Chapter §6.07 Federal Circuit's Expansion of the Written Description Requirement
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§6.07 Federal Circuit's Expansion of the Written Description Requirement
Starting in the late 1990s, the Federal Circuit steadily expanded the applicability of the written description of the invention requirement well beyond the traditional time-gap or priority-policing situations described above. In a series of high-profile cases culminating with an en banc decision in 2010, the Federal Circuit has evolved the written description of the invention requirement from its traditional, relatively narrow moorings in policing priority (i.e., ensuring that claims presented later in time are truly entitled to the benefit of an earlier filing date) to a general purpose disclosure requirement, independent of enablement, that applies to all claims, regardless of whether they were included in an application when it was filed or added later.151 The progression of Federal Circuit cases summarized below covers the most arguably high-profile decisions illustrating this expansion, but does not purport to include every written description decision by the Federal Circuit since the 1997 Regents of Univ. of Cal. v. Eli Lilly decision.
[A] Regents of Univ. of Cal. v. Eli Lilly and Co. (1997)
In Regents of Univ. of Cal. v. Eli Lilly and Co. (hereafter Lilly),152 the Federal Circuit for the first time relied on the written description requirement as a general-purpose disclosure doctrine to invalidate unamended, originally-filed claims (i.e., claims presented in a patent application on its filing date and not amended thereafter).153
In 1990, the Regents of the University of California (UC) sued Eli Lilly and Company (Lilly) for infringement of UC patents directed to the use of recombinant DNA technology to produce human insulin.154 The patents were based on UC's successful cloning of the rat insulin gene, a breakthrough development that has been viewed as "open[ing] the way to modern insulin production."155 Specifically, UC's U.S. Patent No. 4,652,525 ('525 patent) included claims 1, 2, 4, 6, and 7, which were genus claims that recited complementary DNA (cDNA) encoding vertebrate or mammalian insulin.156 In contrast, claim 5 of UC's '525 patent specifically recited cDNA encoding human insulin. Claim 3 recited "a nucleotide sequence having the structure of and transcribed from the rat gene for insulin."157
Critical to the Lilly saga was that as of the 1977 filing date of the application leading to the '525 patent, UC had determined and isolated the preproinsulin (PPI) and proinsulin (PI) cDNA sequences found in rats, but not in humans.158 UC included in its patent application a constructive or "prophetic" example describing a method that could be used to obtain the human insulin-encoding cDNA recited in claim 5, as well as the amino acid sequences of human insulin A and B chains.159 However, UC did not actually isolate and sequence human cDNA until nearly two years after the application's 1977 filing date.160
Accused infringer Lilly did not assert that the '525 patent specification failed to enable the human insulin cDNA and vertebrate and mammalian insulin cDNA claims in accordance with §112, ¶1 of the Patent Act.161 Lilly's decision to forego a challenge to the '525 patent on enablement grounds was not surprising; UC's isolation of the rat insulin cDNA made the human insulin cDNA "relatively easy" to "fish out" thereafter.162 Instead, Lilly attacked the validity of the asserted claims on the grounds that the '525 patent did not provide an adequate written description of the human, mammalian, and vertebrate cDNA inventions claimed.
The Federal Circuit agreed, affirming a district court's conclusion that all the asserted claims of UC's '525 patent were invalid for failure to comply with the written description of the invention requirement.163 The appellate court first analyzed species claim 5, which recited human insulin-encoding cDNA, and concluded that the '525 specification was fatally defective for failing to structurally describe the claimed cDNA. The human insulin-encoding cDNA of claim 5 was not adequately described, the court held, because the '525 patent's specification lacked a disclosure of that cDNA's "relevant structural or physical characteristics."164 The court specifically pointed to the absence in the specification of "sequence information indicating which nucleotides constitute human cDNA. . . ."165 Nor did the '525 specification's provision in Example 6 of a process that could be used to isolate the human cDNA remedy the perceived deficiency of the disclosure; the Federal Circuit concluded that "describing a method of preparing a cDNA or even describing the protein that the cDNA encodes, as the example does, does not necessarily describe the cDNA itself."166
The Federal Circuit in Lilly then turned to the '525 patent's genus claims 1, 2, 4, 6, and 7, which more broadly recited cDNA encoding vertebrate and mammalian insulin. Like species claim 5, the appellate court held the generic claims invalid as not supported by an adequate written description.167 The extent of the written description required to support claims 1, 2, 4, 6, and 7 mirrored, on the genus level, the court's earlier pronouncement that a structural description must be provided to support a claim to a species of cDNA:
[A] cDNA is not defined or described by the mere name "cDNA," even if accompanied by the name of the protein that it encodes, but requires a kind of specificity usually achieved by means of the recitation of the sequence of nucleotides that make up the cDNA. . . . A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. 168
In the Federal Circuit's view, a "functional" definition of cDNA was insufficient because it indicated only "what the gene does, rather than what it is."169 The Lilly court viewed such a functional definition as merely a statement of result and observed that "[m]any such genes may achieve that result."170 Without more, UC's "generic statement[s]" such as "vertebrate insulin cDNA" and "mammalian insulin cDNA" did not constitute an adequate written description of the generic claims because they did "not distinguish the claimed genus from others, except by function."171
In the view of this author, the Lilly decision represents an anomalous application of written description principles, contrary to binding precedent.172 Regardless, Lilly is the foundation on which the Federal Circuit has built its expansive written description jurisprudence. Originally-filed claims constitute their own disclosure, and by their inclusion in the originally filed application clearly signal that the applicant considered herself to be in possession of the claimed subject matter as of the filing date.173 There is no "time gap" or priority claim present by which an applicant could unfairly obtain an advantage in terms of the extent of prior art that would be legally available for citation against her originally-filed claim.
Although the question whether a patent application provides an enabling disclosure having a scope reasonably commensurate with the scope of the originally-filed claims may legitimately be at issue in some cases,174 this is a completely separate inquiry from compliance with the written description of the invention requirement. In this author's view, the latter requirement has no applicability to unamended originally-filed claims.
To be clear, the Federal Circuit's case law has developed in a different direction. As described below, the court in 2010 went en banc in in Ariad Pharms., Inc. v. Eli Lilly and Co. to hold that the written description of the invention requirement does apply to originally-filed claims and is no longer limited to priority policing situations.175
[B] Enzo Biochem., Inc. v. Gen-Probe, Inc. (2002)
Following their 1997 decision in Lilly, Federal Circuit judges continued to debate the proper role and scope of the written description of the invention requirement.176 In 2002, the court again expanded the reach of the written description requirement by holding in Enzo Biochem., Inc. v. Gen-Probe, Inc.177 that satisfaction of the possession test is not necessarily dispositive of written description compliance. The Enzo court's enlargement of the possession test was discussed supra.178
[C] Univ. of Rochester v. G.D. Searle & Co. (2004)
In 2004, a panel of the Federal Circuit decided the closely watched case of Univ. of Rochester v. G.D. Searle & Co.;179 a subsequent order denying rehearing of the case en banc produced four dissenting votes and five opinions.180 Rochester's U.S. Patent No. 6,048,850 ('850 patent) claimed methods "for selectively inhibiting PGHS-2 activity in a human host" by "administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to [or in] a human host in need of such treatment."181 This invention provided a screening method for use in determining whether a particular drug selectively inhibited the activity of COX-2 so as to reduce inflammation without the gastrointestinal side effects associated with prior art methods that inhibited not only COX-2 but also COX-1, a distinct cyclooxygenase.
The university filed its first application directed to the invention in 1992. After filing a series of continuation, continuation-in-part, and divisional applications relating back to the 1992 parent, it received in 1998 U.S. Patent No. 5,837,479 ('479 patent) claiming "methods for identifying a compound that inhibits prostaglandin synthesis catalyzed by [PGHS-2]." Rochester's '850 patent in suit issued in 2000 from a related divisional application.
Rochester sued Pfizer in 2000 for infringement of the '850 patent based on Pfizer's sale of its CELEBREX® and BEXTRA® COX-2 inhibitors. The parties disputed...
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