Biologics Act in the United States
Biologics Act 2009, the FDA and Patent Litigation
by Rene Ciria-Cruz (2011)
The era of mega patent battles over biologics, a new breed of biotech drugs, loomed ever larger last fall when Israel’s Teva Pharmaceutical Industries launched a second clinical trial for a drug called Rituxan. The new Teva product is a knockoff of a blockbuster biologic that treats non-Hodgkin’s lymphoma made by Roche, the Swiss health care company, and which raked in more than $5 billion in sales last year.
About $80 billion worth of biologics—which are used as vaccines and as treatments for cancer and diabetes—will lose patent protection in less than half a decade. Teva’s move to make a less expensive “biosimilar” of Rituxan spotlights a new area of Big Pharma patent face-offs spurred by recent federal legislation that creates an approval process for such drugs.
Unlike traditional chemical-based medications, biologics are based on proteins derived from living cells. As such, they can’t be exactly copied to make a generic version; any copycat version of biologics can only be “similar,” and so they’re called “biosimilars” or “follow-on biologics.”
The U.S. Food and Drug Administration (FDA) already had an established approval process for branded and generic chemical drugs, as well as for biologics, but it didn’t have one for biosimilars until the Biologics Price Competition and Innovation Act of 2009 was passed as part of the health care reform law signed last March.
The Biologics Act creates the theater for new patent litigation. Under the statute, after the FDA licenses a brand-name biologic, the agency must wait twelve years before approving any biosimilar drugs (though manufacturers can submit applications after four years).
The law also creates mechanisms that make it easier for innovators to identify potential infringement.
“The statute [attempts] to make both innovators and biosimilar producers happy, but the jury is still out,” says Douglas H. Carsten, a partner with Foley & Lardner in San Diego.
FDA Commissioner Dr. Margaret Hamburg told members of the Generic Pharmaceutical Association last year that the agency won’t use “a one-size-fits all approach” in refining the parameters of the biosimilar approval pathway. Public hearings on the new process began in November.
Like the approval process for generics of chemical-based drugs, this pathway is likely to be paved with lawsuits. Jessica Wolff, a partner with Cooley Godward Kronish’s office in San Diego, predicts that the Biologics Act “will eventually be clarified by litigation regarding the powers of the FDA and other unforeseen issues.”