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Patent ‘shenanigans’ keep drug costs high

Bloomberg News//December 20, 2017

Patent ‘shenanigans’ keep drug costs high

Bloomberg News//December 20, 2017

Bob Kelsey can’t afford a cancer drug that could save his life.

The retired firefighter, 53, needs Revlimid to stay healthy. Celgene Corp. has raised the price 88 percent over the past seven years. The drug doesn’t have substantial competition from a less expensive generic version, and probably won’t for another eight years. Celgene has worked hard to make sure of that.

Drugmakers typically have exclusive rights to sell brand-name medicines for 12 or 13 years. After that, cheaper copycats can hit the market. Celgene and a growing number of other pharmaceutical giants are taking advantage of an array of loopholes to extend the exclusivity period, keeping less expensive alternatives away from needy patients like Kelsey.

“Revlimid is the quintessential example of the way in which a pharmaceutical company can use a variety of tactics to extend their monopoly and then exploit that monopoly to increase revenues,” said Ameet Sarpatwari, a Harvard Medical School instructor.

The expiration date for the main Revlimid patent will be 2019. But Celgene’s business tactics, also used by other drugmakers, could allow the company to put off unrestricted competition from generics until 2026. That would cost Americans an extra $45 billion just for Revlimid, according to I-MAK, a consumer advocate.

Scott Gottlieb, commissioner of the U.S. Food and Drug Administration, is so fed up with a range of different drugmakers’ machinations he delivered a sharp rebuke last month: “End the shenanigans.”

 Never-ending profits

Drugmakers use obscure rules and intellectual-property law to extend their patents and keep cheaper versions of drugs from patients.

New patents on old drugs: Celgene got 61 patents on Revlimid, many granted years after the drug was first approved. They could make Celgene the dominant manufacturer for 20 years.

Patient (and profit) safety: Jazz Pharmaceuticals has used an FDA safety program to keep generic-drug makers from being able to move forward with cheaper versions of narcolepsy drug Xyrem, critics said. As of a recent settlement, Jazz will most likely be the exclusive maker until 2023.

Citizen petitions: The FDA lets the public petition it with concerns about the drug approval or testing process. Drugmakers can file them, too — which ViroPharma did 24 times between 2006 to 2012 for its antibiotic Vancocin, delaying a generic competitor, according to a lawsuit.

Restrictive deals: Johnson & Johnson’s exclusive contracts kept its drug Remicade on pharmacy shelves instead of Pfizer’s less costly version, according to a lawsuit.

Among the shenanigans: Securing new patents that extend old ones. Keeping brand-name drugs under wraps so generic makers can’t copy them. Filing so-called citizen petitions that gum up the FDA approval process for rivals. Negotiating restrictive deals with drug plans that crowd out less expensive drugs.

Over the past year, Bloomberg has been looking into the price of pharmaceuticals, cataloging how drugmakers have been able to use a series of tactics to retain profits for years, undermining the deal they made more than three decades ago to allow generics on the market.

Celgene “has legitimate safety concerns” about generic companies’ use of its products, spokesman Brian Gill said in a statement. The company is “committed to helping patients access Revlimid” and has given aid to 75,000 people through its support program, Gill said.

The expectation of more exclusivity fuels investment in drug companies, potentially leading to future breakthroughs—even as some patients have trouble paying for the drugs, said Craig Garthwaite, a professor at Northwestern University’s Kellogg School of Management. “It’s just a fundamental tradeoff,” he said.

Under a 2015 deal with Celgene, one generic company will be allowed to sell generic Revlimid in 2022, although with restrictions on its market share.

Bob Kelsey used to stand 6 feet tall. His blood cancer has so weakened his spine that his back is bent at a sharp angle. He’s unable to completely lift his head. At last measurement, he was 5-foot-3.

He’s gotten so self-conscious about how he looks, he shied away from photos at his daughter’s wedding, according to his wife, Tammie.

But if his photo could help people afford medications, “he would pose for a thousand pictures,” Tammie Kelsey said.

Bob Kelsey said Celgene is providing him with free doses until a charity comes through for him. But even if he does get the grant, he’s worried the money won’t last a year and he’ll have to reapply elsewhere.

Revlimid is $662 a capsule, and it can come to $180,000 a year. Celgene spent $800 million on research and development for all its products over the 14 years it prepared Revlimid for sale, regulatory filings show. The drug exceeded $1 billion in annual sales in 2008, its third full year on the market, and last year had sales of $6.97 billion.

Today, a year’s worth of 10-milligram Revlimid doses costs about $240 to produce, according to a University of Liverpool researcher. Under Kelsey’s Medicare plan, his annual out-of-pocket cost would be more than $10,000, too steep for him to pay.

“I want to be here to see my grandchildren,” he said.

Jennifer Drake, 38, also could face a prohibitive price tag for her narcolepsy treatment.

For most of her life, Drake was tired all the time. Even 18 hours of sleep wasn’t enough. It got so bad she quit her job as a computer-database manager in 2015. Her mother took over care of her teenage daughter.

This spring, a doctor diagnosed her with severe narcolepsy and she started on Jazz Pharmaceuticals Plc’s Xyrem. It changed her life. She said she needs only six hours of sleep and she’s ready to return to working full-time.

But Xyrem costs Drake more than $12,000 a month. Medicaid covers almost all of this, but if Drake started working she would have to switch to private insurance — with no way to tell how much it would cover, she said.

“I feel like I’m being held hostage” by Jazz, Drake said. “I don’t understand how it’s legal for them to monopolize the product like that. It’s so unfair.”

Critics said Jazz has blocked generics makers using an FDA program meant to ensure drug safety. Xyrem is a chemical variant of the so-called date-rape drug GHB.

Jazz not only patented the drug, it patented its Xyrem safety program, also called REMS for Risk Evaluation and Mitigation Strategies. By law, generics makers have to follow the same protocol that the branded companies use. A patent throws up barriers to compliance.

The Federal Trade Commission may be considering whether Jazz deliberately thwarted competition, the company said in a regulatory filing.

Jazz spokeswoman Kristin Rogers said innovative research and development has led to patents on multiple inventions, including those pertaining to the Xyrem distribution system. Because some of that intellectual property is in litigation, the company declined to comment on it, but said, “We believe that all of our patents were properly issued by the patent office and should be upheld.”

As for the price of the drug, Rogers said it reflects many things, ranging from the costs associated with the REMS program, its investment in new drugs and support for patients.

Citizen petitions are another way brand-name drug companies delay approval of competitors’ products. The petitions were designed to elicit public concerns about the drugs. The FDA is required to divert resources to address each one.

From 2011 to 2015, brand-name drugmakers filed 108 citizen petitions during the approval process for cheaper versions, and 91 percent were denied, according to a paper by Rutgers University Law Professor Michael Carrier.

The petitions “can play a crucial role in delaying generic entry,” he wrote.

Drug companies also use new patents to extend their exclusivity. Nearly three-fourths of drugs associated with new patents were for medicines already on the market, according to Robin Feldman of the University of California Hastings College of the Law. She calls it a “pervasive problem endemic to the pharmaceutical industry.”

Federal lawmakers have taken notice of drugmakers’ shenanigans, but legislation has consistently taken a back seat to other issues in Congress.

So Bob Kelsey waits, dealing with blood cancer while managing the stress of not knowing if a charity can get him Revlimid in the new year.

Drug-company owners are making millions “on the backs of sick people,” he said.

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