Opinion ID: 6938610
Heading Depth: 1
Heading Rank: 3

Heading: A Jurisdiction

Text: As an initial matter, this court questioned the propriety of reviewing at this time the PTO’s “Final Determination” in a declaratory judgment action. Was the question of its correctness raised in a case or controversy? U.S. Const, art. Ill, § 2. Upon review of all of the circumstances, we hold that the constitutional limitation on review is satisfied. The dispute arose between appellees and the FDA, which refused to publish new expiration dates pursuant to a claim of entitlement under URAA. In that connection, the PTO’s ruling may be reviewed inasmuch as the FDA adopted the PTO’s interpretation of the statute as the basis for its action. Further, appellants are damaged by reason of them entitlement to notice from generic manufacturers depending on the patent expiration date which they would not receive without publication of the new date. An actual case or controversy is presented. Cf. DuPont Merck Pharmaceutical Co. v. Bristol-Myers Squibb Co., 62 F.3d 1897, 35 USPQ2d 1718 (Fed.Cir.1995). B. Standard of Review Respecting our review of the merits, we are presented with a matter of pure statutory interpretation. Accordingly, this court reviews the district court’s decision on the meaning of the various provisions and their interrelationship de novo. Bristol-Myers Squibb Co. v. Royce Labs., Inc., 69 F.3d 1130, 1134, 36 USPQ2d 1641 1645 (Fed. Cir.1995), cert. denied, — U.S. -, 116 S.Ct. 754, 133 L.Ed.2d 701 (1996). Commissioners Kessler and Lehman contend that “under the familiar instructions of the Supreme Court in Chevron, 467 U.S. at 844 [104 S.Ct. at 2782-83], PTO’s Final Determination is entitled to controlling weight.” The contention is unavailing, based as it is on a mistake as to Chevron’s breadth. Under Chevron, where Congress has authorized an agency to promulgate substantive rules under a statute it is charged with administering, we must uphold the agency’s interpretation of an ambiguity or omission in that statute if the interpretation is a reasonable one. Chevron, U.S.A, Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842-45, 104 S.Ct. 2778, 2781-83, 81 L.Ed.2d 694 (1984). As the Seventh Circuit recently had occasion to note, however, “only statutory interpretations by agencies with Rulemaking powers deserve substantial def erence.” Atchison, Topeka and Santa Fe Ry. Co. v. Pena, 44 F.3d 437, 441 (7th Cir.1994) (in banc) (emphasis added), aff'd, — U.S. -, 116 S.Ct. 595, 133 L.Ed.2d 535 (1996). See also 1 Kenneth Culp Davis and Riohard J. Pierce, Jr., Administrative Law Treatise § 6.3 (1994); Michael Herz, Deference Running Riot: Separating Interpretation and Lawmaking Under Chevron, 6 Admin. L.J. Am. U. 187, 200-03 (1992). As we have previously held, the broadest of the PTO’s rulemaking powers— 35 U.S.C. § 6(a) — authorizes the Commissioner to promulgate regulations directed only to “the conduct of proceedings in the [PTO]”; it does not grant the Commissioner the authority to issue substantive rules. Animal Legal Defense Fund v. Quigg, 932 F.2d 920, 930, 18 USPQ2d 1677, 1686 (Fed.Cir.1991). 6 Because Congress has not vested the Commissioner with any general substantive rulemaking power, the “Final Determination” at issue in this case cannot possibly have the “force and effect of law.” Chrysler Corp. v. Brown, 441 U.S. 281, 302, 99 S.Ct. 1705, 1718, 60 L.Ed.2d 208 (1979) (“[T]he exercise of quasi-legislative authority by governmental departments and agencies must be rooted in a grant of such power by the Congress and subject to limitations which that body imposes.”). Thus, the rule of controlling deference set forth in Chevron does not apply. Such deference as we owe to the PTO’s interpretive “Final Determination” regarding the interrelationship by the URAA and the Hatch-Waxman Act thus arises, not from the rule of Chevron, but solely from, inter alia, the thoroughness of its consideration and the validity of its reasoning, i.e., its basic power to persuade if lacking power to control. See E.E.O.C. v. Arabian American Oil Co., 499 U.S. 244, 257, 111 S.Ct. 1227, 1235, 113 L.Ed.2d 274 (1991); General Elec. Co. v. Gilbert, 429 U.S. 125, 140-46, 97 S.Ct. 401, 410-13, 50 L.Ed.2d 343 (1976); Skidmore v. Swift & Co., 323 U.S. 134, 140, 65 S.Ct. 161, 164, 89 L.Ed. 124 (1944).