Alerts and Updates
Federal Circuit Alert
October 2005
Doctrine of Prosecution Laches Renders Lemelson Bar Code Patents Unenforceable
Symbol Technologies, Inc. v. Lemelson Medical, Education & Research Foundation, L.P., No. 04-1451
In a September 9, 2005 opinion the Federal Circuit revisited its 2002 decision from the same case in which the Court established the legal viability of the doctrine of prosecution laches to continuation and continuation-in-part applications. In this recent Federal Circuit decision, a three-judge panel unanimously affirmed a declaratory judgment of the U.S. District Court for the District of Nevada that the 14 patents asserted by defendant Lemelson Medical, Education & Research Foundation, L.P. ("Lemelson") were unenforceable under the doctrine of prosecution laches.
Symbol Technologies, Inc. ("Symbol"), a manufacturer of bar code scanners and related machine vision products, initiated the declaratory judgment action after Lemelson began sending letters to Symbol's customers stating that the use of Symbol's products infringed various patents held by Lemelson, the assignee of approximately 185 unexpired patents and a number of pending applications of the late Jerome H. Lemelson. Lemelson argued that the 14 patents-in-suit, which related to machine vision and automatic identification bar code technology, were entitled to priority from two patent applications filed in 1954 and 1956, as the patents-in-suit were based on a series of continuation and continuation-in-part applications spanning back to these two patent applications from the 1950s.
During earlier proceedings in the same case, Lemelson argued there was no case or controversy between the parties and that the doctrine of prosecution laches was limited to claims arising out of interference proceedings. The District Court concluded that there was a case or controversy, but dismissed the prosecution laches defense based on Lemelson's arguments. In an interlocutory appeal, however, the Federal Circuit held that prosecution laches was a viable defense and, consequently, reversed the judgment and remanded the matter to the District Court for further proceedings to develop the relevant facts. Symbol Techs., Inc. v. Lemelson Med., Educ. & Research Found., 272 F.3d 1361 (Fed. Cir. 2002).
Following a bench trial and post-trial briefing, Judge Phillip M. Pro of the U.S. District Court for Nevada concluded in January 2004 that Lemelson's patents were unenforceable due to prosecution laches upon finding "strong evidence . . . of intervening private and public rights" and determining that Lemelson's 18- to 39-year delay in filing and prosecuting the asserted claims was "unreasonable and unjustified." In affirming the District Court's judgment of unenforceability due to prosecution laches, the Federal Circuit first noted that there were no firm guidelines for determining when prosecution laches exists and left that determination to the discretion of the district court as a matter of equity, reviewable on appeal only for abuse of discretion.
Stating that the doctrine should be used "sparingly" and "only in egregious cases of misuse of the statutory patent system," the Federal Circuit listed a number of legitimate grounds for refiling a patent application, including: (1) filing a divisional application in response to a requirement for restriction, even where one defers the filing of the divisional application until just before the issuance of the parent application; (2) refiling an application with rejected claims in order to present evidence of unexpected advantages of an invention that was not available at the time of an original rejection; and (3) refiling an application to add subject matter to support broader claims. Even in the absence of any of the above reasons, the Federal Circuit noted that it may be appropriate to refile an application so long as the refiling is not "unduly successive or repetitive."
However, the Federal Circuit noted that refiling an application with claims that were previously allowed for the business purpose of delaying their issuance can be an abuse of the patent system. In the case of multiple examples of repetitive refilings establishing a pattern of unjustifiably delayed prosecution, the Federal Circuit found that the totality of the circumstances may justify application of prosecution laches to remedy the abusive practice.
In affirming the application of prosecution laches to the asserted Lemelson patents, the Federal Circuit specifically noted the following findings of the lower court: i) 18- to 39-year delay between the filing and issuance of the patents-in-suit; ii) Lemelson had engaged in "culpable neglect" during the prosecution; iii) Lemelson patents occupied the "top thirteen positions" for the longest prosecutions in the U.S. Patent and Trademark Office from 1914 to 2001 and ; iv) the presence of intervening private and public rights. In view of these findings, the Federal Circuit agreed with the District Court's conclusion that "if the defense of prosecution laches does not apply under the totality of the circumstances here, the Court can envision very few circumstances under which it would."
For the full opinion, see http://fedcir.gov/opinions/04-1451.pdf
Utility Requirement Not Met by Expressed Sequence Tags from Unidentified Genes
In re Fisher, No. 04-165
In a September 7, 2005 decision of interest to genomic companies and biotech patent practitioners, the Federal Circuit affirmed a decision of the Board of Patent Appeals and Interferences finding that expressed sequence tags ("ESTs") from unidentified genes are unpatentable for failure to satisfy the utility requirements of 35 U.S.C. § 101 and in the process validated the Patent Office's utility examination guidelines.
ESTs are small DNA fragments obtained from cDNA expression library clones. Typically, each clone is partially sequenced to produce a short, unique tag for an unknown but expressed gene from which the cDNA originated. Since a cDNA library yields thousands of clones, the collection of ESTs represents the vast majority of genes expressed in a given cell under a given set of conditions but, without more, provides little other information about those genes.
Monsanto, the real party in interest for the Fisher application, filed a patent application for thousands of ESTs generated from a cDNA library from maize leaf tissue harvested at the time of flowering. The seven uses for the ESTs identified in the specification included: 1) serving as a molecular markers for mapping the maize genome; 2) measuring mRNA levels to provide information about gene expression; 3) providing a source of primers to isolate the corresponding genes; 4) identifying the presence or absence of polymorphisms; 5) isolating promoters via chromosome walking; 6) controlling protein expression; and 7) locating genetic molecules of other plants and organisms.
Ultimately, the only pending claim for consideration required "a substantially purified nucleic acid molecule that encodes a maize protein or a fragment thereof comprising" one of five specified EST sequences. It is noteworthy that the claim scope reached beyond the ESTs to the maize genes encoded thereby. The Patent Office examiner, the Board of Patent Appeals and Interferences, and the Federal Circuit all found this claim lacked utility under 35 U.S.C. § 101 and, as a corollary, enablement under the use prong of 35 U.S.C. § 112, first paragraph.
The Federal Circuit started its analysis with the seminal Supreme Court case on the utility requirement, Brenner v. Manson, 383 U.S. 519 (1966), which holds that an invention must have a substantial utility that provides a specific benefit to the public in its currently available form. However, given the lack of guidance in Brenner on the meanings of "substantial" and "specific," the Federal Circuit explained these terms. First, "substantial" utility requires a "significant and presently available benefit to the public" in its current form, essentially a current real world or practical use. Second, "specific" utility requires a showing of a "well-defined and particular benefit to the public," clarifying this point as "particular to the subject matter and not applicable to a broad class of invention" per the Patent Office's utility guidelines. But the court did not stop there with regard to Patent Office's utility guidelines and stated that Patent Office's standards for assessing substantial and specific utility "comport with this court's interpretation of the utility requirement of § 101."
The Federal Circuit found that Fisher's proposed uses failed both prongs. First, none of the uses constituted "substantial utility" since there was no evidence of record establishing that any of the claimed ESTs had been used for the stated purposes. Further, the Court found none of the uses to be specific for the claimed ESTs, explaining that every EST in the application, of which there were tens of thousands, could potentially be used in the same ways. Hence, the majority likened the ESTs to "research intermediates" or "objects of use testing" for identifying the corresponding genes and their functions, calling the claimed ESTs "not an end to Fisher's research effort, but only tools to be used along the way in the search for a practical utility."
Judge Mayer in dissent, however, characterized the ESTs more as true beneficial research tools and that if such tools enhance research, then the utility requirement under §101 is satisfied. According to Judge Mayer, the real problem is assessing whether ESTs make a sufficient contribution to the advancement of the arts - something the utility requirement is "ill-suited" to handle because it lacks any standard for assessing the state of the prior art and the contributions of the claimed invention. For Judge Mayer, rejecting ESTs for obviousness might have prevented this distortion of the utility requirement but noted that the Federal Circuit "has deprived the Patent Office of the obviousness requirement for genomic inventions" through its decision In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995).
But a note of caution before dismissing ESTs as wholly unpatentable - more narrowly drawn claim language, tailoring the EST claims to a true research tool rather than to a nucleic acid encoding a particular protein (or any fragment of that protein), might have made some of the suggested uses, such as isolating the full-length gene, more acceptable. Likewise, ESTs tied to specific genes may still be patentable. The genomic industry must wait and see.
For the full opinion, see: http://fedcir.gov/opinions/04-1465.pdf
In Construing Scope of U.S. Patent, Little Weight Given to Prosecution History of Corresponding Foreign Application
TAP Pharmaceutical Products, Inc., et al. v. OWL Pharmaceuticals, L.L.C et al., Nos. 03-1634 and -1635
In an August 18, 2005 decision the Federal Circuit affirmed a judgment of the U.S. District Court for the Northern District of Ohio that defendant generic drug manufacturers, OWL Pharmaceuticals, L.L.C. and others (collectively "OWL"), infringed two patents owned by plaintiffs, TAP Pharmaceutical Products, Inc. and others (collectively "TAP"). The asserted patents related to the manufacture of leuprolide, a sustained-release formulation used to treat prostate cancer, marketed by TAP under the trade name Lupron Depot. The panel also affirmed the District Court's conclusions that the two infringed patents were not unenforceable because of inequitable conduct and that OWL did not infringed three other patents owned by TAP.
On appeal, OWL's primary challenge centered on the lower court's claim construction, namely, the construction of the claim limitation "comprising a copolymer . . . of lactic acid and . . . of glycolic acid." The District Court construed the language to include "copolymers composed of lactic acid and glycolic acidmers produced by any method, including the use of lactide and glycolide." This construction is not limited to direct polymerization and includes copolymers made by a "ring-opening" method in which the lactic acid and glycolic acid are first converted into cyclic dimers - lactide and glycolide - and the rings of those dimers are subsequently opened with a catalyst before reacting to form copolymer chains. OWL contended that the District Court's construction was improper and the proper construction required that the copolymer be made through a process of direct polymerization, with lactic acid and glycolic acid as starting materials.
The Federal Circuit upheld the District Court's claim construction, noting that it was the product of a careful analysis of the claim language, specifications, prosecution history and extrinsic evidence provided to the court. Specifically, the Federal Circuit noted the District Court's observations that neither the claims nor the specification of either patent required the copolymers to be produced by direct polymerization. Indeed, the common specification of both patents explicitly provided that the starting material for performing the method of the invention "may be produced by any method."
The Federal Circuit also rejected OWL's contention that its claim construction was supported by arguments made during prosecution of a European application corresponding to one of the asserted patents in which the applicant stated to the European examiner that the invention did not include a polymer made from lactide or glycolide. The Federal Circuit noted that "while the applicant for the European patent characterized the claims in this manner, the European patent examiner rejected that characterization." Given that TAP did not repeat this characterization of its claims and appeared to "recede from that characterization," the Federal Circuit found it proper for the District Court to attribute little weight to this evidence. The Federal Circuit did not suggest arguments presented during prosecution of a foreign counterpart application could not be relevant to claim construction of U.S. Patent - just that in this particular instance, the evidence was too ambiguous to give it any significant weight.
For the full opinion, see http://fedcir.gov/opinions/03-1634.pdf
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