Shire LLC et al. v. Amneal Pharmaceuticals, LLC et al.

Docket No. 2014-1736-41

September 24, 2015

Brief Summary: DC grant of SJ to Shire that its patents are not invalid for obviousness affirmed (e.g., prior art “does not teach a finite and limited class” including precursor compound absent hindsight). DC decision that API supplier Johnson-Matthey was not protected by § 271(e)(1) reversed.

Summary: Multiple defendants (“Amneal”) appealed DC grant of SJ that Shire’s claims relating to the use of amphetamines to treat attention deficit hyperactivity disorder (ADHD) (Vyvanse®) were not invalid for obviousness and denying a motion to amend their invalidity contentions to include an on-sale bar. Johnson-Matthey (JM) separately appealed DC decision that it induced infringement of Shire’s patents by providing the active pharmaceutical ingredient (API) L-lysine-d-amphetamine (LDX). Shire’s patents “describe modifying amphetamine in such a way as to decrease its activity when administered in high doses-as happens when the drug is being abused’ but to maintain activity similar to that of unmodified amphetamine when the modified amphetamine is delivered at lower doses.” Regarding obviousness, the opinion explains that “[f]or a patent to be obvious, ‘some kind of motivation must be shown…so that the jury can understand why a person of ordinary skill would have thought of either combining two or more references or modifying one to achieve the patented method’” (Innogenetics, FC 2008). The defendants argued the prior art disclosed or made obvious the mesylate salt of LDX (used in Shire’s process) but the FC disagreed in part because “AU ‘168 is listed on the face of the patents-in-suit and therefore the examiner is presumed to have considered it” (PowerOasis, FC 2008), “it does not teach a finite and limited class including LDX” (or the salt) (“‘does not indicate any preference’ among the [over 100 possible] options” (Unigene Labs., FC 2011), and the defendants did not “show a reason why one of skill in the art would decide to start with example 24 and remove the protecting group” (“Defendants can only come to LDX by ‘retracing the path of the inventor with hindsight.” (Ortho-McNeil, FC 2008 at 1364; In re Cyclobenzaprine, FC 2012 at 1071-72)) A second reference was not found to overcome the deficiencies of the first (“Defendants have offered no rationale why a person of skill in the art would focus on the specific embodiments of Formula II comprising L-lysine.”) The DC grant of SJ for nonobviousness was therefore affirmed. The FC also found that the defendants had not shown the DC abused its discretion in denying their motion to amend because they did “not persuasively explain[] why their motion…was not filed earlier” or address the magistrate’s finding that certain documents produced by Shire should have led to the argument. JM argued that providing the ANDA defendants with an active ingredient so they could submit the ANDAs was reasonably related to the submission of information under a federal law and was therefore within the safe harbor of § 271(e)(1)” and “that because no direct infringement has yet to occur, it cannot be liable for induced infringement under § 271(b).” The FC panel concluded JM was protected by § 271(e)(1) and the DC erred in finding JM induced infringement of the compound claims. It also disagreed with Shire that the 2007 Forest decision (a party can be liable under section 271(e)(2) for its future infringement under section 271(b) as the ANDA-filers’ API supplier”) because that case “involved the scope of an injunction under § 271(e)(4).” The DC decision on this point was reversed.

This entry was posted in Generics / ANDA, Inducement to Infringe, Infringement, Obviousness. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.