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« Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. (Fed. Cir. 2013) | Main | In Defense of the Patent System: How the Mainstream Media's Representation of it is "Broken" »

July 30, 2013

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There's a whole lot to digest here but a couple things jumped out at me:

"the company may once again be the impetus for the Supreme Court to revisit the scope of its "product of nature" patent ineligibility doctrine."

And we can all be excited by that because Myriad did such a great job representing the biotech industry's interests the first time around.

"The argument that Ambry's testing poses a risk to the public is Myriad's first and foremost argument."

Is the "diminished risk" that Myriad is relying upon supported by the application disclosure to which Myriad claims priority? If not, I don't see what the relative "risk" of the information provided by the competing company's test has to do with Myriad's patent case. Put another way, information that Myriad has discovered *after* its patent applications were filed (e.g., information about additional mutations at the BRCA1 locus) shouldn't be used to justify enjoining an alleged infringer of that patent.

"we live in a world that Myriad made ..."

Sounds like an advertisement. I can hear a whispery voice and a string section surging behind it. Not very convincing, though. ;)

"That outcome is hardly an example of promoting progress."

Neither is creating an oportunity for a private company to prevent people from using old technology to reveal the sequence of certain parts of their own genomes -- but that's exactly what Myriad is trying to do. The probes and primers along with every other sequence in the human genome are ineligible subject matter. But somehow Myriad can prevent me from using those patent-ineligible probes in primers in *old methods* of sequencing and/or sequence identification, in the exact same way that any other primer would be used? That can't be correct. And some vague hand-waving statement towards the end of a nearly incomprehensible, thoughtless Supreme Court opinion does not make it any more likely to be correct.

"if we turn the clock back and let major medical centers in New York, and Boston, and San Francisco, and New Haven, and Bethesda develop BRCA testing, is there any hope or realistic expectation that women in Appalachia, or Oklahoma, or rural communities throughput the country would have had better, or even equivalent access to such testing?"

Equivalent to what? Equivalent to the "test" that Myriad disclosed in the application to which they claim priority? Why isn't it realistic to think that women wouldn't have equivalent access to that test?

If you believe in the benefits that flow from increased knowledge of one's own genome, then "real progress" would be technology that makes it easier and cheaper for men, women and children to obtain that information. Allowing third parties to control where the information-gathering technology is pointed (what Myriad is trying to do, by leveraging their "discovery" of the importance of certain sequences) is not "real progress." But it is the kind of "progress" that our patent system seems to increasingly dedicated to promoting: increased control over information and how you get it. I wouldn't be suprised to find a claim pending on a method of forcing people to watch an ad before their sequence information is revealed to them.

LFQE,

Your post rings out the same underlying message that a 'variety' of posters have sounded.

It's a sour note.

And off-key.

That you have any thoughts to further the legal understanding involved, well, I am...

LFQE,
Myriad's brief is completely unapologetic and unconcerned about the fragile feelings of people who supported the ACLU's lawsuit. Don't let it get under your skin. You'll sleep better if you don't.
Can I just point out one thing? The reliability and predicitve value of Ambry's test in relation to Myriad's is relevant because the judge must decide if the public interest would be disserved if he issued a preliminary injunction. It's a real-world "today" inquiry that has nothing to do with what Myriad wrote in its patent application 20 years ago.
Regarding your comment about access -- it is simple commercial reality that the surest way to make a new technology widely available is if someone spends money on getting it adopted and covered. Compare BRCA testing in the United States to BRCA testing in the public health bureaucracies of Europe or Canada, where there are multiple providers and Myriad's patents aren't enforced. These places should be like paradise if one believes the stories told by the AMP or ACLU. Nobody wants to hear this, but despite multiple providers and no patents, BRCA testing in Europe and Canada is less common, patient qualifying criteria are stricter, women have less choice and face higher hurdles, and they have to wait longer for results. There's no free testing for family members if they carry a rare mutation, and they don't receive follow-up letters years later if their mutation is reclassified. Why do you think that is?

While this article tries to give at least the appearance of being balanced and timely, some other issues and items should have been noted.

This 7/30/13 article is also only addressing the 7/9/13 motion for injunctive relief filed by Myriad. It does not mention any of the counterpoints that Ambry made in their 7/18/13 motion to extend their time to respond, which motion the court granted on 7/19/13. Myriad asked on 7/19/13 that the court reconsider that time extension for Ambry, but the court denied that motion on 7/25/13. Since all these further developments occurred prior to this article date of 7/30/13, it seems odd that none are mentioned.

Appropriate and relevant disclosures about the author, Kevin Noonan, are missing, such as when “The Wall Street Journal” quoted Kevin Noonan, it was also noted that he had filed a brief supporting Myriad at the Supreme Court.

For those not already familiar with this site or with this author, disclosures that help the reader be watchful for potential bias are appropriate.

Dear R:

When Ambry responds we will post on it. I didn't think it fair to give Myriad the benefit of all its arguments while relegating Ambry to its motion to extend the time to respond. The motion practice you cite is merely proxcedural. The post sets forth Myriad's substantive arguments to which Ambry is entitled to a substantive response.

Anyone who has been paying attention knows my position, as well as who I am. Which cannot be said for most of the folks who comment on this site (or elsewhere).

Care to step up and take off your mask? If not, please spend more time making arguments on the merits and less time impugning our motivations.

Moocow: "Can I just point out one thing? The reliability and predicitve value of Ambry's test in relation to Myriad's is relevant because the judge must decide if the public interest would be disserved if he issued a preliminary injunction."

I'm sure you realize this, Moocow, but it's not Myriad that is being enjoined. If Myriad's test is more accurate than some other test because of features introduced long after its patent application was filed, then Myriad should feel free to advertise that fact to the public. The public can then decide whether those added features are worth paying whatever additional price Myriad is charging. Why should Myriad be able to rely on the non-patented* services it offers to justify enjoining a competitor? That doesn't make any sense.

*at least, not disclosed or claimed in the patents it is presently asserting

Kevin: "Anyone who has been paying attention knows my position, as well as who I am. "

With all due respect, Kevin, I think the concern being articulated by RS is about the vast majority of people who don't "pay attention" to this blog but who do read the Wall Street Journal or watch public television.

Sorry, Joe - responding to two different threads. To replicate:

When PBS or NPR or any other media outlet quotes me my affiliation with the firm, as well as the fact that I am a biotech patent lawyer, is front and center.

If my own economic self interest was my motivation I would be standing on the sidelines cheering Mayo and AMP; every time the Congress, the President or the Supreme Court makes patent law uncertain the value of my services increases.

So even if the public isn't paying attention to this site, I am always introduced in such a way that listeners can make up their own minds about my motives.

But you know what's funny? Whenever someone in a white coat is interviewed, they never say (nor are they introduced in this way) that they are interested in practicing Myriad's technology because they want to charge patients. Oh, sure, maybe they would charge less, maybe they wouldn't, but none of them are offering to provide testing for free.

Thanks for giving me the chance to clear that up.

We are not living in “Myriad’s world,” because technology has changed a lot in the past 20 years. We now have more advanced testing platforms such as next generation sequencing, which was not listed in Myriad’s patents and can perform these tests better without infringing on Myriad’s remaining patents and for volume much cheaper.

The Supreme Court’s unanimous decision lifted patents off these human genes. There are many laboratories that can now offer this test for a fraction of the price that Myriad charges. With the increasing availability of public data, in about six months, these other companies will also have enough publicly available variant data to make their interpretations as good as Myriad claims now. Please also note that the other labs' results in their first six months will be better than Myriad's results were in their first six years.

There have been so many similar or even more complex discoveries that other scientists have refused to patent and just published instead for everyone to benefit from. Myriad’s world is changing, and change is inevitable, although some are still in denial.

Jim GeneFree,

I would emphasize a point that is often lost in the discussion: The policy drivers of 101 differ from the policy drivers of 102/103 when it comes to timing. The sense that you depend on (changed a lot in the past 20 years) is not a 101-based sense and does not have anything to do with the Myriad decision.

Well, Jim, we do live in a world where doctors and (more importantly) private and public payors believe that genetic diagnostic testing for breast cancer based on mutations in the BRCA genes is reliable and makes economic sense to support. And we all have Myriad to thank for that.

The gene claims were never infringed by the diagnostic methods, and the methods that clearly overreach were invalidated under Bilski. As the post points out, there are different positions on whether the primers and probes are patent-eligible under Myriad, and we will see where that comes out.

If there are "modern" methods that fall outside the scope of Myriad's claims then that is precisely what the patent system is intended to do - motivate others to design around patent claims using new technology.

But new or old, without Myriad access to testing would not be as well developed as it now is.

Kevin,
funny that you'd mention altruistic people in white coats. You mean ... there might be mixed motives that nobody acknowledges? Gasp! I always thought the AMP is motivated by nothing but concern over patient care, and that Ambry is in it for no reason other than pure beneficence. And that Larry Flynt gets up every morning for no reason other than to fight for our First Amendment rights!

Kevin, thanks for the reminder that Ambry is in this for profit, as are the physicians involved in many of these challenges.

One typo I caught: "from each according to her abilities, from each according to her needs" - I think you meant "from each according to her abilities, *to* each according to her needs".

I find the case actually pretty straight forward. As long as the primer and probes are identical to those sequences found in nature then they are not patent eligible. Supreme Court seemed to make this pretty clear, that it's about the sequence not about being man made or not. I can make oligos that correspond to the BRCA gene and ligate them all together to creat the exact BRCA sequence. Can I now patent the gene, don't think so. I can however patent the method of doing this if it were novel. Though no of the methods Myriad is claiming in their patents were actually novel at the time. Also, Myriad doesn't patent any specific primer or probe, they patent any primer or probe 15 bp or longer. Would be shocked if these are not invalidated.

OK. I'm late to this party.... I've wondered about claims to pairs of primers and whether or not they are ineligible subject matter. Assuming that each primer has a "genomic" sequence and neither spans an exon/intron junction. The pair of primers aren't found in the same manner in a genome, just as a collection of sequences on a chip aren't found that way in a genome.

Thoughts?

lorac,

Is your claim different than that of Funk?

"Is your claim different than that of Funk?"

Pretty sure it must be, Skep, because Funk didn't say anything about primers.

Don't Mind Me - don't be pedantic.

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