UNeMed signs Adapt IP Ventures to broker patent deal

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by Charlie Litton, UNeMed Communications

OMAHA, Neb. (June 10, 2013)—UNeMed Corporation will expand its reach in developing and discovering new partners for technologies invented at the University of Nebraska Medical Center (UNMC).

UNeMed, the technology transfer office at UNMC, announced today a new collaboration with patent brokerage firm Adapt IP Ventures.

Adapt IP Ventures will help UNeMed license a patent invented in Nebraska that teaches methods for effectively growing high-yield protein cultures using nanoparticles. Prized in molecular research, high-yield protein cultures are critical for the research, development and manufacture of biological molecules. The technology is especially needed now for the development of next generation biological drugs and new regenerative therapies.

UNMC’s reputation made the patent particularly appealing, Adapt IP Ventures founder and CEO Grant Moss said.

“The university itself has a good reputation as an innovative group,” Moss said. “So there’s a name recognition there that is and was important in my decision to move forward.”

Moss said the technology should be particularly attractive to high-growth companies that perform groundbreaking research and analysis using proteins, such as PerkinElmer and Life Technologies, which is being acquired by Thermo Fisher.

“What we want to see is a company like Life Technologies/Thermo Fisher or PerkinElmer building new products,” Moss said, “and having the university share in the success of a product launch. That’s the goal.”

Moss said another driving force behind the patent’s potential success is that some laboratories might already be using the method or similar methods for high-yield protein cultures. That means companies can adopt the technology at minimum risk and cost, “rather than change or introduce a completely new or different technology,” Moss said.

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UNMC, Omaha VA to conduct 5-year, $2.1 million study to test diabetes treatment

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by Vicky Cerino, UNMC Communications

OMAHA, Neb. (June 6, 2013)—The University of Nebraska Medical Center and the Omaha VA Medical Center and 36 other sites will take part in a nationwide study to compare the long-term benefits and risks of four widely used diabetes drugs in combination with metformin. The project is called the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study.

The five-year, $2.1 million study funded by the National Institutes of Health aims to enroll about 5,000 patients nationwide diagnosed with type 2 diabetes within the last five years currently only taking metformin. During the study, participants will take metformin, along with a second medication randomly assigned from among four classes of medications, all approved for use with metformin by the U.S. Food and Drug Administration.

While short-term studies have shown the effectiveness of different drugs when used with metformin, there have been no long-term studies of which combination works best and has fewer side effects. When metformin is not enough to help manage type 2 diabetes, physicians may add one of several other drugs to lower glucose (blood sugar).

“We know the effectiveness of drugs in lowering the blood glucose levels in the short term, but we don’t know which combinations of medications work the best and how long the combinations work for,” said Cyrus Desouza, M.D., professor and chief of the UNMC Division of Diabetes, Endocrinology & Metabolism. Dr. Desouza also has an appointment at the Omaha VA Medical Center.

“We’ll also evaluate what works better for diverse populations such as in African Americans and Hispanics and how long the drug combinations remain effective in patients,” Dr. Desouza said. “I think the impact is going to be really important because we will be able to individualize therapy for our patients.”

The study will compare the effects of drug combinations on glucose levels, adverse effects, diabetes complications and quality of life over an average of nearly five years.

Three of the classes of medications increase insulin levels. They are: sulfonylurea, which increases insulin levels directly; DPP-4 inhibitor, which indirectly increases insulin levels by increasing the effect of a naturally occurring intestinal hormone; and GLP-1 agonist, which increases the amount of insulin released in response to nutrients. The fourth type of medication is a long-acting insulin.

Study participants will receive diabetes medications for glycemic control including blood glucose, glucose strips and glucose monitor supplies. Participants will make four clinic visits each year, including for laboratory tests for monitoring lipids, A1c and blood pressure. Patients will continue to receive health care through their primary care providers. The providers will receive quarterly reports from UNMC.

Dr. Desouza, who is principal investigator of the study, said he hopes the information will provide new drug treatment guidelines, as the current guidelines are very general. “This also will help primary care providers so that they can apply it in their practices,” he said.

The Centers for Disease Control and Prevention estimates that 7.1 percent of Nebraskans have been diagnosed with diabetes, primarily due to obesity. Implications of not receiving the most optimal drug can result in complications such as kidney failure, lower-limb amputations, and blindness.

Learn more about the study at https://grade.bsc.gwu.edu.

For more information contact Grace Rodriguez at mrodrigu@unmc.edu or 402 559-6244.

GRADE (ClinicalTrials.gov number: NCT01794143) is supported under NIH grant U01DK098246. Additional support in the form of donation of supplies comes from the National Diabetes Education Program, Sanofi-Aventis, Bristol-Myers Squibb, Novo Nordisk, Merck, BD Medical and Roche Diagnostics.
 
Through world-class research and patient care, UNMC generates breakthroughs that make life better for people throughout Nebraska and beyond. Its education programs train more health professionals than any other institution in the state. Learn more at unmc.edu.

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Antibiotic pipeline needs new ideas

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by Charles Litton, UNeMed | June 6, 2013

Scientists, physicians and major media have long been raising alarms about antibiotic-resistant strains of bacteria, but too few have drilled down deep enough.

Resistant bacteria are certainly bad enough, but it’s not our biggest problem.

What should really keep us awake at night is not the bacteria’s ability to adapt to our countermeasures, but our inability to match their pace.

Systemic Antibiotics approved by FDA, 1980-2012

Systemic Antibiotics approved by FDA, 1980-2012
Sources: Infectious Disease Society and Center Watch.

The way things are going, it won’t be long before our marvelous modern medicine may not look or feel so, well, modern.

The antibiotic pipeline is drying up, and there aren’t many pharmaceutical companies working on solutions to so-called “superbugs,” or even average not-so-super bugs for that matter. In the last 10 years, the FDA has approved just eight new antibiotics, or less than half of the 17 that were approved in the previous decade.

At this point it’s tempting to supply some cheeky assurance that it’s not as bad as all that. It would be a great place to work in a reference to “Theodoric of York: Medieval Barber.”

But Brad Spellberg, an infectious disease expert at UCLA, might find the reference more accurate than we’d like.

As he told the New York Times in 2010, “For these infections, we’re back to dancing around a bubbling cauldron while rubbing two chicken bones together.”

TB Ward

Simply put, if research and innovation doesn’t soon start matching pace with bacterial adaptation, then modern hospitals will have to start clearing space for a few retro-styled downgrades: Like a new tuberculosis ward, lined with long rows of beds filled with people waiting to die.

The biggest causes of death back in good old, pre-antibiotic days were infections like pneumonia and tuberculosis. A small cut on the finger while trimming the rose bushes could lead to a funeral. Good times, good times.

Today, we in the developed world worry more about cancer and heart disease partly because antibiotics allow us to live long enough for those diseases to become problems in the first place.  Without antibiotics, aggressive chemotherapy treatments would be nearly impossible. An appendectomy again becomes a procedure with grave risk. And you can forget about organ transplants and joint replacements.

Maybe “rubbing two chicken bones together” is going a bit overboard, but in a world without effective antibiotics, one of the best treatments could be a pungent yet strangely delicious poultice of mashed garlic and fresh honey.

So what’s the problem?

In a 2012 paper, Spellman outlined core causes for the shriveling antibiotic pipeline. Discovering new antibiotics is increasingly more difficult, expensive and time-consuming, which probably shouldn’t be a huge problem.

But antibiotics are different.

They are, in a word, amazing. They actually cure stuff. And by “stuff” we mean scary, kill-you-in-your-sleep stuff.

Take a relatively cheap, $100-bottle of pills for a week or two and a potentially deadly infection goes away.

Many other medications work differently. They manage chronic conditions that can cost tens of thousands, sometimes for the rest of a patient’s life. Think of diabetes or blood pressure medications.

Even when a new antibiotic hits the shelves, physicians are reluctant to use it without first prescribing older medications. New antibiotics become weapons of last resort in a sense, used only when nothing else works. There’s a practicality problem there.

Pharmaceutical firms look at investing more than $1 billion over a dozen years of a difficult and arcane regulatory process, only to watch their product placed in a locked case labeled “break glass in case of emergency.”

You can argue all you want about big pharma profit margins, and what they can or can’t afford to do. I don’t care who you are—$1.5 billion is big boy money, and 12 years is a long swallow on something that isn’t likely to turn a profit.

Volcano LairOne estimate in Forbes, factoring for the price of failure, says the true cost of bringing a new drug to market is more like $4 billion to $11 billion. That’s enough to buy not just an island, but an entire island chain. And there might be enough spare change left over to hollow out a dead volcano for a modest evil lair.

It’s not surprising then that just four of the world’s 12 biggest pharmaceutical companies still research new antibiotics, according to a 2012 story in The Washington Post.

And that might soon drop to three. AstraZeneca, which drops a gob-smacking $11.7 billion for each new drug developed, announced in March that they plan to reduce spending on anti-infectives.

Several ideas exist on how to replenish the pipeline. They range from changing the price structure of antibiotics to amending the regulatory process, which Congress has already addressed in some small measure with the GAIN Act.

It would be nice if those ideas offered some small portion of comfort, but what seems more likely is we need something different—Some new approach, found in some small, underfunded lab.

Not unlike Alexander Fleming and his unkempt London facility in 1928, someone will have to find a whole new way to fight infections.

Hopefully soon.

Fleming’s penicillin needed about 15 years of additional work to arrive at the bedside, and we don’t have the specter of a world war as added motivation.

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New sepsis treatment falls short in trials

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by Lisa Spellman, UNMC Communications

A University of Nebraska Medical Center researcher has determined that the investigational drug Eritoran used in a large clinical trial to treat a severe and often deadly infection known as sepsis did not reduce mortality. As a result of the study Eritoran will not be recommended for wider use and no further clinical trials are planned.

Eritoran would have been the first drug developed specifically to treat sepsis but, as a result of the study, it will not be recommended for use, said Andre Kalil, M.D., an associate professor of medicine at UNMC and principal investigator. The results of the study appeared in the March issue of The Journal of the American Medical Association.

Sepsis, which kills more than one million people a year in the United States, is brought on by any number of infections, such as pneumonia, urinary tract, abdominal or skin infections, and is usually treated by conventional antibiotics.

It is triggered by a component of bacteria called endotoxin that leads to the inflammatory response of the body’s immune system. In a five-year randomized trial at 200 hospitals worldwide, Dr. Kalil found that of the 1,961 patients treated with Eritoran only 72 percent survived.

Dr. Kalil and his collaborators were hoping for better results.

“Even with this powerful inhibitor we did not see improvement in survival,” Dr. Kalil said.

With conventional antibiotics the survival rate is 70 to 75 percent. The hope was that Eritoran would boost those numbers.

Eritoran was administered intravenously and works by grabbing onto the endotoxin that is a potent activator of the acute inflammatory response.

But that is just one pathway that triggers the sepsis, there are several others, Dr. Kalil said, and this might be why the drug was ineffective.

Another reason could be that the drug is not administered soon enough, he said.

“On average, once a patient was found to have developed sepsis, the drug was administered within nine hours of diagnosis, which was faster than previous studies,” he said.

Yet, that doesn’t account for the time lost before the patient presented at the hospital with the symptoms of infection that developed unknowingly throughout the body, Dr. Kalil said. Nor does it account for biological reasons why some people respond better to some drugs and others do not.

The study was conducted between 2006 and 2011 with support from Eisai Inc., the manufacturer of Eritoran. The drug company is not planning to pursue further studies, Dr. Kalil said.

Dr. Kalil is applying similar principles to another study looking at a different method for ridding the body of the bacteria that cause sepsis. Marius Florescu, M.D., an assistant professor in nephrology in the UNMC College of Medicine, is his co-investigator.

Using a device that acts like a filter, Drs. Kalil and Florescu hope to remove the endotoxin from the blood instead of just inhibiting it.

“As a clinician standing at the patient’s bedside, I am always wondering – what more can I do to help? It’s what keeps me going,” Dr. Kalil said.

Through world-class research and patient care, UNMC generates breakthroughs that make life better for people throughout Nebraska and beyond. Its education programs train more health professionals than any other institution in the state. Learn more at unmc.edu.

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Breast cancer patients might avoid chemo with new gene test

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New standard of care set

by Tom O’Connor, UNMC Communications

OMAHA, Neb. (May 30, 2013)—A new gene test for patients with breast cancer – called MammaPrint – could dramatically reduce the number of women who need to undergo chemotherapy to treat the disease.

The test is available at the University of Nebraska Medical Center and its hospital partner, The Nebraska Medical Center. It analyzes 70 key genes and accurately determines which patients are at low risk of breast cancer recurrence and could safely choose not to undergo chemotherapy.

The test has been validated in a peer-reviewed study called MicroarRAy PrognoSTics in Breast CancER (or RASTER), conducted in 16 community-based clinics in the Netherlands. The results were published online earlier this year in The International Journal of Cancer and will later appear in the journal’s print edition.

The five-year study involved 427 breast cancer patients who were given the MammaPrint test. The test determined 219 women to be low risk and 208 to be high risk.

Of the 219 low-risk patients, 85 percent chose not to have chemotherapy. Of those patients, 97 percent were disease-free after five years. Of the 208 high-risk patients, 81 percent chose chemotherapy and 91 percent were disease-free after five years.

Dr. Edney

Dr. Edney

“This is an important breakthrough for breast cancer patients,” said James Edney, M.D., UNMC professor of surgical oncology. “By incorporating MammaPrint results along with the traditional clinical parameters, such as tumor size, grade, patient age and lymph node status, we can significantly reduce the number of women who need chemotherapy. In doing so, they can avoid the side effects and toxicity of chemotherapy treatment, some of which can be permanent and debilitating.”

Long-term side effects of chemotherapy could include damage to the heart, kidneys, lungs, nerves or reproductive organs. There is also the chance of developing a second cancer as a result of chemotherapy, Dr. Edney said.

Dr. Edney has used the test on approximately 160 patients, and it has been met with an extremely positive response, he said.

Unlike other breast cancer genomic tests that are limited to patients with certain disease characteristics, such as certain receptor and lymph node status, Dr. Edney said MammaPrint can be administered to virtually all early-stage breast cancer patients. It requires a breast cancer assay performed on either fresh or fixed tumor tissue.

MammaPrint results benefit the physician, he said, by clearly categorizing all patients as high or low risk and eliminating the uncertainty of indeterminate scores reported by other genomic test methods.

The RASTER study is considered unique, Dr. Edney said, because it is the first and only study to prospectively evaluate the performance of a genomic breast cancer test by using outcome data. In this case, the patient cohort was followed for five years.

The study showed that MammaPrint identified 30 percent more patients as low risk than the traditional clinical parameters often used in the U.S. to determine risk of recurrence. The test has been cleared by the U.S. Food and Drug Administration.

MammaPrint was developed by Agendia, a molecular diagnostic company headquartered in Amsterdam, the Netherlands with a genomics laboratory in Irvine, Calif.

Through world-class research and patient care, UNMC generates breakthroughs that make life better for people throughout Nebraska and beyond. Its education programs train more health professionals than any other institution in the state. Learn more at unmc.edu.

With a reputation for excellence, innovation and extraordinary patient care, The Nebraska Medical Center is ranked by U.S. News and World Report as one of America’s Top Hospitals in cancer, neurology/neurosurgery, orthopaedics, gastroenterology and nephrology. It has earned J.D. Power and Associates’ Hospital of Distinction award for inpatient services for six consecutive years and has also achieved Magnet recognition status for nursing excellence.  As the teaching hospital for the University of Nebraska Medical Center, this 627 licensed bed academic medical center has an international reputation for providing solid organ and bone marrow transplantation and is well known nationally and regionally for its oncology, neurology and cardiology programs.  The Nebraska Medical Center can be found online at www.nebraskamed.com.

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UNMC eye institute will revolutionize eye care in Nebraska

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Will bring new faculty and services to state

by Lisa Spellman, UNMC Public Relations

OMAHA, Neb. (May 22, 2013)–Today the University of Nebraska Medical Center joins the ranks of leading ophthalmology centers with the opening of the Stanley M. Truhlsen Eye Institute.

TruhlsenRendering_front_angledThe new Truhlsen Eye Institute is poised to revolutionize eye care in the region and will allow UNMC to join the ranks of other centers of excellence such as the Wilmer Eye Institute at Johns Hopkins Hospital in Baltimore, and the Massachusetts Eye and Ear Infirmary at Harvard Medical School in Boston.

The Truhlsen Eye Institute is named after legendary Omaha ophthalmologist Stanley M. Truhlsen, M.D., an Omaha ophthalmologist who has been affiliated with UNMC for more than 40 years and made the lead gift on the facility. Dr. Truhlsen, 92, is active in numerous national ophthalmology organizations.

Located at 40th and Leavenworth streets, the Truhlsen Eye Institute is poised to become a center of excellence for eye care and research. This premier eye institute combines state-of-the art diagnostic medicine with the latest advances in clinical research to bring hope to patients suffering from blinding eye diseases such as macular degeneration, glaucoma, corneal dystrophies, uveitis and other ocular inflammatory diseases.

“The Truhlsen Eye Institute positions UNMC to become a world leader in clinical care, research and education in vision disorders,” said UNMC Chancellor Harold M. Maurer, M.D. “More importantly, it elevates eye care for the citizens of Nebraska and brings it to their front door. We thank Dr. Truhlsen and all the donors for making this possible.”

Three of the unique features of the Truhlsen Eye Institute are the:
• Carl B. Camras, M.D., Center for Innovative Clinical Trials in Ophthalmology;
• Ocular Imaging Research and Reading Center; and
• Children’s Eye Care Center.

“The Truhlsen Eye Institute bestows upon us an unprecedented opportunity to combine over 10 ophthalmic subspecialty services together in a state-of-the-art facility,” said Quan Dong Nguyen, M.D., chairman of the UNMC Department of Ophthalmology and Visual Sciences, McGaw Memorial Endowed Professor and director of the Stanley M. Truhlsen Eye Institute.

“Our outstanding faculty along with our dedicated staff will flourish in this amazing establishment and they will have every resource available to treat patients of all ages and diseases. This institute also provides a state-of-the-art facility that allows us to recruit new faculty,” Dr. Nguyen said.

Dr. Nguyen, a uveitis and retinal specialist from Johns Hopkins, and his wife Diana V. Do, M.D., a retina surgeon who serves as vice chair for education and director of the department’s residency training program, joined UNMC earlier this year to lead the new eye institute.

“The creation of the Camras Center will allow for rapid expansion in eye research and will triple UNMC’s clinical research study volume,” Dr. Do said. “We can now offer the latest novel therapies in both retinal diseases and anterior segment disorders to patients.”

She said the increased research combined with the Ocular Imaging Research and Reading Center will aid in the diagnosis and management of ocular diseases, such as macular degeneration, glaucoma and diabetic eye disease.

The Camras Center is named after the late Dr. Camras, who served as UNMC’s chairman of ophthalmology from 2000 to 2009. In 1996 he was one of the developers of latanoprost (trade name Xalatan), a glaucoma drug that is still widely used today as first-line therapy for many patients.

A $20 million, 54,536-square-foot facility, the Truhlsen Eye Institute also features outpatient eye exam facilities, an optical shop, and a comprehensive regional diagnostic center. Plans are in the works for an eye surgery center to be built at a future date. The surgery center will be connected to the Truhlsen Eye Institute to provide maximum convenience and best possible care for patients.

“Situated just two blocks west of the Weigel Williamson Center for Visual Rehabilitation which specializes in helping people with low vision, the Truhlsen Eye Institute is uniquely positioned to treat all aspects of eye disorders,” Dr. Nguyen said.

“The Truhlsen Eye Institute will be transformative, not just for the city, but for the entire state,” said David W. Parke II, M.D., executive vice president and CEO, American Academy of Ophthalmology. “It will foster the close, collaborative interaction of scientists, clinicians, teachers and learners that generates discovery — benefiting thousands every year. I can think of no greater legacy that any man or woman could leave their beloved state.”

For more information about the Truhlsen Eye Institute, links to press kit materials and sound bites go to: https://www.unmc.edu/eye/truhlseneye.htm

UNMC logoThrough world-class research and patient care, UNMC generates breakthroughs that make life better for people throughout Nebraska and beyond. Its education programs train more health professionals than any other institution in the state. Learn more at unmc.edu.

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UNMC researchers pinpoint Parkinson’s effects

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From UNMC public relations

OMAHA, Neb. (May 16, 2013)—A University of Nebraska Medical Center research team has found a way to monitor brain injuries that occur in Parkinson’s disease providing clinicians a rare glimpse into the disease process.

MEG Center

MEG Center photo courtesy UNMC.

By using magnetoencephalography (MEG) imaging Tony Wilson, PhD, an assistant professor in the UNMC Department of Pharmacology and Experimental Neuroscience and lead study investigator, was able to pinpoint the regions of the brain affected by this debilitating disease.

The results of Dr. Wilson’s research were published in the Journal Cerebral Cortex, one of the top ranked neuroscience journals.

In the year-long study, Dr. Wilson and colleagues scanned the brains of 19 patients with Parkinson’s and 16 without to see how different regions of the brain were involved in the initiation of basic movements.

Using MEG imaging, the investigative team identified the regions of the brain that became engaged when the person performed a simple hand movement.

“The scans revealed that patients with Parkinson’s disease had clear deficits in critical brain centers during the movements,” Dr. Wilson said.

Now that the specific regions of the brain affected by Parkinson’s have been identified, the next step is to develop medications designed to slow the disease’s progression.

“Up to this point, we have not had a foolproof way of diagnosing or monitoring Parkinson’s. The hope is that this will become a biomarker that will aid clinicians in determining the best therapeutic methods to use for their patients,” he said.

“This research provides an exciting new avenue for translational research,” said Howard Gendelman, M.D., chairman of the UNMC Department of Pharmacology and Experimental Neuroscience and co-investigator on the study.

Gendelman and his team have, for more than 12 years, worked to not only understand Parkinson’s disease progression but also to slow it through immune therapy. The work would not have been possible without a vigorous collaboration between neurologists, statisticians, psychologists and neuroscientists.

“Nebraska is perhaps one of the few research centers worldwide that boasts of so many people with divergent interests able to work together so effectively,” Dr. Gendelman said.

He said this new technique will aid his research team’s work into a novel therapy that has been proven in mouse models to reverse the neurodegenerative effects of the disease by changing the body’s immune response.

“The technique offers opportunities to accurately diagnose the disease and gauge its progression in ways that are not possible with the standard neurological exam performed in the clinic,” he said.

No other test provides that kind of accuracy with the relative ease and safety that this one does, said R. Lee Mosley, PhD, a study collaborator and associate professor in the PEN department adding that UNMC is one of a few places in the United States that has a MEG system.

Parkinson’s disease is caused by the loss of neurons that produce dopamine, a nerve signaling chemical that controls movement and balance. Dr. Gendelman said the diagnosis and treatment of Parkinson’s disease is of critical importance, not just nationwide, but in Nebraska where the incidence is so high.

The Parkinson’s Disease Foundation estimates that about 1 million people in the United States and more than 4 million people worldwide have the disease. The incidence rate of Parkinson’s disease is higher in Nebraska than in any other state in the country.

“Dr. Wilson has become an indispensible part of the research team providing new and important ways to better diagnosis this disease in a way that ensures patients are not harmed in any way, while still showing that they are responding appropriately to therapy,” Dr. Gendelman said.

The participating authors of this study included: Elizabeth Heinrichs-Graham, a PhD trainee and student in the neuroscience and behavior program at the University of Nebraska at Omaha; UNMC neurologists, Pamela Santamaria, M.D., and Diego Torres-Russotto, M.D.; and UNMC statistician Jane Meza, PhD

UNMC logoThrough world-class research and patient care, UNMC generates breakthroughs that make life better for people throughout Nebraska and beyond. Its education programs train more health professionals than any other institution in the state. Learn more at unmc.edu.

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Physician in residence joins UNeMed team

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by Charles Litton, UNeMed | May 20, 2013

Anyone can glance down the list of staffers here at UNeMed and find a full alphabet soup of extraordinarily qualified and gifted professionals.

The “Triple Lindy” is finding someone who can operate with keen insight and understanding into both the clinical and business sides of biomedical innovation.

We already have an entrepreneur in residence with Gary Madsen, but until recently we didn’t always have ready access to the clinical perspective—a physician in residence.

Dr. Madhavan

Dr. Madhavan

Earlier this week our CEO and president Michael Dixon told me he found such a person in Deepak Madhavan, M.D.

“He can provide clinical insights and clinical connections,” Dixon said. “He’s a physician with a strong business sense.”

My guess is that blend is a rare option found in most other tech transfer toolkits.

Dr. Madhavan (MAH-duh-vuhn) is the director of the Nebraska Medical Center’s comprehensive epilepsy program and an assistant professor at UNMC’s Department of Neurological Sciences.

As innovation rolls out of the minds and research labs on campus, Dr. Madhavan will help get those innovations closer to the patient bedside. It will be interesting to watch how his brand of insight will help innovators expand and develop their ideas from concepts to more focused products that meet specific needs and problems.

Before UNMC reeled him aboard, Dr. Madhavan founded in 2009 a private practice focused on treating epilepsy, Midwest Regional Epilepsy Associates. He is also the president of Lifestyle Innovations for Epilepsy, or LIFE, an Omaha-based nonprofit dedicated to the wellbeing of people living with epilepsy.

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UNMC’s international research collaboration sheds new light on rare lymphoma

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OMAHA, Neb. (April 1, 2013)—Over the 30 years of its the bone marrow/stem cell transplantation program, researchers at University of Nebraska Medical Center and its hospital partner, The Nebraska Medical Center, have forged strong partnerships with researchers around the world. As a result, many patients come from all over the U.S. and world to see medical center experts.

One example of how research plays a critical role in advancing treatment and care of patients is a recent study that shed new light on T-cell lymphoma.

“We don’t see a lot of cases of this rare kind of lymphoma, so our partnership with others around the world is one way everyone can share to advance our knowledge and help patients,” said Julie Vose, M.D., chief of the Division of Hematology/Oncology. “T-cell lymphoma is more common in other parts of the world. It’s very important that we have the resources and expertise to be able to do these types of studies. There has not been adequate information on it.”

Several different clinical trials for T-cell lymphoma currently are ongoing.

Dr. Vose, also a physician on staff at The Nebraska Medical Center, was involved in an international study that looked at 1,300 cases of T-cell lymphoma to identify which treatments were helpful and which ones weren’t. In the United States, there are about 85,000 new cases of lymphoma annually of which about 10 percent are T-cell.

It produced surprising results.

“We found that our current treatments for T-cell aren’t very helpful and that we have to look for new treatments,” said Dr. Vose, the Neumann M. and Mildred E. Harris Professor. “We were surprised to learn patients did so poorly on current treatments. We also found some new types of T-cell lymphoma from genetic information that previously hadn’t been described.”

As a result of the study, she said there will be changes in treatment.

“It’s important to tailor treatment since not all T-cell lymphomas are alike,” she said. “Some are aggressive, some slow growing. Some patients do better with certain combinations of therapies while others do better with other types of treatment. We need to understand why.”

In the past few years, Dr. Vose said two new drugs have been approved for T-cell lymphoma.

She said treatment of lymphomas have come a long way in 30 years, thanks to research. There are 50 different types of lymphoma.

“Physicians used to treat many lymphoma patients with the same treatments,” she said. “We didn’t understand that different types of lymphoma can benefit from different types of treatment. Now we know.”

Through world-class research and patient care, UNMC generates breakthroughs that make life better for people throughout Nebraska and beyond. Its education programs train more health professionals than any other institution in the state. Learn more at unmc.edu.

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UNMC, Invest Nebraska fuel new startup

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Trak Surgical’s freehand, sensor-guided surgical saw. (Photo: Charles Litton/UNeMed)

by Charles Litton, UNeMed

OMAHA, Neb. (March 27, 2013)—About 15 years ago, Hani Haider had an idea.

Haider, a biomedical engineer and professor of orthopedic surgery research at the University of Nebraska Medical Center, thought hip and knee replacement surgeries could be better.

The problem: A successful joint replacement requires a talented surgeon with a mastery of skills gained through countless hours of experience and repetition. Success also requires a complement of specialized nurses, staff and costly equipment.
It’s been that way for decades.

Haider, a mechanical engineer who spent the first half of his career in fluid dynamics, saw a unique solution to the problem—one that has the potential to transform how joint replacement surgeries are performed in the future.

“I changed careers late,” he said, “and when you come in with fresh eyes, you can think outside the box a little.”

But a great idea—even one as promising as Haider’s—gets nowhere without some help.
It would need an infusion of fresh capital, and a savvy entrepreneur nimble enough in the biomedical industry to build an entire business around the new technology.

All those elements came together for Haider, and the result is Trak Surgical, Inc., a new Omaha-based surgical device company with enough Invest Nebraska funding to create as many as seven high-skill, high-paying biomedical jobs.

“This company is a fantastic example of the university, private enterprise and government working together to create high growth companies and jobs in Nebraska,” said Michael Dixon, president and CEO of UNeMed Corporation, the technology transfer arm of UNMC.

UNeMed entered the picture early in the process. It helped file the patent applications, and worked with Haider through a nine-year process of testing, fund-hunting and match-making—a process that is still months, if not years, from impacting patients.

Bruce Lichorowic, a serial entrepreneur from Silicon Valley who has been building and guiding startup companies for more than 30 years, formed Trak Surgical, Inc. in 2012. Lichorowic, who has raised more than $600 million in venture capital enterprises, signed on as Trak Surgical’s CEO and quickly lined up angel investors in California, Texas, and Arizona.

Invest Nebraska, a venture development organization that seeks out technology and high-growth Nebraska entrepreneurs, effectively rooted the new company to Omaha with a recent $500,000 matching capital investment.

Invest Nebraska CEO Mark Crawford said one of the biggest factors in the decision to invest in the new startup was the addition of Licorowic.

“I bet on the jockey, not the horse,” he said. “The cherry on top is the innovative technology.”

Invest Nebraska is partially funded by the state’s Talent and Innovation Initiative, a funding program in the Nebraska Department of Economic Development aimed at encouraging small businesses, innovation and entrepreneurship in Nebraska.

“The technology was invented here. The research and development stays here,” Crawford said. “My hope is future deals can be funded completely inside the state.”

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Feld to speak at Omaha startup conference

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FEB. 26, 2013

Brad feldOMAHA, Neb. — Intersect, an upcoming conference aimed at the Nebraska entrepreneur and startup community, landed a whale with Brad Feld signing on to deliver the keynote address.

Once described as a “serial entrepreneur,” Feld has been a venture capitalist funding startups for more than two decades.

“He’s an internationally known speaker,” said Michael Dixon, one of the principal organizers of Intersect. “I’d say he‘s one of the most quoted and read authors when it comes to entrepreneurship and building a startup community.”

Feld will begin Omaha’s Intersect conference with a keynote address outlining the essential elements of a strong and robust startup community. He is the managing director of the Foundry Group, a venture capital firm in Boulder, Colo., that invests in early stage software and Internet companies throughout the U.S.

Feld said with enough vision and long-term planning, any city in the world could build a strong and vibrant startup community.

“Intersect is a good example of the type of event that adds to the startup community,” he said in an email. “By itself, it isn’t sufficient — it is just one of many things that needs to happen on a continual basis — but it’s a good example of an annual event that glues things together.”

Omaha has been on the “upswing,” gaining national attention from publications as one of the best places to build a business, Dixon said. Dixon is also president and CEO of UNeMed Corporation, the technology transfer arm of the University of Nebraska Medical Center.

“I think perceptions are changing that we’re no longer considered a flyover state,” he said. “Our duty is to show Brad what a great place Nebraska is for startups.”

The daylong conference is April 12 at the Embassy Suites in La Vista, Neb., a suburb of southwest Omaha.

Intersect“Intersect: Connecting Nebraska’s Startup Community” brings together innovators, investors and others to meet, mingle and share lessons learned. The conference will feature Startup Village, where entrepreneurs can showcase their ideas and products. The conference will also feature about 20 short presentations in a “TED Talks” style format, a widely popular lecture series that has generated millions of Internet views.

Intersect is hosted by the University of Nebraska’s NUtech Ventures, UNeMed, and other startup-focused groups such as Southeast Community College and the Nebraska Department of Education.

For more information or to register, visit the Intersect website at https://www.intersectNE.org, or call 402-314-6614.

Contact:
Charlie Litton, Communications Associate, UNeMed, charles.litton@unmc.edu, 402-559-2468

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UNeMed Hosts Professionals From Japanese Companies

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by Agnes Lenagh, UNeMed | Feb. 22, 2013

One of the perks of working at UNeMed is the ability to interact with industry professionals worldwide. We’re always looking for new opportunities to engage companies and establish new friendships with industry personnel.

Such an opportunity arrived earlier this month when UNeMed President and CEO Michael Dixon, PhD, received a request from the International Professional Development (IPD) program manager at the University of Nebraska-Omaha: Japanese professionals interested in biotech, Takehide Kimura and Tatsuke Toya, wished to visit our facilities and discuss technology transfer at the University of Nebraska Medical Center (UNMC).

IPD prepares international professionals to be effective and successful in the world of global business. Companies around the world have participated in IPD since 1989 and enjoyed gaining authority in the global marketplace. The program includes intensive training in English language and communication skills, as well as knowledge of global business practices.

IPD also offers professionals an opportunity to develop their networks and access Omaha’s international business community. To achieve this, part of the program includes corporate visits where trainees spend about four hours interacting with staff and touring facilities. This is where UNeMed comes in, as we work with international companies to promote technology developed at UNMC.

On Friday, Feb. 15, we welcomed our Japanese guests at our office. The UNeMed staff prepared a stimulating schedule highlighting different aspects of technology transfer and a tour of research facilities on campus. “We enjoyed viewing the excellent facilities and discussing with many researchers in the university,” Mr. Kimura said in an email.

Visitors from japanese CompaniesWe exchanged business cards and courtesies, and I had the opportunity to practice my shamefully rusty Japanese. Once our guests settled down, Dr. Dixon described how UNeMed fosters innovation and promotes UNMC technologies with industry collaborations. He was excited to host individuals from two prestigious Japanese companies.

“It’s a great opportunity for us to get more detailed information about global pharmaceutical companies and have an opportunity to expose them to the great research that’s going on at UNMC,” Dr. Dixon said. “I hope we are able to visit their companies in the near future.”

Next, the Japanese visitors presented overviews of their companies and explained their individual roles.

Mr. Kimura works in the Research and Development Department of Kiowa Medex, a member of Kyowa Hakko Kirin group. Kiowa Medex supplies advanced healthcare in vitro diagnostics and equipment. Mr. Kimura was interested in meeting people who worked in sales and marketing of biotech-related products. Kyowa KirinHis area of interest is biomarkers and test kits, as well as biotech/medical in general.

Mr. Toya works in the Legal Affairs Department of Kobayashi Pharmaceutical, which manufactures and sells OTC pharmaceuticals, oral hygiene products, deodorizing air fresheners, sanitary, and other products. Kobayashi PharmaceuticalToya was interested in the legal aspects of the technology transfer process.

The group then discussed various aspects of technology transfer including, invention receipt, intellectual property, marketing, and licensing. UNeMed’s licensing team presented insights into their responsibilities and roles at UNeMed and some of the projects we are working on. Mr. Kimura actively participated in the discussion and was interested in the aspects of licensing and marketing different technologies. There was an emphasis on establishing collaborations with industry and how individuals within companies are essential to the success of technology transfer at the university.

Qian, a licensing associate who also obtained her PhD at UNMC, and I volunteered to provide a tour of several research facilities on campus. Our Japanese guests had the opportunity to visit the cell analysis and flow cytometry core, the confocal microscopy core, the proteomics core, the biosafety level 3 research facilities, and a research lab. This was the first time Mr. Toya had visited a research laboratory. “I had never visited Research facility such as Medical Center, and I learned many things,” Mr. Toya noted in an email.

Building relationships is important in technology transfer and these types of visits serve as networking events. Visits to our office and research labs help place our university and its technologies on the map of these global companies.

“When you would come to Japan, please let me know and visit my company,” Mr. Kimura reminded us in an email.

UNeMed is looking forward to hosting future IPD trainees and other biotech professionals to foster mutually beneficial relationships for all of those that participate.

About the Author

Agnes Picture
Agnes Lenagh, PhD

Agnes is currently a Licensing Specialist at UNeMed. She is a scientist by training, a free thinker by design, and a bohemian soul by nature. Agnes is part of a team that promotes innovation to make the world a better place. She is working to ensure that scientific and technological developments are accessible to the world. She is also committed to pursuing the passions that inspire her while taking non-conventional approaches to accomplish a meaningful life. @SilverAntigen

Contact Agnes: agnes.lenagh@unmc.edu

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What you need to know about royalty distribution

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by Agnes Lenagh, UNeMed | Feb. 15, 2013

Professor at workAs a licensing associate at UNeMed, it’s my job to get industry partners interested in UNMC technologies. On any given day, I will be walking across campus to chat with faculty about their research and discuss any inventions or research tools they may have that possess commercial potential.

A typical conversation with a UNMC professor might provide details about an exciting new mouse model they created and is gaining popularity among researchers of a particular disease. I then help license the new mouse model to a pharmaceutical company that develops drugs for that specific disease. A license agreement allows the company to use the mouse model to test the efficacy of new drug candidates.

The best part is professors would not only share their knowledge and resources, but could also earn royalties because of the license.

Researchers get excited about the prospects of a licensing agreement, but their excitement is often tempered by their confusion about royalties. At first their eyes light up when they see the licensing revenue numbers, and smirk as they ask about their portion of the proceeds. Smirks soon twist into frowns as they try their best to grasp royalty distribution concepts.

QuestionComprehending royalty distribution policies can be difficult unless you have a law degree or experience in the field. Prior to joining UNeMed, I was oblivious to the rules and regulations regarding the handling of technology licensing revenue. Licensing revenue and its subsequent distribution can be particularly complicated in some cases, and most universities have a small army of licensing representatives and committee members to negotiate these deals and distribute the incoming revenue. But complications are normally worth the trouble for the income they help generate. In this article, we’ll take a look at licensing revenue and how it is distributed by the university.

Types of Licensing Revenue

UNeMed manages the technology portfolio for UNMC and also negotiates contracts and license agreements with industry partners interested in technologies and research tools. Payments made to the inventors represent their share of royalty payments from licensees to UNeMed. The particular royalty distribution to the inventor will depend on the specifications of the license, including the amount of incoming royalties, and how the licensee pays (quarterly, annually, or otherwise), the amount of costs invested in the patenting, and if there are any co-inventors.

First, we need to distinguish between different types of payment under a license agreement:

  • Licensing Fee: A one-time payment for the granting of rights to a licensee.
  • Milestone: A payment made by a licensee when the licensed technology is advanced to a specified stage of development.
  • Percent Royalty: A regular payment typically based on a percentage of net sales. Percentages vary with the stage of the technology. For example, royalty percentages might be about 2-3 percent for a technology at pre-clinical testing; 3-4 percent if in clinical trials; 3-5 percent for antibodies; 5-7 percent for an FDA approved drug, and a drug with market share may earn 8-10 percent.
  • Guaranteed Minimum Payment: The minimum amount of royalty payments that the university will receive over a specified time period.

While inventing a commercially valuable technology could make a fortune for the inventors, most inventions do not. It all depends on the innovative nature of the technology; its stage of development; the market potential; and negotiated licensing terms.

Distributing Revenue at UNMC

Royalty DistributionWhereas research institutions may have different distribution percentages, each has a policy that dictates the distribution of revenues associated with technology license agreements. UNeMed is also responsible for managing the expenses and revenues associated with UNMC technology agreements.

The UNMC Royalty and Equity Distribution Policy (7001) states that:

First, the University is reimbursed for all costs associated with protecting, maintaining, defending and commercializing the technology.

Patents are very expensive at $10,000 to $20,000 just to draft and file. The University makes the upfront investment and takes the risk, and sometimes provides assistance with prototyping or software services.

After costs are recouped, revenue is dispersed as follows:

  1. Inventors receive 33 percent
  2. UNeMed receives 15 percent to help cover overhead and operating costs that include things like salary, wages, equipment and other important expenses
  3. Colleges, departments, units and institutes that contributed to the licensed invention all receive a proportional part of a fund created with 10 percent of the first $2 million of royalties, 20 percent for revue greater than $2 million
  4. The remainder proceeds then go “to the UNMC Chancellor’s office to enhance the services of the technology development office to support services to faculty in the filing of disclosure, protection of intellectual property and the marketing, licensing and commercialization of technologies. A portion of these funds may be used for grants to develop prototypes and conduct additional research to facilitate commercialization of technologies.”

If there is more than one inventor or technology on the license, a Royalty Sharing Agreement (RSA) is signed by each inventor. The RSA outlines how any net revenue will be distributed. Without an RSA, the revenue is distributed equally.

Proceeds are used on a case-by-case basis to promote innovation and foster education on campus. Funding is available for specific research projects that may develop existing and future intellectual property with commercial potential.

Getting the money

Inventors often ask us how much money will they make and when. Earning money is an attractive motivation for inventing and licensing a technology, but the actual payment amount can’t be predicted. The royalty distribution to the inventor depends not only on the licensing agreement, but also the merits and commercial success of the invention.

royaltyOnce UNeMed receives the payment from the licensee, they first cover all costs incurred that are associated with the technology. Next, the inventor’s share is one third of the remaining revenue. The royalty payment check will arrive by mail to the inventor’s house and is subject to taxation as income.

Most inventors don’t become overnight celebrities nor retire on technology licensing royalties, but it is possible that the world will be a better place because of their invention. Royalties are an attractive incentive to promote innovation and it doesn’t hurt to have a few extra dollars to buy that state of the art pipette set for the lab.

Join us next week when we discuss more about Patentable Inventions.

About the Author

Agnes Picture
Agnes Lenagh, PhD

Agnes is currently a Licensing Specialist at UNeMed. She is a scientist by training, a free thinker by design, and a bohemian soul by nature. Agnes is part of a team that promotes innovation to make the world a better place. She is working to ensure that scientific and technological developments are accessible to the world. She is also committed to pursuing the passions that inspire her while taking non-conventional approaches to accomplish a meaningful life. @SilverAntigen

Contact Agnes: agnes.lenagh@unmc.edu

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Commercialize your technology: How to bring a product to market

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Dr. Gary MadsenOMAHA, Neb. (Feb. 13, 2013)—“Commercialize your technology: How to bring a product to market” is the title of the second talk given by Dr. Gary Madsen since joining UNeMed as Entrepreneur in Residence last June. His first talk, “What is an EIR and how can he help you” was given at this year’s Innovation Week and introduced the focus and goals of his new position.

The new talk, scheduled for Monday, February 18, is more of a “how to” guide for faculty members to follow when commercializing their technology through a newly formed company.

Before jumping headfirst into a new commercial venture, Dr. Madsen discusses some factors to consider in favor of and against starting a new company. He then methodically takes each step of the new company’s pathway and discusses the most important aspects for founders to focus on.

The seven steps in the process he describes include everything from obtaining a license to implementing a marketing team and sales channel, and everything in between. The talk will be informal and open to lots of questions and discussion.

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Patent-eligible subject matter: Could you patent a man-made life form?

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by Bill Hadley, UNeMed | Feb. 5, 2013

bacteriaInvention disclosures are the lifeblood of university technology transfer offices. Without an influx of quality inventions from faculty, graduate students, and other university employees, these offices would cease to exist. Unfortunately, what qualifies as a patentable invention – especially in the life sciences – can be difficult to understand. Indeed, it is my experience that many university research centers sit on a wealth of intellectual property that has never been disclosed for the simple reason that its creators never realized that they could obtain a patent on the results of their work.

To illustrate the complexity of this issue, take the curious case of Ananda Mohan Chakrabarty. In 1971, Chakrabarty, then working for General Electric, developed bacteria capable of metabolizing crude oil. The bacteria quickly garnered widespread acclaim for its ability to mitigate the damage caused by oil spills. Noting that no naturally-occurring bacteria possessed this property, Chakrabarty and GE applied for a patent.

Consider that for a moment. In effect, Chakrabarty had created a new life form that had never existed in nature, and had the audacity to attempt to patent – monopolize! – the rights to that lifeform.

While the ethical and political ramifications of Chakrabarty’s patent application are staggering, the pertinent question for our purpose is much simpler: “Can you even patent that?” This is, hopefully, the same question many researchers have about their own research. So, without further ado, let’s take a closer look at the types of inventions that are eligible subject matter for patent protection.

The Patent Act of 1952 lists four categories of patentable subject matter for a utility patent:

  • Processes
  • Machines
  • Manufactures, or “Articles of Manufacture”­
  • Compositions of Matter

 

Additionally, any improvement to an existing invention in one of these fields is eligible for patent protection. These terms are ambiguous so let’s take a closer look at each to sort them out.

Processes

planningThe first thing to note here is the term Processes also includes methods.  Process patents can become complex when discussing things like software patents or business method patents. But for most purposes, a process is generally thought to be intended to cover things like manufacturing processes which is a series of steps to make something.

A method generally refers to a specified way of using something.

Thus, a description of a series of steps to cure rubber might be a process, while a method might comprise the steps of a specified administration of a therapeutic agent to treat a condition.

Machine

A Machine can be thought of as a concrete thing, consisting of parts, or of certain devices and combinations of devicesThis includes mechanical devices, or combinations of mechanical powers and devices to perform some function and produce a certain effect or result.  So, a machine may be something like a carburetor, a laser, or a photocopier – devices that autonomously perform a function utilizing a system, or systems, of mechanical devices.

Manufactures

Manufactures, also called Articles of Manufacture, are tangible items or commodities, such as ceramics, alloys, or simple tools.

Patentable Subject Matter

PillsA U.S. patent court decision defined Compositions of Matter as “all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders, or solids.” Put another way, a composition of matter is, essentially, any tangible “thing” which is formed by the combination of two or more components, and which possesses properties belonging to neither parent component in each parent component’s individual capacity.

Inventions Not Eligible for Patent Protection

Interestingly, just as there are certain statutorily defined categories of patentable subject matter, certain types of inventions are excluded from patent eligibility.  These excluded inventions include:

 

A Patent for Chakrabarty’s Invention

The controversy over the patentability of Chakrabarty’s organism reached the Supreme Court in 1980. The court first noted that there was no obvious congressional intent to disavow living organisms as patentable subject matter, noting that “Congress thus recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions…”.

Thereafter, the only remaining issue for the court to determine was whether Chakrabarty’s organism fell into one of the four specified categories. This, in turn, boiled down to whether the organism was an article of manufacture, a composition of matter, or neither. In evaluating this question, the court reasoned that:

[Chakrabarty’s] claim is not to a hitherto unknown natural phenomenon, but a non-naturally occurring manufacture or composition of matter – a product of human ingenuity ‘having a distinctive name, character and use’…[Chakrabarty] has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility.  His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under §101.

The court does not, of course, specify which category Chakrabarty’s organism falls into – that would be entirely too helpful.

So, if the Supreme Court of the United States is unable to accurately figure out how to classify these things, what is a simple researcher to do?  My advice?

Call UNeMed.

If you have any questions or comments, please do not hesitate to contact the author or leave a comment below.

Join us next week when we discuss the Royalty Distribution.

About the Author

Bill Picture
Bill Hadley, JD

Bill has ample experience handling evaluation, development, marketing, and licensing for medical device, software, and telemedicine-based invention disclosures. He received a B.S. in Chemistry from the Colorado School of Mines and a J.D. from the Creighton University School of Law.

Contact Bill: whadley14@gmail.com

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Six Seconds in Dallas: Fair Use and the Kennedy Assassination

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by Bill Hadley, UNeMed | Jan. 9, 2013

Kennedy car

President Kennedy, his wife Jacqueline, and Texas Governor John Connally in the presidential limousine, minutes before Kennedy was assassinated on Nov. 22, 1963.

On November 22, 1963, at precisely 12:30 pm, shots rang out from the Texas School Book Depository overlooking Dealey Plaza in Dallas, Texas.  The shots tore into the motorcade that traveled through the plaza, wounding Texas governor John Connally,  bystander James Tague, and killing John F. Kennedy, the 35th President of the United States.  Also present that day was Abraham Zapruder, a russian immigrant who had, on a whim, decided to film the motorcade as it passed through Dealey Plaza.  While there were many photographers present, in a bizarre stroke of fortune (or misfortune), Zapruder was one of the few people actually capturing the procession on film –  and one of the fewer still who were capturing film from a vantage point that provided an unimpeded view of the presidential motorcade as the bullets ripped through it.

All told, the “Zapruder Film” comprises 26.6 seconds (486 frames) of footage documenting the event. Recognizing the value of the footage, Zapruder promptly sold the original film to Life Magazine for $150,000 (just over $1.1 million today). Three years later, Josiah Thompson, a former employee of Life, decided to publish his own account of the tragedy in his book Six Seconds in Dallas.  Unable to receive Life’s permission to use frames from the Zapruder Film in his recounting of the events, Thompson hired an artist to re-create the relevant frames from the film in the form of charcoal sketches, which were subsequently included in the book for analysis.

Shortly thereafter, Life sued Thompson for infringing its copyright in the Zapruder Film and, inherently, the still frames that make up the film.  Among other defenses, Thompson claimed that his re-creation of the frames was permissible under the Fair Use Doctrine – a principle that permits copyright infringement in certain circumstances (note: at this time Fair Use was a common law principle – today it is formally codified in the Copyright Act).  In 1968, the Federal District Court for the Southern District of New York heard the case and ruled in favor of Thompson (Time, Inc. v. Bernard Geis Assocs., 293 F. Supp. 130 (S.D.N.Y 1968).

If you’re scratching your head over this one, don’t feel bad.  Ostensibly, this is a textbook case of copyright infringement: after all, Thompson duplicated a creative work – the Zapruder Film/frames – to which he had no legal claim, without the permission of the lawful owner, and published the duplicate images for his own financial benefit.  So how on earth did the court find this permissible?  To understand, it’s imperative that one is familiar with the Fair Use defense – perhaps the most ambiguous, frustrating, non-sensical, and necessary, limitation on the scope of copyright protection.

The Fair Use Defense and the Copyright Act of 1976

Fair use (also called “fair dealing” in certain foreign jurisdictions) is an affirmative defense to a charge of copyright infringement that permits limited use of a copyrighted work without permission from the copyright holder.  Typical fair uses of a copyrighted work are for purposes such as criticism, commentary, scholarship, and parody.  At its core, fair use is representative of the balance inherent in all intellectual property schemes; in this case, it is recognized that, in some circumstances, public policy dictates that limited use of copyrighted material should be encouraged, despite the potential negative implications on the incentives offered by §106 of the copyright act.

Note that fair use is an affirmative defense to a claim of copyright infringement.  That is, even if a copyright holder can establish that a defendant infringed their copyright, if the defendant can show its use of the protected work is permitted under the fair use provision of the copyright act, the defendant will not be liable for copyright infringement.  To help determine if a specific use of copyrighted material is permitted as a fair use, Congress has implemented a four-factor test in 17 U.S.C. § 107 to weigh the equity – fairness – of the use.

17 U.S.C. § 107 states, in relevant part:

Notwithstanding the provisions of §106 and §106(a), the fair use of a copyrighted work, including such use by reproduction in copies or phonorecords or by any other means specified by that section, for purposes such as criticism, comment, news reporting, teaching (including multiple copies for classroom use), scholarship, or research, is not an infringement of copyright.  In determining whether the use made of a work in any particular case is a fair use the factors to be considered shall include –

1.   The purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit educational purposes;

2.   The nature of the copyrighted work;

3.   The amount and substantiality of the portion used in relation to the copyrighted work as a whole; and

4.   The effect of the use upon the potential market for, or value of, the copyrighted work.

Note that this is a factors test:  that is, a court will consider each factor independently in order to weigh the overall equity in permitting the infringing use.  Due to the subjective nature of each factor, along with their high degree of sensitivity to specific facts,  it would take pages to summarize the way courts have come out on fair use analyses.  I will not go into that much depth here, but here’s a little taste of what courts tend to look at when considering each factor.

Purpose and Character of the Use

Cartoon

Courtesy of Courtoons.com.

Arguably the most important factor in the fair use analysis is the purpose and character of the use of the work.  In evaluating the use, “transformative” uses are more likely to weigh in favor of the would-be fair user while uses that are “derivative” are more likely to weigh against a fair use finding.  Generally speaking, a work is transformative if it includes independent creativity by the would-be fair user, such as in a piece of criticism (where a copyrighted passage might be reproduced for purposes of analysis in the criticism) or a parody (where copyrighted material might be reproduced in order to comment on it).

For an interesting (and awkward…) discussion of the importance of this principle, check out Campbell v. Acuff-Rose, Music Inc., 510 U.S. 569 (1994), where 2 Live Crew’s  parodic sampling of Roy Orbison’s Oh, Pretty Woman was determined to be a sufficiently transformative fair use of the original work.

Nature of the Copyrighted Work

Arguably the least important factor in the fair use analysis, here courts look to evaluate the degree of creativity of the copyrighted work.  As such, fictional works generally weigh in favor of the copyright holder while non-fiction works are more likely to favor the would-be fair user (as Life Magazine found out…but I am getting ahead of myself).

Amount and Substantiality of Use

In evaluating this factor, courts look at both ‘how much’ and ‘what’ the would-be fair user has taken from the copyrighted work.  Courts have run the gamut here, finding for a fair use defense even when a user has liberated all of a copyrighted work (see e.g. Kelly v. Arriba Soft Corporation, 280 F.3d 934 (9th Cir. 2002)) and against a fair use defense when the user took only a small piece of the copyrighted work (Harper & Row Publishers Inc. v. Nation Enterprises, 471 U.S. 539 (1985).

Overall, there are two primary considerations at play here.  First, did the would-be fair user take as little of the copyrighted work as necessary to complete its own creative work?  If so, it favors a finding of fair use.   Secondly, did what was taken of the copyrighted work make up the “heart” (e.g. most powerful or interesting passages, the definitive quality of the copyrighted work, etc.) of it?  If yes, courts tend to disfavor a fair use finding.

Effect of Use on Copyright Value

The final factor in the fair use analysis considers the effect the would-be fair use has on the market value of the original copyrighted work.  If the fair use harms the market value of the original work, courts tend to disfavor the fair use, while if it has no impact – or increases – the value of the original, courts will generally favor a fair use determination.  Note that while the later decided Campbell case (above) describes the primacy of the “purpose and character” of the use as a factor, earlier cases, such as Harper & Row, assert the primacy of the “Effect of Use” factor as the most important consideration.

 Application of the Fair Use Defense

fair useReliance upon the fair use defense is problematic. Not only can evaluations of the different factors vary widely amongst different courts, but judges are given little guidance as to how the factors should be weighed against each other.  What, for example, is a judge to do with a highly transformative parody, when the underlying copyrighted work was very creative, was copied in its entirety, and the parody significantly diminishes the commercial value of the underlying work?  What about a work that is copied in its entirety, for purely commercial benefit by the would-be fair user, but where the work is minimally creative and the value for the underlying work is not harmed?

Unfortunately, given the subjective nature of the factors involved (e.g. How transformative is “enough”? What is the “heart” of the work?  How creative, exactly, was the underlying work really?) and the factors’ sensitivity to specific fact patterns, fair use case law has a broad spectrum of results and is not very helpful, on the whole, either.

Ironically, the difficulties with the fair use defense were specifically addressed (intended?) by Congress as far back as 1967, when, in an impressively prescient analysis, the House Judiciary Committee noted that:

Although the courts have considered and ruled upon the fair use doctrine over and over again, no real definition of the concept has ever emerged.  Indeed, since the doctrine is an equitable rule of reason, no generally applicable definition is possible, and each case raising the question must be decided on its own facts…the endless variety of situations and combinations of circumstances that can arise in particular cases precludes the formulation of exact rules in the statute. 

Eventually the fair use doctrine was codified in the Copyright Act of 1976 (as 17 U.S.C. §107), but the concerns of House Judiciary Committee persist.  As such, there will always be a degree of uncertainty whenever a fair use defense is in play.

Fair Use and the Zapruder Film

So how did the court find in favor of Thompson based on his fair use claim?  You can find the court’s analysis in para. 131-4 of Time, Inc. v. Bernard Geis Assocs., but the following passage stands out in terms of illuminating the court’s thought process:

There is a public interest in having the fullest information available on the murder of President Kennedy. Thompson did serious work on the subject and has a theory entitled to public consideration. While doubtless the theory could be explained with [other non-infringing representations], the explanation actually made in the Book with copies is easier to understand. The Book is not bought because it contained the Zapruder Pictures; the Book is bought because of the theory of Thompson and its explanation, supported by Zapruder pictures.

In other words, the public’s interest in Thompson’s analysis of the work, enabled by his infringement of the frames of the Zapruder Film, outweighed Life’s interest in the copyright.  Given Thompson’s financial interest in the infringement and the overall bad faith he showed in intentionally copying the frames, this certainly is an interesting outcome for an equitable doctrine – but it goes to show how perplexing the fair use doctrine can be.

So, given everything discussed above, the take-home message is this:  when utilizing someone else’s copyrighted material, try to obtain permission first.  If you do not, are sued, and are subsequently forced to assert a fair use defense, the only person who can be confident of a win will be your attorney.

If you have any questions or comments, please do not hesitate to contact the author or leave a comment below.

Join us next week when we discuss the implications of technology transfer.

About the Author

Bill Picture
Bill Hadley, JD

Bill is a licensing associate at UNeMed, where he handles evaluation, development, marketing, and licensing for medical device, software, and telemedicine-based invention disclosures. He received a B.S. in Chemistry from the Colorado School of Mines and a J.D. from the Creighton University School of Law. Bill is currently in training for next fall’s intramural volleyball league, where he has personally guaranteed at least one victory for the mighty UNeMed Volley Llamas.

Contact Bill: Bill.Hadley@unmc.edu

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