Sequenom v. Ariosa: The Supreme Court Says "No Thanks"
The Supreme Court has refused to hear an appeal in Sequenom, Inc. v. Ariosa Diagnostics. Sequenom’s patent covered to a method for detecting paternally inherited nucleic acid in maternal serum or plasma by amplifying the paternal nucleic acid. The Court of Appeals for the Federal Circuit had held that this invention was not eligible for a patent because it improperly preempted the use of a natural phenomenon.
This means we have to continue to struggle with the two-part test articulated by the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., reiterated in Alice Corp. v. CLS Bank Int’l and promulgated by the USPTO in its Guidance:
First, are the claims directed to a patent-ineligible concept (natural phenomena, laws of nature, abstract ideas)?
If so, do the additional claim elements, alone or in combination, provide something that, in practice, amounts to significantly more than a patent upon the ineligible concept itself?
As to the first part, all method claims, in one way or another, involve natural principles; there is no neat dividing line. As to the second part, there is no legal standard for “significantly more”. Therefore, both parts of the test are arbitrary. (See Robert Armitage’s excellent paper on this.)
The examples provided by the USPTO in its guidelines on determining patent eligibility demonstrate the difficulty. The USPTO identifies the first claim as patent eligible, the second as not:
1. A method of detecting JUL-1 in a patient, said method comprising:
obtaining a plasma sample from a human patient; and
detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.
2. A method of diagnosing julitis in a patient, said method comprising:
obtaining a plasma sample from a human patient;
detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; and
diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.
This result is ironic, because the Supreme Court has identified preemption as the Holy Grail of patent eligibility analysis. However, the first claim preempts the detection of JUL-1 for any purpose, while the second claim preempts its detection for the more narrow purpose of diagnostics.
The arbitrariness of determining exempt categories is apparent: Why is the presence of paternal nucleic acid in maternal plasma considered an exempt “natural phenomenon” (Sequenom), but the presence of JUL-1 in the plasma is not (USPTO)?
As regards the standard for determining “significantly more”, is it the same as, or different from, the standard for determining obviousness? If it is the same, then nothing less than the non-obviousness of the pre-diagnostic steps is necessary to render the second claim patentable. In that case, the diagnostic step is irrelevant to patentability. If the standard is different, what is the lower standard?
We should now proceed with the understanding that steps in a claim other than the diagnostic step must bear the entire burden of anticipation and obviousness.
Here are three possible approaches to writing claims that jump the hurdle of subject matter eligibility and may be non-obvious:
Take the diagnostic step out of your claim.
Instead, rely entirely on the method steps leading up to the diagnosis. This means including elements that have never been done before, alone or in combination. Such elements may include:
The method of detection (it uses an unusual detection system)
The sample source (no one would think to look here)
The method of sample preparation (typically it’s done another way)
The combination of analytes (it might be obvious to detect one, but all of them together?)
The population tested (the selection of persons with these characteristics for this measurement is non-obvious).
The elements can be combined in a single step:
A method comprising detecting, in cancer cells from persons characterized by phenotype P, the presence of biomarkers A, B, C and D by liquid chromatography mass spectrometry.
Add a physical step after the diagnostic step
Including a physical step after the diagnostic step results in a practical application of the “law of nature.”
A method comprising:
a) measuring biomarker B;
b) correlating the presence of biomarker B to responsiveness to drug D; and
c) treating the subject with drug D.
A problem with this approach is that it is likely to involve divided infringement, with the lab performing one part of the claim and the doctor another. However, the steps could be unified in a single step (shout out to Matthew Hinsch of Kilpatrick Townsend for this one):
A method comprising treating a subject possessing biomarker B with drug D.
Use a Jepson claim
The Jepson format is currently disfavored because the preamble admits something is prior art. But, carefully crafted, it can impose meaningful limitations that impart non-obviousness.
In a method of measuring biomarker B in a sample by liquid chromatography mass spectrometry, the improvement comprising tagging biomarker B with mass tag T before liquid chromatography.
Yes, you’ve admitted that detecting the biomarker by mass spectrometry is old, but no one has ever detected it this way, and the Examiner is focused in the improvement.
This is all a shame. Originally, it was understood that a patent could not be taken out on a principle, but only on the practical application of a principle. By requiring a patent to be commensurate with the scope of the invention described and enabled by the specification, there was no danger of preempting the entire principle. In this regime, the well developed doctrines of anticipation, obviousness, written description and enablement bore the main burden of determining patentability. As currently articulated, Section 101, previously used to eliminate only the grossest attempts at patenting principles, has swallowed up the patent law whole. It may require an act of Congress to set things straight.