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September 3, 2009

Healthy Assertion

Martek and Lonza vend a health supplement made "by extracting lipids from fermented microorganisms - specifically certain microalgae." Martek owns patents it asserted against Lonza: 5,340,594; 5,698,244; 6,410,281; and 6,451,567. Some claims were found infringed in district court, and thereupon the inevitable appeal. Lonza attacked priority date by way of parent enablement; fought the finding of infringement via questionable testing; argued prior invention with uncorroborated evidence; and tried to clobber the claim construction using the file wrapper as a club. Meanwhile, Martek had its own appeal query: what's an animal?

Martek Biosciences v. Nutrinova and Lonza (CAFC 2008-1459, -1476) precedential

Docosahexaenoic acid ("DHA") is an essential omega-3 fatty acid that plays an important role in the development of organs such as the heart, brain, and eyes, and is reported to have many additional health benefits. Because the human body produces limited quantities of DHA, it is desirable to provide supplemental DHA.

The patents at issue relate to specified microorganisms that are useful for the commercial production of DHA because they produce high levels of DHA.

Priority Date

As the patents issued from an abandoned application, priority date was pivotal in applying prior art.

The '594 patent is a member of a family of patents, each of which claims priority to an abandoned patent application filed in 1988, U.S. Ser. No. 07/241,410 ("the 1988 application"). "In order to gain the benefit of the filing date of an earlier application under 35 U.S.C. § 120, each application in the chain leading back to the earlier application must comply with the written description requirement of 35 U.S.C. § 112." Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997). "[T]he test for sufficiency of support in a parent application is whether the disclosure of the application relied upon 'reasonably conveys 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) (quoting In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983)). In other words, "the earlier application need not describe the claimed subject matter in precisely the same terms as found in the claims at issue." Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1331 (Fed. Cir. 2008). Whether the written description requirement is met is a question of fact. Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865 (Fed. Cir. 1993). Thus, we will uphold the jury's finding that the '594 patent claims are adequately described by the 1988 patent application so long as that finding is supported by substantial evidence in the record. See United States v. Coyle, 63 F.3d 1239, 1243 (3d Cir. 1995) (reviewing the jury's factual determination for substantial evidence).

The district court had found two claims of the '567 patent invalid as a matter of law, owing to needing "undue experimentation." The CAFC disagreed.

To meet the enablement requirement, "the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation." In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993) (internal quotation marks omitted). "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). As we have explained:

Factors to be considered in determining whether a disclosure would require undue experimentation . . . include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.

Lonza failed to persuade that enablement was lacking in the parent application.

Infringement

Lonza tried to skirt infringement by "failing to conduct comparative testing." The burden to prove infringement is not onerous.

A patentee may prove infringement by "any method of analysis that is probative of the fact of infringement," Forest Labs. v. Abbott Labs., 239 F.3d 1305, 1312 (Fed. Cir. 2001), and circumstantial evidence may be sufficient, Liquid Dynamics Corp. v. Vaughan Co., Inc., 449 F.3d 1209, 1219 (Fed. Cir. 2006).

Martek's two experts were found to be convincing.

Prior Invention

Lonza argued prior invention, though could not corroborate it. Reduction to practice must be demonstrated, not just conception.

The Patent Act provides that "[a] person shall be entitled to a patent unless . . . before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it." 35 U.S.C. § 102(g)(2). Lonza argues that the district court improperly excluded its evidence that the claimed invention is not patent eligible because it was previously made by another inventor, Dr. Long. Because Lonza sought to introduce the testimony of an alleged prior inventor under § 102(g) for the purpose of invalidating a patent, Lonza was required to produce evidence corroborating Dr. Long's testimony. See Finnigan Corp. v. Int'l Trade Comm'n, 180 F.3d 1354, 1367 (Fed. Cir. 1999) ("'[T]he case law is unequivocal that an inventor's testimony respecting [the] facts surrounding a claim of derivation or priority of invention cannot, standing alone, rise to the level of clear and convincing proof.'" (quoting Price v. Symsek, 988 F.2d 1187, 1194 (Fed. Cir. 1993))); see also id. at 1369 ("[C]orroboration is required of any witness whose testimony alone is asserted to invalidate a patent, regardless of his or her level of interest.").

The purpose of this corroboration requirement is to prevent fraud, namely to "provide[] an additional safeguard against courts being deceived by inventors who may be tempted to mischaracterize the events of the past through their testimony." Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1170 (Fed. Cir. 2006). We note that Lonza "faces a particularly high hurdle in attempting to demonstrate abuse of discretion in light of the stringent standard for corroboration." See Tex. Digital Sys. v. Telegenix, Inc., 308 F.3d 1193, 1218 (Fed. Cir. 2002). 4

4 In Texas Digital, we were considering whether the district court abused its discretion when it excluded witness testimony regarding a prior use based on its determination that the testimony could not be sufficiently corroborated. Although the witness testimony at issue in the present case regards prior invention, as opposed to prior use, the principles articulated in Texas Digital and related cases remain relevant to our analysis because the corroboration requirement applies whether the witness claims to be a prior inventor under § 102(g) or a prior user under § 102(a) or § 102(b). See Finnigan Corp., 180 F.3d at 1367 ("[T]he case law is unequivocal that an inventor's testimony respecting facts surrounding a claim of derivation or priority of invention cannot, standing alone, rise to the level of clear and convincing proof. No principled reason appears for applying a different rule when other subsections of § 102 are implicated: a witness's uncorroborated testimony is equally suspect as clear and convincing evidence if he testifies concerning the use of the invention in public before invention by the patentee (§ 102(a)), use of the invention in public one year before the patentee filed his patent (§ 102(b)), or invention before the patentee (§ 102(g))." (internal quotation marks and citation omitted)).

To corroborate Dr. Long's testimony that he had reduced the claimed invention to practice prior to Martek's date of invention, Lonza offered: (1) Dr. Long's 1987 abandoned patent application and (2) evidence that the examples originally disclosed in that abandoned application were later reproduced, generating the results described in the application. On Martek's pretrial motion, the district court excluded Lonza's proffered evidence based on its determination that the evidence could not sufficiently corroborate Dr. Long's testimony. J.A. at 7220. We hold that was not an abuse of discretion.

The district court did not err when it determined that the proffered abandoned patent application was insufficient to corroborate Dr. Long's testimony. An alleged prior inventor "must provide independent corroborating evidence in addition to his own statements and documents," Hahn v. Wong, 892 F.2d 1028, 1032 (Fed. Cir. 1989), such as "'testimony of a witness, other than [the] inventor, to the actual reduction to practice or . . . evidence of surrounding facts and circumstances independent of information received from the inventor,'" id. at 1032-33 (quoting Reese v. Hurst, 661 F.2d 1222, 1225 (CCPA 1981). "Documentary or physical evidence that is made contemporaneously with the inventive process provides the most reliable proof that the inventor's testimony has been corroborated." Sandt Tech., 264 F.3d at 1350-51. Such contemporaneous documentary evidence could include an abandoned patent application. However, while an abandoned patent application is evidence of conception, it is insufficient to corroborate testimony that an alleged prior inventor reduced the invention to practice. See Tex. Digital, 308 F.3d at 1218 (holding the district court did not abuse its discretion when it excluded testimony of a prior public use because an unissued patent application was the only evidence of events prior to or contemporaneous with invention); In re Schlittler, 234 F.2d 882, 885 (CCPA 1956), overruled on other grounds by In re Borst, 342 F.2d 851, 854 (CCPA 1965) (stating that abandoned applications may be "evidence of conception" but "furnish no evidence that the processes or things they describe were ever made or used anywhere" (citation omitted)); see also Singh v. Brake, 222 F.3d 1362, 1370 (Fed. Cir. 2000) ("[T]o corroborate a reduction to practice, [we apply] a more stringent standard than that required to corroborate a conception. Indeed, a notebook page may well show that the inventor conceived what he wrote on the page, whereas it may not show that the experiments were actually performed, as required for a reduction to practice." (citation omitted)); In re Costello, 717 F.2d 1346, 1350 (Fed. Cir. 1983) ("[A]n abandoned application, with which no subsequent application was copending, cannot be considered a constructive reduction to practice. It is inoperative for any purpose, save as evidence of conception."). Thus, the district court correctly determined that the 1988 application could not sufficiently corroborate Dr. Long's testimony as a matter of law.

Claim Construction

Lonza tried to pour salt on an imaginary claim construction wound supposedly inflicted during prosecution.

Thus, Lonza's primary argument on appeal is that Martek disclaimed coverage of NaOH during prosecution of the application that issued as the '281 patent. That argument fails. To support its assertion, Lonza cites selected statements spanning two pages of the prosecution history. Although the selected statements arguably support Lonza's assertion, those statements are undercut considerably by additional statements recited in the same two pages of prosecution history relied upon by Lonza: (1) the applicant's explicit statement that NaOH is a non-chloride sodium salt, and (2) the applicant's statements distinguishing the prior art at issue from the claimed invention on alternative grounds unrelated to the way NaOH was used in the prior art reference. Thus, under this court's precedent, Martek committed no clear and unmistakable disavowal of claim scope. See, e.g., Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314, 1325-26 (Fed. Cir. 2003) ("[F]or prosecution disclaimer to attach, our precedent requires that the alleged disavowing actions or statements made during prosecution be both clear and unmistakable."); Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1252 (Fed. Cir. 2000) ("In determining whether there has been a clear and unmistakable surrender of subject matter, the prosecution history must be examined as a whole.").

The district court was feeling animal spirits when it decided a human was not an animal. The CAFC majority let the claims out of their concocted zoo cage.

All asserted claims of the '244 patent are directed to methods for achieving high concentrations of omega-3 HUFA in an "animal." '244 Patent col.1 ll.21-24, col.2 ll.17- 19, col.9 l.44-col.10 l.58. The district court construed the claim term "animal" to mean "any member of the kingdom Animalia, except humans." Claim Construction Order at 2. Based on the court's construction, Martek stipulated that Lonza does not infringe the '244 patent claims, because neither Lonza nor its customers use the claimed methods to provide omega-3 HUFA to non-human animals. See Stipulated Order Of Non- Infringement at 1, Martek Biosciences Corp. v. Nutrinova Inc., No. 03-896 (D. Del. Apr. 21, 2006); Cross Appellant's Br. at 9. Martek now appeals the district court's claim construction, arguing it is erroneous in light of the patent's stated definition of "animal." We review such issues of claim construction without deference. See Cybor Corp., 138 F.3d at 1456. For the following reasons, we agree with Martek.

When a patentee explicitly defines a claim term in the patent specification, the patentee's definition controls. See Phillips v. AWH Corp., 415 F.3d 1303, 1321 (Fed. Cir. 2005) (en banc) ("[T]he specification 'acts as a dictionary when it expressly defines terms used in the claims . . . .'" (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)); id. at 1316 ("[O]ur cases recognize that the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs."); see also Honeywell Int'l, Inc. v. Universal Avionics Sys. Corp., 493 F.3d 1358, 1361 (Fed. Cir. 2007) ("When a patentee defines a claim term, the patentee's definition governs, even if it is contrary to the conventional meaning of the term."); 3M Innovative Props. Co. v. Avery Dennison Corp., 350 F.3d 1365, 1374 (Fed. Cir. 2003) ("Because 3M expressly acted as its own lexicographer by providing a definition of embossed in the specification, the definition in the specification controls the meaning of embossed, regardless of any potential conflict with the term's ordinary meaning as reflected in technical dictionaries."). Here, Martek explicitly defined the term "animal" in the '244 patent: "The term 'animal' means any organism belonging to the kingdom Animalia." '244 Patent col.5 ll.11-12. That definition controls. Thus, because it is undisputed that humans are members of the kingdom Animalia, it was error for the district court to limit the claim term "animal" to exclude humans.

Thus, we are "governed by the principle that '[a]bsent a clear disclaimer of particular subject matter, the fact that the inventor may have anticipated that the invention would be used in a particular way does not mean that the scope of the invention is limited to that context.'" Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 909 (Fed. Cir. 2004) (quoting Northrop Grumman Corp. v. Intel Corp., 325 F.3d 1346, 1355 (Fed. Cir. 2003)). Under our precedent, because the patent does not clearly disclaim coverage of humans, it would be erroneous to limit the claims to certain types of animals that the inventor anticipated would prove useful in the invention. That is especially true in the present case because the patent expressly defines the claim term "animal" broadly enough to encompass humans and discloses uses of the claimed invention applicable to humans.

Finally, Lonza asserts that the extrinsic evidence of record demonstrates that the ordinary meaning of "animal" is a non-human animal. Appellant's Reply Br. at 57. In this case, because the patentee explicitly defined "animal," Lonza's extrinsic evidence is simply irrelevant. See, e.g., Honeywell Int'l, 493 F.3d at 1361 ("When a patentee defines a claim term, the patentee's definition governs, even if it is contrary to the conventional meaning of the term.").

Martek gets a win on every count.

There were five judges on this case, three forming the majority. Two dissenters would have excepted humans from being animals, because they viewed the patent application, taken as a whole, indicated such.

Our precedents make clear that a patentee is free to be his own lexicographer. See Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). To that end, Martek argues, and the majority agrees, that it defined "animal" in a single line in the '244 patent: "The term 'animal' means any organism belonging to the kingdom Animalia." '244 patent col.5 ll.11-12. Because humans are members of the Animalia kingdom, Martek contends that the district court's exclusion of humans from its claim construction was in error.

This case illustrates the unusual situation in which a purported definition of a claim term in the written description is totally negated by the remainder of the text of the patent. Martek's attempt at lexicography does not conform to the way in which it otherwise describes its invention.

It is fundamental that we must read a claim term in a manner that comports with the written description of the patent as a whole, see Markman v. Westview Instruments, Inc., 517 U.S. 370, 389 (1996), and not simply with a single sentence, even one purporting to be a definition, that is inconsistent with the remainder of the specification. We have stated many times that the specification of a patent is the "single best guide to the meaning of a disputed term," and that the specification is to be viewed in its totality. Vitronics, 90 F.3d at 1582; see Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc) ("[T]he person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification."); id. at 1315 ("The specification is, thus, the primary basis for construing the claims.") (quotation marks omitted). Thus, rather than reading in isolation the single line in the specification that Martek argues provides a definition of "animal," one should review the entire patent to determine the proper construction of the term. Having done so, it is clear that humans should be excluded from the construction of the term "animal" in the '244 patent.

Posted by Patent Hawk at September 3, 2009 7:25 PM | § 112

Comments

Another interesting thing about this case was that it had a panel of 5 judges. I don't ever recall a Federal Circuit panel of 5 before. And the reason for having more than the normal panel of 3 is never explained. Very odd.

Posted by: EG at September 4, 2009 4:19 AM

The application takes an interesting turn when you start to read "animals" as including humans, as the majority does.

"The present invention concerns a method of raising an animal having high concentrations of omega-3 highly unsatrurated fatty acids (HUFA) and food products derived from such animals."

Posted by: BT at September 4, 2009 6:25 AM

"food products derived from such animals"

Indeed.

Posted by: 6000 at September 4, 2009 10:48 AM

Doth not a human infant derive food product from its breast-feeding mother when suckling? And if you giveth the mother Omega-3, doth she not become more invigorated? Rader J. seems to say absolutely never and not. What sayeth the scientific readers of this blog? Let's have a vote.

Posted by: step back at September 4, 2009 9:01 PM

Soylent Green is people!

Posted by: RobertThorn at September 4, 2009 9:04 PM