It would appear that Parke-Davis v. Mulford is one of the favorite
cases of patent lawyers seeking to justify maximal patent-protection for
biotechnology
There is an interesting Guest Post by Dr. Jon M. Harkness
on the patent blog Patently-O entitled
Myriad
Misunderstandings of Parke-Davis v. Mulford.
The opening paragraphs
of that posting explain why the patent lawyers find case particularly
significant:
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)
Judge Robert W. Sweet
discusses Judge Learned Hand's reputation in footnote 46 of his judgment in the
AMP v. Myriad case, in particular citing a reference that establishes
Learned Hand's reputation in the following terms:
“Judge Hand is widely
considered to have been one of the four greatest judges of the first half of the
twentieth century.” Nevertheless, Judge Sweet offers the following
evaluation of Parke-Davis:
Although Judge Hand once
turned his back on the author of this opinion arguing before him on behalf of
the Government, his opinion in Parke-Davis deserves careful review but brings to
mind that oft repeated adage “Quote Learned, but follow
Gus.”
(It seems that Judge Billings Learned Hand had a
cousin, Judge Augustus Hand, who was also a Circuit Judge on the 2nd
Circuit.)
The Guest Post by Dr. Jon M. Harkness on Patently-O
discusses
in detail the lengthy prosecution history of the patents on adrenaline at issue
in Parke-Davis v. Mulford and points out that Learned Hand judged the
case as a 39-year-old district judge, with no prior knowledge of the rudiments
of chemistry. Moreover the case revolved around a priority dispute, and
therefore the issue of unpatentability of products of nature wasn't raised by
the parties in Parke-Davis. Moreover he did not quote case law that was
applicable in his time. Thus Learned Hand would appear to have been ignorant at
the time of the precedents that would have been applicable to the matter before
him, had the case turned on the issue of patentability of isolated and purified
products of nature.
For further background, there is a paper available
on the Social Science Reseach Network entitled Patenting
Nature: A Problem of History, by Christopher Beauchamp that also
discusses the history of the Parke-Davis case.
Judge Sweet
discusses Parke-Davis on pages 114-117 of his judgment in AMP v.
Myriad:
Myriad has relied heavily on the holding of the
Honorable Learned Hand in Parke-Davis & Co. v. H.K. Mulford Co. 189 F.2d 95
(S.D.N.Y. 1911).46 In Parke-Davis, Judge Hand considered a challenge to the
validity of a patent
claiming an adrenaline compound that had been isolated and
purified from animal suprarenal glands. Id. at 97. It had been known that
suprarenal glands in powdered form had hemostatic, blood-pressure-raising and
astringent properties, but could not be used for those purposes in gross form.
The isolated adrenaline, however, possessed the desired therapeutic properties
and could be administered to humans.
Although Myriad argues that the
holding in Parke-Davis establishes that the purification of a natural
product necessarily renders it patentable, the opinion, read closely, fails to
support such a conclusion. The question before the court in Parke-Davis
was one of novelty (a modern-day § 102 question), not of patentable subject
matter (the § 101 question before this Court). In framing the issue, Judge
Hand observed that, “[the validity of the claims] is attacked, first,
because they are anticipated in the art; and second, for a number of technical
grounds which I shall take up in turn.” Id. at 101 (emphasis
added). He went on to conclude that the patented purified extract was not, in
fact, different from the prior art “only for a degree of purity,”
but rather was a different chemical substance from that found in the prior art.
Id.
at 103 (observing that “no one had ever isolated a substance
[adrenaline] which was not in salt form” and that “the [claimed]
base [form of adrenaline] was an original production of [the
patentee's]”). Thus, Judge Hand held that the purified adrenaline was not
anticipated by the prior art, namely, the ground paradrenal gland that was known
to possess certain beneficial properties. See Merck & Co. v. Olin
Mathieson Chem. Corp., 253 F.2d 156, 162 (4th Cir. 1958) (“It was
further held [in Parke-Davis] that the invention was not anticipated,
though the principle was known to exist in the suprarenal
glands.”).
Only after concluding that the claimed purified
adrenaline was novel over the prior art did Judge Hand offer, as dicta, the
statement to Which Myriad cites: “But, even if it were merely an extracted
product without change, there is no rule that such products are not
patentable.” Id. at 103. While the accuracy of this statement at
the time was written is dubious in light of American Wood-Paper (to which
Judge Hand did not cite) it is certainly no longer good law in light of
subsequent Supreme Court cases, which, as noted above, require that a claimed
invention possess “markedly different characteristics” over products
existing in nature in order for it to constitute patentable
subject matter.
Chakrabarty, 447 U.S. at 310; see also Funk Bros., 333 U.S. at
130-32. By the same token, Judge Hand's suggestion that a claimed invention was
patentable since it was a “new thing commercially and
therapeutically,” Parke-Davis, 189 F.2d at 103, is firmly
contradicted by subsequent case law establishing that “it is improper to
consider whether a claimed element or step in a process is novel or nonobvious,
since such considerations are separate requirements” when evaluating
whether a claim is patent-eligible subject matter. Prometheus, 581 F.3d
at 1343; see also Bergy, 596 F.2d at 960-61. Such an approach would also
be inconsistent with the Supreme Court's rejection of the patentability of the
commercially useful mixture of bacteria in Funk Brothers, the refined
cellulose in American Wood-Paper, and the electromagnetic communication
devices in O'Reilly v. Morse, 56 U.S. (15 How.) 62 (1853).
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