Ortho Pharmaceutical Corp. v. Smith

959 F.2d 936, 1992 WL 50376
CourtCourt of Appeals for the Federal Circuit
DecidedMarch 19, 1992
DocketNos. 91-1147, 91-1157
StatusPublished
Cited by41 cases

This text of 959 F.2d 936 (Ortho Pharmaceutical Corp. v. Smith) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Ortho Pharmaceutical Corp. v. Smith, 959 F.2d 936, 1992 WL 50376 (Fed. Cir. 1992).

Opinion

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.

BACKGROUND1

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 “[5]” 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:

[[Image here]]

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. Her-chel Smith, a co-inventor and sole assignee of the ’322 patent, and Wyeth-Ayerst Lab[938]*938oratories, 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 norgesti-mate 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.

The infringed claims and claim 1 upon which they depend, read as follows:3

1. A chemical compound having a gon-4-ene nucleus, said nucleus having attached thereto, in the 13-position, a poly-carbon-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 135 -ethyl-17 a -ethynyl-175 -hydrox-ygon-4-en-3-one.
19. A compound of claim 1 which is 135 -ethyl-17 a -ethynyl-175 -hydrox-ygon-4-en-3-one, acetate.
40. A compound of claim 1 which is a 135-ethyl-17-ethynyl-175-hydroxy steroid or its 17-acetate having a gon-4-ene carbon-carbon skeleton.
43. A compound of claim 1 which is a 135 -ethyl-17 a -ethynyl-17 5 -hydroxy steroid or its 17-acetate having a gon-4-ene‘nucleus and a 3-substituent selected from the group consisting of oxo, hy-droxy, 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:

[939]*939[[Image here]]

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:

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 [940]*940patent), were invalid and unenforceable. 18 USPQ2d at 1987.

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 norgesti-mate 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 norgesti-mate-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.

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.

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Bluebook (online)
959 F.2d 936, 1992 WL 50376, Counsel Stack Legal Research, https://law.counselstack.com/opinion/ortho-pharmaceutical-corp-v-smith-cafc-1992.