Gilead Sciences, Inc. v. Merck & Co, Inc. et al

Filing 254

ORDER APPROVING 229 JOINT PRETRIAL STATEMENT AND ORDER. Signed by Judge Beth Labson Freeman on 2/25/2016. (blflc3S, COURT STAFF) (Filed on 2/25/2016)

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John M. Farrell (CA Bar No. #99649)
[e-mail]
FISH & RICHARDSON P.C.
500 Arguello Street, Suite 500
Redwood City, CA 94063
Telephone: [phone]
Facsimile: [phone]
Jonathan E. Singer (CA Bar No. #187908)
[e-mail]
FISH & RICHARDSON P.C.
3200 RBC Plaza
60 South Sixth Street
Minneapolis, MN 55402
Telephone: [phone]
Facsimile: [phone]

Attorneys for Plaintiff
GILEAD SCIENCES, INC.
Additional counsel listed on signature page

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UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF CALIFORNIA
SAN JOSE DIVISION

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GILEAD SCIENCES, INC.,
Plaintiff,

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Joshua H. Lerner (SBN 220755)
[e-mail]
Laura E. Miller (SBN 271713)
[e-mail]
DURIE TANGRI LLP
217 Leidesdorff Street
San Francisco, CA 94111
Telephone: [phone]
Facsimile: 415-236-6300
Attorneys for Defendants
MERCK & CO., INC., MERCK SHARP &
DOHME CORP. and ISIS
PHARMACEUTICALS, INC.

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Bruce R. Genderson (Pro Hac Vice)
[e-mail]
Jessamyn S. Berniker (Pro Hac Vice)
[e-mail]
Stanley E. Fisher (Pro Hac Vice)
[e-mail]
WILLIAMS & CONNOLLY LLP
725 Twelfth Street, N.W.
Washington, D.C. 20005
Telephone: [phone]
Facsimile: [phone]

Juanita R. Brooks (CA Bar No. #75934)
[e-mail]
FISH & RICHARDSON P.C.
12390 El Camino Real
San Diego, CA 92130
Telephone: [phone]
Facsimile: [phone]

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Stephen S. Rabinowitz
[e-mail]
Patrice P. Jean (Pro Hac Vice)
[e-mail]
Mitchell Epner (Pro Hac Vice)
[e-mail]
HUGHES HUBBARD & REED LLP
One Battery Park Plaza
New York, NY 10004
Telephone: [phone]
Facsimile: [phone]

v.

Case No. 5:13-cv-04057-BLF/PSG
[PROPOSED] JOINT PRETRIAL
STATEMENT AND ORDER

MERCK & CO, INC., MERCK SHARP &
DOHME CORP. and ISIS
PHARMACEUTICALS, INC.,
Defendants

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

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I.

THE ACTION
A. Parties
Plaintiff Gilead Sciences, Inc. (“Plaintiff” or “Gilead”) and Defendants Merck & Co., Inc.

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(“Merck & Co.”), Merck Sharp & Dohme Corp (“MSD Corp.”), and Ionis Pharmaceuticals, Inc.

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(“Ionis”), formerly known as Isis Pharmaceuticals, Inc., (collectively, “Defendants” or “Merck”)

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are the parties that will appear at trial.

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B. Substance of the Action
Gilead manufactures and sells sofosbuvir, the active ingredient of orally administered
drugs prescribed for the treatment of chronic hepatitis C (“HCV”) infection. Merck & Co. is the

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corporate parent of MSD Corp. MSD Corp. and Ionis are joint assignees of two patents: U.S.

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Patent Nos. 7,105,499 (“the ’499 patent”) and 8,481,712 (“the ’712 patent”) (collectively, “Merck

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Patents”), both titled “Nucleoside Derivatives as Inhibitors of RNA-Dependent RNA Viral

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Polymerase.” On August 30, 2013, Gilead initiated this action for declaratory judgment pursuant

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to 28 U.S.C. §§ 2201 and 2202. In its complaint, Gilead alleged that the manufacture, use, offer

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for sale, and/or importation of sofosbuvir and the drug product that is the subject of the first

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sofosbuvir NDA has not infringed, does not infringe, and would not, if marketed, infringe, directly

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or indirectly, any valid claim of the ’499 or ’712 patents and that the ’499 and ’712 patents are

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invalid. (ECF No. 1.) MSD Corp. and Ionis (collectively, “Counterclaimants”) asserted

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counterclaims, seeking declaratory judgment that Gilead’s marketing of sofosbuvir, following

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FDA approval, would induce and contribute to infringement of the ’499 and ’712 patents and

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seeking compensatory damages for infringement arising from any commercial sale and offer for

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sale of sofosbuvir by Gilead. (ECF Nos. 51, 62.) On December 6, 2013, the FDA approved

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Gilead’s NDA 204671 for sofosbuvir (SOVALDI®) used in combination with other drugs as a

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once daily oral therapy for chronic HCV infection. On October 10, 2014, the FDA approved

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Gilead’s NDA 205834 for sofosbuvir used in combination with ledipasvir (HARVONI®) as a once

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daily oral therapy for chronic HCV infection. Gilead makes, sells, and offers to sell sofosbuvir

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(SOVALDI® and HARVONI®) in the United States for treatment of HCV infection. On

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

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November 28, 2014, the Counterclaimants filed amended and supplemental counterclaims seeking

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a judgment that Gilead’s marketing of sofosbuvir induces and contributes to infringement of the

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’499 and ’712 patents and seeking damages for infringement from Gilead’s commercial sale and

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offer for sale of its sofosbuvir products. (ECF No. 98).
Counterclaimants contend that Gilead’s marketing and sale of SOVALDI® and

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HARVONI® induces and contributes to direct infringement of claims 1 and 2 of the ’499 patent

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and claims 1–3, 5, 7, and 9–11 of the ’712 patent by patients and caregivers who use these

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products.1 Induced infringement under 35 U.S.C. §271(b) is present when a person actively

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induces infringement of a patent, knowing of the patent and that the acts induced constitute

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infringement. Contributory infringement under 35 U.S.C. § 271(c) is present when a person offers

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to sell or sells within the United States a component of a patented manufacture or composition, or

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a material for use in practicing a patented process, knowing the same to be especially made or

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especially adapted for use in an infringement of such patent, and not a staple article or commodity

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of commerce suitable for substantial noninfringing use. On February 1, 2016, this Court granted

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summary judgment of infringement. (ECF No. 214).2 The Court further determined that, whether

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the jury should be informed of this Court’s entry of judgement of infringement, and if so, how it

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should be presented, are issues better left for the final pretrial conference. (ECF No. 214).

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Gilead alleges that each of the asserted claims of the patents-in-suit are invalid on the
following grounds:3


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The asserted claims of the ’499 patent and the ’712 patent are invalid for failure to

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meet the enablement requirement of 35 U.S.C. § 112, ¶ 1. Gilead’s position is that, a

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patent’s description of the claimed invention must be sufficiently full and clear to

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Defendants’ infringement allegations are found in their Second Amended and Supplemental
Counterclaims (ECF No. 98) and in their Amended Disclosure of Asserted Claims and
Infringement Contentions, served on Gilead on June 6, 2016.
Gilead objects to the Court’s claim construction of the term “administering” in the claims of
the ’499 patent (ECF No. 140), and reserves the right to appeal or otherwise contest that
construction in further proceedings in this litigation. The Court adopted the parties’ agreed
construction of the term “compound” as used in the asserted claims of the ’712 patent.
Gilead’s invalidity defenses are found in its Complaint, (ECF No. 1, ¶¶ 68, 76), and in
Gilead’s Amended Invalidity Contentions, served on Defendants on June 16, 2015.

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

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enable a person of ordinary skill in the field at the time of filing to make and use the

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full scope of the claimed invention, and must disclose a practical utility for the claimed

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invention. Merck’s position is that a patent’s description of the claimed invention must

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be sufficiently full and clear as to enable a person of ordinary skill in the field at the

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time of filing to practice the claimed invention, and must disclose a practical utility for

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the claimed invention. Gilead contends that the asserted claims of the Merck Patents

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fail to satisfy the “how-to-make,” “how-to-use,” and practical utility subconditions of

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the enablement requirement.

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

The asserted claims of the ’499 patent and the ’712 patent are invalid for failure to

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meet the written description requirement of 35 U.S.C. § 112, ¶ 1. To satisfy the written

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description requirement, the applicant must reasonably convey to those skilled in the

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art that, as of the priority date, he or she was in possession of the claimed invention.

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The asserted claims of the ’499 patent and the ’712 patent are invalid for derivation and

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lack of inventorship under 35 U.S.C. § 102(f) and (g). Under § 102(f), a person is not

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entitled to a patent if “he did not himself invent the subject matter sought to be

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patented.” Under § 102(g), a person is not entitled to a patent if, before the person’s

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invention thereof, the invention was made in this country by another inventor who had

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not abandoned, suppressed, or concealed it.

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The asserted claims of the ’499 patent and the ’712 patent are invalid as anticipated by

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U.S. Patent Application Publication No. 2005/0009737 (“Clark”), under 35 U.S.C. §

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102, to the extent the claims are not entitled to a priority date before Clark published on

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January 13, 2005. For a claim to be invalid as anticipated, all of its requirements must

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have existed in a single device or method that predates the claimed invention, or must

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have been described in a single previous publication or patent that predates the claimed

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invention.

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

The asserted claims of the ’712 patent are invalid as anticipated by Sofia et al.,
“Discovery of a β-D-2’Deoxy-2’-α-fluoro-2’-β-C-methyluridine Nucleotide Prodrug
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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

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(PSI-7977) for the Treatment of Hepatitis C Virus,” J. Med. Chem., 53:7202–7218

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(2010) (“Sofia”), under 35 U.S.C. § 102, to the extent the claims are not entitled to a

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priority date before Sofia published on September 16, 2010. For the claim to be invalid

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as anticipated, all of its requirements must have existed in a single device or method

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that predates the claimed invention, or must have been described in a single previous

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publication or patent that predates the claimed invention.
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The asserted claims of the ’499 patent are invalid as indefinite under 35 U.S.C. § 112,

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¶ 2. A claim is invalid for indefiniteness if its language, when read in light of the

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specification and the prosecution history, fails to inform, with reasonable certainty,

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those skilled in the art about the scope of the claimed invention.

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Merck denies Gilead’s allegations of invalidity, and asserts that Gilead cannot meet its burden of

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proving by clear and convincing evidence that the asserted claims of the patents-in-suit are invalid.

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Merck also asserts that some of these invalidity grounds are not cognizable in this case as a matter

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of law.

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As identified in its Answer to Defendants’ Amended Counterclaims, (ECF No. 67), Gilead

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also asserts equitable defenses to the counterclaims of infringement. These equitable defenses as

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asserted by Gilead are:

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Laches. Laches requires that (a) the patentee’s delay in bringing suit was unreasonable

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and inexcusable, and (b) the alleged infringer suffered material prejudice attributable to

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the delay.

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Waiver. Waiver requires that a patentholder, with full knowledge of the material facts,

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intentionally relinquish its patent enforcement rights or act in a manner that is so

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inconsistent with an intent to enforce its rights as to induce a reasonable belief that

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such right has been relinquished.

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Estoppel. Equitable estoppel requires that (a) the patentholder, through misleading

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conduct, leads the alleged infringer to reasonably infer that the patentholder does not

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intend to enforce its patent against the alleged infringer; (b) the alleged infringer relies

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

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on that conduct; and (c) due to its reliance, the alleged infringer will be materially

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prejudiced if the patentee is allowed to proceed with its claim.

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Unclean hands. A showing of unclean hands requires that one coming for relief have

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committed some unconscionable act immediately and necessarily related to the equity

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that he seeks in respect of the matter in litigation.

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Merck denies these Gilead allegations and asserts that Gilead cannot meet its burden of proving

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them. Merck also asserts that some of these equitable defenses are not cognizable in this case as a

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matter of law.

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C. Relief Sought
Gilead’s Position
Gilead seeks the following relief (described in its Complaint, ECF No. 1):
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A declaration that the asserted claims of the ’499 patent and the ’712 patent are
invalid under 35 U.S.C. §§ 102 and/or 112.

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A declaration that the asserted claims of the ’499 patent and the ’712 patent are

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unenforceable against Gilead under the equitable doctrines of laches, waiver,

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estoppel, and/or unclean hands.

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A declaration that Gilead does not infringe any valid claim of the ’499 patent or the
’712 patent.

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An injunction enjoining Defendants and their agents, representatives, attorneys,

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employees, and those persons in active concert or participation with them who

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receive actual notice herefrom from threatening or initiating infringement litigation

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against Gilead or its customers, dealers, or suppliers, or any prospective or present

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sellers, dealers, distributors or customers of Gilead, or charging them either orally

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or in writing with infringement of the ’499 or ’712 patents.

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A finding that Defendants are not entitled to any damages.

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

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A judgment that this is an “exceptional case” justifying the award of Gilead’s

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reasonable attorneys’ fees, expenses, and costs in this action under 35 U.S.C. § 285

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both until the time of trial and thereafter.

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Merck’s Position

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Merck seeks the following relief (described in the Second Amended and Supplemental
Counterclaims, ECF No. 98):
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A judgment that Gilead’s commercial sale and offer for sale of sofosbuvir induces
and contributes to infringement of the ’499 patent and the ’712 patent.

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An Order dismissing Gilead’s complaint with prejudice and entering judgment in
favor of Merck.

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Damages adequate to compensate Merck for past infringement from Gilead’s

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commercial sale and offer for sale of sofosbuvir, in the form of a reasonable royalty

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on past U.S. sales of SOVALDI® and HARVONI® and including pre- and post-

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judgment interest.

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A reasonable royalty for Gilead’s ongoing and future infringement.

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A judgment that this case is “exceptional” justifying an award of Merck’s

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reasonable attorneys’ fees, expenses and costs under 35 U.S.C. § 285, both until the

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time of trial and thereafter.

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D. Federal Jurisdiction and Venue

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The Parties agree that this Court has subject matter jurisdiction under 28 U.S.C. §§ 1331

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and 1338. Personal jurisdiction and venue are not disputed.

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II.

FACTUAL BASIS FOR ACTION

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A.

Undisputed facts

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1.

Gilead is a company organized and existing under the laws of the State of Delaware

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with its principal place of business at 333 Lakeside Drive, Foster City, California 94404.

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

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2.

Merck & Co. is a company organized under the laws of the State of New Jersey

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with its principal place of business at One Merck Drive, P.O. Box 100, Whitehouse Station, NJ

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08889-0100.

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3.

MSD Corp. is a company organized under the laws of the State of New Jersey with

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its principal place of business at One Merck Drive, P.O. Box 100, Whitehouse Station, NJ 08889-

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0100.

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4.

MSD Corp. is a subsidiary of Merck & Co.

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5.

Ionis is a company organized under the laws of the State of Delaware with its

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principal place of business at 2855 Gazelle Court, Carlsbad, CA 92010.

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6.

MSD Corp. and Ionis are co-owners of the ’499 patent.

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7.

The ’499 patent issued on September 12, 2006.

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MSD Corp. and Ionis are the co-owners of the ’712 patent.

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9.

The ’712 patent issued on July 9, 2013.

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10.

In this action, Merck relies on a priority date of January 18, 2002 for the ’499 and

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’712 patents.

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filed by Merck on January 18, 2002.

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12.

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All facts admitted to in the Requests For Admissions identified in Appendix D and

Appendix E to this pre-trial order.

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The applications that ultimately issued as the ’499 and ’712 patents-in-suit were

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All facts admitted to in the Joint Stipulation filed September 29, 2015 (Dkt. No.

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All facts admitted to in the parties’ statements of undisputed facts in their summary

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judgment papers. (Dkt. Nos. 167-1 and 177-22).
B. Disputed Facts
Gilead’s Statement

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

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1.

Whether there is clear and convincing evidence that the inventions in each of the

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asserted claims of the ’499 patent were derived from information disclosed to Merck by

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Pharmasset regarding the work of Jeremy Clark.

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2.

Whether there is clear and convincing evidence that the inventions in each of the

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asserted claims of the ’712 patent were derived from information disclosed to Merck by

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Pharmasset regarding the work of Jeremy Clark.

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3.

Whether any delay by Merck in asserting the ’499 patent was unreasonable and

inexcusable and, if so, whether Gilead suffered a material prejudice as a result of any such delay.
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Whether any delay by Merck in asserting the ’712 patent was unreasonable and

inexcusable and, if so, whether Gilead suffered a material prejudice as a result of any such delay.
5.

Whether Merck’s conduct during its interactions with Pharmasset was misleading,

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whether that misleading conduct led Pharmasset and Gilead to a reasonable belief that Merck did

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not intend to assert any patent rights and, if so, whether Pharmasset and Gilead relied upon that

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conduct and have suffered material prejudice as a result of that reliance.

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6.

Whether there is clear and convincing evidence that the inventions claimed by the

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’499 patent had first been made in the United States by Jeremy Clark, and whether Jeremy Clark

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abandoned, suppressed, or concealed his invention.

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7.

Whether there is clear and convincing evidence that, as of January 18, 2002, the

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specification for the ’499 patent did not teach a person of ordinary skill in the art to make the

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compounds and all of their prodrugs encompassed by the full scope of the asserted claims of the

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’499 patent, without undue experimentation.

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8.

Whether these is clear and convincing evidence that, as of January 18, 2002, the

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specification for the’499 patent did not teach a person of ordinary skill in the art how to use the

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compounds and all of their prodrugs encompassed by the full scope of the asserted claims of the

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’499 patent, according to the method described by the asserted claims, without undue

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experimentation.

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

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9.

Whether there is clear and convincing evidence that, as of January 18, 2002, the

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specification for the ’499 patent did not disclose to a person of ordinary skill in the art a pratical

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utility for using the compounds and all of their prodrugs encompassed by the full scope of the

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asserted claims of the ’499 patent according to the method described by the asserted claims.

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10.

Whether there is clear and convincing evidence that, as of January 18, 2002, the

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specification for the ’499 patent did not disclose to a person of ordinary skill in the art that the

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inventors of the ’499 patent had possession of a method of treating HCV infection by

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administering the claimed genus of compounds and all possible prodrugs either alone or in

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combination with the active agents listed in claim 2 of the ’499 patent.

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Whether there is clear and convincing evidence that the inventions claimed by the

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’712 patent had first been made in the United States by Jeremy Clark, and whether Jeremy Clark

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abandoned, suppressed, or concealed his invention.

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12.

Whether there is clear and convincing evidence that, as of January 18, 2002, the

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specification for the ’712 patent did not teach a person of ordinary skill in the art to make the

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compounds encompassed by the full scope of the asserted claims of the ’712 patent, without undue

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experimentation.

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13.

Whether these is clear and convincing evidence that, as of January 18, 2002, the

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specification for the ’712 patent did not teach a person of ordinary skill in the art how to use the

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compounds encompassed by the full scope of the asserted claims of the ’712 patent without undue

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experimentation.

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14.

Whether there is clear and convincing evidence that, as of January 18, 2002, the

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specification for the ’712 patent did not disclose to a person of ordinary skill in the art a pratical

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utility for the compounds encompassed by the full scope of the asserted claims of the ’712 patent.

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15.

Whether there is clear and convincing evidence that, as of January 18, 2002, the

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specification for the ’712 patent did not disclose to a person of ordinary skill in the art that the

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inventors of the ’712 patent had possession of the claimed compounds.

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

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16.

Whether Merck’s delay in asserting its patent rights or in making any claim of

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rights to PSI-6130 or PSI-7977 amounted to a knowing relinquishment of its patent rights or

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induced a reasonable belief in Gilead that such rights had been relinquished.

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17.

If the ’499 patent is found to be valid and enforceable, the amount of the reasonable

royalty to which Merck is entitled.
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If the ’712 patent is found to be valid and enforceable, the amount of the reasonable

royalty to which Merck is entitled.

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Merck’s Statement
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Whether there is clear and convincing evidence that a person of ordinary skill in the

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art would not have been able to practice any of the asserted claims of the ’499 patent without

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undue experimentation as of January 18, 2002. 

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20.

Whether there is clear and convincing evidence that the inventions in each of the

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asserted claims of the ’499 patent had first been made in the United States by Jeremy Clark before

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January 18, 2002, and whether Jeremy Clark abandoned, suppressed, or concealed any such

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alleged invention.

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21.

Whether there is clear and convincing evidence that the specification of the ’499

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patent, as filed on January 18, 2002, does not convey to a person of ordinary skill in the art that

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the inventors were in possession of the invention as claimed in any of the asserted claims of the

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’499 patent.

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22.

Whether there is clear and convincing evidence that, as of January 18, 2002, a

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person of ordinary skill in the art would not have been able to practice any of the asserted claims

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of the ’712 patent without undue experimentation.

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23.

Whether there is clear and convincing evidence that the inventions in each of the

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asserted claims of the ’712 patent had first been made in the United States by Jeremy Clark before

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January 18, 2002, and whether Jeremy Clark abandoned, suppressed, or concealed any such

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alleged invention.

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

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24.

Whether there is clear and convincing evidence that the specification of the ’712

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patent, as filed on January 18, 2002, does not convey to a person of ordinary skill in the art that the

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inventors were in possession of the invention as claimed in any of the asserted claims of the ’712

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patent.

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25.

the ’499 patent is not supported by a practical utility.

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26.

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Whether Merck delayed in asserting the ’499 patent after Gilead’s infringement of

that patent had begun and Gilead suffered material prejudice as a result.

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Whether there is clear and convincing evidence that each of the asserted claims of

the ’712 patent is not supported by a practical utility.

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Whether there is clear and convincing evidence that each of the asserted claims of

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Whether Merck delayed in asserting the ’712 patent after Gilead’s infringement of

that patent had begun and Gilead suffered material prejudice as a result.

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Whether any delay by Merck in asserting its patent rights amounted to a knowing

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and intentional relinquishment of its patent rights or was so inconsistent with an intent to enforce

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its rights that it induced a reasonable belief in Gilead that such rights had been relinquished.

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30.

The amount of the reasonable royalty to which Merck is entitled to compensate for

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Gilead’s past, ongoing, and future infringement of the ’499 and ’712 patents.

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III.

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DISPUTED LEGAL AND EQUITABLE ISSUES
The parties are in agreement as to the disputed legal issues relevant to most claims and

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defenses, and those agreed-to areas of dispute are listed in the “Joint Statement,” below. The

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parties do not agree as to the disputed legal issues relevant to some of Gilead’s invalidity defenses

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and, therefore, have included separate statements regarding those defenses.

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Joint Statement

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1.

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Whether any of the asserted claims of the ’499 patent are entitled to a priority date

of January 18, 2002.

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

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2.

Whether Gilead can show by clear and convincing evidence that each of the

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asserted claims of the ’499 patent is invalid under 35 U.S.C. § 112 for failure to disclose a

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practical utility for the claimed methods.

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3.

Whether Gilead can show by clear and convincing evidence that each of the

asserted claims of the ’499 patent is invalid under 35 U.S.C. § 112, for indefiniteness.
4.

Whether any of the asserted claims of the ’712 patent are entitled to a priority date

of January 18, 2002.
5.

Whether Gilead can show by clear and convincing evidence that each of the

asserted claims of the ’712 patent is invalid under 35 U.S.C. § 112 for failure to disclose a
practical utility for the claimed compounds.
6.

Whether Gilead can meet its burden of proving that Merck’s claims for

infringement are barred by the doctrine of laches.
7.

Whether Gilead can meet its burden of proving that Merck’s claims for

infringement are barred by the doctrine of waiver.
8.

Whether Gilead can meet its burden of proving that Merck’s claims for

infringement are barred by the doctrine of equitable estoppel.
9.

Whether Gilead can meet its burden of proving that Merck’s claims for

infringement are barred by the doctrine of unclean hands.
10.

Whether Gilead is entitled to an injunction enjoining Merck and its agents from

20

threatening or initiating infringement litigation against Gilead or its customers, dealers, or

21

suppliers or charging them either orally or in writing with infringement of the ’499 or ’712

22

patents.

23
24
25
26

11.

Whether Merck is entitled to an Order dismissing Gilead’s Complaint with

prejudice and entering judgment in favor of Defendants and Counterclaim Plaintiffs;
12.

Whether this is an exceptional case justifying the award of Gilead’s or Merck’s

reasonable attorneys’ fees, expenses, and costs in this action under § 285.

27
28

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
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13.

Whether Merck is entitled to any damages, including past damages and an ongoing

2

royalty, and, if so, the amount of damages.

3

Gilead’s Statement

4

14.

If any asserted claim of the ’499 patent is not entitled to a priority date of January

5

18, 2002, whether Gilead can show by clear and convincing evidence that it is invalid as

6

anticipated by Clark.

7

15.

Whether Gilead can show by clear and convincing evidence that each of the

8

asserted claims of the ’499 patent is invalid under 35 U.S.C. § 102(f) for being derived from the

9

invention of Jeremy Clark.

10

16.

Whether Gilead can show by clear and convincing evidence that each of the

11

asserted claims of the ’499 patent is invalid under 35 U.S.C. § 102(g) for having first been made in

12

the United States by Jeremy Clark, who did not abandon, suppress, or conceal his invention.

13

17.

Whether Gilead can show by clear and convincing evidence that each of the

14

asserted claims of the ’499 patent is invalid under 35 U.S.C. § 112 for failure to enable a person of

15

ordinary skill in the art to make the compounds and all of their possible prodrugs encompassed by

16

the asserted claims.

17

18.

Whether Gilead can show by clear and convincing evidence that each of the

18

asserted claims of the ’499 patent is invalid under 35 U.S.C. § 112 for failure to enable a person of

19

ordinary skill in the art to use the claimed methods.

20

19.

Whether Gilead can show by clear and convincing evidence that each of the

21

asserted claims of the ’499 patent is invalid under 35 U.S.C. § 112 for lacking a written

22

description of the claimed methods.

23

20.

Whether Gilead can show by clear and convincing evidence that each of the

24

asserted claims of the ’712 patent is invalid under 35 U.S.C. § 102(f) for being derived from the

25

invention of Jeremy Clark.

26
27
28

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

1

21.

If any asserted claim of the ’712 patent is not entitled to a priority date of January

2

18, 2002, whether Gilead can show by clear and convincing evidence that it is invalid as

3

anticipated by Clark.

4

22.

If any asserted claim of the ’712 patent is not entitled to a priority date of January

5

18, 2002, whether Gilead can show by clear and convincing evidence that it is invalid as

6

anticipated by Sofia.

7

23.

Whether Gilead can show by clear and convincing evidence that each of the

8

asserted claims of the ’712 patent is invalid under 35 U.S.C. § 102(g) for having first been made in

9

the United States by Jeremy Clark, who did not abandon, suppress, or conceal his invention.

10

24.

Whether Gilead can show by clear and convincing evidence that each of the

11

asserted claims of the ’712 patent is invalid under 35 U.S.C. § 112 for failure to enable a person of

12

ordinary skill in the art to make the claimed compounds.

13

25.

Whether Gilead can show by clear and convincing evidence that each of the

14

asserted claimed of the ’712 patent is invalid under 35 U.S.C. § 112 for failure to enable a person

15

of ordinary skill in the art to use the claimed compounds.

16

26.

Whether Gilead can show by clear and convincing evidence that each of the

17

asserted claims of the ’712 patent is invalid under 35 U.S.C. § 112 for lacking a written

18

description of the claimed compounds.

19
20
21

27.

Whether Merck may rely on infringement by or mode of action of sofosbuvir as

evidence of practical utility for the asserted claims.
28.

Whether Merck may rely on sofosbuvir’s commercial success as evidence of

22

practical utility for the asserted claims.

23

Merck’s Statement

24

29.

Whether as a matter of law Gilead may assert that the asserted claims of the ’499

25

patent are invalid under 35 U.S.C. § 102(f) for being derived from the work of Jeremy Clark,

26

which post-dates Merck’s filing date of January 18, 2002.

27
28

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
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30.

Whether as a matter of law Gilead may assert that the asserted claims of the ‘’499

2

patent are invalid under 35 U.S.C. § 102(g) for alleged prior invention by Jeremy Clark, whose

3

alleged date of invention post-dates Merck’s filing date of January 18, 2002.

4

31.

Whether as a matter of law Gilead may assert that the asserted claims of the ’499

5

patent are invalid as anticipated by Clark, which was filed and was published after Merck’s filing

6

date of January 18, 2002.

7

32.

Whether as a matter of law Gilead may assert that the asserted claims of the ’499

8

patent are invalid as anticipated by Sofia, which was filed and was published after Merck’s filing

9

date of January 18, 2002.

10

33.

Whether Gilead can show by clear and convincing evidence that each of the

11

asserted claims of the ’499 patent is invalid under 35 U.S.C. § 112 for failure to enable a person of

12

skill in the art to practice the claimed invention.

13

34.

Whether as a matter of law Gilead may assert that the asserted claims of the ’712

14

patent are invalid under 35 U.S.C. § 102(f) for being derived from the work of Jeremy Clark,

15

which post-dates Merck’s filing date of January 18, 2002.

16

35.

Whether as a matter of law Gilead may assert that the asserted claims of the ‘712

17

patent are invalid under 35 U.S.C. § 102(g) for alleged prior invention by Jeremy Clark, whose

18

alleged date of invention post-dates Merck’s filing date of January 18, 2002.

19

36.

Whether as a matter of law Gilead may assert that the asserted claims of the ’712

20

patent are invalid as anticipated by Clark, which was filed and was published after Merck’s filing

21

date of January 18, 2002.

22

37.

Whether as a matter of law Gilead may assert that the asserted claims of the ’712

23

patent are invalid as anticipated by Sofia, which was filed and was published after Merck’s filing

24

date of January 18, 2002.

25

38.

Whether Gilead can show by clear and convincing evidence that each of the

26

asserted claims of the ’712 patent is invalid under 35 U.S.C. § 112 for failure to enable a person of

27

skill in the art to practice the claimed invention.

28

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
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IV.

ESTIMATE OF TRIAL TIME

2

The parties anticipate that trial will take two weeks.

3

The parties are in disagreement as to the order in which trial should proceed. It is Gilead’s

4

position that because this Court has entered judgment of infringement, the case should commence

5

with Gilead’s invalidity defense and that Gilead, as the party with the burden of proof, should

6

present first and should be permitted to present a rebuttal presentation on invalidity. It is also

7

Gilead’s position that because there is no liability for an invlaid claim, the issue of damages

8

should only be presented after liability. It is also Gilead’s position that it should be permitted to

9

call live or by deposition adverse witnesses during its case in chief regardless of whether Merck

10

intends to call the same witness live or by deposition during its case in chief.

11

It is Merck’s position that Merck should present first because it is the patentee and has the

12

burden of proof on damages. It is also Merck’s position that regardless of the order at trial, Merck

13

should be permitted to present a rebuttal case on damages. It is Merck’s position that deposition

14

testimony should not be presented at trial for any witness who is testifying live at trial. It is also

15

Merck’s position that if Gilead wishes to cross-examine a Merck witness it should be permitted to

16

do so only after that witness has testified on direct examination in Merck’s case, with the

17

understanding that such cross-examination need not be limited to the scope of the direct

18

examination. The reciprocal arrangement would apply to Merck’s cross-examination of Gilead’s

19

witnesses.

20

V.

TRIAL ALTERNATIVES AND OPTIONS

21

A.

22

Pursuant to the ADR L.R. 3-2 and 3-4(b), the parties stipulated to Private ADR in the form

Settlement Discussion

23

of direct discussions between the parties; the Court approved the parties’ stipulation. (ECF Nos.

24

64, 65.) The parties filed a Joint Notice of ADR Compliance on January 21, 2014, reporting that

25

Private ADR was conducted as stipulated and ordered. (ECF No. 70.) The parties were not able

26

to reach a resolution. Moreover, pursuant to the Court’s Jury Pretrial Standing Order, lead trial

27

counsel met and conferred on February 5, 2016 to discuss the possibility of settlement.

28

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

1

B.

2

Neither Gilead nor Defendants have any proposed amendments to the pleadings. Neither

3

Gilead nor Defendants seek to dismiss any claims or counterclaims.

4
5

Amendments or Dismissals

C.

Bifurcation or Separate Trial of Issues

Indefiniteness

6

As described above, Gilead maintains that each of the asserted claims of the ’499 patent is

7

invalid as indefinite. The parties agree that claim indefiniteness is a matter of law for the Court’s

8

adjudication that turns on underlying facts. Gilead’s position is that while the evidence

9

concerning indefiniteness can be presented simultaneously with the other matters within the jury’s

10

purview, Gilead would move the Court to rule as a matter of law at the close of evidence If the

11

Court determines to adopt Merck’s position, Gilead asks that that ruling applies only to evidence

12

that is relevant exclusively to Gilead’s indefiniteness defense.

13

Merck’s position is that any evidence pertaining to this defense should be presented

14

outside the presence of the jury, and that the defense be reserved for resolution by the Court.

15

Gilead’s Equitable Defenses

16

Gilead proposes that these defenses be addressed in briefing following trial and that, if

17

there is a need for the Court to hear further evidence, that can also be discussed post-trial. If the

18

Court determines to adopt Merck’s position, Gilead asks that that ruling applies only to evidence

19

that is relevant exclusively to resolution of Gilead’s equitable defenses.

20

It is Merck’s view that any evidence pertaining to these defenses should be presented

21

outside the presence of the jury, and that these defenses be reserved for resolution by the Court.

22

VI.

23

APPENDICES TO PRETRIAL ORDER
The following Appendices are attached hereto:

24

Gilead’s Witness List

Appendix A

25

Defendants’ Witness List

Appendix B

26

Gilead’s Exhibit List (and objections)

Appendix C-2

27

Defendants’ Exhibit List (and objections)

Appendix C-3

28

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

1

Gilead’s Discovery Responses

Appendix D-1

2

Gilead’s Deposition Designations (and
objections)
Defendants’ Discovery Responses

Appendix D-2

Defendants’ Deposition Designations (and
objections)

Appendix E-2

3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28

VII.

Appendix E-1

STIPULATIONS
The following stipulations were agreed upon by the parties as discussed below, and are

made a part of this Pretrial Order.
A. Trial Exhibits & Demonstratives
1. The listing of a document on a party’s exhibit list is not an admission that such
document is relevant or admissible when offered by the opposing party for the
purpose that the opposing party wishes to admit the document. Each party reserves
the right to object to the relevancy or admissibility of any evidence offered by the
other party, at the time such evidence is offered, in view of the specific context in
which such evidence is offered.
2. The parties will each provide to each other’s counsel of record via email a list of
witnesses that it intends to call in Court, live or by deposition, by 7:00 p.m. two
calendar days before the witness will testify. For witnesses testifying by
deposition, each party will also provide a transcript (and video, if applicable) of
those portions of the deposition it intends to play.
3. Although the parties have made good-faith efforts to identify the sponsoring
witness or witnesses through which they expect to introduce exhibits at trial,
neither party is precluded from using or introducing an exhibit with a different
witness. Unless otherwise agreed to by the parties during trial, the parties will each
provide to each other’s counsel of record via e-mail a written list of exhibits, by
exhibit number, for each witness that it intends to call in Court by 7:00 p.m. two
calendar days before the day the witness will testify. Objections to any of the
19
[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG

1

disclosed exhibits shall be made by no later than 7:00 p.m. the following day, and

2

the parties will meet and confer regarding any objections by 9:00 p.m. that same

3

evening.

4

4. The parties will provide, by e-mail, any demonstrative exhibits (in color as

5

applicable) they anticipate using on direct examination of a witness at trial to the

6

other party’s counsel of record. Gilead proposes that such an exchange occur no

7

later than 7:00 p.m. on the calendar day before the witness is called. Merck

8

proposes that such an exchange occur no later than 8:00 a.m. on the calendar day

9

before the witness is called. Any objections to demonstrative exhibits shall be

10

made by 9:00 p.m. that same day, and the parties shall meet and confer as soon as

11

possible thereafter to resolve such objections. Any disputes as to demonstrative

12

exhibits shall be raised with the Court as appropriate before trial resumes on the

13

day of their anticipated use.

14
15
16
17
18
19
20

5. Demonstrative exhibits exchanged will not be used by the opposing party prior to
being used by the disclosing party.
6. The parties agree that demonstrative exhibits that the parties intend to use at trial
need not be included on their respective lists of trial exhibits.
7. The Federal Judicial Center video entitled “The Patent Process: An Overview for
Jurors” will be shown to the jurors after jury selection, before opening arguments.
8. The foregoing notice provisions regarding demonstrative exhibits shall not apply to

21

demonstrative exhibits created in the courtroom during live testimony at trial or to

22

the enlargement, highlighting, ballooning, or excerpting of trial exhibits that have

23

been admitted in evidence or trial testimony. Mere enlargement, highlighting,

24

ballooning, or excerpting of trial exhibits admitted in evidence or trial testimony

25

does not create a demonstrative exhibit.

26
27
28

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Case No. 5:13-cv-04057-BLF/PSG

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2

VIII. BINDING EFFECT OF THE JOINT PRETRIAL STATEMENT AND ORDER
The foregoing admissions having been made by the parties, and the parties having

3

specified the foregoing issues of fact and law remaining to be litigated, this order shall

4

supplement the pleadings and govern the course of trial of this action, unless modified to prevent

5

manifest injustice.

6
7

Dated: February 11, 2016

FISH & RICHARDSON P.C.

8
By: /s/ Douglas E. McCann
Douglas E. McCann

9
10

Attorneys for Plaintiff
GILEAD SCIENCES, INC.

11
12
13

Dated: February 11, 2016

WILLIAMS & CONNOLLY LLP

14
15

By: /s/ Jessamyn Berniker
Jessamyn Berniker
Attorneys for Defendants
MERCK & CO., INC.; MERCK SHARP &
DOHME CORP.; ISIS PHARMACEUTICALS,
INC.

16
17
18
19

SIGNATURE ATTESTATION

20
21
22

Pursuant to Civil Local Rule 5.1(i)(3), I attest under penalty of perjury that concurrence in
the filing of this document has been obtained from its signatory
/s/ Doulas E. McCann

23
24
25
26

SO ORDERED
February 25, 2016

HONORABLE BETH LABSON FREEMAN

27
28

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[PROPOSED] JOINT PRETRIAL STATEMENT AND ORDER
Case No. 5:13-cv-04057-BLF/PSG