Bonum Certa Men Certa

The Federal Circuit Grapples With Extreme Measures Like Embargoes Over Patents

War on generics, or when judges choose between life and death

Amgen embargoes



Summary: The latest developments from the Federal Circuit (CAFC), which has been increasingly hostile towards patent maximalism in recent years, leading to less frequent death knells by court

THE Federal Circuit (CAFC) and the USPTO have changed a great deal since Alice. It's no longer easy to be granted and then enforce (have upheld) software patents. That's a positive development of course.



We typically write about how the ITC helps US giants embargo their competition, using as little as a few patents and hardly even a proper trial. Based on the "UPDATE FEBRUARY 8" in MIP, the "Federal Circuit has stayed the permanent injunction for Praluent pending Sanofi and Regeneron's appeal. The story published below on February 7 has been updated to reflect this." Well, the story as it originally appeared said this:

Last month’s granting of an Amgen permanent injunction motion in its cholesterol drug patent dispute with Sanofi and Regeneron would “give another arrow in the quiver” of those seeking permanent injunctions in similar cases, if it is upheld on appeal

Saying she was caught "between a rock and a hard place," Judge Sue Robinson in the District Court of Delaware last month decided to grant Amgen’s motion for a permanent injunction against Sanofi and Regeneron in an infringement suit over competing cholesterol drugs.


This is about cholesterol drugs, i.e. a classic case where lives are at stake (notably cardiac problems). What is noteworthy here is that the ruling by CAFC can mean the life (or death) of many people who are unable to afford some overpriced drugs from Amgen. Here is another new article (IAM "report") about CAFC:

Drug manufacturers cannot avoid infringement by dividing method between physicians and patients



[...]

Thus, the Federal Circuit removed any doubt as to whether drug manufacturers may avoid infringement by dividing the steps of a patented method for drug administration between physicians and patients. Under such circumstances, infringement cannot be circumvented by instructing physicians to require that patients perform a step of the method before administration of the generic drug. Accordingly, entities seeking FDA approval to market generic versions of patented drugs should take caution and ensure that any instructions for administration of the drug do not merely divide the steps of a patented method between two or more parties. This case should come as welcome news to many existing patent holders, providing another tool for more effective exclusion of market competitors and potentially increasing the value of patented methods for drug administration.


This simply means that the CAFC chose the side of the maximalists in this case. Who would have trouble sleeping at night? The executives, the judge/s, or those who will die needlessly?

"Who would have trouble sleeping at night? The executives, the judge/s, or those who will die needlessly?""In a short opinion," Patently-O wrote about another CAFC case, "the Federal Circuit has reversed a lower court infringement claim — holding instead that Watson’s generic product does not infringe."

So sometimes they get the balance right. Patently-O's Crouch, separately, has an ongoing rant (and paper) about CAFC's "judgments without opinion" as he calls these [1, 2]. We sure hope that CAFC will be hearing also from affected patients. The EPO certainly does not care about them.

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