September 2012

Claims to Isolated DNA and Screening Method Are Patent Eligible, but Claims to Analyzing and Comparing Methods Are Not
Carla Mouta

In Association for Molecular Pathology v. U.S. Patent & Trademark Office, No. 10-1406 (Fed. Cir. Aug. 16, 2012), the Federal Circuit affirmed-in-part and reversed-in-part the district court’s decision that certain medical organizations, researchers, genetic counselors, and patients (collectively “Plaintiffs”) had standing under the DJ Act to challenge patents owned by Myriad Genetics, Inc. and the Directors of the University of Utah Research Foundation (collectively “Myriad”).  The Court also affirmed-in-part and reversed-in-part the district court’s grant of SJ that all of the challenged claims are drawn to nonpatentable subject matter under 35 U.S.C. § 101.

The Plaintiffs filed suit against Myriad, seeking a declaration that fifteen claims from seven patents assigned to Myriad are drawn to patent-ineligible subject matter under § 101.  The challenged claims include composition claims directed to two “isolated” human BRCA genes and certain mutations associated with a predisposition to breast and ovarian cancers, method claims directed to “analyzing” or “comparing” a patient’s BRCA sequence with the wild-type sequence to identify the presence of
cancer-predisposing mutations, and a method claim directed to a method of screening potential cancer therapeutics.

Regarding standing, Myriad argued that they did not have adverse legal interests with the Plaintiffs and that the Plaintiffs failed to allege a controversy of sufficient immediacy and reality to warrant the issuance of a DJ.  The Court noted that “to establish an injury in fact traceable to the patentee, a [DJ] plaintiff must allege both (1) an affirmative act by the patentee related to the enforcement of his patent rights,” slip op. at 26 (citing SanDisk Corp. v. STMicroelecs., Inc., 480 F.3d 1372, 1380-81 (Fed. Cir. 2007)); “and (2) meaningful preparation to conduct potentially infringing activity,” id. (citing Cat Tech LLC v. TubeMaster, Inc., 528 F.3d 871, 880 (Fed. Cir. 2008)).

The Court found that only three of the plaintiffs alleged an injury traceable to Myriad, and that only one of those, Dr. Harry Ostrer, clearly alleged a sufficiently real and imminent injury because he alleged an intention to actually and immediately engage in allegedly infringing activities.  “Myriad’s challenged . . . claims undisputedly provided ‘an absolute barrier’ to Dr. Ostrer’s ability to undertake BRCA diagnostic testing activities, and a declaration of those claims’ invalidity would remove that barrier.”  Id. at 35.  The Court “conclude[d] that it [was] likely, not merely speculative, that Dr. Ostrer’s injury [would] be redressed by a favorable decision.”  Id.

Regarding the other plaintiffs, the Court held that “[s]imply disagreeing with the existence of a patent on isolated DNA sequences or even suffering an attenuated, non-proximate, effect from the existence of a patent does not meet the Supreme Court’s requirement for an adverse legal controversy of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”  Id. at 35-36 (citing MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 (2007)).  The Court thus reversed the district court’s holding that the plaintiffs other than Dr. Ostrer had standing to maintain the DJ suit.

Having found one plaintiff with standing to maintain the action, the Court turned to the merits of Myriad’s appeal of the district court’s SJ decision that all fifteen challenged claims were invalid under § 101.  The Court noted that the issue before them was patent eligibility, not patentability, and held that the composition claims and the screening method claim were patent eligible, while the analyzing and comparing method claims were not.

In addressing the patent eligibility of the composition claims, the Court noted that the parties and the government appeared to agree that isolated DNAs are compositions of matter, but disagreed on whether and to what degree such molecules fall within the patent-ineligible exception for products of nature.  The Court held that the challenged claims to isolated DNAs, whether limited to cDNAs or not, are directed to patent-eligible subject matter under § 101.  The Court reasoned that “[o]ne distinction . . . between products of nature and human-made invention for purposes of § 101 turns on a change in the claimed composition’s identity compared with what exists in nature.”  Id. at 44.  The Court held that “the claims cover molecules that are markedly different—have a distinctive chemical structure and identity—from those found in nature,” and therefore were patent eligible.  Id.  “Under the statutory rubric of § 101, isolated DNA is a tangible, man-made composition of matter defined and distinguished by its objectively discernible chemical structure.”  Id. at 49.

The Court rejected the government’s earlier-proposed “magic microscope” test as misunderstanding the difference between science and invention, and as failing to take into account the existence of molecules as separate chemical entities.  “The ability to visualize a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds away from possessing an isolated DNA molecule that is in hand and usable.”  Id. at 50.  “Visualization does not cleave and isolate the particular DNA; that is the act of human invention.”  Id.

The Court disputed the dissent’s analogy to snapping a leaf from a tree, stating that “[s]napping a leaf from a tree is a physical separation, easily done by anyone,” whereas “[c]reating a new chemical entity is the work of human transformation, requiring skill, knowledge, and effort.”  Id. at 52 (citing Mayo Collaborative Servs. v. Prometheus, Inc., 566 U.S. ___, 132 S. Ct. 1289, 1294 (2012)).  The Court also disputed the dissent’s analogy to removing a kidney from the human body, stating that “[a] kidney is an organ, not a well defined composition of matter or an article of manufacture specified by § 101,” whereas “[a]n isolated DNA is properly characterized as a composition of matter under § 101 . . . .”  Id. at 53.

The Court then turned to the method claims and held that the claims directed to a method of analyzing or comparing DNA sequences are not patent eligible, while the claim directed to a method of screening is.  Regarding the analyzing and comparing claims, the Court found that they were directed to abstract mental processes.  “Although the application of a formula or abstract idea in a process may describe patent-eligible subject matter, Myriad’s claims do not apply the step of comparing two nucleotide sequences in a process.”  Id. at 57 (citation omitted).  “Rather, the step of comparing two DNA sequences is the entire process that is claimed.”  Id.  The Court found these claims to be indistinguishable from the claims the Supreme Court found invalid under § 101 in Mayo.

Regarding the screening claim, the Court held that it “includes more than the abstract mental step of looking at two numbers and ‘comparing’ two host cells’ growth rates,” because it “applies certain steps to transformed cells that . . . are a product of man, not of nature.”  Id. at 60-61.  “The fact that the claim also includes the steps of determining the cells’ growth rates and comparing growth rates does not change the fact that the claim is based on a man-made, non-naturally occurring transformed cell—patent-eligible subject matter.”  Id. at 61.  The Court noted that “the claim does not cover all cells, all compounds, or all methods of determining the therapeutic effect of a compound,” but rather “is tied to specific host cells transformed with specific genes and grown in the presence or absence of a specific type of therapeutic.”  Id.  The Court thus held that the screening method was directed to patent-eligible subject matter under § 101.

Judge Moore concurred-in-part.  Judge Moore joined the majority with respect to standing, the method claims, and the claims directed to isolated DNA sequences, but “wr[o]te separately to explain [her] reasoning.”  Moore Concurrence at 2.  Judge Moore stated that even when an invention does not exist in nature in the claimed state, it may still be directed to subject matter that is not patentable.  Judge Moore contended that “courts have long applied the principles articulated in Funk Brothers and Chakrabarty to different factual scenarios in order to determine whether an invention, as claimed, falls into the laws of nature exception,” and that “[she] see[s] no reason to deviate from this longstanding flexible approach in this case.”  Id. at 7 (citing Diamond v. Chakrabarty, 447 U.S. 303 (1980); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)).

Judge Bryson concurred with the majority’s decision on standing, the cDNA claims, and the method claims, and dissented with regard to claims to BRCA genes and gene fragments.  In Judge Bryson’s view, “the process of isolating genetic material from a human DNA molecule [does not make] the isolated genetic material a patentable invention.”  Bryson Dissent at 3.  Judge Bryson stated that “a contrary ruling is likely to have substantial adverse effects on research and treatment in this important field.”  Id. at 4.