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Shire LLC v. Abhai LLC

United States District Court, D. Massachusetts

November 9, 2016

SHIRE LLC and SHIRE U.S. INC., Plaintiffs,
ABHAI, LLC, Defendant.



         I. BACKGROUND

         Shire LLC and Shire US, Inc. ("Shire") commenced this suit against Abhai, LLC ("Abhai") for alleged infringement of two of Shire's patents: RE42, 096 ("'096 Patent") and RE41, 148 (""148 Patent") -[1]

         Shire is the manufacturer of the drug ADDERALL XR, an amphetamine-based pharmaceutical used in the treatment of Attention Deficit Hyperactivity Disorder ("ADHD"). Compl. Patent Infringement ("Compl.") 9, ECF No. 1. The '096 and "148 Patents pertain to a delayed-release medicine, which delivers two doses of medication: one delivered shortly after administration, and one delivered about four to six hours later. Compl. Ex. A, '096 Patent col. 3 11. 10-13, ECF No. 1-2; Compl. Ex. B, U48 Patent col. 3 11. 23-26, ECF No. 1-3. This delayed-release mechanism allows a patient to take one pill per day instead of two, which is more convenient for children, common consumers of ADDERALL XR. '096 Patent col. 3 11. 5-17; U48 Patent col. 3 11. 16-30.

         To accomplish that end, the drug is administered via a pill that contains multiple layers. '096 Patent fig. 2A; '148 Patent fig. 2A. The first layer is an outer shell designed to dissolve quickly and provide an immediate dose of amphetamine. Within the first layer of amphetamine is a second, thicker shell, containing a second dose of amphetamine, designed to be delivered later in the day. '096 Patent col. 4 11. 53-65; U48 Patent col. 4 1. 66 - col. 5 1. 11. A key component of the invention is the creation of a drug coating that ensures the second dose of amphetamine is delivered about four to six hours after the first release. '096 Patent col. 4 11. 6-16; U48 Patent col. 4 11. 18-29. This coating must withstand the stress of passing through the stomach without prematurely delivering the medicine. '096 Patent col. 4 11. 21-30; U48 Patent col. 4 11. 34-43. Shire accomplished this effect by using a thicker, PH-resistant shell around the second dose of the drug. '096 Patent col. 4 11. 31-35; U48 Patent col. 4 11. 44-58.

         The Food and Drug Administration ("FDA") issued to Shire a New Drug Approval for ADDERALL XR for the treatment of ADHD. Compl. ¶ 13. The FDA has listed the '096 and "148 Patents in its Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as "The Orange Book") . Id.

         Abhai is a drug manufacturer which recently filed an Abbreviated New Drug Application ("ANDA") with the FDA to develop a generic version of ADDERALL XR prior to the expiration of the "096 and "148 Patents. Compl. ¶ 14; Def. Abhai, LLC's Answer, Defenses, Countercls. ("Answer") 4, ECF No. 30. Abhai's ANDA also contained certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the "096 and "148 Patents, which set forth the legal and factual basis for Abhai's position that those patents are invalid, unenforceable, or would not be infringed by Abhai's contemplated manufacture and sale of generic ADDERALL XR. Compl. ¶ 15; Answer 8-9.

         On September 20, 2016, this Court conducted a Markman Hearing, during which the parties argued their proffered constructions of the disputed claims in the "096 and "148 Patents. This memorandum pertains only to the manner in which this Court construes the following section of claims 1 and 12 of the '148 Patent: "a delayed enteric release dosage form that provides delayed release upon oral administration . . . ."[2]


         Infringement analysis is a two-step process: (i) claims must be construed; and then (ii) the allegedly infringing device is compared to the properly-construed claims. See Interactive Gift Express, Inc. v. CompuServe Inc., 256 F.3d 1323, 1330-31 (Fed. Cir. 2001) (citations omitted). Construing a patent's claims is a matter reserved for the judge. Markman v. Westview Instruments, Inc., 517 U.S. 370, 386 (1996) . Since claim construction is a mixed question of fact and law as the meaning of the claim term is the meaning understood by a person skilled in the art, the Supreme Court has recognized some deference must be shown to a district judge who makes factual findings in construing a claim. Teva Pharms., USA v. Sandoz, Inc., 135 S.Ct. 831, 837-38 (2015).

         The starting point for construing claims is the actual claim language. In particular, "[t]he inquiry into how a person of ordinary skill in the art understands a claim term provides an objective baseline from which to begin claim interpretation." Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc) (citation omitted).

         The claims should not be interpreted in isolation, because "the 'ordinary meaning' of a claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321. Instead, claim language is to be read in light of "intrinsic evidence" such as the specification and prosecution history.[3]Id. at 1313; Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) ("[T]he specification is . . . the single best guide to the meaning of a disputed term.").

         While courts may "rely heavily on the [specification] for guidance as to the meaning of the claims, " Phillips, 415 F.3d at 1317, they are warned not to read limitations from the specification into the claims, Texas Dig. Sys., Inc. v. Telegenix, Inc., 308 F.3d 1193, 1205 (Fed. Cir. 2002) . In certain circumstances, however, particular uses of language within the specification can be especially determinative when construing a claim. For instance, the words "the present invention" or "this invention" in the specification can provide clear evidence of a claim term's scope. Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1308 (Fed. Cir. 2007) ("When a patent thus describes the features of the 'present invention' as a whole, this description limits the scope of the invention.").[4] Nevertheless, these words are not always so limiting, "such as where the references to a certain limitation as being the 'invention' are not uniform, or where other portions of the intrinsic evidence do not support applying the limitation to the entire patent." Absolute Software, Inc. v. Stealth Signal, Inc., 659 F.3d 1121, 1136 (Fed. Cir. 2011).

         Finally, it is a well-established principle of claim construction that language that is repeated throughout other claims in the same patent should be given identical construction when possible. Phillips, 415 F.3d at 1314. A corollary to that canon of construction is the doctrine of claim differentiation, which provides that "[t]here is presumed to be a difference in meaning and scope when different words or phrases are used in separate claims." Tandon Corp.v.Int'l Trade Comm'n., 831 F.2d 1017, 1023 (Fed Cir. 1987). Differently worded but similar claims in related patents, however, may still be construed identically where those patents share a specification and other technical details. Welker Bearing Co.v.PHD, Inc., 550 F.3d 1090, 1098-99 ...

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