Comments on: Do Gene Patents Hurt Research?

By: David Koepsell

David Koepsell — Tue, 22 Dec 2009 15:51:48 +0000

For me, the line is at the sequences. Patent the invention as a whole, if it is new, non-obvious, and useful, but the claims that are being challenged in the ACLU v. Myriad case are claims on bare sequences, not even modified (not cDNA), but rather, naturally-occurring mutations identified in naturally-occurring genes. This, as I have argued, is akin to patenting elements on the periodic table, rather than new combinations of existing elements.

By: Bruce Quinn

Bruce Quinn — Tue, 22 Dec 2009 14:51:58 +0000

To date, I don’t understand where anti-patent advocates draw the line between patenting a gene (which they don’t like) and patenting a test that is used clinically. For example, there is a commercially developed screening test for bladder cancer that was very costly to develop (a large clinical trial). It detects four bladder cancer genes with a sensitive method in screened urine samples. Would an organization like Assoc Molec Pathologists (pursuing the Myriad lawsuit) allow the commercial rights on that test to stand? Or should they be able to replicate the oligonucleotides and produce the test informally? (A) If they should want to reproduce the test informally, why would anyone invest large sums in developing the test in the first place? Remember we are in an environment where insurers want larger and larger studies before providing insurance coverage for a new test, larger and larger a priori investments. Or (B) If they should not reproduce the bladder cancer test informally, what “bright line” legal standard to they use to separate that test from other commercializations using molecular information? I certainly can’t tell from their lawsuit.

By: David Koepsell

David Koepsell — Tue, 22 Dec 2009 09:18:25 +0000

Of course, some of us are unconcerned with utilitarian arguments, and focus instead on the ethics of taking what are essentially laws of nature, unmodified in any significant way, and turning them into profitable monopolies. I argue in my book Who Owns You that “isolation and purification” of genes, by means essentially the same as that used naturally by mRNA in reading genes, is not inventive, and infringes upon what I call a “commons by necessity.” The genome is such a commons not because of utilitarian agreements about enclosing a space (like we make with national parks) but because it is simply “unencloseable,” like laws of nature, mathematics or radio spectra. I argue that attempts at enclosure are a priori unethical because of this, and not due to any utilitarian concerns.

By: Gerry Barnett

Gerry Barnett — Sat, 14 Nov 2009 18:18:12 +0000

(patents = commercialization) is often limited to the idea of excluding others for a monopoly rent. Yes, that happens, but “commercialization” is a larger domain than that. In areas such as electronics and information tech, commercialization includes cross licensing of patents to create shared, competitive platforms and standards on which other good things develop. Want access to a platform? Contribute a stack of patents, or something else of value. With 40,000 gene patents in the wild, it’s possible that there will be more cross licensing and research may be enhanced by broad platforms that provide the impetus to figure things out.

Similar discussions can be had for the role of patents in marking start up efforts for investors relative to established interests, where patents serve a due diligence and protective function, and for the role of patents in quality control, such as enforcing a standard or establishing a benchmark for validated practice.

The worry side of what patents might do badly tends not want to develop the socially useful roles patents can play in bridging research and commercial interests, managing sharing rather than exclusion in competitive environments, and assisting in valuation of effort in mergers and acquisitions. And blaming commercial pressure solely for data withholding misses a number of other motivations that aren’t so trendy but arise due to government funding, status competition within disciplines, personal politics, resistance to predatory behaviors, and the like.

By: jeff williams

jeff williams — Wed, 04 Nov 2009 22:55:07 +0000

Huang and Murray (2008) did a patent-paper citation analysis for patents on human genetics and did find some cause for concern for the limitation of future public knowledge. A potential problem here is that, with private industry being a major driver of medical advances due to genetics, and with private industry frequently building off of public knowledge, there is a chance that private industry in the future will have less genetics-centered public knowledge with which to work, and thus innovation might suffer. However, as the authors stated, their paper did not examine the benefits of private ownership of genetic patents, so this is only part of the picture.

By: Mark Samuels

Mark Samuels — Sat, 31 Oct 2009 15:38:08 +0000

Very interesting comments Tim. It might be useful to distinguish explicitly different eventual uses for gene patents. For human genetics, I think broadly of patents on novel therapeutic versus diagnostic uses. Colleagues at some big pharma companies have suggested to me that they don’t think gene patents for therapeutics are particularly important given the long lead times to a novel drug, which cut away much of the protected time anyway. But for diagnostics, where time to market is much shorter, the issue is more pertinent.

By: Gene Lander

Gene Lander — Fri, 30 Oct 2009 20:13:13 +0000

The distinction you raise between commercialization and research is the key issue. As a Scientist with 35 years experience in the biotechnology industry I can tell you with a high level of confidence that gene patents WILL put a damper on research in industry (why bother researching something if you can’t eventually commercialize it?). On the other hand there is no commercialization pressure in academic research. I think the arguments that patents inhibit research misses the point. Its really all about commercialization.

By: Mary

Mary — Fri, 30 Oct 2009 00:26:41 +0000

Hmmm….I’m all for looking at the data, and I’ll read your sources. But I’m kinda not convinced so far.

1. Commercialization pressure: isn’t this linked to patents? Aren’t companies going to try to protect their IP for commercialization? And their investors would expect them to have that protection. Maybe I just don’t understand the legal constructs there.

2. A lot of the gene patent drama I’m familiar with isn’t human, it’s plants. How broad is your assessment species-wise?

Thanks for stuff that makes me think :)