FTC stance on FDA-listed patents is harmful overreach

Biotechnology Innovation Organization (BIO)

November 21, 2023

We spoke to a BIO expert about how the Federal Trade Commission (FTC) is creating uncertainty around biotech patents. Plus, meat and dairy emissions are on the rise—but biotech has a few solutions to combat methane and create lower-carbon alternatives. (602 words, 3 minutes)

FTC stance on FDA-listed patents is harmful overreach, says BIO

The Federal Trade Commission (FTC) is swerving into the Food and Drug Administration's regulatory space, causing unnecessary instability by questioning patent listings, according to a BIO expert.

The background: Since 2005, BIO and drug makers have asked FDA for regulatory clarity on the category of patents that includes drug delivery devices, like inhalers and EpiPens. FDA held public consultations on how these patents are listed in the FDA “ Orange Book,” but has yet to act.

FTC stepped in two weeks ago, writing to 10 companies to challenge 100 patent listings and threatening legal action. The FTC said in a press release that unclear patent listings can delay market entry of generics.

FTC’s approach creates uncertainty about patents, negatively impacting investment and making it harder to support investment in new medicines, said Hans Sauer, BIO’s VP for Intellectual Property.

The approach is also unneeded: “Ironically, some of the exact same companies that have asked the FDA for clarification without receiving an answer for 18 years are now being threatened with enforcement by the FTC,” said Sauer.

BIO’s view: “What is needed at this point is not the threat of enforcement or legal liability, but rather increased regulatory clarity,” Sauer wrote in comments to the FTC. “BIO would be pleased to engage in further dialogue with the Commission about this ongoing work.”

Read more in Bio.News.

More Health News:

Reuters: Researchers return to Alzheimer’s vaccines, buoyed by recent drug success
“Clinical trials are underway or completed for at least seven Alzheimer’s vaccines designed to harness the immune system to rid the brain of the disease-related proteins beta amyloid or tau, a review of the U.S. government’s ClinicalTrials.gov database found. More are on the way.”

Food has an emissions problem – but biotech can help

“Disclosed emissions from the world’s 20 largest publicly-listed meat and dairy companies rose 3.3% from 2022 levels, according to a report by investor network FAIRR Initiative,” reports Bloomberg—another reminder to advance biotech for food and agriculture.

The big picture: The food industry accounts for one-third of global greenhouse gas emissions—with livestock’s methane emissions accounting for 14.5% of emissions, says Bloomberg.

What we need to do: Food and agriculture needs to cut emissions by 3% each year between 2020-2030, says Science-Based Targets, a UN-backed initiative to reduce corporate emissions.

Biotech has solutions for livestock methane—notably, feed additives that can reduce methane emissions from cow belches by as much as 85%. But U.S. regulations treat feed additives as drugs, meaning they must wait 3-5 years to hit the market, something BIO’s working to change.

Biotech is also advancing plant-based alternatives—using precision fermentation and machine learning to develop plant-based cheese and meat with similar taste and texture but reduced environmental impact.

How about “upcycling” dairy products? Ginkgo Bioworks announced a partnership with Foremost Farms to find new uses for dairy co-products and contribute to reducing the industry’s overall footprint.

What BIO’s doing: Already a member of Agriculture Innovation Mission (AIM) for Climate, an initiative of COP26, BIO will head to COP28 in Dubai to ensure biotech solutions for agriculture and climate change have a seat at the table.

Correction: Yesterday’s Good Day BIO implied the Farm Bill was extended through January 19, 2024. Appropriations for USDA and FDA go through January 19 as part of the new CR, but the Farm Bill is extended through September 30, 2024.

BIO Beltway Report

President Biden’s Tuesday: Holding a meeting at the White House about efforts to counter the flow of fentanyl. He’ll head to David Rubenstein's home in Nantucket for Thanksgiving with family, per the Daily Mail.

What’s Happening on Capitol Hill: Lawmakers can head home for the holiday, with no official activity scheduled for the rest of this week.