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Janssen Biotech Inc., maker of blockbuster arthritis biologic medicine Remicade (infliximab), sued Celltrion Healthcare and Hospira Inc. over their application to make a biosimilar copy of the drug ( Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd. , D. Mass., No. 1:17-cv-11008, complaint filed 5/31/17 ).
Janssen is taking no chances under the Biologics Price Competition and Innovation Act. Its latest suit is a defensive measure aimed at fending off limitations on what damages, including the recovery of lost profits due to infringement of its Remicade patent, could be available to it in the future.
Janssen’s suit, filed May 31 in the U.S. District Court for the District of Massachusetts, illustrates the complexity, procedural uncertainty and strategic risks litigants face under the BPCIA statute.
In 2015, Remicade was one of the top 10 best-selling drugs in the world so the potential for damages could be huge. Meanwhile, Celltrion and Hospira, its partner in marketing Inflectra, Celltrion’s biosimilar version of Remicade, asserted Janssen was required to bring the suit or be limited to only a reasonable royalty as an infringement remedy.
The BPCIA created an abbreviated licensure pathway for biological products that are shown to be “biosimilar” to, or “interchangeable” with, a reference product that already has been licensed by the FDA. It was signed into law as part of the Affordable Care Act in 2010.
But the BPCIA’s complex patent infringement litigation resolution procedure, which practitioners often refer to as the “patent dance,” has led to considerable uncertainty, including the implications of patent dance strategies on what patent infringement remedies will be available.
“This shows what happens when you have a complicated law interpreted by smart lawyers,” Kevin E. Noonan of McDonnell Boehnen Hulbert & Berghoff LLP in Chicago told Bloomberg BNA in a June 5 telephone interview. “It’s an illustration of how, when you have people playing these statutory interpretation games, it can do exactly the opposite of what Congress intended the statute to do.”
“How the statute has played out has provided a certain opportunity for mischief,” said Noonan, who is a member of the Bloomberg BNA health-care advisory board.
In particular, biosimilar applicants have been able to use the statute to their advantage, he said.
Biosimilar applicants are already at an information advantage over the reference product sponsor [RPS], the maker of the original biologic medicine, he said. Unlike the RPS, they know what their manufacturing process is and they know what their abbreviated biologics license application [aBLA] says, he said.
“The way it’s turned out, at least so far, you do have biosimilar applicants able to get the courts to interpret the law in a way that’s advantageous to them,” he said. “This is part of the way every statute gets fleshed out. Whether the results are what Congress intended is something we’ll find out.”
In its complaint, Janssen said it brought the third infringement suit “to avoid being exposed to the limitation on remedies of 35 U.S.C. 271(e)(6)(B) in a future-filed lawsuit.” The suit contains the same infringement allegations the Johnson & Johnson subsidiary brought against Celltrion and Hospira in its earlier suits over Inflectra.
Janssen said it wanted “to avoid the burden of responding to any future argument by Defendants” that limitations on its legal remedies would apply if it chose not to bring suit again.
But Janssen made clear in its complaint it didn’t agree with the defendants’ contention the BPCIA required it to file a new action to preserve its future remedies.
The Food and Drug Administration accepted Celltrion’s application to offer Inflectra for review in October 2014. On Feb. 5, 2015, Celltrion provided notice of its intent to market upon FDA approval. This kicked off the patent dance provisions of the BPCIA but, according to Janssen’s complaint, the defendants didn’t play fair.
Although Celltrion provided Janssen with its application, which contained certain manufacturing information, it didn’t contain any additional manufacturing information beyond what was in the aBLA. In addition, Janssen said, Celltrion failed to provide it with the cell culture media it was entitled to under the BPCIA.
In 2015, Janssen sued Celltrion and Hospira, alleging Inflectra infringed its U.S. Patent No. 7,598,083 (the ‘083 patent). That patent claims particular compositions of cell culture media, the material used to grow the living cells that produce biologic medicines such as infliximab.
Celltrion and Hospira’s failure to comply with the BPCIA’s pre-litigation procedures and provide critical information handicapped Janssen in fleshing out its initial infringement claims against them, Janssen asserted. In 2016, after learning additional information, Janssen brought a second infringement suit against the defendants, adding claims of direct and induced patent infringement. Those suits have since been consolidated.
After an adverse court ruling in 2016, Celltrion and Hospira said they were reopening good-faith negotiations under the BPCIA. Because they were restarting procedures under the statute, they contended Janssen had 30 days to bring a new patent infringement suit or the company’s damages would be limited to no more than a “reasonable royalty.”
Hospira, a subsidiary of New York-based Pfizer Inc., has been marketing Inflectra for Celltrion in the U.S. since 2016, the complaint said.
Celltrion also markets a biosimilar of Remicade in Europe. Celltrion’s biosimilar, called Remsima in Europe, already has captured 30 percent of the European market since it received regulatory approval there in 2016.
The case is before Senior Judge Mark L. Wolf.
Celltrion is a Korean company with its principal U.S. operations in Cambridge, Mass. Hospira is based in Lake Forest, Ill.
Patterson Belknap Webb & Tyler LLP in New York, Akin Gump Strauss Hauer & Feld LLP in Philadelphia, and Nutter McClennen & Fish LLP in Boston represent Janssen.
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The complaint is at http://src.bna.com/puX.
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