By Donald Zuhn --
On Monday, an en banc panel of the Federal Circuit heard oral argument in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. (see "Ariad v. Lilly: Oral Argument"). During the hearing, several members of the Court as well as counsel for the Government focused on perceived differences between the positions taken by Plaintiffs-Appellees ("Ariad") in their principal and reply briefs. (For a discussion of Ariad's principal brief, please see "Next Up: Ariad v. Lilly Rehearing En Banc"). Today, we examine Ariad's reply brief.
Ariad begins the brief by listing the points on which the parties and amici find common ground, stating that:
Lest it be obscured by rhetoric, it is important to note that there is much common ground amongst the parties and amici. Specifically, they agree that:
1. The specification must provide a written description of the invention and of the manner and process of making and using it.
2. The description requirement of § 112 applies to all claims, whether they were originally present in the application or not.
3. The description requirement of § 112 polices an applicant's ability to add or amend claims during prosecution.
4. A patent may not claim an invention that is not described in the specification.
5. The description requirement of § 112 prevents claims that extend beyond the inventor's contribution as set forth in the specification;
claims of broad applicability must correspond to an invention that is identified in the specification by a broadly applicable common principle.
Ariad then summarizes the "actual disagreement" between the parties as concerning the issue of:
[W]hether § 112, first paragraph requires a written description of the invention that is separate from enablement. Specifically, is the entire written description required by § 112 (i.e., the description of the invention, and of the manner and process of making and using it) measured by the statutory duty to describe the invention in "such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same," as Plaintiffs-appellants contend? Or, as urged by Lilly, does § 112 impose a written description requirement independent of the rest of the statute and measured by the judicially-created "possession" test of Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) and its progeny?
Ariad's brief next addresses the language of § 112, first paragraph, providing a table comparing the statutory constructions proposed by the parties:
[S]evers the "written description of the invention" not only from the requirement to enable, but also from the requirement that it be in "full, clear, concise, and exact" terms. There is no reason for Congress to demand a written description of "the manner and process of making and using" the invention that is "full, clear, concise, and exact" while tolerating a "written description of the invention" that is incomplete, unclear, long-winded, and inexact.
As in its principal brief, Ariad examines and compares the statutory language from the Patent Acts of 1793, 1836, and 1952, and concludes that:
The history of the Patent Act also shows that, since 1793, the requirement for a description of the invention has always been linked with the requirement to describe the manner of making and using the invention, and has been measured by the text that follows, i.e., clear, concise and exact, etc.
Ariad's brief next provides a discussion of relevant Supreme Court precedent. Contending that Lilly "mischaracterizes the Supreme Court decisions on which it relies," Ariad states that "Supreme Court precedent both before 1836 and after 1836 provides no support for the view that the written description requirement is to be separated from its statutory standard for enablement, let alone that it be judged by this Court's current 'possession' test." Ariad notes that Lilly has failed to produce "even one post-1836 Supreme Court opinion in which the description of an invention claimed or otherwise identified at the time of filing was found to be deficient under any standard other than the enablement standard." According to Ariad, the reason for this failure is that:
The Supreme Court cases have never decoupled the "written description of the invention" from rest of the statutory language and have never held that a written description of an invention sufficient to enable others to practice a claimed invention could nonetheless fail because the description somehow did not "establish that the applicant was in possession of the claimed invention."
Ariad explains that when § 112, first paragraph, is interpreted as proposed in its briefs, the "description requirement" serves two purposes by: (1) "prevent[ing] patent applicants from introducing new or amended claims directed to a different invention than is described in an earlier-filed specification," and (2) "ensur[ing] that the claims -- whether original or amended -- match the inventor's contribution to the art." With respect to the second objective, Ariad notes that claims encompassing more than the particular embodiments disclosed in the specification must be supported by an identification of "the common principle that defines the invention and distinguishes it from the prior art."
In the last portion of its reply brief, Ariad outlines how the claims at issue in the appeal satisfy the "description requirement" of § 112, when § 112, first paragraph, is construed as proposed in Ariad's briefs. Ariad then summarizes its opponent's argument by stating that:
Under Lilly's view, even though the claims-in-suit might be directed to novel, useful, non-obvious, and statutory methods, and even though the '516 patent applicants might have complied with their statutory duty to provide a written description of their invention "in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same," the asserted claims are nevertheless worthless and void because the '516 patent applicants purportedly did not comply with a "separate", non-statutory, judicially-devised duty to describe their invention in terms that a court or jury might deem sufficient to prove that the '516 patent applicants had "possession" of the claimed methods to a legally sufficient degree.
Ariad, however, counters by arguing that:
The discoverer of a new and non-obvious process, whose use is not tied to particular materials or machines, has never been restricted in his or her patent protection to the details of particular instrumentalities that were then the best-known ways of carrying out the process. Lilly's "written description" arguments are aimed at denying patent protection to upstream researchers who discover and disclose generally applicable methods that Lilly would then subsequently exploit.
For additional information regarding this topic, please see:
• "Ariad v. Lilly: Oral Argument," December 9, 2009
• "Amicus Briefs in Ariad v. Lilly: Regents of University of California et al.," December 6, 2009
• "Amicus Briefs in Ariad v. Lilly: Briefs by Companies," December 6, 2009
• "Amicus Briefs in Ariad v. Lilly: American Intellectual Property Law Association," December 1, 2009
• "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association," November 29, 2009
• "Amicus Briefs in Ariad v. Lilly: Intellectual Property Owners Association," November 25, 2009
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009