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, Ph.D., 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, Ph.D., 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 Ph.D. 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, Ph.D.

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, Ph.D., 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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The importance of technology transfer

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by Agnes Lenagh, UNeMed | Dec. 18, 2012

domino effect of booksContrary to popular belief, publishing your research will not guarantee that someone will notice your discovery and continue developing it into a tangible product that will reach the end user. As I previously mentioned, technologies first need to be developed and that is achieved through collaborations with industrial partners. For example, once a lead compound is identified it must go through a drug development process that includes pre-clinical research, development, and clinical trials. Additionally, drug development is focused on addressing the regulatory requirements of regulatory authorities, such as the FDA and later on for marketing approval. Overall, the process can be quite expensive and may exceed $100 million dollars per drug compound.

How Does Technology Transfer Occur?

authorTechnology is typically transferred through a license agreement in which the university retains ownership of the intellectual property, while the industrial partner obtains conditional rights to use and develop a technology. Before the technology transfer can take place, inventors must define and disclose the nature of their invention to the institution’s technology transfer office. New inventions are evaluated by technology licensing experts, who determine the intellectual property position and potential market for the technology. The technology transfer office will not be able to proceed with the invention if there is no intellectual property available, no value to industry or appropriate competitiveness in the market. On the other hand, inventions with an appropriate intellectual property and market position are given the green light and intellectual property rights are pursued. An invention management and commercialization strategy can begin once the intellectual property rights are established.

Technology transfer requires a proactive approach that combines engaging researchers, promoting the technology, and encouraging potential industrial partners to use the technology.

AgreementThe end goal of the commercialization strategy is to establish a commercial relationship with another party (e.g., employment, a sale or license), and negotiating a contract (e.g., compensation). A license is a contract between a licensor (e.g., the holder of a patent) and a licensee (e.g., an industry partner) that includes a number of conditions that the third party must satisfy. The licensee may be an established company or a new business start-up (that may be founded by the researcher).

The technology transfer office may grant nonexclusive, partially exclusive, or exclusive licenses. Multiple nonexclusive licenses may be granted to several companies to offer better opportunities to broaden the use of an invention across different fields. As mentioned above, the industry partner must satisfy a number of conditions which may include creating a satisfactory development or marketing plan, supplying information about the company’s ability to implement the plan, develop and commercialize the invention within a specified period of time, and making financial payments to the university. These payments are distributed to the inventors and shared within the institution to provide support for additional research, education, and participation in technology transfer activities.

Why is Technology Transfer important?

Technology transfer helps develop early stage intellectual property into tools for direct use by the research community, or into bases for new platforms, products, or services to be made into products for public use. Successful collaborations are formed between researchers across different universities or industries in order to advance the knowledge in a particular field or to further develop a technology. These collaborations may result in licensing or sponsored research opportunities that benefit both partners. In addition, technology transfer ensures that the interests and rights of the university in the intellectual property are protected. The university is able to retain the intellectual property rights of the technology and issue a license for the conditional use of the technology.

PillsSuccessful transfer and development of the technology helps promote the research institution and its commercial partners. The university obtains recognition and increases its reputation for their research and innovation potential. Industry partners can also reduce the costs incurred during their research and development stage by licensing technology from a university. Another benefit for the university involves using the licensing revenue to support further research and education at the institution. Universities protect their investments in research by patenting new technologies, which gives them an opportunity to reach the stream of commerce. The university’s investments in the technology help stimulate local economic development. The ultimate beneficiary of technology transfer is the public, who benefits from both the products that reach the market and the jobs resulting from the development, manufacturing, and sale of products.

I hope that this overview helped illustrate the field of research commercialization. Technology transfer works to complement academic research by pushing innovations out the lab door and into the hands of industry partners who will develop them into products for the benefit of the general public. Remember, if you have a research discovery that helps solve a significant problem, if the idea is innovative and unpublished, or if you believe you have discovered something unique with commercial potential or research value, don’t hesitate to consult with your technology transfer office. Here at UNeMed, we are always eager to help the University of Nebraska Medical Center faculty, staff, and students with any possible inventions they may have.

Contact us via email to report a research tool, or to discuss possible inventions. If you have any questions or comments, please do not hesitate to contact the authors or leave a comment below.For more information, you may also refer to our Inventor’s Handbook.

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Technology transfer 101: Defining research commercialization

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by Agnes Lenagh, UNeMed | Dec. 11, 2012

authorAs a graduate research assistant I constantly heard about the importance of performing valuable research that will someday help develop a diagnostic, prevention, or treatment for a disease. Typically, researchers publish their work to announce their discoveries to sustain and further their career and with the hope that someone will notice and use their idea to improve public health. Unfortunately, most ideas and technologies that stem from research activities are at an early stage of development. Research at academic institutions is geared to gaining better understanding in the field of study and while discoveries have great scientific significance, they might not have immediate commercial value because they lack proof-of-concept studies, a prototype, or a specific product to be commercialized. Before a diagnostic or therapeutic reaches the end user, it will be further developed in compliance to strict regulation and eventually undergo clinical trials. Most research institutions don’t have the means to cover the expensive and often lengthy development process and clinical trials. For this reason, universities partner with pharmaceutical and biotech companies.

Enter Research Commercialization and Technology Transfer

AgreementResearch commercialization allows technology created during research activities to be further developed into marketable products for the benefit of the public. This is achieved through technology transfer, which is the process by which technology, skills, or knowledge developed during research activities at the research institution are applied and used in another place. Technology transfer often refers to transferring a technology between a research laboratory and a commercial partner, including industry, academia, and state and local governments.

The technology transfer process typically involves:

  • Identifying new technologies stemming from research activities
  • Protecting the intellectual property of technologies through patents and copyrights
  • Forming marketing strategies to further develop and commercialize the technology to existing private sector companies or newly created startup companies

The federal government has actively supported and encouraged technology transfer with respect to technologies generated with federal funds. All researchers in federally funded laboratories are required to consider technology transfer an individual responsibility and new discoveries and technologies must be reported to the funding agency.

Investigators are obligated to report any inventions resulting from research activities to the federal funding agency.

LawA series of laws have been established to increase the technology transfer between federally-funded laboratories and nonfederal organizations while providing external entities with a means to access new technologies. Of these laws, the Bayh-Dole Act is credited for stimulating interest in technology transfer, as well as increasing research commercialization, educational opportunities, and economic development in the United States.

The Bayh-Dole Act of 1980 (P.L. 96-517) established boundaries regarding patents and licenses for federally-funded research and development. This Act allows universities, small businesses, and non-profit organizations to have ownership rights to inventions resulting from federally-funded research programs. Major provisions of the Bayh-Dole Act include the following:

  • Make efforts to protect (file patents) and commercialize (promote the use) innovations they elect to own
  • Submit progress reports to the funding agency
  • Give preference to small businesses that demonstrate sufficient capability of bringing the invention to practical application
  • Sharing any resulting revenues with the inventors
  • The government retains march-in rights and a non-exclusive license to practice the patented invention throughout the world

Why does Intellectual Property Matter?

IDEATechnology is typically transferred through a license agreement in which the university retains ownership of the intellectual property created during research activities, while the industrial partner obtains conditional rights to use and develop a technology.

Intellectual property is regarded as subject matter that can be protected under the laws governing the different forms of intellectual assets. These intellectual assets may include products resulting of the human intellect, including inventions, discoveries, creations, developments, or other forms of expressing an idea. Intellectual property may be protected using patents, copyrights, trademarks, and trade secrets. The rights to an article of intellectual property may be bought, sold, leased, rented, or transferred between parties. Additionally, the transfer of intellectual property rights can affect a product’s marketability.

Intellectual property is an essential component when evaluating an invention’s commercialization potential. A common occurrence among researchers is the desire to make their discoveries known and yet, a publication or presentation will not guarantee that the invention will be developed into a marketable product. On the contrary, patent rights are affected by public disclosures, such as presentations and publications in some form. Because patent laws vary by country, a publicly disclosed invention may have restricted or minimal patent protection outside of the United States. Biotechnology companies are interested in not only helping people but also in generating revenue, and as a consequence, technologies need to have strong intellectual property position.

Kepts safe in secretFor this reason, it is critical that confidentiality is maintained until the intellectual property rights have been secured. For example, let’s analyze a typical situation that could happen to any researcher. A new compound that functions as an antibiotic is discovered in a lab and the researchers confirm the results. They also discover that this compound not only has great efficacy and cures bacterial meningitis in an animal model but it also appears to have low toxicity. While preparing the manuscript for publication, the graduate student in charge or the project realizes that his favorite scientific conference is now accepting abstracts. Wanting to share his discovery with the other researchers in the microbiology field, he submits an abstract and is accepted to present a poster. At the conference, a representative from fictitious MicroPharma observes the results and has a good chat with the student. Several weeks after the conference, the primary investigator receives a call from a MicroPharma business development representative. They are interested in more information about the technology. The call is directed to the technology transfer office, who is very excited to work with both the researchers and MicroPharma. Unfortunately, the staff of the technology transfer office had never heard of the compound. While they proceed with the necessary steps to evaluate and protect the technology, they cannot obtain intellectual property protection outside of the United States. The company hesitates to invest in the technology because they were interested in developing the compound in India, where there is a need for new antibacterial compounds. Once again, public disclosure has created a disadvantage for technology transfer.

The example might have been a bit farfetched but it’s not unrealistic. Sometimes researchers disclose their research ideas and developments after they have presented or published it. Often, the technology is abandoned because of the intellectual property cannot be protected. To ensure that the intellectual property is appropriately protected, researchers are highly encouraged to first disclose their discovery to their institution’s technology transfer office (e.g. UNeMed) before sharing the invention with people outside the university.

Contact us via email to report a research tool, or to discuss possible inventions. If you have any questions or comments, please do not hesitate to contact the authors or leave a comment below.For more information, you may also refer to our Inventor’s Handbook.

Join us next week when we continue our discussion on the importance of technology transfer.

About the Author

Agnes Picture
Agnes Constantino, PhD

Agnes is currently a Licensing Associate with UNeMed. She is working to ensure that scientific and technological developments are accessible to the world and that the world, in turn, understands their implications. She is also committed to pursuing the passions that inspire her while taking non-conventional approaches to accomplish a meaningful life. Follow @SilverAntigen

Contact Agnes: aaconstantino@unmc.edu

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Limitations on Copyright: The First-Sale Doctrine

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by Bill Hadley, UNeMed | Nov. 19, 2012

Textbooks are expensive – really expensive. In fact, according to the U.S. Government Accountability Office, over the past two decades, the price of college textbooks has tripled, averaging around $1,200 a year for most students. Considering most students are on fairly tight budgets, it should come as no surprise, then, that there is a vibrant secondary market for used textbooks, and many students elect to save a healthy amount of money each year buying used books. In fact, this practice is so commonplace that the act of buying a used textbook is seen by most students as more or less a rite of passage in the college experience. Supap Kirtsaeng, however, saw it as an opportunity.

Used booksKirtsaeng, a native of Thailand, came to the U.S. in 1997. While in the U.S., Kirtsaeng attended Cornell University and later received a Ph.D. in mathematics from the University of Southern California. In order to subsidize his college expenses, Kirtsaeng did what many college students do: he sold used textbooks. There was only a small difference – Supap Kirtsaeng (allegedly) made over 1.2 million dollars doing so.

So how did Kirtsaeng pull that off? It’s actually quite simple:  publishers generally charge more for textbooks sold in the U.S. than for those sold abroad. For example, where the market clearing price for a new textbook in the U.S. might be $200, a substantially similar version of the book might only be affordable for the equivalent of $20 to a student in Thailand. Recognizing this, Kirtsaeng’s family members would buy textbooks in Thailand at the reduced cost, ship them to Kirtsaeng, and Kirtsaeng would sell the books in the U.S. at a price undercutting the domestic cost of the textbook.

Catching onto this scheme in 2008, textbook publisher Wiley & Sons sued Kirtsaeng for infringing Wiley’s copyrights in the textbooks. Wiley eventually won the case, but certiorari was granted to Kirtsaeng’s appeal on April 16, 2011. On Monday, October 29, Kirtsaeng v. John Wiley Sons., Inc. was argued before the Supreme Court. The case highlights important aspects of the First Sale Doctrine – the principle which gives purchasers of a copyrighted work the right to sell that copy of the work to another downstream purchaser.

The first sale doctrine is an important limitation on the scope of copyright protection, so in light of having a copyrights case argued in front of our nation’s highest court, this seems as good a time as any to discuss it.

Codification of the First Sale Doctrine

The First Sale Doctrine is codified in U.S. under 17 U.S.C. § 109(a), which states, in relevant part:

Notwithstanding the provisions of §106(3), the owner of a particular copy or phonorecord lawfully made under this title, or any person authorized by such owner, is entitled, without the authority of the copyright owner, to sell or otherwise dispose of the possession of that copy or phonorecord…

Copyright saleIn other words, once a copy of a copyrighted work is purchased from the copyright holder (or otherwise “lawfully made”), the purchaser of that copy becomes the unlimited owner of the distribution rights (under §106(3) of the Copyright Act) in that copy. The purchaser is thereafter permitted to control, exclude, dispose of, transfer, or otherwise distribute the copy as the purchaser sees fit. The first sale doctrine does not give the purchaser a copyright interest in the author’s creative work; it only transfers to the purchaser the right to distribute their interest in the copy of the work.

Issues at Play in Wiley v. Kirtsaeng

In theory, the first sale doctrine is fairly straightforward. Unfortunately, even the simplest legal principles can become startlingly complex in unforeseen circumstances – and that is certainly the case here. There are a variety of difficult issues the court is looking at in Kirtsaeng which will impact the rights enshrined in §109(a). Fortunately, a brief examination of these issues will serve as a good mechanism for understanding the application of the first sale doctrine in practice.

Let’s look at these outstanding issues now:

1.)    Conflict with Import Rights

While §109(a) gives the owner of a lawfully-obtained copy of a copyrighted work the right to freely transfer ownership of that copy, 17 USC §602(a)(1) states that, “Importation into the United States, without the authority of the owner of copyright under this title, of copies or phonorecords of a work that have been acquired outside the United States is an infringement of the exclusive right to distribute copies or phonorecords under §106…”.  In other words, importing of a copyrighted work into the US, without permission from the copyright owner, is considered copyright infringement under §106.

§602 carves out no exceptions for importation of works lawfully owned by an importer under the first sale doctrine; a plain reading of the text §602(a)(1) therefore conflicts with a plain reading of §109(a) when a person imports a copyrighted work which was lawfully obtained in accordance with the first sale doctrine.  Clearly this makes no sense – and this is the primary reason the case has reached Supreme Court. It will be interesting to see how this conflict is resolved in the decision.

2.)    Contractual Restraints on Alienability

Books around the worldEach textbook sold abroad by Wiley was marked, “Authorized for sale in Europe, Asia, Africa, and the Middle East only…The Publisher may recover damages including but not limited to lost profits and attorney’s fees in the event that legal action is required.” Does this restraint reach through a lawful purchase to limit the distribution rights of the purchaser of the textbook?

Generally speaking, United States common law disfavors unreasonable restraints on alienability built into the transfer or sale of property. In fact, the Supreme Court noted that such unreasonable restraints highlight the need for the First Sale Doctrine in the first place (see e.g.  Bobbs-Merrill Co. v. Strauss, 210 U.S. 339 (1908)). On the other hand, recent cases (e.g. the 9th Circuit’s decision in Vernor v. Autodesk, Inc., No. 09-35969, slip op. at 13871-72), have found that a copyrighted work was licensed to a purchaser – as opposed to sold – and that title to the copy of the protected work was not transferred.  Therefore, the first sale doctrine was not implicated and the restraints on alienability in the license were permissible.

While it is not likely that Kirtsaeng’s purchase of the textbooks overseas will be considered a ‘license’ to the textbooks, Vernor highlights an important principle that should be considered whenever the first sale doctrine is implicated:  was title to the copy of the protected work actually transferred?

The First Sale Doctrine as a Policy

As an observer, determining who will prevail at the Supreme Court level is never easy; interestingly, it can be even more difficult to evaluate who we want to win. That is, the policy implications of a Supreme Court ruling are often just as difficult to untangle, if not more so, than the legal ramifications. Compounding the problem is that who we “want” to prevail is based on entirely subjective notions of fairness.

For example, is it fair to students in the U.S. (many of whom are, or will be, in difficult financial situations) that Wiley charges astronomical prices for its books in the US while charging barely above the break-even price for the same product abroad? It may not seem so at first blush, but it is important to remember that one of the hallmarks of intellectual property is that the rights-holder, by virtue of its monopoly power, has the right to sell his protected goods at a price of his choosing. Generally it is wise for the rights holder to choose the price that makes the most economic sense from a profit perspective – but should that include the right to segment the market (e.g. domestically and abroad), and if so, to what extent?

domino effect of booksMoreover, consider the impact of the outcome: if Kirtsaeng wins and legitimate owners of copies of protected works are able to import them freely into the U.S., what will result? Probably not lower domestic textbook prices. Rather than drop prices domestically,  Wiley and other publishers will more likely elect to sell each textbook at the same domestic price worldwide – thus, nullifying the incentive to import. The net effect of this is that domestic text book prices in the U.S. stay the same, while textbooks for students abroad become virtually nonexistent in some markets. Is that fair? On the other hand, if Wiley wins, what does that say about the first sale doctrine as a limitation on the scope of copyright considering the effects of globalization on the modern economy?

Let’s be clear: the Supreme Court is only supposed to rule on the matters of law in front of it, policy implications be damned. In theory, the view of the court is that, if ruling on the law results in bad policy, it is the job of the elected members of Congress to draft a law that reflects a good policy. In practice, however, it is naïve to think that policy matters are not considered by the court. Given that the scope of copyright – a policy – should be given at least some consideration in Kirtsaeng, it will be interesting to see how the court rules.

Cases like Kirtsaeng make it all the way to Supreme Court very rarely and the outcome could set a narrative for the way the court interprets the scope of copyrights for years to come – a particularly compelling topic considering the ambiguity in the copyright law as it pertains to the internet and digital mediums of expression.

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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You’re an inventor… now what? Three things you can do with your intellectual property

Comments Off on You’re an inventor… now what? Three things you can do with your intellectual property Blog

by Joe Runge, UNeMed | Nov. 7, 2012

IDEAIntellectual property is an asset which affords its holder the right to exclude others from the use of a particular idea. In this way, an author can prevent a publisher from printing her story or an inventor can stop a company from manufacturing his machine.  Yet it is not always obvious how an intellectual property holder can recover any value from it. Bob Kearns may have invented the intermittent windshield wiper, but his efforts to recoup value from that invention (as recounted in the 2008 movie Flash of Genius) were not at all simple.  As Kearns’ odyssey demonstrates, an inventor may have a great new invention or an improvement to an existing product, but lack the capability to make products that use the invention. To make the most of the asset, creators of intellectual property need to have an end goal in mind: how to convert intellectual property to income.

1. Suing for Patent Infringement

patent infringementAs discussed before, patents give the owner the power to prohibit others from making, using, selling, offering to sell, or importing the protected invention. An obvious method to gain profits from a piece of intellectual property is litigation, through which an intellectual property holder can assert rights and sue infringers. Unfortunately, infringement lawsuits can be enormously expensive, even if they settle early. For patent infringement, the median cost of a lawsuit is over half a million dollars, and requires an infringer that the rights-holder can identify.  Litigation can be enormously lucrative, but it is a very risky way to get a return on intellectual property.

2. Selling a Protected Product Yourself

Another approach to commercialize an invention is to actually make, publish or otherwise produce the idea the intellectual property protects. If there is a good intellectual property position and there is a market for it, the exclusive rights granted by the intellectual property can provide a distinct commercial advantage against competitors. A trademark, for example, gains value only as a business uses that mark to provide goods and services to its customers. That being said, innovators are not always entrepreneurs. Just as some authors are not interested in publishing their own books, some inventors that own intellectual property are not interested in forming their own companies. Moreover, in an age of specialized production and mass media, it can often be very difficult to get the appropriate regulatory approval, start-up capital, good manufacturing process or mass market appeal to profitably exploit intellectual property. As you might imagine, for many innovators, selling products based on their intellectual property may not be a feasible option.

3. IP Licensing

FranchiseA third commercialization approach is for the rights holder to license the intellectual property to a third party. Intellectual property licensing is very complex but it creates an efficient method by which authors, inventors, and other intellectual property holders can get a return for their rights.

Intellectual property licensing is essential for a number of industries, many of which are not technology driven.  Franchising, for example, is built around licensed intellectual property; an entrepreneur can license the right to use the trademarks, know-how, advertising, and other intellectual property of an existing company in order to start a business. In return, the company who licenses their assets may receive a royalty or a fee from the entrepreneur.  Franchising shows the power of licensing intellectual property in the modern economy.  Intangible assets such as know-how, supply chain, methods to find a physical location, and the goodwill associated with a particular brand can be readily packaged and distributed worldwide. It makes possible, for better or worse, the precise application of a successful business model throughout the world.  It also maintains control of the intellectual property with its owners – thereby allowing only the licensee’s conditional use of it.

In technical fields, intellectual property licensing is also powerful. An individual inventor can spend decades perfecting a new process and years seeking a patent to protect it.  She can then identify a company that would benefit from the process and license that company the right to use her patents (while still retaining ownership over them). A patent license further provides the basis for the inventor to provide additional know-how. The license is the transaction whereby the inventor fundamentally transfers the ability to use the technology to the licensee.

There are, however, many considerations an inventor must take into account when licensing his intellectual property. One critical issue is exclusivity: does the company getting the license have only the permission to use the intellectual property or can they exclude others from using the intellectual property? Exclusivity fundamentally changes the nature of the license.  If the inventor of the new process can broadly apply it to a number of competing business, she may be able to non-exclusively license it to each competitor or she could license it to just one competitor exclusively.  Each warrants different terms: an exclusive license needs to capture the whole value of the intellectual property where the rights holder can convey multiple non-exclusive licenses.

AgreementIn addition to exclusivity, another license consideration can be field-limitations.  A franchisee may own the franchise rights for an entire geographical region; such as the license may convey exclusive rights but only for a specific city or state. Similarly, a musician may record a song and license it for many different uses – an advertising company may have exclusive rights to use the song for commercials, a sports team may have exclusive rights to use it during the pre-game show and multiple production companies may have non-exclusive rights to play the song during films and television shows. As with any contract, field-limited licenses need to be specific in defining the field.  Does a license to use a song for television shows include home video reproductions of the show? Does it include web-only broadcasts?  Careful drafting on fields and other definitions of intellectual property licenses is critical for the rights holder to maximize the value of her intellectual property.

Efficient Commercialization of Intellectual Property is Critical

Intellectual property licensing is more than a way for intellectual property holders to obtain value for their patents, copyrights and other intellectual property. It is a means to transfer not only intellectual property, but all of the intangible value that goes with it. In an increasingly specialized marketplace, efficient means to transfer intellectual property and the associated know-how is critical for innovation to benefit the economy.

 

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