Shire LLC v. Abhai, LLC

In addition to finding the patents-in-suit infringed, the court sanctioned defendant for reporting for the first time—in the middle of trial—that it performed its FDA testing incorrectly.

March 22, 2018

GENERICally Speaking

Case Name: Shire LLC v. Abhai, LLC, Nos. 15-13909-WGY (D. Mass. Mar. 22, 2018) (Young, J.) 

Drug Product and Patent(s)-in-Suit: Adderall® XR (dextroamphetamine sulfate / dextroamphetamine saccharate / amphetamine aspartate monohydrate / amphetamine sulfate); U.S. Reissued Patents Nos. RE42,096 (“the ’096 patent”) and RE41,148 (“the ’148 patent”)

Nature of Case and Issue(s) Presented: The court held a bench trial in this ANDA litigation beginning on March 27, 2017. On April 4, 2017, after four days of trial, Abhai filed a motion to amend its pretrial memorandum to include eight new trial exhibits. The exhibits show that the dissolution tests reported by Abhai on its product were performed incorrectly and the data were invalid. The court, after hearing from counsel, suspended the proceedings for 90 days and entered an order requiring full discovery on the incorrect data and tests. The fifth day of trial resumed on September 5, 2017. The ninth and final day of trial was on September 15, 2017. The court found in favor of Shire and sanctioned Abhai.

Why Shire Prevailed: With respect to the ’096 patent, Abhai disputed that its ANDA product met the following claim limitations: (i) “one or more pharmaceutically active amphetamine salts that are covered with an enteric release coating the provides for delayed pulsed enteric release;” and (ii) “wherein said enteric release coating releases essentially all of said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes after initiation of said delayed pulsed enteric release.” But the active ingredients in Abhai’s ANDA product are amphetamine sulfate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and dextroamphetamine saccharate, which are all pharmaceutically active amphetamine salts. They are contained in the drug layer of the delayed-release beads. The drug layer is then covered by a seal coat, then a delayed-release polymer layer, which is made up of Eudragit L30D-55, triethyl citrate, and talc. Eudragit L30D-55 is used for the enteric coating. According to the ’096 patent, enteric polymers include Eudragit L30D-55 and can be used in enteric coatings. Moreover, Abhai’s testing and re-testing of its ANDA product showed rapid and complete release consistent with element (ii).

With respect to the ’148 patent, the court found that each of Abhai’s dosage strengths met the pharmacokinetic and “effective level” claim limitations. Absorption and elimination of amphetamine in Abhai’s ANDA product doses exhibited first-order kinetics, which means that the AUC and maximum concentration are linearly proportional to the dose administered. This suggests that if an individual were to double the dose, it would also double the AUC and maximum concentration. The court also relied on expert witness calculations and data to find that Abhai’s ANDA product also met the “coating thickness” limitations of the ’148 patent.

Finally, the court imposed sanctions on Abhai for proffering its corrected data, which it admitted it had failed to supplement in place of the incorrect data it had originally provided during discovery. Shire asked for $2.75 million. Instead, the court ordered: (i) the Clerk of the Court to send a certified copy of its opinion to the General Counsel of the FDA; (ii) Shire to submit a revised claim for attorneys’ fees and costs limited to recovering for the time wasted dealing with Abhai’s inaccurate stability and dissolution data, discovering the litigation misconduct, and dealing with Abhai’s revised stability and dissolution data; and (iii) Abhai to pay $30,000 to the court for “recklessly squander[ing] five days during which this Court could better have devoted itself to teaching American jurors and attending to litigants prepared to follow the straightforward rules of civil procedures.”

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