CA court to consider dismissal in Gilead case

In line with a BIO amicus brief, the California Supreme Court will consider Gilead’s request for summary dismissal of a lawsuit questioning its decisions about drug development. Plus, BIO applauds progress on the Farm Bill. (482 words, 2 minutes, 24 seconds)

California court to consider dismissal in Gilead case, in line with BIO amicus brief

In line with BIO’s “friend of the court” brief, the California Supreme Court said Wednesday it will consider Gilead’s request for summary dismissal of a lawsuit questioning its decisions about drug development.

The background: The Food and Drug Administration (FDA) approved Gilead’s HIV/AIDS drug made from tenofovir disoproxil fumarate (TDF) in 2001. FDA approved Gilead’s second drug, made from tenofovir alafenamide fumarate (TAF), in 2015.

What’s happening now: Though both drugs are effective and still in use, a lawsuit maintained Gilead should have developed TAF sooner because it has fewer side effects. Gilead will argue for summary dismissal in its appeal to California’s Supreme Court after its earlier request for summary dismissal was denied in January.

BIO’s role: California’s top court agreed with BIO’s March 12 amicus brief arguing dismissal should be considered. It was BIO’s second amicus brief in the case, which BIO will continue to monitor.

Why it matters: “Bringing a new medicine to market is a lengthy and expensive process,” said the latest amicus brief filed by BIO, with other industry groups. The possibility that decisions “will be second-guessed years later … will invariably discourage companies from investigating alternative treatments.” 

What’s next: Gilead has 30 days to file a new brief. The plaintiffs will have an additional 30 days to respond.

BIO praises Farm Bill progress and outlines priorities

BIO issued a statement yesterday commending the work being done in Congress to pass a new Farm Bill.

BIO recommended provisions to ensure the bill is innovation-centric:

• Funding for the Biobased Markets Program, which directs federal agencies to increase purchases of biobased and renewable products.
• Updates to North American Industry Classification System (NAICS) codes to enable measurement of biobased procurement.
• Incentives to help build and retrofit facilities to produce advanced biofuels, renewable chemicals, and other biobased products.
• Support for biostimulants by including the Plant Biostimulant Act (H.R. 1472) to streamline the regulation of safe, biological substances to make plants more resilient and productive.
• Support for Plant Incorporated Protectants (PIPs) with language directing the Environmental Protection Agency to reissue regulations and eliminate unnecessary and non-science-based barriers to commercializing these innovations.
• Streamlined regulation of biotechnology, with a science-based process that allows timely approvals of innovations in plant, animal, and microbial biotech.
• Increased investment in agricultural research programs to fuel ongoing innovation in agriculture and environmental technology.

Why it matters: “The bioeconomy plows nearly a trillion dollars annually” into the U.S. economy, benefitting all Americans, BIO noted.

“Congress has an unprecedented opportunity with this Farm Bill to enable continued biotech breakthroughs to ensure we can meet the world’s environmental challenges and food demands,” said Beth Ellikidis, BIO VP for Agriculture and Environment. “We urge Congress to continue bipartisan efforts to pass the Farm Bill and make the most of this opportunity.”

TODAY, May 3, is the last day to submit nominations for the George Washington Carver and Rosalind Franklin Awards recognizing leaders in agricultural and environmental biotechnology! Click here to learn more and submit your nomination today.

President Biden’s Friday: Awarding the Presidential Medal of Freedom, including a posthumous award to Native American athlete Jim Thorpe.

What’s Happening on Capitol Hill: Enjoy the weekend.