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Sandoz Inc.'s method for producing Zarxio—the first FDA-approved biosimilar drug—and another biosimilar the company is developing doesn’t infringe an Amgen Inc. patent, a court ruled Dec. 19.
Sandoz’s process for making and purifying filgrastim and pegfilgrastim drugs, which are based on naturally occurring human proteins, doesn’t infringe Amgen’s U.S. Patent No. 8,940,878, the U.S. District Court for the Northern District of California ruled. The patent describes protein purification methods to generate the drugs, which boost the immune system.
Amgen’s battle with Sandoz over the biosimilars led to a key Supreme Court decision issued in June holding biosimilar applicants aren’t required under the Biologics Price Competition and Innovation Act to engage in the “patent dance” exchange of patent and manufacturing information with name-brand biologic owners. Amgen filed suit in 2014 after Sandoz refused to provide the information.
“The current decision reflects some of the inefficiencies created by a [biosimilar applicant] refusing to make these disclosures,” Kevin Noonan, a partner with intellectual property law firm McDonnell Boehnen Hulbert & Berghoff LLP, told Bloomberg Law in a Dec. 20 email.
Biosimilars are less expensive versions of complex, FDA-approved biologic drugs. The BPCIA created an accelerated approval process for biosimilars. The law required Amgen to sue Sandoz on patents it believed Sandoz’s biosimilar would infringe, said Noonan, a Bloomberg Law advisory board member.
“As it turns out, it looks like Sandoz’ method for purifying its filgrastim and [p]egfilgrastim products does not infringe Amgen’s patent,” he said. “But this conclusion might have been reached without much of the cost and delay that has occurred in this case if Sandoz had disclosed this information during the statutory ‘patent dance.’
"[T]his outcome illustrates for me the need for the law to be amended to provide some incentives to disclose (which can be disincentives not to disclose), which would avoid the inefficiencies created by clever lawyering, sloppy statute crafting, and some questionable judicial decisions,” Noonan added. “One solution would be for the law to state that the abbreviated biosimilar application pathway would not be available to a party that refused to disclose as Sandoz did.”
Sandoz’s filgrastim biosimilar drug, Zarxio, was the first to obtain Food and Drug Administration approval under the BPCIA. Filgrastim stimulates production of certain white blood cells that support the immune system, and one of its uses is to help prevent and fight off infection during chemotherapy. Sandoz’s Zarxio, approved in 2015, is a biosimilar of Amgen’s Neupogen filgrastim drug, which it began selling in 1991.
Pegfilgrastim is a modified version of filgrastim that remains in the circulatory system longer. Amgen sells a pegfilgrastim drug under the name Neulasta, and Sandoz is seeking FDA approval of a pegfilgrastim biosimilar.
Amgen’s Neupogen worldwide sales decreased 27 percent in 2016 to $765 million, according to the company’s 2016 annual report. Neulasta sales dropped 1 percent to $4.6 billion. Meanwhile, Novartis International AG, Sandoz’s parent company, reported a 31 percent increase in Sandoz biopharmaceutical sales, reaching $1 billion, which it said was fueled in part by the introduction of Zarxio.
Sandoz’s approach to purifying the proteins by separating them from chemicals used in the manufacturing process doesn’t literally infringe an ’878 patent claim, as Amgen argued, Seeborg said. The patent claim describes a three-step process involving three solutions, the court said, while Sandoz’s involved only one step and one solution.
The Sandoz process also didn’t infringe the patent under the “doctrine of equivalents,” in which infringement exists where a method includes steps not substantially different from a patent claim’s. The Sandoz and ’878 patent methods have different functions, are performed differently, and produce different results, the court held.
The noninfringement decision shouldn’t be deferred until after Sandoz replaces its current purification method with another one, which the company plans to do in 2018, the court added. The modified method won’t change the outcome, the court said.
"[T]he method claimed by the ’878 patent involves multiple steps and multiple solutions while Sandoz’s accused method involves only one continuous step and only one solution,” the court said. “This substantial difference between the methods will not be altered by the replacement of the current matrix with the new matrix.”
Attorneys for the parties couldn’t be reached for comment.
Sidley Austin LLP and Paul, Weiss, Rifkind, Wharton and Garrison LLP represented Amgen. Morrison & Foerster LLP and Kirkland & Ellis LLP represented Sandoz.
The case is Amgen Inc. v. Sandoz Inc. , 2017 BL 454091, N.D. Cal., Nos. 14-cv-04741 & 16-cv-02581-RS, 12/19/17 .
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