By Donald Zuhn --
Yesterday, Ariad Pharmaceuticals filed a petition for a panel rehearing of the decision issued by the Federal Circuit in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. In that decision, issued on April 3, the Federal Circuit reversed the District Court's denial of Lilly's motion for JMOL in view of a jury verdict of infringement and validity of the asserted claims, and affirmed the District Court's ruling that Lilly failed to establish the affirmative defense of inequitable conduct (see Patent Docs report). In its petition, Ariad lays out two questions of exceptional importance:
(2) What is the proper test to satisfy the requirement in Section 112, paragraph 1, that a patent specification 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"?
Ariad begins by noting that:
Stating that "[t]he controversy over this Court’s written description cases will not abate until the matter is definitively addressed either by this Court en banc, or by the Supreme Court," Ariad argues that "[t]his case provides a good vehicle for this Court to address the controversy."
Citing Judge Linn's concurrence in Ariad v. Lilly; Judge Linn's and Judge Rader's dissents in University of Rochester v. G.D. Searle & Co., Inc., 375 F.3d 1303, 1325 (Fed. Cir. 2004), denying rehearing en banc; Judge Rader's dissent in Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 976 (Fed. Cir. 2002), denying rehearing en banc; and Judge Rader's concurrence in Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1323 (Fed. Cir. 2003), the petition argues that the test for an adequate written description is whether it provides enough written information for others to make and use the invention, and contends that Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), created a new disclosure requirement having no basis in 35 U.S.C. § 112.
Ariad's petition points to four negative consequences that have resulted from the Federal Circuit's "making written description a free-standing disclosure doctrine":
2. Research universities and small biotechnology companies will be disadvantaged.
3. Claim construction issues will create written description challenges.
4. The Lilly written description test will be hard to apply, as illustrated by the "flip-flop" in Enzo.
Again citing to Judge Rader's concurrence in Moba, the petition concludes that:
Ariad, therefore, argues that "[t]he time has come for this Court to sit en banc to resolve this debate, clarify the law, and speak as one regarding what is the proper disclosure requirement of Section 112, ¶ 1."