court) rule in Myriad’s favor, there will be no other explanation than an ideological belief that business making money trumps individual rights – unfortunately a distinct possibility given the makeup of the current Court.