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14 December 2020Big PharmaMuireann Bolger

Amgen faces struggle to revive cholesterol patents, says Fed Circ judge

Amgen is unlikely to succeed in its bid to revive its patents for the cholesterol drug Repatha, a judge at the US Court of Appeals for the Federal Circuit has told the pharmaceutical company.

Judge Alan Lourie described the company’s attempt to overturn a decision by the US District Court for the District of Delaware, which invalidated the patents in August 2019, as an “uphill battle” at a hearing on Tuesday, December 9.

Amgen has waged a dispute with Sanofi and Regeneron Pharmaceuticals over the patents since 2014, when it accused its rivals of infringement after they collaborated to create a competitor to Repatha, known as Praluent. Both Repatha and Praulent are used to treat adults whose cholesterol cannot be controlled by diet and statin treatment.

The patents, US numbers 8,829,165 and 8,859,741, cover antibodies which target PCSK9 (proprotein convertase subtilisin/kexin type 9). PCSK9 is an enzyme that binds to and causes certain liver cell receptors to be destroyed, reducing the capacity and effectiveness of the liver cells’ ability to reduce cholesterol.

Sanofi and Regeneron countered by arguing that the patents didn’t adequately describe the invention or explain how to make the full scope of antibodies the patents cover.

In February 2019, a jury for the federal court of Delaware confirmed the validity of the patents but this decision was then overturned at the same court six months later.

According to the revised ruling, the patents failed due to a lack of “enablement”, meaning that the filed application would not have been sufficient to teach a skilled person how to make and/or use the full scope of the claimed invention without undue experimentation.

The court further held that Amgen’s two patents should never have been granted “because it would take a substantial amount of time and effort to enable an expert to recreate the genus of antibodies claimed by the patents”.

It stated that “the fact that you knew that there was gold in the hills and that you knew how to use a pan to find it, doesn’t mean you were entitled to every ounce of gold on every square mile of the California countryside”.

At the hearing this week, Amgen argued that its patents clearly explain how a skilled artisan can identify all 400 distinct antibodies it covered using the standard tools of antibody science.

But Sanofi and Regeneron took issue with the cited number of antibodies, which they said Amgen had never presented to the courts.

They argued, instead, that the number of possible potential antibody candidates is “astronomical if you follow the rules of the patent,” and such an undertaking would be categorised as “undue experimentation”.

Judge Laurie agreed that the companies’ description of the required process to gauge the number of antibody candidates “sounds like undue experimentation, which was a key factor in enablement,” which, he added, meant that it was unlikely that the district court’s August 2019 decision could be reversed.

According to Amgen, Repatha had worldwide sales of $152 million in the second quarter of 2019, while Regeneron reported Praluent sales of $73.7 million for the same period.

LSIPR has approached Amgen for comment.

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