Shire LLC v. Amneal Pharms. LLC

Affirming finding of validity and infringement of patents-in-suit, but finding a supplier of components reasonably related to the submission of an ANDA falls within the safe harbor provision of 35 USC § 271(1) and is not liable for infringement

October 14, 2015

GENERICally Speaking

Case Name:  Shire LLC v. Amneal Pharms. LLC, 2014-1736, -1737, -1738, -1739, -1740, -1741, 2015 U.S. App. LEXIS 16908 (Fed. Cir. Sept. 24, 2015) (Circuit Judges Moore, Mayer, and Linn presiding; Opinion by Linn, J.) (Appeal from D.N.J., Sheridan, J.)

Drug Product and Patent(s)-in-Suit: Vyvanse® (lisdexamfetamine dimesylate); U.S. Patents Nos. 7,105,486 ("the '486 patent"), 7,655,630 ("the '630 patent"), 7,659,253 ("the '253 patent"), and 7,662,878 ("the '878 patent")

Nature of the Case and Issue(s) Presented: Amphetamines are used to treat a variety of disorders, including ADHD. One drawback of using amphetamines, however, is their potential for overdose and abuse. The patents-in-suit disclose modifying amphetamines to decrease this risk. The defendants, except Johnson Matthey Pharmaceutical Materials, filed an ANDA for making and selling generic versions of Vynase, asserting that the claims of the patent-in-suit were invalid and/or not infringed. Johnson Matthey supplied the LDX dimesylate that the co-defendants used to manufacture the ANDA products, and filed a corresponding master drug file with the FDA.

Shire sued defendants, alleging infringement of its patents, then filed a motion for summary judgment that its claims were valid and infringed. The district court found in Shire’s favor and found that Johnson Matthey induced infringement of the claims. The defendants appealed to the Federal Circuit, which reversed the judgment as to Johnson Matthey and affirmed the rest of the opinion.

Why Shire Partially Prevailed: Defendants’ main argument was that the patents-in-suit were obvious in light of Australian Patent Application No. 54,168/65 ("AU '168") which, they argued, taught the use of the mesylate salt of LDX. Thus, defendants claimed, the modified amphetamine taught by the patents-in-suit described in the prior art. Because AU '168 was listed on the face of the patents-in-suit, the examiner was presumed to have considered it. The Federal Circuit found that the defendants did not provide enough evidence to overcome the heightened burden accompanying this presumption. Nothing in the reference taught combining d-amphetamine with L-lysine to make LDX. Rather, AU ’168 disclosed a Markush group whose components could be selected from one of three lists. The first list contained 17 amino acids, the second over 100 combinations of amino acids, and the third an indefinite list of compounds.  This disclosure, the court reasoned, did not provide enough specificity to invalidate the patents-in-suit. Further, although an example final compound was similar to LDX, it contained a tosyl group. Because this example was a final product, a person of ordinary skill would not be motivated to remove the tosyl group to create LDX. Thus, defendants’ argument amounted to hindsight, and the claims were affirmed as valid.

Why Johnson Matthey Partially Prevailed: Johnson Matthey argued that because it only provided the LDX and did not file an ANDA, its actions fell into the safe harbor of 35 U.S.C. § 271(e)(1), which states that it is not an act of infringement to make, use, offer to sell, or sell a patented invention “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” The Federal Circuit agreed. Johnson Matthey’s sale of LDX to the other defendants was reasonably related to the submission of an ANDA and thus fell within the safe-harbor provision.

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