Cumberland Pharma., Inc. v. Mylan Institutional LLC

Case Name: Cumberland Pharma., Inc. v. Mylan Institutional LLC, Case No. 12 C 3846, 2012 U.S. Dist. LEXIS 177941 (N.D. Ill. Dec. 14, 2012) (Pallmeyer, J.)

Drug Product and Patent(s)-in-Suit: Acetadote® (N-acetylcysteine); U.S. Pat. No. 8,148,356 (“the ’356 patent”)

Nature of the Case and Issue(s) Presented: The issues presented concern Mylan’s inequitable conduct counterclaim and affirmative defense. In particular, Mylan alleged that the inventor of the ’356 patent failed to disclose certain references to the USPTO, failed to disclose communications from the FDA regarding the removal of EDTA in the formulation of the covered product, and made misrepresentations regarding the then-marketed Acetadote formulation as compared to the claimed formulation.

Cumberland sought to dismiss the counterclaim and affirmative defense on three grounds: (i) Mylan failed to alleged sufficient facts to demonstrate why the withheld information would have had any effect on whether the ’356 patent issued; (ii) the purportedly withheld information was cumulative of art already before the USPTO Examiner; and (iii) Mylan failed to specifically identify claims and/or limitations that would be materially affected by the withheld information.

Mylan argued that it sufficiently plead facts to support why the withheld information would have affected the issuance of the ’356 patent as the information would have rendered the asserted claims obvious and/or anticipated. Mylan further argued that the allegations, taken as true, provide a basis to infer the requisite intent for an inequitable conduct claim. Finally, Mylan argued that the withheld information was not cumulative as it alleged that the information would have changed the examiner’s decision regarding the patentability of the claims of the ’356 patent. Relying on the Federal Circuit’s decision in Exergen Corp. v. Wal-Mart Stores, Inc., the district court denied the majority of Cumberland’s motion.

Why Mylan Prevailed:  Mylan alleged that the inventor of the ’356 patent knew of several FDA-issued references that were material to the patentability of the claims of the ’356 patent. The court did not require that Mylan specify which claims the references would be material to; it found it sufficient that Mylan identified particular portions of the references that allegedly taught various limitations found in the claims of the ’356 patent. The court found that Mylan’s allegations of what information should have been presented to the examiner and how that information would have affected patentability were sufficient to demonstrate that the references were not cumulative.

Likewise, the court found that Mylan’s allegations regarding the inventor’s alleged misleading statements to the PTO were sufficient because the allegations identified which statements were false and/or misleading and the information upon which Mylan asserts demonstrates that the inventor knew these particular statements were false and/or misleading.  Mylan was not required to identify particular claims or limitations in the patent with respect to the alleged false statements.

The district court, however, did grant Cumberland’s motion regarding allegations that it failed to disclose prior art regarding pharmacokinetics of acetylcysteine. Mylan failed to set forth allegations demonstrating why these prior art references were related to the ’356 patent. The claims of the ’356 patent did not contain a specific limitation regarding pharmacokinetics such that the court was not able to infer the materiality of the withheld information.

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