Classen Immunotherapies v. King Pharmaceuticals, No. CIV. WDQ-04-3521.

• Decision Date: 06 December 2005
• Docket Number: No. CIV. WDQ-04-3521.
• Parties: CLASSEN IMMUNOTHERAPIES, INC., Plaintiff, v. KING PHARMACEUTICALS, INC., et al., Defendants.
• Court: U.S. District Court — District of Maryland

Page 451

403 F.Supp.2d 451

CLASSEN IMMUNOTHERAPIES, INC., Plaintiff, v. KING PHARMACEUTICALS, INC., et al., Defendants.

No. CIV. WDQ-04-3521.

United States District Court, D. Maryland, Northern Division.

December 6, 2005.

COPYRIGHT MATERIAL OMITTED

Joseph J. Zito, Zito TLP, Damascus, MD, for Plaintiff.

Daniel L. Malone, F. Dominic Cerrito, Gasper J. Larosa, Jones Day, New York City, Gregory Andrew Castanias, Jones Day, Washington, DC, for Defendants.

MEMORANDUM OPINION AND ORDER

QUARLES, District Judge.

Classen Immunotherapies, Inc. ("Classen") sued King Pharmaceuticals, Inc. ("King"), Elan Corporation, PLC, and Elan Pharmaceuticals, Inc. ("Elan") for patent infringement. Elan and King have counterclaimed alleging noninfringement and unenforceability of Classen's patents. Pending are: 1) King's motion for summary judgment; 2) Elan's motion for partial summary judgment; 3) Elan's motion to amend its answer; 4) Elan's motion to file a supplemental reply in support of its motion to amend its answer; and 5) King and Elan's motions to bifurcate.

For the following reasons, King's motion for summary judgment will be granted; King's motion to bifurcate will be denied; Elan's motion for partial summary judgment will be denied; Elan's motion to file a supplemental reply in support of its motion to amend its answer will be granted; Elan's motion to amend its answer will be granted; and Elan's motion to bifurcate will be denied.

I. Background

Classen Immunotherapies, Inc. ("Classen") is a Maryland corporation that has developed and patented methods for identifying and commercializing new uses of existing drugs. Complaint, p. 1. Classen is the holder of Patents 6,219,674 B1, "System for Creating and Managing Proprietary Product Data" (the "674 patent"), and 6,584,472 B2, "Method, System and Article for Creating and Managing Proprietary Product Data" (the "472 patent"). Id. The 674 patent was issued on April 17, 2001. The 472 patent was issued on June 23, 2004. Id.

Classen alleges that King and Elan infringed the 674 and 472 patents in their development and sale of the muscle relaxant Skelaxin. Id. at 3. King acquired Skelaxin from Elan in June, 2003 and is now solely responsible for its manufacture, marketing and sale. Plaintiff's Opposition, p. 8. Classen has not alleged that King was involved in the research and development of Skelaxin.

II. King's Motion for Summary Judgment

King has moved for summary judgment arguing that the 17 patent claims that Classen alleges King infringes are all dependent claims and that Classen has failed to establish that King infringed any independent claims. Classen responds that: 1) King directly infringes the 674 and 472 patents under 35 U.S.C. § 271(g) by selling a product made by a patented method; and 2) that King infringes the Classen patents under the doctrine of joint infringement.

Summary judgment is appropriate when there is no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). A dispute about a material fact is genuine "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The court will view the facts and reasonable inferences drawn therefrom "in the light most favorable to the party opposing the motion." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986).

Classen has alleged that King has infringed claims 45, 46, 60 and 61 of the 674 patent and claims 52, 54, 55, 59, 61, 78, 80, 82, 84, 116, 118, 119, and 120 of the 472 patent. Plaintiff's Responses to King's First Set of Interrogatories, No. 2. These claims are dependent claims; reflecting that King did not participate in the research and development of Skelaxin. 674 patent at Col. 15-16; 472 patent at Col. 27-30,32.

Claims 45 and 46 of the 674 patent are dependent on Claim 15. 674 patent at Col. 15. Claims 60 and 61 of the 674 are dependent on Claim 47. 674 patent at Col. 16. Classen alleges that King violated one element of Claim 15 by commercializing new uses for Skelaxin. Claim Chart, Claim 15. Classen has neither alleged nor provided evidence that King violated any element of Claim 47.

Claims 52, 54, 55, 59, 61, 118, and 119 of the 472 patent are dependent on Claim 33. 472 patent at Col. 27-28,32. Claims 78, 80, 82, 84, 116, and 120 are dependent on Claim 62. 472 patent at Col. 29-30,32. Classen alleges that King violated one element of Claim 33 by commercializing new uses of Skelaxin, but has neither alleged nor provided evidence that King violated any element of Claim 62.

Dependent claims cannot be infringed unless the claims on which they depend are found to be infringed. Minnesota Min. & Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1299 (Fed.Cir.2002); Wolverine World Wide, Inc., v. Nike, Inc., 38 F.3d 1192, 1199 (Fed.Cir.1994); Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed.Cir.1989). Absent evidence that King infringed Claims 15 and 47 of the 674 patent and Claims 33 and 62 of the 472 patent, King cannot be found to have infringed claims 45, 46, 60 and 61 of the 674 patent and claims 52, 54, 55, 59, 61, 78, 80, 82, 84, 116, 118, 119, and 120 of the 472 patent.

A. Infringement under 35 U.S.C. § 271(g)

Classen argues that whether King infringed dependent or independent claims, King infringed the 674 and 472 patents under 35 U.S.C. § 271(g). Section 271(g) provides that the party who "sells or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer," Classen argues that because King is selling a product created using Classen's patented method, King is liable for infringement under § 271(g).

To be considered "made by a process patented in the United States," the patented process must be used directly in the manufacture of the product, and not merely as a means to identify the product to be manufactured. Bayer v. Housey, 340 F.3d 1367, 1378 (Fed.Cir.2003). The identification and generation of data are not steps in the manufacture of a final drug product for the purposes of § 271(g). Id. at 1377. Therefore, a drug created "using the claimed research processes...is not a product made by those claimed processes." Id. at 1378.

Classen accuses King of infringing the 674 and 472 patents by selling a product that was created using the patented method, Plaintiff's Reply pp. 5-7, but has not produced evidence that Skelaxin is manufactured using a method patented by Classen. Therefore, Classen's claim for patent infringement under § 271(g) fails for lack of evidence.

B. Joint Infringement

Classen argues that although King has infringed only one element of Claims 15 and 33 (in both cases the commercialization of Skelaxin), Elan performed the other elements of both claims. Therefore, Classen argues, the combined actions of Elan and King satisfy every element of both claims.

A party may be liable for infringement even when certain steps of the patented process are performed by a different party. Marley v. Mikron, 66 U.S.P.Q.2d 1701 (N.D.Ill.2003); Faroudja Laboratories v. Dwin Electronics, Inc., 1999 WL 111788 (N.D.Ca.1999); E.I. DuPont De Nemours & Co. v. Monsanto Co., 903 F.Supp. 680 (D.Del.1995); FMC Corp. v. Up-Right, Inc., 816 F.Supp. 1455 (N.D.Ca. 1993); Shields v. Halliburton, 493 F.Supp. 1376. However, there must be some connection between the entities performing the steps of the patent. Mikron, 66 U.S.P.Q.2d at 1703, 2003 WL 1989640 (connection found when Mikron contracted another party to perform the first step of a patented process and there was some indication that the third party was controlled by Mikron); Faroudja, 1999 WL 111788 (no connection when users of defendant's product had no control over earlier steps of patented process); Monsanto, 903 F.Supp. 680 (connection found when defendant contracted another party to complete the first step of a three step process); FMC, 816 F.Supp. 1455 (connection found when defendants worked together in performing the patented process).

King purchased Skelaxin from Elan in May 2003. Goldman Affidavit, p. 2. Plaintiff's Opposition, p. 8. Under the terms of the sale, King paid Elan $775 million and agreed to pay royalties of five percent of net sales through December 2005 and ten percent of net sales in excess of $50 million annually thereafter. Elan's 2002 Annual Report and Form 20-F. Classen has not produced evidence that King helped develop Skelaxin.

That the Elan and King agreement requires ongoing royalty payments does not support a finding of joint infringement. There is no evidence that King controlled Elan or that the two companies cooperated in the development and commercialization of Skelaxin. As the only connection between the two parties is the sale of a product developed before the sale, King and Elan are not joint infringers.

As, Classen has not produced evidence that King performed every element of any independent claim, King cannot be found to have infringed any dependent claim. Accordingly, Classen's motion for summary judgment will be granted.

III. Elan's Motion for Partial Summary Judgment

Elan has moved for partial summary judgment arguing that: 1) Elan is not liable for infringement of the 674 patent after it sold the rights to Skelaxin in May 2003; and 2) Elan is not liable for infringement of the 472 patent because the patent was issued after the rights to Skelaxin had been sold. Classen argues in response that: 1) Elan continues to receive royalties for Skelaxin and, therefore, continues to infringe the 674 patent; and 2) although the 472 patent was not issued before Elan sold the rights to Skelaxin, the patent application was published before the sale and, therefore, Classen may recover for Elan's infringement under 35 U.S.C. §...