PATENT CASE OF THE WEEK

Persion Pharms. LLC v. Alvogen Malta Operations Ltd., Appeal No. 2018-2361 (Fed. Cir. Dec. 27, 2019)

In this week’s Case of the Week, the Federal Circuit affirmed a district court judgment finding asserted claims of related pharmaceutical patents invalid as obvious. The patents claimed extended-release, single-active-ingredient formulations of hydrocodone for treating pain in patients with hepatic impairment, and following a bench trial, the district court found the claims obvious in view of two prior art references, the state of the prior art at the time of the invention, and public labels for existing pharmaceuticals. On appeal, the patentee raised arguments relating to, inter alia, the relevance of certain evidence considered by the district court and the objective indicia of non-obviousness.

For example, the patentee argued that the district court’s consideration of immediate-release, combination formulations was irrelevant to the obviousness of the claimed extended-release, single-active-ingredient formulation. The district court had relied on the FDA’s acceptance of safety data for an immediate-release, hydrocodone-and-ibuprofen drug as part of the application for approval of the claimed formulation, finding that the FDA’s willingness to accept such data supported the view that such “combination” formulations were relevant to a POSITA’s motivation to combine the prior art. The Federal Circuit rejected the patentee’s argument that the obviousness conclusion was undermined because the FDA did not find such data sufficient to establish proper dosage of the claimed formulation, citing with approval the district court’s explanation that “[t]he standard to find a motivation to combine is far below what is sufficient to prove safety and efficacy to the FDA,” and that the fact that the FDA found a given comparison insufficient to satisfy those standards “does not speak to the issue of obviousness.”

As to objective indicia of non-obviousness, the Federal Circuit rejected the patentee’s argument that the district court impermissibly treated asserted objective indicia as an “afterthought relegated to rebutting a prima facie case,” finding that “while the district court’s discussion of objective indicia followed its discussion of the asserted prior art, the substance of the court’s analysis makes clear that it properly considered the totality of the obviousness evidence in reaching its conclusion.” The Court also found no clear error in the district court’s weighing of the objective indicia evidence.

The opinion can be found here.