Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC

Because a person of ordinary skill would not have found it obvious to modify the prior art of record to arrive at the claimed invention, trial court ruling of invalidity was reversed.

October 19, 2017

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name:  Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC, No. 2016-2583, 2017 U.S. App. LEXIS 20441 (Fed. Cir. Oct. 19, 2017) (Circuit Judges Dyk, Linn, and Hughes presiding; Opinion by Hughes, J.) (Appeal from D. Del., Sleet, J.) 

Drug Product and Patent(s)-in-Suit: NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring); U.S. Patent No. 5,989,581 (“the ’581 patent”)

Nature of the Case and Issue(s) Presented:  The ’581 patent claimed a contraceptive device. Warner Chilcott conceded infringement. One challenge in the design of the contraceptive device was ensuring that both progestin and estrogen were released at a stable rate. Earlier prior-art designs combined etonogestrel (ETO) and ethinyl estradiol (EE) in a single compartment, but could not properly control the release rate for each compound simultaneously. The ’581 patent purported to solve this problem by providing a contraceptive product made of a polymer that is super-saturated with ETO. Importantly, claims 4 and 11 both required at least a single-compartment that included a progestogenic steroidal compound and an estrogenic steroidal compound. Claim 4, for example, required direct release of “physiologically required amounts” of both compounds from one compartment. Claim 11 likewise required “at least one compartment” to include a “mixture of a progestogenic steroidal compound and an estrogenic steroidal compound” in specific ratios and concentrations.

At trial, Warner Chilcott argued that the asserted claims were anticipated or rendered obvious by International Patent Application WO 97/02015 (“PCT ’015”). Like the ’581 patent, PCT ’015 also disclosed a contraceptive ring that released ETO and EE. PCT ’015, however, relied on a two-compartment design, in which a first compartment included ETO only, and a second compartment included ETO and EE. It also criticized one-compartment vaginal rings. The district court found that PCT ’015 rendered the ’581 patent claims obvious. The district court also found that PCT ’015 disclosed target release rates for ETO and EE, and that “it would have been obvious for a person of skill to derive the claimed ratios of progestin and estrogen” from the target release rates. Merck appealed. The Federal Circuit reversed.

Why Merck Prevailed:  PCT ’015 did not actually disclose a ring with a second compartment that comprised 97% of the ring, and included a higher concentration of ETO than EE in the second compartment. Instead, PCT ’015 disclosed a broad range of values for the relative size of each compartment as well as concentrations of each compound. To arrive at the hypothetical ring that the district court relied on for obviousness, the person of ordinary skill would have had to make the second compartment 97% of the total ring, which was outside of the usual or preferred range disclosed in PCT ’015. And the person of ordinary skill would also have had to pick a concentration of ETO from the high end of the disclosed range, but conversely select a concentration of EE from the low end of the range. Thus the Federal Circuit found that nothing in PCT '015 suggested picking these values out of the innumerable possible combinations of ETO concentrations, EE concentrations, and compartment length ratios. Instead, the only way to arrive at the hypothetical ring was by relying on improper hindsight.

Moreover, PCT ’015 expressly stated that one compartment rings were undesirable because it was difficult to control the release rates for both compounds. Yet the district court found that a person of ordinary skill would have been motivated to use a single compartment to reduce manufacturing costs. But the Federal Circuit reasoned that a person of ordinary skill in the art would pursue “identified, predictable solutions,” not designs that were seemingly inoperable. The dosage rates disclosed in PCT ’015 also applied to a two-compartment ring. So an ordinary artisan would have needed to calculate the relative concentrations for a two-compartment ring, and apply those concentrations to a single compartment, which claim 11 contemplated. But again, PCT ’015 warned that release rates for single compartment rings were difficult to control.

Because it was not obvious to load the claimed concentrations of progestogenic compounds and estrogenic compounds in one compartment, the Federal Circuit reversed the district court’s obviousness finding.

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