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The conflict between genetic diagnostic test makers eager to recoup development costs through patent protection and patient groups seeking broader access to the tests resurfaced during the first of two hearings required by the patent law overhaul enacted in September. The hearing was held by the U.S. Patent and Trademark Office (USPTO) and is required to study how to ensure availability of confirming genetic diagnostic tests where gene patents and exclusive licensing for such tests exist. The final report is due June 16. Industry advocates oppose government efforts to force them to ensure independent second opinion genetic diagnostic testing, calling that an unlawful infringement of their patents. Patient advocates oppose the patenting of genes and genetic diagnostic tests, saying the resulting patent monopolies harm patients.
Do you think regulatory agencies should be required to provide stronger evidence of the clinical effectiveness of cancer drugs, including a greater emphasis on patient survival time?
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