Haug Partners Successfully Defends Takeda’s Vyvanse® Patents At Trial Against Generic Challenge

On December 27, 2022, Haug Partners LLP and Gibbons PC obtained a key victory as to all counts for its client, plaintiffs Takeda Pharmaceutical Co. Ltd. and Takeda Pharmaceuticals U.S.A., Inc., defeating a generic challenge by Norwich Pharmaceuticals Inc. to Takeda’s Orange Book-listed patents for Takeda’s multibillion dollar Vyvanse® product.  In a 107-page Opinion, Judge Stanley R. Chesler (D.N.J.) found that Takeda prevailed on all fourteen asserted claims in the matter of Takeda Pharm. Co. Ltd. et al. vs. Norwich Pharmaceuticals, Inc., C.A. No. 2:20-cv-08966, a pharmaceutical patent litigation arising under the Hatch-Waxman Act.  Judge Chesler held that all of Takeda’s asserted patents were infringed, not invalid under 35 U.S.C. §§ 103, 102, and 112 ¶ 1, and enforceable.  As a result, Judge Chesler enjoined Defendant Norwich from bringing its generic product to market until August 24, 2023, upon expiration of Takeda’s Pediatric Exclusivity period for Vyvanse®.

Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of ADHD and binge-eating disorder in children and adults and earns over $2.3 billion annually in sales.  The trial focused on fourteen claims asserted across nine Orange Book-listed patents.  The broad scope of the various asserted claims concerns novel technology related to the compound lisdexamfetamine, its salt forms, prodrugs, isolation, formulation, water content, salts, pharmacokinetics, pharmacodynamics, and methods of treatment.  Defendant Norwich asserted defenses of invalidity under pre-AIA 35 U.S.C. §§ 103, 102, and 112.  Shortly before trial, Norwich stipulated to infringement of all asserted claims.

In a detailed Opinion, Judge Chesler analyzed and rejected Norwich’s invalidity challenges on multiple grounds.  With respect to Norwich’s primary obviousness challenge (asserted against all claims), Judge Chesler repeatedly credited the testimony of Takeda’s expert witnesses Dr. Alexander M. Klibanov, Dr. Leonard J. Chyall, Dr. James J. McGough, and Dr. David R. Taft.  Norwich’s obviousness defense was premised on the well-known “lead compound” analysis, and the Court cited multiple failures by Norwich in “assess[ing] the possible alternative solutions offered by the prior art, a point that Dr. Klibanov made at length and which Norwich acknowledges.”  (ECF No. 483 at 50).

Although the Court’s conclusions with respect to the lead compound analysis were dispositive of Norwich’s obviousness challenge, the Opinion also presented additional case-dispositive findings.  With respect to Takeda’s claims reciting salts of lisdexamfetamine, and in contrast to the testimony of Takeda’s expert Dr. Chyall, the Court found that Norwich’s salt expert was “not credible” and gave his testimony “no weight.”  (Id. at 73; see also id. at 74-76).  The Court further found Takeda’s expert Dr. McGough “to be far more persuasive” than Norwich’s expert physician (id. at 88), and credited the testimony of Takeda’s expert Dr. Taft in rejecting Norwich’s inherency allegations.  The Court also afforded significant weight to admissions by Norwich’s Rule 30(b)(6) witnesses elicited during depositions and played at trial.  (Id. at 78-79, 90).

With respect to the issues of anticipation and enablement, Norwich’s defenses were dismissed, in part because the arguments were “not timely disclose[d]” and “not sufficiently explained.”  (Id. at 97, 99).  On the merits, the Court rejected Norwich’s attempt to argue that a POSA could not make and use the full scope of Takeda’s claimed invention, concluding that “methods of salt selection and salt formation were well known in the art.”  (Id. at 99-100).

The trial victory tops off a series of significant decisions obtained by Haug Partners and Gibbons on behalf of Takeda, including an early disposal of Norwich’s venue challenge (which allowed the case to proceed before Judge Chesler) and two claim construction opinions where the Court found that Takeda clearly won the “battle of the experts.”  Haug Partners and Gibbons previously successfully litigated the Vyvanse® patents against several first-to-file ANDA filers (C.A. No. 2:11-03781-SRC-CLW (consolidated)).  In that suit, Judge Chesler granted summary judgment of infringement and no invalidity, which was affirmed by the Federal Circuit in 2015.  Despite this extensive history of validity challenges, not a single one of Takeda’s 400+ U.S. patent claims covering Vyvanse® has been invalidated.

Haug Partners Chairman and lead counsel Ed Haug called the result a “great team effort” made possible by the hard work and collaboration between Takeda’s knowledgeable and motivated in-house personnel with many talented attorneys at Haug Partners and Gibbons PC, as well as the significant preparation and analyses provided by Takeda’s expert witnesses.  “I am proud that we were able to build on the Firm’s longstanding history of defending the robust patent portfolio protecting Takeda’s first-of-its-kind Vyvanse® product,” he said.

The asserted patents are U.S. Patent No. 7,655,630 (“the ’630 patent”), U.S. Patent No. 7,662,787 (“the ’787 patent”), U.S. Patent No. 7,687,466 (“the ’466 patent”), U.S. Patent No. 7,105,486 (“the ’486 patent”), U.S. Patent No. 7,678,770 (“the ’770 patent”), U.S. Patent No. 7,671,031 (“the ’031 patent”), U.S. Patent No. 7,223,735 (“the ’735 patent”), U.S. Patent No. 7,700,561 (“the ’561 patent”), and U.S. Patent No. 7, 671,030 (“the ’030 patent”).

A copy of Judge Chesler’s December 2022 Opinion can be found here.