國
立 政 治 大 學
‧
N a tio na
l C h engchi U ni ve rs it y
written description requirement, an invention involving a chemical genus requires a precise definition, such as by structure, formula, or the chemical name of the claimed subject matter sufficient to distinguish it from other materials,395 or “functional characteristics when coupled with a known or disclosed correlation between function and structure.”396 Thus, the patenting of the biological pathway can rely on functional characteristics coupled with correlation to satisfy the written description requirement. However, as will be discussed in section B, the Federal Circuit has not developed a consistent body of law in this area.
B. Case Study for Written Description Requirement
1. Regents of Univ. of Cal. v. Eli Lilly & Co.
Regents of Univ. of Cal. v. Eli Lilly & Co, limited the scope of the claims to the disclosed embodiments of the invention. In Eli Lilly, the inventors at University of California discovered the rat cDNA sequences for PI and PPI insulin.397 However, the human, vertebrate and mammalian cDNA were not discovered at the time of the application, and thus were not disclosed. In their application, the inventors broadly claimed not only the cDNA sequences for rat insulin, but also the human, vertebrate and mammalian PI and PPI.398 The court invalidated those claims of the undisclosed cDNA sequences, reasoning that “a generic statement” of cDNA sequences “does not distinguish the claimed genus from others, except by function.” Such generic statements, without more, are not adequate written descriptions of the genus.399
The Lilly court thus adopted a rigorous written description requirement standard, and rejected the patentability of broad functional claiming. Under Lilly, a definition by function
“does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is.”400 “[T]he written description of an invention involving a chemical genus . . . ‘requires a precise definition, such as by structure, formula, [or] chemical name,’
of the claimed subject matter sufficient to distinguish it from other materials.”401
395 Eli Lilly & Co., 119 F.3d at 1568.
396 Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316, 1324 (Fed. Cir. 2002).
397 Eli Lilly, 119 F.3d 1559 (Fed. Cir. 1997), at 1562-1563. PI and PPI stand for preproinsulin and proinsulin, respectively.
398 Id. at 1568.
399 Id.
400 Id.
401 Id. at 1562-1563.
‧ 國
立 政 治 大 學
‧
N a tio na
l C h engchi U ni ve rs it y
2. Enzo Biochem, Inc. v. Gen-Probe Inc.
Enzo Biochem, Inc. v. Gen-Probe Inc., by contrast, allowed claims having a broader scope than what was set out in the disclosed embodiments.402 In Enzo, the patentee discovered three nucleic acid probes and deposited them at the American Type Culture Collection, together with six strains of Neisseria gonorrhoea and of Neisseria meningtidis.403 The patentee sought to claim the three deposited probes even though the sequences of these probes were not determined.404 In addition, the patentee claimed a genus of “nucleic acid probes thatselectively hybridize to the genetic material of . . . Neisseria gonorrhoeae” over that of Neisseria meningitides.405 The Federal Circuit, in its first decision, applied Lilly's test and invalidated the genus claim for failure to meet the written description requirement.406
A mere three months later, the Federal Circuit vacated its first decision and held that “it is not correct . . . that all functional descriptions of genetic material fail to meet the written description requirement.”407 The Enzo II court held that even if the patentee did not disclose any structural features commonly possessed by members of the genus, the application could satisfy the written description requirement “if one of skill in the art would find the generically claimed sequences described on the basis of Enzo’s disclosure of the hybridization function and an accessible structure …”408 Thus, under the Enzo II decision,
"functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics," may satisfy the written description requirement.409
The Enzo II decision has been criticized for “relax[ing] the requirement of Eli Lilly and open[ing] a door for overly broad claims.”410 However, a distinction can be made between Enzo and Eli Lilly. In Enzo, “the claimed nucleotide sequences preferentially bind to the
402 Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316 (Fed. Cir. 2002).
403 Id. at 1321.
404 Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013, 1016 (Fed. Cir. 2002).
405 Enzo Biochem, Inc., 296 F.3d at 1320; see also, Wenrong Huang, Enzo's Written Description Requirement:
Can It an Effective Check Against Overly Broad Biotechnology Claims?, 16 ALBANY LAW JOURNAL OF SCIENCE AND TECHNOLOGY 1, 17 (2006) (explaining that the genus comprises numerous possible probes. "[E]ntirely different DNA sequences [can] display similar selectivity, but .. . bind to other parts of the N. gonorrhoeae DNA . . . [i]t's like a blind person discovering the tail of an elephant.").
406 Enzo Biochem, Inc., 285 F.3d at 1015 (The first Enzo court further invalidated the claims to three deposited probes because a publicly accessible depository does not provide "such descriptive means ... that fully set forth the claimed invention.").
407 Enzo Biochem, Inc., 296 F.3d at 1324.
408 Id. at 1328.
409 Id. at 1324.
410 Huang, supra note 510, at 13. (2006); see also, Paula K. Davis, Questioning the Requirement for Written Description: Enzo Biochem v. Gen-Probe and Overly Broad Patent Cases, 37 INDIANA LAW REVIEW 467, 490-491 (2004) ("The [Enzo 's genus] claims are not limited to specific metes and bounds but instead describe an unknown but potentially astronomical number of compounds of unknown sequences and structures, yielding overly broad claims.").
‧
genomic DNA of the deposited strains of [Neisseria] gonorrhoeae and have a complementary structural relationship with that DNA ....”411 By contrast, this “complementary structural relationship” is absent in Eli Lilly. There, the patentee defined the claimed cDNA sequences by “the mere name ‘cDNA’” or “the name of the protein.”412 Thus, one can distinguish Enzo from Eli Lilly by examining the presence or absence of a correlation between the function and structure.
Subsequent to Enzo II, the Federal Circuit has developed further requirements for functional claiming, and held that applicants cannot "define the unknown [structures] by . . . another unknown," when relying on the functional characteristics coupled with a known or disclosed correlation between function and structure.413 In Noelle v. Lederman, the applicant discovered a “mouse” form of a monoclonal antibody that specifically binds to a CD40CR antigen.414 As the patentees in Eli Lilly, the applicant sought to claim more than the scope of the disclosure—the “human” form of the antibodies and the “genus” form of the antibodies.415 As in Eli Lilly, the Federal Circuit held that the applicant “failed to disclose the structural elements of human CD40CR antibody or antigen . . . ,” and thus did not provide a sufficient written description of the claimed “genus” or “human” form of antibodies.416 However, unlike in Eli Lilly, the Federal Circuit held that it would have allowed functional claiming if the applicants had disclosed a “fully characterized antigen.”
Here, the binding affinity to the antigens alone could not sufficiently describe the “human”
form of antibody. Therefore, “[i]f Noelle had sufficiently described the human form of CD40CR antigen, he could have claimed his antibody by simply stating its binding affinity for the ‘fully characterized’ antigen.”417
The Federal Circuit further articulated the “full characterization” requirement in In re Wallach: if the functional “characterization contributes little . . . to the description” of the claimed genus, the written description requirement is not met, even if there is “disclosure of a partial structure.”418 There, the applicants sought to claim a genus of genes encoding for a
411 Enzo Biochem, Inc., 296 F.3d at 1328.
412 Regents of Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1569 (Fed. Cir. 1997).
413 Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir. 2004).
414 Id. at 1345-1346; Antibody is a Y-shaped protein on the surface of B cells that is secreted into the blood or lymph in response to an antigenic stimulus, such as a bacterium, virus, parasite, or transplanted organ, and that neutralizes the antigen by binding specifically to it; an immunoglobulin; see Noelle, 355 F.3d at 1346 (the applicants claimed the “mouse” form of CD40CR antibody in claim 42 of the application: “A monoclonal antibody or fragment thereof which specifically binds to an antigen expressed on activated T cells, wherein said antigen is specifically bound by the monoclonal antibody secreted by hybridoma MR1 which hybridoma has been deposited and accorded ATCC Accession No. HB 11048.”).
415 Id. at 1346 (explaining that the “human” form of CD40CR antibody was claimed in claim 52: “The monoclonal antibody or fragment of Claim 51, wherein said CD40CR is expressed by activated human T cells.” The “genus” form of CD40CR antibody was claimed in claim 51: “A monoclonal antibody or fragment thereof which specifically binds CD40CR.”).
416 Id. at 1349.
417 Id.
418 In re Wallach, 378 F.3d 1330, 1334 (Fed. Cir. 2004) (stating that the applicants disclosed a partial (5 percent)
‧ 國
立 政 治 大 學
‧
N a tio na
l C h engchi U ni ve rs it y
protein, even though 95 percent of the amino acid sequence was not determined at the time of the application.419 The Federal Circuit rejected the applicants’ argument that the written description was satisfied because they “were in possession of the protein” and the sequences of the protein were merely “an inherent property of the protein.” Physical possession does not amount to knowledge of the sequence.420
Following Enzo II, the Wallach court did not reject patentability by functional claiming, but held that “functional description can be sufficient only if there is also a structure-function relationship known to those of ordinary skill in the art.”421 Disclosure of a complete amino acid sequence may suffice for written description of the genus of the DNA molecules encoding for the protein because, analogous to the case of the nucleotide hybridization in Enzo, “such a well-known relationship exists between a nucleic acid molecule's structure and its function in encoding a particular amino acid sequence ....”422 However, a mere partial sequence cannot describe the structures of the genus. There is no evidence of “any known or disclosed correlation between the combination of a partial structure of a protein, the protein's biological activity, and the protein's molecular weight, ... and the structure of the DNA encoding the protein ....”423
3. Univ. of Rochester v. G.D. Searle & Co.
In Univ. of Rochester v. G.D. Searle & Co., the Federal Circuit seemed to have returned to Eli Lilly's holding, limiting the scope of the claims to the disclosed embodiments of the invention.424 In Rochester, the University discovered the existence and separate functions of two distinct cyclooxygenases, “COX-1" and "COX-2.”425 The University “hypothesized that it would be possible to reduce inflammation without gastrointestinal side effects if a method could be found for selectively inhibiting the activity of COX-2 . . . without inhibiting COX-1 activity.”426 The University “developed a screening assay for use in determining whether a particular drug displayed such selectivity,”427 but failed to disclose or identify even a single selective compound.428 The claims to assay methods were allowed and issued in a prior patent.429 The University further sought to patent a method of selectively inhibiting COX-2
amino acid sequence of a protein together with the molecular weight of the complete protein).
419 Id. at 1334.
420 Id. at 1334-1335.
421 Id. at 1335.
422 Id. (explaining that given the amino acid sequence, one can determine the chemical structure of all nucleic acid molecules that can serve the function of encoding that sequence).
423 Id.
424 Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004).
425 Id. at 917.
426 Id. at 918.
427 Id.
428 Id. at 928.
429 Id.
‧ 國
立 政 治 大 學
‧
N a tio na
l C h engchi U ni ve rs it y
activity in a human host by administering a non-steroidal compound that selectively inhibits COX-2 activity to a human host in need of such treatment.430 The Federal Circuit ruled that this method claim was invalid for lack of written description, because the application did not disclose any COX-2 selective compound. “Without such disclosure, the claimed methods cannot be said to have been described.”431
However, the Rochester court did not close the door for functional claiming in pharmaceutical patents, and has left many questions unanswered. In rejecting Rochester’s written description requirement arguments, the court seemed to suggest that functional claiming was not available because the genus was described by a “vague functional description.”432 An ordinarily skilled artisan would not be able to “identify any compound based on this vague functional description as ‘a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product.’ Conversely, if the functional description was not vague, the court would be willing to consider the functional claiming.