By Opinion entered by The Honorable Leonard P. Stark in Idenix Pharmaceuticals LLC et al. v. Gilead Sciences, Inc., Civil Action No. 14-846-LPS (D.Del. February 16, 2018), the District Court granted in part Defendant Gilead Sciences, Inc.’s renewed motion for judgment as a matter of law (“JMOL Motion”) after finding that the asserted claims of the patent-in-suit, U.S. Patent No. 7,608,597 (“the ‘597 patent”) are invalid for failure to meet 35 U.S.C. § 112’s enablement requirements. The Court denied Defendant’s JMOL Motion as to damages and written description. Id. at *2 and 51.

By way of background, the science involved in this case involves groundbreaking work by both parties in the field of treatments for the Hepatitis C virus infection. The ‘597 patent is entitled “Methods and Compositions for Treating Hepatitis C Virus. It was issued on October 27, 2009. Id. at *1. Prior to trial, Defendant Gilead stipulated that, under the Court’s claim construction, its accused products, Harvoni and Sovaldi, infringe the asserted claims of Idenix’s ‘597 patent. Id. At the end of a two week trial in December 2016, the jury found that Gilead failed to prove that the asserted claims are invalid and awarded Idenix $2.54 billion in damages. Id. Thereafter, Gilead renewed its JMOL motion, which the Court had taken under advisement during trial and later denied as moot and with the opportunity to renew following entry of judgment. Id.

In its JMOL motion, Gilead asked the Court to set aside the jury’s verdict on grounds that Idenix’s asserted patent claims are invalid for failure to meet 35 U.S.C. §112’s written description and enablement requirements. Id. Alternatively, Gilead requested the Court to reduce the $2.54 billion damages award as unsupported by the evidence. Id.

After reviewing the record and evaluating the JMOL motion, the Court found that “a reasonable jury, even taking all the evidence in the light most favorable to Idenix and drawing all reasonable inferences in favor of Idenix, could only have concluded that Idenix’s ‘597 patent is invalid due to lack of enablement. The only reasonable finding, based on the trial record, is that Gilead met its burden to prove nonenablement by clear and convincing evidence. The trial revealed that there are no genuinely disputed material facts with respect to enablement.” Id. at *50-51. Accordingly, the Court concluded that Gilead is entitled to judgment as a matter of law that the asserted claims of the ‘597 patent are invalid for lack of enablement. Id. at *51.

The effect of the Court’s Order will be the setting aside of the jury’s $2.54 billion damages award to Idenix.  A copy of the Opinion is attached.


The United States District Court for the District of Delaware has announced new procedures for assignment of cases to Senior Judge Gregory M. Sleet in light of Judge Sleet’s retirement from the bench during the fall of 2018 and two current District Judge vacancies on the Court. With respect to new civil cases, for the time being, Senior Judge Sleet will continue to draw a share of new civil cases equal to that of the Court’s active District Judges. The Court has begun the process of reassigning a portion of the civil cases currently on Judge Sleet’s docket – primarily those scheduled for trial in 2018. With respect to criminal cases, Judge Sleet will no longer be assigned new criminal matters beginning sometime in the spring of 2018. At and after that time, all new criminal cases will be assigned to the Court’s active District Judges.

In the announcement, the Court clarified that the procedures for the assignment of cases to the Vacant Judgeship docket (“VAC”) remain unchanged and no new visiting judges have been added to the list since the September 2017 announcement.

A copy of the Announcement is attached.

By Memorandum Opinion entered by The Honorable Gregory M. Sleet in Genentech, Inc. et al. v. Amgen Inc., Civil Action No. 17-1407-GMS (D.Del. January 22, 2018), the Court denied defendant Amgen Inc.’s motion to transfer two patent infringement actions from the United States District Court for the District of Delaware to the United States District Court for the Central District of California where Amgen has a declaratory judgment action pending. Both Plaintiff and Amgen are incorporated in Delaware with their principal places of business in California. Id. at *1.

In support of its motion, Amgen argued that the Jumara factors weighed heavily in favor of transfer and that transfer was warranted under the first-to-file rule. Id. at *4. In weighing the Jumara factors, the Court found that Amgen’s choice of forum weighed in favor of transfer, but not as strongly as Plaintiff’s choice of forum weighed against transfer. Id. Two factors weighed slightly in favor of transfer: where the claims arose and the convenience of the witnesses. Id. The remaining factors weighed against transfer or were neutral. Id. Thus, because the balance of the Jumara factors did not strongly weigh in favor of transfer, the Court found that Amgen did not carry its burden of demonstrating the transfer was warranted under those factors. Id.

With respect to the first-to-file rule, the Court found that the California action was anticipatory in nature, and there are convenience factors that weigh against transfer in addition to the Jumara factors weighing against transfer. Id. at *13-15. Therefore, the Court refused to apply the first-to-file rule in favor of transfer. Id. at *15.

A copy of the Memorandum Opinion is attached.

By Memorandum Opinion entered by The Honorable Richard G. Andrews in Acceleration Bay LLC v. Activision Blizzard, Inc., Civil Action No. 16-453-RGA (D.Del. January 17, 2018) (consolidated), the Court rendered its Markman ruling construing eight (8) disputed terms in U.S. Patent Nos. 6,701,344 (“the ‘344 patent”), 6,714,966 (“the ‘966 patent”), 6,829,634 (“the ‘634 patent”), 6,910,069 (“the ‘069 patent”), 6,732,147 (“the ‘147 patent”), and 6,920,497 (“the ‘497 patent”).

A copy of the Memorandum Opinion is attached.

By Memorandum Opinion entered by The Honorable Richard G. Andrews in Sanofi-Aventis U.S. LLC et al. v. Merck Sharp & Dohme Corp., Civil Action No. 16-812-RGA (D.Del. January 12, 2018), the Court rendered its Markman ruling construing nine (9) disputed terms in U.S. Patent Nos. 8,603,044 (“the ‘044 patent”), 8,679,069 (“the ‘069 patent”), 8,992,486 (“the ‘486 patent”), 9,526,844 (“the ‘844 patent”), 9,533,105 (“the ‘105 patent”), 9,457,152 (“the ‘152 patent”), 9,592,348 (“the ‘348 patent”), 7,476,652 (“the ‘652 patent”), 7,713,930 (“the ‘930 patent”), and 9,604,008 (“the ‘008 patent”) . The patents-in-suit generally relate to a diabetes pharmaceutical, or to pen-type injectors used to administer the pharmaceutical. Id. at *1.

A copy of the Memorandum Opinion is attached.

By Memorandum Opinion entered by The Honorable Leonard P. Stark in GN Netcom, Inc. v. Plantronics, Inc., Civil Action No. 12-1318-LPS (D.Del. January 3, 2018), the Court denied Plaintiff GN Netcom’s motion for a new trial. Following a six-day jury trial, the jury returned a verdict in favor of Defendant Plantronics, Inc. Thereafter, GN Netcom moved for a new trial contending the Court erred and prejudiced GN Netcom’s substantial rights in two ways: (1) with regard to Plantronics’ spoliation of evidence, by providing the jury a permissive adverse instruction rather than a dispositive sanction, and “present[ing] a sanitized version of facts regarding Plantronics’ spoliation that vastly ignored how egregious its misconduct was and how detrimental the consequences were on GN’s case”; and (2) refusing to admit evidence of the government’s notice of disbarment to Plantronics based on the General Services Administration’s review of the Court’s opinion imposing sanctions on Plantronics for its spoliation of evidence. Id. at *3. Upon evaluation of the motion, the Court concluded that GN Netcom failed to show that either of those errors affected its substantial rights. Id. at *4.

A copy of the Memorandum Opinion is attached.

By Memorandum Order entered by The Honorable Gregory M. Sleet in Amgen Inc. v. Macleods Pharmaceuticals, Ltd., Civil Action No. 17-817-GMS (D.Del. December 19, 2017) (consolidated), the Court denied the Motion for Judgment on the Pleadings of defendants Macleods Pharmaceuticals, Ltd. and Macleods Pharma USA, Inc. (collectively, “Macleods”).

Plaintiff Amgen filed the patent infringement action against Macleods s for infringement of one or more claims of Amgen’s U.S. Patent No. 9,375,405 (“the ‘405 patent”) after Macleods filed its Abbreviated New Drug Application (“ANDA”) seeking approval to manufacture, use and/or sell of a generic version of Amgen’s Sensipar® product prior to the expiration of the ‘405 patent. In its Motion for Judgment on the Pleadings, Macleods claimed that its ANDA products do not contain any of the listed excipients required by the ‘405 patent; thus, Amgen could only assert a claim under the doctrine of equivalents. Id. at *2. Macleods also asserted that any claim by Amgen under the doctrine of equivalents was barred by the doctrine of prosecution history estoppel. Id.

In response, among other things, Amgen argued that Macleods motion should be converted into a motion for summary judgment because it required resolving factual issues and, if converted, should be denied because there are material facts in dispute. Id. at *3. The Court agreed that the motion should have been brought as a motion for summary judgment given the presence of material factual disputes, but decided not to convert the motion into a motion for summary judgment. Id. Instead, the Court found that there are material disputes of facts between the parties concerning the prosecution history of the ‘405 patent and denied Macleods’ Motion for Judgment on the Pleadings. Id. at *3-5.

A copy of the Memorandum Order is attached.

By Memorandum Order entered by The Honorable Leonard P. Stark in Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc. et al., Civil Action No. 04-1371-LPS (D.Del., December 8, 2017), the Court dismissed without prejudice U.S. Patent No. 6,229,366 (“the ‘366 patent”) from the action, which was filed more than a dozen years ago, given that the U.S. Patent and Trademark Office allowed amended claims during Fairchild’s ex parte reexamination, issued a reexamination certificate and the reexamination amendments effected a substantive change in claim scope. Thus, any cause of action predicated on the original claims of the ‘366 patent was extinguished when the reexamination certificate issued. Id. at *5.

A copy of the Memorandum Order is attached.

By Memorandum Order entered by The Honorable Leonard P. Stark in Javelin Pharmaceuticals, Inc. et al. v. Mylan Laboratories Limited et al., Civil Action No. 16-224-LPS (D.Del., December 1, 2017), the Court denied without prejudice the motion to dismiss for improper venue or, in the alternative, to transfer venue to the Northern District of West Virginia of Defendant Mylan Laboratories Limited, Mylan, Inc. and Mylan Pharmaceutical Inc. (collectively, the “Mylan Defendants”). In doing so, the Court granted Plaintiffs’ request for venue-related discovery to proceed contemporaneously with the remainder of the case as it proceeds on the merits and ruled that the Mylan Defendants could renew the motion after a period of venue-related discovery. Id. at *1 and 12. The Court also held that Mylan’s venue challenge was not untimely and Mylan did not waive its challenge to venue by failing to press it until after the U.S. Supreme Court decided TC Heartland LLC v. Kraft Foods Grp. Brands LLC, 137 S. Ct. 1514 (2017) because the venue objection was not available until after that decision was rendered. Id. at *2.

A copy of the Memorandum Order is attached.