Initiative for Medicines, Access & Knowledge

A New Shot for Cancer Is Convenient, but Poised to Keep Prices High

The scheme, known as a “product hop”, will effectively allow Merck to restart its patent monopoly on Keytruda just as the 20-year monopoly on the IV version comes to an end. This is blatant abuse of the U.S. patent system.
www.nytimes.com/2025/09/19/h...

Merck is launching a patent-protected injectable version of Keytruda before biosimilars of the IV version of Keytruda enter the market.

Swipe to see reactions to the recent @nytimes.com story on Merck's product hopping scheme.

A new shot for cancer is convenient, but poised to keep prices high To keep Keytruda revenue flowing, Merck developed a new version of the cancer treatment drug, given as a shot under the skin, which the FDA approved Friday.

“Merck is just the latest in a long line of drug companies that have introduced new versions of their medicines that allow them to keep charging high prices [to patients] even as their original patents expire.”
www.seattletimes.com/nation-world...

1️⃣ Read The New York Time’s new investigation into Merck’s product hop on Keytruda.

2️⃣ Watch the video be published back in May detailing exactly how Merck is doing it.

A New Shot for Cancer Is Convenient, but Poised to Keep Prices High

@nytimes.com investigates Merck’s product hop on the cancer drug Keytruda.

“Merck has sought nearly 300 patents related to Keytruda, according to I-MAK. (Merck disputed I-MAK’s count but declined to provide a different figure.)"
www.nytimes.com/2025/09/19/h...

🚨BREAKING: The New York Times investigates Merck’s product hop on Keytruda.

We have extensive data detailing Merck’s patenting tactics on Keytruda. I will share more here soon.

A New Shot for Cancer Is Convenient, but Poised to Keep Prices High

My team at @imakglobal.bsky.social has been warning for years that Merck would game the patent system to product hop its blockbuster cancer drug Keytruda. Today, the New York Times published an investigation into the company’s tactics.
www.nytimes.com/2025/09/19/h...

Sept 2025: Two bipartisan bills target patent abuse Building a more just and equitable medicines system for all

Our September newsletter is out! In it, @tahiramin.bsky.social breaks down two bipartisan bills seeking to address patent abuse so medicines can be more affordable for patients

📄The ETHIC Act
📄The Medication Affordability and Patent Integrity Act

www.i-mak.org/2025/09/18/s...

Their findings are consistent with what @imakglobal.bsky.social uncovered in our two recently-published reports, “The Burden of Patent Thickets” and “Overpatented, Overpriced 2025.”

→ www.i-mak.org/burden-of-pa...
→ www.i-mak.org/overpatented/

Estimating Costs of Market Exclusivity Extensions For 4 Top-Selling Prescription Drugs in the US This cross-sectional study estimates excess US spending associated with delays in generic competition due to extended market exclusivity for 4 top-selling brand-name drugs that experienced new generic...

A new study in @jama.com by Dongzhe Hong, @seansst5.bsky.social‬, and Reed F. Beall looks at the cost of extended market exclusivities due to patent term extensions and patent gaming.
jamanetwork.com/journals/jam...

“History will not remember how profitable our cures were, only how many were left to die waiting for them.”

- Jonathan Lee, B.A., B.S., UC Berkeley
www.bcphreview.org/article/1412...

MedPath unpacked key findings from our latest Overpatented, Overpriced report.

📊Read our report: www.i-mak.org/overpatented/
📄Read MedPath's analysis: trial.medpath.com/news/1926871...

AbbVie’s strategy is simple: threaten competitors with drawn-out patent lawsuits to force settlement agreements that keep them off the market, all while charging sky-high prices to cancer patients.

Over the six years competitors are delayed, Americans will spend $8 BILLION on AbbVie’s branded Imbruvica.

Keeping that many competitors off the market is big business.

An FDA study found that when there are six or more generic competitors on the market, drug prices drop more than 95%.

Zydus isn’t the only competitor AbbVie bullied off the market.

Five other drug companies signed settlement agreements to delay their generic versions of Imbruvica.

Patent lawsuits can cost millions of dollars and drag on for years. Rather than face a costly legal battle against AbbVie, Zydus signed a settlement agreement to delay the launch of its generic until 2032.

When the drug company Zydus began seeking FDA approval for a generic version of Imbruvica, AbbVie asserted 18 of their 98 patents against them.

AbbVie has amassed 98 patents on Imbruvica, and is using them to bully competitors into signing settlement agreements to keep generic Imbruvica off the market.

The patent covering Imbruvica’s main compound is set to expire in 2026. When that happens, competitors *should* be able to enter the market. But that’s not what’s happening.

Imbruvica is a life-saving cancer drug marketed by AbbVie.

Its list price has climbed to $220,000 a year.

AbbVie used its patent thicket to block six competitors from launching cheaper versions of a $220,000 cancer drug.

SEN. BLUMENTHAL: Do all of you agree that reforms in the patent laws would enable lower costs for consumers?

…Yes

…Yes

…Yes

…Yes

However, the real change begins when we get to the root of the problem and address the kind of patents that are being granted in the first place.

Right now, patents are listed in the Orange Book based on an “honor system” where the FDA doesn’t review them. Like Prof. Francis explains, having the USPTO review any listed Orange Book patents is a logical step to take towards ensuring that unworthy patents aren’t delaying much needed competition.

The brand-name company then files an infringement suit against the generic which triggers a 30-month period during which the generic company cannot obtain FDA approval.

When a generic company wants to enter the market before the drug’s Orange Book-listed patents have expired, it can file a “Paragraph IV” certification stating that the patents are invalid or that they will not be infringed.

Brand-name drug companies list patents covering their FDA-approved drugs in a federal repository managed by the FDA called the Orange Book.

The 30-month stay is one of several abused aspects of the Hatch-Waxman Act. It was a concession given to brand-name drug companies, who convinced legislators it was necessary for them to have time to resolve patent litigation with the generics.