This month, Bloomberg Law exposed Merck’s plan to execute a product hop to extend its monopoly over top-selling cancer drug, Keytruda.
Here’s what they’re doing: Merck will change the way Keytruda is delivered, from an IV infusion to a subcutaneous injection. They will then shift patients to the injectable version of Keytruda, which has more recently filed and granted patents protecting it, before IV biosimilars enter the market. As reported by Barron’s, “[t]he effect will be to have shifted a significant chunk of patients away from the old version by the time biosimilar versions of the old version are available, locking in market share for the new version.” Those of us familiar with the industry’s track record of patent abuse have seen this coming for a while.
Merck’s product hop is a brazen abuse of the patent system that will deny the public access to more affordable versions of a life-saving cancer drug that carries a list price of over $200,000 per year. Product hopping schemes like the one Merck is employing are particularly egregious, but it’s important to remember that they represent just one page of the pharmaceutical industry’s patent abuse playbook.
While the media and some regulators are now sounding the alarm around Merck’s plan to product hop Keytruda, many still assume that IV biosimilars will enter the market when Keytruda’s primary patents expire in 2028. This assumption misses Merck’s ongoing efforts to expand its patent thicket around Keytruda. In a new analysis we conducted last month, we found that Merck has filed over 100 patent applications and secured almost 30 more patents on Keytruda since our 2022 review of the drug’s patent thicket. In total, the company has filed nearly 300 patents on Keytruda and holds over 100 granted patents. We will be publishing this update to our drug patent database, the Drug Patent Book, this year.
A patent thicket this big can easily be used to delay IV biosimilar competition and even when it does enter the market, neutralize any price-lowering impact it would bring. As reported in ProPublica, Celgene used similar tactics with its cancer drug Revlimid, surrounding it with a thicket of 206 applications and 107 granted patents. Celgene leveraged this hefty patent thicket to coerce generic competitors into signing a settlement agreement that severely limits the volume of generic Revlimid they can sell until 2026. In doing so, Celgene created the illusion of competition while extending its ability to charge monopoly prices.
The pharmaceutical industry’s patent abuse playbook is sophisticated, but it is obvious to anyone who cares to look. History tells us that branded drug companies will stop at nothing to block competition. Only those who are willing to fight for lower prices by reforming the patent system stand in their way.
Onwards,
Tahir
Other News:
- Our legal analyst Namita Dhawan-Muren is tracking Sandoz’s lawsuit against Amgen over its Enbrel biosimilar. Read her analysis of how Amgen built its “ill-gotten, supercharged (and invalid) patent thicket” around Enbrel.
- ICYMI: We released a new brief exposing how Novo Nordisk and Eli Lilly’s financialized business model drives them to abuse the patent system to monopolize the lucrative GLP-1 drug market. Read The Heavy Price of GLP-1 Drugs
- Watch our 2-minute video detailing how Merck will product hop its top-selling cancer drug, Keytruda.
- ProPublica health care reporter David Armstrong spoke to NPR’s Fresh Air about his battle with multiple myeloma and Celgene’s monopoly over Revlimid.