Animal Legal Defense Fund v. Quigg

• Decision Date: 30 April 1991
• Docket Number: No. 90-1364,90-1364
• Parties: ANIMAL LEGAL DEFENSE FUND, the American Society for the Prevention of Cruelty to Animals, the Marin Humane Society, Wisconsin Family Farm Defense Fund, John Kinsman, Michael Cannell, Humane Farming Association, Association of Veterinarians for Animal Rights, People for the Ethical Treatment of Animals, Plaintiffs-Appellants, v. Donald J. QUIGG and C. William Verity, Defendants-Appellees.
• Court: U.S. Court of Appeals — Federal Circuit

Page 920

932 F.2d 920

18 U.S.P.Q.2d 1677

ANIMAL LEGAL DEFENSE FUND, the American Society for the

Prevention of Cruelty to Animals, the Marin Humane Society,

Wisconsin Family Farm Defense Fund, John Kinsman, Michael

Cannell, Humane Farming Association, Association of

Veterinarians for Animal Rights, People for the Ethical

Treatment of Animals, Plaintiffs-Appellants, v. Donald J. QUIGG and C. William Verity, Defendants-Appellees.

No. 90-1364.

United States Court of Appeals, Federal Circuit.

April 30, 1991.

Valerie Stanley, Galvin, Stanley & Hazard, Washington, D.C., argued for plaintiffs-appellants. Steven M. Wise, Fraser & Wise, P.C., Boston, Mass., argued for plaintiffs-appellants. Joyce S.A. Tischler, Animal Legal Defense Fund, San Rafael, Cal., was on the brief for plaintiffs-appellants. Kenneth D. Ross, Ross & Harrington, Chicago, Ill., of counsel.

John F. Daly, Dept. of Justice, Washington, D.C., argued for defendants-appellees. Stuart M. Gerson, Asst. Atty. Gen., William T. McGivern, U.S. Atty., Barbara L. Herwig, Dept. of Justice, Washington, D.C., were on the brief for defendants-appellees. Also on the brief was Fred E. McKelvey, Sol., U.S. Patent & Trademark Office, Arlington, Va., of counsel.

Before NIES, Chief Judge, and MARKEY, ARCHER, MAYER and LOURIE, Circuit Judges. ¹

NIES, Chief Judge.

This is an appeal from the order of the District Court for the Northern District of California (Smith, J.) granting defendants' motion to dismiss the complaint in Animal Legal Defense Fund v. Quigg, 710 F.Supp. 728, 9 USPQ2d 1816 (N.D.Cal.1989), for failure to state a claim under the Administrative Procedure Act, Pub.L. No. 89-554, 80 Stat. 383 (1966) (APA). Various plaintiffs, individual farmers and groups of animal husbanders or nonprofit organizations whose goal is the protection of animals, filed suit in district court under the APA challenging, on procedural and substantive grounds, a Notice issued by the Department of Commerce Patent and Trademark Office (PTO) which stated, inter alia, that the PTO "now considers non-naturally occurring, non-human multicellular organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. Sec. 101 [the patent statute]." Plaintiffs seek to impede, indeed, stop issuance of patents for animals. The defendants, Donald Quigg, then Commissioner of Patent & Trademarks, and C. William Verity, then Secretary of Commerce, countered with a motion to dismiss the complaint under Fed.R.Civ.P. 12(b)(6) for failure to state a claim. The district court granted defendants' motion on the grounds that the challenged Notice fell within an exception to the public notice and comment requirements of the APA and that the Commissioner did not exceed his statutory authority in issuing the Notice. The court further held that whether any "animal" patents which might be issued by the PTO would exceed its authority under section 101 was not raised by the suit. We affirm but on the alternative ground that the plaintiffs lack standing. Because of the nature of the injury alleged by some of the parties, however, our ruling on standing subsumes the ground relied on by the district court.

I

Section 101 of Title 35, United States Code, provides the statutory definition of the subject matter upon which a patent may be granted:

Sec. 101 Inventions patentable

Whoever invents or discovers any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

35 U.S.C. Sec. 101 (1988). In 1980, the Supreme Court decided Diamond v. Chakrabarty, 447 U.S. 303, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980), wherein the Court held that non-naturally occurring man-made living microorganisms fall within the definition of patentable subject matter in section 101. Following that decision, the PTO's Board of Patent Appeals and Interferences applied the Chakrabarty decision to conclude that non-naturally occurring man-made multicellular plants were patentable under section 101 in Ex Parte Hibberd, 227 USPQ 443 (Bd.Pat.App. & Int.1985). Also following that decision, the Board applied Chakrabarty to hold that section 101 was not a bar to patentability for a specific non-naturally occurring genetically altered strain of polyploid oysters in Ex Parte Allen, 2 USPQ2d 1425 (Bd.Pat.App. & Int.1987), aff'd, 846 F.2d 77 (Fed.Cir.1988) (Table). On April 7, 1987, within days of the Board's decision in Allen, the PTO issued the following notice:

A decision by the Board of Patent Appeals and Interferences in Ex parte Allen, (Bd.App. & Int. April 3, 1987), held that claimed polyploid oysters are nonnaturally occurring manufactures or compositions of matter within the meaning of 35 U.S.C. 101. The Board relied upon the opinion of the Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303 [100 S.Ct. 2204, 65 L.Ed.2d 144], 206 USPQ 193 (1980) as it had done in Ex parte Hibberd, 227 USPQ 443 (Bd.App. & Int., 1985), as controlling authority that Congress intended statutory subject matter to "include anything under the sun that is made by man." The Patent and Trademark Office now considers nonnaturally occurring non-human multicellular living organisms, including animals, to be patentable subject matter within the scope of 35 U.S.C. 101.

The Board's decision does not affect the principle and practice that products found in nature will not be considered to be patentable subject matter under 35 U.S.C. 101 and/or 102. An article of manufacture or composition of matter occurring in nature will not be considered patentable unless given a new form, quality, properties or combination not present in the original article existing in nature in accordance with existing law. [Citations omitted].

A claim directed to or including within its scope a human being will not be considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. Accordingly, it is suggested that any claim directed to a non-plant multicellular organism which would include a human being within its scope include the limitation "non-human" to avoid this ground of rejection. The use of a negative limitation to define the metes and bounds of the claimed subject matter is a permissible form of expression. In re Wakefield, 422 F.2d 897 , 164 USPQ 636 (1970).

Accordingly, the Patent and Trademark Office is now examining claims directed to multicellular living organisms, including animals. To the extent that the claimed subject matter is directed to a non-human "nonnaturally occurring manufacture or composition of matter--a product of human ingenuity" (Diamond v. Chakrabarty ), such claims will not be rejected under 35 U.S.C. 101 as being directed to nonstatutory subject matter. [Hereinafter "Notice" or "Rule".] ²

1077 Official Gazette 24 (April 21, 1987).

More than a year after this Notice was published, the various plaintiffs ³ filed suit in district court alleging in Count I that the Commissioner of Patents and Trademarks had violated the APA in issuing this Rule without complying with the public notice and comment period of the APA, 5 U.S.C. Sec. 553 (1988). Plaintiffs sought to enjoin the PTO from approving or issuing any patents on multicellular living organisms, including animals, ⁴ or taking any action to effectuate the Rule, until it complied with the APA procedural requirements. In Count II plaintiffs alleged that the Commissioner violated section 706(2)(C) of the APA, 5 U.S.C. Sec. 706(2)(C) (1988), by acting in excess of statutory authority under the Patent Act, 35 U.S.C. Sec. 1, et seq. As relief under Count II, plaintiffs sought a declaration that the Commissioner acted in excess of his statutory jurisdiction or authority by including animals as patentable subject matter and an injunction against his issuance of any patents on multicellular living organisms, including animals, until authorized and mandated to do so by Congress. Defendants filed a motion to dismiss the complaint for failure to state a claim, and this motion was granted by the district court.

The district court expressly assumed without deciding that the various plaintiffs had standing and based the order of dismissal of Count I solely on its conclusion that the Rule fell outside the public notice and comment provisions of the APA, 5 U.S.C. Sec. 553(b), (c) (1988). Animal Legal Defense Fund, 710 F.Supp. at 729, 732, 9 USPQ2d at 1816, 1819. Per the district court, the Rule was "interpretative" of prior decisional precedent and thus was expressly exempt from notice and comment under section 553(b)(A). The court held further that because the Rule itself, which did no more than interpret decisional law, neither abridged nor enlarged the rights of anyone, it was clearly within the Commissioner's authority to promulgate. Finally, the court concluded that the question whether the precedent was correct and whether any "animal" patents actually issued were invalid was not raised by the subject action. Id. at 732, 9 USPQ2d at 1819.

The various plaintiffs then appealed that order of dismissal to the United States Court of Appeals for the Ninth Circuit. While recognizing that the APA created the causes of action, that court issued an order transferring the appeal to the Court of Appeals for the Federal Circuit. See Animal Legal Defense Fund v. Quigg, 900 F.2d 195 (9th Cir.1990). We exercise jurisdiction over the appeal pursuant to 28 U.S.C. Sec. 1295(a)(1) (1988). ⁵

Appellants not only seek to overturn the district court's rulings of no procedural error or abuse of authority but also urge us to hold that "animal" patents are not patentable subject matter under section 101. The government urges affirmance of the court's rulings and also urges affirmance of the judgment on the alternative ground raised below, namely, that appellants lack standing....