A recent GEN poll about gene patenting rules related to providing second-opinion molecular tests indicate how divided people are on this topic. More voters sided with patient groups seeking broader access to genetic diagnostic tests over test makers eager to recoup development costs through patent protection. A near-majority of respondents (45.2%) called for doing away with gene patents, while another 6.5% favor creating a safe harbor for confirmatory test providers, something else sought by the patient groups. By contrast, 12.9% would require licensing of gene patents while an equal percentage wants to see alternative incentives developed. The remaining 22.6% would keep the current system as is, while no respondents were undecided—an indication of how sharply divisive the issue has become.
The conflict resurfaced during two recent hearings required by the patent law overhaul enacted in September and held by the U.S. Patent and Trademark Office (USPTO). The new patent law requires USPTO 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.