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Aids Healthcare Foundation, Inc. v. Gilead Sciences, Inc.

United States Court of Appeals, Federal Circuit

May 11, 2018

AIDS HEALTHCARE FOUNDATION, INC., Plaintiff-Appellant
v.
GILEAD SCIENCES, INC., JAPAN TOBACCO INC., Defendants-Appellees JOHNSON & JOHNSON, JANSSEN SCIENCES IRELAND UC, Defendants

          Appeal from the United States District Court for the Northern District of California in No. 3:16-cv-00443-WHA, Judge William H. Alsup.

          Daniel P. Hipskind, Berger & Hipskind LLP, Los Angeles, CA, argued for plaintiff-appellant. Also represented by Dorian S. Berger.

          Gary 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.

          Jerome 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.

          Before Newman, Dyk, and Stoll, Circuit Judges.

          Newman, Circuit Judge.

         This 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.[1] On appellate review, we conclude that this action does not meet the requirements of the Declaratory Judgment Act.

         Background

         The 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.

         Healthcare 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.

         The 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.

         The 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 ...


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