Did esteemed jurist Learned Hand truly make a “rookie mistake” in an important 1911 patent case, as Hamline Law grad Jon Harkness, JD ’11, argues?
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 current—and potentially landmark —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 had taken a close look at what actually happened in the 1911 case and its possible implications relative to Myriad—until Harkness came along. In addition to his J.D., Harkness has a Ph.D. in history of science from the University of Wisconsin and has held appointments in history of science programs at Cornell University and the University of Minnesota. As a newly registered patent attorney, he is embarking on a career in patent litigation. He also has an insatiable intellectual curiosity.
“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,” said Harkness, whose interest in the case began as part of a Seminar course, IP Stories, taught by Professor Sharon Sandeen. “Coincidentally, my first day in the archives was the same day that the Federal Circuit initially heard oral arguments in Myriad.”
Some of that research has since been published as an article in the Journal of the Patent and Trademark Office Society (JPTOS): Dicta on Adrenalin(e): Myriad Problems with Learned Hand’s Product-of-Nature Pronouncements in Parke-Davis v. Mulford, 93 J. PAT. & TRADEMARK OFF. SOC’Y 363 (2011).
The major policy point of Harkness’s 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.”
Harkness’s article was published within weeks of the Supreme Court’s announcement in March that it wanted the Federal Circuit court to reconsider Myriad in light of another recent decision. However, many court-watchers, including Harkness, expect it to find its way back to the Supreme Court. The Federal Circuit will hear oral arguments on July 20, 2012.
Harkness’s article has received much attention and Harkness would not be surprised to see it cited in the Federal Circuit reconsideration of the Myriad case. “The journal in which I published (JPTOS) is one that the Federal Circuit cites quite frequently,” he said. “In fact, two of the three opinions cited articles from JPTOS in the initial round of Myriad at the Federal Circuit.”
According to Hamline Associate Dean Ed Butterfoss, what Harkness has accomplished is remarkable. “Law professors spend their entire careers trying to discover a novel take on court decisions and influence courts dealing with cutting edge issues—and Jon has done that before the ink has even dried on his diploma.” Professor Sandeen added that she always encourages her Seminar students to work with her during or after the course to take their papers to the next level and pursue publication opportunities.
Harkness said he uncovered two revelations while conducting his research. The first was that 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 his 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. 1889 Dec. Comm’r Pat. 123 (1889). 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 second major revelation 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. Harkness said, “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 become a living legal legend. According to Harkness, 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. And Harkness’s 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.
As for Harkness, he says 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. “However,” Harkness said, “we may need to reclassify his error as a lucky mistake.”
Harkness will be watching the Myriad proceedings closely knowing that his work may yet play a role in the case. Even if it doesn’t, he is pleased with what he uncovered and the response his research has received. One of his proudest possessions is a personally signed letter he received from United States District Court Judge Robert W. Sweet thanking him for the article. “It certainly fortified me since we share the same view of Judge Hand’s opinion,” wrote Judge Sweet. "[T]he article is a great piece of work for which I’m grateful.”
For a copy of Harkness's full article, send an email request to firstname.lastname@example.org.