WASHINGTON, D.C. — The Federal Trade Commission is urging a federal appeals court to reject Amgen Inc.’s argument that its acquisition of patent rights protecting the arthritis drug Enbrel is immune from antitrust scrutiny, warning that the transaction prolonged the drug’s market exclusivity and blocked lower-cost competitors.
In a brief filed Aug. 17 with the U.S. Court of Appeals for the Fourth Circuit, the agency argued that purchases of pending patent applications can violate federal antitrust law when they allow companies to maintain or expand monopoly power.
The case stems from a lawsuit filed by CareFirst of Maryland Inc. and affiliated insurers against Amgen, Immunex Corp. and Amgen Manufacturing Limited LLC. The insurers allege that Amgen acquired exclusive rights to patent applications covering Enbrel and used the resulting patents to prevent competing versions from reaching the market.
Enbrel, also known as etanercept, was introduced in the United States in 1998 to treat rheumatoid arthritis and other inflammatory conditions.
Immunex initially obtained a nonexclusive license to intellectual property held by F. Hoffmann-La Roche. That arrangement allowed Roche to develop its own version of the drug or license the technology to another potential competitor.
After acquiring Immunex, Amgen renegotiated the Roche agreement in 2004 and secured exclusive rights to the relevant patent family, including control over two pending applications and the ability to sue potential competitors, according to the FTC’s brief.
Those applications produced patents in 2011 and 2012 that extended protection for Enbrel through April 2029. The brief states that Amgen subsequently obtained permanent injunctions blocking competing biosimilars developed by Sandoz and Bioepsis.
Amgen’s original Enbrel patents had been scheduled to expire in 2012, according to the filing.
The U.S. District Court for the Eastern District of Virginia declined to dismiss CareFirst’s lawsuit, rejecting Amgen’s argument that acquiring pending patent applications cannot constitute anticompetitive conduct. Amgen appealed that ruling.
The company also argues that the Noerr-Pennington doctrine protects the transaction because it subsequently pursued the patent applications before the U.S. Patent and Trademark Office and enforced the resulting patents through litigation.
That doctrine generally shields efforts to petition the government, including certain regulatory proceedings and lawsuits, from antitrust liability.
The FTC countered that any protection for patent proceedings or litigation does not extend to the underlying commercial agreement through which Amgen obtained the patent rights.
“While Noerr-Pennington may protect Amgen’s petitioning activity, that protection does not attach to prior conduct that maintains monopoly power through anticompetitive means,” the agency wrote.
The brief also argues that pending patent applications can present distinct competitive risks because their owners may revise claims, preserve earlier filing dates and pursue related applications as competing products develop.
Such flexibility can allow a company to shape the eventual scope of patent protection around products already entering the market, potentially extending barriers to competition beyond those associated with an issued patent.
The FTC acknowledged that the 2004 licensing arrangement had received early termination of a federal merger-review waiting period. It argued that the procedural decision neither established the transaction’s legality nor prevented subsequent antitrust scrutiny.
Although the agency filed its brief formally in support of neither party, it urged the appellate court to reject categorical immunity for patent-application acquisitions and private commercial transactions.
The commission authorized the filing by a 2-0 vote.
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