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November 18, 2005
Clonetech Gets Clobbered
Invitrogen
v. Clonetech Labs is a patent law ecosystem unto itself: conception, enablement,
written description, and infringement. The factual bases are extensive, resulting in
a CAFC 47-page opinion (04-1039), but teasing out the legal reasoning in evaluating the facts
is the focus here.
Invitrogen appeals from the judgment of the United States District Court for the District of Maryland, invalidating two hundred and twenty-one claims, in three related Invitrogen patents, as anticipated by § 102(g)(2) prior art.
The patents are 5,244,797, 5,688,005, and 6,063,608.
Conception
Conception is a legal conclusion premised on various underlying facts. Singh v. Brake, 222 F.3d 1362, 1367 (Fed. Cir. 2000); Cooper v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir. 1998); Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986). As the partial summary judgment ruling arose in the context of Clontech’s motion for summary judgment of invalidity, Clontech was required to identify clear and convincing evidence of the factual underpinnings for Goff’s conception. See Apotex USA, Inc. v. Merck & Co., Inc., 254 F.3d 1031, 1036 (Fed. Cir. 2001) (requiring the party asserting invalidity to prove by clear and convincing evidence that the invention was not abandoned, suppressed, or concealed under § 102(g)); cf. Lindemann Machinenfabrik GmbH v. Am. Hoist and Derrick Co., 730 F.2d 1452, 1459 (Fed. Cir. 1984).
In sum, the court must affirm the district court’s partial summary judgment on conception in favor of Clontech if, in view of the heightened evidentiary burden at trial and drawing all reasonable factual inferences most favorably to Invitrogen, it finds no disputed issue of material fact underlying the conception analysis, and Clontech was entitled to the determination that Goff’s conception preceded Invitrogen’s. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).
Conception defines the legally operative moment of invention under § 102(g). It is the “formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.” Hybritech, 802 F.2d at 1376. An idea is sufficiently definite and permanent for conception if it provides one skilled in the art with enough guidance to “understand the invention,” that is, “when the inventor has a specific, settled idea, a particular solution to the problem at hand, not just a general goal or research plan he hopes to pursue.” Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994). The inventor must be able to “describe his invention with particularity.” Id. This requires both (1) the idea of the invention’s structure and (2) possession of an operative method of making it. Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1206 (Fed. Cir. 1991). Thus, with regard to a claimed chemical compound, conception requires that the inventor “be able to define” the compound “so as to distinguish it from other materials, and to describe how to obtain it.” Id.
This description, and the “definite and permanent idea of the complete and operative invention” for conception, require more than unrecognized accidental creation. “[A]n accidental and unappreciated duplication of an invention does not defeat the patent right of one who, though later in time, was the first to recognize that which constitutes the inventive subject matter.” Silvestri v. Grant, 496 F.2d 593, 597 (CCPA 1974). Thus, “[t]he date of conception of a prior inventor’s invention is the date the inventor first appreciated the fact of what he made.” Dow Chem. Co. v. Astro-Valcour, Inc., 267 F.3d 1334, 1341 (Fed. Cir. 2001). In other words, conception requires that the inventor appreciate that which he has invented.
Although such conscious problem solving suggests conception comes first, under some conditions conception is delayed until a reduction to practice. See Burroughs, 40 F.3d at 1229; Amgen, 927 F.2d at 1206; Alpert v. Slatin, 305 F.2d 891, 894 (CCPA 1962).8 Such delayed conception is often described by the rule against nunc pro tunc conception. That is, a reduction to practice at time A necessarily requires the inventor to possess the knowledge about the invention to show a conception. However, the law will not sanction the inference that reduction to practice at time A implies conception at earlier time B.
With unrecognized accidental duplication, the invention exists but remains unrecognized. The priority determination requires evidence that the inventor actually first made the invention, and that he understood his creation to have the features that, comprise the inventive subject matter at bar. Thus, the court must identify when, during an emerging recognition that a particular invention includes something new, the inventor’s understanding reaches the level needed for appreciation. In the appreciation analysis, the relevant uncertainty relates to the emerging recognition of something new.
That analysis requires objective corroboration of the inventor’s subjective beliefs. Heard v. Burton illustrates the importance of the inventor’s actual knowledge or beliefs. 333 F.2d 239, 243 (C.C.P.A. 1964). In Heard, a priority contest arose in an interference proceeding. The “essence of the invention” was “using eta-aluminum, a specific type of hydrated aluminum oxide, as support material for platinum” in a reforming process in which the platinum-alumina combination served as a catalyst. Id. at 240. The record showed that the compound could only be identified by its x-ray diffraction pattern. Id. at 241 n.1. The critical date was April 23, 1952, when Burton filed a patent application on the invention.
Although Heard actually made the novel compound in 1949 and 1950, the record showed that he never recognized it. Only in 1954 did the successor to Heard’s work, the Standard Oil Company, confirm by x-ray diffraction analysis that the 1949 compound contained the novel catalyst; only in 1961 did Standard Oil Company – again by x-ray diffraction – establish that the new catalyst was also present in the 1950 compound. Id. at 242. As the court observed, “we consider it fatal to [Heard’s] case that not until after the [critical date] did Heard recognize that his ‘ammonia-aged’ catalyst . . . ‘contained any different form of alumina at all.’” Id. at 243. The fact that Heard “relegated the spent catalysts to storage cages” rather than further develop them confirmed the lack of recognition. In short, the inventor – Heard – never suspected what he had created, and the context – a novel compound whose existence is shown by inspecting its x-ray diffraction pattern – required the most specific of objective evidence, which was missing. Heard was an easy case.
While Heard made clear the importance of an inventor’s subjective beliefs about his invention, objective evidence is also an important part of the appreciation inquiry. Indeed, because of the danger in post-hoc rationales by an inventor claiming priority, the court requires objective evidence to corroborate an inventor’s testimony concerning his understanding of the invention. See Jolley, 308 F.3d at 1321 (“Because conception is a mental act, ‘it must be proven by evidence showing what the inventor has disclosed to others and what that disclosure means to one of ordinary skill in the art.’”) (quoting Spero v. Ringold, 377 F.2d 652, 660 (CCPA 1967)). Thus, it is not enough that a party adduce evidence that objective test results comport with an inventor’s testimony concerning his state of mind. Rather, there must also be evidence that the junior party timely interpreted or evaluated the results, and understood them to show the existence the invention. See Langer v. Kaufman, 465 F.2d 915, 919 (CCPA 1972).
In Langer, the court extended Heard to provide that where there is an objective basis for identifying the novel features of an invention, there must be evidence that the inventor timely considered it. The facts of the Langer interference were essentially identical to those in Heard: the invention called for a catalyst using a particular crystalline compound,9 and as defined in the count the new compound was identified by a characteristic x-ray diffraction pattern. Id. at 917-18. But in contrast to Heard, Langer photographed x-ray diffraction patterns of the new compound two years before the critical date. Id. at 919. Reviewing those photos roughly eleven years after the critical date, Langer’s co-inventor identified evidence of the new catalyst. Id. The problem was that nothing showed, before the critical date, that anyone had either looked at the photos or understood what they meant. Quoting the opinion below, the court observed that there was “no evidence of any contemporaneous interpretation or evaluation of the patterns” by the inventors or anyone working with them. Id.
In Silvestri v. Grant, 496 F.2d 593, 597 (CCPA 1974), the court applied these principles to a priority contest in view of a record showing uncertainty in interpreting the test results corroborating the inventor testimony on appreciation. Notwithstanding that uncertainty, the court tested the evidence against the junior party’s burden at the interference, and concluded that the record showed appreciation. In short, Silvestri requires an objective basis corroborating the inventor’s belief to show, consistent with the appropriate burden at trial, that persons skilled in the art at the time of the recognition would have recognized the existence of the relevant inventive features.
On January 15, 2002, the Master recommended partial summary judgment in favor of Clontech under § 102(g)(2), establishing that Goff (1) conceived Invitrogen’s invention first, and (2) diligently reduced it to practice. On March 18, 2002, the district court accepted the Master’s report and recommendation (“R&R”) and granted partial summary judgment in favor of Clontech.3 Invitrogen now challenges this ruling as to Goff’s conception.
As a matter of law, the court’s conclusion is unsustainable. Langer and Silvestri require some connection between the physical result (the invention) and the belief (by the inventor). Here, the district court never identified corroborating evidence of Goff’s purported belief, nor identified how it could determine that Goff had reviewed such evidence and understood its import. There is no evidence that merely sequencing the mutant RT gene could, in 1986, establish the corresponding enzyme’s properties.
Although the district court’s conception analysis misapplied the law to the facts, this court must examine whether correctly applying the law of appreciation to this record would dictate a different result. See Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 164 (Fed. Cir. 1985). As shown below, we cannot affirm the invalidity judgment under a correct application of the law... The question becomes whether, as a matter of law, the trial court ignored a genuine issue of fact that should have been given to a jury.
In short, as the factual inferences must be drawn adverse to Clontech, the district court erred in granting partial summary judgment establishing Goff’s conception before January 27, 1987.
On remand, we remind the district court that the material factual dispute we perceive regarding appreciation affects not only the proper date of conception, but also the date of reduction to practice. “It is now well settled that in [an accidental creation] there is no conception or reduction to practice where there has been no recognition or appreciation of the existence of the new form.” Silvestri, 496 F.2d at 597. Because we reserve the question of appreciation for the jury, its determination on this issue will decide the date of conception (as well as reduction to practice).
Enablement
Section 112 requires that the patent specification enable “those skilled in the art to make and use the full scope of the claimed invention without ‘undue experimentation’” in order to extract meaningful disclosure of the invention and, by this disclosure, advance the technical arts.16 Koito Mfg., 381 F.3d at 1155 (quoting Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (citation omitted)). Because such a disclosure simultaneously puts those skilled in the art on notice of the enforceable boundary of the commercial patent right, the law further makes the enabling disclosure operational as a limitation on claim validity. “The scope of [patent] claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation.” Nat’l Recovery, 166 F.3d at 1196; see also In re Goodman, 11 F.3d 1046, 1050 (Fed. Cir. 1993) (“[T]he specification must teach those of skill in the art ‘how to make and how to use the invention as broadly as it is claimed’.”); In re Fisher, 427 F.2d 833, 839 (CCPA 1970) (“[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art.”).
Although Clontech’s validity argument might have force had Invitrogen limited its claims to modified RT by reference to point mutation, Clontech overlooks the fact that the claims are not limited by the method of achieving the mutation. As the district court noted, “[t]he enablement requirement is met if the description enables any mode of making and using the invention.” Johns Hopkins Univ. v. Cellpro, Inc., 152 F.3d 1342, 1361 (Fed. Cir. 1998); accord Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1335 (Fed. Cir. 2003); Engel Indus., Inc. v. Lockformer Co., 946 F.2d 1528, 1533 (Fed. Cir. 1991). In this case Invitrogen’s teaching regarding deletion mutation is sufficient to satisfy its part of the patent bargain, as it fully teaches a mode of making the claimed invention.
Enablement does not require the inventor to foresee every means of implementing an invention at pains of losing his patent franchise. Were it otherwise, claimed inventions would not include improved modes of practicing those inventions. Such narrow patent rights would rapidly become worthless as new modes of practicing the invention developed, and the inventor would lose the benefit of the patent bargain.
The court therefore affirms the district court’s judgment that the claims at bar are not invalid for lack of an enabling disclosure on point mutation.
Written Description
Clontech filed for summary judgment, arguing that this fashion of claiming the modified RT fails the § 112 written description requirement and renders the claims-in-suit invalid.Invitrogen opposed and filed a cross-motion that the claims were not invalid on this ground.
The district court tested the common written description of the patents-in-suit against the PTO guidelines. The guidelines state that the written description requirement of 35 U.S.C. § 112, ¶ 1, can be met by
show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics . . . i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
Guidelines for Examination of Patent Applications under 35 U.S.C. § 112, first paragraph, “Written Description” Requirement, 66 Fed. Reg. 1099, 1106 (Jan. 5, 2001).19 The court adopted this standard in Enzo Biochem Inc. v. Gen-Probe, Inc., 323 F.3d at 964.
Unlike conception and enablement, compliance with the written description requirement is a question of fact. Enzo Biochem, 323 F.3d at 962-63; Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). Like the facts underlying conception and enablement, invalidating a claim requires a showing by clear and convincing evidence that the written description requirement has not been satisfied. Enzo Biochem, 323 F.3d at 962. In response to Invitrogen’s partial summary judgment motion, the law required Clontech to come forward with evidence raising at least a genuine issue of fact regarding whether the patents failed the written description requirement. Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043, 1046 (Fed. Cir. 2001).
In short, Clonetech misfired on all its written description arguments.
The court concluded that the undisputed evidence was entirely one sided in favor of Invitrogen, and granted partial summary judgment, ruling that the claims at issue were not invalid for lack of written description.
Infringement
Clonetech had a two-pronged approach to arguing against infringement: an alleged factual dispute, and claim construction.
The trial court’s claim construction is a legal issue that we review de novo. See Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998) (en banc). The court’s comparison of the properly construed claims to the accused products is a factual matter, Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1323 (Fed. Cir. 2002), and in reviewing the trial court’s partial summary judgment this court ascertains, as a matter of law, whether the trial court overlooked genuine issues of fact weighing against infringement.
A material factual dispute must be genuine. “[T]he mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment.” Anderson, 477 U.S. at 247-48. A genuine dispute requires evidence “such that a reasonable jury could return a verdict for the non-moving party.” Id. at 248. Evidence that is “merely colorable,” or is “not significantly probative,” will not prevent summary judgment. Id. at 249-50. Of course, in assessing a putative dispute “the judge’s function is not himself to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial.” Id. at 249.
Claim construction requires the court to determine the meaning of disputed claim terms to one of ordinary skill in the art at the time of the invention. See 35 U.S.C. § 112; Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc); Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1360 (Fed. Cir. 2004); Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1332 (Fed. Cir. 2001). The court determines this meaning by examining the claim language, as it relates to the invention set forth in the written description, the drawings, and where relevant the prosecution history. See Phillips, 415 F.3d at 1313-17; Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
Clonetech's claim construction arguments wilted. Further, Clonetech's alleged factual dispute fizzled, as Clonetech's cited prior art references were deemed irrelevant.
We hold that the district court misapplied the law of appreciation when dating conception by the Columbia researchers and ignored genuine issues of fact precluding partial summary judgment in favor of Clontech. Thus, the court vacates the invalidity judgment and the district court’s conception ruling and remands for further proceedings.
Turning to Clontech’s cross-appeal, we affirm the district court’s rulings on enablement and written description. Clontech’s remaining cross-appeal challenges the district court's partial summary judgment of literal infringement for Invitrogen. Because we find no error in the district court’s claim construction, or its treatment of the facts, we affirm.
Posted by Patent Hawk at November 18, 2005 1:35 PM | Litigation