New Study Shows Gene Patents Stifle Innovation And Put People At Risk

from the and-there-you-go dept

Following the recent ruling in the Myriad Genetics case, that gene patents are invalid, it was amusing (if it a bit frightening) to watch some patent attorneys, who specialize in the field, react as if the world had been turned upside down, and that major scientific advances in health and medicine were all going to collapse into a giant blackhole. Of course, they had no evidence to back that up. As we've seen time and time again, the evidence suggests exactly the opposite -- and now there's even more evidence, specifically when it comes to patents on genes and related processes. Justin Levine points us to an Economist article highlighting a series of recently released studies that found that gene patents are quite damaging:

Even more striking is the claim made by the Duke researchers that patent exclusivity is not necessary to spur innovation in genetic testing. Dr Cook-Deegan argues that testing, unlike pricey drug development, has low barriers to entry and is relatively cheap, so a monopoly is not required to lure investors. As evidence, he points to the case of cystic fibrosis: unlike breast cancer, no monopoly patent blocks access to the relevant gene, and dozens of rival testing companies flourish.

The research also found that thanks to gene patent monopolies, many people may suffer in being unable to get access to important tests, and worse (as was the case in the Myriad suit), the monopoly kills off the potential of getting any sort of second opinion -- which can be incredibly important in properly judging the situation. Of course, I fully expect the typical group of patent attorneys to ignore this evidence yet again. The full set of studies, led by Robert Cook-Deegan, at Duke University can be read online. It was done in response to a request from the US Dept. of Health -- so perhaps the US gov't is finally starting to look at actual evidence in figuring out patent policy as well. The different studies look at the impact of patents on a variety of different diseases. The results definitely differed depending on the case study, but it's difficult to see any evidence of patents helping with innovation in any of the studies.

Filed Under: gene, patents, studies

More On The Gene Patent Ruling: What Happens Next

from the onto-the-appeal dept

The big news yesterday, of course, was the district court ruling that found that genes were unpatentable. The full decision was over 150 pages, so I wanted to spend some time reading through it. It's mostly a really good ruling that makes a number of important statements. Dan Vorhaus has a good post highlighting some of the key points, including this particular sentence:

The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent.

This is a point that often seems to get lost in this debate, with patent system supporters assuming some sort of "sweat of the brow" argument for patents: that hard work automatically deserves protection. But that's not how the patent system works, and it's good that the judge recognizes this.

The one point that the judge punted on was the Constitutional question -- basically noting that the case didn't even need to get that far, since it could be decided based on other issues. This is somewhat unfortunate, because the issues being raised by the ACLU are important ones for patents (and copyrights). As summarized by Joe Mullin in his post about the ruling:

The ACLU argued that genetic patents aren't only banned under the patent laws, but that they violate the First Amendment because they prevent research and discussions with patients; and that they violate the so-called "Progress Clause" of the U.S. Constitution because patents like Myriad's don't "promote the progress" of science.

This is unfortunate because we've long argued that the Constitution makes it clear that if copyrights or patents do not, in fact, "promote the progress," then they are not valid. This is an issue that gets ignored frequently, but it would be good to get addressed. Also, the First Amendment argument is another important one, as the courts have generally punted on cases where lawyers have brought up the conflicts between the First Amendment and copyright law. It would be interesting to see the issue approached from the patent side of the house as well.

In the meantime, while this is an important ruling, it really means very little until the appeal happens (not for a while, most likely), and CAFC weighs in. On that front, there may be some good news. I'd been meaning to write up a ruling from last week on CAFC which a few people submitted, invalidating a specific gene patent held by Harvard and MIT. If you look closely at that ruling you can get a sense of how CAFC is viewing these kinds of patents:

Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. "[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion." Id. at 930 n.10 (quoting Brenner, 383 U.S. at 536). Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of "invention"--that is, conceive of the complete and final invention with all its claimed limitations--and disclose the fruits of that effort to the public.

Thus, there's a question of how CAFC will view Myriad's BRCA patents. Will it see them as just a description of something found in nature, as the lower court did, or will it see them as a true invention.

Filed Under: gene, patents