In the ongoing legal battle between Regeneron Pharmaceuticals and Sanofi versus Amgen, the United States Court of Appeals for the Federal Circuit upheld a decision from the District Court for the District of Delaware that found that patent claims asserted by Amgen are invalid based on a lack of enablement. The case started back in 2014, when Amgen sued Sanofi and Regeneron alleging that Praluent infringed on Amgen’s intellectual property, as both drugs are antibodies that target PCSK9 and decrease LDL cholesterol levels. Both drugs were approved within two weeks of each other in July 2016 and have since demonstrated an ability to decrease the risk of heart attacks.
In 2016, a jury affirmed Amgen’s patents and the company won an injunction against sales of Praluent, but that decision was stayed pending an appeal by Sanofi and Regeneron. Through the appeal, Judge Richard Andrews of the United States District Court for the District of Delaware found that Amgen’s claims did not meet the enablement legal standard (clear and convincing evidence must prove that a person of ordinary skill in the art would not be able to practice the claimed invention without “undue experimentation”).
Judge Andrews wrote that “Even taking the testimony in the light most favorable to [Amgen], the testimony of [Amgen’s] own experts indicates that the experimentation necessary to enable the full scope of the claims would take a substantial amount of time and effort.”
The Federal Circuit agreed with Judge Andrews’ assessment surrounding enablement, writing, “To prove that a claim is invalid for lack of enablement, a challenger must show by clear and convincing evidence that a person of ordinary skill in the art would not be able to practice the claimed invention without ‘undue experimentation’” and that challenge is even greater when the “invention is in an unpredictable field of science with respect to satisfying the full scope of the functional limitations,” agreeing with the lower court that the Amgen claims were in such a field.
The Federal Circuit also found that “the evidence showed that the scope of the claims encompasses millions of candidates claimed with respect to multiple specific functions, and that it would be necessary to first generate and then screen each candidate antibody to determine whether it meets the double-function claim limitations.”
This most recent ruling means that Regeneron and Sanofi have invalidated all five of Amgen’s asserted claims.
As one might expect, Regeneron was thrilled with the outcome, releasing a statement saying, “We are pleased with today’s decision by the Federal Circuit, which affirms our longstanding position that Amgen’s patents claiming PCSK9 antibodies purely by their function are overly broad and invalid,” said Joseph LaRosa, Executive Vice President, General Counsel and Secretary of Regeneron. “Praluent was developed using Regeneron’s proprietary technology, and the Federal Circuit validated that Amgen has no claim to Praluent or its development, helping to provide closure on this matter.”