Brief of petitioner for Bilski v. Doll; 08-964 - Oyez

iTABLE OF CONTENTSTable of Contents ........................................................ iTable of Cited Authorities ......................................... iiInterest of Amicus Curiae.......................................... 1Summary of the Argument ........................................ 3Argument.................................................................... 4I. The Federal Circuit’s new test is overly restrictive. ..4II.The Framers of the Constitution intended to promoteadvances in medical diagnosis and treatment. ...................6III. Congress intended advances in medical diagnosis andtreatment to be patentable subject matter.........................12Conclusion ................................................................ 16

1INTEREST OF AMICUS CURIAE 1The University of South Florida (hereinafter,“USF”) is the nation’s ninth largest public universityand a leading research institution. Founded in 1956,USF has over 46,000 students and more than 13,000faculty and staff members, with an annual operatingbudget in excess of $1.8 billion dollars. USF’smission includes research and scientific discovery forthe generation, dissemination, and translation ofnew knowledge across disciplines; to strengthen theeconomy; to promote civic culture and the arts; andto design and build sustainable, healthycommunities. Fueled by its research efforts, USFhas a substantial economic impact on its regionestimated at over $3.2 billion dollars annually.USF medical researchers strive to expand thefrontiers of medicine, searching for improvedmethods of diagnosing, prognosing, and treatingdiseases such as cancer, HIV, diabetes, andneurological disorders such as Alzheimer’s andParkinson’s diseases. USF is one of the top 501 In accordance with Supreme Court Rule 37, amicus curiaestates that this brief was not authored in whole or in part bycounsel for any party, and that no monetary contribution to thepreparation or submission of this brief was made by any personor entity other than amicus curiae or its counsel. Counsel ofrecord for all parties were timely notified 10 days prior to thefiling of this brief. Petitioners have consented to the filing of allamicus curiae briefs in support of either or neither party, andrespondent has consented to the filing of this brief via aseparate letter of consent dated July 14, 2009. A copy of thisletter has been filed with the Clerk of the Court.

3SUMMARY OF THE ARGUMENTThe Federal Circuit’s “machine-ortransformation”test is more restrictive than anySupreme Court precedent, excluding from patenteligibility certain processes that Congress intendedto be patent eligible. The test has been applied toinvalidate issued claims directed to certain medicalmethods. There is no legislative basis for such arestriction. Methods that promote the progress ofmedicine, diagnosis and treatment in particular,were clearly contemplated by the Framers of theConstitution as well as members of Congress to bepatent eligible. Courts should not read into thepatent laws limitations and conditions whichCongress has not expressed. Despite this, theFederal Circuit adopted the “machine-ortransformation”test as the sole test for patenteligibility of a process, thereby excluding from patenteligibility subject matter that Congress clearlyconsidered patent eligible. This was error. The firstquestion presented should be answered in theaffirmative, and the Federal Circuit’s error should bereversed.

4ARGUMENTI. The Federal Circuit’s new test is overlyrestrictive.The Federal Circuit’s holding that a processclaim that “neither recites a particular machine orapparatus, nor transforms any article into adifferent state or thing, is not drawn to patenteligiblesubject matter” unnecessarily, unwisely, andimproperly excludes from patent protectiontechnologies that Congress clearly intended to bepatentable. In re Bilski, 545 F.3d 943, 961 (Fed. Cir.2008). This “machine-or-transformation” test isuseful as a starting point for determining whetherprocess claims are directed to patent eligible subjectmatter. This Court has held that the “machine-ortransformation”test is sufficient to qualify a processclaim as patent eligible, but the Court has declinedto state that passing this test is a necessaryrequirement for the patent eligibility of a processclaim. See Parker v. Flook, 437 U.S. 584, 588 n.9(1978); Gottschalk v. Benson, 409 U.S. 63, 71 (1972).Excluding from patent eligibility certain processesinvolving medical diagnosis and treatment merelybecause they do not recite a particular machine orapparatus or transform an article into a differentstate or thing is improper, as such processes areunquestionably within the realm of patent eligiblesubject matter. Yet this is exactly what the FederalCircuit’s “machine-or-transformation” test has done.The Federal Circuit first applied its new“machine-or-transformation” test in a singleparagraph,nonprecedential opinion in Classen

5Immunotherapies, Inc. v. Biogen IDEC, affirming adistrict court judgment invalidating claims tomethods of immunizing a mammalian subject. 2 304F.App’x 866 (Fed. Cir. Dec. 19, 2008), reh’g denied enbanc reh’g denied (Feb. 9, 2009). While the claims atissue might well have been found invalid on othergrounds (for example, as obvious or anticipated), asdiscussed below, they are certainly within the realmof subject matter contemplated as patent eligible bythe Framers of the Constitution and Congress. Thus,applying the “machine-or-transformation” test as the2The district court had summarized the Classen claims asrequiring “1) comparing the incidence of immune mediateddisorders in treatment groups with different vaccinationschedules; and 2) immunizing patients on a schedule identifiedas low risk.” Classen Immunotherapies, Inc. v. Biogen IDEC,Civil No. WDQ-04-2607, 2006 WL 6161856, at *5 (D. Md. Aug.16, 2006). Rather than properly construing the claims as “amethod for reducing the incidence of chronic immune mediateddisorders” and recognizing that an improved process ofvaccination is a human invention, the district court held thatthe claims describe a natural correlation. Id. Characterizingthe correlation between vaccination schedules and incidents ofimmune mediated disorders as a natural phenomenon, thecourt held the claims invalid as an attempt to patent a naturalphenomenon. Id. The district court’s reasoning was faulty: theexistence of an immune response in mammals is a naturalphenomenon. Human experimentation, manipulation, andoptimization of the immune response to achieve beneficialresults is not a natural phenomenon. On appeal, the FederalCircuit did not discuss whether the claims describe a naturalphenomenon. Instead, the panel applied the new test withoutanalysis, declaring “Dr. Classen’s claims are neither ‘tied to aparticular machine or apparatus’ nor do they ‘transform[ ] aparticular article into a different state or thing.’ Therefore weaffirm.” Classen, 304 F.App’x at 867 (quoting In re Bilski, 545F.3d. at 954) (alteration in original).

only test for patent eligibility is clearly improper.6II.The Framers of the Constitutionintended to promote advances in medicaldiagnosis and treatment.The Constitution grants Congress broad powerto legislate to “promote the Progress of Science anduseful Arts, by securing for limited Times to . . .Inventors the exclusive Right to their . . .Discoveries.” U.S. CONST. art. I, § 8, cl. 8. At thetime the Constitution was drafted, medicine had formore than two thousand years been known as one ofthe “useful Arts.” The Oath of Hippocrates refers tomedicine as “the art,” “this art,” or “my art” on fiveoccasions. HIPPOCRATES, THE OATH AND LAW OFHIPPOCRATES, reprinted in 38 HARVARD CLASSICS, pt.1 (Charles W. Eliot ed., P.F. Collier & Son 1910)(1909). The first sentence of The Law of Hippocratesstates “Medicine is of all the Arts the most noble; butowing to the ignorance of the ones who practiceit, . . . it is at present far behind all the other arts.”Id. In the late 18th century, those who wereeducated in classical learning included ThomasJefferson, and they were well aware that medicinewas one of the “useful Arts.”In Graham v. John Deere, this Court discussedthe legislative history of patent law at length,including analysis of the influence of ThomasJefferson on the development of our patent system,noting “[b]ecause of his active interest and influencein the early development of the patent system,Jefferson’s views on the general nature of the limitedpatent monopoly under the Constitution, as well as

7his conclusions as to conditions for patentabilityunder the statutory scheme, are worthy of note.”383 U.S. 1, 7 (1966). As illustrated below,Jefferson’s writings and other writings of his timeindicate that medicine, including methods oftreatment and diagnosis, would have been includedin the Framers’ definition of “useful Arts.”In Jefferson’s time and in Jefferson’s mind,medicine was clearly understood to be one of the“useful Arts.” The first edition of the EncyclopædiaBritannica states:Medicine is generally defined to be, The artof preserving health when present and ofrestoring it when lost . . . . Most arts requirethe experience of ages before they can arriveat a high degree of perfection. Medicine isunquestionably one of the most ancient; andconsequently, the improvement of it might beexpected to bear some proportion to itsantiquity but, whilst philosophy, in all itsbranches, has been cultivated and improvedto a great extent; medicine, not withstandingthe collateral advantages it has of latederived from anatomy and other sciencesstill continues to be buried in rubbish andobscurity.3 A SOC’Y OF GENTLEMEN IN SCOT., ENCYCLOPÆDIABRITANNICA 58 (1st ed. 1771) [hereinafterENCYCLOPÆDIA BRITANNICA] (emphasis added).Jefferson’s letters make clear that he consideredmedicine to be one of the “useful Arts” in need of

8advancement through both observation andinnovation. For example, in his letter on “Freedomof Mind” to William Green Munford dated June 18,1799, Jefferson states:Surgery is well advanced; but prodigiouslyshort of what may be. The state of medecine[sic] is worse than that of total ignorance . . . .We have a few medecines, as the bark, opium,mercury, which in a few well defineddiseases are of unquestionable virtue: butthe residuary list of the materia medica, longas it is, contains but the charlataneries ofthe art; and of the diseases of doubtful form,physicians have ever had a false knowledge,worse than ignorance. Yet surely the list ofunequivocal diseases & remedies is capableof enlargement; and it is still more certainthat in the other branches of science, greatfields are yet to be explored to which ourfaculties are equal, & that to an extent ofwhich we cannot fix the limits. I join youtherefore in branding as cowardly the ideathat the human mind is incapable of furtheradvances.THOMAS JEFFERSON, WRITINGS 1065 (Merrill D.Peterson ed., Library of America 1984) (emphasisadded). Similar evidence is found in Jefferson’sletter entitled “Unlearned Views of Medicine” to Dr.Caspar, dated June 21, 1807. In this letter,Jefferson provides his opinions on the state ofmedicine and medical education:. . . [F]ulness of the stomach we can relieve

9by emetics; diseases of the bowels, bypurgatives; inflammatory cases, by bleeding;intermittents [fevers], by the Peruvian bark;syphilis, by mercury; watchfulness, byopium; etc. So far, I bow to the utility ofmedicine. It goes to the well-defined formsof disease, & happily, to those the mostfrequent. But the disorders of the animalbody . . . are as various as the elements ofwhich the body is composed . . . . To anunknown disease, there cannot be a knownremedy. Here then, the judicious, the moral,the humane physician should stop . . . . Butthe adventurous physician goes on, &substitutes presumption for knolege [sic] . . . .It is in this part of medicine that I wish tosee a reform, an abandonment of hypothesisfor sober facts, the first degree of value seton clinical observation, and the lowest onvisionary theories . . . . I would wish theyoung practitioner . . . to have deeplyimpressed on his mind, the real limits of hisart.Id. at 1181-1185 (emphasis added). Yet anotherexample can be found in Jefferson’s letter “TheValue of Classical Learning” to John Brazier datedAugust 24, 1819. Jefferson advocated studying theClassics in their original Greek and Latin and wasthoroughly familiar with the writings of Hippocrates.In discussing the benefits of classical learning and inparticular its utility to various members of society,Jefferson notes that the Greek and Roman textshave given to physicians:

10as good a code of his art as has been givenus to this day. Theories and systems ofmedicine, indeed, have been in perpetualchange from the days of the goodHippocrates to the days of the good Rush,but which of them is the true one? Thepresent, to be sure, as long as it is thepresent, but to yield its place in turn to thenext novelty, which is then to become thetrue system, and is to mark the vast advanceof medicine since the days of Hippocrates.Our situation is certainly benefited bythe discovery of some new and very valuablemedicines; and substituting those for some ofhis with the treasure of facts, and of soundobservations recorded by him (mixed to besure with anilities of his day) and we shallhave nearly the present sum of the healingart.Id. at 1424 (emphasis added). Thus, substantialevidence exists that Jefferson and others of his timeconsidered the term “useful Arts” to encompassmedicine. Moreover, these letters indicate thatJefferson considered medicine, including medicaldiagnosis and treatment, to be a field in which greatprogress was both possible and needed for thebenefit of society.The 1771 edition of Encyclopædia Britannicaagain echoes Jefferson’s sentiments regarding theneed for progress in the “art” of medicine:In every art which is not founded on knownfacts and established principles, new projects

12the “useful Arts.” It is also clear that procedures fordiagnosis and treatment of diseases were consideredarts within the more general art of medicine.Moreover, Jefferson and his contemporariesrepeatedly voiced an acute need for progress in theart of medicine. The Constitution was thus draftedwith an understanding of medicine as a “useful Art”in which “progress” was greatly desired.III.Congress intended advances in medicaldiagnosis and treatment to be patenteligible subject matter.From the first Patent Act, Congress has broadlydescribed the class of inventions eligible to beconsidered for Patents. Later acts of Congress madeclear that medicine, including methods of diagnosisand treatment, were meant to be included in thatdescription. As further discussed below, reading thePatent Act in a manner which excludes methods ofdiagnosis and treatment from the class of patenteligible inventions is contrary to the legislativehistory as interpreted by this Court.This Court has repeatedly recognized that thelegislative history of the Patent Act supports a broadconstruction of patent eligible subject matter. InDiamond v. Chakrabarty, this Court noted that:The Patent Act of 1793, authored by ThomasJefferson, defined statutory subject matteras “any new and useful art, machine,manufacture, or composition of matter, orany new or useful improvement [thereof].”Act of Feb. 21, 1793, § 1, 1 Stat. 319. The

14matter provisions of the patent law have been cast inbroad terms to fulfill the constitutional andstatutory goal of promoting ‘the Progress of Scienceand the useful Arts’ with all that means for thesocial and economic benefits envisioned byJefferson.” Chakrabarty, 447 U.S. at 315. Asdiscussed above, advances in medicine, particularlymethods of diagnosis and treatment, were socialbenefits that Jefferson hoped for and envisioned.The current act provides further evidence thatCongress intended processes of diagnosis andtreatment to be patent eligible subject matter. In1996, the act was amended to explicitly excludemedical practitioners from liability for infringing apatent by the performance of a medical or surgicalprocedure on a body (including a human body, organ,or cadaver, or a non-human animal). OmnibusConsolidated Appropriations Act, 1997, Pub. L. No.104-208, 110 Stat. 3009-67 (codified as amended at35 U.S.C. § 287(c) (2006)). Significantly, § 287excludes from its application the practice of patentedbiotechnology processes and certain pharmacy andclinical laboratory services, for which medicalpractitioners remain liable for patent infringement.35 U.S.C. § 287(c) (2006). The fact that Congress feltthe need to create such exclusions makes clear thatthey intended new and useful medical processes suchas methods of diagnosis or treatment to be patenteligible subject matter.In United States v. Dubilier Condenser Corp.,this Court cautioned: “We should not read into thepatent laws limitations and conditions which the

15Legislature has not expressed.” 289 U.S. 178, 199(1933). The Federal Circuit’s “machine-ortransformation”test as set forth in In re Bilski ismore restrictive than required by this Court’sprecedent and finds no support in any legislation. Inpractice, it has already been applied to strike downpatents directed to methods of immunizing patientswith improved efficacy and safety thereby casting acloud on the validity of a great many process patentsin the medical and biotechnological fields.The “machine-or-transformation” test is a usefulstarting point for analysis of patent eligibility ofprocess claims. However, if a process claim is nottied to a particular machine or does not recitetransformation of an article into a different state orthing, the inquiry should not stop there, as theprocess may still be patent eligible as long as it doesnot attempt to claim “laws of nature, naturalphenomena, [or] abstract ideas.” Diamond v. Diehr,450 U.S. 175, 185 (1981). The inquiry shouldcarefully analyze whether the claimed process istruly claiming a phenomenon of nature, ever mindfulof the difference between phenomena that areentirely products of nature and inventions that arethe result of how nature reacts to the purposefulactivity of man. Where the activities of man cause auseful, tangible, concrete result that did not existbefore, the process should be considered patenteligible.

16CONCLUSIONThe Federal Circuit’s holding that a “process”must be tied to a particular machine or apparatus, ortransform a particular article into a different stateor thing, to be patent eligible is too restrictive. Theholding excludes subject matter that Congressclearly intended to be patent eligible. Therefore,amicus curiae respectfully requests that the Courtreverse the decision of the Federal Circuit andanswer the first question presented in theaffirmative.Respectfully submitted,Jeff LloydCounsel of RecordSaliwanchik, Lloyd & SaliwanchikA Professional AssociationP.O. Box 142950Gainesville, FL 32614-2950(352) 375-8100Attorney for Amicus CuriaeThe University of South Florida