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It Took Myriad Years to Juxtapose Forethought with Ingenuity and Link BRCA Mutations to Breast Cancer: Will it Take Another Myriad to Settle Rights?

CIPA Journal
September 2012

Tridico Ph.D., Anthony C., Mouta Ph.D., Carla


Authored by Carla Mouta, Ph.D. and Anthony C. Tridico, Ph.D.

In ancient Greek mythology, Prometheus, the "Forethinker," protector and benefactor of humankind, inherits foresight from his mother and ingenuity from his father. With these traits, Prometheus suffers myriad years for having returned fire and taught the useful arts to the human race, saving it from destruction. Nowadays, women (and men) worldwide inherit cancer as a trait, carrying gene mutations linked to predisposition to breast and ovarian cancer, the discovery of which allowed the development of diagnostic and treatment technologies based on the same. Myriad Genetics, Inc. is the exclusive licensee of a number of patents on those technologies. Prometheus, Inc. also holds a patent portfolio on diagnostic-, prognostic-, and treatment-related technologies for various disorders. Both Myriad and Prometheus have had their patents challenged under 35 U.S.C. § 101, as allegedly encompassing subject matter that is not eligible for patent protection under U.S. law. Thus far, Prometheus has lost at the U.S. Supreme Court while Myriad remains standing even after reevaluation under Mayo v. Prometheus. But there is still time for a possible albeit unlikely return to the Federal Circuit for an en banc opinion, and even to the Supreme Court. Will it take Myriad years?

Indeed, this past March, the U.S. Supreme Court unanimously reversed the Court of Appeals for the Federal Circuit (the Federal Circuit) and held that Prometheus's claims drawn to methods for determining the optimal dosages of thiopurine drugs to treat certain diseases encompassed nonstatutory subject matter under 35 U.S.C. § 101 and therefore we not patent-eligible. Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S.Ct. 1289 (2012). See, "Like Zeus the Supreme Court Punishes Prometheus: But What Does it all Mean for Patentable Subject Matter?" CIPA Journal, April 2012. A week later, the U.S. Supreme Court issued a GVR (grant [certiorari], vacate, and remand) order in the Association for Molecular Pathology v. PTO decision (better known as ACLU v. Myriad), remanding the case to the Federal Circuit for reevaluation in light of Mayo v. Prometheus.  Given that Mayo v. Prometheus had been taken to the Supreme Court solely on the eligibility of "method"-type claims, this remand, a priory, would seem insufficient to resolve all of Myriad's claims. To be sure, the ACLU v. Myriad claim to fame was the case in which the Federal Circuit addressed (and upheld) the eligibility of "composition"-type claims to isolated DNA for patenting under § 101. See, "The Myriad Scare: Isolated DNA Molecules Remain Patent Eligible (for now!). CIPA Journal, September 2011. Accordingly, on remand, the Federal Circuit asked the parties to brief the Court, in advance of the oral hearings on one question: What is the applicability of the Supreme Court's decision in Mayo v. Prometheus to Myriad's isolated DNA claims and to method claim 20 of [U.S. Patent No. 5,747,282], the '282 patent?

After holding Oral Hearings in July, the Federal Circuit affirmed in part and reversed in part the district court's grant of summary judgment that all of the challenged Myriad claims are drawn to subject matter that is not patent-eligible 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 DNA" molecules encoding human BRCA proteins 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 direct to a method of screening potential cancer therapeutics.

The Court was clear 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 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 inventions for purposes of § 101 turns on a change in the claimed composition's identity compared with what exists in nature." Id. at 44. According to the court, "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. Moreover, "[w]hether its unusual status as a chemical entity that conveys genetic information warrants singular treatment under the patent laws as the district court did is a policy question that we are not entitled to address. Cf. Nat'l Fed'n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566, slip op. at 6 (2012) ("[W]e possess neither the expertise nor the prerogative to make policy judgments. Those decisions are entrusted to our Nation's elected leaders, who can be thrown out of office if the people disagree with them." Id.).

The Court rejected the 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 also 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)). Similarly, the Court 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 . . . ."

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 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. "Rather, the step of comparing two DNA sequences is the entire process 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, stating that while she joined the majority with respect to the method claims and the claims directed to isolated DNA sequences, she "wr[o]te separately to explain [her] reasoning." J. 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 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 the cDNA claims, and the method claims, and dissented with regard to claims to the isolated 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." J. 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.

Disagreement over the scientific and legal aspects of patentable subject matter divides two Nobel Prize winners—W. Gilbert founded Myriad Inc. whereas J. Watson argued against their patent monopoly as amicus curiae in this remand—, frustrates six Federal Circuit judges, and isolates an agency (USPTO) from the U.S. Department of Justice. Both the Supreme Court and the Federal Circuit have invoked Congress to craft "more finely tailored [patent eligibility] rules" without changing "so substantially the rules of the game" as to "disrupt the settled expectations of the inventing community." Afterall, Congressman are those that "can be thrown out of office if the people disagree with them." Meanwhile, patent attorneys may need to have the foresight and forethought of a modern-day Prometheus to advise their clients on investing and claiming exclusive rights only in subject matter that will be ruled patent-eligible, at least for the duration of their patents. And while cognizant that patent eligibility cannot "depend simply on the draftsman's art, "all too frequently "[t]he name of the game is the claim." See, Giles S. Rich, The Extent of the Protection and Interpretation of Claims-American Perspectives, 21 Int'l Rev. Indus. Prop. & Copyright L., 497, 499 (1990) ("To coin a phrase, the name of the game is the claim."). More than ever, when dealing with diagnostic claims and claims similar to those found in the Myriad patents, a claim needs to be a work of art and not of trickery.

As we learned from the Supreme Court, not all types of public disclosures are considered eligible for patent protection in the US. For example, "laws of nature, natural phenomena, and abstract ideas" are settled judicial exceptions to otherwise permissive § 101. That is, one that unveils or discovers a law of nature may keep that knowledge to him or herself, seek trade-secret protection, disclose it in a scientific article, become famous, sell or disseminate that knowledge in a myriad of ways, but cannot, under current law, obtain a patent claim to having an exclusive right to stop others from using, making, selling or offering for sale that law of nature. But, with that knowledge, derive any material thing (e.g., a compound, a machine, an apparatus) that (1) "is not found in nature" and (2) "is mark-edly different—have a distinctive chemical structure and identity—from those found in nature" and you have patent-eligible subject matter under the current judicial reading of § 101. As such, the claim drafting principle we derive from this is to define, use, and combine the right set of terms in such manner that even the broadest reasonable interpretation of the claim reads only on matter that "is not found in nature." Thus, consider including sufficient support in the specification for specific provisos, it you think you will need to proviso any embodiments out of or into the claim to expedite prosecution. In addition, include in the specification (but not necessarily in the claims) details on what differences exist "in name, character, and use" between your matter and naturally existent matters. This language suggests that not only structural but functional differences may serve to support both patent eligibility, and not just novelty and nonobviousness.

One can also pursue a claim to a process or method that is a practical application of any of such discovered "laws of nature, natural phenomena, and abstract ideas." One rule is that the claim "include steps that are sufficient to ensure that the claim amounts to significantly more than the natural principle itself" as well as significantly more than a law of nature plus the general instruction to simply "apply it." Here, one should inquire with the discoverer if he/she has brought into that process or method a specific reagent, thus transforming the claimed invention to a patent-eligible practical application because it does not cover substantially all practical applications of the discovered law of nature, as it is limited to those applications that use that specific reagent. For example, if the discovered law of nature can be applied to diagnose a certain disease, limit the claim to methods that use certain tools or reagents that are "man-made" and have "enhanced function and utility" and it should become patent-eligible. It is possible, if not likely, that these tools or reagents do not even need to be new. According to the USPTO Interim Guidelines, a claim that recites a novel drug or a new use of an existing drug, in combination with a natural principle, would be sufficiently specific to be drawn to patent-eligible subject matter because the claim would amount to significantly more than the natural principle itself." Alternatively, include in the claimed method a combination of assays that are not routinely used together. Whatever you do, don't include a "mental step" in the claim. Forethought forbids it and not another myriad years is likely to change it.

Originally printed in CIPA Journal. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm's clients.