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Abbreviated regulatory approval pathways for biosimilars were created to accommodate intellectual property protection, foster competition and lower drug prices, but their success in achieving these goals has been mixed.
Voluntary pledges to make intellectual property broadly available to address urgent public health crises can overcome administrative and legal hurdles faced by more elaborate legal arrangements such as patent pools and achieve greater acceptance than governmental compulsory licensing.
The interaction between patents and FDA’s De Novo and 510(k) regulatory pathways has the potential to threaten follow-on innovation for medical devices.
Obtaining patent protection for microbiome therapeutics has been affected profoundly by the US Supreme Court decisions in Myriad and Mayo, which redefined the scope of which natural phenomena, including microbiome therapeutics, are patent eligible.
Bioprinted 3D and 4D tissues and organs are expected to revolutionize the biomedical field, eliminating the need for laboratory animals, but little is known about the future impacts of these technologies on drug development.
Patent law’s existing public policy exclusion should be reinterpreted and a new method introduced for assessing the moral and public policy implications of commercializing emerging technologies.
What impact have Mayo and Vanda had for applicants attempting to obtain patent protection for inventions involving methods of diagnosis and methods of treatment?