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The unpredictability inherent to biological systems poses singular obstacles for biotechnology patents regarding the satisfaction of the enablement and written description requirements.
Although the clinical application of induced pluripotent stem cells is still in its infancy, the development of iPSC technologies reflected by an increasing number of patents provides hope that they will realize their therapeutic potential.
Administrative patent review procedures are an effective way of correcting erroneously granted biologic patents and may help promote timely drug competition for the benefit of patients and the US healthcare system.
Intellectual property safeguards should be more widely incorporated into the bilateral contracts that underpin the translational R&D process to preserve the public interest, especially where public funds and resources have spearheaded the innovation process.
More can be done to diversify the AI innovation ecosystem, especially in the emerging field of biotechnology AI, where women’s participation is associated with substantial value.
Policy changes are needed to ensure that Cooperative Research and Development Agreements and patent applications filed by the US National Institutes of Health are aligned with the interests of the American public.
Novel beneficial traits in agricultural microbes represent inventive steps of nature, but the inability of patent laws to reward nonhuman inventors has led to conflicts over microbial ownership rights and presents barriers to the sharing of benefits.
The COVID-19 pandemic brought mRNA vaccines to market in a short period, pointing the entire drug development field in the direction of mRNA treatment.