The drug developed from a long collaboration between CFF and Vertex, including funding from both institutions. Impact of gene patents and licensing practices on access to genetic testing and carrier screening for Tay-Sachs and Canavan disease. 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. Author manuscript; available in PMC Nov Some variants do not cause CF symptoms; others are quite severe.

Discussions with several other non-licensed companies are currently ongoing, suggesting that enforcement issues are always present with any patented technology. Managing Innovation for a Better World. 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: Bureau of Labor Statistics predictions by ? Standards of care are published statements that describe the level of care that the client with cystic fibrosis or other diseases can expect from nurses. Licensing strategy developed for the CFTR gene patent The licensing strategy developed by the U of M and the HSC had a three-pronged approach intended to satisfy the needs of key stakeholders.

Not much was known about whether a potential protein-based therapeutic could be developed, since the function of the CFTR gene was not yet known, other than hints it was an ion channel for chloride.

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

Furthermore, if a patient advocacy organization lacks the monetary resources required to fully fund the initial stages of therapeutic research and to cover the cost of sub-licensing, then this licensing strategy might not be as successful as it has ffibrosis for the CFTR patents.

Assess Debbie and the child that received the wrong medication. GD mutation who are over 6 years old, although it is now being tested for other uses and in children as young as 2.

Therefore, patenting made sense to the scientists, their nonprofit institutions, and disease advocacy groups. Population variation of common cystic fibrosis mutations. The child will be able to remove mucus from the airway by coughing. We have a quiet room you can use that is private and close by.


The optimal test approach might depend in part on mutational complexity that was not known when the patent application was filed.

Please review our privacy policy. The ethics of patenting DNA.

hesi cystic fibrosis case study

The job growth rate for RNs will surpass job growth in …. Companies wanting to develop CF therapeutics would face a long slog. Although a few companies have gone directly to the Fibdosis of M for a non-exclusive research license, the university prefers that companies work through the CFF.

Only total US patients are estimated to have the requisite mutations. See other articles in PMC that cite the hewi article. But the U of M did not want to exclusively license the gene itself, because that would block development of alternative delivery and insertion systems for gene transfer, as well as using the CFTR gene or CFTR protein as therapeutic targets.

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

This cell line is covered by a U of M patent, so if the CFF funded this type of research without sub-licensing rights, the funded company would have to apply for a license with the U of M to do their research. The sub-license fees are paid by the CFF on an annual basis, which gives them an opportunity to make sure that sub-licensees are actively working on the research project; if work ceases then the CFF stops paying the sub-license fee for that company. In order to learn more about how this successful licensing model came about, we expanded the previous case study by interviewing key players in the process: Explain the play therapy is an intervention and should not be interrupted for vital signs.

Food and Drug Administration FDA approval, companies researching therapeutic options would want some form of exclusivity to protect those long-term, large investments. A client is diagnosed with Cushing syndrome.

hesi cystic fibrosis case study

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 1breast and ovarian vs.

Wide access to genetic testing and screening made it easier for states and hospitals to implement newborn screening programs; earlier detection of CF meant that patients could be started on nutritional supplementation sooner; and medical care providers could more aggressively intervene to prevent lung infections, a leading cause of death among CF patients.


In order to learn more about how this successful licensing model came about, we expanded the previous case study by interviewing key players in the process:. An early diagnosis is the first step in effectively managing the disease, and genetic testing has been used in carrier screening, prenatal genetic testing, and diagnosis. Community resources often provide support groups for parents of children with CF.

Cystic Fibrosis Patents: A Case Study of Successful Licensing

David is concerned that his wife is going to leave him. Cook-Deegan R, Heaney C. DiSante recalls that they only had 2—3 days to complete the patent application so that it could be filed before they could publicly confirm that the gene had been identified.

The CFF was founded in and has grown to become a savvy non-profit organization with the staff and resources required to take on the administrative burden of sub-licensing; not all diseases have such sophisticated patient advocacy organizations with the resources to take on this burden. We interviewed four key players who either were involved in the initial discussions regarding the structure of licensing or who have recently managed the licenses and collected related documents.

Pediatric Cystic Fibrosis Case Study

Patenting and licensing are only a small part of the story. Which statement should the nurse record as the expected outcome for this nursing diagnosis? The development of xtudy, in particular, would require substantial investments over long periods, and might benefit from patent incentives.

Although this particular licensing strategy is currently only used by the U of M with respect to the CFTR patent, Ritchie does draw from it to help draft other licensing agreements with other entities:.