Dicta on Adrenalin(e): Myriad Problems with Learned Hand’s Product-of-Nature Pronouncements in Parke-Davis v. Mulford

Abstract

Gene patents of the type at issue in the Myriad case, which might soon be heard by the U.S. Supreme Court, arise from an exception to the rule that products of nature cannot be patented. This exception allows that isolated products of nature can be patented if they have commercial utility, which is widely recognized as traceable to language from an opinion issued by Judge Learned Hand in Parke-Davis v. Mulford. This 1911 case was a patent dispute over a therapeutic version of the hormone adrenaline. This article is based on a detailed historical examination of Parke-Davis and the patent application process that predated the litigation by roughly a decade.

Parke-Davis was a classic (and protracted) priority dispute; the litigants gave no discernible attention to whether isolated products of nature could be patented. Hand’s now-famous Parke-Davis pronouncements on the patentability of isolated products of nature were under-informed dicta, which conflicted with existing patent law. Between 1900 and 1903, a senior patent examiner repeatedly rejected the Adrenalin patent application because he believed that the hormonal product was merely an isolated product of nature and, therefore, unpatentable according to principles articulated in Ex parte Latimer (an 1889 case denying a patent on a pine-needle core used for making textiles, because the core was an isolated product of nature). The Adrenalin patent applicant accepted Latimer as controlling and succeeded in obtaining a patent by arguing that his medical product was different than the hormone — not just a purified version thereof.

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. By 1958, Hand had become a living legal legend, and his judicial colleagues did not recognize that, in 1911, a 39-year-old district court judge — less than two years removed from law practice on Wall Street (handling one of his first patent cases) — had made an uninformed mistake in Parke-Davis. In the years since 1958, Hand’s errant Parke-Davis pronouncements have ascended from obscurity to conventional wisdom.

These revelations have potentially important implications for the outcome of Myriad. The significance of this historical analysis is, perhaps, further amplified because Judge Kimberly Moore acknowledged that her recent Federal Circuit swing vote in Myriad was largely determined by a history of “settled expectations,” which she identified as starting with Parke-Davis.

Keywords: Patent Law, Products of Nature, Gene Patents, Myriad, Parke-Davis v. Mulford, Ex parte Latimer, Learned Hand, Jokichi Takamine, adrenaline, Adrenalin