Ariad’s Patent On NF-κB Inhibitors Valid and Infringed by Lilly

Posted on | March 21, 2008 | No Comments

2008-1248 Ariad Pharm v. Eli Lilly
D/MA 02cv11280

Defendant Eli Lilly appeals form Judge Rya Zobel’s denial of its JMOL following a jury verdict that its Xigris and Evista products infringe 6,410,516.  The jury rejected all of Lilly’s invalidity and unenforceability arguments, and plaintiffs were awarded approximately $65 million plus future royalties.   The ’516 is generally directed to inhibiting or reducing NF-κB activity in cells.

This case has been more fully discussed and critiqued elsewhere, including Fred Cohen’s Pharma’s Cutting Edge blog.  In essence, one of the arguments by Lilly is that the claims are so broad as to cover the body’s naturally occurring inhibitors of NF-κB.  Lilly’s JMOL also raises:

• Written description.  The ’516 defines a class of chemical inhibitors solely by function (they inhibit NF-κB activity) without identifying any structure or other common elements that would allow on of skill in the art to identify class members.  Citing, e.g., Univ. California v. Lilly, and Univ. of Rochester v. G.D. Searle.

• Enablement.  A claim that purports to cover any and all ways of achieving a result is not enabled as a matter of law.  See O’Reilly v. Morse.

• Non-infringement.  The claims require that the inhibitor enter the cell to reduce NF-κB activity, and there was no evidence that the accused drugs entered the cell.

• Lilly did not induce or contribute to another’s infringement because it didn’t know it would infringe.

• Anticipation.  The claims are inherently anticipated.

• Excluded evidence.  The PTO has apparently rejected the asserted claims of the ’516 in reexamination.  The evidence relied upon by the PTO, generally in the form of later-written material that Lilly argues shows inherency, was excluded by the court as hearsay.

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