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Writing in The Hill, BIO’s Chief Policy Officer John Murphy explains how IP enables innovation and access to COVID technology. Meanwhile, BIO has joined an amicus brief against a lawsuit that questions a drug company’s decisions about the pace of drug development. (481 words, 2 minutes, 24 seconds) |
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BIO in The Hill: IP enables innovation |
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Strong intellectual property protections enable the development of new drugs while facilitating the sharing of existing COVID treatments and diagnostics worldwide, BIO Chief Policy Officer John Murphy writes in The Hill.
Catch up: In 2022, the U.S. Trade Representative (USTR) supported a waiver of IP rights for COVID vaccines at the World Trade Organization (WTO). USTR is considering a proposal to expand the waiver to COVID diagnostics and therapeutics. BIO opposed the first waiver and opposes expansion.
But here’s the thing: A U.S. International Trade Commission report (prepared at USTR’s request) says the waiver “would do immense damage to America’s high-tech industries—without delivering tangible benefits to people still battling COVID-19 around the world,” writes Murphy.
Why it matters: U.S. biotech originated nearly two-thirds of the world’s new drugs in the past decade and provides more than 3% of GDP—enabled by strong U.S. IP protections.
“Everyone benefits when innovators can be assured of the security of their IP,” says Murphy, citing how global IP protections allowed Pfizer and Merck to license production of generic versions of their COVID therapeutics in lower-income countries.
The bottom line: “Our life sciences sector wouldn’t be so robust and globally competitive without strong IP protections. That’s why the actions at the WTO are so serious and far reaching,” he concludes. Read and share the op-ed. |
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BIO argues against suit questioning drug maker’s development decisions |
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BIO has joined a “friend of the court” brief arguing against a lawsuit in California that questions Gilead’s decisions about the pace of drug development.
The background: The Food and Drug Administration (FDA) approved Gilead’s HIV/AIDS drug made from tenofovir disoproxil fumarate (TDF) in 2001, then 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, Gilead is facing a lawsuit from plaintiffs who say Gilead should have developed the second drug sooner because TAF has fewer side effects.
Why it matters: Lawyers for Gilead note the plaintiffs’ claim is unprecedented because they are not saying the product was defective. “Plaintiffs conceded the point in oral argument: TDF has ‘been beneficial’ and ‘greatly helped patients with HIV and AIDS,’” according to Gilead’s supplemental brief to the appeals court.
BIO’s view: “Plaintiffs seek to hold innovative biopharmaceutical companies making scientific breakthroughs liable for not making those breakthroughs sooner,” says an amicus brief filed by BIO and other industry groups. If courts enforced such liability, “it would be highly damaging to scientific and medical innovation, which is affected by the prospect of litigation.”
The impact: “Without sensible protections from unbounded liability, the California pharmaceutical industry might well contract, harming patients in need of innovative treatment,” the amicus brief continues.
What’s next: Gilead has appealed for summary judgment. A decision is expected in January. Read more in Bio.News. |
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President Biden’s Friday: Making his first campaign speech in 2024 in Valley Forge, PA, per CBS News.
What’s Happening on Capitol Hill: Congress remains in recess until next week. |
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