Judge Dyk Would Add Reduction To Practice To Patent Eligibility Requirement

03 December 2015 PharmaPatents Blog
Author(s): Courtenay C. Brinckerhoff

As noted in this article, the Federal Circuit has denied rehearing in Ariosa Diagnostics, Inc. v. Sequenom, Inc.. The per curiam order was accompanied by two separate concurring opinions, one authored by Judge Lourie (joined by Judge Moore) and one authored by Judge Dyk, and one dissenting opinion authored by Judge Newman. Here, I look at Judge Dyk’s concurrence. 

Judge Dyk’s Views on Patent Eligibility

Judge Dyk starts with the premise that “the framework of Mayo and Alice is an essential ingredient of a healthy patent system,” but expresses concern with regard to how recent patent eligibility jurisprudence is being applied to “laws of nature.” According to Judge Dyk, “[t]he Mayo/Alice framework works well when the abstract idea or law of nature in question is well known and longstanding, as was the situation in Mayo itself,” and also “works well with respect to abstract ideas,” but may not be appropriate when the law of nature at issue is a novel discovery:

[A]s I see it, there is a problem with Mayo insofar as it concludes that inventive concept cannot come from discovering something new in nature—e.g., identification of a previously unknown natural relationship or property. In my view, Mayo did not fully take into account the fact that an inventive concept can come not just from creative, unconventional application of a natural law, but also from the creativity and novelty of the discovery of the law itself. This is especially true in the life sciences, where development of useful new diagnostic and therapeutic methods is driven by investigation of complex biological systems.

Judge Dyk then identifies “[t]he primary concern with a patent on a law of nature” as being “undue preemption—the fear that others’ innovative future applications of the law will be foreclosed,” and proposes a new test for ensuring that does not occur:

[I]f the breadth of the claim is sufficiently limited to a specific application of the new law of nature discovered by the patent applicant and reduced to practice, I think that the novelty of the discovery should be enough to supply the necessary inventive concept. My proposed approach would require that the claimed application be both narrow in scope and actually reduced to practice, not merely “constructively” reduced to practice by filing of a patent application replete with prophetic examples. …. [S]o long as a claim is narrowly tailored to what the patent applicant has actually invented and reduced to practice, there is limited risk of undue preemption of the underlying idea.

According to Judge Dyk, “limiting the scope of patents based on new discoveries to narrow claims covering applications actually reduced to practice, would allow the inventor to enjoy an exclusive right to what he himself has invented and put into practice, but not to prevent new applications of the natural law by others.”

Judge Dyk expressly rejects the notion that the enablement and written description requirements of 35 USC § 112 provide adequate limitations on claim scope, noting that they “generally require only that one or a handful of representative embodiments be described by the patentee. “Therefore, the doctrines of enablement and written description would not entirely prevent claims that preempt future applications of the law of nature by others.”

Turning to the Sequenom claims, Judge Dyk opines that they are invalid because they are too broad:

For example, claim 1 of the ’540 patent broadly covers any method of detecting paternally inherited cffDNA from maternal serum or plasma via amplification and detection of that cffDNA. …. Even the somewhat narrower claim 21 of the ’540 patent, which recites a method of performing a prenatal diagnosis based on the presence, quantity, or sequence of paternally inherited cffDNA detected by the method of claim 1, still broadly encompasses any diagnosis of any disease, disorder, or condition. …. Such claims appear to be impermissible attempts to capture the entire natural phenomenon of cffDNA rather than any particular applications thereof developed and actually reduced to practice by the inventors.

Thus, Judge Dyk suggests that this may not be the best case for the Supreme Court to take up for review.

Serving the Purpose of § 101, but What About the Purpose of Patents?

Judge Dyk believes that “allowing narrow claims that have been actually reduced to practice when those claims embody an inventive, newly discovered law of nature would promote the fundamental policies underlying § 101,” but would it adequately promote the fundamental policies underlying the patent system?

Would innovators find that scope of protection sufficient quid pro quo for disclosing their inventions in their patent applications?

Would companies find that scope of protection sufficient to justify investment in research and development?

If not, Judge Dyk’s test would just be a more complicated “too restrictive test for patent eligibility” that “may discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences.”

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