from the United States District Court for the Northern
District of California in No. 3:16-cv-00443-WHA, Judge
William H. Alsup.
P. Hipskind, Berger & Hipskind LLP, Los Angeles, CA,
argued for plaintiff-appellant. Also represented by Dorian S.
N. Frischling, Irell & Manella LLP, Los Angeles, CA,
argued for defendants-appellees. Gilead Sciences, Inc. also
represented by John Preston Long, Yite John Lu, Keith A.
Orso, Jason Sheasby.
Wayne Hoffman, Holland & Knight, LLP, Jacksonville, FL,
for defendant-appellee Japan Tobacco Inc. Also represented by
Neal N. Beaton, New York, NY; Bruce C. Haas, Christopher Earl
Loh, Fitzpatrick, Cella, Harper & Scinto, New York, NY.
Newman, Dyk, and Stoll, Circuit Judges.
Newman, Circuit Judge.
appeal is from the dismissal of a declaratory judgment action
filed by AIDS Healthcare Foundation, Inc.
("Healthcare" or "AHF") against Gilead
Sciences, Inc. et al. ("Defendants") in
the United States District Court for the Northern District of
California. On appellate review, we conclude that this
action does not meet the requirements of the Declaratory
Defendants produce or sell several drug products containing
the antiviral agent tenofovir alafenamide fumarate
("TAF"), which is used in the treatment of AIDS.
The first TAF-containing drug product, brand name
Genvoya®, received FDA approval in November 2015 and is a
combination drug product containing TAF and other specified
antiviral agents. Dist. Ct. Op. at *3. In 2016, the FDA
approved two additional TAF-containing combination
products-Descovy® and Odefesey®-each of which
contains at least one other antiviral agent. Id. The
Defendants have patents or are licensees of patents on TAF
and its combination products.
Healthcare provides medical care to persons afflicted with
AIDS, including providing antiviral drugs such as the TAF
products that Healthcare buys from the Defendants.
Id. Healthcare filed this suit requesting
declarations of invalidity for five patents purportedly
covering TAF and various combination products. Healthcare
told the district court that it brought this declaratory
action in order to "clear out the invalid patents"
so that it "would have the ability then to partner with
generic makers and purchase generic TAF as soon as it could
become available" on expiration of the five-year New
Chemical Entity exclusivity set forth in 21 U.S.C. §
355(j)(5)(F)(ii). Tr. of Hr'g at 17:10-13, June 23, 2016,
ECF No. 102; Dist. Ct. Op. at *4-5.
argued that in view of the lengthy time consumed by
litigating patent validity, such litigation needed to start
well in advance of expiration of the five-year exclusivity
period. See, e.g., AHF Br. 5; Dist. Ct. Op. at *4-5.
Healthcare filed this declaratory action in January 2016, two
months after the FDA approved Gen-voya®-the first
TAF-containing product to receive FDA approval. The other TAF
products were still undergoing clinical trials and FDA
approval procedures. It is undisputed that no unlicensed
source was offering a TAF product or preparing to do so when
this declaratory action was filed.
district court asked Healthcare to clarify its role with
respect to TAF products:
Court: But the Healthcare, AIDS Healthcare is not going to be
manufacturing anything? Or will you even be buying anything?
Counsel: We would be purchasing it . . . .
Court: So AIDS Healthcare Foundation is a consumer?
Counsel: It is a consumer . . . .
Tr. of Hr'g at 16:13-24, June 23, 2016, ECF No. 102.
Healthcare told the district court that it "had reached
out to a number of generic makers" but that "none
of the generic makers wanted to enter the market because
there was the fear of liability because of these
patents." Id. at 17:3-10.
district court ruled that Healthcare's actions in
encouraging others to produce generic TAF products in the
future, and Healthcare's interest in purchasing such
products, did not create a case of actual controversy in
terms of the Declaratory Judgment Act. Dist. Ct. Op. at *5-6.
Healthcare appeals, arguing that there are several grounds on