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HGC Urges UK to Review Biomarker Patent Policies

NEW YORK (GenomeWeb News) – The UK needs to start developing a plan to review its policies and practices regarding DNA and biomarker patents and how these programs are monitored and managed, according to a new report issued by the Human Genetics Commission.

The HGC report, "Intellectual Property and DNA Diagnostics," urged the establishment of national strategies for reviewing IP and licensing practices covering these patents, after a symposium found that UK policies may be inconsistent and could create an uncertain environment for businesses and public agencies.

Based on an HGC-led seminar held last October that included private and public sector input, the report claims that there is "a profound divergence between a commercial diagnostics sector intent on exploiting the financial value of biomarker patents and a public sector laboratory community that routinely infringes such copyrights."

Somewhere in the middle between these public and private interests, according to HGC, is the academic research community, "who continue to patent publicly-funded biomarker discoveries in the hope of capturing their commercial value."

The seminar and the report were charged with reviewing how IP is inhibiting and benefiting research in DNA diagnostic innovations and patient access, whether there is a consensus of what a fair framework for the IP environment should look like, and how developments could impact this field in the UK.

Alastair Kent, chair of the HGC's Monitoring Group on Intellectual Property, said in a statement Friday that the seminar "identified conflicting views on intellectual property and advances in genetics," and found that the DNA patents debate is "extremely complex."

The report generated four recommendations for further review, study, and development.

First, the report proposes that the UK's research councils and other major research funders, such as the Wellcome Trust, Cancer Research UK, and the British Heart Foundation, conduct a review of their guidelines on licensing.

The HGC also advises that the UK Department of Health (perhaps in concert with other departments) should establish a function for monitoring biomarker IP. This office would gather and analyze evidence on the impact of current policies on the incentives for public and private sector biomarker-based innovation. It also would encourage private sector IP holders to contribute genetic data to public databases, and it would develop guidelines for out-licensing and in-licensing IP by the public sector.

According to the HGC report, NHS also should also support development of capacity at the national level to manage biomarker patenting issues.

The report found that the development of new polygenic tests that can be used in a range of applications, as well as the arrival and implementation of new companion diagnostics and whole-genome sequencing are making it necessary to generate more evidence to address the "many unknowns in this area."

The HGC also recommended that more independent evidence is needed on the ways that biomarker IP may affect new diagnostic innovations.

"An appropriate forum and process will be required that provides time for detailed deliberation and an assessment of the divergent needs and preferences of a range of stakeholders," HGC advised.

"In recent years, the area of personalized medicine and molecular diagnostics has greatly expanded," Berwyn Clarke, CSO and Founder of the UK-based diagnostics firm Lab21 and a contributor to the seminar, said in a statement Friday marking the release of the report. "Respect for IP and complying with the regulatory framework for IVD clinical testing is critical in supporting investment and encouraging the development of high-class diagnostics in the UK market."

The HGC report noted that Clarke suggested that IP infringement in the UK is problematic, particularly in regards to the NHS.

For example, Lab21's license agreement for BRCA IP with Myriad Genetics "isn't worth the paper it's printed on," for commercial purposes, because NHS labs are infringing that and other patents, the HGC report noted in its summary of Clarke's presentation.

The HGC suggested that while patents have not been enforced strictly against NHS, that situation is likely to change in the future.

According to HGC, the seminar included much discussion about how patent procedures in the US are "far less complicated than they are in Europe," and that "widespread public sector infringement" of biomarker IP in Europe was beginning to make the EU less attractive for diagnostics companies. The UK may be suffering the same problem as Europe, the report suggested.

HGC quoted one unidentified business representative as saying, "If you are developing a new biomarker there is absolutely no incentive to filing IP in the UK because you know good and well that the public sector is just going to walk all over it and do what they like anyway."