Expert: Supreme Court Case on Patenting Human Genes Will Likely inflict "Devastating Harm on the American People"

(Editor’s Note: Last week, the Supreme Court decided to hear an intellectual property case where it will decide whether human genes can be patented. The case started several years ago when the Public Patent Foundation filed a lawsuit with the ACLU challenging some patents that concerned genes affecting breast cancer and ovarian cancer. Daniel Ravicher is one of the lead attorneys on the case. He was interviewed by Steven Rosenfeld for AlterNet radio.)

Steven Rosenfeld: Daniel, first, congratulations for having the Supreme Court take the case.  Were you surprised?     

Daniel Ravicher: Well, thank you for having me on and thanks for the congratulations. No, we weren’t surprised that the Supreme Court agreed to hear our case because the lower court had come to such an incorrect decision. In fact, the lower court decision was a split decision amongst three judges. That was even further proof that the lower court decision was not correct.

SR: As your brief says the key central question is, ‘Can genes be patented?’ When you get into the brief, you have some really interesting language, where you talk about the laws of nature versus what I would call the products of man. Talk about that distinction.

DR: Well, the Constitution gives Congress the power to grant patents to inventors in order to promote progress. The theory is that if we grant patents to people who come up with an invention that will incentivize people to create these inventions. 

It’s always been understood that if you were to grant patents on things that God gave us, the laws of nature, E=mc2, or natural phenomenon, like gold or water, that would be too much power given to the patent holder. They then can use that patent to exclude other people from making or using the covered thing. So there’s a line between that, what God gave us, that cannot be patented and that, what humans make. Now of course, everything a human makes comes from what God gave us, right? Humans don’t create materials out of thin air. They change what’s been given to us.  So there has to be enough of a change from what we were given by God to what we’ve actually created with human ingenuity. 

SR: Now in this case, you have a company, a biotech firm that has isolated two genes that are used to identify whether a woman is likely to have breast cancer or ovarian cancer. In your brief, you discuss not only how they’ve sought patents for these but in the application and use of these, they’ve actually prevented other researchers from studying these genes. They’ve prevented women from getting second opinions based on other tests that cannot be developed that are tied to using these genes. Talk about why that is, first of all, a constitutional violation and why it’s just so offensive.  

DR: Let’s remember that these patents were granted by our federal government. Some bureaucrat in the Washington DC area decided that it was smart to give one company the exclusive control over the patented thing and eliminate every other American’s right to do that thing. In this case, the patent holder claims to have been the first entity to realize that if you have certain mutations in a couple of different places along your genetic code in every cell of your body, then you’ve got an increased risk of breast or ovarian cancer.

The vast, vast majority of breast cancer is not genetically caused. It’s through environmental and behavioral decisions of the woman or man. Men can also get breast cancer. But there is a small percentage of people who can get breast cancer because they received genetic mutations from one of their parents. In fact, that type of breast cancer is generally much more aggressive and begins much earlier in life. So this is critical information, and because there’s no exception from patent infringement for fair use, unlike in copyright law and trademark law where we do have exceptions for fair use or the exercise of constitutional rights, there’s no constitutional exception in the patent laws.  Any making or using of the patented thing is infringement. 

We represent women, real women, who have a family history of breast and ovarian cancer that led their doctors to tell them that they should have their genes looked at. It’s almost as simple today as having your temperature taken by a thermometer. To do it, you actually have to withdraw blood from the patient, and you just run it through a machine, and the machine prints out the answers for you. It’s not very difficult at all. In the near future, most patients will likely have their entire genome mapped so that they can understand what diseases they’re at risk for.

The patent holder, in this case, wasn’t letting anyone else do that or offer that service, even to poor women who couldn’t afford their test, because they were making super-competitive profits.  They were charging ten times as much, if not more, to do the test than it actually cost to do. They had no sympathies if a woman wasn’t capable of affording it. As you mentioned, they wouldn’t let women even who paid them to take the test, if they wanted to get a second opinion from a different lab, from a different person doing the analysis, the patent holder wouldn’t let them do that. Women had to make very life-altering decisions about prophylactic surgeries, to either undergo or not undergo, based on just this one company’s opinion about their genetic code. We have proof that they had given patients both false negatives and false positives in the past, which is not necessarily because they’re bad guys, it’s just because in all things medical there can be mistakes and errors. That’s why we need second opinions. It’s because of their aggressive use of these patents to impede on women’s rights, that’s why we took the case.  

SR: I’ve read, in some of the business press, like ‘corporate counsel’ columns, that the patent bar was baffled that there would be a civil liberties argument here. Indeed, in your brief, you say that there are First Amendment violations, and I think there’s also Article 1, Section 8, Clause 8.  What are those constitutional infringements?    

DR: The Article 1, Section 8 issue is that granting these patents violates the Constitution in that they don’t promote progress. They actually deter progress by granting a monopoly over a fact of nature to one entity. The First Amendment breaches come in because these patents can be used to impede the speech between doctors and their patients. It also impedes upon thought, because these patents are so broad that if you merely recognize that someone does or does not have an alteration in one of these genes and then correlate that to the risk or lack of risk for early-onset aggressive breast and ovarian cancer, you’ve infringed their patent just by having that thought. So the government is now granting patents, making it illegal to think certain thoughts, to think about science, to think about knowledge, and that impedes upon the First Amendment. 

SR: It’s like a prior restraint in a sense?  

DR: The government acts… A lot of people try to say, ‘Well, this is a private company.’ The government is an actor here that is granting… Every Tuesday there are 4,500 things you’re no longer allowed to do, because the patent office granted 4,500 patents every Tuesday. There is insufficient checks and balances to ensure that when they do that, it is justified. They have a financial conflict of interest. The patent office makes 10 times as much money when it grants a patent as opposed to when it denies it. So there are all sorts of problems with our patent system, which have caused it to create real serious negative harms to the public, like in our case.   

SR: I’m wondering how much this case is indicative of larger trends? Whether it’s problems with the patent system itself, as you were just discussing, or since we’re in this ascendant biotech era, how many other applications are out there? I wonder, for example, if you really can distinguish between patenting human genes or Monsanto doing seed stock? I know you’ve been involved in that litigation. 

DR: Unfortunately, I hope I’m wrong, but I think this is just the first of many instances where our patent system is going to be causing devastating harm to the American people. Because, to date, most American people don’t realize how the patent system negatively affects them. If they know anything at all, they think patents are rewards for garage inventors. But that’s not at all the case. The patent system is an excuse for corporate welfare, where the government intervenes in free-markets and freedom and gives control to corporations. It’s in some ways, I’ve called it ‘outsourced fascism.’ There’s no adequate control. Our patent office is complete rubber stamp that gives corporate America anything it wants so it can raise prices and reduce availability. 

We go and talk about alternative fuels. You know who’s got the most patents on alternative fuels? The oil companies. Why? Because they want to keep those technologies from being developed and brought to the marketplace. 

SR: Well thank you very much.  This has been really helpful. I appreciate your time today.