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« Court Report | Main | Patent Profile: Fate Therapeutics to Receive First U.S. Patent for Induced Pluripotent Stem Cell Technology »

February 08, 2010

Comments

Kevin,

There's an expression (apparently misattributed to the Nazi Minister of Propaganda, Joseph Goebbels) that: "If you repeat a lie often enough, it becomes the truth." That expression seems to apply in spades to how the media is treating (or more appropriately distorting) the debate on gene patenting. I have no problem with an informed and reasoned debate on this subject. But I do have a big problem with inaccuracy, misinformation, rhetorical nonsense, and downright falsehood that is being presented as supposed "truth" on this subject. This Newsweek story just reaffirms my cynical view that journalism is dead in the media.

Kevin,

Don't know about others, but I think there may be some flaws in your arguments.

1. How odd to be condoning massive widespread infringement as a defense of patenting. Myriad deserves credit for sharing mutation data and permitting research. They note 7,000 papers on BRCA have been published. What is perhaps less obvious is most of those papers--any that involved BRCA DNA manipulations in the US, Canada, Australia or New Zealand--infringe one or more Myriad patents unless the DNA analysis was done by Myriad or covered by the 1999 NCI Memorandum of Understanding. Myriad has never said it *will not* sue, it has merely stated the fact that it *has not* sued--except twice (once against U Penn for "non-research commercial testing" of just the type you cite as research in your blog, and once against Oncormed). Post Madey, Myriad clearly retains the right to sue BRCA researchers, and it has never put in writing that it won't. If this is good policy, which we seem to agree, then it should be real policy.

2. It's simply false that universities don't develop genetic tests. There were already multiple labs offering BRCA testing when Myriad introduced its BRCAnalysis. We can argue about the merits of testing methods and other aspects, but it's simply wrong to assert that introducing these tests depends on exclusivity.

3. This is not unique to BRCA. In ten clinical conditions studied for SACGHS, three had nonexclusive or no licensing. Seven had exclusive licensing in one or more genes. In no such case was the exclusive licensee first to market; in some cases, they "cleared the market" of university and reference labs whose tests were already available. There may be cases where exclusive rights are needed to get to market, but it is clearly not historically the norm in Mendelian conditions.

Dear Bob:

With regard to your last point, please see the Nature Biotech article from a few months ago showing that gene patenting is not a barrier to genetic testing. The SACHGS report is seriously flawed by the pre-determined outcome imposed by its members - see Brian Stanton for more on that, and our coverage of Birch Bayh et al. last week. We will be providing more coverage over the next week or so.

I didn't say that universities don't develop genetic tests, just that they don't develop commercial embodiments of those tests. And frankly, I don't think universities are the best sources of reliable, large-scale testing - they have neither the time nor the resources to do the kind of widespread validation studies that are (or should be) required, and frankly that isn't the best use of their time - if they make the best discovery and license the rights to companies in the business of commercialization, they can go back to what they do best - discovery. And licensing provides economic support for further university research.

I agree that Mendelian-inherited diseases are less susceptible than most diseases (which are multivariate) to being difficult to reverse engineer. But I disagree that such diseases should be the norm, since they are (relatively) rare. As a representative of a breast cancer group said to me (on a panel organized last fall by Dan Ravicher), the overwhelming majority of women don't carry BRCA mutations, but 9% of women will get breast cancer. We should be adjusting the incentive system for most cancers (and other diseases like diabetes and heart disease), where reverse-engineering diagnostic tests will be difficult.

As I've said before, a legislative "fix" to Madey v. Duke is something worth considering, provided that it made clear that any commercialization stemming from such research was subordinate to patent-holder rights.

Finally, the article is about banning gene patents, not genetic diagnostic method patents. We can argue the policy pros and cons of alternatives - nonexclusive licensing, Bayh-Dole march-in rights, physician exemptions to infringement liability, etc. - but only when the issue isn't "gene patents, yes or no?" So long as that is the debate, I can't see any reason to credit arguments like the ones in Ms. Begley's article.

Thanks for the comment.

"These treatments and tests are developed by companies, not universities, and companies require investment, if only to maximize the likelihood that the treatments will work and the diagnoses will be reliable. While discoveries would still occur in the absence of patents, commercialization would not[...]"

So we need allow patents on products of nature to allow for the commercialization of therapies developed from those products? Is our patent law outdated or is having a private pharmaceutical industry? Should we allow the invisible hand of the market determine what therapies we develop? I increasingly find myself questioning whether some public services should not be left to companies.

Dear Dylan:

"Products of nature" have always been patent-eligible, provided that what is patented a) isn't already in the prior art (on the principle that a new method of making an old article doesn't make the old article patentable) and b) that it shows "the hand of man" (i.e., that it has been changed in some way). Claims to "homogeneous preparations of X" are such claims, and can be directed to antibiotics (lincomycin), anticancer drugs (taxol) etc. So there is no a priori prohibition against "product of nature" claims, even if there are allusions to such a ban in patent law textbooks. Sloppy scholarship doesn't make it so.

Now, a therapy without a therapeutic isn't worth much, so there should be claims to the therapeutic agent per se. Diagnostic testing claims are a different matter, and there is a lot of room for debate on those (as well as proposals for exempting basic research and physicians (but not big diagnostics companies) from infringement liability). Tough to have a rational discussion in a climate where "gene patents are just wrong" is the level of debate, however.

The market question can be answered by making sure there are sufficient incentives to develop new diagnostics and therapeutics. These incentives include, for example, orphan drug protection. It is far from perfect, but there has yet to be a different system that is better (or as good).

Thanks for the comment.

While discoveries would still occur in the absence of patents, commercialization would not

Millions of non-patented commercial items and compositions for sale, including medical items, prove this statement false.

Dear Keep:

Context, context, context - the discussion is about patenting genes used to make therapeutic drugs and diagnostics. The point is whether something can be reverse-engineered, and for pharma (as one example), patents are vital. So insofar as we are talking about biologic drugs, the existence of millions of unpatented items is irrelevant.

Context is also relevant to industries selling products that can be easily reverse-engineered and then made more cheaply abroad. I think patents that keep some goods "expensive" are overall good for the country because 1) they keep jobs here 2) they help our foreign trade balance and 3) they provide for future investment (either in promoting design-arounds or the next generation of technology).

And, of course, the added benefit that after a relatively short time, the information (including the best mode of practicing an invention) goes into the public domain, where cheaper knockoffs are a benefit without most of the attendant negatives caused by early, unrestricted copying.

Thanks for the comment.

You can read my published law review article on why gene patents should inspire legislative reform at : http://omnilegalgroup.com/publications.html

That was very informative and well written. Mentioned below is an article on gene patent debate:
"The amicus brief submitted by the Department of Justice (DOJ) in the Breast Cancer Gene patent appeal before the Federal Circuit has drawn great attention during the last week. A US District Court had earlier rejected isolated gene sequence claims in Myriad's patent stating that they do not satisfy the patentable subject matter requirement because they are products of nature. Aggrieved by the decision of the District Court, Myriad appealed to the Federal Circuit. The Department of Justice has filed an amicus brief before the Federal Circuit stating that the District Court's opinion was right with respect to genomic DNA sequences. As the DOJ's opinion is very persuasive, it has once again brought the gene patent debate to life."......read more at http://www.patentpill.com/2010/11/gene-patent-debate-is-alive-again.html

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