Impax Laboratories Inc. et al v. Lannett Holdings Inc. et al
Filing
169
TRIAL OPINION. Defendants have failed to prove the Dearn patents are invalid. If desired, Defendants should request an opportunity to cross-examine Ms. Allen within one week. If Defendants do not make that request, the parties should submit an agreed upon form of final judgment within two weeks. Signed by Judge Richard G. Andrews on 3/29/2017. (nms)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
IMPAX LABS., INC., ASTRAZENECA AB,
and ASTRAZENECA UK LTD.,
Plaintiffs,
Nos. 14-cv-984, 14-cv-999 (RGA)
v.
LANNETT HOLDINGS INC. and LANNETT
Co., INC.,
Defendants.
TRIAL OPINION
Steven J. Balick, Esq., Tiffany Geyer Lydon, Esq., Andrew C. Mayo, Esq., Ashby &
Geddes, Wilmington, Del.; Jim Hurst, Esq., Marcus E. Sernel, Esq., Alyse Wu, Esq.,
Kirkland & Ellis LLP, Chicago, Ill.; Stefan M. Miller, Esq., Ashley Borom, Esq., Sam
Kwon, Esq., Kirkland & Ellis LLP, New York, N.Y., attorneys for Plaintiffs Impax
Labs., Inc., AstraZeneca AB, and AstraZeneca UK Ltd.
Seth A. Niederman, Esq., Austen C. Endersby, Esq., Fox Rothschild LLP,
Wilmington, Del.; Joseph F. Posillico, Esq., Frank Carroll, Esq., Fox Rothschild LLP,
Philadelphia, Pa.; Michael W. Glynn, Fox Rothschild LLP, New York, N.Y., attorneys
for Defendants Lannett Holdings, Inc., and Lannett Co., Inc.
/}{,}
March.~L
2017
Plaintiffs Impax Laboratories, AstraZeneca UK ("AZUK"), and AstraZeneca
AB ("AZAB") brought suit against Defendants Lannett Holdings, Inc. and Lannett
Company, Inc. for infringement of U.S. Patent Nos. 6, 750,237 and 7,220, 767 ("the
Dearn patents").
The Dearn patents claim invention of a nasal formulation for zolmitriptan.
Zolmitriptan is a member of the triptan class of drugs, which treat migraines.
AstraZeneca Pharmaceuticals LP holds New Drug Application No. 21450 for
zolmitriptan nasal spray. Zolmitriptan nasal spray, as well as other zolmitriptan
products, are marketed as Zomig. The Dearn patents are listed in the Orange Book
as covering Zomig.
Plaintiffs brought this infringement suit after Defendants filed Abbreviated
New Drug Application No. 206350. Defendants stipulated to infringement.I (D.I.
136). Defendants argue, however, that (1) Plaintiffs do not have standing to bring
suit, (2) the Dearn patents are invalid as anticipated, and (3) the Dearn patents are
invalid as obvious.
1 Defendants waited until after trial to offer this stipulation. Yet, they offered no evidence on noninfringement at the trial. Nor have they offered any colorable argument as to why their ANDA, as
filed, would not infringe the asserted claims, as construed. This delay required Plaintiffs to put on
unnecessary expert testimony on infringement and wasted everyone's time for no apparent reason.
2
The Court held a three day trial on September 6, 7, and 8, with closing
arguments on the 9th. I now address each of Defendants' arguments in turn. My
findings of fact and conclusions oflaw are stated below.
I.
STANDING
Defendants challenge Plaintiffs' standing to bring suit. Essentially,
Defendants argue that Plaintiffs have failed to establish the exact ownership
arrangement of the patents, and, as such, I cannot be sure that all the ownership
interests are represented.
Standing to sue is a jurisdictional requirement under Article III of the United
States Constitution. Lujan v. Defs. of Wildlife, 504 U.S. 555, 560 (1992). In the
patent context, standing usually requires the plaintiff to have legal title to the
patent. Abraxis Bioscience, Inc. v. Navinta LLC, 625 F.3d 1359, 1364 (Fed. Cir.
2010). Further, when ownership is divided, all owners usually must participate as
plaintiffs for standing to be proper. See Textile Prods., Inc. v. Mead Corp., 134 F.3d
1481, 1484 (Fed. Cir. 1998).
Following the bench trial, both parties submitted briefing on standing (D.I.
145, 152, 157)2 and Plaintiffs submitted a declaration by Amy Allen (D.I. 145-1), the
Director of Sales Planning and Operations for AstraZeneca, (Id. at
2
All docket references are to the docket in No. 14cv984.
3
if 1).
A.
Admissibility of the Allen Declaration
As a preliminary matter, Defendants move to strike the Allen declaration.
(D.I. 152 at 17-19). Defendants argue it is unfair to allow Plaintiffs to submit new
evidence this late and without an opportunity for them to cross-examine Ms. Allen.
I do not agree that the admission of the declaration or other evidence of
standing is unfair or untimely. While parties are supposed to use the pretrial order
process to identify the issues for trial, see D. Del. LR 16(c)(5), 16(d)(4), Defendants
did not raise standing as an issue to be tried in the pretrial order (see D.I. 140), and
only brought it up at the pretrial conference (D.I. 121 at 24). That is why, at the
conference, I told the parties that I did not consider standing an issue for trial. (Id.).
It would be unfair to Plaintiffs if, after telling them not to produce evidence of
standing at the trial, I then told them they also could not produce evidence of
standing outside the trial.
I do not believe cross-examination of Ms. Allen is necessary to rely on her
statements to find standing. Defendants argue that Ms. Allen's prior testimony calls
her knowledge into question. (D.I. 152 at 18). Specifically, in her deposition, Ms.
Allen stated that she did not know how Zomig came to AstraZeneca. (D.I. 152-2 at
3). She also stated that she was unsure if anyone other than Impax approached
AstraZeneca about licensing Zomig. (Id.). Neither issue is at all relevant to the
standing question in the case.
Nevertheless, out of an abundance of caution, if Defendants want to have Ms.
Allen testify live, which is not a request they have made, I will schedule such a
4
hearing at a convenient date. In the meantime, I have made a provisional ruling on
standing based on the Allen declaration. Defendants have one week to request a
hearing. If that hearing so requires, I will reconsider my standing ruling.
B.
Analysis
On the faces of the Dearn patents, AZAB is the assignee. (See also DX 111 at
30-37 (USPTO Notice of Recordation of Assignment Document)). The patents issued
in 2004 and 2007, and they both ultimately relate back to application 10/129, 773,
filed on November 28, 2000.
The patents claim priority from a 1999 United Kingdom patent application,
No. 9928578.5. On June 27, 2000, AZUK assigned to AZAB all rights related to the
UK patent application. (PX 239). Plaintiffs contend this assignment applies to the
Dearn patents. (D.I. 145 at pp. 2-3). The agreement stated that AZUK was granting
AZAB "all rights in the Inventions [contained in various patent applications
including GB 9928578.5] and its rights to apply for prosecute and obtain patent or
similar protection in respect of the Inventions in any and all of the countries of the
world .... " (PX 239 at pp. 1, 4). The agreement does not appear to contemplate any
reservation of interest by AZUK.
AstraZeneca also contends that a 2002 Patent Administration Services
Arrangement applies to the Dearn patents. (D.I. 145 at pp. 6-7; D.I. 145-1
at~
4).
The 2002 administration agreement explicitly reserves to AZUK a "beneficial
ownership" interest in "certain patent[s]." (PX 240 at 1-2). This agreement does not
appear to describe which patents are the "certain patent[s]" covered. (PX 240 at 1).
5
Plaintiffs have proffered no addendum or definitional section showing that the
Dearn patents are covered by the 2002 Agreement.
While AZAB is the assignee of both patents and the 2000 assignment
agreement purports to give AZAB all rights in the patents, the 2012 licensing
agreement is between AZUK and Impax. (PX 8). The 2012 licensing agreement
purports to bind AZUK and its affiliates. (Id. at 60). Affiliates are defined by the
agreement as two entities under common control. (Id. at 8). Ms. Allen, who
represented AztraZeneca in negotiation of the licensing agreement, stated that
AZAB consented to the license. (D.I. 145-1 at
if 8). Ms. Allen's declaration also
confirms that AZAB and AZUK are commonly owned by AstraZeneca PLC and thus
would be affiliates. (Id. at
if
7).
Impax holds an exclusive license. (PX 8 at 61). Ms. Allen also swore in her
declaration that the patents have not been further licensed or assigned. (D.I. 145-1
at
ifif 9-10).
Defendants hone in on the gap between AZAB and AZUK. They argue that I
cannot be sure that all ownership interests are represented without Plaintiffs
having filled this gap. There is no reason to believe, however, that all ownership
interests are not represented. I credit Ms. Allen's assertion that AZAB consented to
an exclusive license to Impax and that no further assignments of the Dearn patents
have been made. Her assertion is bolstered by the fact that Impax was satisfied that
it had successfully executed an exclusive license to the patents, which it could not
have done had a third party had some interest in them.
6
It is possible, based on the documents before the Court, that AZUK has no
ownership interest in the patents, in which case AZUK should not be a plaintiff. On
the one hand, the 2012 licensing agreement between AZUK and lmpax is consistent
with Plaintiffs' argument that the 2002 service arrangement covers the Dearn
patents. On the other hand, Plaintiffs have offered no proof that the 2002
agreement does, in fact, extend to the Dearn patents. Defendants, however, have
not moved to dismiss AZUK, but only to dismiss the case in toto for lack of standing.
Because there is a valid assignment of the patents to AZAB, AZAB has consented to
an exclusive license to lmpax, and there is no evidence that the Dearn patents have
been assigned outside of the three plaintiffs, I find that within the plaintiff class
there is standing. There is no missing plaintiff. Thus, I have subject matter
jurisdiction. As stated earlier, I will reconsider this holding if Defendants request a
hearing with Ms. Allen and that hearing necessitates reconsideration.
II.
INVALIDITY
Defendants have two invalidity arguments. Defendants argue that two of the
asserted claims are anticipated by prior patents. Defendants also argue that all of
the asserted claims are obvious in light of the prior art.
First, I describe the inventions in the asserted claims. Second, I make
findings on the person of ordinary skill in the art. Third, I make findings on the
scope of the prior art that is relied on for Defendants' anticipation and obviousness
arguments. Fourth, I address Defendants' anticipation argument and find that
Defendants have failed to prove by clear and convincing evidence that the asserted
7
claims are anticipated. Fifth, I address Defendants' obviousness argument and find
that Defendants have failed to prove the patents are obvious by clear and
convincing evidence.
A. The Patents in Suit
The '767 patent is a continuation of the '237 patent and both generally relate
to pharmaceutical formulations of zolmitriptan. Claims 4, 11, 12, and 14 of the '237
patent and claims 6, 14, 15, and 16 of the '767 patent are asserted in this case. (D.I.
151at48-49). Claim 14 of the '237 patent and claim 14 of the '767 patent have four
and twelve possible iterations respectively.
Each claim involves zolmitriptan with different combinations of five
characteristics: (1) form, (2) pH, (3) buffer, (4) sterility, and (5) packaging.
All but two claims require a pharmaceutical formulation suitable for
intranasal administration. Claims 15 and 16 of the '767 patent require an aqueous
solution. Defendants have made no unique invalidity arguments as to Claims 15
and 16. Thus, I will treat them in kind with the other claims.
The other characteristics are claimed and asserted in the following
combinations:
4
5
NIA
Buffered
(+I- .04)
11
4.5 to 5.5
NIA
Buffered in citric
8
NIA
14(i)
14(ii)
NIA
Intranasal administration
device packaged to protect
the formulation from light
NIA
NIA
Intranasal administration
device packaged to protect
the formulation from light
Intranasal administration
device packaged to protect
the formulation from light
4.5 to 5.5
5
(+I- .04)
14(iii)
<7
Buffered in citric
acid and disodium
phosphate
NIA
14(iv)
4.5 to 5.5
Buffered in citric
acid and disodi um
phosphate
NIA
Intranasal administration
device packaged to protect
the formulation from light
:7'67 ~arent
6
3.5 to 5.5
Buffered in citric
acid and disodium
phosphate
NIA
NIA
14(i)
<6
NIA
NIA
14(ii)
3.5 to 5.5
NIA
NIA
14(iii)
<6
Buffered
NIA
Intranasal administration
device packaged to protect
the formulation from light
Intranasal administration
device packaged to protect
the formulation from light
Intranasal administration
device packaged to protect
the formulation from light
14(iv)
3.5 to 5.5
Buffered
NIA
Intranasal administration
device packaged to protect
the formulation from light
14(v)
<6
Buffered in citric
acid and disodi um
phosphate
NIA
Intranasal administration
device packaged to protect
the formulation from light
14(vi)
3.5 to 5.5
Buffered in citric
acid and disodium
phosphate
NIA
Intranasal administration
device packaged to protect
the formulation from light
9
t~~J;;;:f~ti~t~'.:~>~-; ,',
14(vii)
<6
NIA
Sterile
14(viii)
3.5 to 5.5
NIA
Sterile
14(ix)
<6
Buffered
Sterile
14(x)
3.5 to 5.5
Buffered
Sterile
14(xi)
<6
Buffered in citric
acid and disodium
phosphate
Sterile
Intranasal administration
device packaged to protect
the formulation from light
14(xii)
3.5 to 5.5
Buffered in citric
acid and disodium
phosphate
Sterile
Intranasal administration
device packaged to protect
the formulation from light
15
<6.0
Buffered
16
3.5 to 5.5
Buffered
NIA
NIA
NIA
NIA
B.
Intranasal administration
device packaged to protect
the formulation from light
Intranasal administration
device packaged to protect
the formulation from light
Intranasal administration
device packaged to protect
the formulation from light
Intranasal administration
device packaged to protect
the formulation from light
Person of Ordinary Skill in the Art
The skilled artisan is an individual with a bachelor's of science or master's
degree in pharmacy or chemistry and five years of experience related to
pharmaceutical formulations, or a doctorate or medical degree and a lesser degree
of experience. The experts did not significantly disagree on the person of ordinary
skill in the art. (See Tr. at 409, 689-90). The skilled artisan here need not have a
specialty in nasal formulations. (Tr. at 690).
10
C.
Prior Art
In assessing Defendants' anticipation and obviousness arguments, first I
must make factual findings on the state of the art at the time of invention.3
Defendants rely on all four references for their obviousness case and the Chauveau
and Marquess references for anticipation.
The priority date for both patents is December 3, 1999, the date of the U.K.
patent application. (Tr. 689-90; see '237 Patent; '767 Patent). All asserted prior art
predates December 3, 1999, and their status as prior art is not contested.
i.
Sumatriptan Nasal Spray
As of 1997, a sumatriptan nasal spray was being used to treat migraines. (Tr.
at 185). 4 The branded name of sumatriptan nasal spray is Imitrex. (Tr. at 90). As
formulated, Imitrex is buffered in disodium phosphate and has an approximate pH
of 5.5. (DX 63 at 8; D.I. 146 at 14; D.I. 151 at 35). Imitrex has "a very bad taste, a
very bitter taste." (Tr. at 195).
Both sumatriptan and zolmitriptan are triptans, a migraine specific family of
drugs. (DX 117 at pp. 403-04). Sumatriptan was the first to market; zolmitriptan
3
Defendants cited other prior art to show that pH, buffer, sterility, and packaging were
previously disclosed. While I have considered those references, because my invalidity opinion hinges
on the basic invention at issue, namely putting zolmitriptan into a nasal spray, here I have focused
on the prior art relevant to that issue.
4
The trial transcript ("Tr.") is available at D.I. 164, 165, 166 and 167. It is consecutively
paginated.
11
the second. (Id. at p. 403). In 1999, there were seven additional triptans in testing.
(Tr. at 213; see also DX 117 at pp. 403-04).
As I will discuss, zolmitriptan has a more powerful, active metabolite that is
created when zolmitriptan passes through the liver. Sumatriptan, in contrast, does
not have an active metabolite. (Tr. at 214). Only two other triptans, eletriptan and
almotriptan, have active metabolites, but their metabolites "don't really contribute
at all to the efficacy of those drugs." (Id.). Zolmitriptan stands alone in the class of
triptans as having an active, more potent metabolite. (Id.).
ii.
Chauveau
U.S. Patent No. 6,326,401 (JX 4) and French Patent Application No. 2, 773,489
(DX 3) (collectively "Chauveau") both claim a pharmaceutical formulation containing
Labrasol for oromucosal administration. On both the patent and the application,
Jacques Chauveau is the first named inventor. The U.S. Patent claims priority from
the French application and the two documents are the same in relevant part. The
U.S. Patent was filed January 6, 1999. The French Application is dated January 15,
1998.
Chauveau discloses administration through the mouth, nose, or pharynx.
Nasal administration, however, is the preferred route.
Chauveau describes the invention as aimed at solving the problem of active
substances that degrade in the gastrointestinal tract when taken in pill form. (See
'401 Patent, col. 1, 11. 15-20 ("However, this administration route, in which the
active substance is administered by the buccal route, to be delivered into the
12
stomach and the small intestine, has its limits, in particular because a large
number of active substances are degraded in the gastrointestinal tract."); 29-31
("For this reason, new pharmaceutical forms are still being sought, in particular for
active substances which are degraded particularly in the gastrointestinal tract.");
48-52 ("It would thus be desirable to have available an effective pharmaceutical
formulation .. .in particular suitable for medicaments which have a tendency to be
degraded particularly by oral administration."); see also DX 3 at 2-3).
Chauveau offers a laundry list of potential active ingredients. In the '401
patent, over twenty-five categories or examples of medications are given. (' 401
Patent, col. 2., 1. 38-col. 3, 1. 14; see also DX 3 at 4-5). For example, Chauveau
suggests "antibiotics, bacteriostatics, antihistamines, analgesics, .... " Importantly for
present purposes, included in the list is the following: "The active substance can
also be, in particular, an anti-migraine active substance, such as a triptan, such as
sumatriptan or zolmitriptan." ('401 Patent, col. 3, 11. 12-14; DX 3 at 5 (disclosing
same)). The most preferred embodiment in Chauveau has the peptide IS 159 as the
active substance. (Tr. at 720; '401 Patent, col. 2, 1. 50- col. 3, 1. 11; DX 3 at 4).
The Chauveau specification discusses a broad range of pHs. It describes a
preferred embodiment as a "liquid nasal formulation, characterized in that it has a
pH of between 4 and 9, in particular between 5 and 8." ('401 Patent, col. 3, 11. 61-63;
see DX 3 at 6 (disclosing same)). It also describes an embodiment where IS 159 is
the active ingredient and is prepared "in a dose which is effective for the pernasal
route, and in that it has a pH of 4 to 8, in particular 6 to 7." ('401 Patent, col. 4, ll.
13
13-16; see DX 3 at 6 (disclosing same); see also '401 Patent, col. 4, 11. 26-29
(disclosing IS 159 with a pH between 6 and 7); DX 3 at 7 (disclosing same)). In
example 3 of the specification, a pH of 2.5 for triethylaminephosphoric acid is
disclosed. ('401 Patent, col. 6, 1. 28, col. 7, 1. 63; DX 3 at 10, 13). Chauveau's claims
disclose the same pHs as its specification. ('401 Patent, col. 10; DX 3 at 17). These
are the only discussions of pH in Chauveau.
ni.
Marquess
Defendants cite to international application No. PCT/US99/12751 with
Daniel Marquess listed at the first inventor. (JX 3). Marquess mentions
zolmitriptan by name. (E.g., id. at 17). The application was filed June 7, 1999 and
published December 16, 1999. (Id. at 1).
Dr. Alexander Klibanov 5 testified, and I credit the testimony, that
zolmitriptan as used in Marquess is different than zolmitriptan as used in the
Dearn patents. (See Tr. at 729-30 ("[Z]olmitriptan is clearly outside of the scope of
[Marquess.]")). Marquess is directed at drugs that are covalently linked to other
drugs. (Tr. at 728-29). In my claim construction opinion, I rejected Defendants'
argument that zolmitriptan as used in the Dearn patents includes covalently
5
Dr. Alexander Klibanov is one of Plaintiffs' expert witnesses. He teaches and researches
chemistry and bioengineering at MIT and has done so for nearly forty years. He is a prolific writer
(authored 310+ scientific articles), is an inventor in his own right (holds 21 patents), and is an
entrepreneur in the pharmaceutical formulation space (founded six pharmaceutical companies). He
also has specific experience in pharmaceutical formulations. (D.I. 125-1 at 60-100).
14
bonded zolmitriptan. (D.I. 60 at 7-9). Marquess, therefore, does not disclose
zolmitriptan as used in the asserted claims.
Marquess discusses intranasal administration as one of seven listed methods
of drug delivery. (Tr. at 729; JX 3 at 33). It does not refer to the pH of a nasal
formulation. Defendants argue that because Marquess incorporates by reference
Remington's Pharmaceutical Sciences (DX 6) in its entirety (JX 3 at 35), Marquess
discloses a pH level. (D.I. 146 at 13). At page 1502, Remington's discusses nasal
solutions and states that they "usually are isotonic and slightly buffered to
maintain a pH of 5.5 to 6.5." (DX 6 at 1571). I do not find this reference to the
entirety of Remington's effectively discloses a single reference to pH on one page of a
volume spanning over 1900 pages. See Advanced Display Sys. Inc. v. Kent State
Univ., 212 F.3d 1272, 1282-83 (Fed. Cir. 2000). Thus, Marquess also does not
disclose a pH for zolmitriptan, even covalently bonded zolmitriptan.
w.
Tepper and Rapoport
In a November 1999 review article entitled The Triptans: A Summary (DX
117), Drs. Stewart Tepper and Alan Rapoport state that a "nasal spray form [of
zolmitriptan] is under development." (DX 117 at p. 404). The article also indicates
that studies had been conducted on zolmitriptan nasal sprays and fast melt tablets.
(Id. at p. 409). The article, however, only makes passing reference to the nasal
spray.
This article, in discussing zolmitriptan, makes reference to the fact that
zolmitriptan creates an active metabolite when digested. (Id. at p. 408). The article
15
discusses zolmitriptan encouragingly, explaining that "a large comparative trial"
found it more effective than sumatriptan. (Id. at p. 409).
The article does not discuss any other elements of the asserted claims such as
pH, buffer, sterility, or packaging.
D.
Anticipation
Having made findings on the scope of the prior art, I turn to Defendants' first
invalidity argument. Defendants argue that the Marquess and Chauveau references
anticipate claim 4 of the '237 patent6 and claim 15 of the '767 patent. (D.I. 146 at
23-26, 28-30).
A patent claim is invalid as anticipated under 35 U.S.C. § 102 if "within the
four corners of a single, prior art document ... every element of the claimed
invention [is described], either expressly or inherently, such that a person of
ordinary skill in the art could practice the invention without undue
experimentation." Callaway Golf Co. v. Acushnet Co., 576 F.3d 1331, 1346 (Fed.
Cir. 2009) (alterations in original) (internal quotation marks omitted).
"[T]he hallmark of anticipation is prior invention." Net MoneyIN Inc. v.
Verisign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). Thus, "the prior art reference ...
Defendants state in a headline to their brief that claim 14 of the '237 patent is anticipated
(D.I. 146 at 27), but direct no argument to it (see id. at 27-28). Claim 14 requires specific packaging
and Defendants have not even attempted to show that Marquess or Chauveau include a packaging
disclosure.
6
16
must not only disclose all elements of the claim within the four corners of the
document, but must also disclose those elements 'arranged as in the claim."' Id.
Both claim 4 and claim 15 require at least (1) zolmitriptan, (2) in a nasal
spray (3) at a certain pH. Thus, to anticipate, the prior art must at least disclose
zolmitriptan in a nasal spray at the claimed pHs of either 5 (+/-.04) or <6. 7
Defendants rely on Marquess for anticipation. As I found, supra II.C.iii.,
Marquess does not disclose a pH and does not disclose zolmitriptan as used in the
Dearn patents. Thus, Marquess does not anticipate the claimed inventions.
Defendants also rely on Chauveau for anticipation. Chauveau discusses pH
at several points. Several of its disclosures, however, relate to the pH of specific
substances, in particular, to a pH for IS 159 and for an acid. Zolmitriptan is not the
referenced acid, nor is it IS 159, and thus those disclosures are not anticipating.
The only potentially relevant disclosure, then, is the description of an
embodiment including a "liquid nasal formulation, characterized in that it has a pH
of between 4 and 9, in particular between 5 and 8."
Both 4 to 9 and 5 to 8 are broad ranges and include both acidic and alkaline
pHs. (Tr. at 723). All of the asserted claims are under 7 and thus are acidic, not
The asserted claims also require a buffer. Defendants argue both that a buffer is inherent
and that Chauveau's reference to excipients discloses a buffer. First, a buffer is not inherent because
a nasal spray does not necessarily function with the use of a buffer. In fact, all nasal examples in
Chauveau are unbuffered. (Tr. at 724-25). Second, Chauveau's generic reference to excipients does
not disclose a buffer. Chauveau makes no mention of buffers and no other language in Chauveau
would lead a skilled artisan to think it means buffer when it says excipients. (Id.).
17
alkaline. See "Alkaline," Merriam-Webster Dictionary (Online ed.) (accessed Mar. 21,
2017). Chauveau's broad disclosure is not "sufficient[ly] specific to anticipate th[e]
limitation[s] of the claim." Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999
(Fed. Cir. 2006). Even if it was sufficiently specific, Chauveau gives no reason to
connect this discussion of pH and zolmitriptan. (Tr. at 724). Thus, the reference
does not disclose all of the elements as arranged in the claim.
E.
Obviousness
Having rejected Defendants' anticipation argument, I turn to Defendants'
second invalidity argument. Defendants argue that all of the asserted claims are
obvious.
The presumption that all patents are valid is the starting point for any
obviousness determination. 35 U.S.C. § 282. A patent claim is invalid as obvious
under 35 U.S.C. § 103 if the novel aspect of the claimed invention "would have been
obvious ... to a person having ordinary skill in the art .... " Id. § 103(a); see also KSR
Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406-07 (2007).
Obviousness is a question of law that depends on the following factual
inquiries: (1) the scope and content of the prior art; (2) the differences between the
claims and the prior art; (3) the level of ordinary skill in the relevant art; and (4)
any objective indicia of nonobviousness. See KSR, 550 U.S. at 406; see also
Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d
1340, 1347 (Fed. Cir. 2012).
18
A court is required to consider secondary considerations, or objective indicia
of nonobviousness, before reaching an obviousness determination, as a "check
against hindsight bias." In re Cyclobenzaprine Hydrochloride Extended-Release
Capsule Patent Litig., 676 F.3d 1063, 1079 (Fed. Cir. 2012). Relevant secondary
considerations include commercial success, long felt but unsolved needs, failure of
others, praise, unexpected results, and copying, among others. Graham v. John
Deere Co., 383 U.S. 1, 17 (1966); Ruiz v. A.B. Chance Co., 234 F.3d 654, 662-63
(Fed. Cir. 2000); Diversitech Corp. v. Century Steps, Inc., 850 F.2d 675, 679 (Fed.
Cir. 1988).
To prove obviousness, a party must show that a skilled artisan would have
been motivated to combine the prior art teachings to create the claimed treatment
method with a reasonable expectation of success. See Allergan, Inc. v. Sandoz Inc.,
726 F.3d 1286, 1291 (Fed. Cir. 2013). The improvement over prior art must be
"more than the predictable use of prior art elements according to their established
functions." KSR, 550 U.S. at 417. Evidence of obviousness, especially when that
evidence is proffered in support of an 'obvious-to-try' theory, is insufficient unless it
indicates that the possible options skilled artisans would have encountered were
'finite,' 'small,' or 'easily traversed,' and that skilled artisans would have had a
reason to select the route that produced the claimed invention." In re
Cyclobenzaprine Hydrochloride, 676 F.3d at 1072 (quoting Ortho-McNeil Pharm.,
Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008)). Obviousness must
be proven by clear and convincing evidence. Id. at 1078.
19
i.
First Pass Metabolism
When ingested, a drug travels through the gastrointestinal tract, is absorbed
into the bloodstream through the small intestine, and "goes right through the portal
system to the liver." (Tr. at 215). In the liver, a portion of the drug is converted to
metabolites. (Tr. at 215-16). In the normal case, the metabolites are inactive. (Tr. at
215). The inactive metabolites are then expelled from the body. (Id.).
Only after this process-called "first pass metabolism"-does an ingested
medication "work on the endO organ." When nasal formulations are used, first pass
metabolism is delayed. (Tr. at 216-17). The drug enters the bloodstream directly
through the nasal mucosa and circulates longer before reaching the liver. (Id.).
None of the active ingredient is lost initially. (Tr. at 217). This is one of the main
benefits of putting a drug in a nasal formulation.
Zolmitriptan, however, has a unique attribute that changes the calculus.
First pass metabolism results in an active metabolite, 183C91, which is two to eight
times more powerful than zolmitriptan itself. (Tr. at 219, 779; see also Tr. at 629).
183C91 is only created, though, when zolmitriptan is metabolized by the liver.
Thus, bypassing the liver, which is a benefit of nasal sprays for most drugs, would
appear to be a detriment for zolmitriptan.
This attribute of zolmitriptan supports nonobviousness in three ways.
First, the state of the art taught away from putting zolmitriptan in a nasal
spray because of its active metabolite. A skilled artisan would have been aware of
183C91. The skilled artisan would have been discouraged from using a method that
20
did not fully utilize the metabolite. Dr. Rapoport testified, Dr. Klibanov echoed, and
I agree that it would be "absolutely counterintuitive to make a nasal spray when
you have an active metabolite which is more potent ... than the drug itself.... " (Tr. at
261, see Tr. at 780). While resisting the conclusion, Defendants' expert, Dr.
Sveinbjorn Gizuarson, 8 acknowledged that a skilled artisan would have been aware
of 183C91 and would have considered its greater potency. (Tr. at 629-31).
As all other triptans, including sumatriptan, do not rely on an active
metabolite for therapeutic effectiveness, a skilled artisan would look to any of the
other triptans before looking to zolmitriptan to develop a pharmaceutical product
that would not take advantage of first pass metabolism.
Chauveau specifically teaches away from using zolmitriptan because of its
active metabolite. While not using the term "first pass metabolism," Chauveau
states it is solving the problem of drugs that degrade when digested.9 A skilled
artisan would read Chauveau and be pointed away from a zolmitriptan nasal spray,
because zolmitriptan's "degrading" is what made it a beneficial drug.
8
Dr. Sveinbji:irn Gizuarson is one of Defendants' expert witnesses. He holds a doctorate in
pharmacy and has focused on intranasal drugs. He has taught for 10+ years at the University of
Copenhagen and the University oflceland and founded a research and development company
focused on creating intranasal drugs. (D.I. 124-1 at 3).
9
Marquess also teaches away from placing zolmitriptan in a nasal spray. Marquess says that
"drugs that act indiscriminately" have undesirable side effects. (JX 3 at 4). Dr. Klibanov explained
that this language would discourage a skilled artisan from using zolmitriptan without covalently
attaching it to another drug. (Tr. at 731).
21
The state of the art at the priority date taught away from using zolmitriptan
in a nasal spray. This is strong evidence of nonobviousness.
Second, because of zolmitriptan's reliance on its active metabolite, the prior
art failed to teach that zolmitriptan by itself would be effective. When administered
nasally, 183C91 takes longer to appear in the bloodstream. (PX 74 at 4-5; Tr. at
219-20; see also Tr. at 634). One study compared Zolmitriptan administered by a
nasal spray at pH 5.0 to a Zolmitriptan oral tablet and studied the presence of
183C91 in the plasma over time:
-]1t:rf-¢c14~ttuJ fllt'$..l\I ~>Rtl' !"'#~ ~
ln·O'\~t tf)l.O\fl 1.-\~i ~A.a~·~;_.· .i;
l.ntttt:·tt1Wlr11ttilft\t»1:t
"
Time PDSldo•e (mtnute&J
,\ ,,.,~-rwl/'f,,rt :urf11,'u,',·1r ,!:1.U .1 J:, t J /111i:f~
~t'lt~· ..:
n
JJt:,'i•
:,·)11-,-pu~1,,r ri,,•I 1?.'J.'<'J Hrf<"·11' ill/.- .J,VLf f'f ( .. f a;,f .1, T
(PX 74 at 5). As this graph shows, 183C91 does not show up in the bloodstream
until thirty minutes after taking a nasal spray. It is never present in as high a
concentration as it is from an oral tablet. The metabolite is not present at an equal
level until three hours after administration.
22
Zolmitriptan itself, in contrast, was present in the bloodstream faster with
the nasal spray:
-lntr:JtJ1ty•·, ,,~l ""''"''~pH•,·.
l"Jfn"Jhtr.til' -.a".,.")I M>Wf pl j ; .l
r :""I/I •Jfl"J ,'1>-''1•,",f .,,' "; fli
,J:lo
·""•!
lPltl,'
;.,;:.f,tr1 ';.
, ,,,,;...;,~ ''\
13
I~
;;_•;
(Jd.). Thus, any relief from a nasal spray before the thirty minute mark is from
zolmitriptan itself, not from 183C91. (Tr. at 219-21).
The state of the art in 1999 did not teach that zolmitriptan itself would have
any therapeutic effect. Dr. Alan RapoportlO testified he was unaware of any
reference that taught as much. (Tr. at 221). When Dr. Gizuarson was asked to point
to such a reference, he was unable to do so. (Tr. at 639).
Third, a skilled artisan would not have had a motivation to combine
zolmitriptan with a nasal spray. Defendants have not shown the motivation existed,
and the prior art did not give a reason to do so. Given what was known about how
10
Dr. Alan Rapoport was one of Plaintiffs' expert witnesses. He is a medical doctor focused on
neurology. He has extensive experience treating migraine patients and participating in medical
discourse on the best treatments for migraines. He is a co-author of the prior art reference bearing
his name. (D.I. 125-1at1-27).
23
zolmitriptan worked, a skilled artisan would not have had a reasonable expectation
of success in combining zolmitriptan in a nasal spray. Thus, there is not a prima
facie case of obviousness.
ii.
Secondary Considerations of Nonobviousness
Secondary considerations of nonobviousness are important because they
"serve as insurance against the insidious attraction of the siren hindsight .... " W.I.
Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1553 (Fed. Cir. 1983).
Defendants' evidence fails to establish a prima facie case that the Dearn patents are
obvious. Nonetheless, I will also examine the secondary considerations.
A patentee is not required to present evidence of secondary considerations.
See Prometheus Labs., Inc. v. Roxane Labs., Inc., 805 F.3d 1092, 1101 (Fed. Cir.
2015). That said, if the patent challenger establishes a prima facie case of
obviousness, "the patentee would be well advised to introduce evidence sufficient to
rebut that of the challenger." Id. (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348,
1360 (Fed. Cir. 2007)). There must be enough evidence, however, for me to make a
finding that a given secondary consideration exists by a preponderance of the
evidence. See Apple, Inc. v. Samsung Elec. Co., Ltd., 839 F.3d 1034, 1053 (Fed. Cir.
2016) (en bane). If there is, I will then consider the probative value of each
secondary consideration in light of the evidence produced. That does not mean,
though, that the burden of persuasion on the ultimate question of obviousness
transfers to the proponent of the secondary consideration. Pfizer, Inc., 480 F.3d at
1359. That burden stays always with the patent challenger. Id. at 1359-60.
24
Plaintiffs presented evidence of (1) licensing, (2) commercial success, (3)
industry praise, (4) long felt need, and (5) unexpected results. 11 I will discuss each
in turn.
Licensing
Impax paid AstraZeneca $130 million for an exclusive license to the Zomig
franchise and agreed to varying royalty rates, including 40% on the nasal spray. 12
(Tr. at 78-79; PX 8 at 71). That payment included the rights to the nasal spray and
oral formulations. (Tr. at 81). The payment of $130 million is an objective indicator
that the market valued the licensed technology. The question then is whether there
is a nexus between the payment and the Dearn patents specifically.
The license went into effect January 31, 2012. (PX 8 at 7). Mr. Clark testified
that the patents protecting the oral formulations expired in April 2013, a little more
than one year later. (Tr. at 81). In contrast, the Dearn patents do not expire until
2021. (Tr. at 80-81).
The prior sales data (PX 42) do not suggest that Impax would recoup its
entire investment from oral formulations sales in the period where the tablets still
11
Plaintiffs also argued that copying by Summit is an objective indicia of the nonobviousness of
the pH claimed by the Dearn patents. (D.I. 151 at 26). That argument, however, does not speak to
the main invention, putting zolmitriptan in a nasal spray and is not strong either way. See BristolMyers Squibb Co. v. Teva Pharma. USA, Inc., 923 F. Supp. 2d 602, 676 (D. Del. 2013), aff'd, 752 F.3d
967 (Fed. Cir. 2014) (stating that copying in the Hatch-Waxman context "is not compelling evidence"
of nonobviousness).
12
There can be no serious dispute Zomig nasal spray embodies the claims of the Dearn patents.
(See Tr. at 137-38).
25
had patent protection. The net sales from a twelve month period ending September
30, 2011, the year before the licensing agreement took effect, totaled $163 million.
(PX 8 at 271). The prior sales data show during that same time the nasal spray
made up about twelve percent of Zomig sales and the oral formulations about
eighty-eight percent. (PX 42). Without expert testimony or profit data, it is difficult
to say how much of the licensing payment lmpax could expected to recoup from the
oral formulations. I think it is clear, however, lmpax could expect to recoup a
significant sum from sales of the oral formulation in the fifteen month period the
patents would last. If sales remained constant, then Imp ax could expect net sales of
$116.5 million during that period, after the royalty payment to AstraZeneca. 13 Thus,
I find there is a nexus between the licensing of the nasal spray and the licensing
payment, as I find that a portion of the $130 million had to be based on expected
profits from Zomig nasal spray. This conclusion is bolstered by the press release
issued following the licensing agreement. In it, lmpax emphasized the nasal spray
as the focus of the acquisition. (PX 8 at 271) ("[W]e look to build sales of the Zomig®
nasal spray dosage form.").
I find that Plaintiffs' licensing evidence is proof of a secondary consideration
of nonobviousness.
is To arrive at this number, I multiplied the percent of sales attributable to the oral formulations,
eighty-eight percent, by the net sales for the twelve month period, $163 million. I then subtracted
the thirty-five percent royalty payment to AstraZeneca and calculated a per month average and
multiplied that average by fifteen months.
26
Commercial Success
Plaintiffs presented evidence of commercial success in the form of revenue
growth and market share.
Plaintiffs' evidence of revenue growth is inconclusive. It demonstrates
revenue growth but only after Impax took over in 2012. (See Tr. at 86). With
Impax's stated focus on increasing marketing of the nasal spray (PX 8 at 271), the
growth cannot be clearly attributed to the invention in the Dearn patents.
The market share data is also inconclusive. It does not speak for itself and
Plaintiffs did not offer sufficient context for it to carry probative force.
Ninety-six percent of the migraine treatment market remains oral
formulations. (Tr. at 89; PX 42). Zomig nasal spray represents about one percent of
the total market. (Id.).
The nasal spray market is as follows:
NASAL MARKET SHARE
27
(Tr. at 90; PX 42). 14 As a branded drug, zolmitriptan (Zomig) far outpaces
sumatriptan (Imitrex). Zomig does not have a close generic. (See Tr. at 101, 104).
Sumatriptan's generic has half the total nasal market. Compared to sumatriptan's
total nasal market share, fifty-five percent, zolmitriptan is behind at thirty-five
percent. The problem with this data, ultimately, is that there is no point of
reference to understand it. Plaintiffs offered no expert testimony on the significance
of zolmitriptan's market share. For the reasons discussed, the market share data
does not speak for itself. Thus, it provides no probative evidence of commercial
success. I find that commercial success has not been established.
Ind us try Praise
Plaintiffs offer evidence of industry praise or acclaim in three forms. First,
Dr. Rapoport testified Zomig nasal spray was and is his number one migraine
treatment. (Tr. at 223). Second, Plaintiffs proffered an industry newsletter touting
that the nasal spray "answers pressing need in migraine." (PX 48). Third, Plaintiffs
proffered a marketing survey of 197 neurologists and pediatric neurologists. (PX
96). This evidence has little probative force.
First, Dr. Rapoport, while undoubtedly a leading expert in migraine
treatment, does not describe industry praise by testifying about his personal
14
The market share adds up to 101 % because of rounding.
28
practices and beliefs. His testimony, therefore, is not proof of objective indicia of
nonobviousness.
Second, the industry newsletter, dated July 4, 2001, while praising Zomig
nasal spray, is unsigned. Without knowing who wrote it, attributing any weight to
it would be speculative. It is less than clear that it was written by a person of
ordinary skill in the art and it could well be based on AstraZeneca's self-promotion.
Third, while the marketing survey appears to offer support for the
proposition that Zomig nasal spray is well regarded by neurologists, it was offered
without context. Plaintiffs offered the survey with the testimony of Greg Clark,
Impax's Director of Marketing for the Zomig franchise. (Tr. at 73, 98). 15 Mr. Clark
was not offered as an expert witness nor was any expert or other witness offered to
explain the methodology of the survey and to interpret its meaning. The survey is
also largely irrelevant, as it focused on marketing information and not product
performance.
Thus, I find inadequate proof to support a finding of industry praise.
Long Felt Need & Failure of Others
Plaintiffs have four arguments that zolmitriptan nasal spray met long felt
needs or succeeded where others failed. "In the pharmaceutical industry, the failure
15
At trial, Defendants objected to admission of PX 96 as hearsay. (Tr. at 94). I provisionally
overruled the objection and directed Defendants to renew their objection in the post-trial briefing.
(Tr. at 98). In their briefs, Defendants criticized the survey as "highly subjective," but did not renew
the objection. (D.I. 158 at 21). Thus, it is waived.
29
of others to develop a safe and effective drug often supports the nonobviousness of a
drug that finally achieves success." Bristol-Myers Squibb Co. v. Teva Pharma. USA,
Inc., 923 F. Supp. 2d 602, 680 (D. Del. 2013), aff'd, 752 F.3d 967 (Fed. Cir. 2014)
(citation omitted). The long-felt and unmet need inquiries are judged at the time of
the filing date of the patent. Procter & Gamble Co. v. Teva Pharma. USA, Inc., 566
F.3d 989, 998 (Fed. Cir. 2009).
First, Plaintiffs argue that Zomig nasal spray met a general need for
migraine treatment. This argument can be framed in several ways, all of which fail.
More generally, Zomig nasal spray provided a much needed effective and quick
migraine treatment. More narrowly, the argument runs that zolmitriptan nasal
spray met a long felt need for a migraine treatment nasal spray and succeeded
where others failed. These arguments are flawed in several ways.
For one, Plaintiffs failed to show that other migraine treatments were true
failures. Contrast ViiV Healthcare UK Ltd. v. Lupin Ltd., 6 F. Supp. 3d 461, 496 (D.
Del. 2013), aff'd, 594 F. App'x 686 (Fed. Cir. 2015) (Claimed combination to treat
HIV showed "impressive clinical results" at time when "the art of HIV treatment
was littered with failures .... "). For two, Plaintiffs failed to show that Zomig nasal
spray is clearly considered superior to other migraine treatments. Zomig nasal
spray still only constitutes one percent of the migraine treatment market and
sumatriptan nasal spray still holds a larger overall share of the market. Further,
the marketing survey (PX 96) suggests that many doctors prefer other migraine
treatments.
30
Second, Plaintiffs argue Zomig nasal spray met the long felt need for an
effective treatment of cluster headaches. The nasal spray is approved to treat
cluster headaches in Europe and is the only nasal spray recommended by the
American Headache Association for treatment of cluster headaches. (Tr. at 258-60).
Zomig tablets, however, have also proved effective at treating cluster headaches.
(PX 63 at 11). Sumatriptan injections have as well. (PX 54 at 2). Plaintiffs do not
really dispute the success of either the tablets or the injections. To the extent
Plaintiffs are arguing Zomig nasal spray meets a long felt need for a nasal spray to
treat cluster headaches, they have not produced evidence of that need.
Third, Plaintiffs argue zolmitriptan nasal spray met the long felt need of
treating patients with allodynia. Patients with allodynia experience pain from
physical contact and touching. (Tr. at 251). Allodynia can be difficult to treat
because it happens inside of the brain while medications work outside of the brain.
(Tr. at 252). Zomig nasal spray, however, because it works so quickly, can provide
relief to patients that experience allodynia. (Tr. at 254; PX 195). One study tested
six triptans and only found "significant pain reduction" in one group, those treated
with zolmitriptan nasal spray. (PX 195). Again, while this is an impressive attribute
of zolmitriptan nasal spray, Plaintiffs have failed to provide the necessary context
to characterize this as satisfying a long felt need. For example, while this one study
shows zolmitriptan was the only effective triptan, it does not settle the question of
whether other drugs can effectively treat allodynia. Nor have Plaintiffs produced
evidence of the failed attempts of others.
31
Fourth, Plaintiffs argue that zolmitriptan nasal spray satisfies a long felt
need because it is approved to treat teenagers. In fact, it is the only nasal spray
approved to treat teenagers. (Tr. at 76). Here, Plaintiffs present some evidence of
the failure of others. Dr. Rapoport was asked, "did ... the producer of sumatriptan
nasal spray ... make any effort to get themselves approved to treat adolescents
suffering from migraines?" (Tr. at 250). Dr. Rapoport responded "Yes." (Jd.). No
further context, however, was provided. For example, it is unclear whether these
attempts were in the past or present or how significant they were. Again, without
context, Plaintiffs have failed to offer evidence with any probative force that
zolmitriptan nasal spray met a long felt need.
Thus, I find Plaintiffs have not proved long felt need or failure of others.
Unexpected Results
Plaintiffs argue that Zomig nasal spray "is unexpectedly rapid, efficacious,
and powerful despite delayed formation of its more potent, active metabolite .... "
(D.I. 151 at 40). This unexpected results argument, however, is just a reframing of
the central nonobviousness contention, namely, that zolmitriptan should not have
worked in a nasal spray because in tablet form it relies on 183C91, its metabolite,
for therapeutic effect.
Thus, I find no proof of unexpected results as a secondary consideration.
32
iii.
Other Claim Elements: pH, Buffer, Sterility, and
Packaging
Plaintiffs presented secondary arguments that the asserted claims were not
anticipated because of the pH they identified, the inclusion of a buffer generally or
of a buffer of citric acid and disodium phosphate specifically, the requirement of
sterility, or the added element of packaging for intranasal administration generally
or packaging that protects from light specifically. None of these added limitations
contribute an element of invention.
A skilled artisan already seeking to put zolmitriptan in a nasal spray would
logically consider the proper pH and the most obvious thing to do would be to look
at the pH of the closest drug, sumatriptan, which was about 5.5 in Imitrex. About
5.5 overlaps with all of the pH ranges in the asserted claims except for claim 4 of
the '237 patent. Thus, a skilled artisan who was motivated to put zolmitriptan in a
nasal spray would have started where those claims ended. The pH of claims 11, 12,
and 14 of the '237 patent as well as 6, 14, 15, and 16 of the '767 patent would have
been obvious.
Claim 4 requires a pH of 5 +/- .04. Imitrex, therefore, does not literally
disclose this pH but still makes the claimed pH obvious. First, it directs a skilled
artisan to pHs in the range of 5.5. Second, it debunks the proffered reasons for why
a pH of 5 would be counterintuitive. For example, Plaintiffs argued that a skilled
artisan would not consider an acidic pH because it would lead to absorbability
problems (Tr. at 795), but the success of Imitrex at 5.5 teaches otherwise. Thus,
33
even for claim 4, the narrowest claim, finding the pH would have been obvious in
light of the prior art.
As to the other elements, drugs are frequently buffered and using a taste
masking buffer would be obvious given the trouble with the taste of Imitrex.
Sterility is a standard practice. Thus, if the basic concept of the claims-putting
zolmitriptan in a nasal spray-is obvious, all of the claims fall with it.
w.
The Dearn Patents Are Not Obvious
The question of obviousness is a close one. Clear and convincing evidence,
however, requires "evidence that places in the fact finder an abiding conviction that
the truth of [the] factual contentions are highly probable." In re Copaxone Consol.
Cases, 2017 WL 401943, at *11 n. 3 (D. Del. Jan. 30, 2017) (internal quotation
marks omitted) (alteration in original).
On the one hand, zolmitriptan was a successful and promising migraine
treatment. It had good bioavailability, lower dosage rates, and better "no pain"
response than sumatriptan. This would have been encouraging to a skilled artisan
motivated to make an anti-migraine nasal spray better than Imitrex.
On the other hand, zolmitriptan had a known, powerful metabolite, the
creation of which would be delayed and diminished by nasal administration. This
would point a skilled artisan away from including zolmitriptan in a nasal spray.
This teaching away demonstrates that the Dearn patents were not obvious. See
Gore, 721 F.2d at 1550 (faulting the district court for "considering the references in
34
less than their entireties, i.e., in disregarding disclosures in the references that
diverge from and teach away from the invention at hand").
Further, I credit Plaintiffs' experts on obviousness over Defendants' experts.
Dr. Rapoport is at the vanguard of migraine treatment and Dr. Klibanov is an
expert in formulation. Both articulated their opinions convincingly and with
reasoned support. Dr. Gizuarson offered a competing opinion, but in his career he
has focused on nasal sprays. As the adage goes, to a hammer everything is a nail. 16
Because of the active metabolite and its role in making zolmitriptan effective,
placing zolmitriptan in a nasal spray was not obvious.
III.
CONCLUSION
Defendants have failed to prove the Dearn patents are invalid. If desired,
Defendants should request an opportunity to cross-examine Ms. Allen within one
week. If Defendants do not make that request, the parties should submit an agreed
upon form of final judgment within two weeks.
Defendants also offered the testimony of Dr. Jinnian Gao. He is employed by Summit
Biosciences, a company that has a relationship to Defendants. (Tr. at 929). His testimony focused on
pH. (See Tr. at 905-24).
16
35
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