Ariosa Diagnostics, Inc. v. Sequenom, Inc.
788 F.3d 1371 (2015)
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Rule of Law:
A method claim is not patent-eligible under 35 U.S.C. § 101 if it is directed to a natural phenomenon and the additional steps consist only of applying well-understood, routine, and conventional activities already known in the art.
Facts:
- In 1996, Drs. Dennis Lo and James Wainscoat discovered the existence of cell-free fetal DNA (cffDNA) in maternal plasma and serum, a component of blood that was previously discarded as waste.
- Based on this discovery, Drs. Lo and Wainscoat developed a method to detect paternally inherited nucleic acids within the cffDNA to determine fetal characteristics.
- The method involved obtaining a maternal blood sample, amplifying the cffDNA contained in the plasma or serum using known techniques like polymerase chain reaction (PCR), and then detecting the presence of the specific paternally inherited DNA.
- Sequenom acquired the rights to this invention, obtained U.S. Patent No. 6,258,540, and commercialized the method as its MaterniT21 test, a non-invasive prenatal diagnostic tool.
- Ariosa Diagnostics, Inc. began making and selling a competing non-invasive prenatal test called the Harmony Test.
- Natera, Inc. also made and sold a Non-Invasive Paternity Test utilizing fetal DNA found in maternal blood.
Procedural Posture:
- Ariosa Diagnostics, Inc., and others filed declaratory judgment actions in the U.S. District Court for the Northern District of California against Sequenom, seeking a ruling that they did not infringe U.S. Patent No. 6,258,540.
- Sequenom filed counterclaims for patent infringement.
- The district court denied Sequenom's motion for a preliminary injunction.
- Sequenom appealed the denial to the U.S. Court of Appeals for the Federal Circuit, which vacated the denial and remanded the case for reconsideration of subject matter eligibility in light of a recent Supreme Court decision.
- On remand, the parties filed cross-motions for summary judgment on the issue of patent validity under 35 U.S.C. § 101.
- The district court granted summary judgment for Ariosa, holding the asserted patent claims invalid for being directed to non-patentable subject matter.
- Sequenom, the appellant, appealed the district court's grant of summary judgment to the U.S. Court of Appeals for the Federal Circuit, with Ariosa as the appellee.
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Issue:
Does a method claim directed to detecting a naturally occurring phenomenon become patent-eligible under 35 U.S.C. § 101 by adding steps that are well-understood, routine, and conventional in the field?
Opinions:
Majority - Reyna
No. A method claim directed to a naturally occurring phenomenon does not become patent-eligible simply by adding steps that are well-understood, routine, and conventional. The court applied the two-step framework from Mayo v. Prometheus. First, the court determined the claims are directed to a natural phenomenon: the existence of cffDNA in maternal plasma. The method begins with a natural phenomenon (cffDNA in blood) and ends with information about a natural phenomenon (the paternally inherited cffDNA). Second, the court searched for an 'inventive concept' by analyzing the additional claim elements. It found that the steps of amplifying DNA via PCR and then detecting it were well-understood, routine, and conventional activities in 1997, as confirmed by the patent's own specification and expert testimony. Simply applying these conventional activities to the newly discovered natural phenomenon is not an inventive application, but is merely an instruction to 'apply it.' The court rejected the argument that the claims were patentable because they did not preempt all uses of cffDNA, stating that the absence of complete preemption does not demonstrate patent eligibility. While the discovery was groundbreaking, the Supreme Court in Myriad established that a brilliant discovery alone does not satisfy the § 101 inquiry.
Concurring - Linn
No. Although the claims are invalid under current precedent, the law compels an unfortunate result. Judge Linn joins the majority opinion only because he is bound by the 'sweeping language' of the Supreme Court's test in Mayo. He argues this case represents an unintended consequence of that broad test, excluding a meritorious and groundbreaking invention from patent protection. He distinguishes this invention from the one in Mayo by noting that while the steps of amplification and detection were known, no one before this invention was applying them to maternal plasma to detect cffDNA; in fact, the plasma was routinely discarded. Unlike in Mayo, where doctors were already performing all the claimed steps, the '540 patent claimed a new method that effectuated a practical result never before attained. Judge Linn believes that but for the broad holding in Mayo, this 'paradigm shift' in prenatal diagnosis should be patent-eligible.
Analysis:
This decision solidifies a narrow interpretation of patent eligibility for diagnostic methods under 35 U.S.C. § 101, reinforcing the Supreme Court's framework in Mayo. It establishes that the novelty of a method claim must come from the process steps themselves, not from applying old process steps to a newly discovered natural phenomenon. The ruling significantly raised the bar for patenting diagnostic methods, creating uncertainty and concern in the biotechnology industry that investments in discovering new biomarkers might not be protectable if their detection relies on conventional laboratory techniques. The case highlights the tension between preventing the preemption of natural laws and incentivizing groundbreaking scientific discoveries that have immense practical benefits.
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