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...
