About the Authors

  • The Authors and Contributors of "Patent Docs" are patent attorneys and agents, many of whom hold doctorates in a diverse array of disciplines.
2018 Juristant Badge - MBHB_165
Juristat #4 Overall Rank

E-mail Newsletter

  • Enter your e-mail address below to receive the "Patent Docs" e-mail newsletter.

Enter your email address:

Delivered by FeedBurner

Contact the Docs

Docs on Twitter


Disclaimer

  • "Patent Docs" does not contain any legal advice whatsoever. This weblog is for informational purposes only, and its publication does not create an attorney-client relationship. In addition, nothing on "Patent Docs" constitutes a solicitation for business. This weblog is intended primarily for other attorneys. Moreover, "Patent Docs" is the personal weblog of the Authors; it is not edited by the Authors' employers or clients and, as such, no part of this weblog may be so attributed. All posts on "Patent Docs" should be double-checked for their accuracy and current applicability.
Juristat_165
Juristat #8 Overall Rank

Pharma-50-transparent_216px_red

« USPTO Schedules Roundtable Discussion on Worksharing | Main | NVCA Study Shows Increase in Third Quarter Venture Funding »

October 22, 2009

Comments

This is an interesting article. However, I'm not sure that taking an unwavering position regarding gene patenting is advisable at this point, because so many significant considerations are still unknown. The issue is so new, and future technologies are so uncertain, that specific policy details will likely have to be hashed out in future patent litigation. Please keep us posted as things progress.
http://www.GeneralPatent.com

Dear Gena:

One thing to keep in mind. The vast majority of human genes will no longer be eligible for patenting after about 2020. Most of these genes were disclosed, either in patent applications or in the Human Genome Project database, prior to 2000. Since the U.S. changed its patent term to 20 years from the earliest filing date, all human gene patent applications filed at that time cannot extend past 2020, and if these genes have not been filed by that time, their disclosure in public databases would also preclude patenting.

It will be interesting to see whether alternative claiming strategies, espoused by some participants in the gene patenting debate, fill the breach. I suspect the same voices will remind us that, having identified a gene sequence, expressing that sequence or using the encoded protein would be obvious and therefore unpatentable.

But you are right: the most prudent course is simply "stayed tuned.' Thanks for the comment.

Kevin,

Just to point out, your response to Gena is at serious variance with your own blog of just a few days ago. You wrote in laudatory terms about Myriad exclusively licensing a patent (turns out it's a Johns Hopkins PCT patent application). It's 2009. That patent will expire in 2029. If granted, it will be a "gene patent" of some sort, since it will be based on the mutations newly associated with familial pancreatic cancer. Either there will continue to be such patents or there won't. The number of total DNA patents peaked in 2000 and dropped until 2006, but it is back up again. The argument that "it's not so bad, these patents will just go away," is not compelling for many reasons. Many gene-based inventions will surely continue to be both patent-eligible and patentable.

Dear Bob:

What I said was "the vast majority" of gene patents. So "serious variance" is a serious overstatement.

But you raise an important point. While the vast majority of gene patents will expire by 2020, what is being worked out now are mechanisms of disease and how genetic polymorphisms are associated with disease. There will continue to be claims such as "a method for identifying a risk of disease Y, by detecting a polymorphism in gene X." And that was the subject of the piece on the pancreatic cancer gene.

I think these are different claims, impacting different aspects of the gene patenting debate. Those who believe gene patenting is "wrong" don't care about the distinction, but there is a very practical difference. If I cannot protect the gene for protein A, which treats disease Y, then I think my chances of taking the risk of bringing a therapeutic drug to market is essentially zero. These drugs won't exist.

On the other hand, if I cannot protect the correlation between polymorphism Z in gene X related to disease Y, then as I have said these polymorphisms will be identified but not disclosed, in order to justify the expense of bringing them to market. I think that is bad public policy, but unlike in the therapeutic arena the tests will be available.

I frankly don't know what will happen once the "vast majority" of genes go off-patent in 2020 with regard to therapeutic drugs. But it may not be pretty.

Thanks for the comment.

Kevin:

Where is the evidence for your statement that without patent protection, the biomarker correlations will be identified but not disclosed? You do understand that almost all biomarker correlations that are identified are done so by researchers at universities, non-profits, and government labs, right? You're telling me that these entities are going to start behaving like Coca-Cola and keep all their correlation discoveries secret? I don't think so. Moreover, no physician will order a test unless he/she knows the biological basis for the test (I know that most physicians are not scientists, but they're not dummies either). And I haven't even mentioned the fact that there are federal and state regulations (i.e., CLIA) which would prohibit secret tests. Finally, the notion that companies will not undertake the expense of getting a test based on a correlation up and running without patent protection is not only inaccurate, it's bizarre. Go look at the roster of tests offered by the largest reference laboratories such as Quest and LabCorp. The overwhelming majority of these tests are not patented. These companies make their money by volume and efficiency. I know that those terms are heresy to some patent attorneys out there, but that's the way most American companies make their money.

Dear Gary:

No, I don't think that universities will act in that way. Indeed, looking over my hypothetical, I said it would be companies that would do so. If you doubt that companies can compete in this space with academia, revisit the Human Genome Project versus Craig Venter.

I think physicians will accept a test that has a good prognostic track record. If a salesman could come into a physician's office and show that a chip could reliably predict disease, I think there would be less concern about the specifics.

I note that both Quest and Labcorp have licensed patents to protect their tests, and while it is true that these companies make their money by volume and efficiency, there is a place for patenting in their business models, too (and these are established companies, not start-ups, just the companies that could be expected to adopt my hypothetical approach).

Indeed, your argument about "efficiency and volume" sounds a lot like what used to be said about Japanese and German companies in the 1970's and 1980's - before it we widely recognized that the FTC had forced many US companies to give licenses on its technology to foreign companies due to antitrust concerns. The fact is that nascent industries need patent protection, and if we preclude that protection it will favor just those established companies least likely to do cutting edge innovation. I don't think that is the kind of behavior we should be promoting.

Thanks for the comment.

Dear Kevin,

Craig Venter made enormous progress in the HGP, as we know, by piggybacking off the publicly-funded science (his map was only 50% his data, the rest was taken from the public domain HGP). Moreover, the conclusion of the article you cite indicates that the uncertainties caused by gene patents are, in fact, holding up research to a degree, even if not to a large degree). In the case of BRCA 1 and 2 as you know, and as you more or less admitted last week at the forum in NYC, the exclusive licensing by Myriad is a poor policy, and bad PR (it also is hindering science). You might also point out that in Europe, there is mandatory licensing for basic research, so the same sort of thickets do not occur in Europe. I also agree with the commentators above, as you know, that the science would proceed just fine, and disclosure would occur as part of the institutions of science, without patents. You should have attended the screening and panel the following night of the movie "In The Family" because there we heard from a genetic counselor and a clinical physician, both of whom had received cease and desist letters for their clinical work, or had been unable to conduct their work appropriately due to these sorts of patents. The crime is that it's not even just the basic science that is being hindered where firms choose to hold exclusive patents and won't license, but health care is also impacted.

It was good to meet you finally, and it was great to hear you at a public forum being civil, rather than throwing around words like "lies" as you did some time ago, both in reference to the Myriad suit and to my book.

best,
David

Dear Dave:

It was also good to meet you. I think you are very well aware of the difference between misusing a right, and not being entitled to the right in the first place.

And the funny thing (that I mentioned) is that it the legal uncertainty, not the patents, that is causing the present difficulties.

Thanks for the comment.

David Koepsell said: “You might also point out that in Europe, there is mandatory licensing for basic research, so the same sort of thickets do not occur in Europe. I also agree with the commentators above, as you know, that the science would proceed just fine, and disclosure would occur as part of the institutions of science, without patents.”

Of course, this enlightened European mandatory licensing policy was adopted with the same European certitude that drove the Netherlands to abolish the patent system in 1869 (only to restore it 43 years later). They too, thought that science and technology would progress “just fine without patents.”

and, in fact, it did:
http://www.atypon-link.com/doi/abs/10.1257/0002828054825501

here's the full Moser article, which contradicts the notion that without patents, somehow Dutch innovation languished: http://www.google.com/url?sa=t&source=web&ct=res&cd=7&ved=0CCYQFjAG&url=http%3A%2F%2Fweb.mit.edu%2Fmoser%2Fwww%2Fpat501.pdf&ei=OXDxSrr0GuDOjAfV6_yVAQ&usg=AFQjCNFK7aRz7FuMw2PmmfCMDgFmtTt4aw

The comments to this entry are closed.

December 2019

Sun Mon Tue Wed Thu Fri Sat
1 2 3 4 5 6 7
8 9 10 11 12 13 14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29 30 31