52 F.3d 1026 (Fed. Cir. 1995), 93-1166, Ortho Pharmaceutical Corp. v. Genetics Institute, Inc.

Docket Nº:93-1166.
Citation:52 F.3d 1026
Party Name:34 U.S.P.Q.2d 1444 ORTHO PHARMACEUTICAL CORP., Plaintiff-Appellant, and Cilag Gesellschaft M.B.H., Cilag N.V., Cilag Ltd., Cilag S.A.R.L., Cilag G.M.B.H., Cilag S.P.A., Cilag-Medicamenta, LDA., Johnson & Johnson S.A. (Cilag Division), Cilag AB, Cilag AG and Cilag AG International, Plaintiffs, v. GENETICS INSTITUTE, INC. and Amgen Inc., Defendants-A
Case Date:April 05, 1995
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit

Page 1026

52 F.3d 1026 (Fed. Cir. 1995)

34 U.S.P.Q.2d 1444



Cilag Gesellschaft M.B.H., Cilag N.V., Cilag Ltd., Cilag

S.A.R.L., Cilag G.M.B.H., Cilag S.P.A., Cilag-Medicamenta,

LDA., Johnson & Johnson S.A. (Cilag Division), Cilag AB,

Cilag AG and Cilag AG International, Plaintiffs,


GENETICS INSTITUTE, INC. and Amgen Inc., Defendants-Appellees.

No. 93-1166.

United States Court of Appeals, Federal Circuit

April 5, 1995

Page 1027

[Copyrighted Material Omitted]

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Eugene M. Gelernter, Patterson, Belknap, Webb & Tyler, New York City, argued for plaintiff-appellant. With him on the brief was David F. Dobbins.

William F. Lee, Hale & Dorr, Boston, MA, argued for defendants-appellees, Genetics Institute, Inc. With him on the brief were William G. McElwain and David B. Bassett. Jon O. Nelson, Allegretti & Witcoff, Ltd., Boston, MA, argued for defendants-appellees, Amgen, Inc. With him on the brief was D. Dennis Allegretti. Of counsel was Steven M. Odre and Stuart L. Watt, Amgen, Inc., of Thousand Oaks, CA.

Before ARCHER, Chief Judge, NIES [*] and MICHEL, Circuit Judges.

NIES, Circuit Judge.

This appeal raises a question of a patent licensee's standing to sue an infringer in the name of the patentee/licensor. Ortho Pharmaceutical Corporation is a licensee of Amgen, Inc., owner of United States Patent No. 4,703,008 (the '008 patent). Ortho and its sublicensees filed suit against Genetics Institute for infringement of the '008 patent in the District Court for the District of Massachusetts. The district court dismissed Ortho's suit concluding that Ortho was a nonexclusive licensee and, therefore, lacked standing. Ortho Pharmaceutical Corp. v. Genetics Institute, Inc., Civil Action 91-12174-Y (D.Mass. Dec. 4, 1992) (judgment) (reported sub nom. Amgen, Inc. v. Chugai Pharmaceutical Co., 808 F.Supp. 894, 27 USPQ2d 1578 (D.Mass.1992)). We affirm.


The '008 patent claims a product used for the production of erythropoietin (EPO), a hormone that stimulates the synthesis of red blood cells in bone marrow. The '008 patent claims a purified and isolated DNA sequence encoding human EPO and host cells transformed or transfected with a DNA sequence in a manner allowing host cells to express EPO. The claims do not claim the EPO product itself. 1

In 1984, three years prior to the issuance of the patent, Amgen and Kirin Brewery Co., Ltd., established a joint venture, Kirin-Amgen, Inc. At that time, Amgen, as owner of the then-pending application for the '008 patent, assigned certain rights to Kirin-Amgen. In 1985, Ortho entered into Product License

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Agreements (PLAs) 2 with Kirin-Amgen and Amgen separately under which Ortho was allowed limited rights to manufacture in the United States and sell EPO in the United States and in certain foreign countries in which the licensors were seeking to obtain patents on various products and processes, including EPO itself.

On October 27, 1987, the date the '008 patent issued, Kirin-Amgen assigned the patent to Amgen. On the same date, Amgen brought suit for infringement against Genetics and Chugai. The trial of Amgen's suit was bifurcated into liability and damages phases. Shortly before trial on liability, Ortho attempted to intervene under Fed.R.Civ.P. 24, either as a matter of right or permissively, based on its rights under the license from Amgen. This motion was denied on the grounds of untimeliness and because Ortho's interests were adequately represented by Amgen respecting liability, a decision Ortho did not appeal. Following a bench trial on liability, claims 2, 4, and 6 of the '008 patent were held not to be invalid or unenforceable and found to be infringed by both Chugai and Genetics Institute. Amgen, Inc. v. Chugai Pharmaceutical Co., 13 USPQ2d 1737, 1989 WL 169006 (D.Mass.1989). This court affirmed that judgment on interlocutory appeal. Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d at 1200, 18 USPQ2d at 1016.

Ortho and its European sublicensees then filed a suit against Genetics Institute in the same court. Before an answer was filed, they amended the complaint to name Amgen as a defendant and subsequently moved to realign Amgen as an involuntary plaintiff. Genetics and Amgen filed motions to dismiss or for summary judgment on the ground of the plaintiff's lack of standing or for failure to state a claim. Ortho and the co-plaintiffs cross-moved to intervene in the Amgen litigation for the purpose of securing part of the damages. Ortho's suit was consolidated with the Amgen suit.

In reply to the defendants' motions, Ortho again asserted its rights as a licensee of Amgen. In particular, Ortho relied on Paragraph 2.01 of the PLA license, which provides:

(a) AMGEN hereby grants to ORTHO but not AFFILIATES, except as hereinafter provided, an exclusive license to make in one location, have made and use LICENSED KNOW-HOW, LICENSED PATENTS and LICENSED PRODUCTS in the LICENSED TERRITORY in the LICENSED FIELD and to sell LICENSED PRODUCTS in the LICENSED TERRITORY.

(b) AMGEN, having received the consent of Kirin Brewery Co., Ltd., hereby grants to ORTHO but not AFFILIATES, an exclusive license, except as against AMGEN's rights under this AGREEMENT in the LICENSED TERRITORY, to make EPO in one location in the United States for use and sale outside the LICENSED TERRITORY but not including China and Japan. AMGEN shall provide to ORTHO all information and any assistance and know-how required to ORTHO to achieve the purposes of this paragraph....

The agreement defined the LICENSED TERRITORY as the United States and the LICENSED FIELD as "all indications for human use except dialysis and diagnostics." In return, Amgen received royalties on Ortho's resulting sales of EPO in the United States. 3 Thus, one of the effects of paragraph 2.01(a), as interpreted by the court, was to grant Ortho the implied right to use the invention claimed in the '008 patent in one location to make EPO, for use or sale in the United States, for all human use except dialysis or diagnostics. Paragraph 2.01(b) repeated the implied grant to Ortho to use the '008 invention to make EPO in one location in the United States and, with Kirin-Amgen's consent, the right to make certain foreign sales of EPO.

The PLA executed by Ortho and Amgen also contains section 8.02 entitled "Infringement

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by Third Parties." Amgen argues that this section precludes Ortho's suit because Amgen exercised its right to sue alone, as provided therein. However, Ortho disputes that the provisions control to bar a second suit by Ortho in Amgen's name, even though Amgen has sued.

In ruling on the motion, the court first rejected Ortho's argument that it could premise standing based upon paragraph 2.01(a) of the license agreement. The court reasoned that because Amgen did not promise not to sublicense its own right to use its '008 invention to manufacture EPO in the United States, Ortho held a nonexclusive license under this provision. 808 F.Supp. at 902, 27 USPQ2d at 1584. The court also found no merit in Ortho's argument that paragraph 2.01(b) granted it an exclusive field-of-use license for sales of EPO abroad. The court emphasized that the '008 patent did not cover sales of EPO itself. Thus, Ortho's right to sell EPO abroad could not be a right arising from or a license under the U.S. patent grant. As in paragraph 2.01(a), Ortho's license to use the '008 patented technology was held to be nonexclusive. 808 F.Supp. at 904, 27 USPQ2d at 1585. The district court did not rule on the effect of the right to sue provisions in the contract. Upon entry of the judgment of dismissal, the trial judge vacated the order of consolidation with the Amgen litigation. This appeal followed. The sole issue on appeal is whether Ortho's license gave it standing to sue.


The Patent Act of 1952 provides "a patentee shall have remedy by civil action for infringement of his patent." 35 U.S.C. Sec. 281 (1988). The term patentee includes "not only the patentee to whom the patent was issued but also the successors in title to the patentee." 35 U.S.C. Sec. 100(d) (emphasis added). Thus, the statute requires that the parties to an infringement suit will have the patentee on one side and the accused infringer on the other. Without the patentee as plaintiff, the remedies provided in the patent statute are unavailable except in extraordinary circumstances "as where the patentee is the infringer, and cannot sue himself." Waterman v. Mackenzie, 138 U.S. 252, 255, 11 S.Ct. 334, 335, 34 L.Ed. 923 (1891) (suit dismissed because not brought by record owner); Crown Die & Tool Co. v. Nye Tool & Mach. Works, 261 U.S. 24, 40-41, 43 S.Ct. 254, 258, 67 L.Ed. 516 (1923) (plaintiff must have legal title to patent at the time of infringement); 4 see also Arachnid, Inc. v. Merit Indus., Inc., 939 F.2d 1574, 1579, 19 USPQ2d 1513, 1517 (Fed.Cir.1991) (relying on Crown Die ).

Courts look to the substance of an agreement to determine whether it has the effect of an assignment and, thus, satisfies the statutory requirement that the "patentee" must sue. Where a patentee makes an assignment of all significant rights under the patent, such assignee may be deemed the effective "patentee" under the statute and has standing to bring a suit in its own name for infringement. Vaupel Textilmaschinen KG v. Meccanica Euro Italia S.P.A., 944 F.2d 870, 875, 20 USPQ2d 1045, 1049 (Fed.Cir.1991) (transfer of substantially all rights held to be assignment); Bell Intercontinental Corp. v. United States, 381 F.2d 1004, 1011, 180 Ct.Cl. 1071, 152 USPQ 182, 184 (1967); see Waterman, 138 U.S. at 260, 11 S.Ct. at 337 (mortgagee held to be patent owner). Any other party seeking enforcement of the patent can sue, if at all, only with the patentee or in the name of the patentee. "Any rights of the licensee must be enforced through or in the name of...

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