Aug 2023: Medicare Negotiation and the Momentum for Patent Reform

28 Aug 2023

It’s not hyperbole to say the last week of August has been a historic week in the fight to end America’s drug pricing crisis: Medicare announced the first 10 prescription drugs selected for its new price negotiation program.

The basic facts of Medicare negotiation alone are worth celebrating. It’s a hard-fought victory that comes after a decades-long fight and, most importantly, it will result in cheaper medicines for millions of seniors and billions in savings for the U.S. healthcare system. But, beyond those direct outcomes, this is also a potentially critical inflection point for reforming the broken patent system.

First of all, woven into Medicare’s program is an acknowledgement of patent abuse’s centrality to the drug pricing crisis. Many of the 10 drugs selected are prime examples of patent manipulation – as documented in our research on Enbrel and Imbruvica and in our Drug Patent Book database, which features every patent and patent application we could find on some of the drugs that will be up for price negotiation. In another indicator of the need to reckon with patent abuse, the Center for Medicare Services will be considering how much exclusivity companies have / could have when selecting drugs and maximum fair price (MFP).

Secondly, this takes us a step closer towards clearing up the cloud of secrecy drugmakers have created around their patenting practices. As a part of negotiations, drugmakers whose products are selected must disclose all of their relevant drug patenting data and, in the event that they resist or fail to provide pertinent information, Medicare is threatening punitive action. While this is promising progress towards stopping the industry’s intentional obfuscation of its patenting strategies, it’s also a testament to just how much has been and is being hidden from us.

Finally, Medicare winning the right to negotiate is a sobering look at just how much power we’ve let the industry accumulate. After their $400 million lobbying effort failed to stop the Biden Administration from enacting a policy that 8 in 10 Americans support, the industry has resorted to a final, desperate barrage of lawsuits and outright threats. While the industry’s threats ring hollow (drugmakers already slow-walk new medicines and, as we’ve long pointed out, prioritize incremental “innovation” over therapeutically-beneficial invention), their public tantrum should inspire policymakers to stand firm.

Medicare negotiating prices for some of the most expensive, widely-used drugs in the U.S. is important. But all of us involved in this work – from policymakers to patient advocates to industry experts – should take stock of the significance of this moment and use it as a springboard for broader structural change. That means bipartisan action on patent reform, democratizing important data, and addressing the power imbalance the pharmaceutical industry has created in its favor.

What we’re doing

With the 10 drugs that Medicare will start its negotiations with announced, it’s worth re-upping Protect Our Care’s report that used our data and analysis to highlight the impact negotiations will have on Enbrel, Imbruvica, Januvia, and Xarelto.

Against the backdrop of the industry’s threats about lost treatments, Families USA released an excellent report that cites our data in explaining how drugmakers deprioritize innovation to protect patents and profits. I felt this quote from Dr. Robert Pearl really nailed the current state of the drug development system: “In the 21st century, most drug companies have replaced moonshots with chip shots.”

I-MAK was honored to serve on the advisory committee for another important report, Liberation in a Generation’s From Big Business to a Liberation Economy: A Racial Justice Agenda for Reining in Monopoly Power. Highlighting AbbVie’s abuse of the patent system for its drug Humira, used to treat arthritis and which disproportionately impacts Black and brown people, the report shows how the co-governance relationship between the government and big business allows big business to build their wealth and create an oppressive economy  — one that negatively impacts people of color the most.

Relevant news rundown

The historic wins this month are not solely domestic. Our longtime allies at The Health Justice Initiative, led by Fatima Hassan, just won a massive victory in their lawsuit compelling the South African government to disclose the contracts it entered into with pharmaceutical companies for Covid-19 vaccines. This decision is monumental, as it sets a precedent for future pandemics and shows governments that dealings with pharmaceutical companies must be made public. It is imperative this spirit of transparency and accountability is brought to the U.S. to better inform policy around pharmaceutical and health industry practices.

New research published by our colleagues in JAMA confirms that continuation patents are being deployed more and more, as they’re now a key part of companies’ U.S. strategy for building patent thickets. It’s worth noting that the U.S. is the only country in the world that operates this particular type of continuation or continuation-in-part application system and is a major factor in why other countries access generics and biosimilars — and their lower prices — far earlier than Americans.

Meanwhile, Senator Elizabeth Warren and Representative Pramila Jayapal, two legislators who’ve stepped to the forefront of the patent reform fight, sent another letter urging regulators to address patent abuse. This time, they wrote to U.S. FDA Commissioner Califf and set out various actions the FDA can take to close loopholes that the industry exploits when listing patents with the agency in order to block generic competition. One of those suggestions includes preventing the listing of patents relating to safety and distribution programmes for a drug that are not required under current law, but which companies do in order to delay generic entry as reported recently in The New York Times.

Something Hopeful

Building on the progress in recent years of national media outlets like The New York Times, which have covered the link between patents and exorbitant drug pricing, it’s heartening to see that folks at the local level are joining in. In a Kansas newspaper, the author of this letter to the editor urges his state’s senators to support The Affordable Prescriptions for Patients Act of 2023 and references I-MAK’s report with the American Economic Liberties Project.

Let’s admit it, patent abuse and the legislative steps needed to end it can seem wonky and unapproachable. This op-ed is a great example of how everyday Americans and voters are paying attention and building grassroots energy for reform, which is a tide shift we’ve been working toward for decades.

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