Drug Development, Test Development & Patents Linked

The value of intellectual property and even the validity and necessity of gene patents has recently been questioned.  Let's be clear: despite what some groups might suggest, gene patents do not give any company the right to own any of the genes in your body. Patents are only granted for inventions that are novel and non-obvious (e.g., the first description of a new mutation linked to a disease), and the protection afforded by a patent, which is by design and definition a short-term monopoly, simply gives a company the incentive and protection necessary to take risks and to move ahead with drug or diagnostic test development. 

Despite current disagreement about the value of gene patents, there is one fact that has never been in dispute: a bad test can be every bit as dangerous as a bad drug, and test development, like drug development, requires major resource commitment. Patents are generally required to secure funding or obtain commitment to a project within a company. The development and regulation of a companion diagnostic - the test the FDA determines must be used in order to stratify and identify patients who will benefit from a regulated drug or therapy - is rightfully getting more attention.

This move toward development of one standardized and regulated test is particularly timely and important, as pharmaceutical companies involved in clinical trials have acknowledged publically that the test results from the very biomarker tests used to include or exclude patients in their clinical trials can vary between their test centers, as each test center generally uses its own Laboratory Developed Test.

Invivoscribe holds exclusive worldwide rights (ex-Japan) to a series of issued and pending patents covering testing for the most clinically important type of mutation of the FLT3 gene. As FLT3-ITD mutations are highly determinative of outcome for patients with karyotype normal acute myeloid leukemia, we are working directly with the FDA to develop a standardized test for therapies linked to this biomarker.  Through our wholly-owned CLIA- and CAP-accredited international clinical laboratory, LabPMM, we continue to make our standardized test readily available to clinicians and patients worldwide. Once patents expire, the diagnostic community will have a single robust and reliable standardized test, ensuring that the vision and promise of Personalized Molecular Medicine is achieved: the right patient, gets the right drug, at the right time, at the right dose.