The extract below is taken from Judge Sweet's opinion, in which he granted summary judgment to the petitioners (AMP et. al.) against Myriad Genetics.

(Case 1:09-cv-04515-RWS, Document 255, Filed 03/29/2010). This extract covers the ‘purification’ cases, with discussion of the denial of patentability to pure tungsten, uranium and vanadium, adrenaline, prostoglandin, vitamin B₁₂.

District Judge Robert W. Sweet is the trial judge, in the Southern District of New York, before whom the plaintiffs represented by ACLU and PubPat brought their case against Myriad Genetics

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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

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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.

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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

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subject matter.⁴⁷ 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).

The distinction between considerations of novelty and patentable subject matter similarly undermines Myriad's reliance on Bergstrom and In re Kratz, 592 F.2d 1169 (C.C.P.A. 1979), both of which presented issues of novelty

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and anticipation rather than the question of patentable subject matter. In Bergstrom, the C.C.P.A. considered an appeal from a rejection by the Board of Patent and Interferences (“BPAI”) of a patent claiming the purified rostaglandins PGE₂ and PGE₃ that had been extracted from human or animal prostate glands. 427 F.2d at 1398. Although the BPAI cited § 101 in its rejection, the C.C.P.A. recognized the issue as a § 102 question of novelty. Id. at 1400 (“Tested by the conventional evidentiary criteria or ‘conditions for patentability’ relevant to the present factual situation which Congress has expressed in the various provisions of 35 U.S.C. § 102, appellants are undoubtedly correct, for the Patent Office has not been able to … establish that the claimed subject matter lacks 'novelty.’”); see also id. at 1401 (“[T]he fundamental error in the board's position, as we see it, is the analysis and answer it gave to the sole issue it accurately posed - whether the claimed pure materials are novel as compared with the less pure materials of the reference.” (internal citation and uotation marks omitted)). Indeed, the C.C.P.A. itself has subsequently recognized that Bergstrom is properly viewed as a case concerning novelty. Bergy, 596 F.2d at 961 (“Our research has disclosed only two instances in which

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rejections for lack of novelty were made by the PTO under § 101.… In In re Bergstrom we in effect treated the rejection as if it had been made under § 102, obServing in the process that ‘The word “new” in § 101 is defined and to be construed in accordance with the provisions of § 102.’” (internal citation omitted)).

Kratz examined the rejection of a patent claiming a substantially purified chemical compound naturally occurring in strawberries, called 2-methyl-2-pentenoic acid (“2M2PA”). 592 F.2d at 1170. The patentee had appealed from the BPAI's determination that the purified compound was obvious over the prior art under § 103. See _id. Although there was some discussion about whether the composition claimed was a naturally-occurring compound, the C.C.P.A. did not view the question before it as a § 101 inquiry. Instead, the court treated the appeal as a question of novelty and anticipation pursuant to § 102.⁴⁸ See, e.g., id. at 1174 (“It should be clear that an

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anticipation rejection in such a case is necessarily based on a dual footing.”).⁴⁹

Finally, Merck & Co., Inc. v. Olin Mathieson Chem. Corp., 253 F.2d 156, cited by Myriad, is entirely consistent with the principle set forth in Funk Brothers and American Fruit Growers that something derived from a product of nature must “possess a new or distinctive form, quality, or property” in order to become patentable subject matter. Am. Fruit Growers, 283 U.S. at 11. In Merck, the Fourth Circuit considered the validity of a patent claiming a Vitamin B₁₂ composition useful for treating pernicious anemia. Id. at 157. Although naturally occurring Vitamin B₁₂ produced in cows had known therapeutic properties and was commercially available, the court found the purified B₁₂ Compositipn, which was obtained from a microorganism, patentable. In upholding the validity of the patent, the court held:

Every slight step in purification does not produce a new product. What is gained may be the

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old product, but with a greater degree of purity. Alpha alumina purified is still alpha alumina, In re Ridgway, 76 F.2d 602,[] and ultramarine from which floatable impurities have been removed is still ultramarine, In re Merz, 97 F.2d 599 …

Id. at 163. Because the court concluded that the purified B₁₂ was more than a “mere advance in the degree of purity of a known product,” it determined that the claimed invention was entitled to patent protection. Id. at 164.

In sum, the clear line of Supreme Court precedent and accompanying lower court authorities, stretching from American Wood-Paper through to Chakrabarty, establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must pogsess “markedly different characteristics” in order to satisfy the requirements of § 101.

NOTES

⁴⁶ The invocation of Judge Hand is frequently practiced in this Circuit. See, e.g.,United States v. Rigas, 583 F.3d 108, 121 n.3 (2d Cir. 2009) (quoting Learned Hand for the proposition that appellate courts may not find facts); United States v. Parker, 554 F.3d 230 (2d Cir. 2009) (quoting Learned Hand for his formulation of the requirements of conspiracy); In re City of New York, 522 F.3d 279, 284 (2d Cir. 2008) (citing Learned Hand for his formulation of negligence); In re Hyman, 501 F.3d 61, 67 (2d Cir. 2007) (quoting at length Learned Hand's inconclusive discussion of the meaning of the word “defalcation” in 11 U.S.C. § 523(a)(4)); United States v. Brand, 467 F.3d 179, 190 (2d Cir. 2006) (quoting Learned Hand's definition of inducement by the government); In re Enron Corp., 419 F.3d 115, 123 (2d Cir. 2005) (quoting Learned Hand's critique of statutes of limitations); Shannon v._Jacobowitz, 394 F.3d 90, 95 (2d Cir. 2005) (quoting Learned Hand's instruction that “[w]ords are not pebbles in alien juxtaposition.&ellip;”); Danahy v. Buscag1ia, 134 F.3d 1185, 1189 (2d Cir. 1998) (quoting Learned Hand on the rationale for qualified immunity). See a1so, Remarks of the Honorable John N. Walker, Jr. Upon Receiving the Learned Hand Meda1 for Exce11ence in Federal Jurisprudence, 76 St. John's L. Rev. 595, 596 (2002) (“Judge Hand is widely considered to have been one of the four greatest judges of the first half of the twentieth century.”); James L. Oakes, Personal Ref1ections on Learned Hand and the Second Circuit, 47 Stan. L. Rev. 387 (1995); Gerald Gunther, Learned Hand: the Man and the Judge (1994); Kathryn Griffin, Judge Learned Hand and the Ro1e of the Federa1 Judiciary (1973); Marvin Schick, Learned Hand's Court (1970); Marcia Nelson, ed., The Remarkable Hands: An Affectionate Portrait (1983); Hershel Shanks, ed., The Art and Craft of Judging: The Decisions of Judge Learned Hand (1968). 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.” See Oakes, 47 Stan. L. Rev. at 389 n.175. This author, confronted by genomics and molecular biology, also emphatically empathizes with Judge Hand's complaint in Parke-Davis about his lack of knowledge of the rudiments of chemistry. See Parke-Davis, 189 F. at 114.

⁴⁷ Notwithstanding Judge Hand's reputation, see supra note 46, his opinion in Parke-Davis was one of a district court judge and does not supersede contrary statements of the law by the C.C.P.A. or the Supreme Court.

⁴⁸ The differences between the test applied in Kratz and the “markedly different” requirement set forth in Chakrabarty and other Supreme Court precedent further demonstrates that the Kratz court was engaged in a § 102 anticipation analysis and not a § 101 statutory subject matter analysis. See id. at 1174 (requiring, for a finding of anticipation, that “the natural composition must inherently contain the naturally occurring compound” and that “the claim must be of sufficient breadth to encompass both the known natural composition and the naturally occurring compound.”).

⁴⁹ Bergy, also cited by Myriad, considered the question of whether microorganisms constituted patentable subject matter, an issue subsequently addressed by the Supreme Court in Chakrabarty. It did not address the patentability of purified natural products, and its citation to Merck and Parke-Davis was only for the purpose of noting that courts had upheld patents on pharmaceutical compounds such as vitamin B₁₂ and adrenaline. See Bergy, 596 F.2d at 974-75 & n.13.

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