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July 22, 2014

Myriad Patent Case Argued Before The Supreme Court – Some Snippets

I confess that I’ve become addicted to this case and just finished all 63 pages of the transcript of the oral argument that took place on Monday. I won’t try to summarize it, but rather will try to review some trends.

1)  Four of the Justices (Scalia, Kennedy, Kagan and Roberts) all expressed concern that ruling that isolated DNA is not patent-eligible would discourage investment in the research needed to lead to further useful inventions based on isolated genes. The question is, of course, how concerned are they? However Hansen, arguing for Myriad was questioned about this early in his time slot.

2)  As often as he could, Hansen emphasized that patents on products of nature, block further research on them: “When you lock up a product of nature, it prevents industry from innovating and making new discoveries.” Solicitor General Verrelli agreed with him. Myriad’s attorney, Gregory Castanias, never challenged this argument, e.g., inter alia, that even if you could not isolate the gene, you could use its DNA sequence in research. Breyer specifically noted the inherent “uneasy compromises” in the patent system – providing an incentive to invent vs. tying up things that could be used for further advances.

3)  The case is going to turn on whether or not a majority of the court believes that, as Justice Roberts put it, simply “snipping out the gene” to obtain the isolated DNA is enough to avoid whatever the scope of the natural products doctrine is. The parties spent a lot of time considering whether or not a “new plant found in the jungle” and brought back to the U.S. would be patentable. The simple answer is, “The Supreme Court explicitly said ‘no’ in Chakrabarty”, but that decision was barely mentioned in anyone’s argumentation.

4)  I agree with the other commentators who predict that the Court may “split the baby” as urged by the Solicitor General and find that while isolated genes are not patent-eligible because they are natural products, cDNA and recombinant DNA are man-made enough to meet s.101. This is made more likely by the fact that Hansen admitted that cDNA is not found in nature. Nonetheless, Gregory Castanias, arguing for Myriad ably made the argument that an isolated gene is “a new molecule that had never before been known to the world.” Although his closing statement: “There is no risk of anything being preempted other than what the claims properly claim, which are human-made inventions of isolated molecules”, was to the point, his analogy to drug synthesis in which two known molecules are combined to yield a new drug was slapped down by Justice Roberts: “there you’re obviously combining things and getting something new. Here you’re just snipping, and you don’t have anything new, you have something that is part of something that has existed previous to your invention.”

5)  With all due respect to the gentlemen who argued the case, and to the Justices, none of the parties has a scientific background that would enable them to create a sensible discourse on cDNA vs.recombinant DNA vs. pseudogenes, vs. undifferentiated gene fragments formed in vivo that might include BRCA DNA. Mr. Castanias was quizzed on the latter by Justice Breyer and simply got lost for 4 pages in the transcript. A brief answer might have been, “Even if such DNA exists in the body at some point due to cell death, it is certainly not an “isolated gene” as term is used in the question before us.” Castanias’ arguments about deference to the PTO’s utility guidelines were DOA.

6)  Of course I am prejudiced, but I think that a chemical prosecutor with a Ph.D. in molecular biology or cellular physiology with a good track record at the Board would have done as well as someone with experience arguing before the Court on matters such as civil rights or tax law. For example, such a hypothetical prosecutor-advocate might have designed a closing argument wherein a known drug was fragmented to yield a new drug – e.g., the new drug was snipped from the larger molecule. I know that hind sight is 20/20 but I did post on this.

7)  Perhaps the most ironic exchange came early in Mr. Hansen’s argument, when Justice Sotomayor said, “The isolation [of the gene] itself [would not yield a valuable product]; it’s the use you put the isolation to.” Hansen answered, “That’s exactly correct”. Sotomayor then said, “So the isolation of the gene has no value.” Hansen replied, “You can look at it to see if there’s a mutation in it and tell the sample provider it is there.” Yes indeed, but you can’t patent that valuable use of the isolated gene, thanks to AMP’s victory below at the Fed. Cir, where this diagnostic use was found to be a patent-ineligible abstract idea. This may have led Justice Sotomayor to her next statement, “That’s a failure of the patent law. It doesn’t patent ideas.” After Monday’s  exchanges, a new failure of the patent law may be staring us all in the face.

Transcript of Oral Arguments

© 2014 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.

About the Author

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Warren Woessner is a registered patent attorney and a founding shareholder of Schwegman, Lundberg & Woessner. His practice focuses on chemical patent law, including biotechnology, pharmaceuticals, vaccines, medical treatments, diagnostics, and biofuels and agricultural chemistry, including related opinion and licensing matters.

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