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Schering Corp. v. Mylan Pharma., Inc.

Case Name:  Schering Corp. v. Mylan Pharma., Inc., Civ. No. 09-6383-JLL, 2012 U.S. Dist. LEXIS 59160 (D.N.J. May 29, 2012) (Linares, J.)

Drug Product and Patent(s)-in-Suit: Vytorin® and Zetia® (ezetimibe); U.S. Pat. No. RE 42,461 ("the '461 patent")

Nature of the Case and Issue(s) Presented:  The following two issues were before the Court:  (i) whether the '461 patent was invalid for incorrect inventorship; and (ii) whether the '461 patent was unenforceable due to inequitable conduct.  Mylan argued that another Schering employee, Dr. Afonso, should have been named an inventor on the patent and that Dr. Afonso was omitted from the '461 patent as a result of a deceptive intention on the part of Dr. Afonso and the inventor Dr. Rosenblum.  The Court determined that Mylan failed to provide corroborating clear and convincing evidence that Dr. Afonso's work on related compounds made any contribution to the stereochemistry that the inventor Dr. Rosenblum selected for ezetimibe.  With regard to inequitable conduct, Mylan argued that Dr. Rosenblum and Dr. Afonso committed inequitable conduct with respect to two predecessor patents by not naming Dr. Afonso an inventor and that the '461 patent was unenforceable due to the Doctrine of Infectious Unenforceability.  The Court determined that Dr. Afonso was not an inventor on the predecessor patents and therefore the Doctrine of Infectious Unenforceability did not apply.   The Court also found that the '461 reissue was properly invoked and that the prosecuting attorneys did not seek reissue to remove traces of Dr. Afonso's work as Mylan contended. 

Why Schering Prevailed: Schering prevailed with respect to inventorship because Mylan did not submit sufficient corroborating evidence of Dr. Afonso's conception of the claimed invention.  The Court was not convinced that Dr. Afonso was the first to create the ezetimibe-related compounds.  The Court criticized the timeline of events that Mylan presented and found that Dr. Afonso's process for making these related compounds was not novel, since they were described in a prior publication.  Thus, the Court concluded that Dr. Afonso was not the first to conceive the operative method used to create these compounds.  In addition, the Court noted that Mylan failed to present corroborating evidence that Dr. Rosenblum relied on any of this information to create ezetimibe-the compound claimed in the patent-in-suit.  Mylan failed to introduce any evidence by way of a report, notebook, or witness testimony that affirmatively established a link between Dr. Afonso's work and Dr. Rosenblum's invention.

With respect to the inequitable conduct argument, Schering prevailed due to Mylan's failure to establish Dr. Afonso's inventorship claim with respect to the patent-in-suit and any predecessor patents.  Thus, the Court found that the Doctrine of Infectious Unenforceability did not apply.  In addition, Mylan claimed that the patent was unenforceable as a result of the deceptive intent on the part of Dr. Afonso and Dr. Rosenblum.  During his deposition, Dr. Afonso vigorously denied having any deceptive intent when he told Dr. Rosenblum that he was not the inventor of the claimed subject matter.  The Court also found that the prosecuting attorneys did not commit inequitable conduct by invoking reissue proceedings.  Mylan failed to demonstrate that the prosecuting attorneys had the specific intent to deceive the patent office.  Schering instituted the reissue proceedings in an attempt to narrow the claims over prior art.  Mylan was unable to demonstrate that the prosecuting attorneys' rationale for reissue was false and rather an attempt to remove traces of Dr. Afonso's work.  In addition to failing to prove the intent prong, according to the Court, Mylan failed to prove materiality since Schering properly determined that Dr. Afonso was not an inventor and provided documents from a previous litigation referencing Dr. Afonso's inventorship claims. 

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