On February 24, the U.S. Patent and Trademark Office (USPTO) issued a notice in the Federal Register indicating that the nation’s patent agency was reopening the comment period related to its request for comments (RFC) on collaboration initiatives with the U.S. Food & Drug Administration (FDA). Previously closed on February 6, the comment period on USPTO-FDA collaboration initiatives is now extended until March 10. The reason stated in the Federal Register notice for reopening and extending this comment period is to “ensure that all stakeholders have a sufficient opportunity to submit comments on the questions presented” in the agency’s RFC on ways that the two agencies could cooperate to improve market entry of generic drugs and biosimilars, and to reduce the number of patent grants related to certain drugs. The reopening of the comment period comes a few weeks after the USPTO also reopened and extended the deadline for responding to the agency’s RFC on ensuring robust and reliable patent rights. As reported at that time, while it’s understandable that the agency is interested in hearing from as many stakeholders as possible, some have said the extensions are creating uncertainty as to which stakeholders are being given more time to prepare their full comments for submission.
Two major trade organizations representing global vaccine manufacturers are officially backing a proposal submitted to the G20 and G7 countries in July that they claim offers practical solutions for future pandemics to avoid the inequities that have been highlighted by the COVID-19 pandemic. The Berlin Declaration was proposed in July 2022 by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and calls on industry to commit to “reserve an allocation of real-time production of vaccines, treatments and diagnostics for priority populations in lower income countries and take measures to make them available and affordable.”
How about some good economic news? That’s in short supply these days as the nation teeters on the brink of recession, driven by raging inflation and skyrocketing gas prices. But in good times and bad, our technology transfer system created by the Bayh-Dole Act just keeps chugging along. A just released study by the Biotechnology Innovation Organization (BIO) and AUTM, which represents the academic technology management profession, shows that academic patent licensing contributed up to $1.9 trillion to the U.S. economy while supporting 6.5 million jobs between 1996 – 2020. Even more impressively, this impact increased substantially since the last survey was released three years ago. That showed an economic impact of $1.7 trillion with 5.9 million jobs supported.
The Biotechnology Innovation Organization (BIO) recently submitted comments in support of a National Institute of Standards and Technology [NIST] rulemaking on “Rights to Federally Funded Inventions and Licensing of Government Owned Inventions.” The proposed rule caps a nearly three-year effort by NIST, through engagement with stakeholders, to improve federal technology transfer and the commercialization of federally funded inventions. That effort resulted in a comprehensive Green Paper, “Unleashing American Innovation” in April 2019, which reviewed federal research efforts and made detailed recommendations to maximize the taxpayers’ return on investment.
Representative Nydia Velázquez (D-NY), Senator Mazie K. Hirono (D-HI), Senator Thom Tillis (R-NC), and Congressman Steve Stivers (R-OH) yesterday reintroduced the Inventor Diversity for Economic Advancement Act (IDEA Act), which seeks to direct the United States Patent and Trademark Office (USPTO) “to collect demographic data – including gender, race, military or veteran status, and income level, among others – from patent applicants on a voluntary basis.” Senators Chris Coons (D-DE) and Patrick Leahy (D-VT) are co-sponsors of the legislation.