CAFC reverses D. Del. on obviousness in vaginal ring (NuvaRing® ) case

Procedurally, this was an appeal by patentee Merck of a finding of obviousness.
The ’581 patent in question relates to a vaginal ring used for contraception,
and its commercial embodiment is sold under
the brand name NuvaRing®. Warner Chilcott is seeking
to introduce a generic version of NuvaRing®, and concedes
that its generic product would infringe the ’581
patent if the claims are found valid.

In an appeal from the United States District Court for the
District of Delaware in No. 1:13-cv-02088-GMS, District Judge
Gregory M. Sleet, the CAFC concluded:


The dosage rates disclosed in PCT ’015, however, apply
to a two-compartment ring. Thus, an ordinary artisan
would need to calculate the relative concentrations for a
two-compartment ring, and apply those concentrations to
a single compartment. But again, PCT ’015 warns that
release rates for single compartment rings are difficult to
control. Indeed, PCT ’015 explains that its design can
achieve consistent release rates because there are two
compartments. See, e.g., J.A. 3040 at ll. 7–23 (describing
how a ring-shaped device containing two separate compartments
fulfills the requirement of a good release
pattern). Therefore, an ordinary artisan would not discard
the two-compartment design but still expect the ring
to deliver a controlled dose of both compounds.

Because it was not obvious to load the claimed concentrations
of progestogenic compounds and estrogenic
compounds in one compartment, we reverse the district
court’s finding of invalidity.



Merck wins.

The district court had treated the issue
as one of obviousness because of routine
optimization:


the court reasoned that “a person of ordinary
skill would have been motivated to optimize PCT ’015
such that the second compartment released physiologically
required amounts of ETO and EE.” J.A. 19–20. The
district court also found that PCT ’015 discloses 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. J.A. 21. Accordingly, the district court held that
claims 4 and 11 are invalid as obvious.