Welcome to the Week in Review.
New USPTO Proposal Could Undermine Biosimilar Competition
The United States Patent and Trademark Office (USPTO) is considering a new rule that would make it harder for biosimilar manufacturers and patient advocacy groups to challenge drug patents through the Patent Trial and Appeal Board (PTAB) — a process that is faster and more cost-efficient than lengthy court battles. Increased competition through the introduction of generic drugs and biosimilars into the market is one of the most effective tools for lowering the price of prescription drugs, but the difficulty of challenging bad or frivolous patents is one of the biggest barriers to getting these drugs onto the market. Between May and September of this year, the USPTO denied 60% of PTAB challenges, tripling historical rates. If finalized, the new proposed rule would make those denials standard practice. That shift would extend drugmakers’ monopolies and keep prices high for longer, particularly for biologics, which make up just 2% to 5% of prescriptions but accounted for half of all pharmaceutical company revenue in 2024. With patients depending on affordable alternatives, maintaining a strong and accessible PTAB process is critical to protecting competition and ensuring lower prices for consumers. P4AD will be submitting comments urging the USPTO to protect access to this process. — [HealthAffairs, Health Affairs Scholar, GoozNews, KFF Health News]
Fake “Patient Advocacy” Group Backs PERA and Drug Monopolies
A new letter from The Alliance for Aging Research (AFAR) is circulating in support of the Patent Eligibility Restoration Act (PERA), a harmful bill that would broaden what can be patented, allowing drugmakers to claim new protections for minor tweaks to existing drugs. It’s no surprise who’s behind the push. Despite its branding, AFAR is a pharma-funded front group that P4AD exposed in a report earlier this year. They receive significant funding from industry-tied donors in exchange for doing their bidding on Capitol Hill, most recently by supporting the harmful EPIC Act that would undermine Medicare Negotiation. The industry’s renewed promotion of PERA is a last-ditch effort to secure another handout before lawmakers head home for the holidays. — [Congress, P4AD, P4ADNow, Economic Liberties]
GLP-1 Prices Are Driven by Corporate Strategy, Not Patient Impact
After Trump announced deals to bring Novo Nordisk and Eli Lilly’s blockbuster GLP-1 drugs to TrumpRx at discounted prices, Novo quickly moved to undercut Lilly by dropping its own prices even earlier through its direct-to-consumer website. For patients paying cash directly to Novo, Ozempic and Wegovy will cost $199 for the first two months before rising to $349 — the same price point planned for TrumpRx. This response is a critical reminder: these companies can lower their prices at any time, because the list prices for GLP-1s bear no relation to their production costs – Ozempic costs only $5 to manufacture. While the recent voluntary deals we’ve seen do have the potential to save money for a select group of patients, they rely on the goodwill of drug companies and therefore can be taken away at any time. We need system-level reform to ensure lower prices for all Americans, not just for patients covered by a one-off deal or a temporary competitive maneuver. — [CNN, The Hill, Axios, Endpoints News]
DC District Court Rejects Teva Pharmaceuticals’ Challenge to Medicare Negotiation
Yesterday, the U.S. District Court for the District of Columbia rejected Teva Pharmaceuticals’ challenge to the Medicare Drug Price Negotiation Program — marking the 16th defeat against the industry’s nationwide legal campaign to prevent the law from lowering prices. Teva manufactures Austedo and Austedo XR — used to treat involuntary movements associated with Huntington’s disease and tardive dyskinesia — which are included in the second round of negotiation. The deadline for the second round of lower negotiated prices to be announced is November 30th. The court dismissed both Teva’s Fifth Amendment argument as well as the company’s attempt to challenge the law’s grouping of multiple products under a single negotiation unit. Austedo and AustedoXR share the same active ingredient and differ only in delivery mechanism, undermining the company’s claim that the drugs should be treated as separate. The ruling reaffirmed the constitutionality of the historic medicare negotiation program, which is supported by more than 80% of Americans. — [DC District Court, AV]
New Public Citizen Report Exposes Pharma Lobbying
A new report from Public Citizen has revealed the scale of Big Pharma’s lobbying campaign to undermine the Medicare price negotiation program. The analysis found 545 lobbyist-client relationships tied to the ORPHAN Cures Act, EPIC Act, and MINI Act. The findings come as PhRMA reported spending a record-breaking $30 million in the first three quarters of the year. For an industry that continues to claim it can’t afford lower prices, pharma continues to prove it has no trouble paying to protect its profit machine and undermine the will of the American people. — [Washington Post, Public Citizen]
ICYMI
P4AD’s Merith Basey and Fairmark Partners LLC’s Michael Lieberman joined the McGill Journal of Law and Health podcast to discuss pharma’s ongoing legal crusade against drug price negotiations, and how patient advocates are fighting back. You can listen to their conversation here.
Patient Advocate Spotlight: John Aadland
Background: Patient advocate living with COPD in Central Point, OR.
Drug: Trelegy ($300 per month)
In her words: “Even with insurance, my Trelegy prescription costs me more than $300 a month. This forces me to have a friend in Mexico buy it for me at less than a quarter of the price I have to pay here in the United States. A lower price on the medication would allow me to buy it here in the U.S. and avoid the workarounds to be able to access my medication.”
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