Ortho Pharmaceutical Corp. v. Smith

• Decision Date: 19 March 1992
• Docket Number: Nos. 91-1147,91-1157,WYETH-AYERST,s. 91-1147
• Citation: 22 USPQ2d 1119,959 F.2d 936
• Parties: ORTHO PHARMACEUTICAL CORPORATION, Plaintiff-Appellant, v. Herchel SMITH and American Home Products Corporation, Defendants/Cross-Appellants.LABORATORIES, Defendant-Appellee, v. JOHNSON & JOHNSON CORPORATION, Defendant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

Page 936

959 F.2d 936

22 U.S.P.Q.2d 1119

ORTHO PHARMACEUTICAL CORPORATION, Plaintiff-Appellant, v. Herchel SMITH and American Home Products Corporation,

Defendants/Cross-Appellants.

WYETH-AYERST LABORATORIES, Defendant-Appellee, v. JOHNSON & JOHNSON CORPORATION, Defendant-Appellant.

Nos. 91-1147, 91-1157.

United States Court of Appeals, Federal Circuit.

March 19, 1992.

Stephen B. Judlowe, Hopgood, Calimafde, Kalil, Blaustein & Judlowe, New York City, argued, for plaintiff-appellant and defendant-appellant. With him on the brief were Dennis J. Mondolino and Marguerite Del Valle.

Paul H. Heller, Kenyon & Kenyon, New York City, argued, for defendants/cross-appellants and defendant-appellee. With him on the brief were Scott A. Wisser, Steven J. Lee, Jean Barish and Thomas J. Meloro. Also on the brief were Egon E. Berg and Robert Wiser, American Home Products Corporation, New York City, of counsel.

Before NIES, Chief Judge, COWEN, Senior Circuit Judge, and MICHEL, Circuit Judge.

NIES, Chief Judge.

Ortho Pharmaceutical Corporation and Johnson & Johnson Corporation appeal from the judgment of the United States District Court for the Eastern District of Pennsylvania holding claims 5, 19, 40, and 43 of U.S. Patent No. 3,959,322 (the '322 patent) not invalid. 18 USPQ2d 1977, 1990 W 121353 (1990). Appellants concede infringement. American Home Products Corporation and Dr. Herchel Smith cross-appeal from (1) the district court's denial of attorney fees pursuant to 35 U.S.C. § 285 (1988), and (2) the district court's refusal to modify the language of its permanent injunction. We affirm the district court's judgment in all respects.

BACKGROUND ¹

The inventions in this case relate to steroids used in oral contraceptives. As stated in the district court's opinion, steroids comprise:

a class of chemical compounds which has a distinctive four ring structure of three hexagonal rings of carbon atoms (the "six-membered rings") and one pentagonal ring (the "five member[ed] ring") all fused together in a substantially linear shape. The three hexagonal rings are lettered A, B and C; the five membered ring is D. The 17 carbon atoms which make up the four rings are numbered 1-17; a single carbon atom with 3 attached hydrogen atoms (a "methyl group") at position C-13 is numbered 18. The steroid molecule is basically a flat plane. The top side (above the plane) is called the "[B ]" face; the bottom side (below the plane) is called the "[a ]" face.

18 USPQ2d at 1978. The numbering of a steroid molecule can be understood by reference to the following diagram:

NOTE: OPINION CONTAINS TABLE OR OTHER DATA THAT IS NOT VIEWABLE

Ortho Pharmaceutical Corporation commenced this action in January, 1990, by filing a declaratory judgment action against American Home Products, the exclusive licensee of the '322 patent, Dr. Herchel Smith, a co-inventor and sole assignee of the '322 patent, and Wyeth-Ayerst Laboratories The infringed claims and claim 1 upon which they depend, read as follows: ³

                a subsidiary of American Home Products engaged in the manufacture and sale of contraceptives, seeking to declare the '322 patent invalid. 2  AHP counterclaimed for infringement, naming Johnson & Johnson, Ortho's parent company, as an additional defendant.   The district court issued a preliminary injunction against infringement and, at AHP's request, subsequently modified the injunction to enjoin Ortho from using any data generated from the making, using, or selling of norgestimate products, including "transmitting said data to any foreign affiliates or to any third party [or] permitting said foreign affiliates to use such data ... except [for submission to the FDA]."  After a subsequent bench trial, the district court, inter alia, held:  (1) Ortho had not proven claims 5, 19, 40, or 43 of the '322 patent invalid for double patenting or obvious from the prior art under 35 U.S.C. § 103 (1988);  (2) Ortho had not proven inequitable conduct;  and (3) AHP had proven infringement of claims 5, 19, 40 and 43 of the '322 patent
                

1. A chemical compound having a gon-4-ene nucleus, said nucleus having attached thereto, in the 13-position, a polycarbon-alkyl radical having 2 to about 16 carbon atoms, said compound containing at least 19 and up to a maximum of 40 carbon atoms in its carbon-carbon skeleton.

5. A compound of claim 1 which is 13B -ethyl-17a -ethynyl-17B -hydroxygon-4-en-3-one.

19. A compound of claim 1 which is 13B -ethyl-17a -ethynyl-17B -hydroxygon-4-en-3-one, acetate.

40. A compound of claim 1 which is a 13B -ethyl-17-ethynyl-17B -hydroxy steroid or its 17-acetate having a gon-4-ene carbon-carbon skeleton.

43. A compound of claim 1 which is a 13B -ethyl-17a -ethynyl-17B -hydroxy steroid or its 17-acetate having a gon-4-ene nucleus and a 3-substituent selected from the group consisting of oxo, hydroxy, and a group convertible thereto by hydrolysis.

The steroids of claims 5, 19, 40 and 43 of AHP's '322 patent are illustrated in the following four diagrams:

NOTE: OPINION CONTAINS TABLE OR OTHER DATA THAT IS NOT VIEWABLE

----------

The steroid of claim 5 is contained in AHP's commercial contraceptive product, "norgestrel."

Ortho manufactures the infringing steroid, "norgestimate," which is depicted in the diagram below:

NOTE: OPINION CONTAINS TABLE OR OTHER DATA THAT IS NOT VIEWABLE

Ortho admitted infringement of claims 40 and 43 (but contested their validity). The district court found claims 5 and 19 infringed under the doctrine of equivalents because Ortho's norgestimate had been shown to break down in the body to, among other things, norgestrel (the product of claim 5) and norgestrel acetate (the product of claim 19), and those two breakdown products are primarily responsible for the biological activity of norgestimate. ⁴ This holding is not appealed.

The district court additionally found that Ortho's infringement was not willful or otherwise exceptional, and hence, attorney fees were not warranted. In that respect, the court found Ortho had received and relied upon opinions from patent counsel (February 6, 1976 and April 18, 1977) which indicated that both the '322 and its parent patent, U.S. Patent No. 3,850,911 (the '911 AHP sought no damages for the infringement but obtained an injunction. Pursuant thereto, Ortho was enjoined from "making, using or selling any product containing the chemical compound norgestimate in violation of [AHP's] '322 Patent UNTIL the expiration of [the '322 patent] in November of 1991." An exception to this prohibition is that Ortho "MAY engage in activities with respect to norgestimate RELATED SOLELY for uses reasonably related to obtaining FDA approval, as provided by 35 U.S.C. § 271(e)(1)." ⁵ The district court, in spite of explicitly enjoining Ortho from using or transmitting to its foreign affiliates any data generated from the making, using, or selling of norgestimate-containing products in the preliminary injunction, refused AHP's request to include such a prohibition in the permanent injunction. The court also denied AHP's request to extend the above mentioned prohibition for two years past the date of expiration of the '322 patent.

patent), were invalid and unenforceable. 18 USPQ2d at 1987.

ISSUES

1. Is the '322 patent invalid for obviousness-type double patenting? Despite the expiration of the patent during the appeal, this issue is not moot because of its bearing on other issues.

2. Did the district court clearly err in finding that Ortho's infringement was not willful?

3. Did the trial court abuse its discretion by refusing to enjoin Ortho from using or transmitting infringement generated data and by refusing to extend this prohibition for two years beyond the term of the '322 patent?

DISCUSSION

I. Ortho's Appeal--Double Patenting

The patent statute by 35 U.S.C. § 101 (1988) precludes a patentee from obtaining more than one patent on the same invention. In re Longi, 759 F.2d 887, 892, 225 USPQ 645, 648 (Fed.Cir.1985). By interpretation, this prohibition has been extended to preclude a second patent on an invention which "would have been obvious from the subject matter of the claims in the first patent, in light of the prior art." Id. at 893, 225 USPQ at 648. A second issued patent may not improperly extend the term of protection for an earlier patented invention. In re Braat, 937 F.2d 589, 592, 19 USPQ2d 1289, 1291-92 (Fed.Cir.1991). These concepts are encompassed within the rubric of "double patenting." See In re Braithwaite, 379 F.2d 594, 601, 54 CCPA 1589, 154 USPQ 29, 34 (1967). At issue in this case is obviousness-type double patenting.

Unlike "same-invention" double patenting, obviousness-type double patenting can be overcome by filing a terminal disclaimer. As stated in section 1490 of the Manual of Patent Examining Procedure:

A disclaimer is a statement filed by an owner ... of a patent or of a patent to be granted, in which said owner relinquishes certain legal rights to the patent.... [A] terminal disclaimer under 37 CFR 1.321(a) and (b) [is] used to disclaim or dedicate a portion or the entire term of all of the claims of a patent.

By disclaiming that portion of the second patent which would extend beyond the expiration of the first, the patentee gives up any extension of patent protection that might have resulted. Braithwaite, 379 F.2d at 601, 154 USPQ at 35.

Initial patent applications involved in the present case were filed in England, and later, corresponding applications were filed in the United States. In October, 1962, an omnibus continuation-in-part application containing over 450 working examples was filed in the United States. This application During prosecution of the '911 patent, the patent examiner initially required the applicant to restrict the claimed invention to one of seven subject matter categories, denominated Groups I-VII. Applicant elected to proceed with compounds in Group I. Subsequently, the examiner required a further restriction of the elected...