Over a century ago, in the famous Parke-Davis adrenaline patent infringement case, Judge Learned Hand articulated what many consider the origin of the legal premise that isolated components or purified extracts of natural products may be patent eligible:
[E]ven if [patentee Takamine’s purified adrenaline] were merely an extracted product without change, there is no rule that such products are not patentable. Takamine was the first to make it available for any use by removing it from the other gland-tissue in which it was found, and, while it is of course possible logically to call this a purification of the [adrenaline], it became for every practical purpose a new thing commercially and therapeutically. That was a good ground for a patent.1
While subsequent authors and courts may have differed on whether Judge Hand’s proclamation was dicta,2 the Parke-Davis decision has been often cited over the years in support of the validity of patent claims to chemical substances isolated or purified from their natural state,3 most recently by Respondents, Myriad Genetics et al., in the Supreme Court’s June 13, 2013 decision in Ass’n for Molecular Pathology v. Myriad Genetics, 569 U.S. ____ (2013) (“Myriad”).4
The unanimous Myriad Court did not specifically discuss Parke-Davis or its progeny in finding that isolated genomic DNA is ineligible for patent protection. Yet some of the rationale in the Court’s opinion may cast doubt on the patent eligibility of non-DNA chemical substances that are isolated or purified from natural sources, although other aspects of the Court’s rationale may leave the door to patent eligibility open.5
Myriad’s Rationale for Patent Ineligibility of Isolated Genomic DNA Applied to Isolated Non-DNA Chemical Substances
In Myriad, the Supreme Court, reversed the Court of Appeals for the Federal Circuit and held that a naturally-occurring genomic DNA segment – “isolated” from its chromosomal components by severing the chemical bonds linking the termini of the segment to the rest of the chromosome – is a product of nature and is therefore not patent eligible.6 In reaching this conclusion, the Court rationalized from a variety of facts from Myriad’s discovery and isolation of the natural BRCA1 and BRCA2 genes that encode for BRCA proteins. These facts can be analogized to the isolation or purification of non-DNA chemical substances from their natural state – substances such as small molecule pharmaceuticals as well as larger structures including proteins, such as antibodies – and raise questions about the patent eligibility of these non-DNA chemical substances.
For example, the Court noted that “Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within [the relevant] chromosomes,” yet the “location and order of the [claimed] nucleotides existed in nature before Myriad found them” and “that discovery, by itself, does not render the BRCA genes ‘new … composition[s] of matter,’ § 101, that are patent eligible.”7
Applying these findings to a hypothetical situation of a small molecule or protein isolated or purified from a natural source, the hypothetical patentee may similarly have discovered “the location” of such a small molecule or protein in a rare plant in the Amazon or a tunicate deep in the South Pacific after isolation and extraction from the natural source. Moreover, analogous to Myriad’s identification of the sequence of the BRCA1 and BRCA2 genes, the hypothetical patentee may also have determined the chemical structure of the small molecule or the peptide sequence of the protein. Nevertheless, the location and structure/sequence of the small molecule or protein would have “existed in nature before [the patentee] found them,” and the discovery of the location and structure/sequence may therefore not render the small molecule or protein “new compositions of mater” satisfying § 101’s requirements for patent eligibility.
The Myriad Court also noted that “Myriad [did not] create or alter the genetic structure of DNA” and, more bluntly, therefore that “Myriad did not create anything.”8 In locating and isolating or purifying a small molecule or protein from its natural state, the hypothetical patentee too may not have “create[d] or alter[ed] the [chemical or peptide] structure” of the small molecule or protein. In short, the patentee may “not [have] create[d] anything,” and, although the patentee may have “found an important and useful” small molecule or protein, “separating [either] from its surrounding [natural state] is not an act of invention.”9 Even though, like Myriad, the hypothetical patentee may have engaged in “extensive research efforts” to identify and isolate the small molecule or protein, “extensive effort alone is insufficient to satisfy the demands of § 101.”10
Myriad’s Lack of Deference to Past USPTO Practice
The Myriad Court was equally unpersuaded by the U.S. Patent and Trademark Office’s past practice of awarding gene patents. Although Judge Moore of the Federal Circuit considered the PTO’s position to be influential in concluding Myriad’s isolated genomic DNA to be patent eligible,11 the Myriad Court disagreed, finding that “Congress has not endorsed the views of the PTO in subsequent legislation” and placing weight instead on the administration-dependent views of the Department of Justice over that of the Department of Commerce.12
In considering patent eligibility of a small molecule or protein isolated or purified from a natural source, at present, the latest edition of the PTO’s Manual of Patent Examining Procedure (“MPEP”)13 instructs that “[p]urer forms of known products may be patentable” and that “[p]ure materials are novel vis-à-vis less pure or impure materials because there is a difference between pure and impure materials,”14 suggesting potential patent eligibility of purified substances from natural sources. To the extent that such guidelines support patentability of a small molecule or protein isolated or purified from a natural source, and to the extent that the PTO has previously granted claims to such substances, Myriad suggests that these current and past practices by the agency may not be entitled to deference.
Myriad’s Possible Opening for Patent Eligibility of Isolated Non-DNA Chemical Substances
Interestingly, the Myriad Court expressly acknowledged that Myriad’s isolation of the BRCA1 and BRCA2 genomic DNA severs chemical bonds “and thereby creates a nonnaturally occurring molecule.”15 While this process, which admittedly “technically creates new molecules with unique chemical compositions,”16 was sufficient to convince at least Judge Lourie of the Federal Circuit of the patentability of Myriad’s isolated genomic DNA,17 the Myriad Court disagreed and found that the chemical bond cleavage incident to separation of the claimed genomic DNA could not confer patent eligibility because
Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.”18
As noted by the Myriad Court, Myriad’s claims to genomic DNA are functional in format, claiming, for example, “[a]n isolated DNA coding for a BRCA1 polypeptide,” i.e., an isolated DNA sequence with the genetic information that instructs a cell to produce a BRCA1 polypeptide.19 Due to the natural degeneracy of the genetic code, a large number of genomic DNA sequences may encode for a BRCA1 polypeptide, which is a likely reason that Myriad’s claims were drafted using functional language that encompasses all such sequences. Yet this decision to define the claimed genomic DNA by function/information instead of “in terms of chemical composition” or as a “unique molecule” seems to be an important factor that led the Myriad Court to conclude that an isolated genomic DNA segment is a patent ineligible natural product, even though through isolation the segment becomes a “new” and “nonnaturally occurring molecule.”20
In contrast, small molecule pharmaceuticals exist as unique chemical entities amenable to patent claiming by more traditional chemical formulas and nomenclature that delineate particular structures. Claiming small molecules purified or isolated from natural sources in a defined structural way (coupled with a limitation specifying a measure of isolation or purity) may overcome the Myriad Court’s pronouncement against claiming via information in lieu of chemical composition. Similarly, claiming peptides and proteins isolated or purified from their natural state via sequence homology to a specified sequence/structure (again, coupled with a limitation specifying a level of purity or isolation) may instill sufficient chemical structure into such claims to distinguish from Myriad.
Of course, as endorsed by the Myriad Court, such claimed isolated or purified small molecules or proteins should still comport with the Court’s prior holding in Chakrabarty in that they should have “markedly different characteristics from any found in nature,”21, i.e., from their natural or unpurified forms. This is in contrast to the claimed Myriad genomic DNA, wherein the informational characteristic of the DNA – the nucleotide sequence – was unchanged on isolation, leading to the conclusion that “Myriad did not create anything.”22 Compliance with Chakrabarty also steers the focus of the claimed substances to their practical differences from what existed before in nature, potentially leading to the conclusion that the purified or isolated forms are “for every practical purpose a new thing commercially and therapeutically.”23, 24
Continued Patent Eligibility of Methods Using Isolated Non-DNA Chemical Substances
The Supreme Court appears to have made some effort to highlight that method claims were not at issue in Myriad and that methods of using the isolated genes could potentially be patent eligible,25 the Court’s prior holding in Prometheus26 notwithstanding.
By analogy, Myriad may have little impact on the patent eligibility of methods of using small molecules or proteins isolated or purified from nature, provided that the methods themselves are novel and unobvious. Of course, a composition of matter claim to the isolated or purified substance itself is more valuable than a claim to, for example, a particular method of treatment. Moreover, claims to relatively broad methods (for example, a method of treating cancer generally) may encounter barriers under § 112 not otherwise posed by composition of matter claims, leaving patentees with narrower and less valuable method claims (such as, a method of treating a specific cancer) that are more readily enabled and adequately described.
Many are predicting that Myriad will have a limited impact for the biotechnology industry because other aspects of the Court’s holding (patentability of cDNA27 and the potential patentability of method claims) leave adequate incentives for developing gene technologies and because isolated DNA patents are generally older and nearer to expiration and are being issued by the PTO at a declining rate. However, Myriad may significantly impact other areas in chemistry and biotechnology that rely on isolation or purification of non-DNA chemical substances from nature – such as small molecules and proteins – areas the unanimous court may not have intended. Whether Myriad leaves open an avenue to patent eligibility for such non-DNA chemical substances remains to be seen.