Hospira Wins Dismissal But Loses Time

Posted on | August 6, 2008 | No Comments

2008-1499 Aventis Pharma v. Hospira
CD/CA 07-CV-8137
Judge Mariana R. Pfaelzer

Aventis has appealed from Judge Pfaelzer’s Order granting Hospira’s motion for judgment on the pleadings and dismissing Aventis’s infringement claim with prejudice based on collateral estoppel. 

Aventis owns U.S. Patent No. 5,389,618 claiming enoxaparin sodium sold under the brand name LOVENOX®.  Enoxaparin sodium is
used for the treatment and prevention of deep vein thrombosis.

The ’618 patent is no stranger to litigation.  In 2003 and 2004,
Aventis sued Amphastar and Teva for infringement of the ’618 patent
after each had filed ANDAs for enoxaparin sodium products.  In 2005,
the Central District of California granted summary judgment in
Amphastar’s case, finding the ’618 patent unenforceable for inequitable
conduct–the Court held that Aventis and its agent failed to disclose
material information to the PTO.  While the Federal Circuit agreed that
Aventis had failed to disclose material information, it remanded the
case for trial on the issue of "Aventis’s intent to deceive the PTO.  In 2007, after a four-day bench trial, the Central District of California again found the ’618 patent unenforceable.  Aventis Pharma S.A. v. Amphastar Pharmaceuticals, Inc. 475 F. Supp. 2d 970, 994 (C.D. Cal. 2007).   

While an appeal of that decision was pending, Hospira filed ANDAs for enoxaparin sodium products and sent the required notice to Aventis, triggering the 45-day clock for Aventis to file an action.  On the last day of that window, Aventis filed the instant infringement action. Citing the Court’s earlier unenforceability decision, Hospira moved for judgment on the pleadings under Rule 12(c).

The gist of Hospira’s motion was simple:  Aventis’s claims are barred under collateral estoppel because the Court already determined that the ’618 patent was unenforceable.  As Hospira argued, Aventis simply filed its infringement action to "game the system"–it knew that the filing would trigger a 30-month stay of Hospira’s ANDA approval. 

Aventis, however, never hid this fact.  It not only acknowledged the prior ruling in its Complaint, but it offered to waive the 30-month stay if the ANDA was approved before the Federal Circuit decided Aventis’s appeal.  Aventis even admitted that it filed suit to "preserve" its rights. 

The end result was a "damned if you do, damned if you don’t" scenario under Hatch-Waxman.  Aventis argued that staying the action was prudent because dismissal would terminate its Hatch-Waxman rights–for good–even if the Federal Circuit ultimately overturned the adverse inequitable conduct ruling.  At that point, Aventis’s  only recourse against Hospira would have been a preliminary injunction.  Hospira countered that anything short of dismissal with prejudice–including Aventis’s requested stay–was "functionally equivalent" to a preliminary injunction.  And because the Hatch-Waxman Act does not provide for a private waiver of the statutory stay, Aventis’s waiver offer was useless. 

Ultimately, the Court asked the parties to wait it out.  While the Court never formally  issued a stay order, judgment was reserved until the Federal Circuit ruled–and it ruled against Aventis.  Upon receiving the Federal Circuit’s opinion, the Court indicated that it would grant Hospira’s motion.  Aventis sought a writ of mandamus to stay judgment pending Aventis’s motion for rehearing en banc.  While the Federal Circuit issued a temporary stay order, it ultimately denied Aventis’s requested writ.  Aventis asked  Judge Pfaelzer for a stay one last time, but the Court granted Hospira’s motion and entered judgment dismissing Aventis’s case with prejudice.   

Notes:

• In addition to appealing Judge Pfaelzer’s Order dismissing the case with prejudice, Aventis is still pursuing its motion for rehearing–and receiving a bit of amicus support. 

• Coverage of the underlying Amphastar can be found at the Orange Book Blog.

• While not shelved for 30 months, Hospira’s ANDAs were stayed over six months because of the lawsuit.

More Reading:

Hospira’s Brief In Support Of Judgment On The Pleadings

Aventis’s Brief In Opposition

Hospira’s Reply Brief

Counsel:

For Hospira: Winston & Strawn, Los Angeles (Gail J. Standish and Daniel Whang), Chicago (James F. Hurst and Kathleen B. Barry), and Washington (Charles B. Klein)

For Aventis:  Finnegan, Henderson, Farabow, Garrett & Dunner, Washington (Donald R. Dunner and Allen M. Skoal) and Atlanta (Robert C. Stanley); Morris, Polich & Purdy, Los Angeles (Daniel L. Ridge and Megas S. Wynne)
 

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