Using a natural phenomenon can be eligible for patent protection. ILLUMINA v. ARIOSA

A patent is a set of exclusive rights granted to the inventor of a new, useful and not obvious invention. In the United States an inventor gains a patent by filing a patent application with the United States Patent and Trademark Office. The patent application is reviewed by a patent examiner at the United States Patent and Trademark Office and if the patent application meets all the requirements, the inventor is granted a patent on the invention. A patent gives its owner the exclusive right to make, use, sell and import the invention in the United States.

Patent law is constantly evolving so even once a patent is granted, it can still be invalidated. One of the grounds for invalidating a patent is the subject matter to which the invention relates. A patent can be granted on any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof. This requirement is articulated in §35 U.S.C. 101 of United States Patent Law. There are also some judicially created exceptions to patent eligible subject matter, namely, laws of nature, physical phenomena, and abstract ideas. Patents that have been granted in the past can be deemed invalid if court precedent changes the definition of these judicially created exceptions.

These exceptions exist because monopolizing the basic tools of scientific work might tend to impede innovation more than it would tend to promote it. However, the United States Supreme Court has advised that these exceptions must be applied cautiously, because too broad an interpretation of these exceptions could eviscerate patent law.

Laws of nature and natural phenomena are not patentable, but applications and uses of such laws and phenomena may be patentable. A claim to otherwise statutory subject matter does not become ineligible by its use of a law of nature or natural phenomenon.

To distinguish claims to patent-eligible applications of laws of nature and natural phenomena from claims that impermissible claims, two-part test is used by courts. First, the claims are examined to see if they are “directed to” a law of nature or natural phenomenon. If the claims are directed to a natural phenomena, then the court will examine whether the limitations of the claim transform the nature of the claim into a patent-eligible application.

ILLUMINA, INC., v. ARIOSA DIAGNOSTICS, INC., 2019-1419 (C.A.F.C. 2020) is a case which revolves around a patent on a method which exploits a natural phenomena. The plaintiff in this case U.S. Patent 6,258,540, which claimed a method for detecting the small fraction of paternally inherited cell-free fetal DNA in the plasma and serum of a pregnant woman. That patent was invalidated under 35 U.S.C. § 101 in 2015 as being directed to a natural phenomena, ie that cell-free fetal DNA exists in maternal blood. The plaintiff also owns U.S. Patent 9,580,751 and U.S. Patent 9,738,931. These patents relate to a method of distinguishing and separating the tiny amount of fetal DNA from the vast amount of maternal DNA in a blood sample.

The plaintiff filed suit against the defendant alleging infringement of the ’751 and ’931 patents. The defendant moved for summary judgment on the grounds that the the patents are invalid under 35 U.S.C. § 101. The district court granted Roche’s motion for summary judgment, holding that the claims of the ’751 and ’931 patents are directed to ineligible subject matter. The plaintiff appealed this decision to the Court of Appeals for the Federal Circuit.

The Federal Circuit found that the patent was a method of preparation case and not a diagnostic case or method of
treatment case. The Federal Circuit noted that the focus of the dispute in this case is whether the claims of the ’751 and ’931 patents are “directed to” the natural phenomenon, i.e., whether they claim the discovered natural phenomenon itself versus eligible subject matter that exploits the discovery of the natural phenomenon. The Federal Circuit concluded that the claims are not directed to that natural phenomenon but rather to a patent-eligible method that utilizes it.

The ’751 and ’931 patents did not merely observe or detect the presence of a natural phenomena, rather the patents claimed a process that exploits a natural phenomena to purify a mixture so fetal DNA could be separated from maternal DNA. Accordingly the Federal Circuit found the patents were not directed to a natural phenomena, therefore the second step of the test did not need to be performed.

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