Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. and Apotex, Inc. et al.
Docket No. 2023-1247 (https://cafc.uscourts.gov/opinions-orders/23-1247.OPINION.5-10-2023_2124577.pdf) (Non-Precedential)
DYK, BRYSON, PROST
May 10, 2023
Brief Summary: DC obviousness findings regarding Vanda’s method of treatment claims affirmed. Summary: Teva and Apotex (“Apotex”) appealed DC holding that its ANDA infringed four claims of four of Vanda’s patents relating to “a method of treating Non-24-Hour Sleep-Wake Disorder (“Non-24”) with tasimelteon” (Hetlioz®). The disputed patents (RE46,604; US 10,149,829; 9,730,910; and 10,376,487) are four of many listed on the FDA’s Orange Book for this product. The FC panel wrote that “[i]n a thorough opinion, the district court held that all four claims were invalid for obviousness” (over combinations of Hack, the ‘244 Publication, and Lankford or Hardeland). Vanda argued the DC erred regarding RE604 claim 3 “in stating that a skilled artisan would look to Hack, a prior art reference that explains that melatonin can be used to entrain blind patients with Non-24, when considering whether there would have been a reasonable expectation that tasimelteon would entrain” (“tasimelteon and melatonin are not identical”, although “tasimelteon has high affinity for both the [melatonin] receptors”), but the FC panel found no error with the DC’s conclusion. Vanda also argued that “none of the prior art references ‘would give a skilled artisan a reasonable expectation of success in using 20mg of tasimelteon . . . to entrain’”, but the FC panel disagreed, finding the evidence “sufficient to support” the DC’s finding. Vanda also argued the DC “erred in its assessment of the objective indicia of non-obviousness” but the FC panel disagreed (e.g., Plant Genetic Sys., FC 2003 (“[t]he fact that the district court did not in its opinion recite every piece of evidence does not mean that the evidence was not considered”); Therasense (FC 2010) (“[O]bjective evidence of non-obviousness fails [when] it is not ‘commensurate in scope with the claims”)). Regarding ‘487 patent claim 5, the FC panel agreed with the DC that “it would have been obvious to try administering tasimelteon without food”, citing KSR (US 2007 (“When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.”) and Valeant (FC 2020 (“If one of these predictable solutions leads to the anticipated success, the combination was obvious to try.”) (e.g., here, “there was market pressure (regulatory advice) to determine if food would have an effect on the efficacy of a drug”)). Regarding ’910 patent claim 4 (“(A) discontinuing the rifampicin treatment and then (B) treating the patient with tasimelteon”) and similar ‘829 patent claim 13, the FC panel agreed with the DC’s obviousness conclusion, finding no error in its conclusion that “a skilled artisan would have looked to the ramelteon art because ramelteon and tasimelteon bind to the same receptors, have similar half lives in the body, and are structurally similar” (Pfizer, FC 2007 (“Obviousness does not require certainty—it requires a reasonable expectation of success”)) and there was no teaching away. The DC decision was therefore affirmed.