United States v. Gilead Scis., Inc.
| Decision Date | 28 January 2021 |
| Docket Number | C.A. No. 19-2103 (MN) |
| Court | U.S. District Court — District of Delaware |
| Parties | The UNITED STATES of America, Plaintiff/Counterclaim Defendant, v. GILEAD SCIENCES, INC., Defendant/Counterclaim Plaintiff, and Gilead Sciences Ireland UC, Defendant. |
Laura D. Hatcher, Shamoor Anis, U.S. Attorney's Office, Wilmington, DE. Walter W. Brown, Philip Charles Sternhell, Patrick C. Holvey, U.S. Department of Justice, Washington, D.C. – Attorneys for Plaintiff.
Frederick L. Cottrell, III, Kelly E. Farnan, Alexandra M. Ewing, Richards, Layton & Finger, P.A., Wilmington, DE. Ronald C. Machen, Wilmer Cutler Pickering Hale and Dorr LLP, Washington, DC. David B. Bassett, Wilmer Cutler Pickering Hale and Dorr LLP, New York, NY. Vinita C. Ferrera, Emily R. Whelan, George P. Varghese, Timothy A. Cook, Wilmer Cutler Pickering Hale and Dorr LLP, Boston, MA. – Attorneys for Defendants.
On May 29, 2020, Defendants Gilead Sciences, Inc. ("Gilead") and Gilead Sciences Ireland UC ("Gilead Ireland") (collectively, "Defendants") filed their Second Amended Answer and Affirmative Defenses and Gilead's Second Amended Counterclaims (D.I. 21) ("the Second Amended Answer"). Before the Court are a motion to strike (D.I. 29) the equitable defenses raised in the Second Amended Answer and a motion to dismiss (D.I. 30) Gilead's counterclaims of noninfringement and invalidity, which were filed by the United States of America ("Government" or "Plaintiff") on June 26, 2020. Both motions were fully briefed, (D.I. 29, 30, 35, 36, 40, 41), and the Court heard argument on October 30, 2020, (D.I. 60). For the reasons set forth below, Plaintiff's motion to strike and motion to dismiss will be DENIED.
The Government alleges that the Department of Health and Human Services (HHS) is, by virtue of its administrative control of the Centers for Disease Control and Prevention (CDC), the owner of U.S. Patent Nos. 9,044,509 ("the ’509 Patent"), 9,579,333 ("the ’333 Patent"), 9,937,191 ("the ’191 Patent") and 10,335,423 ("the ’423 Patent") (collectively, "the Patents-in-Suit"). (D.I. 1 ¶ 10, 12). The Patents-in-Suit relate to two-drug regimens, known as pre-exposure prophylaxis (PrEP), which were developed by researchers at CDC in the mid-2000s and effectively prevent new HIV infections
. (Id. ¶ 2, 5). These regimens consist of (1) emtricitabine (FTC) and (2) tenofovir or a tenofovir prodrug. (Id. ¶ 2). Truvada and Descovy, medications developed by Gilead, each contain FTC and a tenofovir prodrug. (Id. ¶¶ 47–49, 54). Gilead received approval from the U.S. Food and Drug Administration (FDA) to sell Truvada
as a PrEP regimen on July 16, 2012. (D.I. 21 at 94 ¶ 14). Descovy was approved as a PrEP regimen by the FDA on October 3, 2019. (D.I. 1 ¶ 57).
Between 2004 and 2008, Gilead and CDC executed several Material Transfer Agreements ("MTAs"), pursuant to which Gilead provided CDC with FTC, tenofovir, and tenofovir disoproxil fumarate (TDF)2 for use in CDC research. (Id. ¶ 120; see, e.g. , D.I. 1, Ex. 30). Pursuant to amendments to an MTA executed in 2005, Gilead continued to provide materials to CDC until 2014. (D.I. 21 at 73 ¶¶ 31–32).
Under the terms of the MTAs, CDC was to "promptly disclose to [Gilead] all results, data, and other information or materials derived from" any materials and confidential information provided by Gilead, as well as to "promptly notify [Gilead] of any Inventions." (D.I. 1 ¶¶ 122–23). In addition to the MTAs, the Government and Gilead entered into a Clinical Trial Agreement ("CTA"). (D.I. 21 at 75 ¶ 37). Under the CTA, Gilead agreed to provide antiviral products for a clinic trial about HIV prevention in Botswana, and the Government agreed "to put the results of the Trial, patentable or otherwise, in the public domain for all to use without obligation or compensation to CDC" as well as "not to seek patent protection in connection with any inventions that derive from the use of the Study Drug in the Trial." (Id. ).
CDC filed U.S. Provisional Patent Application No. 60/764,811 ("the ’811 Provisional") on February 3, 2006. (D.I. 1 ¶ 128). On January 31, 2007, CDC filed U.S. non-provisional patent Application No. 11/669,547 ("the ’547 Application"), claiming priority to the ’811 Provisional. (Id. ). All Patents-in-Suit claim priority to the ’811 Provisional and ’547 Application.
The inventions described in the ’811 Provisional and the ’547 Application were the result of the studies described in the MTAs, for which Gilead provided drugs to CDC. (D.I. 21 at 74 ¶ 36). The Government relied on information derived from the Botswana trial contemplated in the CTA to make decisions concerning prosecution of the ’547 Application. (Id. at 75 ¶ 37). The Government breached its obligations under the MTAs and CTA because it "not only filed patent applications seeking patent protection for purported ‘Inventions’ derived from the use of the compounds Gilead supplied under the MTAs and CTA, but also failed to disclose to Gilead the purported invention(s)." (Id. at 75 ¶ 38). Further, the Government did not provide notice of the claimed inventions until October 2014 at the earliest and did not assert that Gilead required a license under the Patents-in-Suit until March 11, 2016. (Id. ).
During prosecution of the Patents-in-Suit, the Government allegedly, knowingly, and willfully failed to provide material information to the Patent Office relating to the inventiveness of the claimed inventions. (Id. at 77 ¶ 45). In August 2019, Gilead filed petitions for inter partes review of claims 1–18 of the ’509 Patent, see Petition, No. IPR2019-01453 (P.T.A.B. Aug. 21, 2019), and claims 1–17 of the ’333 Patent, see Petition, No. IPR2019-01454 (P.T.A.B. Aug. 21, 2019) (collectively, "the IPR Petitions"). Among the prior art asserted in the IPR Petitions were CDC's 2005 guidelines on post-exposure prophylaxis (PEP)3 ("the CDC-PEP Guidelines"). (D.I. 21 at 78 ¶ 47; see D.I. 21, Ex. J). The CDC-PEP Guidelines were published on January 21, 2005, more than one year before the February 3, 2006 filing of the ’811 Provisional. (D.I. 21 at 79 ¶ 49; see also D.I. 1 ¶ 128). Two of the named inventors of the Patents-in-Suit, Robert Janssen and Ronald Otten, were identified as "federal consultants" for the CDC-PEP Guidelines. (D.I. 21 at 78 ¶ 47). The CDC-PEP Guidelines identified a combination of TDF and FTC as "one of two ‘preferred’ backbone combinations" for use in PEP and noted that Truvada
is an oral formulation containing a combination of TDF and FTC. (Id. at 78 ¶ 48).
The Government did not disclose the CDC-PEP Guidelines to the Patent Office during prosecution of the ’509 Patent and ’333 Patent, and the examiners did not consider the CDC-PEP Guidelines. (Id. at 79 ¶ 52). Individuals with a duty to disclose material information during prosecution, such as named inventors and prosecuting attorneys, allegedly failed to disclose the CDC-PEP Guidelines during prosecution of the ’509 Patent and ’333 Patent. (Id. at 82 ¶ 62). Defendants allege that claims 12–18 of the ’509 Patent and claims 12–17 of the ’333 Patent are anticipated by the CDC-PEP Guidelines, and that reference renders all challenged claims of the ’509 and ’333 Patents obvious. (Id. at 79 ¶ 53). Furthermore, claim 12 and dependent claims 12–18 of the ’509 Patent and claim 12 and dependent claims 14–17 of the ’333 Patent do not specify that the two-drug regimen must be administered prior to an actual or potential exposure to HIV, which is a key difference between PEP and PrEP. (Id. at 80 ¶¶ 54–55).
The Government also did not disclose the CDC-PEP Guidelines in its initial application for what would later issue as the ’191 Patent, and did not alert the examiner to the alleged materiality of the reference even when it eventually disclosed the CDC-PEP Guidelines two months after the original filing. (Id. at 80 ¶ 59). After that disclosure, the examiner rejected claims in reliance on the CDC-PEP Guidelines, "noting that [the reference] disclosed the use of Truvada® for PEP purposes and that it would have been obvious to treat uninfected individuals ‘who are exposed to or at risk of exposure to HIV’ with Truvada®." (Id. at 82 ¶ 61 (citing D.I. 21, Ex. O at 5–6)). Following this rejection, the patent application was amended to include a limitation confining the claim to pre-exposure administration. (Id. at 82 ¶ 61 (citing D.I. 21, Ex. P at 3)).
In addition, the Government allegedly encouraged the prescription and public use of Truvada for PrEP purposes even before the FDA approved Truvada for that purpose in 2012. (Id. at 67 ¶ 5). In January of 2011, CDC issued guidelines that identified "1 tablet of Truvada ... daily as part of [b]eginning [a] PrEP medication regimen." (Id. (internal quotations omitted)). The Government "actively encouraged [Gilead] to seek FDA approval for the PrEP indication for Truvada," (id. ), and Truvada had already been publicly used for PrEP "before the inventions of the [Patents-in-Suit] and/or more than one year before the earliest priority date to which each claim of the [Patents-in-Suit] is entitled," (id. at 96 ¶ 20). The Government alleges that Truvada had earned Gilead more than $3 billion from global sales in 2012, (D.I. 1 ¶ 174; D.I. 1, Ex. 63 at 3), and more than $6.7 billion from domestic sales since the ’509 Patent was issued in mid-2015, (id. ¶ 255).
On November 6, 2019, the Government filed this suit against Defendants. The Government alleges that Gilead's actions with respect to Truvada and Descovy for PrEP constitute willful infringement of the ’509 Patent and the ’423 Patent. (D.I. 1 ¶¶ 282–85, 307–10). It further alleges that Gilead's actions with respect to Truvada for PrEP constitute willful infringement of the ’333 Patent and the ’191 Patent. (Id. ¶¶ 291–94, 299–302).
Defendants filed their Answer and Affirmative Defenses and Gilead's Counterclaims (D.I. 7) on ...
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...to PrEP, alleged that Gilead had infringed those rights, and sought damages. 229 See Complaint, United States v. Gilead Scis., Inc., 515 F. Supp. 3d 241 (D. Del. Nov. 6, 2019) (No. 19-cv-2103), 2019 WL 5942984. On May 9, 2023, Gilead prevailed in a jury trial. See Judgment Following Jury Ve......