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By Liz Crampton
Pfizer Inc.’s suit alleging Johnson & Johnson stopped a competing lower-priced drug is likely to answer questions about how pharmaceutical companies can structure contracts with providers, practitioners told Bloomberg BNA.
Last week, Pfizer filed a suit in the U.S. District Court for the Eastern District of Pennsylvania claiming that J&J sought to preserve a monopoly for its rheumatoid arthritis drug by scheming to ensure that biosimilars, lower-priced copies of expensive biotechnology drugs, “would never become viable competitors,” the complaint said. Pfizer’s lawsuit is the first of its kind.
Pfizer contends that J&J prevented insurers and hospitals from using Pfizer’s biosimilar, Inflectra, through “exclusionary contracts.” Inflectra received FDA approval as the first biosimilar to Johnson & Johnson’s drug, Remicade, in 2016. Immediately after Pfizer began marketing Inflectra, J&J launched a “Biosimilar Readiness Plan.” The plan’s core features are exclusionary contracts that foreclose Pfizer’s access to an “overwhelming share of consumers,” Pfizer said in the complaint.
“Biosimilars is definitely going to be the next round of a lot of litigation and fights,” said Will Garvin, an attorney at Buchanan, Ingersoll and Rooney.
“The scope of what’s acceptable in that fight and what we’re going to deem unacceptable is yet to be clarified,” he added.
Much of the antitrust litigation in the pharmaceuticals industry has focused to date on “product-hopping” cases, in which companies make minor changes to a drug, such as dosage levels, to extend a patent.
But the Pfizer suit could open the door to more challenges to contracts that bar providers from covering a particular drug’s costs. Pfizer is seeking monetary damages and a court order ruling J&J’s conduct unlawful and barring its use of exclusionary contracts.
The breadth of potential litigation is limited for now because there’s only a handful of biosimilars on the market. They have faced a mix of patent and other legal problems. Of the seven biosimilar drugs the FDA has cleared since 2015, only three are available for sale. But antitrust lawyers expect the market to grow in coming years.
The Pfizer case could provide a clue as to what terms are deemed legal in drug companies’ contracts with providers, particularly if J&J’s contracts are found to be exclusionary, Carrie Amezcua, an attorney at Buchanan, Ingersoll and Rooney, told Bloomberg BNA.
“This is a significant lawsuit,” she said. “The complaint is very detailed about these exclusionary contracts J&J entered into with insurers and providers.”
Exclusive contracts aren’t automatically illegal under antitrust law,” Amezcua said. But they can be deemed anticompetitive if they foreclose a competitor from the market. They also could simply be one way that companies establish their place in the market. The court is in a position to provide meaningful guidance on that distinction.
Pfizer’s complaint said J&J’s plan to stop it from entering the market also included anticompetitive bundling and coercive rebate policies designed to block insurers from reimbursing and hospitals and clinics from purchasing Inflectra or other biosimilars of Remicade, despite their lower cost.
“The harm to Pfizer and to competition as a whole — and, ultimately, to consumers, businesses, and the U.S. government, who bear the brunt of rising health care costs nationwide — is manifest,” the company said.
J&J responded to the charges by saying that it is “effectively competing on value and price” and Pfizer has “failed to demonstrate sufficient value to patients, providers, payers and employers.”
“Competition is bringing down the overall cost of Remicade, and will continue to bring down costs in the future,” said Scott White, president of Janssen Biotech, the J&J unit that makes Remicide, Bloomberg News reported. “There is no merit to this lawsuit.”
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