OFFICE OF RESEARCH ADMINISTRATION NEWSLETTER | February 2007
(Volume VI, No. 8)
ORA HOME | NEWSLETTER ARCHIVES | CONTACT US
|
OFFICE OF RESEARCH ADMINISTRATION NEWSLETTER | February 2007 |
|
What's Inside RESOURCES
|
RESEARCH & COMMERCIALIZATION NEWS UNIVERSITY OF MISSOURI NEWS
OTHER NEWS OF INTEREST
UM Research Board System Compromised, New Submission System Being Developed for Extended Proposal Deadline of March 15 After an unauthorized access to the UM Research Board online submission web pages was detected on January 16, 2007, University IT staff took the system off-line. The old system has been completely disabled and the University is working to establish a different process for the current grant competition. The deadline for submissions has been extended to March 15, 2007. An online FAQ page was developed to answer questions: http://www.umsystem.edu/ums/departments/aa/rbgafaq.shtml Watch for more information on how to submit your proposals. Contact Shannon Nichols at 314-516-5899 or nicholss@umsl.edu with any questions. l
Appeals Court Rejects UM's Bid to Extend Lawsuit Immunity Into the Realm of Patent Law: 11th Amendment immunity waived by requesting an interference proceeding From Patently-O January 23, 2007 By DENNIS CROUCH of Counsel at McDonnell Boehnen Hulbert & Berghoff LLP Visiting Assistant Professor, Boston University Law School Vas-Cath v. University of Missouri (Fed. Cir. 2006). Interference proceedings arise when two patent applicants both hope to obtain a patent on the same invention. 35 USC §135. The PTO holds a mini-trial and (usually) grants a patent to the party with priority. This case arose over claims to a dual-lumen catheter used in prolonged hemodialysis. The University of Missouri filed its patent application first, but Vas-Cath pushed its through the PTO more quickly — resulting in an issued patent. On Missouri’s request, the PTO initiated an interference — a process that lasted six years and eventually resulted in all nineteen claims being awarded to the University. Vas-Cath appealed and the case was heard in the Western District of Missouri. Unfortunately for Vas-Cath, the district court quickly dismissed the case based on Missouri’s Eleventh Amendment immunity from suit in federal court. (District Court Decision). Vas-Cath then appealed to the Court of Appeals for the Federal Circuit (CAFC). 11th Amendment Sovereign Immunity: The 11th Amendment, ratified in 1798 provides that:
This has been interpreted to provide a state (or a state university) with absolute immunity from an action in federal court unless the immunity is waived or the State’s actions violate someone’s 14th Amendment due process guarantee. In general, a state’s participation in the patenting process does not imply any waiver of immunity. Here, Vas-Cath argued that the University’s request for and participation in the interference constituted waiver, and the CAFC agreed:
The CAFC found that the University had indeed waived its immunity by voluntarily entering into the litigation-type interference — thus negating its “assertion of immunity to bar appeal of that adjudication.” l Notes: As State Universities play increasingly greater roles in the patent game, state immunity questions will likely continue to rise. Recently, we have several immunity decisions, namely: Tegic v. U.Texas, Pennington Seed v. Produce Exchange No. 299 and Univ. of Arkansas, Intel and Microsoft v. Commonwealth Scientific (foreign immunity).
Harvard Alters its Approach to Scientific Study: Collaboration a key to plan Excerpted The Boston Globe (boston.com) January 19, 2007 By GARETH COOK The Harvard University corporation will devote $50 million to begin an ambitious effort to encourage interdisciplinary science research, signaling the governing board's determination to make fundamental changes in the university's approach to science, even as it searches for a new president. The money, Harvard officials said yesterday, will be under the control of a powerful new, university-wide science and engineering planning committee, a striking change for an institution that has traditionally given enormous power to the relatively autonomous heads of its academic departments. The committee will use the money to create new interdisciplinary departments, hire faculty, fund research, and pay for new equipment and laboratory space for research that crosses traditional boundaries. Possible areas of focus that have been under discussion include stem cell research, engineering new devices modeled on living organisms, and innovative uses of computing. The corporation yesterday expressed general support for a new department focused on stem cell biology. Research in this Department of Developmental and Regenerative Biology would range from basic science to medical applications. The department, which is still in the planning stages and has not been approved, would be another historic first for Harvard: A university-wide department, bringing together researchers from the medical school and the faculty of arts and sciences. The changes are a response to a scathing faculty report, completed last year, which said the university's entrenched bureaucratic structures stifle collaboration and threaten its leadership in scientific research. Many universities are struggling to find ways to reorganize their approach to science and engineering as the boundary lines between traditional disciplines such as chemistry and biology dissolve. The corporation's decisions, which are part of planning for the new campus in Allston, are a sign that Harvard is moving quickly. "The fact that Harvard, which has probably been more famous than any university for the insularity of its programs, is undertaking this, is a terribly important signal to the entire research community," said Robert M. Berdahl, president of the Association of American Universities in Washington, D.C. The restructuring in science research, which would probably lay the groundwork for more sweeping changes under a new president, is already controversial. Some Harvard scientists fear that new departments would not maintain the same academic standards as today's departments. Others worry that in seeking to stay on the leading edge, the university will devote too many resources to scientifically fashionable areas. "Regenerative medicine is a very important arena, but it may not be the most important problem facing us in terms of the huge and potentially dramatic changes in our global climate and environment," said Harvard zoologist Farish A. Jenkins Jr. But other faculty members are eager for changes. In the draft report released last July, a group of faculty proposed reorienting the university's scientific administration, to emphasize collaboration, interdisciplinary research, and encouragement of younger faculty and undergraduates. l
Drugs in Testing Show Promise for Lupus: New treatments target disease, not just symptoms; first big advances in 50 years Excerpted from The Wall Street Journal January 23, 2007 By HEATHER WON TESORIERO Read Complete Article Online (subscription required) The last time a new drug was approved to treat lupus, a serious autoimmune disorder that afflicts an estimated 1.5 million Americans, Dwight D. Eisenhower was president. But after a 50-year stretch without a major advance, there are finally some promising treatments on the horizon. Several drug makers are in advanced-stage trials for lupus drugs. Human Genome Sciences Inc. will begin enrolling patients in the next two weeks in the largest ever late-stage lupus trial, following positive results in earlier testing; Bristol-Myers Squibb Co. is conducting lupus trials on Orencia, its rheumatoid arthritis drug; and Genentech Inc. and Biogen Idec Inc. are conducting late-stage trials on Rituxan, a cancer drug that has been used off-label for lupus. This is welcome news for lupus sufferers, 90% of whom are women who experience onset of the disorder between the ages of 15 and 40. A chronic inflammatory disease that can affect almost any part of the body, lupus produces complications ranging from serious skin rashes and joint pain to organ malfunction and atherosclerosis, or hardening of the arteries. The condition can be life threatening: The most common cause of death is heart attacks and strokes. To treat symptoms, doctors have worked off a stable of old medicines. Steroids and immunosuppressants, drugs that shut down the body's natural defenses and that can provide some relief to patients, are the most commonly used. There are often significant side effects, including an impaired immune system, opening patients up to infections, and weight gain, which prompts other problems. Doctors have also turned to a number of medications that are approved for other conditions. Doctors are allowed to prescribe any approved medicine for uses beyond those contained on the label, but patients can have difficulty getting insurance coverage for such off-label treatments. With the lack of remedies for the disorder, the government began investing more heavily in lupus research and now spends roughly $89 million a year on the disease. As results emerged, doctors and researchers saw clues into how lupus works in the body's cells. And, while no reliable numbers on growth exist -- a deficit Dr. Lim's patient registry aims to fill -- experts agree the lupus population has expanded along with better diagnoses. In turn, some drug companies began to pay more attention to the disorder. "Drug companies weren't interested in it because they thought it was a small market," Gary Gilkeson, head of the medical and scientific board of the Lupus Foundation of America, says. "They realized that was wrong." By one estimate, the lupus drug market, which was $300 million in 2005, could reach $1.3 billion in 2015 if the potential treatments prove to be efficacious. There's now a horse race among a few drug companies to be the first one in 50 years to gain approval to make and market a lupus drug. There are currently four drugs in late-stage lupus trials, as well as two being tested for lupus nephritis. Most of these drugs are monoclonal antibodies, which attempt to target the cells that contribute to the damaging antibodies. Early results for a trial for Lymphostat-B, a collaboration between Human Genome Sciences and GlaxoSmithKline PLC, showed to reduce lupus disease activity. Now, the new international trial will enroll more than 1,600 patients to try and confirm the findings. Bristol-Myers is conducting late-stage trials with Orencia, its rheumatoid arthritis drug that came out in the U.S. last year, to see if it helps lupus patients. The international trial will enroll 180 to 190 patients. Orencia, which is administered about every 28 days via a 30-minute intravenous infusion, targets T-cells, which are believed to have a major hand in inflammation. And Genentech in collaboration with Biogen Idec is going ahead with plans to test Rituxan, a blockbuster cancer and rheumatoid arthritis drug, in lupus patients, both with and without lupus nephritis. The lupus trial will enroll 250 patients and the nephritis trial will enroll 140. Last month, the FDA issued a warning following two deaths from a viral infection of lupus patients using the drug off-label. Doctors and analysts took heed, but say that they're still hopeful that the drug will be approved, noting that because lupus patients have compromised immune systems, it's impossible to determine whether Rituxan was responsible. Aspreva Pharmaceuticals Corp. is testing anti-organ-rejection treatment CellCept for lupus nephritis. CellCept, a drug for organ transplant recipients, is often prescribed off-label to lupus patients. Results from the first phase of its late-stage trials are expected this year. l
|
| The Office of Research Administration supports and advocates research and technology transfer by faculty, graduate students and staff. The ORA provides services in conjunction with external and internal sources of funding for research, along with services related to commercializing discoveries through technology transfer. The goal of this newsletter is to inform the campus community of grants received, to highlight the accomplishments of our faculty, graduate students and staff, and to share with you a calendar of important events and deadlines. Please direct any comments or questions regarding the newsletter to Tamara Wilgers (wilgerst@umsl.edu). | University of Missouri- Office of Research Administration Fax: 314-516-6759 |