Selected Developments in Biotechnology Law and the Biotechnology Industry

Abstract

Biotechnology Law ReportVol. 42, No. 1 News BriefsFree AccessSelected Developments in Biotechnology Law and the Biotechnology IndustryBy Steven J. ZweigBy Steven J. ZweigSteven J. Zweig is the Managing Editor of Biotechnology Law Report.Search for more papers by this authorPublished Online:15 Feb 2023https://doi.org/10.1089/blr.2023.29299.sjzAboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail WHITE HOUSE REQUESTS PUBLIC INPUT ON BIOTECHNOLOGY AND BIOMANUFACTURINGBy the time you read this News in Brief, the Biden White House's Office of Science and Technology Policy (OSTP) will have received and be considering public comments on how biotechnology and biomanufacturing can help the nation reach “goals that were previously out of reach” as well as regarding “what steps can be taken to ensure we have the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy.” The Administration had launched a US $2 billion biotechnology and biomanufacturing initiative in mid-September 2022, with the goal of “lower[ing] prices, creat[ing] good jobs, strengthen[ing] supply chains, improv[ing] health outcomes, and reduc[ing] carbon emissions.” The OSTP called for public comments about this initiative, which comments were due by January 20, 2023.SAUDI ARABIA HOSTS SECOND RIYADH GLOBAL MEDICAL BIOTECHNOLOGY SUMMITJanuary 25, 2023, Saudi Arabia will host a two-day medical biotechnology summit in its capital city of Riyadh. The summit, which takes place under the aegis of Crown Prince Mohammed bin Salman, is part of the Kingdom's Vision 2030 national development agenda, which seeks to diversify the petrostate's economy beyond oil: petroleum currently accounts for nearly half (42%) of gross domestic product (GDP) and a stunning 87% of the government's budget.1 While the nation has been doing well economically based on strong oil prices,2 such a reliance on a single industry sector creates an obvious vulnerability: a decline in demand for oil or in oil prices, or an increase in the cost of oil extraction or production, would be devasting. Hence the interest in diversification, with biotechnology seen as a particularly promising industry. The goal of the summit, which brings together stakeholders from industry and academia, is to create a “Riyadh Declaration for Biotechnology” to help transform Saudi Arabia into a global biotech hub and establish global partnerships.BELATED BUT WELCOME APPROVAL FROM CHINA FOR GM CROPSChina recently approved importation of eight genetically modified (GM) crops; this permits, among other things, the importation of GM alfalfa for the first time in a decade. The long-overdue approval was welcomed by seed manufacturers: China's extremely slow approval process not only impacted sales directly to China but also has a ripple effect elsewhere because as China is one of the world's largest agricultural markets, what is—or is not—approved for sale to China has an outsize impact on the allocation of product development and production.3The approvals are only for importation of GM crops as animal feed; China's enormously cautious approach to GM technology still does not permit GM food crops for humans. But the approvals nonetheless are “a positive step towards resolving the longstanding challenges biotechnology developers face in obtaining import approvals in China,” according to the Biotechnology Innovation Organization (BIO) in Washington, the world's largest biotech trade association. China's approval makes possible larger-scale plantings of the approved crops in areas—such as several western U.S. states—which supply export markets and the U.S. government has in fact hailed the approvals as good news for U.S. farmers.Hopefully, these approvals are but the harbingers of more frequent or rapid approvals: China had promised to speed access to its markets under the Phase 1 trade deal it entered into in 2020 with the Biden Administration. Speeding market access can function as a goodwill gesture to offset problems in China-United States caused by clashing geopolitical ambitions.In addition to U.S. agriculture—and the seed companies which supply it—other winners from the recent round of approvals include Brazil (GM sugar cane approved) and domestic Chinese developers of GM crops.U.S. BIOENERGY FUNDING OPPORTUNITIES TO COMEThe U.S. Department of Energy (DOE) intends to issue two funding opportunity announcements (FOAs) for the production of biofuels and bioproducts in early 2023. The planned FOAs are (at least at presently) titled, respectively, “Reducing Agricultural Carbon Intensity and Protecting Algal Crops (RACIPAC)” and “2023 Conversion R&D.” Their intention is to foster sustainable use of domestic biomass (including waste) to produce biofuels and other bioproducts, supporting the Biden Administration's dual related goals of increasing the percentage of energy needs met by clean energy while reducing emissions.The RACIAPC FOA is aimed at reducing the agricultural carbon footprint with “smart” agricultural practices for low-carbon-intensity feedstock and the protection of algae crops. The 2023 Conversion R&D FOA seeks to support technologies for the conversion of domestic lignocellulosic biomass4 and waste resources into biofuels and bioproducts to, again, reduce the carbon footprint. Both FOAs are in the service of meeting the “Sustainable Aviation Fuel Grand Challenge”5 of reducing aviation emissions by a fifth by 2030 and having 100% of U.S. domestic aviation fueled by sustainable aviation fuel by no later than 2050.BIONTECH MOVES TO INVALIDATE CUREVAC MRNA VACCINE TECHNOLOGYBioNTech has brought a motion in the German Patent Court to invalidate a competitor's (CureVac's) 2010 patent for mRNA vaccination technology. The January 2023 motion is a response to CureVac's 2022 patent lawsuit by CureVac. In its motion, BioNTech argues that CureVac's patent should never have been granted because its subject matter is not based on an inventive step. The CureVac lawsuit to which the motion is a response was one in which CureVac sought “fair compensation” from BioNTech and two of its subsidiaries for alleged infringement of CureVac's intellectual property rights—a claim which BioNTech vociferously denies, asserting that its work was original and that “We will vigorously defend it against all allegations of patent infringement.”1 https://www.cia.gov/the-world-factbook/countries/saudi-arabia/#economy2 https://www.imf.org/en/News/Articles/2022/08/09/CF-Saudi-Arabia-to-grow-at-fastest-pace3 By way of analogy: the author used to work in K-12 educational publishing, where he learned that Texas educational standards influence school books sold in all 50 states: as the largest centralized U.S. educational market (California decentralizes textbook purchasing decisions to a much greater degree than Texas), school books have to take cognizance of Texas standards since if you can't sell to Texas, the book may not be worth publishing. For another example, consider the fact that California, as the U.S.'s largest car market, influences auto safety, emissions, and gas mileage standards for cars sold in all 50 states. Any large market in any industry segment influences product development and production decisions outside that market.4 Basically, material from woody plants.5 https://www.energy.gov/eere/bioenergy/sustainable-aviation-fuel-grand-challengeFiguresReferencesRelatedDetails Volume 42Issue 1Feb 2023 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:By Steven J. Zweig.Selected Developments in Biotechnology Law and the Biotechnology Industry.Biotechnology Law Report.Feb 2023.1-2.http://doi.org/10.1089/blr.2023.29299.sjzPublished in Volume: 42 Issue 1: February 15, 2023Online Ahead of Print:February 2, 2023PDF download