Supplemental Brief — Hikma Pharmaceuticals USA Inc., et al., Petitioners v. Vanda Pharmaceuticals Inc.

No. 18-817

In the Supreme Court of the United States

__________

HIKMA PHARMACEUTICALS USA INC., AND WEST-WARD

PHARMACEUTICALS INTERNATIONAL LTD., N/K/A HIKMA

PHARMACEUTICALS INTERNATIONAL LTD., PETITIONERS

v.

VANDA PHARMACEUTICALS INC., RESPONDENT

__________

ON PETITION FOR A WRIT OF CERTIORARI TO THE UNITED

STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT

__________

SUPPLEMENTAL BRIEF FOR PETITIONERS

__________

STEFFEN N. JOHNSON

ADAM W. BURROWBRIDGE

Wilson Sonsini

Goodrich & Rosati, PC

1700 K Street, N.W.

Washington, DC 20006

(202) 973-8800

sjohnson@wsgr.com

MICHAEL W. MCCONNELL

Wilson Sonsini

Goodrich & Rosati, PC

650 Page Mill Road

Palo Alto, CA 94304

CHARLES B. KLEIN

Counsel of Record

ANDREW C. NICHOLS

EIMERIC REIG-PLESSIS

SHARON LIN

Winston & Strawn LLP

1700 K Street N.W.

Washington, DC 20006

(202) 282-5000

cklein@winston.com

Counsel for Petitioners

PARTIES TO THE PROCEEDINGS

The Rule 29.6 Statement included in the petition

for a writ of certiorari, as updated by the brief in opposition for respondents, remains accurate.

ii

TABLE OF CONTENTS

Page

INTRODUCTION ........................................................ 1

ARGUMENT ................................................................ 4

CONCLUSION .......................................................... 11

iii

TABLE OF AUTHORITIES

Page(s)

Cases

Alice Corp. Pty. Ltd. v. CLS Bank, Int’l,

573 U.S. 208 (2014) ................................................ 3

Athena Diagnostics, Inc. v. Mayo

Collaborative Servs., LLC,

927 F.3d 1333 (Fed. Cir. 2019)............... 2, 3, 10, 11

Bilski v. Kappos,

561 U.S. 593 (2010) .................................... 2, 3, 5, 9

Caraco Pharm. Labs., Ltd. v. Novo

Nordisk A/S,

566 U.S. 399 (2012) .......................................... 9–10

Diamond v. Diehr,

450 U.S. 175 (1981) ................................................ 6

Funk Brothers Seed Co. v. Kalo

Inoculant Co.,

333 U.S. 127 (1948) ................................................ 6

Helsinn Healthcare S.A. v. Teva Pharm.

USA, Inc.,

139 S. Ct. 628 (2019) .......................................... 7–8

Mayo Collaborative Services v.

Prometheus Laboratories, Inc.,

566 U.S. 66 (2012) .........................................passim

Natural Alternatives Int’l, Inc. v.

Creative Compounds, LLC,

918 F.3d 1338 (Fed. Cir. 2019)....................... 10–11

Parker v. Flook,

437 U.S. 584 (1978) ............................................ 5, 6

iv

Seminole Tribe v. Florida,

517 U.S. 44 (1996) .................................................. 5

Statutes

21 U.S.C. § 355(b)(2)(A) ............................................... 9

21 U.S.C. § 355(j)(2)(A)(vii) ......................................... 9

21 U.S.C. § 355(j)(2)(A)(vii)(IV) ................................... 9

35 U.S.C. § 101..................................... 6, 7, 8, 9, 10, 11

35 U.S.C. § 102............................................................. 7

35 U.S.C. § 103............................................................. 7

35 U.S.C. § 112............................................................. 7

35 U.S.C. § 273............................................................. 9

Other Authorities

Antonin Scalia & Bryan A. Garner,

Reading Law (2012) ............................................... 8

Rule 10(c) ..................................................................... 9

INTRODUCTION

As the government’s brief dramatically illustrates,

there is a raging debate over the scope and wisdom of

this Court’s unanimous decision just seven years ago

in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). That decision set

forth a general approach to determining the patentability of methods that consist merely of natural laws

and recommendations to doctors about dosage levels

of previously existing drugs. An ambiguous dictum in

Mayo suggested that “a typical patent on * * * a new

way of using an existing drug” might present a different case. Br. 13 (quoting 566 U.S. at 87). The Court

in Mayo observed that the steps in such a patent

might be “less conventional” than the dosage recommendations at issue there. 566 U.S. at 87.

As the government explains, the majority below

read that dictum in a manner that conflicts with the

decision’s overall “logic,” which “arguably implies the

opposite.” Br. 8. Although Mayo’s holding suggests

that Vanda’s “concrete treatment step” is “conventional activity because it is not independently new”

(Br. 13, 14), the majority below exploited Mayo’s dictum to effectively nullify the Mayo framework in cases involving method-of-treatment patents.

As the government further explains, the resulting

“uncertainty” has “considerable practical consequences for various types of medical innovations,” “tens of

thousands” of method-of-treatment claims, and the

PTO’s “ability to provide direction.” Br. 15, 9, 16.

The government thus agrees that the decision below

“implicates important and recurring questions” that

“warrant[] review in an appropriate case.” Br. 8.

2

There are three basic ways for the Court to resolve

the alleged tension between Mayo’s holding and its

dictum. First, it could reaffirm Mayo’s holding and

make clear that it means what it says, notwithstanding the dictum. Second, it could repudiate Mayo, as

the government prefers. This would also entail repudiating Bilski v. Kappos, 561 U.S. 593 (2010), which

the government regards as the original sin in this area of law. Third, it could embrace the split-the-baby

approach. This would entail confining Mayo to its

facts and defining method-of-treatment patents as

categorically patentable without regard to Mayo’s

second step—an odd approach in that, as the government then noted, Mayo itself involved a “method

of treating a patient.” U.S. Mayo Br. I (No. 10-1150).

The Court has before it two relevant petitions:

this one, and one in Athena Diagnostics, Inc. v. Mayo

Collaborative Services., LLC (No. 19–430). This case

involves a method-of-treatment patent; Athena involves a method-of-diagnosis patent. The first approach—reaffirming Mayo and Bilski—would entail

reversing in this case and affirming in Athena. The

second approach—repudiating Mayo and Bilski—

would entail affirming in this case and reversing in

Athena. The third approach—categorically distinguishing between method-of-diagnosis and method-oftreatment claims—would entail affirming in both.

The government says Athena is a better “vehicle.”

Br. 8, 21. But that claim is predicated entirely on the

government’s questionable view of the merits—

namely, that Mayo should be repudiated. Br. 8. On

that view, the government suggests that a decision

here would not make a “practical difference.” Br. 8,

9. But all that the government means by this is that,

under its view of the law, the decision below would be

3

affirmed—as if there were some rule that this Court

should only grant certiorari to reverse. On the same

reasoning, if this Court reaffirms Mayo, there will be

no “practical difference” in Athena.

It thus turns out that the Solicitor General’s “vehicle” objection is not a “vehicle” objection at all; it is

entirely merits-based, and it is untenable. It is the

majority decision below, not Athena, that breaks from

this Court’s precedents. Indeed, the government all

but admits that Hikma would prevail if “Mayo’s approach” were applied as this Court applied it in Mayo.

Br. 12–14.

Further, virtually every argument pressed by the

government was rejected just seven years ago in

Mayo—unanimously. The Court has since reaffirmed

Mayo’s two-step framework—unanimously.

Alice

Corp. Pty. Ltd. v. CLS Bank, Int’l, 573 U.S. 208

(2014). The suggestion (Br. 8) that Mayo, Bilski, and

Alice reconceptualized patent-eligibility law rests on

a highly selective reading of precedent. And it is the

majority ruling below that threatens to make patentability for method-of-treatment claims “depend simply on the draftsman’s art,” thus rendering this Court’s

“bright-line” “prohibition against patenting laws of

nature” a “dead letter.” Mayo, 566 U.S. at 72, 89.

For all these reasons, this case is the better vehicle. Alternatively, the Court should review both cases, which would enable it to consider both a methodof-treatment case (this one) and a method-ofdiagnosis case (Athena) in resolving the alleged tension between Mayo’s holding and dictum. Unless the

Court is certain that it unanimously erred in Mayo

and Alice, however, it makes little sense to review only Athena. Certiorari should thus be granted.

4

ARGUMENT

1. According to the government, the majority below “marshaled very weighty evidence” that its ruling

was faithful to Mayo. Br. 14–15. In support, however, the government quotes just one half-sentence from

Mayo—its “language” distinguishing “‘a typical patent on a new drug or a new way of using an existing

drug.’” Br. 14 (citations omitted).

This language warrants due consideration. But it

is dictum, and ambiguous dictum at that. The halfsentence does not explain what makes method-oftreatment claims “typical,” and it does not suggest

that method-of-treatment patents are exempt from

case-specific analysis of whether they genuinely claim

new or conventional uses of old drugs. In fact, the

same paragraph elsewhere suggests that what might

distinguish another patent are “less conventional”

features than the dosage steps there (566 U.S. at 87)

—a step-two analysis.

This case is almost identical to Mayo. Vanda’s

claims call for administering a prior art drug for a

prior art purpose, and they cover any dosage “of 12

mg/day or less”—i.e., every possible reduction from

the prior art dosage of 12–24 mg/day. Pet. 11–12; cf.

Mayo, 566 U.S. at 72, 78 (involving “processes that

help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether

a given dosage level is too low or too high,” where

“doctors used [the] drugs to treat patients suffering

from [those] disorders long before anyone asserted

these claims”). This case thus provides an opportunity to clarify what Mayo’s dictum means—i.e., when

methods of using existing drugs are “new”—and

whether Mayo implicates method-of-treatment claims

5

that “apply a natural law using only routine and conventional steps.” Pet. i.

Further, the government admits that Mayo’s “logic” and “reasoning” support the dissent below. Br. 8,

13–14; see also Br. 8, 14 (the opinions below track

Mayo’s “internal inconsistency,” “conflicting signals,”

and “conflicting strands”). For example, the government acknowledges that if, as in Mayo, “the metabolizing of a drug” is “an ‘entirely natural process[]’”

and “precise mathematical correlations” are “‘laws of

nature,’” “the same would arguably be true” here. Br.

12, 13. Further, the government states that while

“Vanda’s patent concludes with a concrete treatment

step,” “the Court’s reasoning in Mayo” suggests that

it might well “be discounted as routine, conventional

activity.” Br. 13–14.

Unlike “dicta,” a decision’s “rationale” is binding;

“it is not only the result but also those portions of the

opinion necessary to that result by which [the Court

is] bound.” Seminole Tribe v. Florida, 517 U.S. 44,

66–67 (1996). That makes the government’s merits

analysis quite untenable, except as a disguised call

for overruling Mayo.

2. More broadly, the government contends that

Mayo and Bilski “recast decades of precedent” and

calls for a return to the good old days. Br. 17. This is

a tendentious account of precedent.

Most remarkably, the government never mentions

Parker v. Flook, 437 U.S. 584 (1978), which Mayo

called “controlling.” 566 U.S. at 80. As Flook held,

“[t]he notion that post-solution activity, no matter

how conventional or obvious in itself, can transform

an unpatentable principle into a patentable process

exalts form over substance.” 437 U.S. at 590. Be-

6

cause “[a] competent draftsman could attach some

form of post-solution activity to almost any [natural

phenomenon],” “the discovery of [a natural] phenomenon cannot support a patent unless there is some

other inventive concept in its application.” Id. at 590,

594; see Mayo, 566 U.S. at 81–82 (the Flook “steps”

were “‘well known,’” not “inventive”). Likewise, Diamond v. Diehr, 450 U.S. 175 (1981)—another decision

that Mayo deemed “controlling”—taught that § 101

“‘cannot be circumvented by attempting to limit the

use of the formula to a particular technological environment’ or adding ‘insignificant postsolution activity.’” 566 U.S. at 80, 73 (quoting Bilski, 561 U.S. at

610–611 ((quoting Diehr, 450 U.S. at 191–192)). Yet

the government never mentions this portion of Diehr.

The government also implies that the patent in

Funk Brothers Seed Co. v. Kalo Inoculant Co., 333

U.S. 127 (1948), claimed only a natural phenomenon:

“the tendency of particular bacteria to inhibit other

bacterial species’ growth.” Br. 11. The claim there,

however, required “aggregation of select strains of the

several species into one product”—i.e., “an application

of that newly-discovered natural principle.” 333 U.S.

at 131. The claim was invalidated because this “simple step” lacked creativity, and an application must

not only be “new and useful,” but “also satisfy the requirements of invention or discovery.” Id. at 132, 131.

Flook, Funk Brothers, Diehr, and “[o]ther cases”

confirm that Mayo did not create its two-step framework out of whole cloth. Mayo, 566 U.S. at 82. And

Mayo itself rejected “the Government[’s] argu[ment]

that virtually any step beyond a statement of a law of

nature itself should transform an unpatentable law of

nature into a potentially patentable application,” noting that it “would make the ‘law of nature’ exception

7

to § 101 patentability a dead letter.” Id. at 89. Thus,

Vanda’s claims are not patent-eligible simply because

they “‘claim[] an application of [a natural] relationship’” by requiring “administration of a specific dosage.” Br. 7 (quoting Pet. App. 32a).

3. Indeed, nearly every argument in the government’s brief was made and rejected in Mayo.

First, the government complains that Mayo’s second step “causes the Section 101 inquiry to overlap”

with “the novelty and nonobviousness requirements

of Sections 102 and 103.” Br. 18, 19. Likewise, in

Mayo the government argued that “the barrier to patentability is imposed not by Section 101 but by 35

U.S.C. § 102 and § 103.” U.S. Mayo Br. 11. Recognizing that these inquiries “might sometimes overlap,”

however, the Court explained that “shift[ing] the patent-eligibility inquiry entirely to these later sections

risks creating significantly greater legal uncertainty,

while assuming that those sections can do work that

they are not equipped to do.” 566 U.S. at 90. The

Court thus “decline[d] the Government’s invitation to

substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101,” reaffirming that

§ 101 poses a threshold bar on conventional claims.

Id. at 91.

Nor is that approach “atextual.” Br. 8. Rather, 35

U.S.C. § 101 requires an “invention” or “discovery”

that is “new and useful.” Despite decades of opportunity, Congress—which made major revisions to the

Patent Act in 1952 and 2011—has not disturbed the

Court’s settled framework for analyzing patent eligibility. See Helsinn Healthcare S.A. v. Teva Pharm.

USA, Inc., 139 S. Ct. 628, 634 (2019) (“In adopting

the language used in [an] earlier act, Congress ‘must

8

be considered to have adopted also the construction

given by this Court to such language[.]’” (citation

omitted); Antonin Scalia & Bryan A. Garner, Reading

Law 331 (2012) (“Legislative revision of law clearly

established by judicial opinion ought to be by express

language or unavoidably implied contradiction. We

know of no case to the contrary.”).

Second, the government stresses that iloperidone

is “human-made,” and that “the relevant distinction

under Section 101” is “between products of nature”

and “human-made inventions.” Br. 11 (internal quotations omitted). Similarly, in Mayo it argued that

thiopurine drugs are “products of human ingenuity,”

and that “[t]he reaction of the human body to thiopurine drugs is not an unaltered ‘law of nature.’” U.S.

Mayo Br. 9, 20. But the Court, aware that thiopurine

was “human-made,” held that the claimed “relationships between concentrations of certain metabolites

in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm”

were “laws of nature.” 566 U.S. at 77.

Third, the government criticizes treating “highly

specific relationships” like dosing regimens as “laws

of nature.” Br. 12. So too in Mayo. U.S. Mayo Br. 23

(“‘laws of nature’” should not “be defined at that level

of particularity”). The Court, however, refused to

rule on the basis that “the particular laws of nature

that its patent claims embody are narrow and specific,” explaining: “[O]ur cases have not distinguished

among different laws of nature according to whether

or not the principles they embody are sufficiently

narrow.” Mayo, 566 U.S. at 88-89 (collecting cases).

In sum, the Court’s analysis in Mayo was no oversight. The Court carefully considered the very points

9

pressed again here, unanimously rejecting them

based on precedent going back decades and in some

cases more than 150 years. The government’s admission that Mayo’s “logic” and “reasoning” support the

dissent below (Br. 8, 15) is thus a powerful reason to

grant review. Rule 10(c) (review is warranted where

a federal court of appeals “has decided an important

federal question in a way that conflicts with relevant

decisions of this Court”).

4. Citing the Hatch-Waxman Act (Br. 9–10), the

government also argues that Congress contemplated

“patents that ‘claim[] a use for [a] drug.’” 21 U.S.C.

§ 355(b)(2)(A) and (j)(2)(A)(vii). Nothing in HatchWaxman, however, purports to alter substantive patentability requirements, much less make method-oftreatment claims categorically patent-eligible. Cf.

Bilski, 561 U.S. at 608 (“while [35 U.S.C.] § 273 appears to leave open the possibility of some business

method patents, it does not suggest broad patentability of such claimed inventions”). Rather, the statute

contemplates that defendants will raise validity defenses in both their “Paragraph IV” certifications and

court. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV).

Whether an eligibility defense carries the day will

thus turn on the specific facts of the individual case.

Where a method-of-treatment patent either is not “directed to” natural laws (Mayo’s first step) or adds an

“inventive concept” (Mayo’s second step), it will satisfy § 101. Patentees might satisfy § 101, for example,

where they claim new methods of combining drugs to

treat diseases not previously treated by the drugs.

Cf. Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S,

566 U.S. 399, 409 (2012) (involving a patent that

“claims a ‘method for treating [diabetes by] administering * * * repaglinide in combination with metfor-

10

min’” (alterations in original)). As with other types of

patents, however, whether method-of-treatment patents satisfy § 101 turns on case-by-case application

of Mayo’s two-step framework.

5. The government identifies no actual “vehicle”

problem barring review. Br. 8. It references the prevailing “uncertainty” and “confusion” in this area of

the law no fewer than five times. Br. 8, 15, 16, 21, 22.

Four more times, it notes that the proper § 101 analysis is “unclear.” Br. 9, 10, 13, 14. And it candidly

explains that the split between the majority and dissent below both is attributable to Mayo’s “conflicting

signals” and “implicates important and recurring

questions” that “warrant[] review in an appropriate

case.” Br. 8.

The government offers just one reason why this is

not that case—its view that the “majority reached the

correct result.” Br. 21. As shown above, however, the

Court would much more likely reverse. The government’s admission that Mayo’s unanimous “logic” and

“reasoning”—the binding stuff—support the dissent

below (Br. 8, 13–14) provides ample reason to doubt

its assessment of the merits. Not surprisingly, the

petitioners in Athena (like the government here) advance mainly arguments unanimously rejected in

Mayo. E.g., Reply Br. for Petitioners 2 (No. 19–430)

(stressing “the role of novel man-made molecules in

method claims” and contending that the Federal Circuit used the wrong “level of abstraction”). And even

if the Court affirmed in this case, the decision would

end the uncertainty affecting “various types of medical innovations” and “tens of thousands” of method-oftreatment patents (Br. 15, 9)—patents the Federal

Circuit continues to uphold at Mayo’s first step. E.g.,

Natural Alternatives Int’l, Inc. v. Creative Com-

11

pounds, LLC, 918 F.3d 1338, 1344, 1345 (Fed. Cir.

2019) (“[t]hese are treatment claims and as such they

are patent eligible” (citing the decision below)).

Denying certiorari here, moreover, would open the

door to “drafting effort[s] designed to monopolize the

law[s] of nature.” Mayo, 566 U.S. at 77. Virtually

any “diagnosis” claim can now avoid § 101 scrutiny by

including “an instruction to doctors to apply the applicable laws when treating their patients.” Id. at 79.

The claim in Mayo, for example, could have survived

under the majority opinion below if, rather than reciting that a certain metabolite level “indicates a need

to” adjust the dosage “subsequently administered” to

the patient, it had expressly required administering a

different dose. As the dissent below recognized, however, “requiring a dosage instead of indicating a dosage” adds only “a conventional application of th[e]

natural law.” App. 49a–50a. And allowing clever

draftsmanship to secure patent-eligibility would render the “bright-line” “prohibition against patenting

laws of nature” a “dead letter.” Mayo, 566 U.S. at 89.

The Court should therefore take this case—not

Athena, which faithfully applies this Court’s precedent. Alternatively, the Court should review both

cases. But review should not be denied here because,

on account of the government’s policy preferences and

continued opposition to Mayo, it views the prospect of

reversal here as sub-“optimal.” Br. 8.

CONCLUSION

For the foregoing reasons, and those stated in the

petition and reply, certiorari should be granted.

12

Respectfully submitted.

STEFFEN N. JOHNSON

ADAM W. BURROWBRIDGE

Wilson Sonsini

Goodrich & Rosati, PC

1700 K Street, N.W.

Washington, DC 20006

(202) 973-8800

sjohnson@wsgr.com

MICHAEL W. MCCONNELL

Wilson Sonsini

Goodrich & Rosati, PC

650 Page Mill Road

Palo Alto, CA 94304

CHARLES B. KLEIN

Counsel of Record

ANDREW C. NICHOLS

EIMERIC REIG-PLESSIS

SHARON LIN

Winston & Strawn LLP

1700 K Street N.W.

Washington, DC 20006

(202) 282-5000

cklein@winston.com

Counsel for Petitioners

DECEMBER 2019