Reply Brief — Hospira, Inc., Petitioner v. Eli Lilly and Company

No. 19-1058

IN THE

Supreme Court of the United States

_________

HOSPIRA, INC.,

Petitioner,

v.

ELI LILLY AND COMPANY,

Respondent.

________

On Petition for a Writ of Certiorari

to the United States Court of Appeals for the

Federal Circuit

________

REPLY BRIEF IN SUPPORT OF

PETITION FOR A WRIT OF CERTIORARI

________

YUSUF ESAT

JENNER & BLOCK LLP

353 N. Clark Ave

Chicago, IL 60654

ADAM G. UNIKOWSKY

Counsel of Record

JENNER & BLOCK LLP

1099 New York Ave., NW

Suite 900

Washington, DC 20001

(202) 639-6000

aunikowsky@jenner.com

i

TABLE OF CONTENTS

TABLE OF AUTHORITIES ........................................... ii

ARGUMENT ....................................................................... 2

I. The

Federal

Circuit’s

Decision

Is

Inconsistent With Festo. .............................................. 2

II. This Court Should Grant Certiorari. .......................... 7

A. The

Federal

Circuit’s

decision

undermines the public notice function of

patents and prosecution records. .......................... 7

B. The Federal Circuit’s inconsistent

outcomes have resulted in mass confusion. ....... 11

CONCLUSION ................................................................. 13

ii

TABLE OF AUTHORITIES

CASES

Caraco Pharmaceutical Laboratories, Ltd. v.

Novo Nordisk A/S, 566 U.S. 399 (2012) .................... 10

Festo Corp. v. Shoketsu Kinzoku Kogyo

Kabushiki Co., Ltd., 535 U.S. 722 (2002) ............ 1, 3, 4

Norian v. Stryker Corp., 432 F.3d 1356 (Fed.

Cir. 2005) ....................................................................... 11

PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) ................ 10

1

In Festo Corp. v. Shoketsu Kinzoku Kogyo

Kabushiki Co., Ltd., 535 U.S. 722 (2002), this Court

held that when a patentee narrows a claim during

prosecution to overcome a patentability rejection, a

“court should presume that the patentee surrendered

all subject matter between the broader and the

narrower language” for purposes of the doctrine of

equivalents. Id. at 740. It further held, however, that

the patentee can overcome that presumption when “the

rationale underlying the amendment … bear[s] no more

than a tangential relation to the equivalent in

question.” Id.

That statement in Festo has spawned an unending

stream of litigation over whether the relationship

between an amendment and an equivalent is

“tangential,” leading to widespread confusion.

Eighteen years after Festo, it is now clear that the

Federal Circuit cannot sort out the scope of the

“tangential relation” exception on its own. This Court’s

guidance is sorely needed to clarify the “tangential

relation” exception and ensure it does not swallow the

presumption of prosecution history estoppel.

This case is the ideal vehicle to consider that issue.

The facts are undisputed and stark. Lilly could easily

have narrowed its claim to pemetrexed and its salts.

Instead, it chose to narrow its claim to one particular

pemetrexed salt: pemetrexed disodium. Now, it seeks

to avoid the consequence of that choice by expanding

its claim via the doctrine of equivalents to cover

competing products that are not pemetrexed disodium.

The doctrine of prosecution history estoppel is designed

for exactly this type of buyer’s remorse argument. The

2

Federal Circuit’s willingness to apply the “tangential

relation” exception is irreconcilable with Festo’s

reasoning and expands the “tangential relation”

doctrine beyond what the Festo Court could have

contemplated. And the Federal Circuit’s decision will

open the door to widespread manipulation of the patent

prosecution process, as patentees narrow their claims

to avoid patentability rejections and then expand them

during patent litigation under the doctrine of

equivalents.

Lilly offers no sound reason for denying review. It

does not dispute the outsized importance of prosecution

history estoppel in modern-day patent litigation. Nor

does it identify any factual disputes or any other

vehicle problem. Lilly characterizes the decision below

as a factbound application of Festo, but ignores large

swaths of Festo’s reasoning that are irreconcilable with

the Federal Circuit’s decision.

Lilly also claims that Hospira’s arguments conflict

with the arguments in the separate petition filed by Dr.

Reddy’s Laboratories, Ltd. (“DRL”). That is not so—

Hospira’s arguments are entirely consistent with

DRL’s arguments. The Court should grant certiorari in

both cases and consolidate them for oral argument.

ARGUMENT

I. The Federal Circuit’s Decision Is Inconsistent

With Festo.

Under Festo, this case should have been easy. To

rebut the presumption of prosecution history estoppel,

“[t]he patentee must show that at the time of the

amendment one skilled in the art could not reasonably

3

be expected to have drafted a claim that would have

literally encompassed the alleged equivalent.” 535 U.S.

at 741. It is plain that Lilly could reasonably have

drafted a claim that would have literally encompassed

the alleged equivalent. It could have simply said

“pemetrexed salts.”

Because Lilly rejected this

obvious option and instead chose to narrow its claim to

one

particular

pemetrexed

salt—pemetrexed

disodium—it should be estopped from rewriting its

claim to encompass all pemetrexed salts via the

doctrine of equivalents.

The Federal Circuit reached a contrary conclusion

based on its view that there was a “tangential relation”

between the amendment and the equivalent. But Festo

framed the “tangential relation” exception as an

example of a case where “one skilled in the art could

not reasonably be expected to have drafted a claim that

would have literally encompassed the alleged

equivalent”—not a freestanding exception that applies

even when the patentee can reasonably draft a claim

that would have encompassed the claimed equivalent.

535 U.S. at 741; see Pet. 16-17.

Festo’s explanation of the purpose of prosecution

history estoppel proves the point. Festo explained:

Prosecution history estoppel ensures that the

doctrine of equivalents remains tied to its

underlying purpose. Where the original

application once embraced the purported

equivalent but the patentee narrowed his claims

to obtain the patent or to protect its validity, the

patentee cannot assert that he lacked the words

to describe the subject matter in question. The

4

doctrine of equivalents is premised on language’s

inability to capture the essence of innovation,

but a prior application describing the precise

element at issue undercuts that premise. In that

instance the prosecution history has established

that the inventor turned his attention to the

subject matter in question, knew the words for

both the broader and narrower claim, and

affirmatively chose the latter.

535 U.S. at 734-35. Thus, Festo holds that an exception

to prosecution history estoppel is warranted in cases

involving “language’s inability to capture the essence of

innovation.” Id. This is plainly not such a case. Here,

the Federal Circuit concluded that what Lilly “actually

invented” was “an improved method of administering

pemetrexed.” Pet. App. 21a. If that is what Lilly

“actually invented,” it could have written the claim to

encompass all pemetrexed salts. Indeed, as the petition

pointed out, Lilly’s own prior patent defined

“pemetrexed” as “the stable salts, acids and free base

forms thereof.” Pet. 15 (quotation marks omitted).

Lilly’s decision to narrow the claim to pemetrexed

disodium in the patent at issue here reflected its own

strategic decision—not any imperfection in language

that warrants relaxing prosecution history estoppel.

Lilly has precious little to say in response. Lilly

entirely ignores the portion of Festo regarding

“language’s inability to capture the essence of

innovation.”

Pet. 21 (quotation marks omitted).

Instead, Lilly offers the conclusory assertion that when

the patentee is “focused on distinguishing prior art

unrelated to the equivalent in question,” that

5

necessarily means the patentee “could not reasonably

be expected” to have drafted a claim encompassing the

equivalent—even if the equivalent was foreseeable.

BIO 17-18. That cannot be right. If Lilly wanted its

claim to encompass all pemetrexed salts, it reasonably

could, and should, have narrowed its claim to the class

of pemetrexed salts, rather than gratuitously limiting

its claim to one specific pemetrexed salt.

Hospira’s petition offered an illustrative example.

A claim in a patent application recited “fruit,” and then,

in response to a rejection, the claim was amended to

“Red Delicious apples.” Anyone would infer that the

amendment excludes other types of apples. Otherwise,

the patentee would have just said “apples.” Yet, under

the Federal Circuit’s decision, a patentee could accuse

Honeycrisp apples of infringement, on the theory that

the patentee could have narrowed its claim to “apples”

to overcome the rejection—a seemingly absurd result,

given the patentee’s specific decision to narrow its

claim to “Red Delicious apples.” Pet. 18.

Rather than distinguishing this case from that

hypothetical, Lilly embraces the hypothetical—it

contends that the patentee could, indeed, assert that all

types of apples infringe, so long as the prior art did not

relate to other types of apples. BIO 18-19. If the Court

is troubled by the prospect that the doctrine of

equivalents would apply in that scenario, it should

grant certiorari and reverse.

Hospira’s petition also gave a second reason that

the Federal Circuit’s decision conflicts with Festo.

Hospira explained that the Federal Circuit’s legal

standard wrongly focuses on the reason for amending

6

the claim at all, rather than the reason for the

particular amendment that the patentee made—which

should have been the inquiry dictated by Festo. Pet.

19-20. Thus, the Federal Circuit should have asked:

why did Lilly use the words “pemetrexed disodium” in

its amendment?

Id.

Lilly’s explanation for its

amendment did not answer that question, because Lilly

did not explain why it added the word “disodium.” Pet.

20. And if the Federal Circuit had posed the right

question, it would have reached the right answer:

prosecution history estoppel applies. Id.

Tellingly, Lilly’s response brief completely ignores

this argument. Hospira will reiterate: there is no

justification for the Federal Circuit’s willingness to

apply the “tangential relation” exception absent any

explanation in the prosecution history record for the

particular words Lilly used.

Rather than address Hospira’s arguments on their

merits, Lilly contends that Hospira’s arguments

conflict with DRL’s arguments in DRL’s separate

petition in No. 10-1061. BIO 19. There is no conflict.

DRL argues that the “tangential relation” exception

applies “‘when an amendment adds multiple limitations

to a claim at the same time, and not all relate to an

examiner’s rejection.’” Id. (quoting DRL Pet. 18).

Nothing in Hospira’s petition is inconsistent with that

position—Hospira has not argued that the “tangential

relation” exception should never apply to foreseeable

equivalents, as Lilly claims. BIO 17.

Hospira’s argument simply addresses when the

“tangential relation” exception should not apply. It

should not apply where, as here, the patentee could

7

reasonably have narrowed its claim to what it now

claims it meant to patent. And it should not apply

where, as here, the patentee cannot give an explanation

for the actual language of its amendment. Lilly is

unable to provide any coherent response, grounded in

Festo, to these arguments. 1

II. This Court Should Grant Certiorari.

This case warrants Supreme Court review in view

of the practical importance of the “tangential relation”

exception to prosecution history estoppel, and in view

of the Federal Circuit’s confusion over the scope of that

exception.

A. The Federal Circuit’s decision undermines

the public notice function of patents and

prosecution records.

As the petition catalogued, the “tangential relation”

exception to prosecution history estoppel is a constant

source of litigation. Pet. 22-23. This litigation is so

common for an unfortunate reason: it is a common

tactic for patentees to artificially narrow a patent claim

in order to induce the Patent Office into allowing the

1 There is also no inconsistency between Hospira’s argument and

the argument in the petition in CJ CheilJedang Corp. v. ITC, No.

19-1062. That petition argues that if the prosecution history

record does not contain an “explicit and contemporaneous

explanation[]” (BIO 20), the presumption of prosecution history

estoppel cannot be rebutted. Here, likewise, as Hospira’s petition

explained, the absence of a contemporaneous explanation for the

phrase “pemetrexed disodium” should be fatal to Lilly’s argument.

8

claim, and then re-expand the claim after the fact via

the doctrine of equivalents.

The Federal Circuit’s decision will make this

gamesmanship worse. The Federal Circuit permitted

patentees to avoid prosecution history estoppel under

the “tangential relation” exception even when it is

absolutely clear that the patentee could have narrowed

its claim so as to encompass the claimed equivalent, and

even without an explanation in the prosecution history

for the particular language of the amendment. As a

result, if the Federal Circuit’s decision stands, avoiding

prosecution history estoppel will be trivially easy. The

patent applicant need only write carefully-worded, selfserving statements regarding the reasons for its

amendments so it may argue after the fact that those

reasons are “tangential” to an equivalent. Pet. 25. The

Court should not countenance such bait-and-switch

tactics.

The Federal Circuit’s decision profoundly

undermines the public notice function of patents and

prosecution history records. In a properly functioning

patent system, the Patent Office, and members of the

public, should be able to infer that when a claim is

rejected in view of prior art, and the patentee

addresses that rejection by narrowing a claim from a

class of compounds to a single salt compound, it follows

that the claim does not, in fact, stretch beyond that salt

compound. But under the Federal Circuit’s decision,

they cannot. Instead, to assess the claim scope that

may be regained through future litigation, they must

start with the actual claim language, and then deduce

all of the myriad broader claims that the patentee could

9

have asserted based on the patentee’s arguments made

to the Patent Office. For instance, here, Hospira was

apparently required to start with the claim language—

“pemetrexed disodium”—and then deduce that Lilly

could have prosecuted a broader claim covering other

pemetrexed salts without risking a patentability

rejection.

That holding will increase uncertainty

regarding the scope of patent claims and hamper

competitors’ ability to design around patents.

In response to these public notice concerns, Lilly

claims that Hospira seeks to overrule Festo, or perhaps

even the doctrine of equivalents as a whole. BIO 25-27.

Not so. Hospira merely asks that the Court follow

Festo’s own reasoning, which is irreconcilable with the

Federal Circuit’s expansion of the “tangential relation”

exception.

Lilly also claims that Hospira’s position would

undermine the public notice function of the prosecution

record by requiring courts to “consider hypothetical

alternative amendments,” that can be “conjure[d] up,”

as opposed to the “objective record.” BIO 27. That is

also incorrect. As Festo explained, prosecution history

estoppel should apply when a patentee could

reasonably have been expected to draft claim language

encompassing the claimed equivalent—not merely

when such language can be “conjure[d] up.” Id. At a

minimum, prosecution history estoppel should apply

where the “objective record” contains no explanation

for the particular words the patentee used. Here, the

“objective record” does not explain why Lilly added the

word “disodium”—and as such, Lilly has not met its

10

burden of rebutting the presumption of prosecution

history estoppel.

Finally, Lilly argues that the Hatch-Waxman

context of this case undermines Hospira’s concern

about public notice. BIO 28. This is a red herring.

First, the doctrine of prosecution history estoppel

applies across patent law; it is not specific to HatchWaxman cases. And the Federal Circuit’s application

of the “tangential” exception in this case did not turn on

Hatch-Waxman.

Second, to the extent Hatch-Waxman is relevant,

the public notice concerns raised by Hospira are

especially salient in the Hatch-Waxman context. The

Hatch-Waxman Amendments are intended to

encourage generic drug competition. Under HatchWaxman, generic drugs can gain FDA approval if they

are bioequivalent to a reference drug that has already

been approved by the FDA. See PLIVA, Inc. v.

Mensing, 564 U.S. 604, 612 (2011). This scheme

promotes the inexpensive manufacturing of generic

drugs. See id. at 612-13. But “[b]ecause the FDA

cannot authorize a generic drug that would infringe a

patent,” “a company filing an [Abbreviated New Drug

Application] must assure the FDA that its proposed

generic drug will not infringe the brand’s patents.”

Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566

U.S. 399, 405-06 (2012). Resultant patent litigation can

grind the approval process to a halt. See id. at 408-09.

It is precisely in that context in which clarity in the

meaning of patent claims is most needed—and in which

the Federal Circuit’s expansion of the “tangential

relation” exception is most harmful.

11

Moreover, Lilly’s position implies that any drug that

is bioequivalent to a reference drug for Hatch-Waxman

purposes infringes a patent on that drug under the

doctrine of equivalents. That position would render

Hatch-Waxman ineffective in facilitating approval of

generic drugs—because the mere filing of an

application asserting bioequivalence to a reference

drug would be a confession of infringement of a patent

on the reference drug. It is no surprise that no court

has ever adopted this position.

B. The

Federal

Circuit’s

inconsistent

outcomes have resulted in mass confusion.

This Court’s intervention is necessary because the

Federal Circuit has shown that it will not clarify the

scope of the “tangential relation” exception on its own.

The Federal Circuit concluded that prosecution

history estoppel did not apply because the purpose of

Lilly’s amendment was to distinguish pemetrexed salts

from other antifolates. Thus, because Lilly could have

overcome the prior art by narrowing its claim to

“pemetrexed salts,” Lilly would not be estopped from

expanding its claim to other pemetrexed salts via the

doctrine of equivalents. Yet, as the petition explained,

the Federal Circuit has repeatedly rejected that exact

argument. In other cases, the court has “held the

patentees to the scope of what they ultimately claim,

and we have not allowed them to assert that claims

should be interpreted as if they had surrendered only

what they had to.” Pet. 28-29 (quoting Norian v.

Stryker Corp., 432 F.3d 1356 (Fed. Cir. 2005)).

12

Lilly asserts that in “all cases,” the Federal Circuit

looks to the “reason for the amendment,” with different

factual records yielding different outcomes. BIO 24.

But in every case in this line, the ultimate legal

question was the same. In every case, the court’s

analysis of the “reason for the amendment” established

that the patentee did not need to surrender the

equivalent in question to overcome the prior art. In

this case, for example, the Federal Circuit’s analysis

established that Lilly did not need to surrender

pemetrexed ditromethamine to overcome Arsenyan. In

every case, the Federal Circuit was faced with the

same question: if the “reason for the amendment”

establishes that the patentee did not need to surrender

the equivalent to overcome the prior art, is that enough

to defeat the presumption of prosecution history

estoppel? In some decisions, including the decision

below, the Federal Circuit answered “yes”; in others,

the Federal Circuit answered “no.” The Federal

Circuit’s inability to provide a consistent answer to this

important question of patent law is further grounds for

granting review. Pet. 29-30.2

*

*

*

2 Lilly claims that Hospira’s petition is inconsistent with DRL’s

petition because Hospira’s petition focused on prior inconsistent

cases, while DRL’s petition cited both prior consistent and prior

inconsistent cases. BIO 21. Lest there was any confusion, Hospira

agrees with DRL that the Federal Circuit has made the same

mistake in several cases, not just this one. See Pet. 30 (noting that

decisions on the “tangential relation” exception “turn on the

random draw of Federal Circuit panel”).

13

The Federal Circuit’s decision is wrong, has

negative practical consequences, and deepens confusion

over the scope of the “tangential relation” exception.

The Court should grant certiorari to restore order in

this important area of patent law.

CONCLUSION

The petition for a writ of certiorari should be

granted.

Respectfully submitted,

YUSUF ESAT

JENNER & BLOCK LLP

353 N. Clark Ave

Chicago, IL 60654

ADAM G. UNIKOWSKY

Counsel of Record

JENNER & BLOCK LLP

1099 New York Ave., NW

Suite 900

Washington, DC 20001

(202) 639-6000

aunikowsky@jenner.com