In Ariad Pharmaceuticals, Inc., et a. v. Eli Lilly and Co., 598 F3d 1336, 94 USPQ2d 1161 (Fed. Cir. 2010) (en banc), the Federal Circuit reversed the district court’s denial of a JMOL and held that the asserted claims of U.S. Patent No. 6,410,516 are invalid as failing to meet the statutory written description requirement. As background, the plaintiffs (herein, collectively referred to as “Ariad”) are the owners of U.S. Patent 6,410,516 (“the ’516 patent”). The patented technology relates to a method of reducing the activity of NF-κB, a transcription factor, in eukaryotic cells. Briefly, NF-κB is a substance that normally exists in cells as an inactive complex with a protein inhibitor, IκB. When a cell encounters extracellular stimuli, such as lipopolysaccharides from a bacterial invader, NF-κB is released from its inhibitor and travels to the cell nucleus, where it binds to NF-κB recognition sites to crank up the production of cytokines that stimulate the immune system to fight the invaders. However, the production of too many cytokines is also harmful to an organism. The inventors of the ’516 patent were the first to identify NF-κB and discovered its mechanism of activating gene expression. The inventors also came up with the idea that it would be useful under certain circumstances to reduce NF-κB activity in cells.
The claims of the ’516 patent that were at issue read as follows (brackets indicate text from the independent claims):
80. [A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-κB-mediated intracellular signaling, the method comprising altering NF-κB activity in the cells such that NF-κB -mediated effects of external influences are modified, wherein NF-κB activity in the cell is reduced] wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB.
95. [A method for reducing, in eukaryotic cells, the level of expression of genes which are activated by extracellular influences which induce NF-κB-mediated intracellular signaling, the method comprising reducing NF-κB activity in the cells such that expression of said genes is reduced], carried out on human cells.
144. [A method for reducing bacterial lipopolysaccharide-induced expression of cytokines in mammalian cells, which method comprises reducing NF-κB activity in the cells so as to reduce bacterial lipopolysaccharide-induced expression of said cytokines in the cells] wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB.
145. [A method for reducing bacterial lipopolysaccharide-induced expression of cytokines in mammalian cells, which method comprises reducing NF-κB activity in the cells so as to reduce bacterial lipopolysaccharide-induced expression of said cytokines in the cells], carried out on human cells.
These claims were interpreted as being genus claims encompassing the use of all substances that achieve the result of reducing the binding of NF-κB to NF-κB recognition sites on genes or that reduce NF-κB activity in cells. The specification described the desired goal of reducing the binding of NF-κB to NF-κB recognition sites on genes and reducing NF-κB activity in cells and hypothesized three types of molecules having the potential to reduce NF-κB activity in cells: decoy molecules, dominantly interfering molecules and specific inhibitor molecules. The specification did not provide any specific examples of decoy molecules and dominantly interfering molecules, and the only example provided of a specific inhibitor molecules was the naturally occurring inhibitor IκB, which had not yet been isolated.
Ariad brought suit against Eli Lilly & Company (“Lilly”) in the U.S. District Court for the District of Massachusetts, alleging infringement of claims 80, 95, 144 and 145. A jury found infringement and held that the claims were not invalid. The district court denied Lilly’s motion for judgment as a matter of law. A three-judge panel of the Federal Circuit reversed the district court and held that the asserted claims were invalid for lack of written description under 35 U.S.C. §112, first paragraph. Ariad petitioned for a rehearing en banc.
For the rehearing, the Federal Circuit directed the parties to address whether 35 U.S.C. §112, first paragraph, contains a written description requirement separate from the enablement requirement and if so, the scope and purpose of the requirement.
The Federal Circuit first discussed the statute itself to determine the proper interpretation with respect to the written description requirement. 35 U.S.C. §112, first paragraph states:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Ariad argued that, as a matter of English grammar, the phrases “of the invention,” “of the manner and process of making and using it,” and “in such full, clear, concise and exact terms” all modify the term “written description such that statute requires only that the written description of the invention identify the invention and provide sufficient information for a person skilled in the art to make and use the invention. In other words, Ariad argued that the written description requirement is actually just a part of the enablement requirement, serving to identify what it is that the specification must teach how to make and use. Lilly, on the other hand, argued that the phrase “in such full, clear, concise and exact terms as to enable any person skilled in the art…to make and use the same” modifies the phrase “of the manner and process of making and using it” such that there are two separate description requirements, a written description (i) of the invention and (ii) of the manner and process of making and using the invention.
The Federal Circuit agreed with Lilly’s interpretation that the statute contains two separate description requirements. In particular, the Federal Circuit held that the statute does not unambiguously support Ariad’s interpretation and stated that if Congress had intended enablement to be the sole description requirement of 35 U.S.C. §112, first paragraph, the statute would have been worded differently. The Federal Circuit also noted that the requirement of a written description had always been a part of the patent statutes since 1793 and that the Supreme Court had applied the description requirement separate from the enablement requirement, citing O’Reilly v. Morse, 56 U.S. (15 How.) 62 (1853), Schriber-Schroth Co. v. Cleveland Trust Co., 305 U.S. 47 (1938) and Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002).
Ariad further argued that the written description requirement does not apply to original claims, since original claims, as part of the original disclosure, constitute their own written description of the invention. That is, the original claims identify whatever they state. The Federal Circuit disagreed that this is always the case. In particular, the Federal Circuit stated that a generic claim may define the boundaries of a vast genus of chemical compounds and the question may arise as to whether the applicant has described species sufficient to support a claim to the genus. The Federal Circuit noted that this problem is particularly acute with respect to genus claims that use functional language to define the boundaries of the claim, in which case, the functional language may merely describe a desired result without describing any species that produce the result. The Federal Circuit stated that the specification must demonstrate that the applicant has made a generic invention that achieves the claims result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus or must describe structural features common to the members of the genus so that one skilled in the art can visualize or recognize the members of the genus.
As examples of recent cases showing a failure of providing sufficient written description to support genus claims, the Federal Circuit discussed Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) and University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916 (Fed. Cir. 2004). In particular, in Rochester, the Federal Circuit had invalidated claims directed to a method of selectively inhibiting a particular enzyme by administering a non-steroidal compound that selectively inhibits the enzyme. In the patent at issue, the specification did not describe any specific compound capable of performing the claimed method and the court had found that a skilled artisan would not be able to identify any such compound based on the functional description. The court in that case stated that the claims merely recite a description of the problem to be solved while claiming all solutions to the problem, leaving it to others to complete the unfinished invention.
In summary, the Federal Circuit stated requiring a separate written description limits patent protection to those who actually perform and complete the work of invention, of conceiving the complete and final invention with all its claimed limitations and disclose the fruits of that effort to the public. The Federal Circuit further stated that the written description requirement is part of the quid pro quo of the patent grant to ensure that the public receives a meaningful disclosure in exchange for being excluded from practicing an invention for a period of time.
In the second part of the opinion, the Federal Circuit discussed the application of the written description requirement to the facts of the present case. In particular, the Federal Circuit discussed the sufficiency of disclosure with respect to each of the three classes of molecules, specific inhibitor, dominantly interfering molecules and decoy molecules, hypothesized in the specification of the ’516 patent as being capable of reducing NF-κB activity. In each case, the Federal Circuit found that the specification only described a vague functional description or desired outcome and did not provide a written description of any specific inhibitor, dominantly interfering molecule or decoy molecule. Accordingly, the Federal Circuit concluded that the district court jury lacked substantial evidence for its verdict that the asserted claims were supported by an adequate written description.
Accordingly, the Federal Circuit reversed the district court and held that the asserted claims were invalid for lack of written description under 35 U.S.C. §112, first paragraph.