Last month, the FDA approved Merck’s injectable version of Keytruda, the world’s best-selling drug. The formulation, marketed as Keytruda Qlex, will launch later this year. When it does, Merck will initiate a product hopping scheme to shift patients to it. According to The New York Times, company executives expect “up to 40 percent of Keytruda users to be on it by 2027.”
Merck created Keytruda Qlex by combining Keytruda’s known immune PD-1 checkpoint inhibitor (pembrolizumab) with a form of the enzyme hyaluronidase (berahyaluronidase-alfa pmph) licensed from the South Korean company Alteogen. In an interview with CNBC, Merck CEO Robert M. Davis described Keytruda Qlex as an “invention”. That characterization suggests novelty and a technique that someone skilled in the field would not deem obvious to try—and, therefore, patent-worthy.
Hyaluronidase, and variations of it, is a well-understood ingredient that companies have long used to enable subcutaneous delivery of biologic drugs. Bristol Myers Squibb used it to create an injectable version of Opdivo (nivolumab, also an immune PD-1 checkpoint inhibitor). Roche also used it to create injectable versions of Herceptin over a decade ago. Using hyaluronidase to enable subcutaneous delivery would be the obvious go-to solution for a scientist skilled in biologic drug development given how many times it has been done to date.
Merck’s product hopping scheme will lock a large share of the Keytruda market under a new 20-year monopoly just before the primary patents on the IV version of Keytruda expire in 2028. This move alone will allow the company to preserve much of Keytruda’s massive revenue stream, which now accounts for nearly half of its total sales. However, it would be naive to expect Merck to simply let biosimilars compete for what remains of the IV market. To date, Merck has sought hundreds of patents on Keytruda. As we have warned for years and as reported by The New York Times, “Some of those patents might give Merck leverage to block the arrival of copycat infusions from competitors for years beyond 2028.”
What is happening to Keytruda is a tragedy. Patients who deserve meaningful access to cheaper versions of a $200,000 cancer treatment are being swept into a new monopoly by a company that has already extracted billions from them. To Merck, this is just business. To everyone else, it is the hijacking of their healthcare and corruption of a regulatory system that is supposed to serve the public.
Onwards,
Tahir
In The News:
- Join us for a webinar on October 22 at 10AM ET, where will present new survey results that break down the growing bipartisan support for patent system reform. Speakers include Tahir Amin, Co-founder and CEO of I-MAK; U.S. Senator Peter Welch (D-VT); Emily Pisacreta, health care journalist; and Berwood Yost, Director of the Center for Opinion Research at Franklin & Marshall College.
- Read The Washington Post’s coverage of Colorado’s effort to lower the price of Enbrel—the latest state-level effort to curb patent abuse to make life-saving drugs more affordable.
- Read new reporting from Vox’s Pratik Pawar on Gilead’s licensing deals with six generics to make the HIV treatment lenacapavir available in 120 low- and lower-middle-income countries. As Tahir Amin explained, the licenses “carve the world into low-value markets where generics can operate [where Gilead won’t be making money anyway], and profitable ones where Gilead keeps its grip”