In a classic tale of who said what to whom, the Court of Appeals for the Federal Circuit overturned an earlier infringement ruling of Purdue University’s patent by ACell, Inc. and denied adding a Purdue inventor to the ACell patent based in part on the inventor’s testimony to the USPTO. Cook Biotech Inc. and Purdue Research Foundation v. Acell, Inc. et al. (Aug. 18, 2006; 05-1458, -1558, -1559)

The technology involves tissue-engineered biomaterial that was developed by ACell, but allegedly infringed on a patent owned by the Purdue Research Foundation and licensed to Cook Biotech Inc. The graft material can be implanted at the site of an injury or damaged tissue to stimulate a unique healing response. Instead of scar tissue, the extracellular matrix remodels new tissue, allowing the body to heal almost as if it had not been injured.

This was an appeal of a jury’s finding that ACell’s product, ACell Vet™, infringed U.S. Patent No. 5,554,389, owned by Purdue Research Foundation and that Drs. Badylak and Spievack willfully induced ACell to infringe. Purdue Research Foundation is responsible for Purdue University’s technology-transfer program.

The CAFC found that the district court erred in its claim construction and that the ACell Vet™ product cannot infringe the ’389 patent. The CAFC also denied Purdue’s appeal of the district court’s rulings in favor of ACell and co-defendants Alan Spievack and Stephen Badylak regarding who was the inventor.

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,” that can be implanted to replace or support damaged or diseased tissues. Claim 1 is for “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.” The ’389 patent names four inventors, one of whom is Badylak who assigned his rights to Purdue.

Spievack, a Harvard University professor and surgeon, visited Badylak at Purdue University and discussed his work on graft compositions. Spievack tried to obtain a license from Purdue for non-SIS products but when turned down, he worked on what he considers to be his own UBM technology, the subject of the ’265 patent and U.S. Patent No. 6,579,538 claiming a tissue graft composition including an epithelial basement membrane (UBM).

While the ’265 patent was still pending, Purdue asked the USPTO to declare an interference claiming that four other individuals, including Badylak, were co-inventors with Spievack of the invention claimed in the ’265 patent.

Purdue sought to establish on summary judgment that Badylak is a joint inventor of the ’265 patent alleging that he collaborated with Spievack in developing the urinary bladder as a tissue graft composition. But, since they failed to assert that Badylak is the sole inventor, they were limited to “omitted” inventors.

The district court didn’t buy it based in no small part on the fact that Badylak had filed papers under oath with the PTO in which he denied inventorship of the ’265 patent (oops!).

Whilte Purdue argued that Badylak worked on a graft composition that included the basement membrane as early as 1994 and that Badylak collaborated with Spievack before the priority date of the Disputed Patents, The CAFC was unmoved. Specifically, Purdue argued that the only other evidence offered as corroboration of Spievack’s alleged completion of the invention was Spievack’s unwitnessed laboratory notebooks, which are legally insufficient corroboration.

However, ACell asserted: (1) there is no evidence that Badylak communicated a contribution to Spievack’s invention during the relevant time period, (2) Purdue admitted under oath that Spievack is an inventor of the ’265 patent, (3) the 1994 Disclosure does not reveal a basement membrane composition, and (4) Badylak disavowed any role in the conception of the invention claimed in the ’265 patent in his testimony and in a letter he sent to the PTO.

The CAFC held that:

First, we do not read Purdue’s brief as challenging the district court’s determination that Spievack is an inventor of the ’265 patent. In fact, Purdue admitted as much when it represented that Spievack was a co-inventor in an application it submitted to the PTO to provoke an interference with the ’265 patent.

Second, the only record evidence argued by Purdue to create a genuine issue of material fact is the 1994 Disclosure and Spievack’s testimony in which he stated that “[Badylak] and I had talked about the basement membrane stuff somewhere along in ’97 and ’98, because I know at some point I had told him about my―the studies I had done in Boston with the dog bladders that we were talking about.” (Spievack Dep. 38:4-7, Aug. 24, 2004.) Spievack’s testimony, however, is not sufficient to create a genuine issue of material fact as to whether Badylak contributed “to the conception of the claimed invention that is not insignificant in quality” by sharing his knowledge of graft compositions, some of which is reflected in the 1994 Disclosure. See Eli Lilly & Co. v. Aradigm, 376 F.3d 1352, 1358-59 (Fed. Cir. 2004). This is especially so in light of Badylak’s disavowal of having conceived of, reduced to practice, or recognized the importance of a basement membrane graft composition.

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