Court Opinion

ID: 9843252
Source: CourtListenerOpinion
Date Created: 2023-09-24 02:31:29.769014+00
Date Added: 2024-06-11T09:13:18.046014
License: Public Domain

RADER, Circuit Judge,
concurring.
This ease reveals a distinct institutional difference between the United States Court of Appeals for the Federal Circuit and the other twelve circuits. Whenever a Federal Circuit panel makes an error interpreting the patent code, every district court in the nation, and even every later Federal Circuit panel, is obliged to follow and perpetuate the error. Even the Supreme Court has difficulty identifying errors for correction because this court’s national jurisdiction requires universal application of a mistake. This particular Moba case does not originate, but perpetuates such an error.
This mistake misapplies both the statutory law and the policy underlying United States patent law. Specifically, this court — contrary to the statute and its own thirty-year body of case law — applies the written description doctrine beyond the purpose for which the doctrine was created, namely priority protection. By making written description a free-standing disclosure doctrine, this court produces numerous unintended and deleterious consequences.
I.
This case illustrates some of the unintended consequences of this judge-made doctrine. Each time a claim encompasses more than the preferred embodiment of the invention described in the specification, a defendant can assert that the patent is invalid for failure to describe the entire invention. Under the expanded written description doctrine, every claim construction argument could conceivably give rise *1323to a validity challenge as well. In this case, for instance, FPS Food Processing Systems, Inc. (“FPS”) argues if claim 24 of the '505 patent encompasses lifting eggs from a moving conveyor, as this court has determined, then claim 24 must be invalid because the '505 patent specification discloses no such conveyor mechanism. FPS’s routine claim construction argument becomes a validity challenge under the non-statutory doctrine created in the Lilly case. Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed.Cir.1997). Fortunately, this court did not fall for FPS’s argument.
Unfortunately, however, this court is not the only judicial actor that must deal with the unintended consequences of the Lilly doctrine. Because FPS argued that the specification did not disclose some feature of the claimed invention, the trial court had to take extensive testimony and ask a jury to speculate whether one of skill in the art would have known that the inventor “possessed” the full invention.
The trial court faced even greater confusion because FPS also asserted that the specification does not enable the claimed invention. Thus, the trial court asked this jury to determine whether one of skill in the art would have been able to make and use the invention based on the patent’s specification. Then the trial court asked to jury to look at the specification again to determine whether the inventor “possessed” the invention. Thus, this jury faced the cumbersome task of separating two doctrines for sufficiency of disclosure in a patent. Under Federal Circuit case law, FPS asked this jury to decide that the patent’s disclosure can enable a skilled artisan to make and practice the entire invention, but still not inform that same artisan that the inventor was in possession of the invention. Puzzling. Moreover, the trial court had to give separate instructions and entertain separate witnesses on these inseparable patent rules to ensure full disclosure. The Lilly doctrine simply makes no sense in this context. In fact, outside its proper context of policing priority, it never makes sense but compounds the confusion, increases the chances for error, and augments the expense of the trial process.
II.
The Patent Act refers to “a written description” in 35 U.S.C. § 112, ¶ 1:
The specification shall contain a 'written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
35 U.S.C. § 112, ¶ 1 (2000) (emphasis added). The language of § 112, ¶ 1 indicates that a patent will contain an adequate description if it provides enough information to enable a person skilled in the art to make and use the invention. Any disclosure that enables one to make and use the invention also, by definition, also shows that the inventor was in possession of that full invention. Consequently, the erroneous written description requirement of Lilly case lacks both a statutory and a logical foundation.
This origins of the Lilly error have been explored at length in Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956 (Fed.Cir. 2002) (rehearing en banc denied) (Rader, J., dissenting). Before 1967, written description was not a requirement separate from enablement. In In re Ruschig, this court’s predecessor court created a new written description requirement for the sole purpose of enforcing priority issues. See In re Ruschig, 54 C.C.P.A. 1551, 379 *1324F.2d 990, 154 USPQ 118 (1967). The court in Ruschig used § 112, ¶ 1 to reject later-drafted claims that encompassed subject matter not disclosed by the original claims and specification. A section of title 35, specifically § 132, directly prohibits the addition of new matter to a disclosure, either in the claims or the rest of the patent application. Nonetheless, this court’s predecessor decided to use § 112 to prevent the addition of new matter to claims, rather than the specific provisions of § 132. This extra license with the language of title 35 did no harm because the Court of Customs and Patent Appeals recognized “that a rejection of an amended claim under § 132 is equivalent to a rejection under § 112, first paragraph.” In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 325 (CCPA 1981).
Thus, from 1967 until 1997, the new matter doctrine, cloaked either in the specific language of § 132 or the innovative new reading of § 112, operated only to determine whether new claim language deserved priority back to the patent’s original filing date. In other words,
[w]hen the scope of a claim has been changed by amendment in such a way as to justify an assertion that it is directed to a different invention than was the original claim, it is proper to inquire whether the newly claimed subject matter was described in the patent application when filed as the invention of the patents. That is the essence of the so-called “description requirement” of § 112, first paragraph.
In re Wright, 866 F.2d 422, 424, 9 USPQ2d 1649, 1651 (Fed.Cir.1989) (emphasis added).
The new matter doctrines did not extend beyond priority issues because § 112 already supplies enablement to ensure that an inventor adequately describes the invention in exchange for temporary rights of exclusivity. For over thirty years, this court and its predecessor understood this basic principle of patent law and confined the written description doctrine to its purpose — policing priority of invention.1
In 1997, this court inexplicably wrote a new disclosure requirement, found nowhere in title 35, and attributed that new requirement to the written description doctrine. This new disclosure doctrine, applied so far only to biotechnology cases, requires a nucleotide-by-nucleotide recitation of the structure of a biotechnological invention. Lilly, 119 F.3d at 1567. Ironically, this court could have reached the same result in Lilly without making a new disclosure rule. Under the statute’s en-ablement rule, this court would have also determined that the invention was not sufficiently disclosed.2 Instead, this court presumed to create another doctrine for sufficiency of disclosure. Although characterized as a written description doctrine, the Lilly rule cannot in fact trace its origin to the statute or to any prior case. See generally Enzo, 323 F.3d at 964-66.
Confusing the Lilly disclosure doctrine with the traditional written description doctrine, this court has stated that written description is separate from enablement. *1325See Amgen, Inc. v. Hoechst Manon Roussel, Inc., 314 F.3d 1313, 65 USPQ2d 1385 (Fed.Cir.2003). Of course, this proposition is true with respect to the traditional written description/new matter doctrine. On the other hand, the only way to distinguish the Lilly rule from enablement is to construe Lilly as requiring more disclosure than necessary to enable one of skill in the art to make and use the invention, a “super-enablement” standard.3 Interpreting Lilly in those terms, however, presents severe consequences for biotechnology. For biotechnological inventions, Lilly purports to require the recitation, nucleotide by nucleotide, of the entire sequence of a new protein or composition. This non-statutory rule jeopardizes the validity of many inventions in biotechnology patented from the advent of the biotech era in the late 1970s. Before judicial creation of the Lilly rule in 1997, no inventor could have foreseen that the Federal Circuit would make a super-enablement rule. Without any way to redraft issued patents to accommodate the new rule, a large number of patents in the field of biotechnology face serious and unavoidable validity challenges.
Even if a drafter of biotechnological patents now knows the new law, compliance may tax a drafter beyond reasonable limits. A new protein or other DNA-related discovery may contain a chain of hundreds of amino acids. Many of the amino acids in the chain have substitutes that may take their place without altering the functional properties of the protein. Consequently, a “precise definition”4 of the new protein, as required by Lilly, apparently requires tedious disclosure of thousands of potential permutations of the amino acid sequence that all fall within a proper description of the protein’s functions, properties, and DNA source.
This burdensome disclosure standard is tantamount to requiring disclosure, for a new software invention, of the entire source code, symbol by symbol, including all source code permutations that would not alter the function of the software. Ironically, the Federal Circuit has expressly rejected such a requirement for software inventions, but apparently enforces the requirement for biotechnology. See e.g. N. Telecom, Inc. v. Datapoint Corp., 908 F.2d 931, 15 USPQ2d 1321 (Fed.Cir. 1990) (overturning a finding that a patent did not adequately disclose “batching” software). This discrepancy emphasizes another problematic aspect of the Lilly doctrine. That is, it imposes a different disclosure standard for biotechnology than for computer technology. Despite the technology-neutral language of the Patent *1326Act, the Lilly rule imposes technology-specific requirements.
Returning to the consequences of the Lilly rule for biotechnology, the burdens of this elevated “precise definition” standard unnecessarily increase the cost and time required to prepare and prosecute a biotechnology patent. Moreover, university inventors and non-corporate biotechnol-ogists must endure significant expense and delay to acquire the sequence of a potential invention for disclosure under the Lilly rule. Sequencing is very expensive. Consequently, the Lilly rule can also have the unintended consequence of pricing non-corporate inventors out of the inventive market for biotechnology.
III.
Fortunately, the viability of the Lilly rule is on the decline. After Enzo, this court recognized “that Eli Lilly did not hold that all functional descriptions of genetic material necessarily fails as a matter of law to meet the written description requirement, rather, the requirement may be satisfied if in the knowledge of the art the disclosed function is sufficiently correlated to a particular, known structure.” Amgen, 314 F.3d at 1332, 1361 (dissent: “[T]he majority ... verges on confining Eli Lilly to its facts.”).
In this case, as in Enzo, the court explained that the written description requirement is satisfied when “one of skill in the art would discern possession of the invention at the time of filing.” Indeed, the Enzo court struggled to distinguish the so-called written description requirement from enablement. In reversing its original decision that deposits of biological material do not satisfy the written description requirement, the Enzo panel cited cases that found that such deposits satisfy the en-ablement requirement.5 In other words, because Lilly did in fact compel the result of the original Enzo panel, the court on reconsideration had to concede that deposited material satisfies the Lilly standard if it meets the enablement standard.
With some understanding of the difficulties and redundancy of the Lilly rule, the Federal Circuit has begun to convert it into the enablement doctrine with a different label. Unfortunately that leaves trial courts in the fix that the trial court faced in this case — presenting the jury two disclosure doctrines with apparently overlapping requirements. After all, to enable is to show possession, and to show possession is to enable.6
IV.
In sum, the Lilly rule is not just a mere one-time mistake. It defies over thirty *1327years of case law. It finds no specific support in any statutory language. It creates a technology-specific rule in a technology-neutral statute. It distorts the statute’s rules for adequate disclosure of inventions. It complicates biotechnology patent drafting to the point of near impossibility and invites invalidating mistakes. It prices non-corporate inventors out of some biotechnological invention markets. Last, but not least, it burdens both trial and appellate courts with unnecessary and confusing procedures in otherwise simple cases like this one.
Of course, this court should recognize and prevent, rather than ignore and create, mistakes in the interpretation of the Patent Act. In the rare event that this court makes this type of error, this Circuit has a unique obligation to swiftly pursue en banc correction. Unlike regional circuits, this court cannot rely on circuit splits to identify an issue for Supreme Court correction. Moreover this court’s jurisdiction over patents requires every trial court and this court itself to multiply this type of error until corrected. Accordingly, this court has a greater responsibility to pursue en banc correction of serious errors in interpretations of the Patent Act, such as the Lilly rule.
Alternatively, as indicated in Judge Bry-son’s concurring opinion, the problem in this area of the law may he in the line of cases stemming from the Ruschig case. In that context, I agree that all priority issues can be more than adequately resolved under the new matter doctrine in 35 U.S.C. § 132.

. See generally Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956 (Fed.Cir.2002) (app.) (rehearing en banc denied) (Rader, J., dissenting) (quoting from every written description case, except Lilly, to show they only employed the doctrine to police priority).

. U.S. Patent No. 4,652,525, at issue in Lilly, claimed priority to a parent application filed in 1977. The art of biotechnology was in its early stages in 1977. Under a proper enablement analysis, the simple disclosure of human insulin cDNA in the '525 patent would have failed to enable a person skilled in the art in 1977 to practice the claimed invention. Thus, the claims at issue would have been found invalid for lack of enablement.

. See Rai, Arti, “Intellectual Property Rights in Biotechnology: Addressing New Technology” 34 Wake Forest L. Rev. 827, 834-35 (Fall, 1999) (“the Lilly court used the written description requirement as a type of elevated enablement requirement.”); Sampson, Margaret, "The Evolution of the Enablement and Written Description Requirements Under 35 U.S.C. § 112 in the Area of Biotechnology” 15 Berkley Tech. L.J. 1233, 1262 (Fall 2000) ("The primary argument against the Federal Circuit's heightened written description requirement for biotechnological invention is that ... it also 'reduces incentives to invest in innovation by depriving potential patentees of the opportunity to fully benefit from their research.’ ”); Mueller, Janice M., “The Evolving Application of the Written Description Requirement to Biotechnological Inventions” 13 Berkeley Tech. LJ. 615, 617 (Spring 1998) (“The Lilly decision establishes uniquely rigorous rules for the description of biotechnological subject matter that significantly contort written description doctrine away from its historic origins and policy grounding. The Lilly court elevate[s] written description to an effective ‘super enablement' standard....”).

. See Eli Lilly, 119 F.3d at 1566 (citing the "precise definition” standard of Fiers v. Revel, 984 F.2d 1164, 1171 (Fed.Cir.1993)).

. See Enzo, 323 F.3d at 965 ("Whether reference to a deposit of a nucleotide sequence may adequately describe that sequence is an issue of first impression in this court. In light of the history of biological deposits for patent purposes [and] the goals of patent law ... we hold that reference in the specification to a deposit in a public depository ... constitutes an adequate description of the deposited material ... The practice of depositing biological material arose primarily to satisfy the enablement requirement of § 112, ¶ 1”) (citing In re Argoudelis, 58 C.C.P.A. 769, 434 F.2d 1390, 168 USPQ 99, 100 (1970) (finding that making the biological material accessible to the public enabled the public to make and use the claimed antibiotics)).

. Patent scholars have encouraged this court to "resist the narcotic of the written description requirement and redirect [its] energies towards refining the enablement concept, particularly as it correlates to claim scope.” Janis, Mark D., "On Courts Herding Cats: Contending with the ‘Written Description' Requirement (and Other Unruly Patent Disclosure Doctrines)” 2 Wash. U.J.L. & Poly 55, 62, 107 (2000) ("the fault [for the confusion about the standard for patent disclosure] lies in the courts' hesitancy to explore the power of the enablement requirement.”).