The term “dormant therapy” refers to a new drug or a new biological product which was made the subject of a request for designation in compliance with the Dormant Therapies Act. According to the legislation, the assignment of dormant therapy is given to a drug or new biological product that has been determined to have insufficient

patent A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an sufficiency of disclosure, enabling discl ...

protection and meets an unmet medical need, improves outcomes, or reduces risks compared to an existing treatment. Many drugs may be abandoned due to their failure to meet a

clinical endpoint Clinical endpoints or clinical outcomes are outcome measures referring to occurrence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials. The term may also refer to any disease or sign th ...

. Over time, manufacturers wanting to re-investigate the abandoned drug will not because the

for the drug has expired or will expire prior to the completion of research and the federal approval process. Weak or no patent protection is a disincentive for drug development as it hinders a manufacturer’s ability to recoup the investment in expensive

clinical trials Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

. This disincentive is even more pronounced for treatments for more complex conditions such as Alzheimer’s, which require more clinical data than conditions which currently have existing treatments.

References

{{Reflist Clinical pharmacology