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« Court Report | Main | GEN Compiles List of Top Selling Drugs for 2012 »

March 11, 2013

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Very disquieting. Hal Wegner (and others) have wondered publicly why Myriad continues to pursue this case; this weak filing only heightens the puzzlement. I'm not a conspiracy theorist, but Myriad's behavior makes one wonder if money has changed hands under the table to ensure that Myriad loses this unnecessary litigation in a way that poisons the waters for many other patentees and applicants.

Well written Dr. Noonan, I look forward to reading the brief later today.

"Emphasizing the negative consequences on progress and innovation of a decision in the ACLU's favor would have provided the Court with greater motivation to pause before taking a broad, sweeping and unnecessary position on where the balance should be struck on patenting isolated human DNA. Myriad's brief gives the Court no basis for doing so."

Kevin,

It is unfortunate that Myriad didn't argue in their brief as you suggest. It's really important that SCOTUS understand the "realities" and especially the adverse impact their decision could have (and has had as a result of Mayo) on innovation, especially American innovation, in view of SCOTUS' currently myopic view of the scope of patent-eligible subject matter under 35 USC 101. Again, and contrary to what SCOTUS might otherwise believe, research & development on biotech, like money, doesn't grow on trees. If you render decisions like Mayo that don't nurture innovation, it will eventually wither and die. And as Joe Allen has said, there are stories that exist, and need to be told to SCOTUS that the ACLU/PubPat would like to see remain hidden of patients begging (correct, "begging") that patents be granted on certain technologies so that these technologies would be developed to cure conditions they're currently dying of. Put differently, there are also "bleeding heart" stories in favor of patenting technology that need to be brought to SCOTUS' attention.

Why does Myriad continue to pursue this case? Could it be the same blinders that caused them to ignore making their case in the court of public opinion years ago?

Kevin,

The "story" I noted from Joe Allen's excellent article "Gene Patents: Gettying Beyond Witch Trials" posted on IPWatchdog:

Linda Bruzzone, a Lynch syndrome patient and Executive Director for Lynch Syndrome International made a telling point. Lynch syndrome is an inherited condition predisposing victims to aggressive cancers, often at a young age. It is a forgotten disease that’s vastly underdiagnosed even though genetic tests are available. Doctors have little awareness of the tests, which insurance companies inconsistently reimburse. Thus: “Our family members are dying.”

Patients with familial breast cancer are referred twice as often for genetic testing than Lynch Syndrome patients, even though the two conditions are equally common. When Lynch patients are lucky enough to be referred, tests vary between laboratories as each works in different ways with different parameters. Ms. Bruzzone said it’s critical to educate physicians on the availability and importance of testing, and for producing clinical data needed for insurance coverage. Because the companies offer slightly different tests, no individual company will invest to solve these issues.

She concluded if Lynch syndrome testing were like BRCA testing with a patent and a company committing the required resources promoting the test, our families could be as fortunate having access to early diagnosis as families affected by hereditary breast cancer.

Again, there are two sides to this one-sided gene patenting "story" as presented by the ACLU/PubPat.

Were we reading the same brief? I thought the Myriad brief was excellent and did exactly what it had to do in emphasizing the role of human invention and ingenuity in Myriad's inventions, dismissing the ACLU/PubPat (and the government's) fuzzy test(s), showing how those tests would cause 101 to cannibalize the intended role of 103, and pointing out all of the negative consequences of a contrary ruling. You, on the other hand, seem already willing to concede defeat on the law because you read the Bilski and Mayo method-claim cases as harbingers of doom. But you forget that Chakrabarty itself was GVRed in light of Flook, which was seen at the time as a similar harbinger of doom, yet the CCPA's decision (which stated, if I recall, that Flook was "irrelevant" to the consideration of product/manufacture claim eligibility) was affirmed by SCOTUS. The brief you wish was submitted might be a useful amicus brief, I suppose, but that's about all.

AA makes good points, especially with regard to the Myriad's briefing on the superior suitability for 102/103/112 for handling these claims.

After all this time, Kevin, you still seem to be struggling with the Prometheus case and its inevitable and necessary result. Myriad's composition claims are profoundly and fundamentally different from the method claims in Myriad. The reason the Supreme Court rejected the 102/103 approach suggested by the government for handling Prometheus' claims is because that approach required that the mental step (thinking about the correlation) be read out of the claim. The Supreme Court reasonably noted that (1) there was no precedent to justify that approach and (2) it would turn the well-understood prohibition under 101 against claims protecting abstractions/mental processes into a dead letter.

These issues do not arise in the case of Myiad's composition claims. Even under the ACLU's unworkable test, a clear understanding of the claim scope (i.e., the structure of the molecule) and its relationship to the prior art is essential. Where the structure isn't clear or enabled, you have a 112 problem (that was the problem with the Funk Brothers claim). If it captures the prior art (i.e., so-called "naturally occuring" compositions), then the claim is invalid under 102/103. Myriad's claims, by the way, are almost certainly invalid under one or more of these statutes.

Breyer and his fellow Justices knew what they were doing when they wrote Prometheus: they were closing the door on the practice of effectively patenting ineligible subject matter (abstractions/mental steps or natural laws) by tying the mere recitation of those abstractions to some old patent-eligible step. That issue is completely absent in the case of a structurally described composition claim.

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