Ariad's NF-κB patent claims invalid for lack of written description

In the mid-1980s, the inventors of the ’516 patent discovered an important transcription factor that they named NF-κB. NF-κB is found in almost all animal cell types and is involved in cellular responses to stimuli such as stress, cytokines, free radicals, ultraviolet irradiation, oxidized LDL, and bacterial or viral antigens. NF-κB plays a key role in regulating the immune response to infection. Consistent with this role, incorrect regulation of NF-κB has been linked to cancer, inflammatory and autoimmune diseases, septic shock, viral infection, and improper immune development. NF-κB has also been implicated in processes of synaptic plasticity and memory.
The inventors of the ’516 patent realized that if NF-κB activity could be reduced artificially, it could ameliorate the harmful symptoms of diseases that trigger NF-κB activation.
Ariad claims methods comprising the single step of reducing NF-κB activity
On April 28, 2006, district court rendered a special verdict finding infringement of claims 80 and 95 with respect to Evista( raloxifene) and claims 144 and 145 with respect to Xigris. The jury also found that the asserted claims were not invalid for anticipation, lack of enablement, or lack of written description.Lilly appealed.
Lilly argues that the asserted claims are not supported by written description because the specification of the ’516 patent fails to adequately disclose how the claimed reduction of NF-κB activity is achieved.
‘516 specification hypothesizes three classes of molecules potentially capable of reducing NF-κB activity: specific inhibitors, dominantly interfering molecules, and decoy molecules. Lilly contends that this disclosure amounts to little more than a research plan, and does not satisfy the patentee’s quid pro quo.
According to Ariad, because there is no term in the asserted claims that corresponds to the molecules, it is entitled to claim the methods without describing the molecules.
CAFC found that Ariad’s legal assertion is flawed. CAFC stated that the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-κB activity so as to “satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.
Specific inhibitors are molecules that are “able to block (reduce or eliminate) NF-κB binding” to DNA in the nucleus(only example of a specific inhibitor given in the specification is I-κB, it contains a vague functional description and an invitation for further research which CAFC does not consider as a written disclosure of a specific inhibitor) . Dominantly interfering molecules are “a truncated form of the NF-κB molecule.”( specification provides no example molecules of this class). Decoy molecules are “designed to mimic a region of the gene whose expression would normally be induced by NF-κB(The full extent of the specification’s disclosure of a method that reduces NF-κB activity using decoy molecules is that NF-κB “would bind the decoy” and thereby, “negative regulation can be effected”). CAFC stated that prophetic examples are routinely used in the chemical arts, and they certainly can be sufficient to satisfy the written description requirement. But this disclosure on decoy molecules is not so much an “example” as it is a mere mention of a desired outcome.

CAFC hence held asserted claims invalid for lack of written description and affirmed the district court’s ruling that the ’516 patent is not unenforceable due to inequitable conduct