Dec 2022: Year in Review – Historic Progress on Patent Reform

29 Dec 2022

As 2022 winds down, we think it’s important to look back and reflect on a year where our fight to reform the broken drug patent system took some historic steps forward. Over the last 12 months, bipartisan calls for action around the patent system heated up just as the federal government made the first serious steps on addressing drug pricing. Meanwhile, we saw a surge in public understanding of patents’ place at the heart of America’s drug pricing problem.

Of course, this year wasn’t all progress. Despite the growing recognition of the role patents and IP play in blocking competition and access, June’s WTO decision on the TRIPS waiver shows how much work there still is to do. After a year and a half of wealthy countries and industry denying that IP/patents were a barrier to Covid vaccine access before later moving the rhetorical goal posts, the WTO members agreed to a watered down deal. As I told Inquiry, it fell tragically short of what was needed.

To put all the gains our movement made in perspective, we put together a timeline of all that’s happened.

This year showed us that people from all across the political and ideological spectrum understand that patent abuse is a problem and that it’s driving devastating drug prices. Our work next year is to take that momentum and turn it into real, substantive change.

We look forward to updating you on that progress in 2023.


Our Steps Forward in 2022

February: A Blueprint for Strengthening Competition
We started the year by launching our “Strengthening Competition” policy blueprint, a result of our Participatory Changemaking process. The blueprint gave policymakers 10 ways to promote lower-cost competition for brand-name drugs, facilitate greater collaboration between federal agencies, and ensure American families can access the medicines they need.

April: The New York Times Says “Save America’s Patent System”
In a watershed moment, the New York Times Editorial Board said, clearly and with conviction, that it’s time to reform the U.S. patent system. Many of the Board’s recommendations – raising the bar for what gets a patent, bringing impacted communities into the system, increasing interagency collaboration – were right in line with I-MAK’s priorities for action.

April: Human Rights Watch Calls Out Patents’ Role in Shameful Insulin Pricing
In their bombshell report on insulin affordability, Human Rights Watch directly pointed to patents as a “driver of the high prices for analog insulin in the US.” The report echoed many of our calls for reform, including limiting the ability of secondary patents and authorized generics to impede entry of generic competition.

June & July: Bipartisan Legislators Call on the USPTO 
This summer, patent reform provided something we rarely see in our era of historic political polarization: real bipartisanship.

  • First, a group of six Senators (three Republicans and three Democrats) requested USPTO Director Kathi Vidal take on patent thickets.
  • Next, three high-ranking Senators asked the FDA and PTO to create an interagency task force to boost coordination (a key recommendation from our Strengthening Competition policy blueprint).
  • Finally, Senator Warren and Congressman Doggett led 100 House and Senate members in writing a letter urging Health and Human Services Secretary Xavier Becerra to “waive patent monopolies and assure reasonable drug prices.”

July: The USPTO Responds to Biden’s Promoting Competition Executive Order
Almost exactly a year after President Biden’s executive order called for more economic competition – and called out patents’ role in the drug pricing crisis – Director Vidal responded. In her letter, Director Vidal acknowledges that “our patent system must not be used to unjustifiably delay generic drugs and biosimilar competition beyond that reasonably contemplated by law,” before going into detail about proposed collaboration between the PTO and the FDA.

August: The Inflation Reduction Act Scores A Historic Win
As a capstone to a multi-year investigation into skyrocketing drug prices, the Biden Administration passed the Inflation Reduction Act. While the IRA doesn’t go far enough in addressing the damage done by pharma’s bad acting and leaves its abuse of the patent system untouched, it was a major victory for payers and patients and one that wouldn’t have been possible without the courageous leadership of the late Congressman Elijah E. Cummings.

October: Overpatented, Overpriced – New Data on the 10 Top-Selling Drugs
In October, we released a new report and a first-of-its-kind database detailing how excessive patenting is extending monopolies and driving up drug prices. Featuring an analysis of the 10 top-selling drugs and a database containing every single patent filed on them, we shed new light on the immense need for policy change.

December: Warren and Jayapal Double Down
Senator Warren and Senator Jayapal followed up on their action this summer, writing the USPTO again and urging it to do more to aggressively combat patent abuse. To quote them directly: “we have ongoing concerns with the high cost of prescription drugs in America and the persistence of anticompetitive abuses of our patent system.”

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