For years, Elizabeth Dempler fought to lessen the flares of Crohn’s disease.
The 49-year-old’s joints swelled so, she could barely stand, her small bowel leaked fecal matter into her body, and she was in so much pain that she couldn’t work for 10 months.
One drug, Humira, finally gave her back her life.
Still, she feels far from free.
She pays just $5 a month because she qualifies for a discount program by the drugmaker AbbVie. But she worries about how she would manage if her financial situation changed. Her twice-weekly shots — a high dose — would otherwise cost her $4,000 a month and there’s no generic alternative.
“The idea that I’d have to stop taking my medication because of the cost is absolutely terrifying,” said Dempler, who lives in Drexel Hill. “I’ve lost so much of my intestinal tract because of Crohn’s, I can’t afford to lose more. It would be a life-or-death decision.”
Despite Humira’s being on the market for 16 years and receiving its first patent in the early 1990s, AbbVie has ensured that the drug won’t face generic competition until at least 2023 by building up a protective padding of about 130 patents and many more patent applications.
The U.S. patent system rewards investment in new medicines by granting drugmakers a period of market exclusivity to recoup research and development costs. The term of a new patent is typically about 20 years. But, increasingly, analysts say, powerful pharmaceutical companies are manipulating the system, filing dozens of patent applications for unremarkable tweaks, such as a change to the packaging, a shinier pill coating, or an alteration to inactive ingredients in order to protect monopoly pricing on blockbuster drugs that bring in billions of dollars a year.
Over-patenting and the effect it has on product prices aren’t unique to the pharmaceutical industry. But the stakes feel higher with lifesaving drugs on the line, said David Blumenthal, a doctor and president of the Commonwealth Fund, a health-policy research organization.
“Everything about health care is magnified in importance by the perception or reality that it’s about life or death,” he said. “The actual legal issues may be the same, but the feeling of urgency and sensitivity to the consequences are almost always heightened.”
As consumer outrage over drug prices builds momentum, lawmakers have been forced to take notice, hauling heavyweights of the health-care industry before congressional committees. There’s been no shortage of finger-pointing — pharmacy benefit managers, drug wholesalers, insurers, and self-funded employers are all part of the equation.
Patent law is upstream of all these players, said Tahir Amin, a cofounder and co-executive director at I-MAK, which studies pharmaceutical patenting and is pushing for patent-law reform.
“It’s a source of power for the pharmaceutical companies," Amin said. "It gives them the monopoly power to dictate how the market is going to function and any other actor in the space -- whether it be a pharmacy benefit manager, an insurance company — they are then playing by those rules.”
Humira is one of the worst offenders, according to a report by I-MAK. The drug has had 247 patent applications, half of which were filed since 2014, when its first patents began to expire, according to I-MAK’s analysis.
Patents filed so long from the drug’s initial development are a sign that the system is being abused, Amin said. They create a “patent thicket” that makes it difficult for any competitor to replicate the drug without infringing on one patent or another.
“I don’t entirely blame [pharmaceutical companies] for trying to get patents. I blame the system because it allows this behavior,” he said.
Biotechnology industry association BIO has challenged I-MAK’s report, arguing that the issue of over-patenting is overstated, as most drugs have far fewer patents and the number of generic drugs is rising.
Patent thickets aren’t the only tactic brand-name companies use to protect their best-selling drugs.
Some have paid would-be competitors to delay generics, a tactic that is lucrative for generic-makers, too. Others “product hop,” which entails changing the medication’s dosage, for example from being a twice-daily to once-daily pill, or switching from a capsule to a tablet.
Another tactic brand-name companies use to extend their period of exclusivity is to get approval for their drug to be used by a different type of patient or medical condition.
For example, Pfizer’s top-selling pain medication Lyrica was supposed to lose patent protection at the end of last year, but then was approved for use by children and granted an extra six months of exclusivity.
“The concern with pediatric exclusivity is it’s designed for a good purpose, to give six months of extra protection to a company that shows the drug works on kids. The concern is it’s been used for drugs that are already on the market to really extend their period of protection when it doesn’t meet it,” said Michael Carrier, a Rutgers University law school professor who specializes in patent and antitrust law.
Lyrica’s price has risen dramatically over the last several years, to a list price of $702 for a bottle of 90 pills, before discounts.
“When pricing our medicines, we strive to maintain a balance between value to patients and society and our ability to invest in future medicines, while ensuring the financial viability of our company,” Sally Beatty, a Pfizer spokesperson, said in a emailed statement.
Lyrica’s price is expected to drop 90 percent when it comes off patent in June, 14½ years after it entered the market, she said.
In the meantime, patients are digging deeper into their pockets.
At $45 a month, the drug’s cost is manageable for Cheryl Dunican-Hein, 62, of Maple Shade. But it means deciding whether she can fill her other prescriptions for fibromyalgia, osteoporosis, and other chronic conditions, which cost a total of about $600 a month.
“I wouldn’t be able to afford the drugs if I didn’t have a spouse who was working. I can readily see how people have chosen between their drugs and food,” said Dunican-Hein, who recently shared her story at a panel about drug costs in Pennsauken organized by U.S. Rep. Donald Norcross (D., Camden).
Sometimes, companies that want to produce a generic version of a drug push back. But even when they do, it’s worthwhile for brand-name patent-holders to fight in court to maintain their monopoly status for as long as possible.
For example, Humira accounts for about two-thirds of maker AbbVie’s annual revenue.
When the drug’s European patents expired last year, generics entered the market and international sales for Humira dropped 28 percent in the first three months of the year, AbbVie reported in its first-quarter filings.
Meanwhile, the drug’s price in the United States has shot up more than 100 percent over the last six years to a list price of about $5,680 for two pen injectors.
“Every day a brand-name company can delay generic competition is another day it will be making millions of dollars,” Carrier said.
AbbVie rakes in about $18 billion a year from Humira. That’s roughly $50 million a day.
In response to questions from The Inquirer, AbbVie defended its pricing and patent strategy.
“Patents encourage and reward the significant investment we’ve made in innovation and we are focused on balancing the need for continued investment in the next generation of medicines while also ensuring affordability and access for our patients today,” Adelle Infante, a spokesperson, said in an emailed statement.
She pointed to the company’s patient-assistance programs for those struggling with the cost. Patients who qualify can receive coupons to reduce the drug’s cost to as little as $5 a month.
Pfizer has a similar coupon program that can reduce the price of Lyrica to $4 a month. But Dunican-Hein isn’t eligible for it because she’s covered by Medicare.
Most manufacturer coupons are available only to people with private insurance. Medicare beneficiaries, who due to age or disability generally have the greatest need for medicines, can’t benefit from coupons.
These programs only disguise the costs that we all continue to pay, Blumenthal said.
Private insurance plans account for their share of high drug costs by raising premiums, while employers who self-fund raise deductibles, putting a greater share of the added cost on workers. Taxpayers foot the bill when Medicare and Medicaid pay more for medications, he said.