AIPPI 2017: Eli Lilly counsel discusses ‘convoluted’ Amgen v Sanofi ruling
A patent counsel at Eli Lilly discussed a recent dispute pitting Amgen against Sanofi and Regeneron, saying an appeals court ruling was convoluted.
Larry Welch, assistant general patent counsel at Eli Lilly, took part in a discussion called “Injunctions: innovator vs. innovator”, at the 2017 AIPPI World Congress in Sydney yesterday, October 16.
Sanofi and Regeneron were ordered to stop selling cholesterol-lowering medicine Praluent (alirocumab) after Amgen obtained an injunction against the companies in January this year.
The judge at the US District Court for the District of Delaware looked at the four eBay v MercExchange factors: irreparable harm; remedies available are inadequate to compensate; that the balance of hardships means a remedy in equity is warranted; and that the public interest would not be disserved by a permanent injunction.
According to Peter Ludwig, senior principal at Fish & Richardson and moderator of the panel, the judge struggled with decision, and public interest was a significant factor.
Ludwig said the public interest factor favoured Sanofi, in that an injunction would be harmful to the public. However, the order was granted anyway.
Amgen had brought a complaint against the companies in October 2014, alleging that they had infringed patents covering the drug Repatha (evolocumab): US numbers 8,829,165 and 8,859,741.
In early October, the US Court of Appeals for the Federal Circuit vacated the injunction in a precedential ruling, finding that the district court had improperly excluded evidence regarding written description and enablement, and had improperly instructed the jury on written description.
“It was a convoluted analysis. The Federal Circuit was kind of chiding the judge for saying that taking the drug off the market would not serve public interest but granting it [the injunction] anyway,” Welch said.
However, the court went on to say that eliminating a choice of drugs is not by itself sufficient to disserve the public interest, he explained.
According to Welch, the criteria used to grant injunctions in the case of innovator v innovator should be different to that used for other cases.
“It all goes back to the public interest factor,” he explained. “If all you’re providing is another choice for consumers, that by itself doesn’t serve the public interest.”
Welch added that generics, by definition, shouldn’t be providing any different therapy to the innovator drug and so public interest isn’t disserved by keeping a generic off the market.
Philip Kerr, senior patent/trademark counsel at Allens, disagreed, claiming that there was no “special reason” why pharmaceutical patents should be treated differently to other patents.
He added that in Australia, the eBay factors would only really come into play when trying to work out whether a preliminary injunction should be granted.
In Germany, it’s “quite easy” to obtain a permanent injunction and a default remedy, explained Dr Matthias Zigann, presiding judge at the Munich Regional Court.
“All patent owners are treated equally; it’s not decisive whether it’s producing the product itself or a non-practising entity. Public interest doesn’t play a role,” he stated.
“We tend to think of public interest in that we need to make this medicine available to the public in the pharma context … but doesn’t public interest also run over to the other side to the question of patent rights? Isn’t it in the public interest to sustain and strengthen and observe patent rights?” Ludwig asked.
The 2017 AIPPI World Congress finishes today, October 17.
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