New Breast Cancer Gene Lawsuit Aims to End to All Gene Patenting. Will it Succeed?

I'd be very curious to hear what the take on this is from people who have patented for their disease community. I've been watching but haven't seen any comment from that perspective yet.

Nice article, btw. I think I'll use that as a reference for some intertube discussions.

It is unfortunate that the other side is not presented, but that would interfere with the trite storyline of eeeevil corporation against damsels in distress. (Yes, your narrative is actually anti-feminist).

Myriad's BRCA1 test is an invention, like any other. People worked hard to develop it, and should be able to profit from their labor.

I concede that Myriad has been obnoxious in their approach to managing and enforcing their property rights since Day 1. Punishing Myriad by removing the patent-based incentive structure of modern biomedical discovery may make you feel good in the short run. But it will have negative consequences on development of biomedical technologies in the long run.

Hmm, my thoughts about gene-patenting are mixed. THere's the obvious, gut response which is NO: Scientific knowledge should be open source, information should be available to everyone. However this is tempered with the more realistic knowledge that gene patents encourage people with money to put into science to provide money.

It's a difficult issue. Especially as I *know* that one of the reasons phage therapy is going nowhere fast is because it's really difficult to patent. Patentability, unfortunately, drives research into useful products quicker than most other things.

Neuro-conservative: No one is challenging or questioning Myriad's right to patent their breast cancer gene test. You're right, Myriad invented it, and they have every right to patent it and profit from it. What's being challenged is their right to patent the genes themselves. That does not = "removing the patent-based incentive structure of modern biomedical discovery." There's plenty of profit to be had from inventions like gene tests, etc. And so far, as I mentioned above, Myriad's response to the situation has been: No comment.

Mary: Yes, there is one case of one woman getting listed as co-patent holder for the gene for her children's rare disorder. But as far as I know, that's the only such case. That woman now runs The Genetic Alliance, which is an advocacy group, but the people who donate tissues through Genetic Alliance don't necessarily become patent holders when their disease genes are found.

Rebecca: It's not an official response to the ACLU compliant, but Myriad's general counsel did issue an oral response earlier this week, as reported by the New York Times. It appears that Myriad believes in the enforceability of both its gene test patents and the patents covering the underlying gene sequence itself and is prepared to fight. Not really much of a surprise there.

Thanks for the excellent article; it will be fascinating to watch how this plays out!

@Skloot #4 -- Actually, the ACLU website is quite ambiguous on the issue of patent challenge for gene-test vs. gene-sequence. For example, one complaint cited is that no "second opinion" testing is available. Can you point me towards a document that clearly specifies that the patent challenge excludes the testing service?

On the issue of the gene-sequence patent impeding research more broadly, I think it is worth noting that a PubMed search on BRCA1 yields more than 6500 papers. I think it's safe to assume that only a small number of these are actually from Myriad itself. So, what is the evidence that research is inhibited by this patent?

@Neuroconservative: The ACLU is not suing over the gene test. The issue with getting a second opinion is about the gene patent: There is no other test besides Myriad's, and no lab besides Myriad is allowed to use their test. So no labs can verify their results, and no researcher can develop new tests.

There have been complex studies looking at how patenting impacts research. Finding 6,500 papers on PubMed is no proof that patenting is or isn't inhibiting science. Search PubMed for breast cancer research that didn't involve BRCA1 or BRCA2 and you'll get a much bigger number: 199,485 publications ... who's to say the researchers producing all those papers wouldn't be working on the BRCA1 and BRCA2 genes (to develop more sensitive tests, treatments, etc) if Myriad allowed it?

If you have more questions about the ACLU suit, I suggest you contact them. This will be my last response to your comments here.

@Skloot#7 -- I'm not sure why you are so quick to cut off discussion, and why you failed to specifically provide evidence/links in response to the two questions I posed @#6.

Reading the actual lawsuit pdf, it appears that the ACLU wants to have it both ways w/r/t the tests. On the one hand, they make several background complaints that the lack of alternative testing harms patients. On the other hand, they only make specific legal objection to patent claims concerning the gene sequence.

IANAL, but putting these two facts together, it would appear that their aim is to vitiate Myriad's right to their tests, but they realize that a direct legal assault on those patent claims would be rejected. My sense is that they hope to make Myriad's testing patent practically unenforceable by eliminating the supporting legal foundation around genetic patenting.

@Neuro-conservative. The reason Skloot is cutting off discussion now is because any further discussion about the legal aspect would involve a huge amount of trailing through legal documents and articals and reviews, something that takes up a lot of time and energy.

There are lots of papers being produced, it iss not research that is being stifled, but instead, as post number seven points out, they are stifling the development of any complementary tests, or trials to test the effectiveness or usefulness of the Myriad product. What they appear to have is a stranglehold monopoly on treatments for breast cancer.

If they 'own' the gene they can maintain this monopoly.

And I'm afraid while I'm happy to keep the discussion going, I cannot answer any legal queries either, I'm revising at the moment and don't have time to wade through what I suspect will be lots of legal-written material. As Skloot said, the ACLU suit is probably your best line of contact for further information about that.

Excellent post! Thanks for provoking discussion on this important issue.

@Lab Rat -- I would have expected that our intrepid reporter would have already done the legwork on understanding the case prior to writing about it. That's why I asked her for specific citations. In the event, I ended up just reading the legal filing myself. It is only 31 pages.

I should note that your understanding of the case is completely different from the one that Skloot is promulagating. She says the lawsuit is about research, not testing. You are saying the opposite. My whole point is that it is decidedly ambiguous.

Finally, I should note that your are certainly mistaken about the "stranglehold on treatments." Myriad does not have a treatment for breast cancer.

Hi Rebecca -

just wanted to point out that if readers want more info after finishing your excellent Slate article, there is actually a book dealing with the BRCA gene patent situation in the US and UK, Myriad, and the protests that gave rise to this lawsuit, called "Building Genetic Medicine: Breast Cancer, Technology, and the Comparative Politics of Health Care."

It's about high time. The patent will not be invalidated wholesale. The claim on the sequences themselves should be invalidated as they do not qualify as novel or non-obvious. They are parts of nature, not the creations of the scientists. This is not a zero-sum proposition, meaning that there is still plenty of room and incentive to innovate, for instance by devising unique tests that can be patented, just as methods of sampling the air for unpatentable elements can themselves be patented even while the elements cannot.

During the progress of the Human Genome Project, numerous companies were actually opposed to gene patents because it impedes not just the basic research, but creates patent thickets and anti-commons that then impede innovation and business. They created commons by entering into things like the HapMap consortium, to ensure that the basic, discovered (rather than invented) bits of nature remained in the public domain.

I wrote extensively about the ethics and legality of gene patents in my recent book "Who Owns You? The Corporate Gold Rush to Patent Your Genes" which was published in March by Wiley-Blackwell. http://www.amazon.com/Who-Owns-You-Corporate-Philosophy/dp/1405187301/r…

I think another good argument is that Myriad charges $3,000 for their test, on what realistically costs $80 (see Family Tree, Ancestry.com http://dna.ancestry.com/welcome.aspx ) to any high throughput DNA lab. And before you claim that Myriad invested millions to discover the gene:

http://en.wikipedia.org/wiki/Mary-Claire_King

Free the genes, keep the patents on pharmaceuticals

Yes, an important point, @Locke. Mary Claire King discovered BRCA1 and BRCA2 (which she should win the freakin Nobel Prize for), and her research was (as Mike the Mad Biologist pointed out this morning) funded by tax dollars.

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I skimmed the ACLU's complaint, which is obviously only one side of the argument (hint to others, you can skip the rather lengthy "Parties" section from about pp 3-14) and I took a quick look a the claims of one of the patents (the '282). Reading between the lines using my experience as a patent litigator, it seems to me that there is more here than just some bad patents.

It seems fairly clear cut that some of the challenged patent claims will ultimately be invalidated for covering unpatentable concepts (i.e., facts of nature). There was, no doubt, some level of bad faith involved in how these patents were obtained. However, there are a number of features about this lawsuit that don't make sense to me, and which suggest that the ultimate goal isn't just to invalidate the patents (thereby opening up a field of research/applications to competition), but to actually force Myriad to relinquish their own research data to the public domain. Here are a few of the points that raise some questions for me:

1) Why bring this lawsuit in this manner and name the USPTO? Normally patent lawsuits arise when someone tries to do something specific (e.g., market a new product like a test for breast cancer susceptibility) and a putative patent holder claims their patent covers the the "something". Once such a patent claim is made a lawsuit is initiated (by either side) in which the patent holder asserts that (a) they have a patent; (b) the patent is valid and enforceable); and (c) the challenged activity is covered by the patent. Patent litigations are 99% of the time bilateral (each side sues the other), since the response to patent-holder is to assert that any of a-c is not true. Such an assertion can be in the form of a request that a court examine the facts and "declare" that a, b, or c are, in fact, not true. Having obtained a successful declaratory judgment, the patent challenger can go ahead and do whatever it was they wanted to do. If the declaration by the court concerns (a) or (b) (e.g., that patent holder doesn't have a patent on what they claim or the patent is no good), then others besides the specific challenger can also get in on the action. The point, however, is that suits between patent holder and patent infringer always arise in the context of someone getting ready to commit, or actually committing an act that would infringe the patent.

Another way to challenge the patent is to actually go to the USPTO directly and initiate a proceeding there that can result in the patent being withdrawn/invalidated. This is the more likely method to use when you have a group of affected entities that may not have a direct commercial interest (i.e., a group of academic researchers), but feel the patent has squelched innovation generally. My point is, there is no reason to name the USPTO as a defendant in a lawsuit seeking to invalidate a patent (as opposed to actually asking the USPTO directly to invalidate the patent) unless you are more interested in the political/sensational aspects of the dispute rather than any practical consequences the allegedly bad patents may have had.

2) What, exactly did Myriad do that is being complained of? While the complaint goes to some length to explain how the various plaintiffs have been harmed by the challenged patents (e.g., breast cancer patients who cannot obtain a second opinion), it is rather short on detail as to exactly what specific actions Myriad took to quash other activities. While the patent says that Myriad "maintains a monopoly" over research and testing in this area, it doesn't actually describe any specific actions that Myriad took to "maintain" this nebulous monopoly -- other than simply own the patents. (The closest the complaint comes is paragraph 49, which is pretty much "we heard through the grapevine that they may have told someone somewhere not to do something"). The complaint even admits (paragraph 97) that Myriad "permitted some researchers" to work in the field. The crux of it is, the only real complaint that is articulated is that Myriad's very ownership of the patent means "[r]esearchers are chilled from engaging in research" (para. 98). Thus (and referring back to point 1 above), the target of this lawsuit is not really Myriad for obtaining bad patents and misusing them, it is against the USPTO for having a policy that allowed such patents to be granted in the first place (thus, see paragraph 50 for the actual point of the whole lawsuit).

Points 1 & 2 above are supported by the lack of any specific relief requested by the lawsuit. They don't ask the court to declare, e.g., that "Lab X can market it's new test for BRCA1", or that "Patient Y can have her DNA tested by someone besides Myriad". All they ask for is that the patent be invalidated. But you don't need the USPTO in the lawsuit to obtain that, so why name them?

3) There are several nebulous references to Myriad's "Database" of information on BRCA1 and BRCA2, and the fact that Myriad has kept its (proprietary) research out of the public knowledge. The complaint also bandies about the word "monopoly" an awful lot more than is necessary or (as noted above) really supported. This could be an indication that another goal of the entire campaign (of which this lawsuit is only a part) is to ultimately force Myriad to release all of the data it has gathered/obtained since the patents were issued. This would also dovetail with one of the other issues aired (but not dealt with) in this specific lawsuit, which is the use of government research monies to further what becomes lucrative private monopolies over information (the monopoly being maintained either through a patent or through trade-secrets laws). One big problem with this, however, is that a claim of patent misuse requires allegations of specific actions taken by the patent holder in "misusing" the patent. Just telling the world "I have this patent, stay away" is not "misuse." They would have to show, e.g., that Myriad exaggerated its own patent claims to intimidate others from working in the area. From the complaint, however, all we get is the sense that a lot of people who are not patent lawyers made (possibly flawed) assumptions about what the patents cover, and decided all on their own not to carry out certain research. It would be a much stronger claim if someone could say "I would have all the data Myriad has except they sued my University and got an order preventing me from doing the research myself". Just because Myriad's patents may be invalid does not automatically mean they have to share the fruits of all of the research they did themselves.

It is fairly clear to me that this lawsuit is merely one piece of a broader campaign for patent reform and the use of government research money (e.g., Rebecca's comment # 15). While those are both admirable goals, the lawsuit itself is probably ill-considered because it is likely to backfire. There are a number of legal/procedural problems with this lawsuit that make it ripe for early dismissal without ever reaching the merits (e.g, whether you can patent a gene). I am sure I haven't seen even half of the potential problems with this complaint, but I can already sense several problem areas that will be raised in motions to dismiss. If the court finds any of the potential flaws, it can dismiss the case which, given the amount of publicity it has received, will only weaken the arguments of those who support the same goals. If the lawsuit is revealed to be more of a publicity stunt than an honest attempt at legal redress, then it will make those involved appear pretty cynical for naming breast cancer survivors and their plights as grounds for relief.

I would like to know why they didn't file a challenge with the USPTO to have the patents invalidated through the administrative process. I suspect the answer is "that takes years and years and doesn't get onto the front page of the NY Times". Ok, I can live with that, I just hope we don't hear loud lamenting about how incompetent the courts are in scientific matters once the lawsuit gets thrown out for being a publicity stunt rather than a serious attempt to challenge a specific set of patents.

@automandc Their monopoly is this. If I wanted to test the DNA of an individual, using my own primers (nothing developed by Myriad), in my own lab, it would be illegal for me to tell that individual what their own DNA sequence is for that gene. That is pretty ridiculous by itself. Also, they want $3000 to look at a couple loci, which is a obscenely HUGE rip-off. If this patent is gone, there would be tons of labs who would do this test in the $50 range. You do need the patent invalidated to free the labs, otherwise they face lawsuits.

That addresses your #1 & 2, about #3, the database, I agree with you. Company data is private.

In a logical world Myriad could market their product as the "most reliable BRCA1 test" and charge more, since they have the largest database. In a few years, however, the database will become meaningless (open-source databases ala http://www.yhrd.org/ ) The ACLU site has some good answers and I suggest you read it: http://www.aclu.org/freespeech/gen/39556res20090512.html

Mary asks for the comments of the affected community. I am BRCA positive. And I am outraged. And astonished that it has taken so long for this patent to be challenged in court in the US. The European patent board overthrew it years ago.

There are active threads about this on the forums at www.facingourrisk.org That website belongs to FORCE, which is an organization of people affected by hereditary breast and ovarian cancer. FORCE supports the lawsuit.

As Skloot says - the problem is that it is not just a technology which is patented, but a part of nature. Everyone has a BRCA1 and BRCA2 gene. Some of us have mutations at that site. What would we think if a corporation could patent another body part? What if the adrenal gland were patented? And only that companies adrenal diagnostic tests could legally be used, even if other cheaper, better tests existed? And all knowledge about the adrenal diseases belonged to the corporation, even that which hasn't been discovered yet, or was discovered by someone else? Why should Myriad own the rights to a part of my body, no matter how microscopic?

Myriad did not individually discover the gene. The research was done over many years, by scientists from around the world building on each others work, much of it with public dollars. As the CEO admits in the film "In the Family", Myriad was started for the express purpose of racing to the finish line with the final tiny piece of the puzzle before anyone else, so it could claim the patent prize, and resultant profits.

Other high quality, accurate, less expensive methods of testing for BRCA mutations do exist, but patients are legally banned from accessing those because of the Myriad patent.

If you think this doesn't affect you, don't get too comfortable. There are tens of thousands of genes for other diseases that this sets precedent for.

automandc:
Re your point #2: what specific actions Myriad did to squash other activities:
"Myriad has sent cease-and-desist letters to several laboratories in the United States to stop them from providing BRCA testing."
That is, providing ANY testing - even when not using Myriads method or technology.

"It is unfortunate that the other side is not presented, but that would interfere with the trite storyline of eeeevil corporation against damsels in distress. (Yes, your narrative is actually anti-feminist). "

What an evil, inhumane sentiment.

=========

"Posted by: Neuro-conservative"

Well, that would certainly explain it.

Locke (#18):

If I wanted to test the DNA of an individual, using my own primers (nothing developed by Myriad), in my own lab, it would be illegal for me to tell that individual what their own DNA sequence is for that gene.

This is a misperception of how patents/patent law work. First of all, if you mean "illegal" in the sense of criminal, then be assured, it is not (illegal). Patent infringement is a civil matter that is settled between two private parties similar to a contract dispute.

It isn't "illegal" for you to offer a product (test) that Myriad happens to think infringes their patent. Yes, potential competitors "face lawsuits" by challenging patents that they think were wrongly granted (e.g. cover something that isn't patentable) or are being misapplied. But that is the way our patent system is designed -- the system is biased towards granting patents with the expectation that those who have the most direct interest in the subject matter of a patent (i.e., potential competitors held at bay by the patent) will be motivated to challenge those patents in court (as plaintiffs or defendants). The Supreme Court referred to potential/accused infringers as "private attorneys general" responsible for policing the patent system of bad patents.

The costs and potential liability of potential patent litigation are merely factors in a business decision to respect (or not respect) a patent. Between $50 (that you think you can offer a competing test for) and $3000 (what Myriad the monopolist is charging) is ample room for your price to cover the expected costs of litigation. The weaker the patent, the less likely Myriad will actually sue, and the less likely they will ultimately win, so the less you have to tack on to your price to cover a potential loss (think lower insurance premiums on less likely risks).

A different system might use taxpayer money to hire ten times the number of patent examiners (if that were even possible given the finite number of qualified reviewers) and thus expending a great deal of money testing the validity of the vast majority of patent applications that will never mean anything to anyone. If you are a testing lab and you want to make a profit selling medical tests, then part of the cost of doing business is showing that you aren't infringing various patents. (There are numerous proposed reforms to the system of patent litigation that would allegedly make it cheaper to challenge/assert patents in court).

The public interest is not left out in the cold, either. Even if a commercial entity (our testing lab) loses an infringement case, it is still not a given that it will be ordered to stop selling the competing infringing product. A court might, for various reasons (including "public interest" or "patent misuse"), force the patent holder to accept a royalty on the tests that the infringer sells, with the applicable royalty rate determined bay a whole host of factors (i.e., the court compels the patent holder to grant a license at specified terms).

If you are a university professor thinking about research in this area, and your university counsel has even an ounce of backbone (which, I recognize, many of them do not), you probably won't be deterred for too long by Myriad's patents. The complaint cites cease and desist letters allegedly sent to Yale, but Yale is not a party to the lawsuit and there is no definitive statement that those letters actually prevented anyone from doing research, which leads me to believe that Yale's lawyers looked at the patents, wrote a nice opinion saying how a patent on a naturally occurring gene would be found invalid by a court, and promptly fired off a STFU letter to Myriad. As the complaint admits (in a backhanded way), Myriad has not been successful in preventing strictly academic research; what it actually alleges is that a lot of researchers (and their institutions) have, without any pressure from Myriad, elected not to test the patent in court -- which is the same as those researchers accepting the validity of the patent on face value (in which case, how can they complain about being restrained by a valid patent?).

The lack of specific detailed instances of overt threats and overreaching by Myriad in the complaint (which is supposed to paint the worst possible picture) suggests to me that invalidating the specific Myriad patents is only a tangential goal of this lawsuit. Generating headlines/publicity about what is observed to be a defect in the patent system, a bad USPTO policy, and the use of federal research grants for private gain is clearly the primary motive here.

I do think a challenge to gene patents could be made for the reasons asserted in the complaint, it just ought to be made as an administrative appeal through the USPTO followed by an appeal to the Federal Circuit. Yes, this would be time consuming and not as media friendly, but it would be the procedurally correct way to assert this type of "society's interest" challenge to a USPTO policy. Filing what is, in essence, a "sham" lawsuit as a means of protesting the patent system's dependence on private litigation is pretty ironic.

"...one case in which a man's cells were patented and licensed for millions of dollars without his knowledge.", "Myriad prohibited anyone else from offering those tests to patients even though it knew that they would provide women with essential information about their risk of developing life-threatening cancer."...
That must be some jokes! What happened to the ethic?

"be assured, it is not (illegal)"
HAHA! do you not understand how patents work? It would be akin to printing Mickey Mouse t-shirts with no licensing agreement.

"Between $50 (that you think you can offer a competing test for) and $3000 (what Myriad the monopolist is charging) is ample room for your price to cover the expected costs of litigation."

$50 for 2 loci is not unreasonable at all:

$79 for 33 STR sites: http://dna.ancestry.com/buyKitGoals.aspx

$399 for a whole mix of SNP's, STR's and some sequencing:
https://www.23andme.com/howitworks/ (note, they have liscensing for 3 specific BRCA mutations.... 3! which means that they can help those with Ashkenazi Jewish heritage... ! https://www.23andme.com/health/brca/ and if you have any actual scientific knowledge in this area, you realize what a joke that is)

$99 for either 12 Y markers, or HVR1 sequencing of mtDNA http://www.familytreedna.com/products.aspx

And you're going to still assert that it's reasonable to charge $3000 for the test because the company aggressively (read paid out, bullied) acquired a patent in the mid 90's that they only had a small part in helping discover. You really want people to think that Myriad wouldn't stop a commercial company from providing the test? That's either a joke or a blatant lie. Why doesn't 23andme just throw in another few primers for a couple bucks? Because as soon as they do they get sued by Myriad.

The thing is Myriad looks bad whether they win or lose. If they win, they are still the monopoly charing stupid prices for a gene that could help save lives. They lose, the test starts being offered for a reasonable price. I'm all for patents for pharmaceutical companies creating drugs, cures, products for profits. I am against prohibiting being told what your own genetic code looks like because some company says they own that part of you.... especially if knowing that information could help save your life.

"HAHA! do you not understand how patents work? It would be akin to printing Mickey Mouse t-shirts with no licensing agreement."

T-shirts are one thing, but limiting one company to produce life saving techniques is another... REVOKE IT!

posts like this still give me a hope...

I have been tested positive for a deleterious mutation, using Myriad BRCA testing and am about to have surgery on June 29th. I feel reassured that Myriad is not distributing my information for multiple reasons. I spoke with a geneticist prior to receiving the test as well as the test results. They inform you that just because your test results come back negative does not mean your chances of still getting breast/ovarian cancer down the road is not obsolete. Going through this process I was not going to base my results on whether or not I should have a prophylactic mastectomy, ( I was going to have it done one way or another ) rather knowing these results would reassure me to whether or not I need to be concerned now and take action or if I would be able to wait (as when you have the breast cancer gene your statistics are 80-90% at any age! Where as most women start looking for breast cancer after the age of forty.) Also if you turn out to be positive your children have a 50% chance of also receiving the mutated gene and the parents test can be used as a landmark for your childrens test. By all means this is all quite controversial and could be argued endlessly, but until you see a loved one die before your eyes in such a destructive manner one could not understand the relief one might encounter after assured results from a test and a proactive plan for their health management is set in place.

While I don't understand half the jargon you lot are using - I can only relate the corporations that patent genes to the giant that is Microsoft.

It's mentioned earlier in these comments that science should be open source and available to all, but also that money is needed to provide funding.

It really comes as no surprise, however, that when something is open source (e.g. linux) then the developments that come from that from people who work on it's advancement on a not-for-gain basis are well ahead of the developments in the program that requires investment. By that I mean that anything that Microsoft comes up with, linux has already achieved many moons before it - in essence they are stealing material that can't be copyrighted as it's written in a different format.

Very simplistic view I know, but I can only assume that an open source approach to genetic science would see advancement far quicker than that of an investment approach. Unfortuantely, money hinders advancement, always has and always will.

I Don't think private industry should be granted any monopoly on any broad gene research. Patents and copyrights shoudld be granted to specific things only, as getting a patent on an entire gene doesn't create an incentive to innovate, it creates an incentive to get as many patents as possible and horde them.

I do think a challenge to gene patents could be made for the reasons asserted in the complaint, it just ought to be made as an administrative appeal through the USPTO followed by an appeal to the Federal Circuit.

I Don't conceive private industry should be granted any monopoly on any broad factor research. Patents and copyrights shoudld be granted to specific things only, as getting a patent on an entire factor doesn't create an motivator to innovate, it creates an motivator to get as many patents as doable and multitude them.

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It's a difficult issue. Especially as I *know* that one of the reasons phage therapy is going nowhere fast is because it's really difficult to patent.

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I think it is a tough issue because there really needs to be a balance on both sides. The pharmaseutical companies need a financial incentive to do expensive research and development. That's how we get the medicine and advanced technology to change things. It does make it hard when they don't share anything but maybe it should be more of they have the jump on things for a period of a few years and after that the patent opens up. That already happens for a lot of drugs which is why for a period of time you get no generics but then when that period expires, the opportunity for generics opens up. It will be interesting to see how it plays out as reported by the internet and television.