Primary Issue(s) Encountered
Dr. Stephen Badylak, a 25-year veteran professor and researcher of Purdue University, discovered in the mid-1980s that certain types of tissues could be used as a “scaffold” for other tissues to build upon for purposes of tissue regeneration. These scaffold tissues became known as extracellular matrices (ECMs) and were sourced from the submucosa of the small intestine (SIS), stomach, liver basement and urinary bladder (UBS) as well as the urinary bladder matrix (UBM). This was coined the “389” patent in the ensuing lawsuits. The UBS and UBM tissues were the subjects of the controversy that is the core of this case study.
Dr. Alan Spievack, a surgeon and Harvard University professor, had been interested in the possibility of regenerative capabilities of epithelial (skin or mucous membrane tissues) basement membranes since the 1950s when his work with salamanders' ability to regenerate limbs garnered him a Fulbright Scholarship. Dr. Spievack met Dr. Badylak in early 1996, prior to the filing of the Purdue patent in question, at a conference where Badylak made a presentation on SIS. Beginning in March of 1996, Dr. Spievack began experiments working with tissue extracted from the bladder wall and in July of that same year, he successfully treated a poison ivy outbreak on his own leg with a composition derived from that same bladder wall.
Dr. Spievack shared the results of his work with Dr. Badylak, but not until after October, 1996, subsequent to the filing of the 389 patent based on Dr. Badylak's research. From the end of 1996 and for the next 3 years, Dr. Spievack visited Dr. Badylak at Purdue and discussed with him the work he was conducting with graft compositions. In 1998, Dr. Spievack tried to acquire licensure from Purdue to the 389 patent strictly for work on the non-SIS products that had been developed. When he was rejected, he continued with his own research, concentrating on urinary bladder matrix.
The district court in the Cook/Purdue initiated lawsuit found that Spievack had completed the invention covered in the 265 patent when he successfully treated his own poison ivy outbreak in summer of 1996, prior to the time he met and began conversing with Dr. Badylak on their shared interests.