Merck lawsuit disputes patents

A lawsuit filed by IU against pharmaceutical giant Merck & Co. alleges the company patented vaccines based on reports by Dr. Darron Brown of the IU School of Medicine. The lawsuit charges Merck with four counts -- declaration of inventorship, unjust enrichment, breach of contract and civil conversion -- surrounding the ownership of patents with a projected market value of $2 billion. \nIn the complaint, IU states Dr. Brown had been working for the University since 1988 studying human papillomaviruses and publishing over 35 papers about the research. \nIn one of his papers, published in the Journal of Clinical Microbiology, Dr. Brown described "a method for obtaining and analyzing DNA from HPV's and the use of that method in obtaining DNA from type 6a HPV." \nThat report, the lawsuit claims, is the first study on the existence of type 6a HPV.\nThe complaint adds in the same year, 1993, Merck established an internal project to develop one or more vaccines against types of HPV. \nA Merck employee, Dr. Kathrin Jansen, was assigned to lead this project for the company. The lawsuit states she worked closely with Dr. Brown and expressed Merck's desire to use vaccines for preventing HPV infections, ultimately publishing a report in 1994 with Dr. Brown, another IU faculty member and seven Merck employees listed as authors. \nThe lawsuit claims this article had "paragraphs taken nearly verbatim from Dr. Brown's Type 6a article..." \nIn 1994, without consulting Brown or IU, Merck filed for two patents. The lawsuit claims one patent application featured paragraphs written by Brown, but without his name attributed anywhere, and another failed to give him credit for a tissue sample he had studied.\n"The September 1994 Patent Application did not even indicate that the tissue sample used for this work had come from Dr. Brown," the complaint said. \nIn December of 1994, Merck and IU entered a research collaboration agreement to study molecular variability together, but under the provision Merck not publish anything without the consent of IU and all discoveries would be owned jointly. The lawsuit claims Merck withheld the previous patents at the time of this agreement. \nThe lawsuit also claims between late 1994 and 1995, Merck patented three additional vaccines without giving proper credit to or consulting Brown.\nThe lawsuit adds trials surrounding the patented HPV vaccine, which could be ready for sale by 2006, have a projected market value of up to $2 billion a year. \nThe complaint notes each of the patents include at least one mention of an inventive contribution by Dr. Brown, but none identify him as an inventor. \nThe issue of the patents arose when IU and Merck began negotiations to enter into a new collaboration in 2001, and IU learned Merck "may not have fully disclosed the scope of its intellectual property efforts." \nIn August 2003, IU gave Merck the opportunity to study the complaint before any legal action. After the investigation was completed, with Merck still unwilling to name Brown as an inventor, IU filed the suit. \nAfter six months of negotiation, the lawsuit against Merck was filed. \nJankowski said the University isn't willing to predict the likelihood of winning the case.\n"I don't think you will find anyone that will try to give you a prediction about how the outcome will be," Jankowski said.\nMerck media relations officials said they were unaware of the lawsuit and couldn't comment at press time.\n-- Contact staff writer Nellie Summerfield at nsummerf@indiana.edu.