No. 2010-1406

United States Court of Appeals for the Federal Circuit

________________

THE ASSOCIATION FOR MOLECULAR PATHOLOGY, THE AMERICAN COLLEGE OF MEDICAL GENETICS, THE AMERICAN SOCIETY FOR CLINICAL PATHOLOGY, THE COLLEGE OF AMERICAN PATHOLOGISTS,

HAIG KAZAZIAN, MD, ARUPA GANGULY, PHD, WENDY CHUNG, MD, PHD, HARRY OSTRER, MD, DAVID LEDBETTER, PHD, STEPHEN WARREN, PHD, ELLEN MATLOFF, M.S., ELSA REICH, M.S., BREAST CANCER

ACTION, BOSTON WOMEN’S HEALTH BOOK COLLECTIVE, LISBETH CERIANI, RUNI LIMARY, GENAE GIRARD, PATRICE FORTUNE, VICKY THOMASON, and KATHLEEN RAKER,

Plaintiffs-Appellees,

v.

UNITED STATES PATENT AND TRADEMARK OFFICE,

Defendant, and

MYRIAD GENETICS, INC.,

Defendant-Appellant,

(caption continued on inside cover)

Appeal From The United States District Court For The Southern District of New York

In Case No. 09-CV-4515, Senior Judge Robert W. Sweet

SUPPLEMENTAL BRIEF FOR THE APPELLANTS

BRIAN M. POISSANT LAURA A. CORUZZI EILEEN FALVEY JONES DAY 222 East 41st Street New York, NY 10017 (212) 326-3939

ISRAEL SASHA MAYERGOYZ DENNIS MURASHKO JONES DAY 77 West Wacker Drive Chicago, IL 60601 (312) 782-3939

GREGORY A. CASTANIAS JENNIFER L. SWIZE JONES DAY 51 Louisiana Avenue, N.W. Washington, D.C. 20001 (202) 879-3939

(additional counsel listed on inside cover)

Attorneys for Defendants-Appellants Myriad Genetics, Lorris Betz, Roger Boyer, Jack Brittain, Arnold B. Combe, Raymond Gesteland, James U. Jensen, John Kendall Morris, Thomas Parks, David W. Pershing,

and Michael K. Young

and

LORRIS BETZ, ROGER BOYER, JACK BRITTAIN, ARNOLD B. COMBE, RAYMOND GESTELAND, JAMES U. JENSEN, JOHN KENDALL MORRIS, THOMAS PARKS, DAVID W. PERSHING, and MICHAEL K. YOUNG, in their official capacity as

Directors of the University of Utah Research Foundation,

Defendants-Appellants.

Of counsel for Defendant-Appellant Myriad Genetics, Inc.:

Benjamin G. Jackson Myriad Genetics, Inc. 320 Wakara Way Salt Lake City, UT 84108 (801) 883-3328

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CERTIFICATE OF INTEREST

Counsel for the appellants, Myriad Genetics, Lorris Betz, Roger Boyer, Jack Brittain, Arnold B. Combe, Raymond Gesteland, James U. Jensen, John Kendall Morris, Thomas Parks, David W. Pershing, and Michael K. Young, certifies the following:

1. The full name of every party or amicus represented by me is:

Myriad Genetics, Lorris Betz, Roger Boyer, Jack Brittain, Arnold B. Combe, Raymond Gesteland, James U. Jensen, John Kendall Morris, Thomas Parks, David W. Pershing, and Michael K. Young

2. The name of the real party in interest represented by me is:

Myriad Genetics, Inc.; the University of Utah Research Foundation

3. All parent corporations and any publicly held companies that own 10 percent or more of the stock of the party or amicus curiae represented by me are:

None.

4. The names of all law firms and the partners or associates that appeared for the party or amicus now represented by me in the trial court or agency or are expected to appear in this court are:

Jones Day (Gregory A. Castanias; Jennifer L. Swize; Brian M. Poissant; Laura A. Coruzzi; Barry R. Satine; Eileen Falvey; Lynda Q. Nguyen; Israel Sasha Mayergoyz; Dennis Murashko).

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TABLE OF CONTENTS

CERTIFICATE OF INTEREST ................................................................................ i TABLE OF AUTHORITIES ................................................................................... iii TABLE OF ABBREVIATIONS ............................................................................. vi INTRODUCTION AND SUMMARY ...................................................................... 1 ARGUMENT ............................................................................................................. 2 I. MAYO DOES NOT ALTER THIS COURT’S CONCLUSION THAT

THE COMPOSITION CLAIMS ARE PATENT-ELIGIBLE ........................ 2 A. Mayo Does Not Affect Composition Claims ........................................ 2 B. Mayo’s General Principles And Policy Considerations Do Not

Alter This Court’s Prior Conclusion That The Composition Claims Are Patent-Eligible .................................................................... 6 1. This Court’s Conclusion That The Isolated BRCA

Molecules Have A “Distinctive Name, Character, And Use” From Naturally Occurring Genetic Material Satisfies Mayo ............................................................................. 6

2. The Differences Between What Is Recited Here And In Mayo Further Show That These Claims Are Patent-Eligible ...................................................................................... 11

3. The Policy Concerns Discussed In Mayo Favor Eligibility .................................................................................. 14

II. MAYO DOES NOT ALTER THIS COURT’S CONCLUSION THAT METHOD CLAIM 20 IS PATENT-ELIGIBLE ........................................... 18 A. Claim 20 Is Not Before The Court ...................................................... 18 B. Claim 20 Is Patent-Eligible ................................................................. 19

CONCLUSION ........................................................................................................ 20 CERTIFICATE OF SERVICE

CERTIFICATE OF COMPLIANCE

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TABLE OF AUTHORITIES

Page(s)

CASES

Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011) ...................................................................passim

Bilski v. Kappos, 130 S. Ct. 3218 (2010) ................................................................................ 3, 4, 11

Diamond v. Chakrabarty, 447 U.S. 303 (1980) .....................................................................................passim

Diamond v. Diehr, 450 U.S. 175 (1981) .............................................................................................. 3

Dillon v. United States, 130 S. Ct. 2683 (2010) ........................................................................................ 19

Ex parte Latimer, 1889 Dec. Comm’r Patent 123 (1889) .................................................................. 8

Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) .......................................................................................... 4, 5

Gottschalk v. Benson, 409 U.S. 63 (1972) ............................................................................................ 3, 4

Graham v. John Deere & Co., 383 U.S. 1 (1966) .................................................................................................. 7

Green Edge Enters., LLC v. Rubber Mulch, Etc., LLC, 620 F.3d 1287 (Fed. Cir. 2010) .......................................................................... 14

Hartranft v. Weigmann, 121 U.S. 609 (1887) .............................................................................................. 4

Hewlett-Packard Co. v. Bausch & Lomb, Inc., 909 F.2d 1464 (Fed. Cir. 1990) ............................................................................ 3

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In re Bergstrom, 427 F.2d 1394 (C.C.P.A. 1970) ............................................................................ 4

In re Bergy, 596 F.2d 952 (C.C.P.A. 1979) .................................................................... 4, 5, 10

In re Chakrabarty, 571 F.2d 40 (C.C.P.A. 1978) ................................................................................ 4

In re Grams, 888 F.2d 835 (Fed. Cir. 1989) .............................................................................. 4

In re Kratz, 592 F.2d 1169 (C.C.P.A. 1979) ............................................................................ 4

J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001) ........................................................................................ 8, 14

Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) .................................................................................passim

Merck & Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156 (4th Cir. 1958) ................................................................................ 4

Neilson v. Harford, 151 Eng. Rep. 1266 (1841) ................................................................................... 3

O’Reilly v. Morse, 56 U.S. 62 (1854) .................................................................................................. 3

Parker v. Flook, 437 U.S. 584 (1978) ...................................................................................... 3, 4, 5

STATUTES

35 U.S.C. § 100 .......................................................................................................... 3

35 U.S.C. § 101 .................................................................................................passim

OTHER AUTHORITIES

European Patent Office Board of Appeals. No. T 1213/05 (2007) ......................... 12

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Letter from Eric Y. Drogin & Robert A. Armitage to David Kappos re: Genetic Diagnostic Testing (Apr. 16, 2002), available at www.uspto.gov/aia_implementation/gene-comment-aba.pdf ............................ 17

I William C. Robinson, The Law of Patents (1890) .................................................. 7

Sup. Ct. R. 14.1(a) .................................................................................................... 19

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TABLE OF ABBREVIATIONS

The abbreviations set forth in Appellants’ Opening Brief (at x-xi) and Reply

Brief (at vii) are also used in this Supplemental Brief, as well as “MReply __” to

refer to Appellants’ Reply Brief. Additionally, as in Appellants’ prior briefs, all

emphasis in this Supplemental Brief is added unless otherwise indicated.

INTRODUCTION AND SUMMARY

The Court’s April 30, 2012 Order asks: “What is the applicability of the

Supreme Court’s decision in Mayo to Myriad’s isolated DNA claims and to

method claim 20 of the ‘282 patent?” The answer is that Mayo has no effect on the

Court’s prior judgment that these claims are patent-eligible.

As to the isolated DNA claims: By its terms, Mayo addresses method patent

claims, not composition claims. Even if Mayo’s general principles could be

broadly analogized to composition claims, that would only confirm the panel’s

prior holding. Mayo asks whether a method patent claim does “significantly more”

beyond reciting a law of nature and “well-understood, routine, conventional

activity.” Here, the panel previously held that the isolated DNA composition

claims are patent-eligible because the inventors produced isolated BRCA

molecules having structures and utilities with a “distinctive name, character, and

use” from anything found in nature. That already answered the overarching

question addressed by Mayo—whether humans applied “invention” beyond that

which existed a priori (laws of nature in Mayo; “products of nature” here). Thus,

the panel’s prior holding that the composition claims are the product of human

invention should be reinstated. As evidence of their patent-eligibility, the claims

do not preempt or monopolize “the basic tools of scientific and technological work.”

As to method claim 20 of the ‘282 patent: The panel’s prior unanimous

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decision upholding that claim is final and undisturbed by the Supreme Court’s

GVR order; it is not properly before the Court. Plaintiffs’ petition for certiorari did

not seek review of this Court’s holding as to method claim 20; to quote the petition:

“None of the method claims is the subject of this petition.” The order granting

certiorari did not encompass claim 20. In any event, that claim easily survives

Mayo because it involves “significantly more” than the addition of “well-

understood, routine, conventional activity” to a “law of nature.” Indeed, claim 20

starts not with a “law of nature,” but with a new and useful product of human

ingenuity—a transformed cell containing an altered BRCA1 gene—and applies

method steps using that invention. The claimed method is thus a human invention.

The composition claims, and claim 20, remain patent-eligible after Mayo.

ARGUMENT

I. MAYO DOES NOT ALTER THIS COURT’S CONCLUSION THAT THE COMPOSITION CLAIMS ARE PATENT-ELIGIBLE

A. Mayo Does Not Affect Composition Claims

The question presented in Mayo narrowly asked “whether the claimed

processes have transformed . . . unpatentable natural laws into patent-eligible

applications of those laws.” Mayo Collaborative Servs. v. Prometheus Labs., Inc.,

132 S. Ct. 1289, 1294 (2012). Indeed, the Court disclaimed any intent to break

new ground, emphasizing that its decision reflected merely “an examination of the

particular [method] claims before [it] in light of the Court’s precedents.” Id. And

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Mayo did not concern any of the other categories of eligible subject matter—

machines, manufactures, or compositions of matter. See 35 U.S.C. § 101; see also

id. § 100(b).1 Mayo never addressed, and did not alter, the composition-of-matter

test previously applied in this case, the “distinctive name, character and use” test of

Diamond v. Chakrabarty, 447 U.S. 303, 309-10 (1980) (internal brackets omitted).

Rather, Mayo’s “detailed consideration of the controlling precedents” solely

addressed process cases. 132 S. Ct. at 1298.2

Mayo’s only invocation of product cases such as Chakrabarty was at the

highest level of generality. See id. at 1293. For instance, Mayo cited Chakrabarty

for the basic principle that laws of nature, natural phenomena, and abstract ideas

are not patent-eligible. Id. (internal quotation marks omitted).

Conversely, the Supreme Court applied only its product cases in deciding

1 Process (or method) claims fundamentally differ from the other three types

of patent-eligible claims, generically referred to as product claims. Process claims cover “what a device does”; product claims cover “what a device is.” Hewlett-Packard Co. v. Bausch & Lomb, Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990).

2 Mayo relied on Bilski v. Kappos, 130 S. Ct. 3218, 3231 (2010) (process for hedging risks of commodity price fluctuations); Diamond v. Diehr, 450 U.S. 175, 177 (1981) (process for molding rubber); Parker v. Flook, 437 U.S. 584, 585 (1978) (process for adjusting “alarm limits” in catalyctic conversion of hydrocarbons); Gottschalk v. Benson, 409 U.S. 63, 64 (1972) (process for converting decimals into binary numbers); O’Reilly v. Morse, 56 U.S. 62, 86 (1854) (process for making or printing characters, letters, or signs); and Neilson v. Harford, 151 Eng. Rep. 1266, 1266 (1841) (process for producing heat). This analysis followed the Supreme Court’s approach in its other recent process case—Bilski—which tracked process precedent from Benson to Flook to Diehr. See Bilski, 130 S. Ct. at 3229-31.

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Chakrabarty. Thus, although it mentioned method cases when discussing general

principles, it applied solely product cases to determine the patent-eligibility of the

composition claims in that case. Compare 447 U.S. at 309 (discussing general

principles) with id. at 310 (applying Hartranft v. Weigmann, 121 U.S. 609 (1887),

and Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)—product

cases—to determine that the claimed compositions were patent eligible).3

In view of the different eligibility analyses applied to composition versus

method claims, a different track record has developed for each. Several decisions

by the Supreme Court, this Court, and its predecessor have ruled method claims

ineligible under § 101.4 Mayo’s holding is consistent with those decisions. But no

appellate court has ruled a product patent ineligible since the 1952 Act.5 The

panel’s prior decision on the composition claims was a straightforward application

of that longstanding case law, and yielded a result consistent with past practices:

All three panel members appropriately relied on Chakrabarty and other product

3 Plaintiffs themselves acknowledged and sought to gain from these distinct

analyses when they told the Supreme Court that, unlike the Court’s long line of cases on “the patentability of methods,” it “has not addressed the patentability of compositions of matter” since Chakrabarty. Petition for Writ of Certiorari at 16, Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 11-725 (Dec. 6, 2011).

4 Bilski, 130 S. Ct. at 3231; Flook, 437 U.S. at 585; Benson, 409 U.S. at 71-72; In re Grams, 888 F.2d 835, 836 (Fed. Cir. 1989).

5 In re Bergy, 596 F.2d 952, 956 (C.C.P.A. 1979); In re Kratz, 592 F.2d 1169, 1170 (C.C.P.A. 1979); In re Chakrabarty, 571 F.2d 40, 43 (C.C.P.A. 1978); In re Bergstrom, 427 F.2d 1394, 1402 (C.C.P.A. 1970); Merck & Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156, 157 (4th Cir. 1958).

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cases, not process cases, to determine eligibility.6 Likewise, each judge addressed

Myriad’s method claims using method precedents.7

Much the same thing happened in Chakrabarty itself. The composition

claims were upheld under § 101; an intervening Supreme Court decision involving

method claims (Parker v. Flook) was issued; the prior judgment was vacated; and

the court again, on reconsideration, upheld the composition claims. See In re

Bergy, 596 F.2d at 956-57 (recounting Chakrabarty procedural history); see also

Chakrabarty, 447 U.S. at 306-07. The court explained that “Flook was concerned

only with the question of what is a ‘process’ under § 101” and “[n]o method or

process claim [was] involved” in Chakrabarty. 596 F.2d at 964-65. “The only

thing . . . in common” between the two cases was that both “involved § 101.” Id.;

see also id. at 967 (“To conclude on the light Flook sheds on these cases . . . we

find none.”). Accordingly, the court adhered to its original judgment. The

Supreme Court ultimately affirmed. See 447 U.S. at 306, 310.

The same result is compelled here. Mayo sheds no new light on the patent-

eligibility of the isolated DNA claims, and thus should not alter the Court’s prior

6 See Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 653

F.3d 1329, 1350-55 (Fed. Cir. 2011) (applying Chakrabarty and Funk Brothers as the “framework for deciding the patent eligibility of isolated DNA molecules”); id. at 1358-49 (Moore, J., concurring in part) (same); id. at 1374-80 (Bryson, J., concurring in part and dissenting in part) (applying Chakrabarty).

7 See 653 F.3d at 1355-58 (citing Benson, Diehr, and Bilski).

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judgment that those claims are the patent-eligible work of human inventors.

B. Mayo’s General Principles And Policy Considerations Do Not Alter This Court’s Prior Conclusion That The Composition Claims Are Patent-Eligible

At most, Mayo’s relevance to composition claims can be found in its

discussion of general principles of eligibility. Those principles are fully consistent

with and confirm this Court’s prior analysis and conclusion that the isolated BRCA

molecules of the challenged claims are patent-eligible.

1. This Court’s Conclusion That The Isolated BRCA Molecules Have A “Distinctive Name, Character, And Use” From Naturally Occurring Genetic Material Satisfies Mayo

At the most fundamental level, Mayo asks whether a claim is drawn to a

product of human “invention.” This Court already resolved that question here by

ruling that the claimed BRCA molecules were human-made inventions, and did so

in a way consistent with Supreme Court precedent, including, now, Mayo.

In Mayo, the Supreme Court reaffirmed and applied the basic and

longstanding principle that eligibility requires the application of human ingenuity

to produce something beyond the natural law itself, and beyond what an ordinary

mechanic could add to the natural law. Mayo, 132 S. Ct. at 1293-94. Applying

this general principle to the process claims before it, Mayo asked “whether the

claims do significantly more than simply describe the[] natural relations” used in

the claims. Id. at 1297. Mayo held that claims stating a law of nature, and then

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telling the doctor to apply it, failed § 101. Id. at 1297-98. The Court found that

the particular claims before it added no human ingenuity to the natural laws. In

other words, in holding that a law of nature, plus additional steps that consist of

“well-understood, routine, conventional activity,” was not patent-eligible under

§ 101, the Supreme Court essentially ruled that the Prometheus method claims did

not reflect human invention. Id. at 1294, 1298 (twice), 1299 (adding only “obvious,

already in use or purely conventional” steps does not confer patent eligibility).8

When composition claims are at stake, Mayo recognized, “a novel and useful

structure” is patent-eligible, even if “created with the aid of knowledge of

scientific truth.” 132 S. Ct. at 1294, 1300 (quoting Mackay Radio & Tel. Co. v.

RCA, 306 U.S. 86, 94 (1939)). The proper distinction is “between products of

nature” and “human-made inventions.” Chakrabarty, 447 U.S. at 313; accord

I William C. Robinson, The Law of Patents 115 (1890) (“Every invention has its

origin in man. It is his addition to the agencies already existing in nature” that

creates an invention.). Every product has its origin in something that exists in

nature; every process operates according to some kind of a priori natural law; thus,

there is no requirement that a claimed invention be wholly artificial. Human

8 Mayo’s use of terms like “obvious” or “conventional” to describe steps that

do not confer patent eligibility confirms that the Supreme Court was moved by the absence of human invention. What is now known as “obviousness” under the 1952 Act was, prior to that Act, rooted in the absence of the statutory requirement of “invention.” See, e.g., Graham v. John Deere & Co., 383 U.S. 1, 11-12 (1966).

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ingenuity must simply have played a role. Chakrabarty, 447 U.S. at 312-13

(something “created wholly by nature unassisted by man” is ineligible, while

something produced by man “in aid of nature [is] a patentable invention”).

In its earlier decision in this case, this Court properly concluded that the

isolated BRCA molecules were human-made inventions, and thus satisfied § 101,

by applying a test for composition claims rooted in Supreme Court precedent—

whether human invention produced compositions with a “distinctive name,

character [and] use” from what exists in nature. 653 F.3d at 1351 (brackets in

original). This formulation is traceable to the Supreme Court’s decision in

Chakrabarty (447 U.S. at 309-10), and fully consistent with Mayo’s inquiry asking

whether those method claims did “significantly more” than describe natural laws.9

9 Chakrabarty’s discussion of the 1930 Plant Patent Act (“PPA”) is

particularly instructive in understanding this line between “invention” and an uninventive “product of nature.” Prior to 1930, it was “belie[ved] that plants, even those artificially bred, were products of nature for purposes of the patent law.” 447 U.S. at 311 (crediting Ex parte Latimer, 46 O.G. 1638, 1889 Dec. Comm’r Patent 123 (1889), as giving rise to that belief). By enacting the PPA, however, Congress “explained at length its belief that the work of the plant breeder ‘in aid of nature’ was [a] patentable invention.” Id. at 312. The Supreme Court noted statements in the PPA’s congressional reports that “a plant discovery resulting from cultivation is unique, isolated, and is not repeated by nature, nor can it be reproduced by nature unaided by man.” Id. at 313. Against this historical backdrop, the Court recognized that the “relevant distinction” for purposes of patent eligibility “is between products of nature . . . and human-made inventions.” Id. Further, in J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124, 130-44 (2001), the Court confirmed that patent protection for plants arises not only under plant-specific statutes such as the PPA, but also under § 101. Just like patent-eligible human-made plants, the claimed molecules here are “unique,”

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In its prior decision, this Court recognized the claims’ human ingenuity.

Native DNA exists in the human body only as one of forty-six contiguous DNA

molecules, themselves part of a larger structure of chromosomes. See 653 F.3d at

1351. An isolated DNA molecule, by contrast, “is a free-standing portion of a

native DNA molecule, frequently a single gene.” Id. Critically, “human

intervention in cleaving or synthesizing a portion of a native chromosomal DNA

imparts on that isolated DNA a distinctive chemical identity from that possessed

by native DNA.” Id. at 1352; see also id. at 1363 (Moore, J., concurring in part)

(“isolated DNA is a distinct molecule with different physical characteristics than

the naturally occurring polymer containing the corresponding sequence in nature”).

These “synthesized” portions have “chemically severed” backbones not found in

nature. Id. at 1351. Even the dissent observed that there is a “material change”

between natural DNA and the claimed isolated DNA.10 Id. at 1375 (Bryson, J.,

concurring in part and dissenting in part). That material change came about

“isolated,” “not repeated in nature,” and cannot “be reproduced by nature unaided by man.” Chakrabarty, 447 U.S. at 313.

10 With respect, the dissent improperly placed controlling weight on the similarities between genomic DNA and isolated molecules, instead of focusing upon the differences, which are material, and which render the isolated DNA claims human-made inventions. The isolated BRCA DNA molecules have different structural characteristics and bring with them functional utilities that do not exist in native DNA. (A3445; A3468-70; A3494-96; A3707-10; A4320-22; A4325; A4410-12; A4416; A4540; A4723; A5301; A5304-05; A5314-15; A5594-96; A6561-65; A6769; A6772-74; A6848; A6947; A7286; A7369-71.)

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through human knowledge, creativity, and scientific advancement—invention.

As this Court ruled, the claimed isolated DNA molecules have a “distinctive

chemical identity and nature . . . from molecules that exist in nature” that renders

them patent-eligible. Id. at 1354. By virtue of the artificially cleaved (i.e., human-

assisted) chemical bonds and new chemical structure, which yields substantial new

utilities, these molecules are markedly different from what exists in nature—they

are “not nature’s handiwork, but [the inventors’] own.” Chakrabarty, 447 U.S. at

310; see also 653 F.3d at 1364-67 (Moore, J., concurring in part) (although cDNA

claims are “inspired by nature,” they “have a distinctive name, character, and use,

with markedly different chemical characteristics from” what is found in nature, and

other claims of isolated BRCA molecules are likewise chemically different from

what exists in nature and have a “new utility which makes the molecules markedly

different from nature”).11

11 Under plaintiffs’ analysis, the bacterium in Chakrabarty would not have

been patent-eligible. That bacterium was identical to the naturally occurring one, except for a few small pieces of DNA that had been transferred to it with the aid of human researchers (essentially through a process of selective breeding). See Bergy, 596 F.2d at 968-71. It had the same genome and the same internal components. It also retained all of its original functions and properties; it just gained a few new ones. In fact, the invention in Chakrabarty merely added known utilities from one bacterium into another (by contrast, the isolated molecules in the present case gave rise to entirely new utilities that were impossible before, such as sequencing a patient’s BRCA1 gene). But those changes so altered the nature and utility of the bacterium as to make it patent-eligible. In the words of Mayo, what Chakrabarty had created represented “significantly more” than what was found in nature. His “contribution” to the art was significant.

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2. The Differences Between What Is Recited Here And In Mayo Further Show That These Claims Are Patent-Eligible

Other critical distinctions between Mayo and the present case support the

panel’s prior judgment. Under § 101, the Supreme Court has always engaged in a

fact-intensive analysis of the “particular claims before [it] in light of the Court’s

precedents,” Mayo, 132 S. Ct. at 1294, and has discouraged “categorical rules that

might have wide-ranging and unforeseen impacts.” Bilski, 130 S. Ct. at 3229-30.

Mayo focused on the claims’ recited general steps of analyzing known analytes for

known purposes, with the only contribution over that known art being a refined

clinical conclusion. See Mayo, 132 S. Ct. at 1297-98.

By contrast, the molecules recited in the composition claims here are

entirely new. “‘While a scientific truth, or the mathematical expression of it, is not

a patentable invention, a novel and useful structure created with the aid of

knowledge of scientific truth may be.’” Id. at 1294 (quoting Mackay, 306 U.S. at

94). Myriad did not here discover a new use for an old composition. Nor did

Myriad merely refine the clinical conclusion that could be gleaned from measuring

an old analyte in conventional ways. Instead, Myriad invented a new structure and

discovered a new analyte entirely. Moreover, those new structures gain functions

not possessed by the native BRCA genes. (MBr. 8-9, 35-36, 47-48.) Those new

and useful structures, the product of human invention, are patent-eligible.

In Mayo, the claims themselves recited a law of nature together with a few

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well-understood, routine, and conventional steps. Here, however, plaintiffs have

never pointed to any element in the claimed molecules—i.e., any element of the

claims themselves—that was well-understood, routine, or conventional at the time

of filing. The laboratory processes used in isolating BRCA DNA, although

themselves innovative, are not part of the claims.12 Rather, what is claimed is a

novel molecule that does not exist in nature, and that cannot be reproduced by

nature unaided by man. The structure was not known before the invention, and so

the elements of the claims (e.g., the sequence of the human-made DNA constructs)

were not “well-understood, routine, or conventional.”

Rather, isolation of the BRCA1/2 genes was widely hailed as “a scientific

accomplishment that required many inventive steps, not the least of which was to

contradict the scientific dogma of the time.” (A4780; see also A4769-79; A279-80;

A588-89; A785-86.) In the 1970s, Myriad’s founders and scientists devised a

technique to map the precise location of a gene. In the ensuing decades, these

12 Even so, those laboratory techniques were themselves groundbreaking,

despite plaintiffs’ claims to the contrary. Scientists in the field were not, prior to the Myriad inventions, engaged in Myriad’s approach. Rather, discovering and isolating the BRCA1 gene “was a major breakthrough which was not obvious to the skilled person.” European Patent Office Board of Appeals, No. T 1213/05 at 69-70 (2007); id. at 12 (“The positional cloning of the BRCA1 gene was very complex and involved many uncertainties, and there could not have been a reasonable expectation of success. During the cloning procedure, the inventors had to take a multitude of decisions many of which had the potential of leading to ultimate failure. Picking the right breast and ovarian cancer families (kindreds) was one of the crucial points that led to success.”); see also A4772-80; A4801-03.

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inventors sought ways to assess cancer risk based on genetic mutations that

correlate to a predisposition to breast and ovarian cancer. (A4802-03.) By 1990, it

was believed that there were one or more genes in which mutations would

predispose a patient to breast and ovarian cancer risk; however, the location of any

such gene, and any sequence thereof, was still unknown. (A4803-04; A4771-72.)

Thus, neither the isolated molecules themselves, nor any genetic diagnostic

applications utilizing those molecules, were available to the public.

To fill that gap, Myriad focused intensely on applying its genetic mapping

technology to locate the BRCA1 molecules, and ultimately the BRCA2 molecules

as well, and then, once identified, to isolate those molecules so that they could be

used as molecular tools to identify mutations in a patient’s own genetic makeup.

(A4804.) The Myriad inventors’ success (in the early 1990s) thus yielded human-

made molecules—with different structures and different utilities from any material

previously existing in nature. The inventors disclosed their inventions to the public

in patents, which (inter alia) allowed thousands of researchers to publish thousands

of papers on these new molecules and their uses. (A3439-40; A3444; A3484-85;

A7382-83; A7454-7662; MBr. 14; MReply 19.) In return for their inventions and

public disclosures, these men and women—inventors all—were appropriately

rewarded with a limited exclusionary right.

The inventiveness of the composition claims is manifest whether those

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advances are measured in decades of inventive effort, the patents’ numerous

innovative approaches and steps, the studies and analyses that preceded them, the

praise, surprise, and world-wide acclaim heaped upon these inventions, or the

millions of dollars in research and development that produced them. Thus, just as

commercial success, widespread praise, unexpected results, unsolved needs, and

prior art that teaches away may show a claimed invention to be nonobvious (i.e.,

inventive), Mayo’s discussion of whether the claims recite anything other than

“well-understood, routine, conventional steps beyond the recited law of nature”

should not change the conclusion the Court previously reached—that the creation

of isolated DNA molecules was “the act of human invention.” 653 F.3d at 1353.13

3. The Policy Concerns Discussed In Mayo Favor Eligibility

The policy factors mentioned in Mayo were also already addressed by this

Court and thus should not alter its prior judgment. Mayo observed that courts

“must hesitate before departing from established general legal rules lest a new

protective rule that seems to suit the needs of one field produce unforeseen results

in another.” Mayo, 132 S. Ct. at 1305. Instead of upsetting those rules through

judicial lawmaking, it is “the role of Congress in crafting more finely tailored rules

where necessary.” Id.; J.E.M., 534 U.S. at 144-46 (cautioning against departures

13 If the Court nonetheless were to conclude that the record is incomplete on this point, and that an obviousness-type inquiry would be merited, at the very least the case should be remanded for further factual development. See Green Edge Enters., LLC v. Rubber Mulch, Etc., LLC, 620 F.3d 1287, 1298 (Fed. Cir. 2010).

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from past practices and policies in interpreting § 101, because of reliance interests

and respect for congressional inaction in the face of consistent practices).

Here, the “established general legal rules,” propounded in decades of case

law, hold that isolated DNA molecules are patent-eligible. (MBr. 38-40.) The

PTO’s 30-year practice of granting tens of thousands of patents to isolated DNA

molecules has reinforced these legal rules and contributed to significant settled

expectations in the inventing community, which are not to be upset lightly. And in

all the years such patents have issued—including years in which plaintiffs and

others have drawn much attention to such patents—Congress has never altered the

PTO’s longstanding practice. See 653 F.3d at 1354 (“the PTO has issued patents

directed to DNA molecules for almost thirty years,” and “changes to longstanding

practice should come from Congress, not the courts”); id. at 1368 (Moore, J.,

concurring in part) (similar). The Court appropriately took the PTO’s past practice

into account in holding that the challenged isolated DNA claims are patent-eligible.

Mayo instructs the Court to reject plaintiffs’ invitation to depart from these

established general legal rules to create a new protective rule that seems to suit the

needs of one field (i.e., BRCA testing) but which will surely produce unforeseen

results in another (i.e., the rest of the biotechnology world and beyond).

Mayo also expressed concern that “even though rewarding with patents

those who discover new laws of nature and the like might well encourage their

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discovery,” such patent protection would inappropriately preempt others from

using “the basic tools of scientific and technological work” and thus “inhibit future

innovation premised upon them.” 132 S. Ct. at 1301. In noting this concern,

however, Mayo recognized that a claim’s preemptive effect is not the test for

patent eligibility. By their nature, all patent claims are preemptive—they confer

the right to exclude (preempt) others from making, using, selling, etc. what is

claimed. See id. at 1305. Mayo’s discussion of “preemption” simply reflected the

conclusion—already reached—that Prometheus’s claim was ineligible.

Here, the isolated BRCA molecules fall comfortably within the bounds of

patent-eligible subject matter. As this Court recognized, “isolating genes to

provide useful diagnostic tools and medicines is surely what the patent laws are

intended to encourage and protect.” 653 F.3d at 1354; see also id. at 1371 (Moore,

J., concurring in part). Rather than seeking to broadly preempt the use of gene

sequencing research, Myriad seeks to protect only its particular invention (the

isolated BRCA1 and BRCA2 molecules), not any of the other 20,000 human or

other genes. The record evidence proves the absence of any undue preemption; for

example, the BRCA molecules and testing for predisposition to hereditary breast

cancer have been widely researched and published. See supra, at 13. Furthermore,

hereditary cancer predisposition can be determined by various other means that are

not preempted by Myriad’s isolated DNA claims, e.g., use of mutation prevalence

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tables (which have been used for decades), gene expression profiles as surrogate

biomarkers, and immunohistochemistry (IHC)-based testing. (A7454-7662.)

Moreover, Myriad’s inventions, which have substantial real-world utility, came

about only by way of considerable private investment to sustain this human

intervention and creativity. That is the patent system operating as it should.14

The impact of this case is not limited to human genetics. In 2012, the era of

human gene discovery has been over for more than a decade, and human isolated

DNA patents are in their twilight. But the consequences of ruling these claims

ineligible would be tragic, and would reach far beyond this field and industry.

Striking them down, despite the reliance of the inventive and investing

communities on the well-established rule, would send a shiver up the spines of

14 Relevant committees of the American Bar Association have recently

recounted how further biotechnological research is substantially advanced—not inhibited—when its achievements are patented. See Letter from Eric. Y. Drogin & Robert A. Armitage to David J. Kappos re: Genetic Diagnostic Testing (Apr. 16, 2002) 13, available at www.uspto.gov/aia_implementation/gene-comment-aba.pdf (last visited June 12, 2012). “[W]ith respect to genetic diagnostic testing, and gene-related patents more generally, there is simply no case to be made that patents have been anything other than a partner in achieving mammoth technological advances that have remarkably improved the therapeutic and diagnostic options available to patients.” Id. at 14.

BRCA gene sequencing improved individualized patient care. See id. at 4. But that development did not come cheaply; it required monumental private investment. See id. at 5. Consistent with reliance on the PTO’s longstanding practice, “[m]uch of that investment was made on a sound expectation that the risks being taken to commercialize new technology hold the promise of producing financial returns commensurate with the magnitude of the inherent risks.” Id.

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future investors and commercial research and development—and not just in

molecular diagnostics. Such a ruling would additionally cast a pall on various

other innovation industries whose existence depends on patent protection.15 Mayo

took pains to distinguish the noninventive method at issue there from a “patent on

a new drug or a new way of using an existing drug” (132 S. Ct. at 1302); this Court,

likewise, should not view Mayo as doing anything to endanger such new, useful,

and inventive compositions (or methods based on inventive compositions).

II. MAYO DOES NOT ALTER THIS COURT’S CONCLUSION THAT METHOD CLAIM 20 IS PATENT-ELIGIBLE

A. Claim 20 Is Not Before The Court

The Court need not revisit method claim 20, for it is beyond the scope of the

remand. Plaintiffs’ substantive question presented asked only (and erroneously)

“Are human genes patentable?” Petition for Writ of Certiorari at i, Ass’n for

Molecular Pathology v. Myriad Genetics, Inc., No. 11-725 (Dec. 6, 2011).

Plaintiffs unequivocally confirmed: “None of the method claims is the subject of

this petition.” Id. at 7 n.2. They made this election knowing that “the patentability

15 Even a limited number of examples makes the point: in pharmaceuticals, any extract or isolate of a naturally occurring substance such as aspirin (from willow bark) or antibiotics or immunosuppressants (from fungi); in biologics, viruses for virus detection and vaccine development such as hepatitis C virus and human papillomavirus, and therapeutic human proteins such as human growth hormone, erythropoietin, and Humira®; in energy, enzymes used to produce biofuel; in agriculture, nutritionally improved fruits and vegetables, biological pesticides, and drought-resistant crops; and in consumer products, flavorants, dyes, and enzymes used in detergents.

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of methods” was pending before the Supreme Court in Mayo. Id. at 16.

Accordingly, plaintiffs have forfeited further proceedings on that claim. See Dillon

v. United States, 130 S. Ct. 2683, 2691 n.5 (2010); Sup. Ct. R. 14.1(a) (only the

questions presented, “or fairly included therein, will be considered”).

B. Claim 20 Is Patent-Eligible

Even so, claim 20, is patent-eligible under Mayo. Claim 20 does

“significantly more than simply describe . . . natural relations.” Mayo, 132 S. Ct.

at 1297. Indeed, claim 20 starts not with a “natural law” (as in Mayo), but with an

inventive composition of matter—“a transformed eukaryotic host cell containing

an altered BRCA1 gene causing cancer” (A665)—and applies additional steps to

that transformed cell so that a new, useful, and inventive method of determining

the efficacy of a cancer therapeutic was made available to the public.

The claim expressly requires two “transformed” cells injected with a

BRCA1 gene altered to cause cancer, and introducing into one of those cells a

compound that is suspected of slowing cancer growth and not introducing the

compound in the other cell. (A665.) The claim further recites determining and

comparing each cell’s growth rate. (A665.)

Each transformed cell is a non-naturally-occurring, human-made creation

that is plainly more than what exists in nature, and each transformed cell is central

to the claim (it is the starting material). As this Court explained, claim 20

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“assesses a compound’s potential as a cancer therapeutic, and growing the cells

and determining their growth rate is what achieves that goal.” 653 F.3d at 1358.

This does “substantially more” than recite a law of nature with only additional

conventional steps. See 132 S. Ct. at 1299. The fact that each cell contains an

isolated BRCA molecule even further distinguishes claim 20 from the Mayo claims.

Until Myriad’s invention, there was no such thing as an isolated BRCA molecule

existing outside of the human body, so claim 20 includes elements that are neither

“obvious” nor “well-understood, routine, conventional activity.” Id. at 1298.

This Court’s prior analysis holds fast, even after Mayo. The steps in claim

20 are transformative and not “manifestly abstract.” 653 F.3d at 1357-58. Claim

20 “does not cover all cells, all compounds, or all methods of determining the

therapeutic effect of a compound.” Id. at 1358. Instead, it is limited to “specific

host cells transformed with specific genes and grown in the presence or absence of

a specific type of therapeutic.” Id. The claims in Mayo, by contrast, “simply t[old]

doctors to gather data from which they may draw an inference in light of the

correlations” and provided no “practical assurance that the process is more than a

drafting effort designed to monopolize the law of nature itself.” Mayo, 132 S. Ct.

at 1297-98. In sum, Mayo does not change this Court’s prior analysis.

CONCLUSION

The judgment of the district court should be reversed.

CERTIFICATE OF SERVICE

The undersigned counsel hereby certifies that two copies of the Brief

for Appellants were served by UPS (overnight delivery) and e-mail on June

15, 2012, upon the following counsel:

Christopher A. Hansen, Esq. American Civil Liberties Union 125 Broad Street 18th Floor New York, New York 10004 Counsel for Plaintiffs-Appellees

Barbara R. Rudolph, Esq. Finnegan, Henderson, Farabow, Garrett & Dunner 901 New York Avenue, N.W. Suite 1100 Washington, DC 20001-4413 Counsel for Amicus Curiae American Intellectual Property Law Association

Stephen B. Maebius, Esq. Foley & Lardner 3000 K Street, N.W. Suite 500 Washington, DC 20007 Counsel for Amicus Curiae Alnylam Pharmaceuticals

Seth P. Waxman, Esq. Wilmer Hale 1875 Pennsylvania Avenue, N.W. Washington, DC 20006 Counsel for Amici Curiae Biotech Industry Organization et al.

Erik P. Belt, Esq. McCarter & English 265 Franklin Street Boston, MA 02110 Counsel for Amicus Curiae Boston Patent Law Association

J. Timothy Keane, Esq. Harness, Dickey & Pierce 7700 Bonhomme Avenue Suite 400 St. Louis, MO 63105 Counsel for Amici Curiae Gilead Sciences et al.

Jennifer Gordon, Esq. Baker Botts 30 Rockefeller Center New York, New York 10112 Counsel for Amicus Curiae Croplife International

Herbert C. Wamsley, Esq. Intellectual Property Owners Association 1501 M Street, N.W. Suite 1150 Washington DC 20005 Counsel for Amicus Curiae Intellectual Property Owners Association

Maxim H. Waldbaum, Esq. Schiff Hardin 900 Third Avenue 23rd Floor New York, New York 10022 Counsel for Amicus Curiae Fédération Internationale des Conseils en Propriété Industrielle (FICPI)

James J. Kelley, Esq. Eli Lilly & Company 940 S. East Street, Dock 88 Lilly Corp. Center – Drop Code 1104 Indianapolis, IN 46225 Counsel for Amicus Curiae Eli Lilly & Company

David S. Forman, Esq. Finnegan, Henderson, Farabow, Garrett & Dunner 901 New York Avenue, N.W. Washington, DC 20001-4413 Counsel for Amicus Curiae Genetic Alliance

Judy Deleon Jarecki-Black, Esq. Merial Limited 3239 Satellite Boulevard Duluth, GA 30096 Counsel for Amicus Curiae Merial Limited

William G. Gaede, III, Esq. McDermott, Will & Emery 275 Middlefield Road Suite 100 Menlo Park, CA 94025 Counsel for Amici Curiae Genomic Health et al.

Kent D. McClure, Esq. Animal Health Institute 1325 G Street, N.W. Suite 700 Washington, DC 20005 Counsel for Amicus Curiae Animal Health Institute

Aaron Stiefel, Esq. Kaye Scholer 425 Park Avenue New York, New York 10022 Counsel for Amicus Curiae Novartis Corp.

Kurt G. Calia, Esq. Covington & Burling 333 Twin Dolphin Drive Suite 700 Redwood Shores, CA 94065 Counsel for Amicus Curiae Pharmaceutical Research and Manufacturers of America

Jacqueline D. Wright-Bonilla, Esq. Foley & Lardner 3000 K Street, N.W. Suite 500 Washington, DC 20007 Counsel for Amici Curiae Rosetta Genomics, et al.

Mark R. Freeman, Esq. U.S. Department of Justice 950 Pennsylvania Avenue, N.W. Room 7644 Washington, D.C. 20530-0001 Counsel for Amicus Curiae United States of America

Ann M. McCrackin, Esq. University of New Hampshire School of Law 2 White Street Concord, NH 03301 Counsel for Amicus Curiae University of New Hampshire School of Law

Erika R. George, Visiting Professor of Law, Esq. Loyola University Chicago School of Law 25 East Pearson Chicago, IL 60611 Counsel for Amici Curiae Erika R. George and Kali N. Murray (e-mail service only; no longer at above address)

Christopher M. Holman, Esq. 5100 Rockhill Road Kansas City, MO 64110 Counsel for Amici Curiae Christopher Holman et al.

Bruce Vignery, Esq. AARP Foundation Litigation 601 E Street, NW Washington, DC 20049 Counsel for Amicus Curiae AARP

George A. Kimbrell, Esq. The International Center for Technology Assessment 660 Pennsylvania Avenue Suite 302 Washington, DC 20003 Counsel for Amici Curiae The International Center for Technology Assessment et al.

Andrew Chin, Esq. University of North Carolina School of Law 160 Ridge Road, CB #3380 Chapel Hill, NC 27599-3380 Counsel for Amici Curiae Scholars of Biotechnology Patent Law

Francis Pizzulli, Esq. 718 Wilshire Boulevard Santa Monica, CA 90401 Counsel for Amicus Curiae The Southern Baptist Convention (e-mail service only; no longer at above address)

Krista L. Cox, Esq. Universities Allied for Essential Medicines 2625 Alcatraz Avenue, #180 Berkeley, CA 94705 Counsel for Amicus Curiae Universities Allied for Essential Medicines (UPS service only)

Larry Frierson, Esq. The Law Offices of Larry Frierson 3265 Lake County Highway Calistoga, CA 94515 Counsel for Amici Curiae Cancer Council Australia and Luigi Palombi

Debra L. Greenfield, Esq. UCLA Center for Society and Genetics Box 957221, 1323 Rolfe Hall Los Angeles, CA 90095 Counsel for Amici Curiae The National Women’s Health Network et al.

Eileen M. Kane, Esq. Penn State Dickinson School of Law 328 Katz Building University Park, PA 16802 Counsel for Amicus Curiae Professor Eileen M. Kane

John L. Hendricks, Esq. Hitchcock Evert LLP 750 North St. Paul Street Suite 1110 Dallas, TX 75201 Counsel for Amici Curiae Canavan Foundation et al.