Cook Biotech Inc. v. Acell, Inc.

• Decision Date: 18 August 2006
• Docket Number: No. 05-1559.,No. 05-1558.,No. 05-1458.,05-1458.,05-1558.,05-1559.
• Parties: COOK BIOTECH INCORPORATED, Plaintiff-Cross Appellant, and Purdue Research Foundation, Plaintiff-Cross Appellant, v. ACELL, INCORPORATED, Stephen F. Badylak and Alan R. Spievack, Defendants-Appellants.
• Court: U.S. Court of Appeals — Federal Circuit

460 F.3d 1365

COOK BIOTECH INCORPORATED, Plaintiff-Cross Appellant, and Purdue Research Foundation, Plaintiff-Cross Appellant, v. ACELL, INCORPORATED, Stephen F. Badylak and Alan R. Spievack, Defendants-Appellants.

No. 05-1458.

No. 05-1558.

No. 05-1559.

United States Court of Appeals, Federal Circuit.

August 18, 2006.

COPYRIGHT MATERIAL OMITTED

Daniel J. Lueders, Woodard, Emhardt, Moriarty, McNett & Henry LLP, of Indianapolis, Indiana, argued for plaintiff-cross appellant, Cook Biotech Incorporated. With him on the brief was Holiday W. Banta.

William P. Kealey, Stuart & Branigin LLP, of Lafayette, Indiana, argued for plaintiff-cross appellant, Purdue Research Foundation.

J. Alan Galbraith, Williams & Connolly LLP, of Washington, DC, argued for defendants-appellants. With him on the brief were Thomas H.L. Selby, Shruti Rana, and Jessamyn S. Berniker.

Before NEWMAN, LOURIE, and PROST, Circuit Judges.

PROST, Circuit Judge.

Defendant-appellants, ACell, Inc. ("ACell"), Stephen F. Badylak, and Alan R. Spievack appeal the decision of the United States District Court for the Northern District of Indiana denying ACell's post-trial motions pertaining to claim construction, infringement, and the adequacy of the jury verdict form following the jury's finding that ACell's commercial product, ACell Vet^TM, infringed U.S. Patent No. 5,554,389 (the "'389 patent") owned by Purdue Research Foundation and that Drs. Badylak and Spievack willfully induced ACell to infringe. Cook Biotech Inc. v. ACell, Inc., No. 4:03-CV-0046 AS, 2005 WL 2136107 (N.D.Ind. Aug.17, 2005) ("Post-Trial Order"). Plaintiffs-appellees, Cook Biotech Inc. and Purdue Research Foundation (respectively, "Cook" and "PRF"; collectively, "appellees" or "cross-appellants"), cross-appeal the district court's grant of summary judgment with respect to inventorship and the district court's denial of their post-trial motions pertaining to willful infringement and whether any relief should have been awarded following the jury's finding of infringement. Because the district court erred in its claim construction which formed the basis for the jury's finding of infringement and because, under the correct construction, there is no material factual dispute that the ACell Vet^TM product cannot infringe claims 1, 7, and 8 of the '389 patent literally or under the doctrine of equivalents, the judgment of infringement is reversed. As a result, the issues raised in Cook's cross-appeal pertaining to its willful infringement case and its requests for relief following the jury verdict in its favor are rendered moot. Finally, because the district court did not err in determining on summary judgment that (1) Dr. Badylak is not a co-inventor of U.S. Patent No. 6,576,265 (the "'265 patent"), (2) Dr. Spievack is an inventor of the '265 patent, and (3) PRF's unjust enrichment claim must fail, we affirm the district court's rulings with respect to those issues as raised in PRF's cross-appeal.

I. BACKGROUND

A. Factual Background

1. Dr. Badylak's activities and the '389 patent

Dr. Badylak was employed by Purdue University from 1977 until October 6, 2002. In the mid-1980s, Dr. Badylak and others in his laboratory at Purdue University discovered that certain tissue compositions could be used as scaffolds for tissue reconstruction. As advancements were made using these tissue compositions, now known as extracellular matrices or ECMs, the tissues came to be categorized according to the source of the tissue, e.g., small intestinal submucosa ("SIS"), stomach submucosa, liver basement membrane, urinary bladder submucosa ("UBS"), and urinary bladder matrix ("UBM"). The two organ tissue sources relevant to this case are UBS and UBM.

The '389 patent, entitled "Urinary Bladder Submucosa Derived Tissue Graft," issued on September 10, 1996. The '389 patent is directed to a urinary bladder submucosa derived tissue graft composition comprising bladder submucosal tissue "delaminated from the abluminal muscle layers and at least the luminal portion of the tunica mucosa of the urinary bladder tissue," '389 patent, col. 1, ll. 56-58, that can be implanted to replace or support damaged or diseased tissues. Claim 1 of the '389 patent is representative of the claims at issue:

1. A composition comprising urinary bladder submucosa delaminated from both the abluminal muscle layers and at least the luminal portion of the tunica mucosa of a segment of a urinary bladder of a warm blooded vertebrate.

'389 patent, col. 5, ll. 20-23 (emphasis added).

The '389 patent names four inventors, one of whom is Dr. Badylak. Pursuant to his employment contract, Dr. Badylak assigned the '389 patent and the rights to other patents on inventions he had developed to PRF. On February 9, 2003, PRF granted Cook an exclusive license with respect to many of its patents in this field of tissue engineering, including the '389 patent for all non-orthopedic and non-cardiac applications.

2. Dr. Spievack, the '265 patent, and ACell

Dr. Spievack, a Harvard University professor and surgeon, developed an interest in the regenerative capabilities of the epithelial basement membrane during his studies as a Fulbright scholar in the 1950s. In early 1996, Dr. Spievack first met Dr. Badylak at a conference during a presentation given by Dr. Badylak pertaining to SIS.

According to Dr. Spievack, in March 1996, he tested techniques for removing various tissue layers of the bladder wall and in July of that year, he successfully treated poison ivy on one of his legs with a bladder basement membrane composition. Dr. Spievack testified that between February and October 1996, he did not discuss the results of his basement membrane tests with Dr. Badylak, but from the end of 1996 through the end of 1999, he visited Dr. Badylak at Purdue University and discussed his work on graft compositions.

Beginning in 1998, Dr. Spievack sought to obtain a license from PRF for non-SIS products. When PRF ultimately turned him down, Dr. Spievack continued to work on what he considers to be his own UBM technology. In 1999, Dr. Spievack formed ACell, Inc. to research and develop extra-cellular matrix technology. On December 22 of that year, Dr. Spievack filed a provisional application on a UBM composition, which led to the issuance of two patents naming him as the sole inventor, the '265 patent and U.S. Patent No. 6,579,538 (the "'538 patent"). The term UBM first appeared in the '265 patent, which issued on June 10, 2003. UBM refers to a matrix of tissues including the basement membrane and tunica propria of the urinary bladder of a mammal. The '265 patent discloses and claims, inter alia, a tissue graft composition including the epithelial basement membrane.

On August 27, 2002, while the '265 patent was still pending, PRF asked the United States Patent and Trademark Office (the "PTO") to declare an interference pursuant to 37 C.F.R. § 1.47(a). In its petition, PRF asserted that four other individuals, including Dr. Badylak, were co-inventors with Dr. Spievack of the invention claimed in the '265 patent.¹

The accused product, ACell Vet^TM, is sold by ACell in three forms: hydrated, lyophilized, and powdered. Since the issuance of the '265 patent, ACell has represented that its product includes the epithelial basement membrane as disclosed and claimed in the '265 patent.

B. Procedural History

1. Appellees' infringement case

Cook and PRF sued ACell for, inter alia, patent infringement of claims 1, 7, and 8 of the '389 patent, correction of inventorship for a number of issued patents² (collectively, the "Disputed Patents"), and common law unjust enrichment for the research and inventions disclosed in the Disputed Patents. On September 4, 2003, appellees moved for a preliminary injunction, seeking to enjoin the sale of ACell Vet^TM. The district court denied the motion based on the record before it, preliminarily finding that claim 1 of the '389 patent "does not ... extend beyond an essentially submucosa composition," and emphasized that its findings were based on a preliminary record and were not intended to be a Markman ruling on claim construction. Cook Biotech Inc. v. ACell, Inc., No. 4:03-CV-0046 AS, slip op. at 10 (N.D.Ind. Dec.22, 2003).

After conducting a Markman hearing, during which the district court solicited the parties' proposed constructions in the form of jury instructions, the district court adopted appellees' proposed instructions. See Cook Biotech Inc. v. ACell, Inc., No. 4:03-CV-0046 AS (N.D.Ind. Oct.25, 2004) ("Markman Order"). Of particular relevance, the district court rejected ACell's proposed construction for "urinary bladder submucosa" and "at least the luminal portion of the tunica mucosa" and adopted appellees' proposed construction of the phrase "at least the luminal portion of the tunica mucosa." The district court rejected ACell's proposed construction of "urinary bladder submucosa" because it believed that the invention disclosed in the '389 patent was broad enough to include compositions that contained tissues other than submucosa. Id., slip op. at 9-10. Further, because the district court believed that ACell's proposed construction of "urinary bladder submucosa" would rewrite the claims (i.e., change an open transition, comprising, into a closed transition, consisting essentially of), it was unwilling to accept that construction. The district court was also convinced by the evidence presented at the hearing and the ordinary meaning of the tunica mucosa that "the luminal portion of the tunica mucosa" refers only to the epithelial cells. Id., slip op. at 10-11.

On June 17, 2005, the district court considered a motion by appellees seeking summary judgment of patent infringement or, in the alternative, partial summary judgment that the only issue remaining for the jury with respect to whether ACell infringes claims 1, 7, and 8 of the '389 patent is whether ACell's product contains submucosa. Based on the submissions of the parties, ...