Reckitt Benckiser Inc., v. Tris Pharma, Inc.

January 03, 2012

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Reckitt Benckiser Inc., v. Tris Pharma, Inc., Civ. No. 09-3125 (FLW), 2011 U.S. Dist. LEXIS 146658 (D.N.J. Dec. 20, 2011) (Wolfson, J.)

Drug Product and Patent(s)-in-Suit: Delsym® (dextromethorphan); U.S. Pat. No. 5,980,882

Nature of the Case and Issue(s) Presented: Whether plaintiffs' expert report contained the adequate factual underpinning necessary to defeat defendants' motion for summary judgment of non-infringement.  After plaintiffs served their opening and rebuttal reports, the defendants filed a motion for summary judgment on the grounds that their generic ANDA formulation did not infringe the asserted claims of the ‘882 patent.  Defendants argued that plaintiffs' expert witness failed to establish infringement because his reports: (i) compared the stability of the accused product to the stability of the plaintiff's product; (ii) analyzed the stability of an experimental Tris Pharma, Inc. (Tris) product, rather than the accused Tris product; and (iii) relied on data provided by a third party laboratory without independently verifying the laboratory's methods or conclusions.  Plaintiffs attempted to remedy those deficiencies by filing a supplemental expert report and expert declaration as exhibits to their opposition to the defendants' summary judgment motion.  The plaintiffs filed a motion to strike the supplemental expert report and declaration, and the motion to strike was granted by the Magistrate Judge and later affirmed by Judge Wolfson.  Accordingly, the plaintiffs were forced to rely exclusively upon the statements and conclusions contained in their opening and rebuttal expert reports in opposing the defendants' summary judgment motion.  

Why Tris Prevailed:  (Unsupported and unverified expert analysis results in flawed infringement position).  The court immediately took exception to the fact that plaintiffs' expert report refers to certain third-party laboratory tests that the expert himself "did not supervise, design or conduct."  Specifically, the court noted that the expert report failed to establish that the third-party testing was scientifically acceptable, that the laboratory was qualified to perform the tests, or that the product manufactured and tested by the laboratory was identical to Tris's accused ANDA formulation.  The court determined that instead of independently verifying any of this information, the expert had simply relied on information that plaintiffs' counsel relayed to him.  Accordingly, the court concluded that the third party test data were insufficient to defeat the defendants' motion for summary judgment.

Next, the court addressed whether Delsym and Tris's generic ANDA product were identical, as was required by claim 23, which calls for a comparison of a "drug-resin complex comprising adding a chelating agent" to "an otherwise identical pharmaceutical composition without the chelating agent."  The court found that Delsym and Tris's generic formulation were not identical, due to the fact that eight of the seventeen ingredients in both products were different.  The court also noted that this was largely an irrelevant point.  In order to establish infringement, the asserted claim required the plaintiffs to establish that a formulation containing EDTA show a 20% reduction in degradation over twelve months as compared to an identical formulation that did not contain EDTA.  Essentially, the plaintiffs were required to compare the degradation of Tris's ANDA formulation with EDTA against an identical solution without EDTA over a twelve month period.  The expert report failed to perform such an analysis.

Finally, the court concluded that the expert's analysis of internal Tris data related to an experimental Tris formulation containing Purolite C100MR resin was unpersuasive.  The accused Tris ANDA formulation contained Amberlite IRP69 instead of Purolite C100MR.  Further, the court noted that the internal Tris data only studied degradation of the experimental formulation over a three month period of time, which was shorter than the twelve month limitation set forth in the asserted claim.  The court found that the expert's conclusion that the three months of data could be extrapolated over the required twelve month period of time was inadequate to satisfy the plaintiffs' burden.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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