Proveris Scientific Corp. v. Innovasystems, Inc.

United States Court of Appeals for the Federal Circuit
2007-1428

PROVERIS SCIENTIFIC CORPORATION
(formerly known as Image Therm Engineering, Inc.),

Plaintiff-Appellee,

v.

INNOVASYSTEMS, INC.,

Defendant-Appellant.

Susan H. Farina, Proveris Scientific Corporation, of Marlborough, Massachusetts,
argued for plaintiff-appellee. With her on the brief were Gary R. Greenberg and Louis J.
Scerra, Jr., Greenberg Traurig LLP, of Boston, Massachusetts.

Stephen P. Pazan, Spector Gadon & Rosen, P.C., of Moorestown, New Jersey,
argued for defendant-appellant. With him on the brief were Timothy J. Szuhaj and D. Andrew
Bertorelli, Jr.

Jeffrey Light, Patients Not Patents, Inc., of Washington, DC, for amicus curiae,
Patients Not Patents,Inc.

Appealed from: United States District Court for the District of Massachusetts

Judge William G. Young
 United States Court of Appeals for the Federal Circuit

2007-1428

PROVERIS SCIENTIFIC CORPORATION
(formerly known as Image Therm Engineering, Inc.),

Plaintiff-Appellee,

v.

INNOVASYSTEMS, INC.,

Defendant-Appellant.

Appeal from the United States District Court for the District of Massachusetts in case
no. 05-CV-12424, Judge William G. Young.

DECIDED: August 5, 2008

Before SCHALL, BRYSON, and GAJARSA, Circuit Judges.

SCHALL, Circuit Judge.

This is a patent infringement case. Innovasystems, Inc. (“Innova”) appeals from

the final judgment of the United States District Court for the District of Massachusetts

that it infringed claims 3-10 and 13 of United States Patent No. 6,785,400 (the “’400

patent”) owned by Proveris Scientific Corporation (“Proveris”). Proveris Scientific Corp.

v. Innovasystems, Inc., No. 05-12424 (D. Mass. May 11, 2007). On appeal, Innova

argues that the district court erred in ruling that the so-called “safe harbor” provision of
the Drug Price Competition and Patent Term Restoration Act of 1984, known as the

“Hatch-Waxman Act,” Pub. L. No. 98-417, 98 Stat. 1585 (1984), codified at 21 U.S.C.

§§ 355, 360cc (2000), and 35 U.S.C. §§ 156, 271, 282 (2000), does not immunize its

accused activity from infringement of the ’400 patent. Innova also argues that the

district court erred in entering judgment as a matter of law (“JMOL”) (i) that it infringed

claims 3-10 and 13 of the ’400 patent and (ii) in favor of Proveris on Innova’s affirmative

defenses that claims 1, 2, and 9 are invalid by reason of obviousness and that claims 3-

8 and 10 and 13 are invalid as anticipated by a single prior art reference. Because we

conclude that Innova is not entitled to the protection of the Hatch-Waxman Act safe

harbor provision, and that the district court did not err in granting JMOL in favor of

Proveris on infringement and on Innova’s affirmative defenses, we affirm.

BACKGROUND

I

The ’400 patent is directed to a system and apparatus for characterizing aerosol

sprays commonly used in various drug delivery devices, such as nasal spray pumps

and inhalers. ’400 patent, col.1 ll.27-35. During drug research and development, spray

characterization measurements are frequently used to calibrate drug delivery devices in

accordance with the exact physical properties of a particular drug, in order to maximize

the efficiency and effectiveness of drug delivery. ’400 patent, col.1 ll.55-59. According

to the ’400 patent, spray characterization also plays an important role in the regulatory

approval process of the Food and Drug Administration (“FDA”) under the Federal Food,

Drug, and Cosmetic Act (“FDCA”), Pub. L. No. 75-717, ch. 675, 52 Stat. 1040 (1938)

(codified at scattered sections of title 21 of the United States Code). Under the FDCA,

2007-1428 2
FDA approval is required for inhaler-based drug delivery devices. ’400 patent, col.1

ll.41-45. The system and apparatus claimed in the ’400 patent are not themselves

subject to FDA approval, however.

Figure 2 of the ’400 patent depicts an embodiment of the claimed invention.

Figure 2 shows a spray data acquisition system (10) which allows researchers to study

and optimize the delivery of various aerosol-based drugs. The system operates through

the action of a pumping device (30) which generates an aerosol spray plume (with a

spray axis (SA)) whose spray characteristic data is collected by an illumination device

(26) and imaging device (12).

The ’400 patent has thirteen claims. Claims 1 and 3 are independent claims.

Claims 1, 2, and 13 are system claims, while claims 3-12 are apparatus claims. Claim 1

is representative. It provides as follows:

2007-1428 3
 A spray data acquisition system comprising:

a housing for supporting a pumping device whereby the pumping
device is responsive to an applied force to generate an aerosol
spray plume through an exit port thereon along a spray axis;

a spray pump actuator, wherein the spray pump actuator is capable
of controlling a pumping force and a duration of the aerosol spray
plume of the pumping device;

an illumination device for illuminating the aerosol spray plume along
at least one geometric plane that intersects the aerosol spray
plume; and,

an imaging device for acquiring data representative of a first
interaction between the illumination and the aerosol spray plume
along the at least one geometric plane.

II

Innova makes and sells a device known as the Optical Spray Analyzer (“OSA”).

The OSA itself is not subject to FDA approval. It is, however, used in connection with

FDA regulatory submissions. In that setting, the device measures the physical

parameters of aerosol sprays used in nasal spray drug delivery devices.

In December of 2005, Proveris filed suit against Innova in the District of

Massachusetts, alleging infringement of claims 1-10 and 13 of the ’400 patent. As part

of its defense, Innova invoked the safe harbor provision of the Hatch-Waxman Act.

The safe harbor provision is codified at 35 U.S.C. § 271(e)(1), which states in relevant

part:

It shall not be an act of infringement to make, use, offer to sell, or
sell within the United States or import into the United States a patented
invention . . . solely for uses reasonably related to the development and
submission of information under a Federal law which regulates the
manufacture, use, or sale of drugs or veterinary biological products.

2007-1428 4
Innova argued that its allegedly infringing activities are immunized by this provision

because its OSA devices are used by third parties solely for the development and

submission of information to the FDA.

In due course, both parties moved for summary judgment on the section

271(e)(1) issue. After initially denying both motions, the district court asked the parties

to brief further the question of what standard should be applied when considering

Innova’s safe harbor defense. After reviewing these submissions, and shortly before

trial, the court ruled as a matter of law that section 271(e)(1) does not immunize

Innova’s OSA devices from infringement of the ’400 patent. The court stated from the

bench, “Also I’ve reflected at some length on this 271 Safe Harbor. As a matter of law,

that’s out.”

At trial, the district court granted JMOL in favor of Proveris with respect to

infringement of claims 3-10 and 13 of the ’400 patent. Thus, as to claims 3-10 and 13,

the court informed the jury that there was “[n]o dispute about infringement as to those

claims.” At trial, the district court also excluded certain expert testimony proffered by

Innova relating to its affirmative defenses that claims 1, 2, and 9 of the ’400 patent are

invalid by reason of obviousness and that claims 3-8 and 10 and 13 of the patent are

invalid as anticipated by a single prior art reference. As a result, the court granted

JMOL in favor of Proveris on Innova’s invalidity defenses. Following trial, the jury found

claims 1 and 2 of the ’400 patent not infringed, and awarded no damages for

infringement of claims 3-10 and 13. Thereafter, the district court entered final judgment

of infringement and issued a permanent injunction barring Innova from infringement of

2007-1428 5
the ’400 patent. Innova then filed this timely appeal. We have jurisdiction pursuant to

28 U.S.C. § 1295(a)(1).

DISCUSSION

On appeal, Innova contends that the district court erred (1) in ruling as a matter

of law that section 271(e)(1) does not immunize it from infringement of the ’400 patent,

(2) in granting JMOL of infringement of claims 3-10 and 13, and (3) in granting JMOL in

favor of Proveris on its affirmative defenses that the asserted claims of the ’400 patent

were invalid by reason of anticipation and obviousness. We address Innova’s

contentions in turn.

I

Innova’s first argument on appeal is that the district court erred in ruling as a

matter of law that its manufacture and sale of the OSA device are not immunized by the

safe harbor provision of 35 U.S.C. § 271(e)(1). Since the pertinent facts are not in

dispute, this argument presents a question of statutory interpretation, an issue of law

that we review de novo. Romero v. United States, 38 F.3d 1204, 1207 (Fed. Cir. 1994).

A

Congress enacted the Hatch-Waxman Act in order to eliminate two unintended

distortions of the effective patent term resulting from the premarket approval required for

certain products by the FDCA. 1

The first distortion was the reduction of effective patent life caused by FDA

premarket approval. Because patent applications were filed early in the regulatory

1
Under the FDCA, various products are subject to FDA regulatory review
prior to market entry. See, e.g., 21 U.S.C. § 360e (medical devices); § 348 (food
additives); § 376 (color additives); and § 355 (new drugs).

2007-1428 6
process, but market entry was delayed pending regulatory review, the early years of the

patent term were spent obtaining premarket approval for the patented invention rather

than generating profits. Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 669 (1990).

The second distortion was the de facto extension of effective patent life at the

end of the patent term, which also resulted from FDA premarket approval requirements.

Prior to the Hatch-Waxman Act, competitors’ activities involving a patented invention

during the patent term constituted an act of infringement, even if undertaken for the sole

purpose of obtaining FDA regulatory approval. See Roche Prods., Inc. v. Bolar Pharms.

Co., 733 F.2d 858 (Fed. Cir. 1984), cert. denied, 469 U.S. 856 (1984). Because such

activities could not begin until patent expiration, patent owners enjoyed a de facto

patent term extension while competitors spent time following patent expiration obtaining

FDA premarket approval necessary for market entry. Eli Lilly, 496 U.S. at 670.

The Hatch-Waxman Act sought to eliminate these distortions via two key

provisions, now codified at 35 U.S.C. §§ 156 and 271(e)(1). The first provision, section

156, sought to eliminate de facto patent term reduction by providing patent term

extension for those patents claiming a “product” subject to regulatory delays caused by

the FDA premarket approval process. 2 For purposes of section 156, the term “product”

2
In relevant part, section 156 provides:

The term of a patent which claims a product, a method of using a
product, or a method of manufacturing a product shall be extended in
accordance with this section from the original expiration date of the patent
. . . if –
***
(4) the product has been subject to a regulatory review period
before its commercial marketing or use . . . .

35 U.S.C. § 156(a).

2007-1428 7
means a “drug product” and “[a]ny medical device, food additive, or color additive

subject to regulation under the [FDCA.]” 35 U.S.C. § 156(f).

The second provision, section 271(e)(1), sought to eliminate de facto patent term

extension. It sought to do so by providing a safe harbor that immunized competitors

from infringement on account of making, using, offering to sell, or selling within the

United States or importing into the United States a “patented invention . . . solely for

uses reasonably related to the development and submission of information under a

Federal law which regulates the manufacture, use, or sale of drugs or veterinary

biological products.” 35 U.S.C. § 271(e)(1). The basic idea behind this provision was to

allow competitors to begin the regulatory approval process while the patent was still in

force, followed by market entry immediately upon patent expiration. Thus, in

Telectronics Pacing Systems v. Ventritex, Inc., 982 F.2d 1520 (Fed. Cir. 1992), we

pointed out that, as a result of section 271(e)(1), “a competitor who anticipates coming

into the marketplace with a product that utilizes a currently patented invention may

make, use, and sell that product so long as it is ‘solely for uses reasonably related to the

development and submission of information under a Federal law which regulates the

manufacture, use, or sale of drugs.’” Id. at 1525.

For purposes of this case, the critical terms in 35 U.S.C. § 271(e)(1) are

“patented invention” and “reasonably related.” In Eli Lilly, the Supreme Court addressed

the issue of whether a patented cardiac defibrillator fell within the section 271(e)(1) safe

harbor. 496 U.S. at 664. In that case, Eli Lilly & Co. (“Lilly”) filed an action against

Medtronic, Inc. (“Medtronic”) in federal district court in Pennsylvania, seeking to enjoin

Medtronic from testing and marketing an implantable cardiac defibrillator. Lilly claimed

2007-1428 8
that Medtronic’s actions infringed two of its patents. Medtronic defended against the

suit on the ground that its activities were reasonably related to the development and

submission of information under the FDCA, and thus exempt from a finding of

infringement under section 271(e)(1). Id. at 664. The district court rejected Medtronic’s

argument, concluding that the exemption did not apply to the development and

submission of information relating to medical devices. Following a jury trial, the jury

returned a verdict for Lilly on infringement of the first patent. After the district court

directed a verdict for Lilly on infringement of the second patent, it entered judgment for

Lilly and issued a permanent injunction against infringement of both patents. Id. On

appeal, this court reversed, holding that by virtue of section 271(e)(1), Medtronic’s

activities could not constitute infringement if they were undertaken to develop

information reasonably related to the development and submission of information

necessary to obtain regulatory approval under the FDCA. The court remanded to the

district court for a determination of whether that condition had been met. Id.

The Supreme Court granted certiorari. The question before the Court was

whether the scope of the section 271(e)(1) safe harbor was limited to drugs, or also

extended to medical devices, such as Medtronic’s defibrillator. The Court held that

medical devices were covered. It thus affirmed the decision of the Federal Circuit. After

analyzing the language of section 271(e)(1), the Court “confirmed” the Federal Circuit’s

interpretation of the statute based upon “the structure of the [Hatch-Waxman] Act taken

as a whole.” 496 U.S. at 669. After reviewing the dual distortions noted above that led

to the Hatch-Waxman Act, the Court stated:

It seems most implausible to us that Congress, being
demonstrably aware of the dual distorting effects of

2007-1428 9
 regulatory approval requirements in this entire area – dual
distorting effects that were roughly offsetting, the
disadvantage at the beginning of the term producing a more
or less corresponding advantage at the end of the term –
should choose to address both those distortions only for
drug products; and for other products named in [35 U.S.C. §
156(f) 3 ] should enact provisions which not only leave in
place an anticompetitive restriction at the end of the
monopoly term but simultaneously expand the monopoly
term itself, thereby not only failing to eliminate but positively
aggravating distortion of the 17-year patent protection. It
would take strong evidence to persuade us that this is what
Congress wrought, and there is no such evidence here.

Id. at 672-73. Continuing, the Court stated that, “[a]part from the reason of the matter,”

there were “textual indications” that sections 156 and 271(e)(1) were “meant generally

to be complementary.” Id. at 673.

The Court noted that interpreting the phrase “patented invention” in section

271(e)(1) to include all products listed in section 156(f) produced a “perfect ‘product’ fit”

between the two provisions. Id. at 672. The Court pointed out that all of the products

eligible for patent term extension under section 156 – including drugs, medical devices,

food additives, and color additives – were subject to FDA premarket approval. Id.

Conversely, all products subject to premarket approval that were not eligible for patent

term extension under section 156(f) – such as new animal drugs and veterinary

biological products – were excluded from the section 271(e)(1) safe harbor provision as

well. 4 Id. at 674. Because of this nearly perfect product correlation between sections

3
At the time Eli Lilly was decided, the products named in section 156(f)
were “[a] human drug product” and “[a]ny medical device, food additive, or color additive
subject to regulation under the [FDCA].” Id. at 671.
4
It is to be noted that the versions of sections 271(e)(1) and 156(f) which
were before the Supreme Court in Eli Lilly in 1990 differed slightly from the current
versions of both provisions. As the Court noted in Eli Lilly, at that time, new animal

2007-1428 10
156 and 271(e)(1), and the roughly offsetting patent term distortions those two

provisions were designed to address, the Court essentially interpreted section 271(e)(1)

to include at least “all inventions” within the ambit of section 156. See id. at 673-74.

In AbTox, Inc. v. Exitron Corp., 122 F.3d 1019 (Fed. Cir. 1997), we applied the

reasoning of the Supreme Court in Eli Lilly. After being sued for patent infringement,

AbTox, Inc. (“AbTox”) alleged in a counterclaim that Exitron Corporation and MDT

Corporation (“defendants”) infringed its U.S. Patent No. 4,321,232 (the “’232 patent”).

The ’232 patent claimed a medical device used in sterilizing medical instruments.

AbTox, 122 F.3d at 1020-21. Defendants moved for summary judgment of

noninfringement, claiming that their use of the invention claimed in the ’232 patent in

pursuit of FDA approval for a plasma sterilizer was covered by the safe harbor provision

of section 271(e)(1). Id. at 1027. After the district court granted the motion, AbTox

appealed.

The patented medical device in AbTox presented an issue not confronted in Eli

Lilly, due to the varying levels of FDA regulation for different medical devices. We

observed that although all three categories of medical devices, Classes I, II, and III, are

subject to varying levels of FDA premarket approval, only Class III medical devices are

eligible for patent term extension under section 156. Id. at 1028-29. Both AbTox’s

drugs and veterinary biological products were simultaneously excluded from both
provisions. 496 U.S. at 674.
In contrast, sections 271(e)(1) and 156(f) now include new animal drugs and
veterinary biological products, unless they have been “primarily manufactured using
recombinant DNA, recombinant RNA, hybridoma technology, or other processes
involving site specific genetic manipulation techniques . . . .”
These slight statutory differences do not undermine the relevance of the Court’s
Eli Lilly analysis. Instead, we think the persisting symmetry between both provisions
over time further confirms the Court’s view that sections 271(e)(1) and 156 operate in
tandem.

2007-1428 11
invention and defendants’ products were Class II medical devices, ineligible for patent

term extension, unlike the eligible Class III medical device in Eli Lilly. Faced with a

tension between the Supreme Court’s broader holding in Eli Lilly that “patented

invention” means “all inventions” within section 156, and the Court’s narrower focus on

statutory symmetry between the two provisions, we adopted the broader holding that

the phrase “patented invention” of section 271(e)(1) includes any medical device,

regardless of its eligibility for patent term extension under section 156. Id.

Precedent also has addressed which activities are sufficiently “reasonably

related” to FDA approval for purposes of section 271(e)(1). In Telectronics, we held that

demonstrating an implantable defibrillator at medical conferences was “reasonably

related” to FDA approval because it facilitated the selection of clinical trial investigators.

982 F.2d at 1523. Most recently, in Merck KGaA v. Integra Lifesciences I, Ltd., 545

U.S. 193 (2005), the Supreme Court interpreted “reasonably related” in determining

whether section 271(e)(1) immunizes the use of patented inventions in preclinical

research if the experimental results are never submitted to the FDA, id. at 195. In

Merck, patented compounds were used in preclinical studies to identify and evaluate

drugs useful for inhibiting angiogenesis. Id. at 198-99. The Court held that “reasonably

related” activity does not require actual submission of information to the FDA; it also

includes those situations in which a party has “a reasonable basis for believing that a

patented compound may work, through a particular biological process, to produce a

particular physiological effect, and uses the compound in research that, if successful,

would be appropriate to include in a submission to the FDA . . . .” Id. at 206-07. On

remand, we held that the preclinical research in question was “reasonably related” to

2007-1428 12
FDA approval. Integra Lifesciences I, Ltd. v. Merck KGaA, 496 F.3d 1334, 1348 (Fed.

Cir. 2007).

B

We turn now to the parties’ contentions on appeal. Innova argues that it is

entitled to the benefit of the section 271(e)(1) safe harbor because it is undisputed that it

has only offered to sell the OSA to pharmaceutical companies and the FDA. Innova

also states that it is undisputed that the OSA is and was used exclusively in applications

for regulatory approval in accordance with the requirements of the FDCA. Innova urges

that “Congress wrote § 271(e)(1) extremely broadly” when it said that it was not an act

of infringement to sell a “patented invention . . . solely for uses reasonably related to the

development and submission of information under a Federal law which regulates the

manufacture, use, or sale of drugs or veterinary biological products.” According to

Innova, Congress intended to include within the safe harbor all “patented inventions”

unless specifically excluded. Innova contends that both Lilly and Merck support its

position and that the safe harbor provision should not be limited so as to exclude

research tools – assuming its OSA device is viewed as such.

Proveris responds that “[t]he patented inventions that fall within the scope of

§ 271(e)(1) do not include patents on equipment that may be used in a pharmaceutical

laboratory, such as microscopes, analytical balances, computers, and Proveris’s Spray

VIEW equipment.” Proveris states that Congress created the patent term extension for

“products” in 35 U.S.C. § 156(a) when it created the safe harbor in section 271(e)(1),

doing so within the context of providing generic drug developers with the means to

compete commercially immediately upon the expiration of a drug’s patent. Under these

2007-1428 13
circumstances, Proveris reasons, section 271(e)(1) extends only to the infringement of

patents that claim “products” as that term is defined in section 156(f) and to other

patented inventions that are inherent to the development of “products.” Thus, in

Proveris’s view, the patents which may be infringed with immunity, if the infringement is

solely for uses reasonably related to the development and submission of information to

the FDA, include patents on drug products, medical devices, food additives, and color

additives. According to Proveris, section 271(e)(1) does not immunize infringement of

patents on laboratory or manufacturing equipment. Proveris also argues that Innova’s

OSA device is not “reasonably related” to FDA submissions because Innova’s

infringement is not for purposes of its own FDA-related research, but rather for

commercial sale to third parties engaged in such research.

C

The district court’s ruling and the parties’ contentions clearly frame the question

before us: whether section 271(e)(1) immunizes the manufacture, marketing, or sale of

Innova’s OSA, which is used in the development of FDA regulatory submissions, but is

not itself subject to the FDA premarket approval process. For the reasons set forth

below, we hold that the section 271(e)(1) safe harbor does not immunize the OSA from

infringement.

We think the Supreme Court’s approach in Eli Lilly is instructive. In Eli Lilly, the

Court examined the language of section 271(e)(1) in light of the overall statutory

structure and underlying policy considerations leading to the enactment of the Hatch-

Waxman Act. In that regard, as seen, sections 156 and 271(e)(1) were enacted in order

to eliminate two unintended distortions of the effective patent term resulting from

2007-1428 14
premarket approval required of certain products pursuant to the FDCA. In Eli Lilly, the

Supreme Court explained that the first distortion was the reduction of effective patent

life caused by the FDA premarket approval process, while the second distortion was the

de facto extension of effective patent life at the end of the patent term – also caused by

the FDA premarket approval process. 496 U.S. at 669-70. The first distortion adversely

affected patentees; the second distortion adversely affected those seeking FDA

approval in order to enter the market to compete with patentees. It is the second

distortion that is relevant to this case.

As far as the second distortion is concerned, Innova’s OSA device is not subject

to FDA premarket approval. Rather, FDA premarket approval is required only in the

case of the aerosol drug delivery product whose spray plume characteristics the OSA

measures. In short, Innova is not a party seeking FDA approval for a product in order to

enter the market to compete with patentees. Because the OSA device is not subject to

FDA premarket approval, and therefore faces no regulatory barriers to market entry

upon patent expiration, Innova is not a party who, prior to enactment of the Hatch-

Waxman Act, could be said to have been adversely affected by the second distortion.

For this reason, we do not think Congress could have intended that the safe harbor of

section 271(e)(1) apply to it. Put another way, insofar as its OSA device is concerned,

Innova is not within the category of entities for whom the safe harbor provision was

designed to provide relief. We thus agree with the district court that Innova is not

entitled to the benefit of the section 271(e)(1) safe harbor.

At the same time, just as Innova is not a party who, prior to enactment of the

Hatch-Waxman Act, could be said to have been adversely affected by the second

2007-1428 15
distortion discussed by the Supreme Court in Eli Lilly, so too Proveris is not a party who,

prior to enactment of the Act, could be said to have been adversely affected by the first

distortion. That is because Proveris is not a patentee who would have been faced with

a reduction of effective patent life caused by the FDA approval process, the reason

being that the invention claimed in the ’400 patent is not subject to the premarket

approval required by the FDCA. We think this is significant because, as noted above, in

Eli Lilly the Court spoke of its interpreting the phrase “patented invention” in section

271(e)(1) to include all products listed in section 156(f) as producing a “perfect ‘product’

fit” between the two provisions. 496 U.S. at 672. The result we reach today achieves

the same kind of fit, or symmetry. Because Proveris’s patented product is not subject to

a required FDCA approval process, it is not eligible for the benefit of the patent term

extension afforded by 35 U.S.C. § 156(f). At the same time, because Innova’s OSA

device also is not subject to a required FDCA approval process, it does not need the

safe harbor protection afforded by 35 U.S.C. § 271(e)(1).

As seen, Innova argues that it is entitled to the protection of section 271(e)(1)’s

safe harbor because it is offering for sale and selling a “patented invention” (the

invention claimed in the ’400 patent) “solely for uses reasonably related to the

development and submission of information under a Federal law which regulates the

manufacture, use, or sale of drugs or veterinary biological products.” Innova’s position

is that its offering for sale and its sale of the OSA device fit squarely within the statutory

language because, like the product claimed in the ’400 patent, the OSA is used in a way

which is “reasonably related” to the “development and submission of information”

pertinent to the FDA premarket approval required for inhaler-based drug delivery

2007-1428 16
devices. The problem with that argument is that it is premised on the proposition that

the device claimed in the ’400 patent is, for purposes of section 271(e)(1), a “patented

invention.” As we have just seen, it is not. We therefore reject the argument.

For the foregoing reasons, we see no error in the ruling of the district court that

Innova’s marketing and sale of its OSA device are not exempted from infringement by

the safe harbor provision of 35 U.S.C. § 271(e)(1).

II

Innova’s second contention on appeal is that the district court erred in granting

JMOL of infringement of claims 3-10 and 13 of the ’400 patent. The district court

employed a special verdict form allowing the jury to consider the infringement of only

claims 1 and 2 of the ’400 patent. The record indicates the court took this action in

response to what it viewed as Innova’s admissions during and prior to trial that it did not

have a defense to Proveris’s claims of infringement of claims 3-10 and 13 of the ’400

patent. Innova argues that the court’s JMOL ruling was in error because a patentee

bears the burden of proof with respect to infringement of every claim. Innova contends

that Proveris failed to meet its burden with respect to claims 3-10 and 13. Proveris

responds that Innova’s counsel conceded infringement of claims 3-10 and 13 during a

pre-trial conference with the district court judge, leaving the jury to consider only claims

1 and 2 at trial. As evidence of this concession, Proveris points to portions of the record

in which Innova purportedly agreed with, or failed to object to, statements that claims 3-

10 and 13 were admittedly infringed. 5

5
For example, during cross-examination, in response to questioning by
Proveris’s counsel that “there’s no issue with respect to infringement as to claims 3
through 10 and 13 of the asserted patent,” Innova’s witness, Mr. Quinn, agreed. Trial

2007-1428 17
 We review a district court’s grant or denial of JMOL under the law of the regional

circuit to which an appeal from the district court would normally lie. Union Carbide

Chems. & Plastics Tech. Corp. v. Shell Oil Co., 425 F.3d 1366, 1372 (Fed. Cir. 2005).

The regional circuit in this case is the First Circuit, which reviews de novo an order

granting or denying JMOL. See Hochen v. Bobst Group, Inc., 290 F.3d 446, 453 (1st

Cir. 2002); Larch v. Mansfield Mun. Elec. Dep’t, 272 F.3d 63, 67 (1st Cir. 2001). JMOL

is appropriate when “a party has been fully heard on an issue and there is no legally

sufficient evidentiary basis for a reasonable jury to find for that party on that issue.”

Fed. R. Civ. P. 50(a)(1). We have reviewed the portions of the record cited by Proveris,

and agree that the only reasonable conclusion is that Innova did indeed concede

infringement with respect to claims 3-10 and 13, leaving a dispute only as to claims 1

and 2 for the jury to consider. Accordingly, we find no error by the district court in its

grant of JMOL of infringement of claims 3-10 and 13.

III

Innova’s final argument on appeal is that the district court erred in excluding or

limiting the testimony of its invalidity experts, and consequently ruling in favor of

Proveris on the issue of validity as a matter of law. In support of its claim that claims 1,

2, and 9 were invalid by reason of obviousness and that claims 3-8 and 10 and 13 were

invalid as anticipated by a single prior art reference, Innova asserted a number of prior

art references. In that connection, it sought to introduce supporting testimony from John

Tr. at 241, Proveris Scientific Corp. v. Innovasystems, Inc., No. 05-12424 (D. Mass.
May 11, 2007). Likewise, during trial the court stated that there was “no real dispute but
what claims 3 through 10 and 13 do infringe the patent,” to which Innova did not object.
Id. at 168. In addition, the court also stated that “as [to] the other claims it’s not
disputed, but it is disputed as to claims 1 and 2, those were infringed,” to which Innova
again did not object. Id. at 286.

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Waters, the president of Innova, as well as Charles Quinn, a patent attorney. The

district court excluded the testimony of Mr. Waters on the ground that he had not

prepared or submitted an expert report. At the same time, the court limited Mr. Quinn’s

testimony to a discussion of the contents of the prosecution history and a discussion of

spray plumes. The court determined this was the correct approach because Mr. Quinn

was a patent attorney with past experience using plumes to maneuver satellites while

employed as an engineer in General Electric’s missile and space division. However, he

had no other relevant experience qualifying him to testify about the devices in question.

Because these evidentiary rulings left Innova without expert testimony to substantiate its

invalidity defenses, the district court entered JMOL in favor of Proveris.

Innova appeals the district court’s evidentiary rulings that resulted in the entry of

JMOL in favor of Proveris on the validity issue. First, it argues that the ’400 patent was

so simple and easily understood that the district court erred in requiring expert

testimony to establish invalidity. Second, it urges that because Mr. Waters and Mr.

Quinn were both persons of ordinary skill in the art, the district court improperly

excluded or limited their testimony. We review a district court’s evidentiary rulings

under the law of the regional circuit. Sulzer Textil A.G. v. Picanol N.V., 358 F.3d 1356,

1363 (Fed. Cir. 2004). The First Circuit reviews evidentiary rulings for an abuse of

discretion. Cavallaro v. United States, 284 F.3d 236, 245 (1st Cir. 2002).

We see no abuse of discretion in the district court’s rulings with respect to the

testimony of Mr. Waters and Mr. Quinn. First, the ’400 patent teaches a device used for

calibrating drug delivery devices; this subject matter is sufficiently complex to fall

beyond the grasp of an ordinary layperson. We thus are not prepared to say the district

2007-1428 19
court abused its discretion in requiring Innova to present expert testimony in order to

establish invalidity. Neither do we see an abuse of discretion in the court’s evidentiary

rulings involving Innova’s proffered expert testimony. Mr. Waters’s testimony was

properly excluded because he did not submit a written expert report in compliance with

Federal Rule of Civil Procedure 26(a)(2)(B). See Pena-Crespo v. Puerto Rico, 408 F.3d

10, 13-14 (1st Cir. 2005) (“In this case, Plaintiff’s expert witness . . . did not prepare or

submit a written report meeting the requirements of Rule 26(a)(2)(B). . . . Accordingly,

the district court did not abuse its discretion in excluding [the witness] from testifying as

an expert witness at trial.”). We come to the same conclusion with respect to the court’s

ruling limiting the scope of Mr. Quinn’s testimony to the prosecution history and the topic

of plumes, because they were the only matters within his relevant expertise. Although a

mechanical engineer by training, his technical experience was limited to satellite design

while employed as an engineer at General Electric. Accordingly, we cannot say the

district court did not act within its discretion in finding Mr. Quinn unqualified to testify

about laboratory equipment used in the development of drug delivery devices. See,

e.g., Malave-Felix v. Volvo Car Corp., 946 F.2d 967, 973 (1st Cir. 1991) (holding that

the trial court acted within its discretion in determining that the expertise of an

automobile systems expert did not extend to the mental processes and human factors

which may have caused an automobile accident).

In sum, we see no abuse of discretion in the district court’s decision to exclude

and limit, respectively, the testimony of Mr. Waters and Mr. Quinn. Accordingly, we will

2007-1428 20
not disturb the district court’s grant of JMOL in favor of Proveris on the issue of Innova’s

affirmative defense of invalidity. 6

CONCLUSION

For the foregoing reasons, we affirm the final judgment of the district court.

AFFIRMED.

6
On appeal, Innova has presented no meaningful argument as to why, if
the district court’s evidentiary rulings stand, the grant of JMOL was improper.

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