Lawyers who work on patents in the pharmaceutical and biotechnology industries are sweating bullets today. It is not a bad thing when patent lawyers are feeling queasy.
The storm that has got them turning green has been building up for many years. It has arrived in the form of a lawsuit that has enormous importance for you, your family and for the future of biomedical research around the world.
The ACLU and a group of prestigious genetic researchers and medical organizations have filed suit against the U.S. Patent and Trademark Office, as well as Myriad Genetics company and the University of Utah Research Foundation, challenging the validity of the patents Myriad and the Foundation hold on two gene sequences associated with women being at high risk of getting breast cancer and ovarian cancer.
Myriad built its business plan around controlling all medical testing for BRCA1 and BRCA2 gene sequences. It applied for a U.S. patent back in 1994 on the BRCA1 gene sequence and later for patent protection on both genetic messages in Europe and other nations. Controversy started as soon as the patents were granted.
Myriad took a tough stance about licensing breast cancer testing. The company basically controlled all testing around the world. What was more or less a monopoly let them charge a very high price, $2,400, to women who sought out BRCA tests.
Some cancer centers, including the one at my own school at the University of Pennsylvania, started offering testing. They did not want to charge Myriad’s rates in part because health insurance would not reimburse at that price. Myriad began growling about enforcing its license in court. A lot of bad blood ensued between doctors and hospitals who wanted to test women at risk but who could not afford the price.
A bit later, large-scale testing for the BRCA1 and BRCA 2 genes was started in the Canadian province of Ontario. Canadians were charged a third of the cost of Myriad’s test and women got the results eight weeks sooner than Myriad provided them. Myriad again threatened lawsuits, now against the province and the doctors involved. The Health Minister of Ontario told Myriad to take a hike. Trade sanctions were threatened by the U.S. ambassador to Canada acting at Myriad’s behest if testing was not stopped.
European health care systems operating with fixed budgets and a promise of universal access found themselves in a bind with respect to the Myriad license and price. They wanted to offer genetic testing to all women at risk but could not afford to do so. Some hospitals began to flout the Myriad patents and offered the tests anyway.
In May 2004, the European Patent Office revoked Myriad’s patents. The removal of the patents, an almost unprecedented event in patent history, came because the Europeans decided that while Myriad had figured out the composition of key genetic sequences, it had not done enough to meet the "inventiveness" standard required of a patent.
In other words, even though the company had figured out hundreds of the key genes involved with a higher risk of breast and ovarian cancer, they had not invented anything. Rather they had simply found something already existing in nature. In a sense, Myriad could no more patent genes than an astronomer could patent a galaxy seen through the Hubble telescope.
By 2007, Myriad was in the middle of another controversy. It had gone into magazines and television with direct-to-consumer ads promoting breast cancer testing to women. While the company claimed it was only targeting women in high-risk groups, those with immediate relatives who had breast or ovarian cancer, the ads scared many women into thinking that they needed to be tested who had no such family history.
Price and marketing were not the only source of backlash against Myriad. Some argued that by enforcing a monopoly the company discouraged the development of more accurate tests. More genes were found after Myriad’s patents but were not incorporated into testing. Critics charged Myriad was locked into an inferior test at an unaffordable price.
Now an American challenge has been brought. The ACLU contends that patenting the genes associated with some forms of cancer limits fundamental scientific research. The suit contends this blocks the free flow of scientific information, and is a violation of the First Amendment.
Challenging Myriad’s patents might get Myriad’s lawyers fired up but why are so many other patent attorneys and biotech execs reaching for their antacids? The ACLU lawsuit has direct implications for every patent on a gene sequence and there are loads of those.
Twenty percent of all human genes are patented. Pharmaceutical and biotechnology companies have a lot invested in those patents. The future of personalized medicine —targeting drugs to fit an individual person’s genes — rests in large measure on the validity of those patents. If Myriad loses, the legal foundation for much of the drug business in the United States and, thus, the whole world would crumble.
So, is Myriad likely to lose? I don’t think so.
Is research free speech?
The notion that patents interfere with free speech by restricting research communication presumes that the constitution recognizes research as a form of free speech and that Myriad has done anything to block researchers from speaking and those are pretty iffy presumptions.
Tossing out the Myriad patents would indeed imperil thousands of other patents, and courts tend not to want to cause that much turmoil.
That forecast offered, those bringing the lawsuit have an important point. Patent offices and courts in the U.S. and other countries have been granting patents on genes without thinking hard enough about the social and health implications of doing so. If companies sit on their patents and restrict licensing, gouge consumers, or fail to develop their patents by improving their tests or therapies then government should step in and yank the patent.
Patents are not given for any reason other than to encourage innovation which advances the public good. They are a privilege — not a right.
Perhaps the ACLU lawsuit, as unlikely to succeed as I think it is, will achieve its goal by reminding the emerging world of genetic medicine that, as Benjamin Franklin understood when he refused to patent his lightning rod, service to humanity is part of the duty of those who invent and innovate.
Arthur Caplan, Ph.D., is director of the Center for Bioethics at the University of Pennsylvania.