By Cheryl Beise, J.D.
Two claims of a patent held by Merck Sharp & Dohme B.V. in connection with the company’s popular NuvaRing® contraception vaginal ring device—asserted against a competitor hoping to sell a generic version of NuvaRing®—were not invalid as obvious in light of a prior art reference, the U.S. Court of Appeals for the Federal Circuit has held. The federal district court in Wilmington, Delaware, erred in concluding that an ordinary person of skill in the art would have been motivated to piece together various elements of the cited reference. The district court’s invalidity judgment was reversed and the case remanded (Merck Sharp & Dohme B.V. v. Warner Chilcott Co. LLC, October 19, 2017, Hughes, T.).
Merck Sharp & Dohme B.V. ("Merck") owns U.S. Patent No. 5,989,581 (the ’581 patent), entitled "Drug delivery system for two or more active substances," relating to a drug-delivery vaginal ring device used for contraception. The ring is inserted in the vagina for 21 days, where it releases a constant daily dose of progestin and estrogen. Merck sells the device under the brand name NuvaRing®.
Warner Chilcott Co. LLC filed an Abbreviated New Drug Application (ANDA) seeking Federal Drug Administration approval to market and sell a generic version of NuvaRing®, prompting Merck to file an action for infringement of the ’581 patent in the federal district court in Wilmington, Delaware. Warner Chilcott countered that both asserted claims (dependent claims 4 and 11) were anticipated and rendered obvious by International Patent Application WO 97/02015 (PCT ’015). Following a four day bench trial, the district court concluded that both asserted claims were not anticipated, but were invalid as obvious under 35 U.S.C. §103. Merck appealed the district court’s invalidity judgment. Warner conceded that its generic product would infringe the ’581 patent if the claims were found valid.
The Federal Circuit disagreed with the district court’s obviousness determination. The appeals court noted that claim 4 (depending from claim 1) and claim 11 (depending from claim 5) both require use of a single-compartment that includes a progestogenic steroidal compound and an estrogenic steroidal compound. PCT ’015, on the other hand, discloses a vaginal contraception ring that releases the progestogenic and estrogenic compounds, etonogestrel (ETO) and ethinyl estradiol (EE), using two separate compartments—one loaded with ETO only, and the other loaded with ETO and EE.
The district court found that a person of ordinary skill in the art would have optimized the size of the second compartment of PCT ’015 (to comprise 97% of the ring), to release physiologically required amounts of ETO and EE. However, the Federal Circuit pointed out that the PCT ’015 provides 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, a person of ordinary skill not only would have to make the second compartment so large as to be outside of the usual or preferred range disclosed in PCT ’015, but also would have to select a concentration of ETO from the high end of the disclosed range, an a concentration of EE from the low end of the range.
Moreover, PCT ’015 expressly warned that a one-compartment ring had sub-optimal release patterns. The ’581 patent purportedly solved this problem by supersaturating the ring with a progestogenic compound, a technique not taught in the prior art of record, the Federal Circuit said. Indeed, "the only way to arrive at the hypothetical ring is by using the ’581 patent as a roadmap to piece together various elements of PCT ’015," the Federal Circuit said. "That represents an improper reliance on hindsight."
Concluding that it would not have been obvious to load the claimed concentrations of progestogenic and estrogenic compounds in one compartment, the Federal Circuit reversed the district court’s invalidity judgment and remanded the case.
The case is No. 2016-2583.
Attorneys: Raymond N. Nimrod (Quinn Emanuel Urquhart & Sullivan, LLP) for Merck Sharp & Dohme B.V. George C. Lombardi (Winston & Strawn LLP) for Warner Chilcott Co., LLC. and Warner Chilcott US LLC.
Companies: Merck Sharp & Dohme BV; Warner Chilcott Co., LLC; Warner Chilcott (US) LLC.
MainStory: TopStory FedCirNews
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