Hoping to fend off Lyrica generics, Pfizer ring-fenced it with 68 patents. Later, to soften the blow from looming copycats, it rolled out a patented, long-lasting formula and steered patients toward it. And along the way, it hiked the drug's price by 163%.
As a recent report (PDF) by nonprofit group Initiative for Medicines, Access & Knowledge (I-MAK) sees it, that is a prime example of how pharma companies are abusing the U.S. patent system—and profiting from it.
“Pfizer’s patenting strategy with Lyrica illustrates how drugmakers game the patent system in order to extend the patent-protected lifespan of their key products and garner billions more in revenue beyond the twenty year period,” says the report.
As the report notes, Pfizer's only one of the pharma companies using patent laws to maximize sales. A host of drugmakers have used excessive patenting—a process known as evergreening—to keep generics or biosimilars from entering the market for as long as possible, while hiking prices without the fear of low-priced rivals, the report contends.
Nor has Pfizer racked up the most patents on a single drug; it's just about average there. That record belongs to AbbVie, with its 247 Humira patents applied. Roche holds the distinction of seeking the longest-term patent coverage, for its aging cancer blockbusters Herceptin, Rituxan and Avastin. Lyrica's 163% price increase since 2012 topped the group.
Overall, the report looked at the 12 best-selling drugs based on 2017 sales and calculated the numbers of patents filed and granted; their price increases over the past six years; and the potential protection duration, should their latest patent application be granted.
It names and shames those three companies—AbbVie, Roche and Pfizer—as the worst offenders who used “aggressive and exploitative patenting strategies” to extend their monopolies and pull off significant price increases.
“Contrary to what the law intends, drugmakers have transformed the patent system into a defensive business strategy to avoid competition and earn outsized profits,” said Tahir Amin, co-founder and co-executive director at I-MAK, in a statement (PDF).
With $18.4 billion in global sales, AbbVie’s Humira is obviously the best-selling drug, but in I-MAK’s eyes, it is also “the worst patent offender” with 247 patent applications, and its 144% price increase since 2012 makes it the third largest among the 12. On average, 125 patent applications have been filed for those 12 drugs, with 71 granted per drug, according to the report.
After patent litigation, AbbVie recently delayed Humira biosimilar entry into the U.S. till 2023 through settlements with Amgen, Samsung Bioepis and Mylan, securing its 2020 Humira sales projection of $21 billion.
Roche’s blockbuster cancer trio Herceptin, Rituxan and Avastin, in that order, are the top three that sought longest patent exclusivity. Herceptin’s first patent was filed in 1985 and is currently slated to face biosims next year. But it has pending patent applications that could extend its life till 2033, according to the report. If granted, the new patent would mean 48 years of protection for the HER2 breast cancer drug, nearly double the 20 years intended under U.S patent law, notes the report.
“Patent and intellectual property laws enable scientific innovations and our ongoing ability to discover and develop breakthrough medicines for patients depends on the protection of our patent and IP rights,” said Roche in a statement to FiercePharma.
AbbVie and Pfizer didn’t respond to FiercePharma’s requests for comments by publication time.
Herceptin already faces biosim attack in Europe, but thanks to the U.S., its global sales were still growing at least in the second quarter. The launch dates for Rituxan and Avastin knockoff versions in the U.S. are not clear as well, especially as many had been turned down by the FDA.
Beyond patent protections on original formulas, drugmakers routinely use extended-release formulas to extend their franchises, and the I-MAK report calls that out as an abuse, too. In addition to its Lyrica CR, Pfizer used the strategy on its antidepressant drug Effexor XR, and in a more recent example, Allergan tried to force patients using its older dementia drug Namenda onto its Namenda XR formula, only to back off after a public outcry.