— Manufacturers of brand-name drugs will try every tack to delay generic entry, experts say
by Shannon Firth , Washington Correspondent, MedPage Today
May 21, 2024
Senators and experts on Tuesday examined the range of tools that brand-name drug manufacturers have used to keep generic and biosimilar competition at bay — from patent thickets and product hopping to “pay-for-delay” settlements — and wrestled with how to prevent such abuses.
“Too often the prices charged by Big Pharma do not reflect a scientific advancement,” argued Sen. Dick Durbin (D-Ill.), during a Tuesday hearing of the Senate Committee on the Judiciary. “Rather, they’re the result of skilled lawyers manipulating the patent system and skirting our nation’s competition laws.”
A textbook example of this is AbbVie’s adalimumab (Humira), a biologic for the treatment of rheumatoid arthritis and inflammatory bowel disease (among other conditions) that was brought to market in 2002. AbbVie “exploited intellectual property laws to build a thicket of 165 patents that allowed Humira to avoid competition,” said Durbin, chair of the committee. He added that for AbbVie, this resulted in $200 billion in revenue over more than 20 years of exclusivity.
One recent analysis showed that the 10 best-selling drugs in the U.S. in 2021 were tied to 1,429 patents and patent applications, 72% of which were filed after FDA approval, Durbin noted.
The committee has already unanimously passed five bipartisan bills targeting “pay-for-delay” agreements (in which brand-name drug manufacturers compensate generic or biosimilar manufacturers for delaying the entry of their drug onto the market); sham citizen petitions(requests submitted to the FDA for the primary purpose of interfering with a competitor’s application); product hopping (in which manufacturers shift patients from an old version of a brand drug to a new brand product); and patent thickets.
Those bills were approved, as was Durbin’s own bill with Sen. Chuck Grassley (R-Iowa) and Sen. Thom Tillis (R-N.C.) that aims to improve information sharing between the FDA and the U.S. Patent and Trademark Office (PTO), but all have yet to receive a vote from the full Senate.
However, Durbin pointed out that the committee’s work is far from complete.
Shifting gears and homing in on the idea that patents are meant to encourage innovation, David Mitchell, president and founder of Patients for Affordable Drugs, explained how patent abuse actually inhibits innovation.
“If drug companies can raise prices on old drugs that should have competition, but don’t, and they can raise them at will, then they have much less incentive to invest in risky, innovative work that can produce new drugs,” he said.
Arti Rai, JD, a professor at Duke University School of Law in Durham, North Carolina, applauded the committee’s work, and was especially enthusiastic about efforts to increase coordination between the FDA and PTO. While she approved of the Federal Trade Commission’s recent efforts to challenge improperly listed patents in the FDA’s Orange Book, she argued that “the PTO could nip the problem in the bud by helping FDA ensure that irrelevant patents are never listed.”
William Feldman, MD, MPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, said that he supported all of the bipartisan bills that had been discussed during the hearing, but noted, “I don’t think these bills go far enough.”
He urged Congress to consider other measures, such as requiring the FDA to review every patent that is submitted to the agency’s Orange Book to determine eligibility for inclusion. At present, the agency serves in a “purely ministerial role,” he said.
Feldman also asked Congress to require that any patent submitted to the Orange Book be resubmitted to the PTO for re-examination; to limit the number of patents that brand-name drug manufacturers can seek to one per family when such manufacturers sue for infringement; and to grant the FDA more flexibility to approve generic drug-device combinations that differ slightly from the original brand-name product but still contain the same active ingredient.
Jocelyn Ulrich, MPH, vice president of policy and research for the Pharmaceutical Research and Manufacturers of America, took a different view, characterizing the nation’s intellectual property framework as a “resounding success.”
She credited the system, in part, for enabling the development and launch of 750 drugs since the year 2000. “Importantly, our IP [intellectual property] system not only incentivizes the development of new medicines, but it spurs competition that lowers healthcare costs,” she said.
Ulrich blamed pharmacy benefit managers (PBMs) for the difficulties that patients face accessing drugs. “Today, three large PBMs now comprise nearly 80% of the market, and each is vertically integrated with health insurers, specialty and mail-order pharmacies, and provider groups to form large healthcare conglomerates and they are significantly impacting whether patients are able to benefit from biopharmaceutical innovation,” she noted.
“Congress should be focused on advancing policies where competition could be advanced without undermining the very foundation of the industry’s ability to innovate,” she added, including the “misaligned incentives” in the PBM market.
While Committee Ranking Member Sen. Lindsey Graham (R-S.C.) noted that he is “very open-minded about stopping abuse,” he added that “what I don’t want to do is kill the goose that laid the golden egg. I don’t want to create a system where we stop developing new drugs that enrich our lives.”