Guest Post by Jeffrey Lefstin, Ph.D., Professor of Law at the University of California Hastings College of the Law. In his previous life Dr. Lefstin was a molecular biologist, studying mammalian gene regulatory mechanisms and DNA-protein interactions. Below, he provides his thoughts on the true stakes in Association for Molecular Pathology v. Myriad Genetics.
Playing with Fire: What's Really at Stake in Myriad
In a previous post I noted that the Supreme Court’s Mayo v. Prometheus decision, while acknowledging that “all inventions can be reduced to underlying principles of nature which, once known, make their implementation obvious,” appears to have revived the analytical framework of Funk Brothers. Funk denied patentability to a mixture of nitrogen-fixing bacteria because, even if the patentee’s discovery about the bacteria was “ingenious,” it was a phenomenon of nature and not patentable. Once that discovery was made, the state of the art made production of the claimed mixture obvious; the patentee therefore had not claimed a patentable application of the law of nature. In Mayo the Court likewise demanded that a claim embody an inventive application of a natural law, denying patentability to a process claim where the steps beyond the natural law consisted of nothing more than “well-understood, routine, conventional activity.”
Mayo’s grounding in Funk means that the Mayo analysis governs the patent-eligibility of a claim to a composition of matter, such as the isolated and purified DNA molecules at issue in Myriad. But the stakes in Myriad are actually far higher. For twenty years after Funk, the lower courts employed the “something else beyond a law of nature” analysis to invalidate a variety of claims that we would probably regard as innocuous today. If the Court reaffirms the analysis of Funk, Parker v. Flook, and Mayo in Myriad, this line of authority presents a disturbing vision for the future.
The line began with Davison Chemical Corp. v. Joliet Chemicals, Inc., 179 F.2d 793 (7th Cir. 1950). Davison Chemical dealt with a process for producing silica gel. While the process of making silica gel was long known in the art, the patentee had discovered that the temperature of the wash step determined the density of the gel. He therefore claimed an improved process wherein the temperature of the wash step was adjusted to control the density of the final product. But the Seventh Circuit regarded the relationship between wash temperature and gel density as “a newly discovered scientific fact.” Under Funk Brothers, it was necessary that the patentee’s application of that fact be inventive. According to the court, once the relationship between temperature and density was discovered, it required “nothing more than the ordinary skill of the scientist” to determine that maintaining the temperature of the wash step would control the density of the silica gel.
The Court of Customs and Patent Appeals followed Davison Chemical in In re Arnold, 185 F.2d 686 (CCPA 1950), involving a claim to a process of electrostatic welding. In Arnold, the applicant had discovered that molecules near the surface of a material responded more readily than interior molecules to alternating electrostatic fields. By selecting a particular frequency, the applicant could selectively weld the surface of the material, or selectively weld a plasticizer applied to the surface. But according to the CCPA, the differential response of surface molecules was a “phenomenon of nature” discovered by the applicant. The claimed process merely selected a particular frequency based on that discovery, and therefore lacked “invention.” (While the Federal Circuit has never cited Arnold, the case, being precedent of the CCPA, is technically binding on the court.)
National Lead Co. v. Western Lead Products Co., 324 F.2d 359 (9th Cir. 1963), was similar to Davison Chemical. In a process for making a lead / lead oxide suspension (useful for storage batteries), the patentee had supposedly discovered that two different crystalline forms of lead oxide were present; by controlling the temperature of the reaction, the patentee could control the proportion of these two forms and thereby the uniformity of the final product. But following Davison Chemical, the patentee’s discovery of the relationship between temperature and product uniformity was not patentable. The question was whether the claimed method would have been obvious to an artisan – an artisan assumed to already know the relationship between temperature and product uniformity. Since the patentee used only conventional methods to regulate temperature of the reaction, the method was unpatentable.
The pinnacle – or perhaps the nadir – of the Davison line was the Third’s Circuit’s decision in Armour Pharmaceutical Co. v. Richardson-Merrel, Inc., 396 F.2d 70 (3d Cir. 1968). The patentee made the surprising discovery that trypsin – a proteolytic enzyme with anti-inflammatory properties – could be absorbed by the small intestine, and thereafter transported into the bloodstream. Whereas the prior art relied on administering trypsin to patients via injection, the patentee determined that oral administration would be possible if the trypsin was given a coating permitting it to resist digestion in the stomach and reach the small intestine. But the Third Circuit concluded that a claim to the enteric-coated trypsin formulation was not patentable under Funk. Once “nature’s secret” was discovered – the ability of the small intestine to absorb trypsin – any artisan would have employed known coatings to enable the trypsin to reach the small intestine. And even if the patentee’s discovery was the anti-inflammatory effect of trypsin administered to the small intestine, not merely the ability of the small intestine to absorb trypsin, the application of that newly discovered principle still lacked inventiveness under Funk.
Despite being framed as “lack of invention,” these are not obviousness cases. In each case the information that might render the invention obvious was the patentee’s own discovery. That is the point of Mayo: despite Diehr’s admonition to the contrary, the Court appears to have resurrected Funk’s rule that a claim must embody a non-obvious application of a law of nature or natural phenomenon to be patent-eligible. And the district courts have already begun applying that analysis to question the patent-eligibility of claims.[1] The Davison line suggests that a wide variety of claims to improvements or optimizations of known processes and compositions are vulnerable under the Mayo analysis. Unless we can distinguish the “natural laws” in these cases from the “natural law” in Mayo, a reaffirmance of Funk and Mayo in Myriad could presage a dramatic contraction in the scope of patent-eligible subject matter in the future.
[1] See, e.g., Aria Diagnostics, Inc. v. Sequenom, Inc., 2012 WL 2599340, at *11-12 (N.D. Cal. July 5, 2012); Tessenderlo Kerley, Inc. v. Or-Cal, Inc., 2012 WL 2054994 at *5-6 (N.D. Cal. June 5, 2012).
