The Mutation On The Description Requirement Gene

The Mutation On The Description Requirement Gene

by Harris A. Pitlick^[1]

Introduction
An inventor files a patent application claiming a chemical compound A. The inventor discloses that he has invented "chemical compound A", and fully discloses what its function is, how to make and use it, as well as the best mode. There is no prior art that would render compound A unpatentable. The inventor, however, has not disclosed the structure, formula, name, or physical properties of compound A, although this information can be obtained by routine experimentation following its preparation. Is the inventor entitled to a patent?

Until a few years ago, the answer would doubtless have been "yes". However, if the compound happens to be a genetically engineered material, such as DNA, the answer now appears to be "no," at least for some of the judges sitting on the United States Court of Appeals for the Federal Circuit bench, on the ground that the description requirement of 35 USC 112 has not been satisfied.

A few months ago, I suggested application of a new approach in description requirement cases.^[2] The recent decision in Regents of theUniversity of California v. Eli Lilly and Co.,^[3] on top of Fiers v. Revel,^[4] decided only a few years before, are such extreme departures from conventional description requirement jurisprudence that the need for new thinking about the issue is now even more manifest. One problem may be nomenclature. As demonstrated later in the text, the term "description requirement" is a misnomer.

Well-settled precedent

The latest in-depth discussion of the meaning and purpose of the description requirement, and of its separateness and independence from the enablement requirement of 35 USC 112, appears in Vas-Cath Inc. v. Mahurkar.^[5] The court reiterated what by then had become the test for compliance with the description requirement, i.e., what I have called the possession test:

Whether the disclosure of the application relied upon reasonably conveys to the skilled artisan that the inventor had possession at that time [i.e., when the application was filed] of the later claimed subject matter.^[6]

So long as claimed subject matter was either originally claimed or found the same or synonymous language in the specification whose filing date was sought, the possession test, and hence the description requirement, has traditionally been held to be satisfied.^[7]

The above is the usual situation. Indeed, in the seminal case of In re Moore,^[8] in which the CCPA outlined the proper approach for applying the relevant parts of the first two paragraphs of 35 USC 112 in a given case, the court recognized that the description requirement is "relatively simple to comply with and thus will ordinarily demand minimal concern on the part of the Patent Office."^[9]

Nor did it matter whether the claimed subject matter was actually reduced to practice or was even based on speculation. In Snitzer v. Etzel,^[10] which involved an interference over the use of the rare earth element ytterbium as a laser-active material, the Snitzer application listed ytterbium among a total of fourteen possible rare earth elements disclosed as useful alone or in any combination. The Snitzer application exemplified only neodymium as the rare earth element and, in fact, not all of the listed fourteen listed elements were operable. Etzel asserted that Snitzer's disclosure of all elements other than neodymium was speculative. The CCPA reversed the Board of Interference's award of priority to Etzel. The court stated:

[W]e fail to see the relevance of the listing of several inoperative species when the species claimed is operative and performs as "speculated." Whether it is labeled "discovery" or "speculation," appellant's conception of trivalent ytterbium as a laser-active material is no less his own, no less original, no less important technologically, and, on this record, earlier than appellees'. His constructive reduction to practice by filing a patent application disclosing the conception and setting in motion the steps by which the public will be apprised of the discovery is in no way diminished if the conception is characterized as "speculation" or if other related conceptions turn out to be practically or technically unsound.^[11]

(Emphasis added.)

That the filing of a patent application is a constructive reduction to practice is a doctrine of patent law that goes back at least 125 years.^[12]

Prevailing precedent has also distinguished the filing of a patent application from other forms of initiating publication. An identical disclosure in a printed publication to that in a patent application is not a constructive reduction to practice.^[13]

I could find no case since the first case^[14] that recognized a separate description requirement under the 1952 Patent Act, and prior to Fiers, in which the Federal Circuit, or its predecessors CCPA or Court of Claims, found the description requirement not satisfied where the claimed subject matter had literal support in the original disclosure or found that such claimed subject matter was not constructively reduced to practice by the filing of a patent application.

This is not surprising. If the above summary of precedent is correct, then it is logically impossible for an inventor not to be in possession of an invention as of the date that invention is disclosed in a patent application. Indeed, as concisely stated by Judge Rich for the court in Vas-Cath as to what invention the inventor must be in possession of: "The invention is, for purposes of the "written description" inquiry, whatever is now claimed."^[15]

Amgen Inc. v. Chugai Pharmaceutical Co.

The seed of change was planted by a three-judge panel of the Federal Circuit in Amgen Inc. v. Chugai Pharmaceutical Co.^[16] Ironically, the description requirement was not even in issue therein.

The issue in Amgen relevant to the present discussion was whether Amgen's patent was invalid under 35 USC 102(g) over prior invention of another. Amgen's patent claimed a purified and isolated DNA sequence encoding human erythropoietin (EPO), i.e., the human EPO gene. Chugai alleged that the invention of one Fritsch was conceived prior to Amgen's invention and thereafter diligently reduced to practice. The evidence of record was such that while Fritsch's goal was to obtain the human EPO gene, and he had an idea of a possible method for obtaining it, Fritsch never did isolate the gene, nor identify its structure, and furthermore, others were unsuccessful using Fritsch's approach. The court held that Fritsch's work did not amount to a conception. The court stated:

We hold that when an inventor is unable to envision the detailed constitution of a gene so as to distinguish it from other materials, as well as a method for obtaining it, conception has not been achieved until reduction to practice has occurred, i.e., until after the gene is isolated.^[17]

(Emphasis added.)

This "holding" is warranted by the facts so long as it is taken in context, which is that of an inventor seeking to establish a date of invention under 35 USC 102(g).

Fiers v. Revel

The Board of Patent Appeals and Interferences wasted no time literally construing the court's expression of its holding in Amgen, without regard to the context in which it came about. That is evident from Fiers v. Revel,^[18] a three way interference between Fiers, Revel and Sugano, wherein the count in issue was drawn to a DNA coding for human fibroblast interferon-beta polypeptide (ß-IF gene). The board awarded priority to Sugano, on the ground that Sugano was first to file a patent application that disclosed the ß-IF gene sequence (and a method of making the gene). A three-judge panel of the court affirmed.

Fiers' case for priority relied on conception when his ideas were brought into the United States from abroad, coupled with diligence toward a constructive reduction to practice on the date he filed a British application disclosing the ß-IF gene sequence. There was evidence that Fiers' ideas, embodied in a draft patent application, included a protocol for isolating the ß-IF gene sequence without undue experimentation. The draft application, however, did not include the gene sequence.

The board had held, citing Amgen, that Fiers was entitled only to the date of his British application, because it was Fiers' first disclosure of the complete sequence of the ß-IF gene. On appeal, Fiers tried to distinguish Amgen on the ground that Fiers had an enabling disclosure while Fritsch in Amgen did not. The court was not impressed. It "reject[ed] Fiers' argument that the existence of a workable method for preparing a DNA establishes conception of that material."^[19] At most, the court continued, the conception was of a product made by that process.^[20] "Conception of a substance claimed per se without reference to a process requires conception of its structure, name, formula, or definitive chemical or physical properties."^[21]

The court thus expanded its "holding" in Amgen by reading the matter emphasized above right out of it,^[22] i.e., whether or not a method to obtain the DNA was envisioned was now irrelevant. At best, a method so envisioned could support a product-by-process claim.

Note that since Fiers was awarded the date of his first-filed patent application as the date of invention, his case for priority did not implicate the description requirement. The court could have simply stopped with its holding that Fiers did not prove conception on the dates alleged. Instead it added:

The difficulty that would arise if we were to hold that a conception occurs when one has only the idea of a compound, defining it by its hoped-for function, is that would-be inventors would file patent applications before they had made their inventions and before they could describe them. That is not consistent with the statute or the policy behind the statute, which is to promote disclosure of inventions, not of research plans. While one does not need to have carried out one's invention before filing a patent application, one does need to be able to describe that invention with particularity.^[23]

(Emphasis added.)

The above excerpt defies easy analysis. On the one hand, the court expressed a concern that inventors would file patent applications on inventions not yet made; on the other hand, the court stated that one need not have carried out one's invention before filing a patent application! By its use of the word describe, the court appeared more concerned that patent applications would be filed before the invention could be described in the dictionary definition sense of expressing it in words. However, it soon becomes clear, when the court discusses Revel's priority case, that it used the word describe in the dictionary sense to be a requirement in the legal, description requirement sense.

The above excerpt is unjustifiably hard on Fiers and others similarly situated. The court belittles such work as "only the idea of a compound" and "research plans", while ignoring Fiers' evidence that one skilled in the art would have been able to use Fiers' method to isolate the gene without undue experimentation.

Revel's case for priority depended upon entitlement to the filing date of an Israeli priority application, i.e., whether the Israeli application complied with 35 USC 112, including the description requirement.

The board, citing Amgen, found that the Israeli application did not meet the terms of the description requirement, because it did not disclose the nucleotide sequence for the ß-IF gene or "an intact complete gene."^[24] The board then concluded that, having not conceived the DNA of the count, the enablement requirement was also not satisfied, since "[l]ogically, one cannot . . . enable an invention that has not been conceived."^[25]

On appeal, Revel argued compliance with both the enablement requirement and the description requirement, the latter in that literal disclosure in the Israeli application contained, as the court stated, "language of similar scope and wording to that of the count."^[26] Since the count did not require recitation of a nucleotide sequence, argued Revel, neither did their disclosure.

The court affirmed on the description requirement issue, and in a footnote, explicitly stated that it was not addressing the enablement requirement issue.^[27]

The court refused to buy into Revel's description requirement argument. It stated:

An adequate written description of a DNA requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the DNA itself. Revel's specification does not do that. Revel's application does not even demonstrate that the disclosed method actually leads to the DNA, and thus that he had possession of the invention, since it only discloses a clone that might be used to obtain mRNA coding for ß-IF. A bare reference to DNA with a statement that it can be obtained by reverse transcription is not a description; it does not indicate that Revel was in possession of the DNA. Revel's argument that correspondence between the language of the count and language in the specification is sufficient to satisfy the written description requirement is unpersuasive when none of that language particularly describes the DNA.^[28]

(Emphasis added.)

By stating that Revel did not demonstrate that his disclosed method produced the claimed DNA "and thus that he had possession of the invention," the court mixed the description requirement with the enablement requirement. The court thus seemingly ignored its careful emphasis only a few years before in Vas-Cath of the independence of these requirements, wherein the Vas-Cath court criticized a previous case as erroneously stating that these requirements are "intertwined."^[29]
Moreover, the court set forth a change to the description requirement possession test, viz., one does not have possession of a claimed invention until one can describe the invention with some minimum amount of specificity. I will refer to this change as the minimum specificity test. What is the minimum amount? The court continued:

As we stated in Amgen and reaffirmed above, such a disclosure just represents a wish, or arguably a plan, for obtaining the DNA. If a conception of DNA requires a precise definition, such as by structure, formula, chemical name, or physicial properties, as we have held, then a description also requires that degree of specificity. To paraphrase the Board, one cannot describe what one has not conceived.^[30]

(Emphasis added.)

The court thus essentially equated the requirements for complying with the description requirement with those for conception of an invention. In so doing, it treated Revel's case for priority, in essence, the same as it treated Fiers', ignoring the fact that Revel, unlike Fiers, was relying on the filing of a patent application, and thus ignoring the century-old doctrine of constructive reduction to practice.

The court termed the above requirement as "a precise definition, such as by structure, formula, chemical name, or physical properties," although its statement earlier in the opinion with regard to conception^[31] also included chemical properties, and did not include the term "such as." Where did the court come up with these alternative definitions? What is their scope? Are they independent or overlapping? Short of a complete sequence listing for a claim to an isolated gene, it is not clear what definition the court will accept. If no sequence listing is disclosed, what physical properties will the court accept? Will a restriction map be sufficient? Will molecular weight or number of base pairs be sufficient? Why did the court list physical properties but not chemical properties after the "such as" phrase? Indeed, why is it not sufficient for an inventor to disclose the ultimate chemical property--that the isolated gene expresses the desired protein? Until the court speaks again on this issue, one must assume that nothing less than a complete gene sequence will be satisfactory.

If Revel's method does not lead to the claimed DNA, then Revel has not complied with the enablement requirement. But according to the court's traditional description requirement jurisprudence, Revel would still have possession of the claimed invention because the claim language had literal support in the specification.^[32] How could Revel possibly have known that the court would impose a new test--the minimum specificity test, a test that is not met with language such as "DNA which codes for [the ß-IF gene]?"

As a practical matter, in this art, the court in essence is requiring an actual reduction to practice, as a minimum, in order to comply with the description requirement, since further identification- structure, formula, etc.--still must be made.

The court concluded its discussion of Revel's priority case by stating that the count at issue, since it purports to cover all DNAs that code for ß-IF, is analogous to a single means claim, and thus does not comply with 35 USC 112, citing In re Hyatt^[33] ("the enabling disclosure of the specification [must] be commensurate in scope with the claim under consideration.") The court continued:

Claiming all DNA's that achieve a result without defining what means will do so is not in compliance with the description requirement; it is an attempt to preempt the future before it has arrived.^[34]

Here again, the court confused concepts of enablement and description. Moreover, the citation of Hyatt is a red herring. A single means claim is rejectable because it embraces every conceivable means for achieving the stated result, while the specification discloses at most only those means known to the inventor.^[35] A single means claim, for example, would be a claim by the first inventor of a cure for AIDS: "A method for curing AIDS." Such a claim fails to satisfy the enablement requirement; the description requirement is not implicated at all. The count in issue in Fiers is not a single means claim. Once a species of DNA is enabled that codes for the gene in question, all other species are enabled in view of knowledge of the degeneracy of the genetic code. If Revel's disclosure complied with the enablement requirement, an issue the court did not reach, there was no single means claim

issue.

While there is little, if anything, to justify the court's decision in Fiers from a jurisprudential point of view, its result is somewhat ameliorated by the fact that it involved an interference where all the parties were would-be patentees and it can at least be argued, from an equitable standpoint, that the party that first set in motion the most complete disclosure to the art justifiably won. The public would be receiving the disclosure and the art would be advanced; the only question was who would reap the reward. Except for Fiers and Revel, nobody in the art could complain about the factual result in that case. Lilly did not involve such a happy circumstance.

Regents of the University of California v. Eli Lilly and Co.

In Lilly,^[36] a panel of the Federal Circuit affirmed the district court's judgment of invalidity of claims in a patent ^[37] ('525 patent) drawn to cDNA coding for vertebrate, mammalian, and human insulin, respectively.^[38]

The patent in issue, owned by the Regents of the University of California (UC), is one of the pioneer patents in the field of synthetically produced insulin. The patent discloses a process for producing such insulin through a recombinant DNA process. While the patent discloses that the process may be applied to the isolation and purification of the insulin gene from higher organisms generally, including humans, and exemplifies, in Example 5 therein, the nucleotide sequence coding for insulin isolated from a rat pancreas (rat cDNA), inserted into a plasmid, transferred to a bacteria and replicated therein, no nucleotide sequence information for any other organism is disclosed. Example 6 therein discloses the steps of the process for isolating and purifying the human insulin gene (human cDNA), i.e., the gene which codes for the human insulin A chain and B chain (whose amino acid sequences, respectively, were already known in the art and also disclosed in Example 6), beginning with a human pancreas, analogous to Example 5. Example 6, however, is a prophetic or constructive example only, and thus was not actually carried out before the filing date of the patent.

The district court's judgment explicitly held that the '525 patent was "invalid for lack of an enabling disclosure"; the judgment is silent regarding the description requirement. In its opinion, the court, under the heading "A. The '525 Patent--Written Description Requirement,"^[39] stated:

The Federal Circuit's holding that an adequate written description of a DNA requires a "precise definition" leads us to conclude the 525's patent specification neither enables the patent's claims to all vertebrates and mammals, nor enables the claim targeting the human species. . . . Consequently, we hold that the specification of the '525 patent adequately describes only the rat insulin cDNA; the inventors' claims to the genera of vertebrates and mammals and to the human species are invalid.^[40]

(Emphasis added.)

The district court thus applied the Federal Circuit's minimum specificity test, set forth in Fiers, and held that the enablement requirement was not satisfied because the minimum specificity test was not satisfied. The words of the district court make it indisputable that the court did not appreciate the distinction between and independence of the description and enablement requirements. Nevertheless, in affirming, the panel characterized the district court's holding of invalidity as failing to comply with the description requirement.^[41] Thus, the panel simply ignored its own court's often-stated role of reviewing judgments, not opinions,^[42] and then proceeded to ignore the actual words of the district court's judgment--perhaps a reflection of an attitude that issues of enablement need not get in the way of striking down patents in this area of technology on description requirement grounds--and confined itself to those grounds. The panel stated:

An adequate written description of a DNA, such as the cDNA of the recombinant plasmids and microorganisms of the '525 patent, "requires a precise definition, such as by structure, formula, chemical name, or physical properties," not a mere wish or plan for obtaining the claimed chemical invention. Fiers v. Revel.[^[43]] Accordingly, "an adequate written description of DNA requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the DNA itself." ^[44]

With regard to Claim 5, drawn to human cDNA, the panel stated:

Whether or not it provides an enabling disclosure, it does not provide a written description of the cDNA encoding human insulin, which is necessary to provide a written description of the subject matter of claim 5. The name cDNA is not itself a written description of that DNA; it conveys no distinguishing information concerning its identity. While the example provides a process for obtaining human insulin-encoding cDNA, there is no further information in the patent pertaining to that cDNA's relevant structural or physical characteristics; in other words, it thus does not describe human insulin cDNA. 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. No sequence information indicating which nucleotides constitute human cDNA appears in the patent, as appears for rat cDNA in Example 5 of the patent. Accordingly, the specification does not provide a written description of the invention of claim 5.^[45]

Nor would the panel find the description requirement satisfied based on the disclosure of the human insulin A and B chains, whether or not that disclosure rendered the claimed human cDNA obvious, citing Lockwood v. American Airlines, Inc.^[46] for the proposition that description of subject matter rendering a claimed invention obvious is not sufficient, and In re Duell^[47] and In re Bell,^[48] for the proposition that a protein sequence does not necessarily render the DNA encoding the protein obvious. The panel concluded for claim 5:

Because the '525 specification provides only a general method of producing human insulin cDNA and a description of the human insulin A and B chain amino acid sequences that cDNA encodes, it does not provide a written description of human insulin cDNA.^[49]

The court cannot be faulted for inconsistency. It treated claim 5 of the '525 patent analogously to its treatment of Revel's case for priority in Fiers. Thus, the court continued its intermingling of the description and enablement requirements, ignored the concept of constructive reduction to practice, and continued its deviation from the description requirement possession test to its new minimum specificity test. Moreover, in citing Lockwood, Duell, and Bell, the court built and shot down an irrelevant strawman. UC never argued that knowledge of the protein sequence for insulin necessarily, to use the court's language, renders the DNA encoding the protein obvious, nor did UC argue that disclosure of the protein sequence necessarily meant the description requirement was satisfied.

The court's citation of Lockwood ^[50] is inapposite for another reason. Lockwood held that a description of an invention is insufficient as a description of an invention obvious therefrom. An obvious invention is a different invention nonetheless. On the other hand, an invention disclosed in the same terms as claimed and wherein routine experimentation is all that is necessary from the disclosed process of making it, may be stated to be obvious over the disclosed process, but the invention described is the same invention claimed. It is only legal obviousness, i.e., section 103 of the Patent Statute obviousness, that Lockwood proscribes. The court ignored this distinction.

The court took a different tack with regard to the claims drawn to vertebrate or mammalian cDNA. The court stated that a description of rat cDNA is not a description of broad classes of vertebrate or mammalian cDNA, likening this art to unpredictable chemical arts, where possession of a genus may not be found based on possession of only specifically enumerated species.^[51] What the court ignored, however, was that under its own description requirement precedent, if the genus was originally disclosed, the inventor ipso facto had possession of it.

The court then sought to distinguish chemical compound generic formulae, where the formula establishes the metes and bounds of the genus, from genetic material, as follows:

In claims to genetic material, however, a generic statement such as "vertebrate insulin cDNA" or "mammalian insulin cDNA," without more, is not an adequate written description of the genus because it does not distinguish the claimed genus from others, except by function. It does not specifically define any of the genes that fall within its definition. It does not define any structural features commonly possessed by members of the genus that distinguish them from others. One ski