Guest Post by Jon M. Harkness. Dr. Harkness is a historian and a newly minted patent attorney. This post is based on his examination of the 1911 Learned Hand adrenaline case, Parke-Davis v. Mulford, which undergirds some of the policies at stake in AMP v. Myriad. His recently published JPTOS article covers the topic in more detail. Download 93JPTOS2011. Readers can reach Dr. Harkness directly at jon.harkness@comcast.net.
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Students of patent law are taught that purified or isolated products of nature possessing utility can be patented because—essentially—"Learned Hand said so" in a case about adrenaline:
[E]ven if it were merely an extracted product without change, there is no rule that such products are not patentable. Takamine [the inventor] 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 principle, it became for every practical purpose a new thing commercially and therapeutically. That was a good ground for a patent. Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95, 103 (C.C.S.D.N.Y. 1911)
Briefs in the AMP v. Myriad "gene patent" suit are thoroughly sprinkled with references to this language, and all four judicial opinions that have been rendered to date in Myriad have discussed this aspect of Learned Hand's 1911 adrenaline opinion.
But it seems that no one has previously taken a close look at what actually happened in this old case. In the spring of 2011, I decided to quench my curiosity by visiting the New York branch of the National Archives to examine approximately 1,000 pages of records from Parke-Davis held there. (Coincidentally, my first day in the archives was the same day that the Federal Circuit initially heard oral arguments in Myriad.)
Two major revelations emerged from my research. First, the prosecution of the Adrenalin patent application, between the fall of 1900 and the spring of 1903, involved an extended debate on the product-of-nature problem. Perhaps my most important finding is that this debate took place within the bounds provided by an 1889 case, Ex parte Latimer, in which a patent on the isolated fibrous core of a pine needle had been rejected as constituting unpatentable subject matter. Download 1889 Dec Commr Pat 123 ex parte Latimer. Relatively early in the Adrenalin patent application process, the applicant, Jokichi Takamine, and his attorneys acknowledged that Latimer provided "the official interpretation of the doctrine involved." Thus, Takamine was forced to argue that his product was chemically different than the hormone—not just purified or isolated. (The arguments were somewhat abstract because the applicant did not know the precise chemical formulae for either his medical product or the naturally occurring hormone.)
The patent examiner, James B. Littlewood (an M.D. with formal training in patent law, who had been head of the USPTO's Division of Chemistry for a decade) was not easily convinced. For example, after one lengthy attempt by Takamine to argue that Adrenalin was "a new article . . . not anticipated by a naturally existing article as was Latimer's claim," Littlewood stated his objections in especially blunt and revealing terms: "The argument of applicant has been carefully read but it is fatally defective for the reason that the product he obtains . . . is simply separated from impurities." Littlewood explicitly pointed to Latimer to justify his rejection: "The examiner does not assert that the active principle [of the adrenal gland] exists, freed from impurities in nature; neither did Latimer's fibre; but it did exist and therefore is not patentable." (A copy from this exchange can be seen here: Download 889-890 Littlewoood rejection.)
Takamine's attorneys never argued that the Latimer rule was invalid nor did they argue that Littlewood's understanding of the rule was flawed. Instead, they repeatedly attempted to convince Littlewood that Adrenalin was something other than a purified or isolated version of the naturally occurring hormone. Eventually, Littlewood accepted this line of argumentation and granted a product patent.
The second major revelation that emerged from my research is that—by contrast to patent prosecution for Adrenalin—the patent litigation between Parke-Davis and Mulford had nothing to do with Adrenalin being an isolated or purified product of nature. It was basically a protracted priority/novelty dispute. None of the briefs submitted to Learned Hand mentioned the product-of-nature issue. And here's some especially striking evidence: each side had a top-notch expert witness, and during a combined total of 53 (!) days of depositions neither expert was asked a single question on the issue of whether Adrenalin was an unpatentable product of nature. Perhaps most significantly, Latimer was not mentioned in a single brief, and Learned Hand (who was less than two years removed from a Wall Street law practice when he wrote his Parke-Davis opinion) seems to have been completely unaware of Latimer—as is implied by Hand's blanket assertion that there was "no rule" against patenting "an extracted [natural] product without change."
Hand's dicta from Parke-Davis essentially lay dormant until 1958, when it was relied upon by Fourth Circuit judges grappling with the patentability of vitamin B12. Merck & Co. v. Olin Mathieson Chemical Corp., 253 F.2d 156 (4th Cir. 1958). By 1958, Learned Hand had, of course, become a living legal legend. His judicial colleagues did not recognize that 47 years earlier, a 39-year-old district court judge had made an under-informed mistake in Parke-Davis. In the years since 1958, Hand's Parke-Davis pronouncements have ascended from obscurity to conventional wisdom.
The major policy point of my article is that those concerned with patent law should no longer view Learned Hand's product-of-nature language in Parke-Davis as flowing from the pen of a jurisprudential giant who had weighed vigorously debated points and counter-points on a challenging legal question. In reality, what we have are poorly informed musings of a young district court judge grappling with one of his first patent cases. If the Federal Circuit (or, later, the Supreme Court—or even Congress) should decide that granting patents on isolated sections of DNA is legitimate, this would not change the historical reality that Learned Hand misstated the law as it existed in 1911. We might, however, need to reclassify his error as a lucky mistake.