United States District Court, Southern District of New York
May 8, 2000
NOVO NORDISK A/S, NOVO NORDISK OF NORTH AMERICA, INC. AND NOVO NORDISK PHARMACEUTICALS INC., PLAINTIFFS,
BECTON DICKINSON AND COMPANY, DEFENDANT.
The opinion of the court was delivered by: Jones, Judge
OPINION and ORDER
Defendant Becton Dickinson has moved for summary judgment on four
issues arguing: (1) that the `535 patent, `323 patent, and the `906
patent are invalid as anticipated under 35 U.S.C. § 102(b) in view of
a June 1991 issue of Novo Nordisk's informational brochure, Medview,
containing an article by Lene Lytzen; (2) that all claims of the `323
patent and claims 11-14 of the `906 patent are invalid as anticipated
under 35 U.S.C. § 102(b) in view of a May 1993 advertising brochure
for Novo's NovoFine G30 pen needle product; (3) that Becton's G31.
insulin pen syringe needle products do not infringe the `906 patent; and
(4) that if Becton is found to have infringed on Novo's 906 patent, no
damages have accrued due to Novo's failure to put Becton on notice of the
A patent is presumed to be valid, see 35 U.S.C. § 282, and this
presumption only can be overcome by clear and convincing evidence to the
contrary. See, e.g., WMS Gaming Inc. v. International Game Tech.,
184 F.3d 1339, 1355 (Fed. Cir. 1999). To be entitled to summary
judgment, therefore, Becton has to establish that there are no material
facts in dispute.
A. Lytzen Article as Prior Art
Becton urges this Court to rule that Novo made a binding admission that
the Lytzen article was a printed publication when it requested
reexamination of the `535 patent. The Court rejects this conclusion as
unfair to Novo and in any event, as without support.
It is recognized that positions are often taken during patent
prosecutions out of convenience and expedience, and therefore such
positions should not be given conclusive effect. See, e.g., Quad Envtl.
Tech. v. Union Sanitary Dist., 946 F.2d 870, 873 (Fed. Cir. 1991)
(refusing to treat the filing of a terminal disclaimer over a double
patenting as an admission that the double patenting reference was
Becton concedes that Novo submitted Lytzen to the Patent Office during
the reexamination with the express proviso that "[t]he Patent Owner
admits, for purposes of this reexamination proceeding only, that Lytzen
is prior art under 35 U.S.C. § 102(b)." (emphasis added) The Patent
Office conducted the reexamination on Nova's conditional representation
that it was a publication for purposes of the reexamination proceeding
and concluded that Lytzen was "not material to the patentability of the
[`535 patent]" and created "no substantial new question of
Under the circumstances, Becton's various arguments regarding the
reexamination proceeding are meritless. First, under the Manual of Patent
Examining Procedure ("MPEP"), if the Patent Office had found Nova's
conditional admission concerning the Lytzen article to be improper, it
would have been obligated to inform Nova and return the citation papers
and refuse to conduct the reexamination.
Second, since the Patent Office did not find the procedure improper,
Becton's contention that conducting a reexamination proceeding based an a
conditional admission constitutes an impermissible "advisory" opinion by
the Patent Office and/or an impermissible expenditure of government funds
is without merit.
Third, Becton's argument that citation of the Lytzen article during the
prosecution of the `323 and `906 patents constitutes an admission that
Lytzen is a prior art publication is incorrect. In Standard Manufacturing
Company v. United States, 25 Cl. Ct. 1, 61 (1991), the United States
Claims Court rejected such an argument holding:
The Patent & Trademark Office clearly recognize[s] that
an applicant may choose to furnish material information
in an Information Disclosure Statement which does not
necessarily depict prior art. The Court, therefore,
finds that Standard's disclosure of the document in
question in the required disclosure statement should
not be considered an acknowledgment, declaration,
concession or any kind of recognition of the fact that
the disclosed publication is prior art.
Id. at 61-62. Moreover, 37 C.F.R. § 1.97 (h) provides that "[t]he
filing of an information disclosure statement shall not be construed to
be an admission that the information cited in the statement is, or is
considered to be, material to patentability. . . ."
Fourth, Becton argues that Nova should have attempted to "correct" the
cover pages of the patents-in-suit to remove the reference to the Lytzen
article. However, the Patent Examiner is required to list on the face of
the patent or reexamination certificate all references considered during
prosecution, regardless of whether those references are technically prior
art. See MPEP § 130.12. Further, citation of a reference in an
information disclosure statement — which requires the Patent Office
to list the reference on the front cover of the patent — does not
constitute an admission that the reference is prior art. Thus, the Lytzen
article is properly cited on the cover pages of the patents-in-suits.
Accordingly, the Court declines to rule that the Lytzen article is
prior art based upon Novo's conditional admission.
B. Lytzen and the Elements of the Patents-in-Suit
To anticipate a claim, a reference must: (1) disclose every element of
the challenged claim; and (2) enable one
skilled in the art to make the
claimed subject matter. See PPG Indus., Inc. v. Guardian Indus. Corp.,
75 F.3d 1558, 1566 (Fed. Cir. 1996). It is not sufficient that each
element be found somewhere in the reference, the elements must be
"arranged as in the claim." Lindemannn Maschinenfabrik GmbH v. American
Hoist & Derrick Co., 730 F.2d 1452, 1458 (Fed. Cir. 1984). Further, the
reference must be sufficiently clear so as to prove the existence of each
and every element in the reference. See Motorola, Inc. v. Interdigital
Tech. Corp., 121 F.3d 1461, 1473 (Fed. Cir. 1997).
1. `535 Patent Claim
a. Claim 1
The elements of claim of the `535 patent are as follows:
(1) An insulin injection system compromising;
(2) a pen shape syringe system comprising;
(3) a cartridge with insulin; and
(4) an injection needle;
(5) wherein the injection needle is a G30 needle; and
(6) the cartridge contains an insulin type which may
freely flow through the G30 needle.
Becton's argument for the proposition that the Lytzen article discloses
the elements of claim 1 of the `535 patent is based on the deposition
testimony of one of its experts:
It [Lytzen] describes the 30-gage needle, describes
the needle, I guess the needle hub itself that's shown
on the — actually shown on the cover, even
though it only — it's only for a 27-gauge
needle, but the concept is there and then the 30-gauge
needle is described in the text portion.
Sharrott Decl. Exh. 37, Synderman Tr. 44:14-20. With respect to the
insulin disclosed in Lytzen, Becton's expert also stated: "As far as the
insulin that would flow freely through a 30-gauge needle, the only
insulin that was available in cartridges is insulin that would flow
through a 30-gauge needle." Id. at 45:9-13.
To rebut this, Novo's expert, see Fischell Declaration, opines that
"[n]owhere in the Lytzen article does it disclose or teach that one
should use a G30 needle with a pen syringe with a cartridge." 1999
Fischell Decl. ¶ 6. Moreover, "[n]o specific insulin is described in
the Lytzen article that can be used with a pen shaped syringe and a
cartridge and a G30 needle." Id. Finally, as Dr. Fischell stated, one
cannot conclude, at this juncture, that "a person of skill in the art of
medical devices could . . . utilize the Lytzen article to construct the
system described in the `535 and `323 patents." Id. at ¶ 23.
In light of these contrary opinions, there are, at a minimum, genuine
issues of material fact as to whether: (1) Lytzen teaches each and every
element of claim 1 of the `535 patent; (2) Lytzen discloses the elements
of claim 1 as arranged and disclosed in the `535 patent; and (3) Lytzen
b. Dependent Claims 2-10 of the `535 Patent
Each of the dependent claims of the `535 patent contain all the
elements of the independent claim 1 and the particular additional
elements recited in each particular dependent claim. See
35 U.S.C. § 114, ¶ 4. Because there are genuine issues of
material fact as to whether Lytzen discloses each element of claim 1 of
the `535 patent, genuine issues of material fact exist as to each of
claim 1's dependent claims. See Corning Glass Works v. Sumitomo Elec.
USA. Inc., 868 F.2d 1251, 1256 n.4 (Fed. Cir. 1986). Moreover, Becton's
moving papers fail to demonstrate an absence of genuine issues of
material fact with respect to claims 2-10 of the `535 patent.
2. `323 Patent Claim
a. Claim 1
The elements of claim 1 of the `323 patent are as follows:
(1) A needle assembly comprising;
(2) a needle hub having a base and a standard insulin
needle fitting for removably mounting said needle
assembly on a
(3) pen-type insulin syringe having a standard
mounting and which accepts;
(4) cartridges containing only insulin types that may flow
freely through a G30 needle; and
(5) a G30 needle secured in said base ad having first
and second needle portions extending from said base in
Becton's expert argues that the `323 patent is also invalid over the
prior art. However, with respect to the element of a "standard insulin
needle fitting," the existence of such a standard fitting, at any given
time, remains a fact issue for trial.
Further, with regard to the requirement of claim 1 of the `323 patent
of "a G30 needle secured in said base and having first and second needle
portions extending from said base in opposite directions," Synderman
opined that Lytzen inherently disclosed the first and second needle
portions relying on a photograph of a G27 PenNeedle in Lytzen. In
contrast, since no G30 pen needle is depicted in Lytzen, Dr. Fischell
concluded that the depiction of the G27 pen needle is insufficient as a
disclosure of a G30 pen needle with the first and second needle portions
in Lytzen. Considering the declaration of Fischell and the deposition
testimony of Synderman, there are genuine issues of material fact as to
whether the Lytzen article discloses each and every element of claim 1 of
the `323 patent.
b. Claims 2-4 of the `323 Patent
Claims 2-4 of the `323 patent are dependent on claim 1 and thus,
contain all the limitations of claim 1 in addition to the further
specific elements retained in each dependent claim. Because there are
genuine issues of material fact with respect to whether Lytzen teaches
each element of claim 1. there are genuine issues of material fact with
respect to claims 2-4 of the `323 patent.*fn2
3. `906 Patent Claim
Becton has not specifically addressed the `906 patent with respect to
Lytzen. With respect to claims 1-10 of the `906 patent, genuine issues of
material fact preclude summary judgment for the same reasons as set forth
for claims 1-10 of the `535 patent above. With respect to claims 11-14 of
the `906 patent, genuine issues of material fact preclude summary
judgment for the same reasons as set forth for claims 1-4 of the `323
A. G30 Needle Brochure
Becton argues that Claims 1-4 of the `323 Patent are anticipated by the
1993 G30 Needle Brochure and that the 1993 Brochure is a prior art
1. Written Description Requirement of 35 U.S.C. § 112
Becton's initial argument centers on the question of whether the
"written description" of the invention in Novo's original PCT application
filed in October 1992 is adequate to support the "needle assembly" claims
in the `323 and `906 patents. If it is, the 1993 Brochure cannot be prior
Application of the written description requirement of 35 U.S.C. § 112
is a question of fact. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563
(Fed. Cir. 1991). "[T]he test for sufficiency of support in a patent
application is whether the disclosure of the application relied upon
reasonably coveys to the artisan that the inventor had possession at that
time of the
later claimed subject matter." Ralston Purina Co. v.
Far-Mar-Co. Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985) (internal
quotation marks and citation omitted). Thus, § 112 does not require
the express recitation in the parent application of every feature of the
claims in a later continuation-in-part application, but rather calls for
a determination on a case-by-case basis of whether a person of ordinary
skill in the art would consider the later claimed subject matter to be
part of the invention as originally disclosed. See id. In reaching that
determination, material which is inherently part of the disclosure, even
though not expressly disclosed, must be considered. See Kennecott Corp.
v. Kyocera Intl., Inc., 835 F.2d 1419, 1422 (Fed, Cir. 1987). Patents are
presumed valid, and the party challenging a patent bears the burden of
proving invalidity by clear and convincing evidence. W.L. Gore & Assoc.,
Inc. v. Garlock, Inc., 721 F.2d 1540, 1553 (Fed. Cir. 1983). "In
addition, the party asserting invalidity also bears the initial
procedural burden of going forward to establish a legally sufficient prima
facie case of invalidity." Ralston Purina, 772 F.2d at 1573. "A party
asserting invalidity based on 35 U.S.C. § 112 bears no less a burden
and no fewer responsibilities than any other patent challenger." Id.
Here, Becton asserts that the elements of the `323 patent claims and
`906 patent claims 11-14 are not supported in the parent application,
therefore rendering the 1993 Brochure prior art to the `323 and `906
patents. Because genuine issues of fact exist, Becton is not entitled to
summary judgment on the issue.
2. Requirement to Produce Drawings
Becton's first argument is that plaintiffs' submission of drawings in
response to the Examiner's drawing requirement is conclusive on the issue
of whether the drawings added disclosure that was not present in the
original application for § 112 purposes. See Becton Br. at 4-5. This
As Novo notes, the application was not rejected for failure to meet the
requirements of § 112 because of the lack of drawings, nor did the
Examiner state that drawings were necessary for the understanding of the
subject matter. See Sharrott Exh. 27.
The Examiner stated that the invention "admits of illustration," which
is a proper ground for requiring drawings even when such drawings are not
necessary for the understanding of the subject matter. See 37 C.F.R.
§ 181(c). In addition, the MPEP provides that when drawings are
deemed necessary for understanding the invention, the applicant must be
informed that the application is incomplete, and no filing date will be
granted. See MPEP ¶ 608.02 ("Drawing Requirements"). Here, the
application was not deemed incomplete, and a filing date of July 2, 1992
was granted. The absence of drawings from the application as originally
filed does not, ipso facto, require a finding that the subject matter
depicted in the drawings was not disclosed in the original application.
Accordingly, issues of fact remain as to whether the application supports
the later claims.
3. The Parent Application and Later Claims
A reasonable trier of fact examining the 2000 Fischell Declaration,
could find that all the features in the claims, though not disclosed
verbatim, were sufficiently supported in the original PCT application to
convey to one skilled in the art that the inventors were in possession of
the subject matter later claimed in the `323 and `906 patents. See 2000
Fischell Decl. ¶ 4; see In re Wright, 866 F.2d 422, 425 (Fed. Cir.
1989) ("The fact, therefore, that the exact words here in question . . .
are not in the specification is not important.")
a. "First and second needle portions"
Claim 1 of the `323 patent and claim 11 of the `906 patent recite that
needle is secured in a hub having a base, having "first and
second needle portions extending from said base in opposite directions."
2000 Fischell Decl. Exhs. A at col. 4, 1. 33-35 & Exh. B. at col. 4, 1.
46-47. This language was absent from the original PCT application.
However, Novo argues, that given the original disclosure's reference to
the "injection portion of the needle," a reasonable trier of fact could
conclude that the inventors contemplated more than one needle portion and
this would have been understood by one skilled in the art. It bases its
argument on the discussion of the embodiment which states that the
"needles may be manufactured in the same length as usual for thicker
needles," but the "injection part of the needle" is limited to 8-12 mm.
2000 Fischell Decl. Exh. C at 3:11-15. As a result, there is an issue of
fact as to whether the "second needle portion," is expressly supported by
the "injection portion of the needle" discussed in the original PCT
application. See 2000 Fischell Decl. ¶ 7.
Novo also argues that the "first needle portion" of the `323 and `906
patent claims, i.e., the portion of the needle extending from the hub
opposite the second, injection portion of the needle, is inherently
disclosed in the original PCT application. It contends that the invention
described in the original PCT application calls for the injection of
insulin from an insulin needle cartridge, through a needle, and into a
patient. See 2000 Fischell Decl. Exh. C. In Novo's view, for the needle
assembly to perform that function, there must be one needle portion to
piece the septum of the insulin cartridge, thereby gaining access to the
insulin in the cartridge, and another needle portion to pierce the
patient's skin and allow for the subcutaneous injection of the insulin.
See 2000 Fischell Decl. ¶¶ 8-9.
Although the first needle portion for piercing the cartridge septum is
not explicitly defined in the original PCT application, as Novo argues a
reasonable juror could find that, one of ordinary skill would have
recognized that such a needle portion was a necessary part of the
structure in the original PCT application. See 2000 Fischell Decl. ¶
9; see Continental Can Co. USA, Inc. v. Monsanto, Co., 948 F.2d 1264,
1268 (Fed. Cir. 1991). At this stage, Becton's argument, which looks only
to the explicit language in the applications, must fail. See Therma-Tru
Corp. v. Peachtree Doors, Inc., 44 F.3d 988, 993 (Fed. Cir. 1995) ("the
later explicit description of an inherent property does not deprive the
product of the benefit of the earlier application.")
b. "Standard insulin needle fitting" and "standard mounting"
Claim 1 of the `323 patent and claim 11 of the `906 patent further
require a "needle hub having a base and a standard insulin needle fitting
for removably mounting said needle assembly on a pen-type insulin syringe
having a standard mounting." 2000 Fischell Decl. Exh. A at col. 4, 1.
27-30 & Exh. B at col. 4, 1. 39-42. Becton argues that the language finds
no support in any application prior to the October 14, 1994
Continuation-In-Part ("CIP") application. However, this Court finds that
there is an issue of fact as to whether this conclusion is warranted
under the written description requirement of § 112.
The original PCT application states that "[t]he needle may have
attaching means . . . [which] may be a needle hub having a thread
cooperating with a corresponding thread on the syringe." 2000 Fischell
Decl. Exh. C at 3:1-5. Novo's foundation for its argument that the
"attaching means" described in PCT application support the later claimed
"standard insulin needle fitting" is the corresponding language of claim
2 of the `323 patent (and claim 12 of the `906 patent), which recites
that the "standard fitting" may be a sleeve with a threaded interior.
See 2000 Fischell Decl. ¶ 13.
Likewise, Novo contends that the "corresponding thread on the syringe"
described in the PCT application supports the later claimed "standard
embodiment of which is recited in claim 2 of the `323
patent as "a standard, externally threaded, hub-receiving part of a
pen-type insulin syringe." 2000 Fischell Decl. ¶ 13, Exh. A at col.
4, 1. 41-42. Moreover, Novo argues that one of ordinary skill in the art
would understand that the inventors had possession of the "standard
insulin needle fitting" and "standard mounting" features of the invention
as early as the 1992 PCT application given the common industry knowledge
that Novo and Becton supplied the overwhelming majority of pen insulin
needles as of 1992, and that both companies' needle assemblies used the
cooperating thread arrangement disclosed in the PCT application. See 2000
Fischell Decl. ¶ 12. At a minimum, genuine issues of material fact
exist as to whether the terms "standard insulin needle fitting" and
"standard mounting" find adequate support in the original PCT to satisfy
the requirements of 35 U.S.C. § 112.
c. "Interior threaded annular sleeve"
Claim 2 of the `323 patent and claim 12 of the `906 patent recite a
"needle assembly according to" the independent claim,
wherein said standard fitting includes an annular
sleeve extending from said base such that said sleeve
surrounds said first needle portion concentrically and
is spaced therefrom, and wherein said sleeve has a
threaded interior by which it may be screwed onto a
standard, externally threaded, hub receiving part of a
pen-type insulin syringe.
2000 Fischell Decl. Exh. A at col. 4, 1. 36-42 & Exh. B at col. 4, 1.
48-54. Novo argues that, contrary to Becton's assertion, this claim
language finds support in the original PCT application, where the
applicant explained that "attaching means may be a needle hub having a
thread cooperating with a corresponding thread on the syringe." 2000
Fischell Decl. ¶ 15. It contends that this disclosure is more
encompassing than the later claimed embodiment, and is sufficient to
inform persons of ordinary skill in the art that the inventors were in
possession of a needle assembly having an "interior threaded annular
sleeve" at least as early as the original 1992 PCT application. See 2000
Fischell Decl. ¶ 16.
d. "Predetermined length"
Claim 3 of the `323 patent and claim 13 of the `906 patent require that
the "second needle portion has a predetermined length appropriate for
injecting insulin into a human patient." 2000 Fischell Decl. Exh. A at
col. 4, 1. 44-45 & Exh. B at col. 4, 1. 55-56. Becton contends that this
limitation was not disclosed until the October 14, 1994 CIP application,
and therefore claims reciting this limitation are not entitled to the
filing date of the original PCT application for priority. See Becton Br.
Novo argues that although the term "predetermined length" is absent
from the original PCT application, the basis for that term does appear in
the original disclosure. Specifically, it contends that the original
disclosure states that "the needle must have a length permitting the
subcutaneous injection of the insulin," which is consistent with the
meaning of "predetermined length" as it is understood by persons of
ordinary skill in the art. See 2000 Fischell Decl. ¶¶ 18-19. As a
result, as Novo argues, a genuine issue of fact remains in dispute as to
whether the original PCT application would have conveyed to persons of
ordinary skill in the art that the inventors were in possession of the
"predetermined length" limitation, even though that term was not added
until later. See Therma-Tru, 44 F.3d at 992-93.
Claim 4 of the `323 patent and claim 14 of the `906 patent read as
A needle assembly according to claim 3 , wherein
said base further comprises a central protrusion which
extends from said base for a predetermined distance
along said second needle portion and embeds said second
needle portion along the said distance, and wherein
said second needle
portion further comprises an exposed
end which projects axially from said central protrusion
and which has a length corresponding to the desired
depth of needle insertion into a human patient.
2000 Fischell Decl. Exh. A at col. 4, 1. 46-54 & Exh. B at col. 4, 1.
Becton contends that the term "embeds" finds no support in the original
PCT application, and therefore is not entitled to claim priority from
that application. See Becton Br. at 3. However, Novo argues that the
structure recited in the above claim was described in the original PCT
The needle hub may have a central protrusion covering
part of the length of the needle. Thereby, the length
of the injection part of the needle is made shorter. . . .
The needles may be manufactured in the same
length as usual for thicker needles and the shorter
injection part may be obtained by the hub protrusion
covering a larger part than usual for the needle.
2000 Fischell Decl. Exh. C at 3:6-15. Novo contends that although the
term "embeds" was not used in the PCT application, persons of ordinary
skill in the art would have appreciated that the idea of the central
protrusion "embedding" the second needle portion is the same as the
protrusion "covering" the needle portion. See 2000 Fischell Decl. ¶¶
21-22. As Novo argues, a genuine issue of fact remains in dispute as to
whether the claim limitation "embeds" is supported in the original PCT
application for purposes of § 112.
4. Prior Art
As discussed above, there are issues of disputed fact as to whether the
challenged limitations of the `323 and `906 patent claims find support in
the original PCT application filed July 2, 1992. Since Becton contends
that the 1993 Brochure was published in May 1993, the brochure cannot be
prior art to claims having an effective filing date prior date to May
1993. See 35 U.S.C. § 102 (b) & 120. Because Becton has failed to
prove the absence of disputed issues of fact underlying the determination
of whether the 1993 Brochure is prior art, Becton's motion for summary
judgment may be denied without further considering the issue of whether
the 1993 Brochure is an anticipating reference.
Becton's argument in support of summary judgment for noninfringement of
the `906 patent by its 31 gauge needle products appears to be twofold.
First, Becton argues that because this Court construed the scope of the
term "thinner than G29" to mean thinner than G29 but not thinner than
G30, infringement of the `906 patent under the doctrine of equivalents by
G31 needles is precluded as a matter of law. See Becton Br. at 9. On this
point, Novo argues that such an argument is meritless given Federal
Circuit precedent. Second, if thinner than 29 gauge claims are patentable
over prior art 29 gauge pen needles, according to Becton, there must be a
substantial difference between pen needles that are thinner than 29 gauge
and 31 gauge. See Becton Br. at 8-9. Novo counters by arguing that this
argument raises several factual issues: (1) whether there is a
substantial difference between prior art 29 gauge and thinner than 29
gauge pen needle assemblies; and (2) even if there is such a difference,
whether it necessarily follows that thinner than 29 gauge pen needles and
31 gauge pen needles are substantially different.
A. Doctrine of Equivalents
Under the doctrine of equivalents, "a product or process that does not
literally infringe upon the express terms of a patent claim may
nonetheless be found to infringe if there is `equivalence' between
elements of the accused product or process and the claimed elements of
the patented invention."
Warner-Jenkinson Co. v, Hilton Davis Chem Co.,
117 S.Ct. 1040, 1045 n.8 (1997). Infringement may be found under the
doctrine of equivalents if every limitation of the asserted claim, or its
equivalents, is found in the accused subject matter, where an equivalent
differs from the claimed limitation only insubstantially. Whether a
component in the accused subject matter performs substantially the same
function as the claimed limitation in substantially the same way to
achieve substantially the same result may be relevant to this
determination. See id. at 1054.
Becton relies on Dolly, Inc. v. Spalding & Evenflo Cos., Inc.,
16 F.3d 394 (Fed. Cir. 1994) to argue that as a matter of law —
because this Court construed the claim element thinner than 29 gauge to
mean thinner than 29 gauge but not thinner than 30 gauge — there
can be no infringement of the `906 patent by Becton's 31 gauge needle
under the doctrine of equivalents. See Becton Br. at 9. However, The
Federal Circuit in Ethicon Endo-Surgery, Inc. v. United States Surgical
Corp., 149 F.3d 1309, 1317 (Fed. Cir. 1998), characterized Dolly as being
a case where "given the marked difference between the allegedly
infringing device and the claim limitation, no reasonable fact finder
could have found equivalence." Id. at 1318. The Federal Circuit stated
Dolly [and other cases citing and quoting Dolly] were
decided on their facts. . . . They simply explained
that on the facts presented, no reasonable finder of
fact could have found infringement by equivalents
because the differences between the allegedly
infringing devices and the claimed inventions were
plainly not insubstantial. But they did not read the
doctrine of equivalents out of existence when a claim
limitation is not expressly met be an accused device.
Id. (internal quotation marks and citations omitted). As a result,
summary judgment must be denied unless no reasonable finder of fact could
find infringement by equivalents because the differences between the
infringing devices and the claimed invention are plainly not
B. Noninfringement under the Doctrine of Equivalents
The relevant inquiry under the doctrine of equivalents regarding
Becton's 31 gauge pen needle assembly is whether or not the differences
between those needle assemblies and the claimed thinner than 29 gauge
needle assemblies are insubstantial.
Novo provides evidence of insubstantial differences in the Second
Supplemental Report of Robert E. Fischell. Fischell opines that the
relevant differences between thinner than 29 gauge and 31 gauge pen
needle assemblies are insubstantial because a 31 gauge pen needle
assembly, in combination with the other elements of the claims of the
`906 patent achieves the same function in the same way and with the same
result as a thinner than 29 gauge needle assembly in combination with
these elements. See Zisk Decl. Exh. A, ¶¶ 3-17.
Becton does not provide the necessary factual and legal support for its
argument that because the invention in the `906 patent distinguishes over
the prior art 29 gauge needle, the difference between a 30 and 31 gauge
needle must not be insubstantial. See Becton Br. at 8-9. Becton argues
that Novo's alleged view of patentability of 30 gauge needle assemblies
over 29 gauge pen needle assemblies precludes there being insubstantial
differences between thinner than 29 gauge pen needle assemblies and 31
gauge pen needle assemblies.
In response, Novo argues that it does not necessarily follow from a
patentable distinction between 29 gauge and thinner then 29 gauge needle
assemblies that the difference between thinner than 29 gauge ad 31 gauge
needles is substantial. Because there are genuine issues of fact in
dispute, summary judgment is inappropriate.
Becton argues that "Novo has never notified [it] that its 31 gauge pen
needles infringe the `906 patent." Becton Br. at 14. Becton argues that
as a matter of law, damages have not yet begun to accrue from its
infringement of the `906 patent. See id. at 14-15.
In response, Novo argues that: (1) Becton was put on notice that its
pen needles allegedly infringe the `906 patent; (2) Becton is ignoring the
specific statutory language of 35 U.S.C. § 287(a) that the "[f]iling
of an action for infringement shall constitute such notice"; (3) the
cases on which Becton relies do not support Becton's argument; and (4)
Becton ignores the fact that Novo filed suit against Becton for
infringement of the `906 patent by Becton's pen needles and pen-type
syringes on the day the `906 patent issued, November 16, 1999. See
Compl., 99 Civ. 11367 (BSJ).
Novo contends that Becton was given the notice required under §
278(a) that its 30 gauge and 31 gauge pen needles and insulin pens
infringe the `906 patent on November 16, 1999. On that day, a complaint
was served on Becton and filed with this Court in which Novo charged that
"[Becton} has made and sold, and continues to make and sell, within the
United States insulin pen needles, which activities infringe upon the
`906 patent," and as well, Novo charged Becton "with the sale,
promotion, and marketing of its insulin pen needles and pen shaped
syringes, has and will continue to actively induce consumers to infringe
upon the `906 patent." See Zisk. Decl. Exh. B. ¶¶ 9-14. The Complaint
specifically accuses Becton of infringing the `906 patent by its
manufacture and sales of its pen needles and insulin pens. According to
Novo, no other notice is required under § 278, as this is a "filing
of an action for infringement" that the statute mandates "shall be such
notice." § 278(a).
Novo contends that while Becton may "submit that when notice is given
by the filing of a complaint, the accused products should be specifically
identified," Becton Br. at 12, in Novo's view, Becton cites no actual
authority for its "submission" and the cases on which Becton relies do
not support this proposition.
Becton cites General Electric Co. v. Grand Gaslight, Inc.,
46 F. Supp. 822 (S.D.N.Y. 1942). General Electric, however, was a case
that pre-dated 35 U.S.C. § 287 (a) and in particular, predated the
mandate in the statute that the filing of a suit constitutes notice under
the section. The case reveals that the court was concerned primarily with
the question: "Is the service of the complaint sufficient notice to the
defendant of the infringement?" Id. at 824. This question did not address
the issue of how much specificity is required for notice regarding the
Contrary to Becton's allegations in its Memorandum of Law, this
District takes a liberal view of the notice requirement under § 287.
For example, in a case involving license negotiations over patented
photographic developer formulations, the Court found the following
language in a letter from the patent holder to the accused infringer to
be adequate notice of infringement in the context of the overall dealings
between the parties:
We are informing the trade that the purchase of the
patented developer from Kodak gives the purchaser the
necessary license to use or resell the purchased
material. As a supplier of this type of developer, we
wanted you to know of this since you may be receiving
inquiries from your customers soon.
Eastman Kodak Co. v. GAF Corp., 195 U.S.P.Q. 644 (S.D.N.Y. 1977).
Thus, an accusation of infringement by a class of product ("type
of developer") is sufficient actual notice under § 287(a) under
at least some circumstances.
Moreover, the Court has specifically denied a defendant's motions that
were based on the same "submission" as put forward by Becton in the
present case. In a series of decisions, Judge Baer denied
three times a
defendant's various motions that argued that notice under § 287(a)
requires as a matter of law that the specific products be identified. See
Accuscan, Inc. v. Xerox Corp., No. 96 Civ. 2579 (HB), 1998 U.S. Dist.
LEXIS 1558, at *17-*19 (S.D.N.Y. Feb. 10, 1998); Accuscan, Inc. v. Xerox
Corp., No. 96 Civ. 2579 (HB), 1998 U.S. Dist. LEXIS 14242, at *36-*37
(S.D.N.Y. Sept. 10, 1998); Accuscan, Inc. v. Xerox Corp., No. 96 Civ.
2579 (HB), 2000 U.S. Dist. LEXIS 2822, at *3-*4 (S.D.N Y Mar. 14, 2000)
In Accuscan, the plaintiff had sent a letter to Xerox accusing Xerox's
facsimile machines of infringing Accuscan's patent and later sued Xerox
for infringement not only by facsimile machines, but also by scanners,
copiers, and document publishing systems. See Accuscan, 1998 U.S. Dist.
LEXIS 14242 at *32-*33. Following a denial of summary judgment on the
issue of notice of specific products, and a first trial in which the jury
found for Accuscan, the Court revisited the issue of compliance with
actual notice under § 287(a) as part of a larger reconsideration of
the case. Judge Baer stated that
there is no authority to support [the defendant's]
proposition that the actual notice requirement cannot
be satisfied as a matter of law unless the specific
accused device is mentioned in the notice, even where
other similar devices are referred to in the notice.
Instead, the Federal Circuit has emphasized that there
is some flexibility involved in determining whether the
actual notice requirement has been met.
Id. at *35-*36 The Accuscan court concluded that "it is well established
that whether § 287 is complied with is an issue of fact for the
jury." Id. at *36 (citations omitted). Following a second trial in which
the jury found that Accuscan had provided actual notice under § 287,
Xerox moved for Judgement as a Matter Of Law ("JMOL"), and Judge Baer
denied JMOL on the notice issue. See Accuscan, 2000 U.S. Dist. LEXIS
2822, at *3-*4.
Thus, the notice requirement under § 287 is treated flexibly
— as a question of fact for the jury. Even where the notice given
went to a merely related product class, such notice may be sufficient and
the question of adequate notice must go to the jury. Here, a reasonable
trier of fact could find that the notice given to Becton was to the
specific products, or at the very least, to the narrow family of products
for which Novo now seeks damages. As a result, summary judgment on the
issue of notice is inappropriate.
For all of the reasons stated above, Becton's motions for summary
judgment are denied. The parties are reminded that: (1) the Joint
Pretrial Order shall be filed on or before May 11, 2000; (2) the final
pre-trial conference in this matter will be held on May 12, 2000 at 10
a.m.; and (3) the trial of this matter will begin on May 15, 2000 at 9