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“Home-Brew” Testing: towards a non-patented innovation

3 May 2010

“Home-brew” or laboratory developed tests (LDTs) are non-patented tests (genetic as well as other types of diagnostic tests) done in a laboratory by mixing reagents and following protocols. In contrast to commercial In-Vitro-Diagnostics (IVDs), they are made in-house, by researchers and clinicians who understand the predictive power of emerging tools and rapidly translate them into the research laboratory and the clinic. However, “home-brew” tests, in contrast to commercial diagnostics, are non-patented tools. They, therefore, do not comply with the In-Vitro Diagnostics Directive (98/79/EC), which sets the basis for commercialising these devices.

Patent protection is a strong driver for private companies to develop IVDs. However, it is a disincentive for public research laboratories who have the technical expertise but, often, not the sufficient means (or willingness) to invest in a patent. It is well recognised that the aim of patenting is protecting innovation by preventing competitors from doing a similar type of activity; however, this limits the access to scientific discoveries and restricts service provision.

In the US, recently, the company Prometheus (California), who is the holder of two TPMT (Thiopurin Methyl Transferase) patents, sued the Mayo Clinic (Minnesota) for patent infringement. The Mayo Clinic was offering the same type of testing as Prometheus, with the difference that the Mayo test was a “home-brew” test (similar to the test patented by Prometheus). In response, the Mayo Clinic, with the support of the American Intellectual Property Association, claimed that Prometheus patents were based on mere observations and this only added costs to health care. Prometheus, on the other hand, claimed that denying patents could stifle innovation. The case, which arose 5 years ago, is still in the court (Marshall, 2009)

So, while the consequences of “home-brew” development seem contested when there is a commercial competitor, they may be particularly important in conditions where there is not enough market to justify a commercial development (e.g. PGx for generic drugs or orphan drugs). In cases like this, private companies are not likely to invest in a commercial test that would not attract enough market (Hogarth and Melzer, 2007). However, not even in these cases, “home-brews” are sufficiently regulated, neither at the point of development, nor at the point of delivery. For this reason, it might be necessary to strengthen the current regulatory system and establish delivery mechanisms driven by clinical utility and good medical practice, instead of only looking exclusively at the patentability of scientific discoveries.

References

HABL, C., ANTONY, K., ARTS, D. & ENTLEITNER, M. 2006. Surveing, Assessing and Analysing the Pharmaceutical Sector in the 25EU Member States. Osterreichisches Bundesinstitut fur Gesundheitswesen. European Commission. DG Competition.

HOGARTH, S. & MELZER, D. 2007. The IVD Directive and Genetic Testing: Problems and proposals. 20th meeting of Competent Authorities. Lisbon.

MARSHALL, E. 2009. Drug Metabolite Prompt Legal Battle. Science, 325.

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