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Quinn Emanuel Successfully Defends Chiesi in Generic Challenge to Its Cleviprex® Pharmaceutical Product

September 2022

In a complete victory for its client Chiesi, Quinn Emanuel defeated a generic challenge and secured a judgment for Chiesi on all counts.  The Honorable Zahid N. Quraishi (District of New Jersey) recently found, after his first trial, that Plaintiff Chiesi prevailed on all three asserted patents in the matter of Chiesi USA, Inc. et al. vs. Aurobindo Pharma USA, Inc. et al., C.A. No. 3:19-cv-18756, a pharmaceutical patent litigation, and found that all of Chiesi’s patents were infringed, not invalid, and not unenforceable.  As a result, Defendant Aurobindo will be enjoined from bringing their product to market until October 10, 2031, when the patents-in-suit expire.

The case arose from Aurobindo’s filing of an Abbreviated New Drug Application (ANDA) seeking FDA-approval to market a generic version of Chiesi’s Cleviprex® (clevidipine) injectable product.  Chiesi asserted that Aurobindo’s ANDA infringed U.S. Patent Nos. 8,658,676, 10,010,537, and 11,103,490.  Aurobindo’s counterclaims sought declaratory judgments of non-infringement, invalidity, and unenforceability of the patents-in-suit.  The Court held a 7-day bench trial in January 2022.  The parties presented closing arguments and submitted post-trial submissions in April 2022.  On August 24, 2022, the Court entered an unsealed Opinion and Order in favor of Chiesi on all counts tried for all patents-in-suit.  

A central issue in the infringement case was whether Aurobindo’s generic product containing 0.0005% EDTA infringed a claimed range with a lower limit of “about 0.001%” EDTA, an antimicrobial agent. The Court agreed with Chiesi and found that 0.0005% EDTA literally fell within the claimed amount.  In so doing, the Court concluded that 0.0005% EDTA served the same purpose as the claimed EDTA amount and that there was no criticality as to the lower limit of the claimed amount.

The invalidity case turned on whether it was obvious to add EDTA to a clevidipine formulation. The Court noted that Aurobindo admitted that developing the formulations at issue “is a complex and unpredictable science.”  The Court found that there was no motivation for a person of ordinary skill to have added EDTA because Aurobindo’s arguments were based on “impermissible hindsight” and that an earlier clevidipine formulation did not “pose[] a problem to be addressed.”

And for unenforceability, Aurobindo accused the inventors, the in-house attorney, and multiple outside prosecuting counsel of inequitable conduct. The Court found that the bases for Aurobindo’s arguments were “not material at all, much less but-for material.”  The Court further observed that, “[i]n an unlikely turn of events,” Aurobindo itself filed a patent application and argued to the Patent Office for its own patent – “those arguments are the same ones that Aurobindo allege[d] in this case were intentionally misleading when made by the applicants” of the patents-in-suit asserted by Chiesi. When confronted about this at trial, Aurobindo’s own expert said that this was “indefensible.”