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Regeneron Pharmaceuticals, Inc. v. Merus B.V.

Citations: 144 F. Supp. 3d 530; 2015 U.S. Dist. LEXIS 148322; 2015 WL 6674818Docket: No. 14 Civ. 1650(KBF)

Court: District Court, S.D. New York; November 1, 2015; Federal District Court

Narrative Opinion Summary

This case involves a dispute over the enforceability of U.S. Patent No. 8,502,018, owned by Regeneron, which filed infringement suits against Merus B.V. and Ablexis LLC. The core issue is the alleged inequitable conduct by Regeneron during the patent's prosecution, where Merus contends that Regeneron withheld material references from the Patent and Trademark Office (PTO) that would have precluded the patent's issuance. The court found that Regeneron's actions, including misleading representations and failure to disclose critical prior art, amounted to inequitable conduct, rendering the patent unenforceable. The court evaluated expert testimonies and determined that Regeneron's conduct demonstrated a specific intent to deceive the PTO. Procedurally, the case involved a bench trial focusing on inequitable conduct, where the court imposed sanctions on Regeneron, including precluding key testimonies and inferring intent to deceive. Consequently, the court found in favor of Merus, concluding that the patent was obtained through misleading conduct, and directed the parties to submit a proposed order to finalize the case.

Legal Issues Addressed

Adverse Inference Sanction

Application: The court imposed an adverse inference sanction against Regeneron, indicating that they acted with intent to deceive during the patent's prosecution.

Reasoning: The Court decided to preclude the testimony of Sme-land, Murphy, and Jones and to impose the sanction of an adverse inference regarding Sme-land and Murphy's intent during patent prosecution.

Claim Construction and Enablement

Application: The court found that the claim construction of the '018 Patent was overly broad and not enabled by the specification, particularly regarding the precise location for DNA insertion.

Reasoning: The Court's broadest reasonable construction of Claim 1 concludes that it pertains to a genetically modified mouse containing human unrearranged variable region gene segments inserted into its Ig locus, with allowances for variations in the constant region.

Inequitable Conduct and Duty of Candor

Application: The court found that Regeneron engaged in inequitable conduct by failing to disclose material prior art references to the PTO, which would have affected the patent's issuance.

Reasoning: Merus claims that Drs. Smeland and Murphy breached their duty of candor to the PTO, alleging they committed inequitable conduct through false statements and misleading results in a January 2013 presentation.

Materiality of Withheld References

Application: The court determined that the withheld references were material and would have led the PTO to reject the claims of the '018 Patent.

Reasoning: The Court concluded that these withheld references would have led the PTO to reject the claims had they been disclosed, applying a preponderance of evidence standard and giving claims their broadest reasonable construction.

Specific Intent to Deceive

Application: The court inferred that Regeneron's actions demonstrated a specific intent to deceive the PTO based on a pattern of misconduct and misleading representations.

Reasoning: The Court concludes that the most reasonable inference from the evidence is that Drs. Smeland and Murphy were aware of certain withheld references and their material significance, making a conscious choice to conceal them.