Drug for Narcolepsy | An unusual way to extend a patent

The pharmaceutical industry is full of stories of companies devising ways to extend their monopoly on lucrative drugs. They tinker with chemicals. They change the dosages. They replace the capsules with tablets.

By accumulating patents, pharmaceutical companies are delaying the day when their competitors can launch similar and cheaper products.

Jazz Pharmaceuticals has found a way to push the envelope even further — a feat that shows how far drugmakers go to rake in extra profits, but two federal courts have ruled it unacceptable.

Jazz’s most important product is a drug for narcolepsy, a sleep disorder. The company patented the drug formulation. But Jazz went further, with a new weapon to block the competition.

Due to the drug’s serious side effects and the fact that it has been used for rape in the past, federal authorities have asked Jazz to put a plan in place to ensure the drug is safely distributed to patients. , without falling into ill-intentioned hands. Jazz’s program called for a single nationwide pharmacy to ship the drug directly to patients.

The manufacturer took the unusual step of patenting this security program and then listing those patents on a federal registry known as the Orange Book.

Under an obscure federal rule, if a rival challenged one of the patents under certain circumstances, federal regulators would be barred from approving that competitor’s product for more than two years.

This is precisely the strategy Jazz deployed when a rival was about to launch an improved version of its drug.

Jazz’s narcolepsy drug, which is used by thousands of patients, is hugely lucrative, generating more than $13 billion in revenue since Jazz acquired it in 2005. Medicare now spends hundreds of millions of dollars per year for this drug, which represented 58% of Jazz’s revenues in 2021.

In other words, for every month that Jazz was able to delay the arrival of competition, the company and its shareholders benefited financially.

But this tactic deprived narcolepsy patients of access to a new drug that was much easier to take.

Patent law experts say this strategy of enforcing the patent on how the drug is delivered has strayed from the goal of the U.S. intellectual property regime, which is supposed to reward drugmakers for taking risks to develop and improve innovative products. According to them, this case is a blatant example of how pharmaceutical companies exploit the patent system to protect their products from competition for as long as possible.

Jazz’s strategy has been criticized by the Federal Trade Commission and rejected by the courts. In November, a federal court in Delaware ruled that the company had improperly used the Orange Book to block the drug from rival Avadel Pharmaceuticals. Jazz appealed. A federal court on Friday upheld the lower court’s decision.

This decision will not have a big impact on the availability of Avadel’s product, which was expected to be marketed in the coming months, regardless of the court’s decision. But it is important, because it shows that there can be limits to the exploitation of the patent system by the pharmaceutical industry to exclude its rivals.

Jazz spokeswoman Aimee Christian defended the company’s strategy but said Jazz would comply with a court order to seek its patent removed from the Orange Book – named after its cover page. in bright colors.

“We remain confident in the strength of our patent portfolio and will continue to appropriately defend our intellectual property, while continuing to focus on the safety of oxybate-treated patients,” she said, adding. referring to narcolepsy medication.

Since 2005, Jazz has enjoyed a virtual monopoly on treating the core symptoms of narcolepsy, which include excessive daytime sleepiness, loss of muscle control and interrupted sleep. Jazz sells two versions of its drug, called Xyrem and Xywav.

The list price for the highest dose of each version is now over $200,000 per year, according to data firm SSR Health. The Xyrem is now 19 times more expensive than it was in 2007 when SSR started tracking it.

Jazz’s drug is a pharmaceutical-grade derivative of gamma-hydroxybutyric acid, or GHB, which is tightly regulated due to its misuse as a date-rape drug after health food stores l sold as a dietary supplement in the late 1980s.

GHB was first synthesized and tested in the 1960s. Jazz, which is legally domiciled in Ireland but has many senior staff based in California, did not do early development work on the version on drug prescription; the company acquired it nearly three years after it was first approved.

A complex drug

Both versions of Jazz’s medication come in liquid form. Patients mix it with water and drink it. They must take two doses a day: the first at bedtime and the second up to four hours later.

Brian Mahn, a 53-year-old consultant from Cypress, Texas, said he had to stop taking Xyrem several years ago because the dosing schedule was too difficult. He would fall asleep despite multiple alarms he set between 2:30 a.m. and 3 a.m., which disturbed his family. Mahn often took the second dose too late, leaving him with such severe brain fog in the morning that he was unable to drive to work.

Avadel’s product, Lumryz, has the same drug substance as Xyrem, but comes in a powder form and, most importantly, has a simpler dosing schedule. Avadel powder is taken only once a day at bedtime, which prevents patients from waking up in the middle of the night.

Prior to the Avadel case, Jazz had sued nine companies seeking permission to manufacture a generic version of Xyrem, accusing them of infringing Jazz’s patents. The strategy worked: these manufacturers reached agreements with Jazz, agreeing to delay the introduction of their products.

Pharmaceutical patent experts have said such tactics constitute an abuse of the patent system.

The programs are “supposed to promote drug safety,” said Dr.^r Aaron Kesselheim, professor of medicine at Brigham and Women’s Hospital and Harvard Medical School. “It’s not meant to be a mechanism to expand revenue streams. »

This article originally appeared in the New York Times.