Invitrogen Corp. v. Biocrest Manufacturing, l.p.

Error: Bad annotation destination
United States Court of Appeals for the Federal Circuit

04-1273, -1274

INVITROGEN CORPORATION,

Plaintiff-Appellant,

v.

BIOCREST MANUFACTURING, L.P.,
STRATAGENE HOLDING CORP., and STRATAGENE, INC.,

Defendants-Cross Appellants.

Francis M. Wikstrom, Parsons Behle & Latimer, of Salt Lake City, Utah, argued
for plaintiff-appellant. With him on the brief were C. Kevin Speirs and Kristine Edde
Johnson. Of counsel on the brief was Alan W. Hammond, Invitrogen Corporation, of
Carlsbad, California.

Marc R. Labgold, Patton Boggs LLP, of McLean, Virginia, argued for defendants-
cross appellants. With him on the brief were Scott A.M. Chambers and Kevin M. Bell;
and Richard J. Oparil, of Washington, DC.

Appealed from: United States District Court for the Western District of Texas

Judge Sam Sparks
 United States Court of Appeals for the Federal Circuit

04-1273,-1274

INVITROGEN CORPORATION,

Plaintiff-Appellant,

v.

BIOCREST MANUFACTURING, L.P.,
STRATAGENE HOLDING CORP., and STRATAGENE, INC.,

Defendants-Cross Appellants.

___________________________

DECIDED: October 5, 2005
___________________________

Before RADER, DYK, and PROST, Circuit Judges.

RADER, Circuit Judge.

On remand from this court, the United States District Court for the Western

District of Texas, on summary judgment, determined that Biocrest Manufacturing, L.P.,

Stratagene Holding Corporation, and Stratagene, Inc. (collectively Stratagene) infringed

Invitrogen Corporation’s (Invitrogen’s) U.S. Patent No. 4,981,797 (issued Jan. 1, 1991)

(the ’797 patent), and that the ’797 patent was not invalid for indefiniteness, although it

was invalid because of public use under 35 U.S.C. § 102(b). Invitrogen Corp. v.

Biocrest Mfg., No. A-01-CA-167-SS (W.D. Tex. Feb. 12, 2004) (Invitrogen II). Although

not specifically enumerating all of the counterclaims on which judgment was obviated

due to its holding on invalidity, the trial court rendered final judgment sufficient to give
this court jurisdiction under 28 U.S.C. § 1295(a)(1) (2000). See Pandrol v. Airboss, 320

F.3d 1354, 1362-63 (Fed. Cir. 2003) (“What essentially is required is some clear and

unequivocal manifestation by the trial court of its belief that the decision made, so far as

it is concerned, is the end of the case.”). This court affirms the trial court’s decisions on

infringement and on non-invalidity due to indefiniteness. Because the district court

relied on an incorrect understanding of public use, this court reverses the trial court’s

judgment of invalidity on that ground and remands.

I.

The ’797 patent involves the introduction of recombinant DNA molecules into

receptive E. coli cells to improve the cells’ “competence,” i.e., their ability to take up and

establish exogenous DNA and replicate this DNA as they multiply. See ’797 patent, col.

1, ll. 11-13. A cell that accepts alien DNA is called a transformable cell.

Claim 1 of the ’797 patent claims:
A process for producing transformable E. coli cells of improved
competence by a process comprising the following steps in order:
(a) growing E. coli in a growth-conductive medium at a temperature of
18°C to 32°C;
(b) rendering said E. coli cells competent; and
(c) freezing the cells.

’797 patent, col. 10, ll. 27-32 (emphasis added). Stratagene makes thirty-four

competent E. coli cell lines by a process “including the steps of incubating cells at 37°C,

growing the cells in a fermenter at 26°C, and freezing the cells.”

Invitrogen sued Stratagene for infringement on March 12, 2001. The district

court construed the claims and then granted Stratagene’s summary judgment motion of

non-infringement. Invitrogen appealed to this court, disputing the lower court’s

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construction of both “improved competence” in the preamble and “growing” in step (a).

This court decided that the trial court had correctly construed the term “improved

competence.” Invitrogen Corp. v. Biocrest Mfg., 327 F.3d 1364, 1370 (Fed. Cir. 2003)

(Invitrogen I). This court noted that the term required only a general increase in

competence, as compared with that generally obtained when cells are prepared by

either (1) growing the cells at 37°C, rendering them competent, and freezing them, or

(2) growing the cells at 37°C, rendering them competent, and not freezing them. Id. At

the same time, however, this court decided that the trial court had incorrectly construed

“growing.” Id. This court construed that term to permit preparatory steps in advance of

step (a), including growth of E. coli at a temperature outside the range in step (a). Id.

Thus, the trial court received the case on remand.

On remand, the trial court properly applied this court’s construction of “growing”

by stating that “the temperature of the medium in which the E. coli cells are grown”

before step (a) “does not matter.” The district court then found literal infringement of

claims 1, 2, 4, 5, 7, 8, 11, 14, and 15 of the ’797 patent; decided that Claim 1 was not

indefinite under 35 U.S.C. § 112, ¶ 2; and found the claims invalid under the public use

provision of 35 U.S.C. § 102(b). The court dismissed all other motions as moot. See

Invitrogen II.

II.

This court reviews a grant of summary judgment de novo, determining whether

the evidence in the record raises any genuine dispute about material facts. In this

review, all reasonable factual inferences are drawn in favor of the non-moving party.

See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1346 (Fed. Cir. 2002), cert. denied,

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538 U.S. 907 (2003). Whether a patent is invalid due to public use under § 102(b) is a

question of law based on underlying questions of fact. Netscape Communications

Corp. v. Konrad, 295 F.3d 1315, 1321 (Fed. Cir. 2002). A patent is presumed valid. 35

U.S.C. § 282 (2000). Overcoming the presumption requires a showing of facts proved

by clear and convincing evidence. Connell v. Sears Roebuck & Co., 722 F.2d 1542,

1549 (Fed. Cir. 1983). That standard of proof also applies in the summary judgment

context. Nat’l Presto Indus., Inc. v. W. Bend Co., 76 F.3d 1185, 1189 (Fed. Cir. 1996).

Overall, this court makes an independent determination, applying the standards for

summary judgment. Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041, 1045

(Fed. Cir. 2001).

The Federal Circuit applies its own law with respect to issues of substantive

patent law and certain procedural issues pertaining to patent law, but applies the law of

the regional circuits on non-patent issues. Institut Pasteur v. Cambridge Biotech Corp.,

186 F.3d 1356, 1368 (Fed. Cir. 1999). Therefore, this court reviews the district court’s

evidentiary rulings under the law of the United States Court of Appeals for the Fifth

Circuit for an abuse of discretion. Snap-Drape, Inc. v. Comm'r of Internal Revenue, 98

F.3d 194, 197 (5th Cir. 1996).

The parties do not dispute that Invitrogen used the claimed process before the

critical date, in its own laboratories, to produce competent cells. Invitrogen did not sell

the claimed process or any products made with it. The record also shows that

Invitrogen kept its use of the claimed process confidential. The process was known

only within the company. Stratagene does not dispute that the claimed process was

maintained as a secret within Invitrogen until some time after the critical date.

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 35 U.S.C. § 102(b) states that a person shall be entitled to a patent unless “the

invention was . . . in public use or on sale in this country, more than one year prior to the

date of the application for patent in the United States.” 35 U.S.C. § 102(b) (2000)

(emphasis added). In Pfaff v. Wells, the Supreme Court considered the meaning of the

phrase “the invention” in § 102(b). Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 60 (1998).

The Court explained that analysis under § 102(b) involves two separate inquiries, one

evaluating whether “the invention” was complete and ready for patenting, and the other

evaluating whether that invention was “on sale.” Id. at 66-67. In that context, the Court

found no role for this court’s “totality of the circumstances” test, which directed a court to

consider the circumstances surrounding the alleged offer for sale together with the

circumstances surrounding the stage of development of the invention that may have

been prematurely exploited in the market. See id. at 66, n.11. In place of that “totality

of the circumstances” test, the Court formulated the now-familiar test that evaluates

both whether the product was subject to a commercial offer for sale (i.e., was it “on

sale”) and whether the invention was “ready for patenting” (i.e., was there an “invention”

at the time of the sale). See id. at 67. Following the Court’s guidance in Pfaff, this court

rejected the totality of the circumstances test in the context of statutory bar disputes.

See EZ Dock v. Schafer Sys., Inc., 276 F.3d 1347, 1351 (Fed. Cir. 2002) (“[T]his court

now ‘follows the Supreme Court’s two-part test without balancing various policies

according to the totality of the circumstances.’”) (quoting Weatherchem Corp. v. J.L.

Clark, Inc., 163 F.3d 1326, 1333 (Fed. Cir. 1998)).

In Pfaff, the Court specifically considered the “on sale” portion of the § 102(b)

statutory bar language, but in so doing, the Court noted that both the “on sale” and

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“public use” bars were based on the same policy considerations. Id. at 64. The Court

noted that both the on sale and public use bars of § 102 stem from the same

“reluctance to allow an inventor to remove existing knowledge from public use.” Id. In

Pfaff, the Court applied the separate components of its test to facts raising the “on sale”

issue. Nonetheless, the Court’s analysis of the statutory term “invention,” or the ready

for patenting prong, applies to both of the other parts of section 102(b), “on sale” and

“public use.” Thus, the Supreme Court’s “ready for patenting test” applies to the public

use bar under § 102(b). A bar under § 102(b) arises where, before the critical date, the

invention is in public use and ready for patenting. This court notes that in applying the

Pfaff two-part test in the context of a public use bar, evidence of experimental use may

negate either the “ready for patenting” or “public use” prong. See EZ Dock, 276 F.3d at

1352 (recognizing an overlap of the experimental use negation and the ready for

patenting standard).

This court’s decisions in Netscape Communications Corp. v. Konrad, 295 F.3d

1315 (Fed. Cir. 2002), and Bernhardt, L.L.C. v. Collezione Europa USA, Inc., 386 F.3d

1371 (Fed. Cir. 2004), do not compel a different analysis. In Netscape, this court

considered a possible public use and formulated its inquiry as a “look to the totality of

the circumstances when evaluating whether there has been a public use within the

meaning of section 102(b).” Netscape, 295 F.3d at 1320 (citing Sinskey v. Pharmacia

Ophthalmics Inc., 982 F.2d 494, 498 (Fed. Cir. 1992), a pre-Pfaff opinion). Likewise, in

Bernhardt, this court stated, “[i]n determing whether an invention was in public use, a

court ‘must consider how the totality of the circumstances comports with the policies

underlying the on sale and public use bars.’” Bernhardt, 386 F.3d at 1379 (quoting

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Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544, 549 (Fed. Cir. 1990) (a pre-

Pfaff opinion)). The language in Netscape and Bernhardt should not be construed to

resurrect a totality of the circumstances test for determining whether an “invention was .

. . in public use . . . more than one year prior to the date” of the patent application. 35

U.S.C. § 102(b) (2000). Such a reading of Netscape and Bernhardt would be

inconsistent with Pfaff and this court’s cases abandoning such a balancing test. See

Pfaff, 525 U.S. at 66 n.11; EZ Dock, 276 F.3d at 1351; Weatherchem, 163 F.3d at 1333.

The proper test for the public use prong of the § 102(b) statutory bar is whether the

purported use: (1) was accessible to the public; or (2) was commercially exploited.

Commercial exploitation is a clear indication of public use, but it likely requires more

than, for example, a secret offer for sale. Thus, the test for the public use prong

includes the consideration of evidence relevant to experimentation, as well as, inter alia,

the nature of the activity that occurred in public; public access to the use; confidentiality

obligations imposed on members of the public who observed the use; and commercial

exploitation, see Allied Colloids, Inc. v. Am. Cyanamid Co., 64 F.3d 1570, 1574 (Fed.

Cir. 1995). That evidence is relevant to discern whether the use was a public use that

could raise a bar to patentability, but it is distinct from evidence relevant to the ready for

patenting component of Pfaff’s two-part test, another necessary requirement of a public

use bar.

The district court reasoned that Stratagene had used the claimed process in its

own laboratories, more than one year before the ’797 application was filed, to “further

other projects” beyond development of the claimed process and to acquire a

commercial advantage. Stratagene admits that it used the claimed process in its own

04-1273,-1274 7
laboratories before the critical date to grow cells to be used in other projects within the

company. The district court determined that use of the invention in Stratagene’s

general business of widespread research generated commercial benefits. The district

court examined the totality of the circumstances and found that this use was “public.”

See Invitrogen II. Stratagene argues, however, that this secret internal use was not

“public use” under the applicable test, because it neither sold nor offered for sale the

claimed process or any product derived from the process, nor did it otherwise place into

the public domain either the process or any product derived from it. Under the proper

test for public use under § 102(b), these facts do not erect a bar.

The basic tenet of U.S. patent law is that an original inventor gains an exclusive

right to the invention. U.S. Const. art. I, § 8, cl. 8. Thus, an inventor’s own work cannot

be used to invalidate patents protecting his own later inventive activities unless, inter

alia, he places it on sale or uses it publicly more than a year before filing. 35 U.S.C.

§ 102(b); see also In re Katz, 687 F.2d 450, 454 (CCPA. 1982); In re Facius, 408 F.2d

1396, 1406 (CCPA 1969) (“[C]ertainly one’s own invention, whatever the form of

disclosure to the public, may not be prior art against oneself, absent a statutory bar.”).

Section 102(a) denies any applicant for a patent an exclusive right to any invention

already “known or used by others in this country” (emphasis added). On the other

hand, § 102(b) can apply to the inventor’s own actions. Section 102(b) expressly

requires a “public use” in this country for a statutory bar to arise based on use by the

inventor himself. See Pennock v. Dialogue, 27 U.S. 1, 23 (1829) (an applicant must be

the “first and true” inventor to obtain a patent, but “if he shall put [the invention] into

public use, or sell it for public use before he applies for a patent . . . this should furnish

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another bar to his claim”); Katz, 687 F.2d at 454 (“Disclosure to the public of one’s own

work constitutes a bar to the grant of a patent claiming the subject matter so disclosed

(or subject matter obvious therefrom).”). Further, to qualify as “public,” a use must

occur without any “limitation or restriction, or injunction of secrecy.” Egbert v.

Lippmann, 104 U.S. 333, 336 (1881); In re Smith, 714 F.2d 1127, 1134 (Fed. Cir. 1983).

In some cases, this court has determined that a use before the critical period was

not public even without an express agreement of confidentiality. See, e.g., Moleculon

Research Corp. v. CBS, Inc., 793 F.2d 1261 (Fed. Cir. 1986) (inventor’s private use and

demonstrations to colleagues were not public). For instance, in TP Laboratories, Inc. v.

Professional Publishers, Inc., 724 F.2d 965 (Fed. Cir. 1984), the inventor was a dentist

who installed the inventive orthodontic appliance in several of his patients. Although the

inventor had not obtained any express promise of confidentiality from his patients, this

court did not consider the use “public” because the dentist-patient relationship itself was

tantamount to an express vow of secrecy. Id. at 972. In reaching that result, this court

opined in general that secret use may be public “within the meaning of the statute, if the

inventor is making commercial use of the invention under circumstances which preserve

its secrecy.” Id.∗ This court noted specifically that, under the facts of TP Laboratories, it

∗
Kinzenbaw v. Deere & Co., 741 F.2d 383 (Fed. Cir. 1984) is more definite
concerning this dicta in TP Laboratories. Kinzenbaw states that commercial use trumps
secrecy. Id. at 390. (“A commercial use is a public use even if it is kept secret.”)
However, this statement was also dicta in Kinzenbaw, because the court did not find it
necessary to resolve the question of whether the use of the invention was secret or not.
Id. A careful reading nonetheless shows that Kinzenbaw is consistent with the basic
principle that a confidential use is not public under § 102 (b) unless there is commercial
exploitation. The use in Kinzenbaw was not confidential. In that case, the jury had
good reason to find Deere’s widespread commercial exploitation of the invention
“public.” The facts showed that:

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could find no “commercial exploitation” of the invention during the critical period,

identifying “commercial exploitation” with sale of the device or a charge for its use of the

invention within the confidential confines of the company to generate commercial

benefits. Id. at 972-73. Thus, TP Laboratories bolsters the general point that an

agreement of confidentiality, or circumstances creating a similar expectation of secrecy,

may negate a “public use” where there is not commercial exploitation.

The classical standard for assessing the public nature of a use was established

in Egbert. In Egbert, the inventor of a corset spring gave two samples of the invention

to a lady friend, who used them for more than two years before the inventor applied for

a patent. Egbert, 104 U.S. at 335. The invention was sewn into a corset and therefore,

by its nature, not visible to the public. Thus, the Court had to decide whether such an

invention could nevertheless be “public.” Although he later married the lady friend, the

inventor in Egbert received no commercial advantage. Nonetheless, on these facts, the

Court established the principle that it was indeed “public” use to give or sell the

Deere’s sales branch, acting through local independent dealers, made the
invention available to farmers (called “customers” in Deere's internal
memoranda) for commercial use. Deere instructed the dealers to keep the
units moving: “If one customer is not going to be using it for a few days
and another customer could, please move it.” In 1973, the farmers used
the planters for 1,000 hours in five states, and in 1974, for 500 hours in 11
states. By the end of 1974, 40,000 acres had been planted with the
machines. . . . [T]hree years after it began using the invention, Deere filed
the application for its patent.

Id. at 389-90. No wonder this court sustained a finding that Deere’s wide-spread
activities were “primarily for commercializing the apparatus” and therefore public. Id.

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invention “to another, to be used by the donee or vendee, without limitation or

restriction, or injunction of secrecy.” Id. at 336.

As the Supreme Court pointed out in Pfaff, supra, secrecy of use alone is not

sufficient to show that existing knowledge has not been withdrawn from public use:

commercial exploitation is also forbidden. Invitrogen’s invention was not given or sold

“to another,” or used to create a product given or sold to another, and was maintained

under a strict obligation of secrecy. Without more, these circumstances are insufficient

to create a public use bar to patentability.

The Supreme Court decided Electric Storage Battery Co. v. Shimadzu, 307 U.S.

5 (1939), in accord with the basic principle of Egbert. In Electric Storage Battery, an

accused infringer put the invention into “public” use. The accused infringer’s public use

came about because he had independently come upon both the method and the

apparatus of the patents, and “continuously employed the alleged infringing machine

and process for the production of lead oxide powder used in the manufacture of plates

for storage batteries which have been sold in quantity.” Id. Thus, that case was marked

by an outright commercial use of the invention by someone other than the applicant,

long before the applicant’s filing date. Those facts allowed the Court to invalidate the

patents at issue, and to observe that “[t]he ordinary use of a machine or the practice of

a process in a factory in the usual course of producing articles for commercial purposes

is a public use.” Id. at 20. Invitrogen, on the other hand, did not sell its invention or any

products made with it, and kept the invention entirely confidential within the company,

distinguishing this case from Electric Storage Battery.

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 While there are instances in which a secret or confidential use of an invention will

nonetheless give rise to the public use bar, this is not such a case. In Metallizing

Engineering Co. v. Kenyon Bearing & Auto Parts Co., 153 F.2d 516 (2d Cir. 1946), the

patentee used a secret process to recondition worn metal parts for its customers before

the critical date. The Second Circuit correctly held “that it is a condition upon an

inventor’s right to a patent that he shall not exploit his discovery competitively after it is

ready for patenting; he must content himself with either secrecy, or [a patent].” Id. at

520. In contrast, there is no evidence that Invitrogen received compensation for

internally, and secretly, exploiting its cells. The fact that Invitrogen secretly used the

cells internally to develop future products that were never sold, without more, is

insufficient to create a public use bar to patentability.

III.

Stratagene argues that it does not infringe the ’797 patent because its cells do

not have “improved competence” as required by the patent’s preamble, although it

admits that it practices each and every element of Claim 1, and does so in the claimed

order. To settle this question, the court ordered tests on each of Stratagene’s thirty-four

cell strains, to determine whether they exhibited “improved competence.” The tests

compared cells grown at 37°C, rendered competent, then frozen, with cells grown at

37°C, rendered competent, but not frozen, and with cells prepared using the claimed

process. Invitrogen’s expert supervised these tests. The tests showed that twenty-

eight strains made using the Stratagene process exhibited enhanced competence, five

exhibited decreased competence, and one exhibited no change.

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 Stratagene argues that those tests, presented in the form of an affidavit from the

Invitrogen expert, are inadmissible. Stratagene contends that the affidavit lacks

credibility because the expert did not conduct the tests personally, and thus does not

have sufficient “personal knowledge” of the results. To the contrary, the district court

carefully considered the admissibility of this evidence, and concluded that the expert

had obtained sufficient personal knowledge through review of the records of the tests.

This court detects no abuse of discretion in the district court’s decision to admit that

evidence.

Stratagene also argues that the tests raise a genuine issue of material fact about

the improved competence of Stratagene’s samples, because some of the samples did

not exhibit improved competence. Again, to the contrary, a great majority of

Stratagene’s samples did exhibit improved competence. The claim requires that the

quantity of E. coli cells that take up and establish exogenous DNA to be generally

increased. The tests show that general increase. In addition, Stratagene’s own

inventor had recorded in his notebooks that he found “improved competence” when the

cells of several cell lines were grown within the claimed range. The record contains no

evidence that contradicts the general increase in competence observed in the tests.

Therefore, the trial court properly resolved this issue as well.

IV.

Stratagene also argues that the ’797 patent is invalid for indefiniteness, objecting

to the phrase “improved competence.” A claim is definite if “one skilled in the art would

understand the bounds of the claim when read in light of the specification.” Personalized

Media Communications, LLC v. ITC, 161 F.3d 696, 705 (Fed. Cir. 1998). Claims are

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indefinite “if reasonable efforts at claim construction prove futile,” that is, if a claim “is

insolubly ambiguous, and no narrowing construction can properly be adopted.” Exxon

Research & Eng’g Co. v. United States, 265 F.3d 1371, 1375 (Fed. Cir. 2001). Even if

it is a formidable task to understand a claim, and the result not unanimously accepted,

as long as the boundaries of a claim may be understood it is “sufficiently clear to avoid

invalidity [for] indefiniteness.” Id. at 1375. Because this court construed the phrase

“improved competence” in Invitrogen I such that one skilled in the art would understand

the bounds of the claim, this court detects no unacceptable indefiniteness in that

language in this appeal. The claim is not “insolubly ambiguous,” i.e., not indefinite.

Stratagene further argues that it would have had to practice the claimed process

in order to determine if it was infringing, even though “[t]he primary purpose of the

definiteness requirement is to ensure that the claims are written in such a way . . . that

interested members of the public . . . can determine whether or not they infringe.”

Oakley, Inc. v. Sunglass Hut Int’l, 316 F.3d 1331, 1340 (Fed. Cir. 2003). Indeed, the

lower court had to have separate side-by-side tests done to determine whether

Stratagene infringed, and other testimony indicates that tests were necessary to

determine infringement. However, Oakley goes on to explain that “a patentee need not

define his invention with mathematical precision in order to comply with the definiteness

requirement.” Id. at 1341. Stratagene is really talking about the difficulty of avoiding

infringement, not indefiniteness of the claim. “The test for indefiniteness does not

depend on a potential infringer’s ability to ascertain the nature of its own accused

product to determine infringement, but instead on whether the claim delineates to a

skilled artisan the bounds of the invention.” SmithKline Beecham Corp. v. Apotex Corp.,

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403 F.3d 1331, 1341 (Fed. Cir. 2005). This court’s and the district court’s constructions

of the claim showed that it contained no material ambiguities, and therefore was not

invalid for indefiniteness. See All Dental Prodx, LLC v. Advantage Dental Prods., Inc.,

309 F.3d 774, 780 (Fed. Cir. 2002).

V.

Finally, Stratagene asks this court to consider its affirmative defenses of

enablement, anticipation, and obviousness, as alternate grounds for invalidity. Final

judgment by the district court included an order that invalidated the ’797 patent based

on public use under § 102(b), and on no other ground. The district court declared moot

the other invalidity claims and made no final judgment on them. Therefore, under 28

U.S.C. § 1295(a)(1) (final judgment rule), this court declines to assert jurisdiction to

consider an appeal on these issues.

This court reverses the trial court’s judgment of invalidity due to public use,

affirms the trial court’s partial summary judgment of infringement and denial of

Stratagene’s motion for summary judgment of invalidity due to indefiniteness, and

remands the case for further proceedings.

COSTS

Each party shall bear its own costs.

AFFIRM-IN-PART, REVERSE-IN-PART, and REMAND

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