Although this licensing model may not be applicable to all gene patents, it serves as a model in which gene patent licensing can successfully enable innovation, investment in therapeutics research, and protect intellectual property while respecting the needs of patients, scientists, and public health. Eight case studies covering ten clinical conditions were published in the April Supplement to Genetics in Medicine 1 — 8. FDA approves Kalydeco to treat rare form of cystic fibrosis. The patents did not therefore produce a single-source testing service, the business model adopted by Athena Diagnostics, Myriad Genetics, and others that has been accompanied by intense controversy see case studies on genetic testing for long-QT and other cardiac channelopathies 1 , breast and ovarian vs. After ten years of working with the CFTR licensing strategy, Ritchie thinks that there is very little, if anything, that he would change about it, and that this strategy would be suitable for other universities and institutions to use: Impact of gene patents and licensing practices on access to genetic testing for hereditary hemochromatosis.

No notification letter was sent, and apparently the laboratory quietly withdrew from the market, or at least stopped advertising its CF testing service so publicly. Part of the variability in CF is due to a large number of genetic mutations that have variable effects on CFTR protein function. In the Public Interest: From — it was also co-funded by the US Department of Energy. Cystic fibrosis CF is a genetic disorder long known to be inherited as an autosomal recessive character, and to be highly variable in its severity, duration, and spectrum of symptoms.

One fibbrosis the benefits of this arrangement for the U of M is that the CFF handles all the administrative aspects of non-exclusive licenses for CFF research collaborations.

And indeed the ivacaftor model will be held up as a success only if it generates sufficient revenue to warrant future similar investments, and if its high cost does not hinder utilization. Although a few companies have gone directly to the U of M for a non-exclusive research license, the university prefers that companies work through the CFF.


DiSante was flooded with phone calls from companies interested in securing an exclusive license from the U of M. Which intervention should the nurse implement first? What are standards of care? The Language of Life: Which nursing diagnosis has the highest priority?

hesi cystic fibrosis case study

Two years later, inthe collaboration paid off: Bureau of Labor Statistics predictions by ? No notification letter was sent, and apparently the laboratory quietly withdrew from the market, or at least stopped advertising its Dtudy testing service so publicly. One group of potential licensees was clearly interested: Annu Rev Genomics Hum Genet.

The drug has only been approved for those with a p. Different license agreements between in-house diagnostic testing and kit gibrosis and sale make it possible for many hospitals and clinics to offer in-house CF genetic testing by removing the large financial barrier imposed by a high licensing fee.

Pediatric Cystic Fibrosis Case Study

Exclusive licensing is quite common as an incentive to startups, and in this case a particular vector system was covered. How about receiving a customized one? Although such a clause was not initially written into the non-exclusive license, the first licensee insisted that such a clause be added to the terms of the license agreement.

The publisher’s final edited version of this article is available at LES Nouv. NumberDecember There were 18—20 active licenses at the time of casse interview. In the United States, an inventor can publicize the discovery or invention before filing a patent application, but many other jurisdictions do not have such a grace period and any public announcement vitiates the subsequent ability to get worldwide patent protection.

There was pressure to select one of these companies for an exclusive agreement, in part because it would have been more lucrative initially. A final important factor that played into the licensing discussions was the mission of the U of M Technology Management Office. In spite of the rush to file the patent application, considerable thought and attention were devoted to constructing an appropriate licensing strategy to allow use of the Fibgosis gene sequence in various applications, including carrier screening, diagnostics, therapeutics, and research.


Cystic Fibrosis Patents: A Case Study of Successful Licensing

Impact of gene patents and licensing practices on access to genetic testing for Alzheimer disease. Which item below correctly describes the U.

hesi cystic fibrosis case study

Make arrangements to meet with Paula privately at the first opportunity. Licensing the CFTR patents was also a tool for managing the quality of genetic testing on at least one occasion 2. What action should the nurse take first?

hesi cystic fibrosis case study

Collins also donated all of his patent royalties to the CFF, rather than accepting them as personal income. Discuss the importance of playing atudy that require Debbie to do physical activity such as running, jumping, or skipping.

HESI Case Studies-Pediatrics-Cystic Fibrosis (Debbie Baker) –

The primary issue considered during these deliberations was anticipating who the potential licensees might be as well as how they might use the technology. What action by the nurse is warranted? Despite the rush to publicize an important discovery and a news leak that forced quick action to preserve world-wide patent rights, careful deliberation and engagement of key stakeholders enabled the U of M and the HSC to develop a licensing strategy that held up well over time.

Food and Drug Administration FDA approval, companies researching therapeutic options would want some form of exclusivity to protect those long-term, large investments. Patenting and licensing are only a small part of the story.