Eli Lilly v. Board of Regents University of Wa

• Decision Date: 03 July 2003
• Docket Number: No. 02-1610.,02-1610.
• Citation: 334 F.3d 1264
• Parties: ELI LILLY & CO., Appellant, v. BOARD OF REGENTS OF THE UNIVERSITY OF WASHINGTON, Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

334 F.3d 1264

ELI LILLY & CO., Appellant, v. BOARD OF REGENTS OF THE UNIVERSITY OF WASHINGTON, Appellee.

No. 02-1610.

United States Court of Appeals, Federal Circuit.

DECIDED: July 3, 2003.

Charles E. Lipsey, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Washington, DC, argued for appellant. With him on the brief were Kenneth J. Meyers and Deborah Katz. Of counsel on the brief were Brian P. Barrett and Steven P. Caltrider, Eli Lilly and Company, of Indianapolis, Indiana.

William F. Lee, Hale and Dorr LLP, of Boston, Massachusetts, argued for appellee. With him on the brief were Lisa J. Pirozzolo, of Boston, Massachusetts; and James L. Quarles III and Henry N. Wixon, of Washington, DC. Of counsel were Maria L. Maebius and William G. McElwain, of Washington, DC.

John M. Whealan, Solicitor, United States Patent and Trademark Office, of Arlington, Virginia, for amicus United States Patent and Trademark Office. With him on the brief were James A. Toupin, General Counsel; and Stephen Walsh and Henry G. Sawtelle, Associate Solicitors.

Before MICHEL, LOURIE, and GAJARSA, Circuit Judges.

GAJARSA, Circuit Judge.

This is an appeal from a patent interference proceeding before the United States Patent and Trademark Office ("PTO") Board of Patent Appeals and Interferences ("Board"). The Board granted the Board of Regents of the University of Washington's ("UW's") motion declaring that no interference-in-fact existed on the grounds that the invention of the corresponding claims of U.S. Reissue Application No. 09/185,663 ("the '663 reissue application") to Eli Lilly & Co. ("Lilly") are separately patentable over that of U.S. Patent No. 5,302,529 ("the '529 patent") assigned to UW. Bd. of Regents of the Univ. of Wash. v. Eli Lilly & Co., Patent Interference No. 104,733, 2002 WL 1305996 (Bd. Pat.App. & Int. June 11, 2002). Because the Director of the PTO's ("Director's") interpretation of 37 C.F.R. § 1.601(n) as establishing a "two-way" test for determining whether two parties are claiming the "same patentable invention" is neither plainly erroneous nor inconsistent with the regulation, and the Board committed no reversible error in applying the two-way test to determine that the '529 patent and the corresponding claims of the '663 reissue application do not define the same patentable invention, we affirm.

I. BACKGROUND

On November 4, 1998, Lilly filed the '663 reissue application to surrender its own U.S. Patent No. 4,775,624 ("the '624 patent") and requested an interference between its reissue application and the '529 patent. The Board declared an interference on August 7, 2001 between the '663 reissue application and the '529 patent. The claimed subject matter relates to a complementary deoxyribonucleic acid ("cDNA") sequence that codes for human protein C, which plays an important role in the regulation of blood coagulation and generation of fibrinolytic activity in vivo. Lilly filed new claims 1-82 and 84-90 of the '663 reissue application and requested that only claim 3 of the '529 patent be designated as corresponding to the sole count in the interference: "A plasmid or transfer vector of Foster claim 3 [of the '529 patent]."

Claim 1 of the '529 patent, which is the independent claim from which claim 3 depends, reads:

1. A bacterial plasmid or bacteriophage transfer vector comprising cDNA coding for the amino acid sequence of FIG. 3, starting with alanine, number 1, and ending with proline, number 419, said cDNA sequence coding for human protein C.

'529 patent, col. 6, ll. 48-52.

Claim 3 recites:

3. The plasmid or transfer vector of claim 1, comprising the cDNA sequence of FIG. 3, from bp [base pair] 127 to bp 1383.

Id. at col. 6, ll. 57-59.

UW's '529 patent was a continuation of, and was accorded the benefit of, U.S. Patent No. 4,968,626 (issued Nov. 6, 1990), which was filed on August 15, 1985. Lilly's '663 reissue application was accorded the benefit of the February 8, 1985 filing date of the '624 patent (issued Oct. 4, 1988). Accordingly, in the declaration of interference in which claim 3 of the '529 patent was the interference count, Lilly was made the presumptive senior party.

During the preliminary motions period, UW filed a motion for judgment on the ground that there is no interference-in-fact, explaining that the parties' cDNA molecules have different sequences, i.e., chemical structures. The Board agreed that the evidence established the differences and found that Lilly's claims do not define the same patentable invention as claim 3 of the '529 patent. Thus, the Board granted UW's motion for no interference-in-fact and dismissed the interference.

After failing to instigate an interference with the '529 patent based upon claim 3, Lilly filed a motion to redefine the interfering subject matter by designating claim 1 of the '529 patent as also corresponding to the sole count in the interference. Lilly proposed two alternative constructions of claim 1 of the '529 patent: (1) a narrow construction claiming the specific cDNA sequence recited in Figure 3 of the '529 patent ("species claim construction"), and (2) a broad construction claiming any cDNA sequence that codes for human protein C ("genus claim construction"). Applying a two-way test pursuant to its regulation, 37 C.F.R. § 1.601(n), the Board found that, whether claim 1 of the '529 patent is construed as a genus or as a species, the corresponding claims of the '663 reissue application do not define the "same patentable invention" as claim 1 of the '529 patent, and determined that there is no interference-in-fact between the corresponding claims of the '663 reissue application and claim 1 of the '529 patent. Accordingly, the Board dismissed as moot Lilly's motion to redefine the interfering subject matter by designating claim 1 of the '529 patent as also corresponding to the count. Lilly timely appealed to this court, and we have jurisdiction pursuant to 28 U.S.C. § 1295(a)(4)(A).

II. STANDARD OF REVIEW

An agency's interpretation of its own regulations is entitled to substantial deference, and that interpretation will be accepted unless it is plainly erroneous or inconsistent with the regulation. Auer v. Robbins, 519 U.S. 452, 461-62, 117 S.Ct. 905, 137 L.Ed.2d 79 (1997) (citing Bowles v. Seminole Rock & Sand Co., 325 U.S. 410, 414, 65 S.Ct. 1215, 89 L.Ed. 1700 (1945)); Am. Express Co. v. United States, 262 F.3d 1376, 1382 (Fed.Cir.2001).

This court reviews a Board decision pursuant to the permissive rules governing a patent interference proceeding for abuse of discretion. Abrutyn v. Giovanniello, 15 F.3d 1048, 1050-51 (Fed.Cir. 1994) (citing Gerritsen v. Shirai, 979 F.2d 1524, 1527-28 (Fed.Cir.1992)). An abuse of discretion occurs if the decision (1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact findings; or (4) involves a record that contains no evidence on which the Board could rationally base its decision. Id. This court reviews the legal conclusion of obviousness without deference. In re Gartside, 203 F.3d 1305, 1316 (Fed.Cir.2000). Anticipation is a question of fact, and this court upholds the decisions of the Board on factual matters if there is substantial evidence in the record to support the Board's findings. In re Hyatt, 211 F.3d 1367, 1371-72 (Fed.Cir.2000).

III. DISCUSSION

A. 35 U.S.C. § 135(a)

This case presents the question of whether the Director's two-way test for determining whether two parties claim the "same patentable invention" reflects a permissible reading of 37 C.F.R. § 1.601(n), promulgated pursuant to 35 U.S.C. § 135(a), where a species claim to a presumptive senior party allegedly anticipates a genus claim to a presumptive junior party. We also consider whether the Board reasonably has applied the two-way test to dismiss as moot a motion to redefine the interfering subject matter by designating a claim as corresponding to a count.

Pursuant to authority granted by 35 U.S.C. § 135, the Director established the current interference rules to implement the Patent Law Amendments Act of 1984, Pub.L. No. 98-622, §§ 201-02. Patent Interference Proceedings, 49 Fed. Reg. 48,416 (Dec. 12, 1984); 37 C.F.R. § 1.601-1.690 (2003). Section 135 of the United States Code, Title 35, governs patent interference proceedings, which are designed to determine whether two patent applications (or a patent application and an issued patent) are drawn to the "same patentable invention" and, if so, which of the competing parties was first to invent the duplicative subject matter. See Conservolite, Inc. v. Widmayer, 21 F.3d 1098, 1100-01 (Fed. Cir.1994). The statutory basis for declaring an interference proceeding, 35 U.S.C. § 135(a), reads in pertinent part:

Whenever an application is made for a patent which, in the opinion of the Director, would interfere with any pending application, or with any unexpired patent, an interference may be declared.... The Board of Patent Appeals and Interferences shall determine questions of priority of the inventions and may determine questions of patentability.

35 U.S.C. § 135(a) (2000) (emphases added). The plain meaning of this statute demonstrates that Congress has expressly indicated its preference that the declaration of an interference pursuant to § 135 be discretionary. Barton v. Adang, 162 F.3d 1140, 1144 (Fed.Cir.1998) ("The plain meaning of this statute is clear from the use of the permissive term `may' that the [Director] has discretion whether to declare an interference."); see also In re Alappat, 33 F.3d 1526, 1531 (Fed.Cir.1994) (en banc) ("When statutory interpretation is at issue, the plain and unambiguous meaning of a statute prevails in the absence of clearly expressed legislative intent to the contrary."). Section 135(a) states that the Board shall determine questions of priority once an interference proceeding is declared. This authority for the Board to determine questions of...