Shire LLC v. Amneal Pharms., LLC (D.N.J.)

Case Name: Shire LLC v. Amneal Pharms., LLC, Case No. 11-3781 (SRC), 2014 U.S. Dist. LEXIS 85369 (D.N.J. June 23, 2014) (Chesler, J.)

Drug Product and Patent(s)-in-Suit: Vyvanse® (lisdexamfetamine dimesylate); U.S. Patent Nos. 7,105,486 (“the ’486 patent); 7,659,253 (“the ’253 patent); 7,659,254 (“the ’254 patent”); 7,671,031 (“the ’031 patent”); 7,678,770 (“the ’770 patent); 7,662,787 (“the ’787 patent”); 7,662,788 (“the ’788 patent”); 7,713,936 (“the ’936 patent”); 7,671,030 (“the ’030 patent”); 7,674,774 (“the ’774 patent”); 7,687,467 (“the ’467 patent”); 7,723,305 (“the ’305 patent”); 7,718,619 (“the ’619 patent”); and 7,678,771 (“the ’771 patent”)

Nature of the Case and Issue(s) Presented:  The defendants include generic ANDA applicants (the “generic defendants”) and the API manufacturer, Johnson Matthey, Inc. and Johnson Matthey Pharmaceutical Materials (collectively “JM”). Six summary judgment motions were filed with the court concerning a smaller subset of 400 claims and 18 patents-in-suit: (i) generic defendants’ motion for partial summary judgment of anticipation for claims 1, 2, and 5 of the ’787 patent; (ii) generic defendants’ motion for partial summary judgment of non-infringement; (iii) generic defendants’ motion for partial summary judgment of invalidity under 35 U.S.C. §101; (iv) generic defendants’ motion for partial summary judgment of no willful infringement; (v) JM’s motion for partial summary judgment of no indirect infringement; and (vi) plaintiffs’ motion for summary judgment that the asserted claims of the ’630, ’787, ’253, and ’486 patents are infringed and not invalid. The court granted the motions in part and denied the motions-in-part.

Why Plaintiffs Prevailed:  The court determined that the defendants infringed at least four of the 18 patents-in-suit; namely, the ’630, ’787, ’253, and ’486 patents. Plaintiffs asserted compound claims for the ’630, ’787, and ’253 patents. The parties did not dispute that generic defendants directly infringe the compound claims if the patents were valid. However, the court determined that JM did not directly infringe those compound patents because the safe harbor provision 35 U.S.C. §271(e)(1) exempts its activity from infringement. The asserted claim of the ‘486 patent was a method claim. The court found that the generic defendants induced infringement of the method claim because plaintiffs pointed to sufficient evidence in the generic defendants’ proposed ANDA label. The generic defendants did not address plaintiffs’ evidence in its opposition brief.  The court also found that JM induced infringement of the ’486 patent. Defendants argued that Plaintiffs failed to address the specific intent or knowledge requirement of inducing infringement. The court determined that plaintiffs offered sufficient evidence and that defendants failed to point to any record evidence that raised any genuine issue of fact.

The court also determined that the ’630, ’787, ’253, and ’486 patents were valid. Defendants argued that the compound patents were anticipated by an Australian patent application, despite not explicitly disclosing the compound lisdexamfetamine dimesylate. Rather, defendants pointed to a passage that listed a variety of amino acid amides and salts. Defendants argued that the phrase “and the like” at the end of that passage limited the class of potential compounds to 20 or fewer. The court determined that this genus could not anticipate the species since defendants did not point to any evidence that one of ordinary skill would understand the genus recited in the passage would include the claimed compound. The court also rejected defendants’ argument that, based on Wm. Wrigley, Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356 (Fed. Cir. 2012), multiple disclosures in the same reference may be combined to be an anticipatory disclosure. Defendants argued that the Australian application disclosed protected lisdexamfetamine and how to deprotect the compound. As an initial matter, the court disagreed with the defendants’ application of Wrigley. Moreover, combining formula ingredients as in Wrigley is not analogous to combining a compound with a technique.

The court also rejected defendants’ obviousness argument that the court was not required to apply a lead compound obviousness inquiry, but rather should focus on the rationale for modifications and a reasonable expectation of success. The court rejected this approach because defendants could not show that lisdexamfetamine or its salts were known in the art. The court found that defendants did not identify a lead compound and that its obviousness argument was an “obvious to try” theory. The court also found that defendants never explained how the disclosed amino acids in the Australian patent application were a finite number of predictable solutions. With respect to the method claim of the ’486 patent, the court determined that defendants failed to provide any evidence except conclusory statements by its own experts. Thus, the court found that the ’486 patent was not invalid.

The court also denied defendants’ motion that claims 1, 2, and 5 of the ’787 patent are invalid as anticipated. After the defendants filed their motion, the parties stipulated to dismissal of the claims, thereby depriving the court of jurisdiction.

Defendants also moved for summary judgment of no direct or indirect infringement of the method claims of the ’486, ’253, ’254, ’031, ’770, ’788, ’936, ’030, ’774, ’467, ’305, ’619, and ’771 patents. Plaintiffs asserted that the complaint did not include any direct infringement claim. But defendants disagreed. The court dismissed any direct infringement claims with prejudice. With respect to inducement, defendants argued that their proposed labels do not: (i) require administration with food; (ii) require the use of various rating scales; and (ii) relate to abuse resistance. The court agreed with defendants, since the proposed labeling: (i) indicated that the drug may be taken with or without food; (ii) did not instruct the use of rating scales; and (iii) did not indicate that abuse resistance was an FDA-approved use.

The court also rejected defendants’ motion under 35 U.S.C. §101. Defendants argued that the claims were unpatentable since they included pharmacokinetic properties. The court rejected this argument because the claims were composition claims, not method claims, and thus, were not claiming processes that apply a law of nature.

The court also found that defendants did not willfully infringe the patents. This is a typical Hatch-Waxman case and plaintiffs could not point to any evidence of misconduct to justify an exceptional case.

Finally, the court rejected JM’s argument that it did not indirectly infringed the patents-in-suit. The court found that plaintiffs’ theory legally viable. Plaintiffs assert that JM induced infringement by inducing the filing of an ANDA as the applicant’s manufacturer/supplier.