Opinion
CIVIL ACTION NO. 02-11280-RWZ
May 12, 2003
MEMORANDUM OF DECISION AND ORDER
In the mid-1980s, scientists at the Massachusetts Institute of Technology, the Whitehead Institute for Biomedical Research, and Harvard University ("plaintiff institutions") identified a protein called Nuclear Factor Kappa B ("NF-KB"). Present in the cytoplasm of many different cell types, NF-KB is what is known as a transcription factor. When activated by various external stimuli, it travels into the cell nucleus and binds to specific DNA sequences, causing the cell to produce proteins that are associated with many diseases, including cancer, AIDS, sepsis, and atherosclerosis. Inhibiting this process has enormous and wide-ranging therapeutic effects. Numerous laboratories now engage in research relating to NF-KB.
Prior to the initial discoveries by the research team at plaintiff institutions, defendant Eli Lilly Co. ("Lilly") patented two compounds, raloxifene hydrochloride and recombinant human activated Protein C ("aPC"). As it happens, these two compounds inhibit NF-KB activity, although Lilly did not know this when it obtained its patents. According to the Complaint, Lilly began marketing raloxifene hydrochloride in 1997 under the brand name Evista to treat osteoporosis, and since 2001, it has been selling aPC under the name Xigris to treat severe sepsis. At the molecular level, these drugs treat osteoporosis and severe sepsis, respectively, by inhibiting NF-KB activity.
Raloxifene hydrochloride is covered by United States Patent No. 4,418,068 ("Jones patent"). The patent for aPC is No. 4,775,624 ("Bang patent").
On June 25, 2002, the researchers at plaintiff institutions were granted patent number 6,410,516 ("`516 patent"), which claims various methods for inhibiting NF-KB activity. On the same day, plaintiff institutions and Ariad Pharmaceuticals, Inc., the exclusive licensee of the `516 patent, filed suit against defendant Lilly, alleging that Lilly's sales and marketing of Evista and Xigris constitute infringement of 20 claims of the `516 patent. Defendant has filed a Combined Motion to Dismiss and Motion for Summary Judgment of Invalidity. Plaintiffs, in turn, have filed a Rule 56(f) motion to deny summary judgment as premature or, in the alternative, staying defendant's motion until the parties have conducted appropriate fact and expert discovery.
Defendant's combined motion has two grounds. First, defendant contends that its patents for raloxifene hydrochloride and aPC anticipate the `516 patent and render it invalid under 35 U.S.C. § 102(b) (e). The record is insufficient at this stage in the litigation to make such a determination. Neither of the two Lilly patents mentions NF-KB, and it is unclear at present whether the administration of Evista and Xigris developed in response to the methods claimed in the `516 patent or derived from methods that were in the public domain prior to plaintiffs' patent. Defendant has not met its burden to win the combined motion on prior art grounds.
The second basis for defendant's combined motion is that the language of the `516 patent merely expresses a desired result — the inhibition of NF-K activity — rather than actual methods to achieve such a result that would "enable any person skilled in the art . . . to make and use the same. . . ." 35 U.S.C. § 112, at ¶ 1. This issue of "enablement" is a serious and troubling one. Despite the enormous volume of paper submitted by plaintiffs, the expert testimony is vague about what actual methods are claimed in the `516 patent. The only remotely specific testimony on the issue can be found in one paragraph of Dr. Thomas D. Gilmore's declaration. According to Gilmore, the patent notes that the process of phosphorylation may activate NF-KB: "The patent then teaches how compounds that can inhibit phosphorylation . . . can inhibit translocation of NF-Kto the nucleus, and that patent also describes various assays that may be used in identifying such NF-KB-modulating compounds." This testimony does not resolve the question of whether the patent describes actual methods for inhibiting NF-Kactivity or improperly claims every method that achieves that result. Nevertheless, defendant has not met its burden by proving that the patent is invalid on enablement grounds. The Court is not prepared to rule on this issue in the absence of more focused expert evidence.
The stack of papers in this case can already be measured by the cubit, due in no small part to counsels' exuberant filing of multiple copies of the same document. For example, the record includes at least five copies of the 106-page `516 patent and multiple copies of one expert's declaration with the 24 exhibits attached thereto. The Court expects counsel to exercise judgment and restraint with all future submissions.
Accordingly, defendant's combined motion is denied, and plaintiff's Rule 56(f) motion is denied as moot.