Billups-Rothenberg v. Associated Regional and University Pathologists and Bio-Rad Laboratories (CAFC 2010-1401) precedential; Judges Gajarsa (author), Linn, Moore

This court reviews an order of summary judgment de novo. See, e.g., Amgen, lnc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1339 (Fed. Cir. 2003). Summary judgment must be granted when, drawing all reasonable inferences in favor of the non-movant, there is no genuine issue as to any material fact. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986); Fed. R. Civ. P. 56(c). We first examine whether the asserted claims of the '681 patent are invalid for lack of written description. Then, we determine whether the asserted claims of the '425 patent are invalid as anticipated.

Written Description

Written description is a statutory requirement set forth in 35 U.S.C. § 112. The written description requirement requires the inventor to disclose the claimed invention so as to "allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed." Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (internal quotations omitted). "Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of 'invention'--that is, conceive of and complete the final invention." Id. The written description requirement exists to ensure that inventors do not "attempt to preempt the future before it has arrived." Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993). In Fiers, a party's priority application failed to provide an adequate written description as it purported to cover all DNAs coding for a specific protein but did not describe the DNA. The party only provided a generic reference that the DNA could be obtained by reverse transcription and this court held that "[c]laiming all DNA's that achieve a result without defining what means will do so is not in compliance with the description requirement." Id.

The "level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology." Ariad, 598 F.3d at 1351 (citing Capon v. Eshhar, 418 F.3d 1349, 1357-58 (Fed. Cir. 2005)). "[A]n adequate description of a DNA requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the DNA itself." Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566-67 (Fed. Cir. 1997) (internal quotations omitted). Complementary DNA ("cDNA") is a form of DNA that only contains exons, stretches of DNA that code for genes. In Regents, a claim to a cDNA invention was held invalid as lacking written description because such a claim "requires a specificity usually achieved by means of the recitation of the sequence of nucleotides that make up the cDNA." Id. at 1569.

Billups got patent greedy without having the science in its pocket.

Billups did not possess a genetic mutation useful for diagnosing hemochromatosis when it filed its patent application in December of 1994. The '681 patent merely represents Billups's research plan. See Ariad, 598 F.3d at 1351.

Billups cannot satisfy the written description requirement merely through references to later-acquired knowledge. This case is like Regents and Fiers, in which the DNA sequences at issue were unknown in the art. Regents, 119 F.3d at 1567-69; Fiers, 984 F.2d at 1171.

The '681 patent claims methods covering the identification of a genus of unknown genetic mutations. '681 patent col.31 ll.19-24. A claim encompassing two or more disclosed embodiments within its scope is a genus claim. For genus claims, "an adequate written description of a claimed genus requires more than a generic statement of an invention's boundaries." Ariad, 598 F.3d at 1349 (citing Regents, 119 F.3d at 1568). Under Ariad, a patent must set forth "either a representative number of species falling within the scope of the genus or structural features common to the members of the genus." Id. at 1350. The '681 patent does not identify even a single species that satisfies the claims. In this case, the eventual discovery of only one species--the C282Y mutation--within the claimed genus does not constitute adequate written description of that genus.

Ariad also explained that "[f]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function." Id. Billups maintains that the '681 patent satisfies the written description requirement because it contains functional claim language.

The district court, however, found that the art did not establish a correlation between structure and function because the "[p]atentee's general location disclosure is too imprecise to constitute structural features necessary to meet the written description requirement." Summ. J. Order 6-9. As explained in the district court's order, the "specification for the '681 patent contains only functional, not structural, characteristics of the predicted mutations." Id. at 7.

Anticipation

A patent claim is anticipated if each and every limitation is found either expressly or inherently in a single prior art reference. 35 U.S.C. § 102.

The district court also granted summary judgment of invalidity of the '425 patent. First, it held that Bio-Rad's '130 patent was prior art under 35 U.S.C. § 102(e) because it was filed on May 23, 1996, which is before the March 1999 filing date of the '425 patent. Id. at 3-4, 10. Then, the district court determined that the asserted claims of the '425 patent are anticipated because they claim "the same genetic test for S65C as is disclosed in the '130 patent." Id. at 10.

Affirmed.