Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.

Ariad Pharmaceuticals, Inc., and others (collectively “Ariad”) (Plaintiff) brought suit against Eli Lilly & Company (Defendant) for infringing patent ‘516. The inventors of the ‘516 patent were the first to identify NF-kB, a gene transcription factor, and to uncover the method NF-kB uses to activate gene expression underlying the body’s immune responses to infection. The inventors discovered that NF-kB normally exists in cells as an inactive complex with a protein inhibitor, named I-kB, and is activated by extracellular stimuli through a series of biochemical reactions that release it from I-kB. Once free of its inhibitor, NF-kB travels into the cell nucleus where it binds to and activates the transcription of genes containing an NF-kB recognition site. The activated genes (cytokines) in turn help the body to counteract the extracellular assault. However, the production of cytokines can be harmful in excess. The inventors therefore recognized that artificially interfering with NF-kB activity could reduce the harmful symptoms of certain diseases. They claimed methods for regulating cellular responses to eternal stimuli by reducing NF-kB activity in a cell. The claims were genus claims, including the use of all materials that achieve the desired result of reducing the binding of NF-kB to NF-kB recognition sites. The specification also hypothesized three types of molecules with the potential to reduce NF-kB activity in cells: decoy, dominantly interfering, and specific inhibitor molecules. Defendant argued that there was no written description to support the asserted claims because the specification of the ‘516 patent failed to sufficiently disclose how the claimed reduction of NF-kB activity was achieved. Ariad (Plaintiff) responded that Lilly’s (Defendant) arguments failed as a matter of law because Plaintiff did not actually claim the molecules. According to Plaintiff, as there was no term in the asserted claims that corresponded to the molecules, it was entitled to claim the methods without describing the molecules. Alternatively, Plaintiff contended that the specification of the ‘516 patent and the testimony of its expert, Kadesh, provided the jury with the substantial evidence of adequate written description of the claimed methods. The jury found that Defendant had infringed patent ‘516 and also found that none of the asserted claims were invalid. The district court denied Defendant’s motion for judgment as a matter of law (JMOL), but the court of appeals reversed, finding that the claims were invalid for lack of an adequate written description as required by 35 U.S.C. § 112. Plaintiff petitioned for a rehearing, challenging the court of appeals’ interpretation of § 112, first paragraph, as containing a separate written description requirement. The court of appeals granted the petition.