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Federal Circuit Holds Medical Diagnostics Patent Invalid under 35 USC 101.

The Federal Circuit, in a three-judge panel, recently decided a medical diagnostics patent case that has an unusual concurrence written by one of the three judges, Judge Linn. In Ariosa Diagnostics, Inc. et.al. v. Sequenom, Inc. et.al. (Fed. Cir. June 12, 2015), (“Sequenom”) the Court affirmed a district court summary judgment holding that U.S. Patent No. 6,258,540 (“the ‘540 patent”) is invalid under 35 U.S.C. § 101 as not directed to patent eligible subject matter.

The Court based its holding on Mayo Collaborative Services v. Prometheous Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289 (2012) (“Mayo”).

The ‘540 patent claims a method for detecting cell-free fetal DNA (“cffDNA”) in maternal blood samples. A sample claim of the ‘540 patent is:

  1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises: amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

The Court followed the two step Mayo method of determining subject matter eligibility for processes claiming the use of laws of nature, natural phenomena, and abstract ideas.

In the first step, the Court determines whether the claims at issue are “directed to” a patent-ineligible concept. Here, the Court held that the claims are directed to a natural phenomenon because the method “begins and ends with a natural phenomenon.”

In the second step, the Court determines whether “additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Here, the Court held that the claims do not pass the second step because “the method steps were well-understood, conventional and routine.”

In its analysis, the Court, citing Alice Corp. v. CLS Bank Int’l, __ U.S. __, 134 S. Ct. 2347, 2354 (2014), (“Alice”) “made clear that the principle of preemption is the basis of the judicial exceptions to patentability.” However, the Court also stated that “[W]here a patent’s claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, as they are in this case, preemption concerns are fully addressed and made moot.” The Court declined to adopt the appellee’s “distinction among natural phenomena based on whether or not they will interfere signifcantly with innovation in other fields now or in the future.” The Court also stated that the Supreme Court has instructed that a “[g]roundbreaking, innovative or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Assn for Molecular Biology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 2117 (2013) (“Myriad”).

Judge Linn wrote a concurring opinion but stated he was doing so “only because I am bound by the sweeping language of the test set out in [Mayo].” He further explained:

“The Supreme Court’s blanket dismissal of conventional post-solution steps leaves no room to distinguish Mayo from this case, even though here no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers.”

Sequenom is notable for the stringent application of the Mayo analysis even in the case of (admittedly) an absence of prior art and the presence of a “new way that revolutionized prenatal care.” This is an indication of the Federal Circuit’s new obeisance to its chastising by the Supreme Court in Alice, Mayo, and Myriad. However, Judge Linn’s concurrence suggests that not all of the members of the Court fully subscribe.

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FTC v. Actavis

The U.S. Supreme Court’s decision yesterday in FTC v. Actavis, Inc. brings some resolution to the decade-long dispute over the level of antitrust scrutiny that is appropriate for evaluating the legality of “reverse-payment” or “pay-for-delay” agreements settling pharmaceutical patent infringement litigation between brand-name and generic drug companies.  Writing for a 5-3 majority in Actavis, Justice Breyer rejected both the scope-of-the-patent test and the presumptive illegality approach, and held instead that courts should review reverse-payment settlements under the rule of reason.   Or say the opinion states.  In reality, the Court appears to have all but in name adopted the presumptive illegality approach it purported to reject.  One might speculate about the political or prudential considerations that went into the majority’s characterization of what it was actually doing, but as I read the opinion reverse-payment settlements of the type at issue in Actavis are now subject to a de facto regime of presumptive illegality.  I have completed a brief essay on the case, which interested readers can access here; see if you agree or disagree with my analysis.

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