Baxalta Incorporated et al v. Genentech, Inc. et al
Filing
262
OPINION & ORDER denying 41 MOTION for Preliminary Injunction Signed by Judge Timothy Belcher Dyk on 8/7/2018. (nmf)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
BAXALTA INCORPORATED and
BAXALTA GMBH,
Plaintiffs,
Civil Action No. 17-509-TBD
v.
GENENTECH, INC. and CHUGAI
PHARMACEUTICAL CO., LTD.,
Defendants.
OPINION & ORDER
On May 4,2017, Baxalta Inc. and Baxalta GrnbH (together, “Baxalta”) brought suit
against Genentech, Inc. and Chugai Pharmaceutical Co., Ltd., alleging infringement of U.S.
Patent No. 7,033,590 (“the ‘590 patent”) by the manufacture, use, sale, oiler to sell, and
importation of an antibody used to treat hemophilia A and known as emicizurnab or ACE9IO,
marketed under the brand name Hemlibra. On December 14, 2017, Baxalta moved for a
preliminary injunction barring further sales or offers to sell Hemlibra in the United States, with
exceptions for certain patients. In addition to two rounds of briefing, the Court held an
evidentiary hearing on Baxalta’s motion on June 13 and 14, 2018, and heard oral argument on
July 2, 2018. Baxalta having failed to meet its burden for showing the propriety of preliminary
injunctive relief, the motion for a preliminary injunction is DENIED. This opinion constitutes
the Court’s findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure
52(a).
BACKGROUND
1. PROCEDURAL FIIsT0RY
Baxalta filed its complaint on May 4,2017, alleging infringement of the ‘590 patent.
Compl. ¶j 37—51, ECF No. 1. Genentech answered on June 30, denying Baxalta’s allegations
and counterclaiming for declaratory judgment of noninfringement and invalidity. Answer &
Counterci.
JJ 37—51,
120-49, ECF No. 9. With the Court’s leave, Baxalta has since amended its
complaint to add allegations of willftilness. 1st Am. Compl.
¶ 37-44,
60—65, ECF No. 239.
On December 14, 2017, Baxalta moved for a preliminary injunction against Genentech
(but not Chugai).’ Mot. Prelim. Inj. 2, ECF No. 41; Prop. Prelim. lnj. Order I, ECF No. 42-1.
Although Baxalta initially asserted seven claims of the ‘590 patent, Bax. Mem., at v, ECF
No. 42, it later filed notice that it would assert only claim I for purposes of this motion, Notice 1,
ECF No. 106.
On May 4, 2018, this action was reassigned to the undersigned, sitting by designation.
Genentech thereafter filed its opposition to Baxalta’s motion, Gen. Mem., ECF No. 154, and
Baxalta filed its reply, Bax. Reply, ECF No. 180. A group of potentially affected hemophilia
patients, Patients for Access to Advanced 1-lemophilia Therapy (PAAHT), filed a brief as amicus
curiae in opposition to Baxalta’s motion. Amicus Br., ECF No. 190. Finally, the parties filed
supplemental letters concerning the claim-construction issues bearing on Baxalta’s motion. Gen.
Ltr., ECF No. 201; Bax. Ltr., ECF No. 202.
Chugai is a Japanese company that invented and manufactures Hemlibra in Japan. See, e.g.,
Yamaguchi Dccl. ¶ 2, 5, ECF No. 20. Hemlibra is then eventually shipped to the United States
and sold by Genentech. See Id. ¶ 7, 10. Chugai previously moved to dismiss for lack of personal
jurisdiction. Mot. Dismiss, ECF No. 19. The parties have resolved this motion by stipulation
approved by the Court. See Stipulation & Prop. Order, ECF No. 220; July 2,2018, Mm. Entry.
2
The Court held a two-day evidentiary hearing on Baxalta’s motion on June 13 and 14,
2018. See Tr., ECF Nos. 214—15. The Court heard oral argument on the motion on July 2, 2018.
The parties then submitted proposed findings of fact and
See Oral Arg. Tr., ECF No. 229.
conclusions of law, as well as replies thereto. See Bay. Prop. F. & C., ECF No. 230; Gen. Prop.
F. & C.. ECF No. 232; Bax. Reply F. & C.. ECF No. 242; Gen. Reply F. & C.. ECF No. 244.
The parties submitted a list of exhibits to be included in the prelirninary-inunction record and
their objections thereto. See Joint Ltr., ECF No. 245.
II. TREATING HEMOPHILIA
A
The body stops bleeding by relying on blood coagulation, also known as clotting, which
is accomplished through a cascade of reactions between proteins, including those proteins known
as cloning factors. See Aledort Deel.
¶J
13—14, ECF No. 46; Sheehan DecI.
J 35.
ECF No. Ill.
Several of these factors are identified by Roman numerals, e.g., Factor I or Factor IX, and when
activated are identified with an appended a, e.g.. Factor IXa. Aledort Dccl.
¶
13. The relevant
steps in this clotting cascade here involve the coming together of Factor Villa and Factor IXa.
See Id. These two activated factors form a complex, which in turn activates Factor X. See Id;
Sheehan DecI.
¶ 36.
Several steps later, the cascade yields a protein known as fibrin, and a blood
clot is formed. See Aledort Dccl.
¶
13; Sheehan Dccl.
¶ 37—39.
Hemophilia A is a genetic disorder in which Factor VIII is reduced, defective, or absent.
See Aledort Dccl.
¶
14; Sheehan Dccl.
¶ 42.
This amounts to a roadblock in the clotting cascade,
and hemophilia A patients therefore suffer from a reduced ability to form quick and effective
bLood clots. Aledort Dccl.
¶
14; Sheehan Dccl.
¶ 42.
Hemophilia A can be classified as mild,
moderate, or severe based on the level of Factor VIII activity. See Sheehan Dccl.
3
¶ 43.
A common treatment for hemophilia A patients is infusion with a Factor VIII
replacement, either natural or synthetic. Aledort DecI.
¶
14; Callaghan Dee!.
J
15, EUF No. 109.
Factor VIII replacement therapy can be administered either as an ongoing prophylactic therapy
and/or on-demand to treat bleeding episodes. See Tr. 205:24—206:13. Baxalta’s Factor VIII
therapies include two products at issue here: Advate and Adynovate. See Bakewell Dccl.
¶ 33,
ECF No. 43; Tr. 299:8—14.
However, up to 35% of patients with hemophilia A develop Factor VIII inhibitors,
antibodies produced by the immune system that block the effect of the Factor VIII replacement.
See Tr. 163:21—22; Aledort Dccl.
¶
15; Young Decl.
inhibitor patients. See, e.g., Aledort DecI.
¶
¶ 20,
ECF No. 110. These are known as
16. Prior to the introduction of 1-lemlibra, there had
been two approaches to treatment of inhibitor patients. Somewhere between 40% and 70% of
inhibitor patients (who cannot receive Factor VIII therapy) are able to build up a tolerance for
Factor VIII therapy through routine injection of the factor in a therapy known as immune
tolerance induction (ITI). See Aledort DecI.
¶
16; Young DecI.
¶ 22—23.
III requires daily
infusion of Factor VIII for months or even years before it is clear whether it has been successful.
Callaghan DecI.
¶
16; Young DecI.
¶ 22.
If inhibitor patients are unable to achieve such a
tolerance, they are unable to receive Factor VIII therapies. See Callaghan Dee).
Dccl.
¶
16; Young
¶ 23.
The second method of treatment for inhibitor patients involves bypassing agents (BPAs),
which bypass the Factor VIII step in the clotting cascade. Aledort Dccl.
This includes Baxalta’s BPA product. Feiba. See Bakewell Dccl.
¶ 33;
¶
17; Young DecI. ¶ 24.
Young Dccl.
¶
24;
Tr. 299:8—14. Feiba is FDA-approved only for inhibitor patients. See, e.g., Aledort Dccl. Ex. J,
at 1, ECF No. 46-10. BPAs can be used in two ways, on-demand when a bleeding episode
4
occurs and/or on a regular schedule as prophylaxis. Aledort Dccl.
¶
17; Young Dccl.
¶ 25.
But
BPAS, like Factor VIII replacement therapies, must be infused, which may impose a substantial
treatment burden on patients and their families. In particular, the infusion can take up to an hour
as often as every other day in order to achieve the desired prophylactic effect. See Callaghan
Dccl. ¶j 20, 26; Young DecI.
¶ 29.
(Baxalta’s expert, Dr. Aledort, testified that he did not think
infusion takes as long as described, but he was unable to provide an alternative estimate. See
Tr. 181:16—182:23.) Moreover, the inftision must be administered directly into a vein or through
a central venous-access device, more commonly known as a port. and each of these methods
entails risk of infection or venous-access issues. See, e.g., Callaghan Dccl.
¶ 49;
Young Dccl.
jJ 19,25.
1-lemlibra, the accused product, treats hemophilia A in yet another manner. In general,
antibodies are Y-shaped, with two arms connected by disulfide bonds. Strohl Dccl.
¶ 22,
ECF
No. 112. Each arm of the 1’ shape contains two polypeptides known as the heavy chain and the
light chain. See Id. Hemlibra is a bispecific antibody, meaning that the heavy chains on its two
arms are not identical. See Krishnaswamy Deci.
¶ 55,
60, ECF No. 47; Strohl Dccl.
¶ 38,
53.
One of its arms binds to Factor IX (or IXa) and the other binds to Factor X. See Krishnaswamy
Deci.
¶ 55.
60; Strohl Dccl.
¶ 53.
Hemlibra replaces Factor Villa in the clotting cascade,
activates Factor X, and allows the process to continue to clot formation despite the deficiency in
Factor VIII caused by hemophilia A. See Krishnaswamy Dccl.
¶ 61,
Strohl Dccl. ¶‘ 178—79.
Unlike BPAs, Hemlibra can be administered by a once-weekly subcutaneous injection using a
syringe rather than by infusion. Callaghan Deci.
¶3 47—48;
Young Dccl.
9 50—53.
The Food and Drug Administration (FDA) approved Hcmlibra for hemophilia A patients
with inhibitors on November 16, 2017, and Genentech launched the product in the United States
5
for that population later that month. Bakewell Dccl.
¶ 40.
For the treatment of noninhibitor
patients, the FDA has granted Hemlibra Breakthrough-Therapy Designation and Priority Review,
Tr. 591:18—24, which generally indicates that the FDA will undertake an expedited review on the
basis of promising clinical data and a treatment’s expected medical benefits, Tr. 589:2—15.
Pursuant to this priority review, Genentech expects approval of Hemlibra for noninhibitor
patients no later than early October 2018—and possibly sooner. See Tr. 592:1—593:24. In the
meantime, some small number of patients falling within the noninhibitor category are being
prescribed 1-lemlibra by their doctors off-label, i.e., notwithstanding the lack of FDA approval for
that patient population. See, e.g., Tr. 526:17—527:4.
To summarize: there are four products at the heart of this litigation. Baxalta offers two
primary Factor VIII replacement therapies for noninhibitor patients: Advate and Adynovate. It
also offers a BPA product for inhibitor patients: Feiba. All three Baxalta products can be
administered prophylactically and/or on-demand to treat particular bleeding episodes. See, e.g.,
Tr. 552:15—554:5. None of Baxalta’s products practices the ‘590 patent. Bakewell Dccl.
¶ 55.
Genentech’s product, emicizumab, is marketed as Flemlibra. It is administered only as
prophylaxis. See, e.g., Tr. 206:14—23. Hemlibra competes with Feiba in the inhibitor market,
and Hemlibra will compete with Advate and Adynovate in the noninbibitor market once FDA
approval is forthcoming.
III. THE PROPOSED INJUNCTION
Along with its motion for a preliminary injunction, Baxalta filed a proposed order that
would bar Genentech from selling or offering to sell Hemlibra to any noninhibitor patients and
would allow sales to inhibitor patients only if they (1) had already been receiving Hemlibra or
(2) met a set of criteria generally indicating some heightened need for Hemlibra treatment. See
6
Prop. Prelim. Inj. Order
fi 2, 4, 6.
Those criteria included a documented annual bleed rate over
a certain threshold; a documented, spontaneous life- or limb-threatening bleeding episode; and
documented venous-access issues. Id.
¶ 4(b)—(c).
The proposed order did not appear to carve
out nonithibitor patients who have already been receiving Hemlibra as part of the clinical trials.
See Id. ¶6; Tr. 199:1—11.
During the hearing on its motion, Baxalta agreed to broaden the scope of this carveout
from its proposed injunction. Tr. 309:23—310:8. In particular, Baxalta agreed “to amend its
proposed carveout to extend to all inhibitor patients for FDA-approved use at this time, assuming
appropriate steps were taken to ensure that off-label sales did not occur.” Tr. 310:4—8.
Following the hearing, Baxalta submitted an amended proposed injunction order that would bar
Genentech from selling or offering to sell Hemlibra except to:
(a) “patients with inhibitors”;
(b) “patients in connection with clinical trials”;
(c) “patients without inhibitors who had received HEMLIBRA (whether in
connection with clinical studies pursuant to 35 Usc § 271(e)(l) or
commercially) prior to entry of [the preliminary injunctionl”; and
(d) “patients without inhibitors whose doctor has certified that the patient has a
medically diagnosed condition that makes intravenous administration of
Factor VIII replacement therapy impracticable.”
Am. Prop. Prelim. Inj. Order ¶ 4, ECF No. 218. The proposed order would further require
Genentech to institute some mechanism for doctors prescribing 1-Iemlibra to certify that their
patient falls within one of these categories. Id.
¶ 5(b).
It would also require Genentech to “make
reasonable efforts to confim” the accuracy of those certifications. Id.
2
¶ 5(c).2
The procedure for doctors to certify—and for Genentech to verify—that patients fall within the
carveout is complicated and perhaps unworkable. But for purposes of resolving this motion, the
Court will treat it as if it were able to be implemented.
7
DISCUSSLON
“A plaintiff seeking a preliminary injunction must establish [I] that he is likely to success
on the merits, [2] that he is likely to suffer irreparable harm in the absence of preliminary relief,
[3] that the balance of equities tips in his favor, and [4] that an injunction is in the public
interest.”
Winier i’.
Nat. Res. Def Council, Inc., 555 U.S. 7,20(2008); accord Benisek v.
Lamone. 138 S. Ct. 1942, 1943—44 (2018) (per curiam); Osorio-A’Iartinez
i’.
Att 5’ Gen. US., 893
F.3d 153, 178 (3d Cir. 2018); Melaicraft ofAfayville, Inc v. Torn Co., 848 F.3d 1358, 1363—64
(Fed. Cir. 2017).
Most recently, the Supreme Court has reiterated that “[als a matter of equitable
discretion, a preliminary injunction does not follow as a matter of course from a plaintiffs
showing of a likelihood of success on the merits,” rather, the other factors must also be
considered and could also support the denial of a preliminary injunction. Benisek, 138 S. Ct. at
1943—44. In Benisek, the Supreme Court affirmed the denial of a preliminary injunction even
assuming a likelihood of success on the merits, because “the balance of equities [including a lack
of diligence] and the public interest tilted against” granting an injunction. Id.
Here, the parties have taken starkly different positions on the merits, i.e., the invalidity
and infringement of the ‘590 patent. Both issues present difficult questions best resolved based
on a ftller record. But, as in Benisek. even assuming Baxalta has some likelihood of success on
the merits, its failure to establish two other prongs—here, irreparable harm and the public
interest—renders a preliminary inj unction unwarranted.
1. LiicLit-iooo OF SUCCESS ON THE MERITS
For purposes of its preliminary-injunction motion, Baxalta asserts only claim I of the
‘590 patent:
8
An isolated antibody or antibody fragment thereof that binds Factor IX or Factor
IXa and increases the procoagulant activity of Factor IXa.
‘590 patent, col. 101,11. 43—45.
A. Infringement
Baxalta contends that Hemlibra is an antibody that otherwise meets the limitations of
claim I. In connection with this motion, Genentech’s only argument in support of
noninfringement is that Hemlibra is not an antibody as defined by the patent in light of the
specification and prosecution history.
The parties’ dispute over infringement thus boils down to their competing constructions
of the term antibody. As will be seen, during prosecution of the ‘590 patent, the term antibody
fragnzent was added to claim I. Baxalta does not contend that this addition added to the scope of
the term antibody. See Tr. 35:23—36:2. Baxalta contends that the term antibody has a plain and
ordinary meaning, namely, “[a] molecule having a specific amino acid sequence comprising two
heavy chains (H chains) and two light chains (L chains).” 2d Am. Joint Claim Construction
Chart 3, ECF No. 166. Genentech urges a narrower construction: “An immunoglobulin
molecule, having a specific amino acid sequence that only binds to the antigen that induced its
synthesis or very similar antigens, consisting of two identical heavy chains (H chains) and two
identical light chains (L chains).” Id. The relevant difference for present purposes is that, under
Gcnentech’s construction, each pair of chains (heavy and light) must be identical. Baxalta
concedes that Hemlibra does not have identical heavy chains and, therefore, that it does not
infringe under Genentech’s construction. See Tr. 8:23—9:24.
To support its construction. Genentech points to the patent specification. Under the
heading “Antibodies and Antibody Derivatives,” the specification states:
9
Antibodies are immunoglobulin molecules having a specific amino acid sequence
which only bind to antigens that induce their synthesis (or its immunogen,
respectively) or to antigens (or immunogens) which are very similar to the former.
Each immunoglobulin molecule consists of two types of polypeptide chains.
Each molecule consists of large, identical heavy chains (H chains,) and two light,
also identical chains L chains,).
‘590 patent, col. 5, Il. 56—63 (emphasis added). Genentech’s proffered construction tracks this
section closely, including the requirement of identical heavy and identical light chains.
According to Genentech, then, a bispecific antibody, i.e., one with nonidentical heavy and/or
light chains, is simply outside the scope of the patent’s definition for antibody.
Baxalta counters that bispecific antibodies cannot be outside the claimed scope because
they are specifically identified in the patent. Indeed, the specification goes on to provide a list of
examples:
The inventive antibodies and antibody derivatives and organic compounds
derived there from comprise human and animal monoclonal antibodies or
fragments threreof, single chain antibodies and fragments thereof and
miniantibodies, bispecuic antibodies, diabodies, triabodies, or di-, oligo- or
multimers thereof
Id., at col. 6, Il. 1—6 (emphasis added). But to Genentech, this list suggests at most that bispecific
antibodies fall into one or more of the categories “antibodies and antibody derivatives and
organic compounds derived there from,” not just “antibodies.” Of these categories, Genentech
contends that bispecific antibodies are antibody derivatives rather than antibodies.
According to Genentech, during prosecution of the ‘590 patent, the applicants disclaimed
antibody derivatives from the scope of the claimed antibody. Claim 1 of the original application
filed in 2000 was directed to “[am antibody or antibody derivative.” Strohl Dccl. Ex. D, at 62,
ECF No. 112-4. The claim was amended to cover an “antibody or antibody fragment.” ‘590
patent, col. 101,1.43. This amendment was made in response to rejections by the examiner for
lack of enablement and written description under 35 U.S.C.
10
§
112. See Strohl Dccl. Ex. K, at 4—
7, ECF No. 112-11; Strohl Deci. Ex. M, at 1—2, ECF No. 112-13. In particular, the examiner
concluded that the application failed to provide support for the full scope of claimed antibody
derivatives, including bispecific antibodies. See Strohl DecI. Ex.
lvi,
at 2 (“[T]he specification
does not reasonably provide enablement for any antibody derivative against factor IX/factor
IXa which increases the procoagulant activity of FIXa in claim I
derivative is
.
.
.
bispecific antibodies
).
.
.
.
wherein said [lantibody
Earlier in the prosecution, the Examiner had
issiLed
and then withdrawn a restriction requirement, stating that as originally claimed in claim 1,
antibody and antibody derivative were separate inventions. See Dudash Ltr. Ex. Vol. 3, PX-14,
at 8—9, 26, ECF No. 245-4.
Genentech argues that the prosecution history evinces a disclaimer of antibody
derivatives—including bispecific antibodies—from the scope of the claims. In its briefing,
Baxalta took the position that there was no disclaimer at all. See Bax. Ltr. 3 & n.4. At the
hearing on its motion, however, Baxalta conceded that it had no argument for why the
applicants’ amendment to remove reference to antibody derivatives was not a disclaimer as to
antibody derivatives. ft. 32:2—21. This concession narrows the parties’ dispute. The question,
then, is whether Hemlibra, a bispecific antibody, falls into the category antibody, antibody
c!erh’ative, or both, as those terms are used in the ‘590 patent.
Baxalta offers two additional arguments in support of its construction in light of the
prosecution history. First, Baxalta argues that Genentech’s claim construction would exclude
1gM and IgA antibodies, which are embodiments of the claimed invention present in some of the
dependent claims. See ‘590 patent, col. 101, II. 49—50; id. col. 104, II. 7—9. This is because 1gM
and IgA antibodies generally contain more than two heavy and two light chains. See, e.g.,
KossiakoffReb. Dccl.
¶ 45, ECFNo.
126; Tr. 374:13—375:1. But Genentech offered expert
Ii
testimony, uncontradicted by Baxalta, that 1gM and IgA antibodies are also present in the blood
as monomers with only two heavy and two light chains (i.e., within the scope of Gencntech’s
claim construction). Tr. 443:23—447:10. Although the expert conceded that this construction
would exclude some of the antibodies disclosed in the patent, including some forms of 1gM and
IgA antibodies, see Tr. 467:5—468:2, it would not categorically exclude all 1gM and IgA
antibodics.
Second, Baxalta argues that Genentech’s claim construction conflicts with claim 4, which
depends from claim 1:
The antibody or antibody fragment according to claim 1, wherein said antibody or
antibody fragment is selected from the group consisting of a monoclonal
antibody, a chimeric antibody, a humanized antibody, a single chain antibody, a
bispecific antibody, a diabody, and di-, oligo-, or multimers thereof
‘590 patent, col. 101,1!. 51—56. The argument is that if bispecific antibodies and the other
members of this list are antibody derivatives, and therefore disclaimed from the claimed scope,
claim 4 is rendered a nullity. Genentech points out that this list is precisely the one used by the
examiner to describe the kinds of antibody derivatives that were not enabled by the patent
application. See Strohl Dccl. Ex. K, at 4; Strohl DecI. Ex. M, at 2.
Baxalta is correct that the Federal Circuit applies “a strong presumption against a claim
construction that excludes a disclosed embodiment,” such as claim 4. Katz v. Am. Airlines, Inc.
(In re Katz Interactive Call Processing Patent Litig.), 639 F.3d 1303, 1324 (Fed. Cir. 2011). But
the Federal Circuit has found such a presumption overcome where necessary based on the
specification and prosecution history, including where a claim amendment was submitted in
order to overcome an enablement rejection. See Regents ofthe Univ. of Cal. v. Dakocytoniation
Cal.,
mc,
517 F.3d 1364, 1375 (Fed. Cir. 2008). Genentech’s interpretation of the specification
and prosecution history here is that the examiner requested—and the applicants made—a
12
universal amendment to the claims that would exclude antibody derivatives, including bispecific
antibodies, yet neglected to make a coordinate amendment with respect to claim 4 specifically.
I conclude that both parties have presented substantial arguments on the issue of
infringement.
B. Invalidity
Genentech argues that the patent lacks sufficient written description to support the
breadth of claim I under 35 U.S.C.
§
112. A leading Federal Circuit ease on the written-
description requirement, which also happens to deal with a patent covering antibodies, is Abb Vie
Deutschland GmbH & Co.
i’.
.Janssen Biotech, Inc., 759 F.3d 1285 (Fed. Cir. 2014). A brief
review of Abb Vie is necessary.
“The essence of the written description requirement is that a patent applicant, as part of
the bargain with the public, must describe his or her invention so that the public will know what
it is and that he or she has truly made the claimed invention.” Id. at 1298. When, as with
claim I here, “a patent claims a genus using functional language to define a desired result, ‘the
specification must demonstrate that the applicant has made a generic invention that achieves the
claimed result and do so by showing that the applicant has invented species sufficient to support
a claim to the functionally-defined genus.” Id. at 1299 (quoting
Ariacl Phonu.,
Inc. v. Eli Lilly
& Co., 598 F.3d 1336, 1349 (Fed. Cir. 2010) (en banc)). A patent can achieve this result in one
of two ways: (I) it can disclose “a representative number of species falling within the scope of
the genus,” or (2) it can disclose “structural features common to the members of the genus so that
one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. (quoting Ariad.
598 F.3d at 1350).
13
Baxalta pursues only the first of these approaches—representative species—in support of
claim 1. Under this approach, the disclosed species must “encompass[1 the breadth of the
genus.” Id. at 1300. InAbb Vie, the patent claimed a genus of antibodies having a neutralizing
function with respect to a particular antigen. Id. at 1299. The patent disclosed several antibodies
that served the claimed function and that all shared a particular structure. Id. at 1300. But the
defendant offered an example of an antibody (the accused antibody) that shared the function but
differed greatly in structure. Id. The court concluded that “the claimed genus covers structurally
diverse antibodies,” Id., but that the written-description requirement was not met because the
patent disclosed no species representative of the structural breadth demonstrated by the accused
antibody, id. at 1300—01.
Genentech first argues that the ‘590 patent, like the one in Abb Vie, fails to disclose a
species representative of the structural breadth demonstrated by 1-lemlibra, namely, bispecific
antibodies. (While Genentech argues that there are written-description problems under either
party’s construction of antibody as used in claim 1, for present purposes the Court addresses
written description using Baxalta’s construction.) The ‘590 patent contains no disclosure of
bispecific antibodies. See, e.g., Tr. 428:13—16. According to Genentech, the absence of
bispecific antibodies alone suggests that the applicants were not in possession of species
representing the full structural breadth of the claimed genus.
The parties also take a more granular approach to examining the species’ structure.
Experts on both sides examined the amino-acid sequences of portions of the antibodies disclosed
in the specification and compared them to the corresponding sequences of Hemlibra. See
Tr. 375:18—387:8, 430:4—440:16. These experts came to widely varying conclusions, finding
14
that the amino-acid sequences of the disclosed antibodies were either very similar to that of
Hemlibra, see Tr. 377:7—382:21, or not at all similar, see Tr. 437:11—440:16.
Genentech also argues that, even if the specification discloses species representative of
the structural diversity of the claimed genus, it fails to disclose species representative in terms of
diversity of functional effect. That is, Genentech argues that the ‘590 patent fails to disclose
species that represent the full breadth of the procoagulant function of the claimed genus. Baxalta
responds that structural diversity is the only axis to be considered under the Abb Vie analysis.
Baxalta is correct that the dispute in Abb Vie concerned structural diversity. 759 F.3d at
1297—1302. But Genentech reads Abb Vie as instructing that the breadth of a genus can and
should also be measured in terms of functionality—or any other axis along which the genus is
diverse. See Id. at 1299—1301. Here, Genentech offered evidence that 1-lemlibra is dramatically
more effective than any of the disclosed antibodies in terms of increasing the procoagulant
activity of Factor IXa. See, e.g., Sheehan DecI.
¶1J 85—86, 93—94,
102. Under Genentech’s
interpretation of Abb Vie, this failure to disclose antibodies representative of the range of
functional effect shows that the written-description requirement was not satisfied.
*
*
*
With respect to both of the merits issues, the parties have presented challenging questions
of law and sharply conflicting expert testimony. Both issues are best decided on the basis of a
more developed record. But Genentech has at the very least established that there are difficult
questions with respect to infringement and invalidity. These difficult merits questions weigh in
favor of denying injunctive relief at this stage. But, even if Baxalta were deemed to have made a
strong showing of likelihood of success, I conclude that a preliminary injunction would still not
be warranted.
15
II. IRREPARABLE HARM
Baxalta advances two types of irreparable harm that it contends it will suffer in the
absence of an injunction. The first are market (or sales-based) harms, such as loss of market
share, loss of sales, loss of revenue, and price erosion. The Federal Circuit “has often explained
that such factors are pertinent to the irreparable harm inquiry.” Trebro Mfg. Inc. v. Firefly
Equip., LLC. 748 F.3d 1159, 1170 (Fed. Cir. 2014) (collecting cases). The second harms are to
Baxalta’s reputation and good will, which can also support a finding of irreparable harm. See,
e.g., Douglas Dvnanzics, LLC v Buyers Prods. Co., 717 F.3d 1336. 1344 (Fed. Cir. 201 3).
Baxalta does not practice the ‘590 patent, but as Baxalta points out, “a party that does not
practice the asserted patent may still receive an injunction when it sells a competing product.”
Trebro, 748 F.3d at 1171.
A. Market Harms
Baxalta’s agreement to carve out the entire inhibitor population from its proposed
injunction changes the landscape of possible market harms that could be prevented by granting
its motion for a preliminary injunction. In particular, Baxalta’s arguments and evidence have
focused primarily on harms related to its own BPA product marketed to the inhibitor population,
Feiba. And while Baxalta may be correct that “jw]ith the entry of[Hemlibra], Baxalta’s share of
inhibitor patients will dramatically decline,” Bax. Mem. 16, under the amended carveout, this
will occur whether or not an injunction is ordered since inhibitor sales are excluded from the
proposed injunction. Any such harm in the inhibitor maket, then, would not weigh in favor of
granting Baxalta’s motion.3 In short, I conclude that Baxalta has not shown irreparable harm
Genentech argued that Baxalta improperly delayed bringing its motion for a preliminary
injunction. This might have been a concern with respect to the inhibitor population, for which
FDA approval was already secured by the time Baxalta filed its motion. But that population is
16
with respect to sales of Hemlibra to the inhibitor market. Since Feiba is FDA-approved only
with respect to the inhibitor market, it follows that Baxalta has not shown irreparable harm with
respect to Feiba.4
That leaves Baxalta’s claims of irreparable harm with respect to its Factor VIII
replacement products, Advate and Adynovate, which are marketed to the noninhibitor
population. With respect to the period between now and the FDA’s approval of 1-lemlibra for
noninhibitor patients, the parties appear to agree that any off-label use by noninhibitor patients
has been a very small share of overall 1-lemlibra sales. See Tr. 137:4—138:5, 293:7—10, 526:17—
527:7. Moreover, the noninhibitor patients receiving off-label prescriptions of Hemlibra would
likely fall within the scope of Baxalta’s proposed carveout, either as participants in clinical trials
or patients with qualifying medical condition. See Am. Prop. Prelim. Inj. Order ¶ 4(b)—(d); Oral
Arg. Tr. 86:14—87:21 (stating that the amended carveout was drafted in response to testimony at
the hearing describing patients who may receive off-label prescriptions); see also Tr. 560:19—
561:6 (discussing the HAVEN 3 and 4 clinical trials for noninhibitor patients); Tr. 568:12—
569:16 (describing off-label prescriptions to a child with venous-access issues); Tr. 636:23—
637:14 (contemplating off-label prescriptions for a child with autism). Indeed, there was no
testimony at the evidentiary hearing about any noninhibitor patients who receive off-label
now fully carved out of the proposed injunction, and Baxalta’s motion was filed well in advance
of the expected approval for the noninhibitor population. Genentech has understandably dropped
its delay argument with respect to the inhibitor population in its proposed findings and
conclusions. See generally Gen. Prop. F. & C.; Gen. Reply F. & C.
“Although it appears Feiba can be and is in rare cases prescribed off-label for use by
noninhibitor patients, Baxalta has not presented arguments based on such use or contended that it
is more than de minimis. See Tr. 299:8—14, 525:14—22, 572:1—4; see also Dudash Reply Aff. Ex.
A., at 77:12—82:2 1, ECF No. 180-2. For example, Baxalta’s expert witness on irreparable harm,
W. Christopher Bakewell, attributed all of Feiba’s 2017 sales to inhibitor patients. See
Tr. 298:8—299:20.
17
Hemlibra but who would not quali under the carveout’s provision for medical conditions that
make intravenous therapy impracticable or are participants in clinical trials. Baxalta has failed to
show that it has experienced or would experience any market harm that would be redressed by
the proposed preliminary injunction in the period following Hemlibra’s introduction to the
inhibitor population up to the time of FDA approval for the noninhibitor population.
With respect to the question whether Baxalta has established that it will suffer irreparable
harm to the sale of Advate and Adynovate after FDA approval for the sale of Hemlibra to the
noninhibitor population, I first consider price erosion. For the average patient, Hemlibra is
priced by Genentech between $448,000 and $482,000 per year, whereas Advate is priced by
Baxalta at $394,000 and Adynovate at $537,000. Bakewell Dccl. Ex. AA, at 2, ECF No. 45-7.
Baxalta’s expert, Mr. Bakewell, testified that the presence of Hemlibra in the market generates
“additional pricing pressure” on these two noninhibitor products: “And the idea that there is an
additional competitor that’s going to be in the marketplace, the standard financial and economic
theory teaches that when you increase competition, prices will eventually run down.”
Tr. 306:12—16; accordlr. 318:10—21, 367:24—368:14. In the seven months that Hemlibra has
been on the market, Bexalta has not lowered the price for Advate or Adynovate. See Yr. 338:16—
342:8. And Baxalta’s own documents appear to project price increases of between 3% and 4%
for both of its products. See Bakewell Dccl. E. M, at 8, ECF No. 43-1. Mr. Bakewell’s
predictions of price erosion have already proved to be overly pessimistic with respect to Feiba,
the inhibitor drug. Whereas Mr. Bakewell previously predicted that Hemlibra’s introduction in
2017 would force Feiba prices down in 2018 (along with Advate and Adynovate prices), that
erosion has not materialized. See Tr. 338:16—342:8. Baxaltas real-world performance has been
consistent with its own internal projections that prices would hold firm in 2018, not with Mr.
18
Bakewell’s predictions of erosion. Compare Id., with Bakewell Dccl. Ex. M, at 9. The Federal
Circuit has instructed district courts to consider real-world market performance, including during
the litigation, in making irreparable-harm determinations. See, e.g., Presidio Components, Inc.
i’.
Am. Tech. Ceramics Coip., 875 F.3d 1369, 1384 (Fed. Cir. 2017). cert. docketed. No. 17-1497
(U.S. May 1,2018). andNo. 17-1649 (U.S. June 8,2018). There is no evidence, other than Mr.
Bakewell’s speculation, that Baxalta’s noninhibitor products will suffer from price erosion when
Hemlibra enters that market, and I therefore conclude that Baxalta has not established price
erosion or the prospect of future price erosion for purposes of the preliminary-injunction motion.
I next consider the extent to which the sale olKemlibra to the noninhibitor population
will adversely affect the sales of Advate and Adynovate after FDA approval of Hemlibra for the
noninhibitor population. By the time the ‘590 patent expires in 2021, Genentech projects that a
majority of its annual sales from Hemlibra will come from sales to noninhibitor patients. See
Dudash Reply Aff. Ex. BB, at 42, ECF No. 180-29. A third-party analysis that predicts
Hemlibra will command roughly 36% of the noninhibitor prophylaxis market by 2023. See
Dudash Ltr. Ex. Vol. 3, PX-7, at 8, ECF No. 245-4. But this does not establish that these
Hemlibra sales will displace existing sales of Advate and Adynovate. These Hemlibra sales will
be made to three classes of patients: (1) those who previously used Advate or Adynovate for
prophylaxis, (2) those who used non-Baxalta products for prophylaxis, and (3) those who were
not receiving prophylactic treatment. While Genentech has conceded that sale of Hemlibra to
the noninhibitor population will result in lost sales to Baxalta, Oral Arg. Tr. 16:7—10, Baxalta has
not shown to what extent prophylaxis or on-demand sales of Advate and Adynovate will be
affected by the sales of Hemlibra as prophylaxis to the noninhibitor population. Mr. Bakewell
testified that the latest estimate is that Baxalta wiLl Lose 30% of its Advate and Adynovate sales
19
to Hemlibra in the short term. Tr. 367:17—23. Genentech’s expert witness on irreparable harm,
Jerry Hausman, Ph.D., agreed that introduction of Hemlibra into the noninhibitor market would
“lead to[,] I think[,] market share loss and revenue loss to ADVATE and the other Baxalta drug
ADYNOVATE.” Tr. 526:11—13. But Baxalta has not shown to what extent noninhibitor
Hemlibra sales will displace existing sales of Baxalta’s Advate and Adynovate products for
either on-demand or prophylactic use.
Baxalta’s own documents do not appear to reflect anticipation of significant losses in the
noninhibitor market. For example, Baxalta projects a roughly 8% increase in annual sales from
Advate and Adynovate before the ‘590 patent’s expiration in 2021. See Bakewell DecI. Ex. M,
at 6. Only for Advate does it expect a loss in market share between 7% and 16%, much of which
is recovered by its expectation that Adynovate will gain between 3% and 7% over the same
period. See itt. at 8. Part of the reason for this is the likely loyalty of patients to the existing
products that they are already utilizing. See, e.g., Tr. 302:10—12 (“Patients have loyalty to the
brand and to manufacturers[,] and physicians are reluctant to switch due to risks.”).
Finally, Mr. Bakewell’s testimony was in some aspects simply not credible. For
example, on redirect examination, he was asked to examine a chart displaying Baxalta’s internal
projections for annual net product sales over a seven-year period. See Tr. 366:12—367:23
(discussing Bakewell Dccl. Ex. M, at 6). Mr. Bakewell testified that the chart “shows [salesj
going down actually markedly with FEIBA, if we look at that line, over time; and for ADVATE
and ADYNOVATE, it shows those going down markedly as well.” Tr. 367:4—7. Mr. Bakewell
then squarely attributed this decline to Hemlibra, Tr. 367:13 (“It’s specific to HEMLIBRA.”),
and he opined that the actual 2018 sales were consistent with this projected decline, Tr. 367:14—
23. But while the chart shows a projected decline in sales for Feiba, it shows a projected
20
increase in sales for Baxalta’s noninhibitor products. See Bakewell DecI. Ex. M, at 6. While
Advate sales are projected to decline, this is more than made up for by Adynovate, and overall
noninhibitor sales of these two products are projected to rise by nearly 8%. See Id. To the extent
Mr. Bakewell is basing his opinions on such misinterpretations of the data, those opinions cannot
be credited.
While Hemlibra will gain sales and market share upon its entrance into the noninhibitor
market at the expense of Baxalta’s products, that evidence suffers from several deficiencies.
First, while it is safe to say that Baxalta would have more sales of its noninhibitor
products in the absence of Hemlibra in that market, the magnitude of that difference has not been
established, and in particular, it has not been shown to be substantial. Baxalta has provided
evidence that is too scant, too inconsistent, and not sufficiently credible to establish a likelihood
of substantial irreparable harm to existing sales of Advate and Adynovate in the noninhibitor
market in the period before patent expiration, Baxalta’s own internal projections suggest that its
sales in this market may in fact increase in the coming years. At most, Baxalta has established
that that increase will not be as great as it would have been absent Flemlibra. But whereas a loss
of market share may in some cases be irreparable, a diminished increase in market share can
likely be compensated by money damages. Baxalta has not shown that the loss of sales and
market share it will experience could not be compensated by money damages. “Evidence of
potential lost sales alone does not demonstrate irreparable harm.” Metaicraft, 848 F.3d at 1368.
Although the Federal Circuit has occasionally found these kinds of harms irreparable, it has done
so in the presence of other unique factual circumstances—such as ecosystem and network effects
or the danger of employee layoffs—not present here. See, e.g., Id. at 1368—69; Apple Inc. v.
Samsung Elecs Co., 809 F.3d 633, 640—46 (Fed. Cir. 2015); Trebro, 748 F.3d at 1170—71.
21
Second, whereas Advate and Adynovate are sold both as prophylactic and on-demand
therapies, Hemlibra will compete only in the prophylactic segment of the noninhibitor market.
Baxalta has not established the extent to which on-demand sales of Advate and Adynovate will
be affected by Hemlibra’s entrance.
Third, the ‘590 patent is expected to expire in 2021, a fact which is hardly addressed in
the parties’ briefing. A preliminary injunction may sometimes be warranted to avoid a loss of
market share that cannot be undone should the accused product eventually be excluded from the
market. But here, there will be at most three years between FDA approval for the noninhibitor
population and the expiration of the asserted patent, and assuming the FDA approves
noninhibitor sales of Hemlibra, even with a preliminary injunction Hemlibra will enter the
noninhibitor market in the near term. Thus, this is not a case where ajury would be tasked with
calculating speculative damages for an ongoing loss of market share that cannot be recouped.
Baxalta will almost certainly lose market share in the near future after patent expiration, and it
can be compensated for any lost sales that occur in the intervening period before patent
expiration.
I conclude that Baxalla has failed to establish substantial irreparable harm from price
erosion or lost sales or market share.
B. Goodwill & Reputation
In addition to the aforementioned market harms, “[i]rreparable injury encompasses
different types of losses that are often difficult to quantify, including.., erosion in reputation
and brand distinction.” Douglas, 717 F.3d at 1344; accord Celsis In Vitro, Inc.
Inc., 664 F.3d 922, 930 (Fed. Cir. 2012).
22
i’.
CellzDirect,
With respect to goodwill and reputation, however, the evidence is even less compelling.
Baxalta contends that its reputation—as an innovator in the treatment of hemophilia and for
protecting its intellectual property—will be harmed in the absence of an injunction. But even
assuming that Baxalta has such a reputation, the evidence to support the risk of harm is entirely
speculative. When asked to describe the nature of the reputational losses Baxalta could sustain,
Mr. Bakewell instead described the market losses detailed above, contending that they “will flow
over or spill over to harm [Baxalta’s] reputation and goodwill.” Tr. 325:23—24; see also
Tr. 289:5—6 (stating in a conclusory fashion that there would be “loss of reputation and good
will”); Tr. 368:9—10 (stating in a conclusory fashion that “the harm to reputation and goodwill
would be present”).
Reputational harm has previously been found to weigh in favor of injunctive relief where
a plaintiff was itself practicing the patented invention and where there was evidence of consumer
confusion, a loss of product distinctiveness, or some risk to that plaintifFs status as an innovator.
See, e.g., Douglas, 717 F.3d at 1344—45. Baxalta has not substantiated a likelihood of these
harms. It does not practice the ‘590 patent, and there is no risk that consumers will be confused
about the source of the various products. Hemlibra will be on the market whether the requested
injunction is granted or not (for example, to inhibitor patients), and the requested injunction will
not stop doctors and patients from associating the innovation of Hemlibra with Genentech. In
this regard, as well, Baxalta has failed to marshal sufficient evidence to establish a likelihood of
irreparable harm to reputation.
Genentech’s witness, moreover, testified that if anything Baxalta’s reputation stands to be
harmed by an injunction, and I agree. Whether an injunction issues or not, Hemlibra “is going to
be on the market and going to be sold [to inhibitor patientsj and doctors are going to know about
23
it.” Tr. 504:22—24. As Dr. Hausman testified, “Baxalta may actually injure their reputation if
doctors know they’re trying to keep [Hemlibraj from patients who can benefit from it quite a
bit.” Tr. 505:1—3; see also Tr. 509:13—17 (“[Djoctors would know that Baxalta was restricting
the ability of these severely noninhibitor hemophilia A patients to get the best treatment. I think,
if anything, it would harm their reputation.”); Tr. 510:15—22, 512:3—13, 517:6—1 8.’
III. PUBLIC INTEREST
The public has two primary interests in this litigation: protection of intellectual-property
rights and access to necessary and effective medical care. At this stage, given the ample
evidence of medical need, the public interest weighs strongly against issuing a preliminary
injunction since Hemlibra has unique medical benefits not available from Baxalta’s competing
products.
There is no question that the public has an interest in the enforcement of patent rights,
especially in the pharmaceutical context, where “investment in drug research and development
must be encouraged and protected by the exclusionary rights conveyed in valid patents.” Celsis,
664 F.3d at 931; see also Abbot! Labs.
i’.
Sandoz, Inc., 544 F.3d 1341, 1632 (Fed. Cir. 2008)
(“The statutory period of exclusivity reflects the congressional balance of interests, and warrants
weight in considering the public interest.”). But in Celsis, for example, the parties “s[oldl the
same products and [we]re in direct competition,” meaning that “the public c[ouldj obtain the
products from [the patenteej.” 664 F.3d at 932. This case is different: the parties’ products,
while competing with each other, differ in meaningful ways. These differences, taken together,
explain why the public’s interest in access to Hemlibra weighs strongly against a preliminary
inj unction.
To the extent that the balance of equities is a separate factor, I conclude it favors neither party.
24
To begin with, it is worth reiterating that Baxalta’s amended proposed injunction carves
out all inhibitor patients. As a result, comparisons to the current treatments available for that
population, such as Baxalta’s Feiba, are no longer relevant as they might have been under the
original proposal.
Instead, the inquiry’ must focus on the treatments available to the noninhibitor population.
The FDA has recognized the importance of making Hemlibra available to the noninhibitor
population by granting it Breakthrough-Therapy Designation and Priority Review. Tr. 591:18—
24. Breakthrough-Therapy Designation is given where “preliminary’ clinical evidence indicates
that the drug may demonstrate a substantial improvement over existing therapies
21 U.S.C.
§
356, and the FDA can grant Priority Review where a drug would “provide
significant improvement in the safety or effectiveness” of treating a serious condition, Levy
Deel.
¶
II, ECF No. 98. As described above, noninhibitor patients are treated with Factor VIII
replacement, as ongoing prophylactic therapy and/or on-demand to treat bleeding episodes. Only
about 60% of adult noninhibitor patients receive Factor VIII replacement as prophylaxis. See Tr.
205:24—206:5. I credit Genentech’s evidence on the effects of Hemlibra, and I specifically find
that Hemlibra confers substantial medical benefits over the existing therapies for noninhibitor
patients. See, e.g., Tr. 209:7—10, 561:7—562:9, 598:21—599:2. For example, one of the lead
investigators on Hemlibra clinical trials, Dr. Guy Young, testified that recent results show a
reduction in these patients’ annualized bleeding rate from 4 to around 1.5 when switching from
prophylactic Factor VIII replacement to Hemlibra, and I credit his testimony. See Tr. 560:10—
562:9. (The annualized bleeding rate is an estimated number of bleeding events for one patient
in one year, extrapolated based on observations over several months. See, e.g., Young DecI.
¶ 68.) In contrast, Baxalta’s expert witness, Dr. Louis Aledort, testified that these 60% do not
25
need Hemlibra: according to him, their current prophylactic treatment is roughly as effective.
See Tr. 204:4—205:6. This testimony from Dr. Aledort is not credible, and to the extent that
Baxalta argues that the medical benefits of Hemlibra are not significant, its position is without
support. For example, it compares two different studies—one of Advate and one of Hemlibra—
that reported roughly similar annualized bleed rates for noninhibitor patients. See Tr. 616:7—
618:7. But as one of Genentech’s witnesses explained, different clinical studies conducted in
different manners cannot be directly compared, and the Advate results specifically counsel
against any such comparisons. See Tr. 618:15—619:3 (discussing Dudash Ltr. Ex. Vol.3, PX-15,
at 56. ECF No. 245-4).
In addition to bleed reduction, Hemlibra has added benefits over existing therapies. As
described by the witnesses at the hearing, the treatment burden for Hemlibra is significantly
lower than for Factor VIII replacement. “The Factor VIII infusions take at best 10 to 15 minutes.
Sometimes they take longer, especially if a child is not being cooperative or if they’re trying to
find a vein and they can’t find one.” Tr. 549:17—21. These infusions are administered “at least
two times a week, often three times a week or every’ other day.” Tr. 552:22—24. For many
patients a once-weekly subcutaneous injection would be a substantial improvement and would
increase their willingness to take prophylactic treatment. In the words of another doctor who
oversees 1-lemlibra development for Genentech, “I’ve heard from patients and from physicians,
who essentially say that even with the spectacular numbers, the numbers are not telling the whole
story of the change that is going on in patients’ lives. It’s dramatic.” Tr. 596:2—6.
Because of the treatment burden involved, many patients who are on phrophylaxis fail to
comply with their treatment regimen. See, e.g., Yr. 563:1—18; 599:19—22. With Hemlibra,
compliance by those patients would significantly increase. See Yr. 198:7—10; 56t.10—24; 596:1—
26
6; Liverman Dee!.
¶ 6,
ECF No. 99. Then there is the remaining roughly 40% of noninhibitor
patients, W11o receive Factor VIII rep!acement only on-demand. The record establishes that
many of these patients “should be on Factor VIII prophylaxis because of the severity of their
hemophilia.
.
,
but they simp!y either cannot do it because of venous access issues or they
cannot do it because of time issues, because of difficulties with the treatment burden.”
Tr. 563:3—8; accord Tr. 564:16—24, 582:4—19. That such a !arge share of the noninhibitor
popu!ation is not on prophy!axis is itself evidence of the treatment burden the current therapies
impose. For these patients, 1-lemlibra is an opportunity to get on a prophylactic therapy with a
significant!y !ower treatment burden. Even Dr. Aledort agreed that these patients, if compliant
with their prescriptions, would experience as much as a 96% reduction in bleeding episodes
when switching from using only on-demand Factor VIII replacement to Hemlibra. See Tr.
206:14—19, 207:13—208:5, 208:22—210:23; see ahvo Tr. 598:5—599:2.
Finally, one of Baxalta’s primary pub!ic-interest arguments is that Hemlibra poses a risk
to the public in the form of adverse events or side effects. The suggestion that Hemlibra is
somehow a danger to the public, based on the evidence in this record, is without support. For
this proposition, Baxa!ta re!ies on a handful of patient deaths and serious adverse events that
have occurred during the clinical trials for 1-lemlibra. But Genentech witnesses exp!ained that
these deaths and adverse events were in some cases entire!y unrelated to Hem!ibra and, in others,
arose from a combination of Hem!ibra and Baxa!ta’s product, Feiba, that has resulted in an FDA
warning to doctors and patients to be vigi!ant with respect to that combination. See Tr. 566:8—
567:6, 600:7—609:13.
For noninhibitor patients—those who would be barred from receiving Hem!ibra under
Baxalta’s proposed injunction— Hemlibra represents a potential sea change in the treatment of
27
their hemophilia. The public interest favors availability of that treatment to the noninhibitor
population once approved by the FDA. The proposed carveouts would not make that treatment
available to the vast majority of noninhibitor patients in need of Hemlibra treatment. In the face
of this overwhelming evidence, Baxalta has not shown that an injunction would be in the public
interest. Any irreparable injury to Baxalta from the sale of Hemlibra to the noninhibitor
population is far outweighed by the public interest in making Hemlibra available to that
population.
28
CONCLUSION
lta’s likelihood of success on
Genentech has raised difficult questions concerning Baxa
‘590 patent and whether claim 1
the merits, including whether Hemlibra infringes claim 1 of the
ent. At the same time, Baxalta has
is invalid for failure to satisfy the written-description requirem
harm or that the public interest
failed to establish that it is at risk of significant irreparable
ming that Baxalta could show a
weighs in favor of enjoining the sale of Renlibra. Even assu
of significant irreparable harm, and
likelihood of success on the merits, in light of the absence
est preliminary injunctive relief is not
Genentech’s especially strong showing on the public inter
ry injunction is DENIED.
appropriate. Accordingly. Baxalta’s motion for a prelimina
71*.
IT IS SO ORDERED this 64 day of August, 2018.
Honorable Timothy B. Dyk
United States Circuit Judge, sitting by designation
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