While February is a little late for New Year’s resolutions, we’re still early enough in 2025 that we can look ahead to the rest of the year and anticipate what’s to come. With that in mind, I have five predictions for what lies ahead in our fight to restore integrity to the patent system.
Here are I-MAK’s five patent predictions for 2025:
Merck will product hop Keytruda and launch a different version of the drug
Last year, I testified in a Senate HELP hearing that Merck would not leave billions of dollars on the table by allowing real biosimilar competition for Keytruda to appear when its primary patents expired. At the same hearing, Merck CEO Robert Davis misled Senator Ben Ray Lujan (D-NM) during questioning, revealing Merck’s plan to switch patients from an IV (intravenous) version of Keytruda to subcutaneous (under the skin) version. During a J.P. Morgan Healthcare Conference last month, Davis reassured investors that Merck will subvert biosimilar competition by shifting patients to the subcutaneous version before competitors enter the market. “We expect to be able to see adoption of about 30% to 40% of all Keytruda [patients],” he said. Merck’s Keytruda product hop may also allow the company to escape the Inflation Reduction Act’s Medicare Drug Price Negotiation Program on the grounds that the subcutaneous form includes an additional ingredient, berahyaluronidase alfa, which could entitle it to a new FDA exclusivity period. Keytruda is one of the most profitable drugs in the world. Members of Congress who want to be recognized for reining in drug prices would be wise to scrutinize Merck’s blatant abuse of the patent system.
There will be a strong industry push for a new USPTO Director who prioritizes corporate interests over the public good
The revolving door of the USPTO has been well-documented in the past, especially under the last Trump Administration. The pharmaceutical industry will recommend another director willing to grant unnecessary patents and loosen regulations, all under the guise of promoting “innovation” by arguing that more patents equals more progress for the United States. If the industry succeeds, the new director, once appointed, will likely continue to use his/her discretion to dismiss patent challenges at the Patent Trial and Appeal Board (PTAB), especially those from generic drugmakers, in order to favor large corporate interests.
PhRMA will try to keep Congress focused on Pharmacy Benefit Manager (PBM) reform
Even though President Trump once accused the pharmaceutical industry of “getting away with murder,” a Public Citizen report found that his first term ended up following the lead of a “five-point plan” created by the Pharmaceutical Research and Manufacturers of America (PhRMA), which shifted scrutiny from drug companies and placed the blame on PBMs. This year, reports concur that the industry is pushing hard to keep President Trump and Congress focused on PBMs. In doing so, the industry can continue abusing the patent system with impunity.
Senators Coons and Tillis will continue to promote legislation that gives power to the pharmaceutical industry
Senators Chris Coons (D-DE) and Thom Tillis (R-NC) are two of the biggest recipients of pharmaceutical industry campaign contributions. Those contributions have paid dividends over the years, as both Senators have been relentless in their attempts to advance dangerous industry-friendly legislation like the PREVAIL Act and PERA. Unfortunately, I think these bills are going to resurface in this Congress. While several Democrats supported one of these industry giveaways at the end of last year, they must now prove to Americans that they will serve the interests of their constituents, not pharmaceutical companies.
There will be an increase in patent applications, inflated by AI and patent thicket strategies.
We have already seen artificial intelligence tools being adopted by practitioners within the patent application workflow as well as by patent examiners, so much so that the Patent Office has been developing new guidance on the issue. With the rapid developments in AI and the promise of profitability, we’re going to see an increase in the number of patent applications discovered using AI. There’s no doubt that the industry will exploit this by flooding the Patent Office with applications to strengthen their patent thickets. We know the industry already files numerous sham patents. With AI tools, this process will be easier and cheaper to do than ever.
Despite some of the challenges ahead, patent reform will remain as the key to solving the drug pricing crisis. This year, we will continue to shine a light on the root cause of high drug prices, like we did in this recent campaign with Politico. In the coming months, we’ll be publishing groundbreaking reports that show how the pharmaceutical industry’s financialized business model is a driver of patent abuse, and the harm it is causing to patients.
We can’t predict the future with certainty but I can guarantee you this: the pharmaceutical industry will stop at nothing to protect its ability to abuse the U.S. patent system—and I-MAK will not back down from exposing them.
In solidarity,
Tahir