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888 F.3d 1231
Fed. Cir.
2018
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Background

  • Merck and Ionis (formerly Isis) prosecuted broad Markush patent applications (leading to U.S. Pat. Nos. 7,105,499 and 8,481,712) claiming classes of nucleoside analogs and methods to treat HCV; Gilead later commercialized sofosbuvir (Sovaldi/Harvoni).
  • Pharmasset (later acquired by Gilead) invented PSI-6130, a single‑ring nucleoside with 2′-methyl (up) and 2′-fluoro (down); Pharmasset disclosed PSI-6130 to Merck under a firewall and confidentiality regime and later published the Clark application claiming PSI-6130.
  • Dr. Phillipe Durette, a Merck chemist-turned-patent-attorney, participated in a March 17, 2004 Merck–Pharmasset call where PSI‑6130’s structure was disclosed despite the agreed firewall; he nevertheless continued to prosecute Merck’s related HCV patent applications.
  • In February 2005, Merck (through Durette) amended claims in the application that became the ’499 patent to a narrower subgenus that encompassed PSI‑6130-type structures; the timing suggested the amendment tracked Pharmasset’s Clark publication.
  • Gilead sued for declaratory judgment of invalidity and noninfringement; the jury found Merck’s patents valid and infringed, but the district court after a bench trial held Merck’s conduct (pre‑litigation firewall breach and Durette’s false testimony) amounted to unclean hands and barred enforcement of both patents; court also awarded fees.

Issues

Issue Gilead's Argument Merck's Argument Held
Whether Merck’s pre‑litigation conduct and litigation testimony support an unclean‑hands defense barring enforcement Merck learned PSI‑6130 improperly via a firewalled call and used that knowledge to amend claims that advantaged its patent position Misconduct was not sufficiently connected or material to the equity sought; internal policies and prosecution differences negate causation Court affirmed: misconduct (firewall breach + continued prosecution) had an immediate/necessary relation to the patents’ enforcement and supports unclean hands
Whether Dr. Durette’s deposition and trial testimony constituted intentional falsehoods that support equitable relief Durette (sponsored by Merck) lied about participating in the March 2004 call and downplayed Pharmasset’s role in the 2005 amendments, infecting Merck’s litigation position Testimony was credible or at least not sufficiently material to bar enforcement Court affirmed: testimony was intentionally false, material to validity/derivation issues, and supports unclean hands
Whether the February 2005 narrowing amendment was causally tied to the improperly acquired knowledge Pharmasset’s disclosure (and Durette’s participation) motivated narrowing to reduce prosecution risk and target PSI‑6130 subgenus The Clark publication and existing claim scope explain the amendment; pre‑amendment claims already encompassed PSI‑6130 so no causal benefit from misconduct Court found adequate evidence that Durette’s knowledge from the call influenced the amendment and that the timing and testimony supported causation
Whether unclean hands as to the ’499 patent also bars enforcement of the related ’712 patent The same misconduct and Durette’s role in prosecuting both patents infected the whole litigation; testimony bore on both patents’ shared specification Misconduct relating to one patent should not automatically defeat unrelated claims under another patent Court held no abuse of discretion: litigation misconduct and Durette’s central role connected both patents such that unclean hands extended to the ’712 patent

Key Cases Cited

  • Keystone Driller Co. v. Gen. Excavator Co., 290 U.S. 240 (1933) (unclean‑hands doctrine bars equitable relief when misconduct has immediate and necessary relation to the matter in litigation)
  • Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806 (1945) (unclean hands prevents equity relief for parties tainted by bad faith related to the controversy)
  • Northbay Wellness Grp., Inc. v. Beyries, 789 F.3d 956 (9th Cir. 2015) (discusses equitable balancing and review standards for unclean‑hands determinations)
  • Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc) (explains limits on inequitable‑conduct findings based on prosecution communications; distinguished but noted)
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Case Details

Case Name: Gilead Sciences, Inc. v. Merck & Co., Inc.
Court Name: Court of Appeals for the Federal Circuit
Date Published: Apr 25, 2018
Citations: 888 F.3d 1231; 2016-2302; 2016-2615
Docket Number: 2016-2302; 2016-2615
Court Abbreviation: Fed. Cir.
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    Gilead Sciences, Inc. v. Merck & Co., Inc., 888 F.3d 1231