Wyeth & Cordis Corp. v. Laboratories, 2012-1223
| Decision Date | 26 June 2013 |
| Docket Number | 2012-1223,2012-1224 |
| Parties | WYETH AND CORDIS CORPORATION, Plaintiffs/Counterclaim Defendants-Appellants, v. ABBOTT LABORATORIES, ABBOTT CARDIOVASCULAR SYSTEMS, INC., AND ABBOTT LABORATORIES, INC., Defendants Counterclaimants-Appellees, AND MEDTRONIC INC., MEDTRONIC VASCULAR, INC., AND MEDTRONIC USA, INC., Defendants/Counterclaimants-Appellees, AND BOSTON SCIENTIFIC CORPORATION AND BOSTON SCIENTIFIC SCIMED, INC., Defendants/Counterclaimants-Appellees. |
| Court | U.S. Court of Appeals — Federal Circuit |
Appeals from the United States District Court for the District of New Jersey in No. 08-CV-0230, Judge Joel A. Pisano.
DAVID T. PRITIKIN, Sidley Austin, LLP, of Chicago, Illinois, argued for plaintiffs/counterclaim defendants-appellants. With him on the brief were CONSTANTINE L. TRELA, JR., WILLIAM H. BAUMAGARTNER, JR., and RUSSELL E. CASS. Of counsel on the brief was BRYAN C. MULDER.
EDWARD A. MAS, II, McAndrews, Held & Malloy, Ltd., of Chicago, Illinois, argued for Defendants/Counterclaimants-Appellees Abbott Laboratories, et al. With him on the brief were SANDRA A. FRANTZEN, STEPHANIE F. SAMZ and KATHLEEN A. DORTON. Of counsel on the brief was SAMUEL F. BAXTER, McKool Smith, P.C., of Dallas, Texas.
MATTHEW M. WOLF, Arnold & Porter, LLP, of Washington, DC, argued for defendants/counterclaimants-appellees Boston Scientific Corporation, et al. With him on the brief were EDWARD HAN and JOHN E. NILSSON.
Before MOORE, BRYSON, and WALLACH, Circuit Judges.
Wyeth and Cordis Corporation (Wyeth) appeal from the U.S. District Court for the District of New Jersey's grant of summary judgment that claims 1 and 2 of U.S. Patent No. 5,516,781 ('781 patent) and claim 1 of U.S. Patent No. 5,563,146 ('146 patent) are invalid for nonenablement.1 Wyeth v. Abbott Labs., Nos. 3:08-cv-0230 and -1021, 2012 WL 175023 (D.N.J. Jan. 19, 2012). Because we hold that there is no genuine issue of material fact that the specification does not enable one of ordinary skill to practice the asserted claims without undue experimentation, we affirm.
The patents-in-suit relate to the use of rapamycin for the treatment and prevention of restenosis, which is the renarrowing of an artery. To open a blocked artery, a physician guides a balloon catheter to the site of accumulated plaque, and then inflates the balloon to crush the plaque. As the balloon inflates, however, it may cause injury to the arterial wall. That vascular injury causes smooth muscle cells to proliferate, which thickens the arterial wall, and, in turn, leads to restenosis.
The claims recite a method of treating or preventing "restenosis in a mammal . . . which comprises administering an antirestenosis effective amount of rapamycin to said mammal." '781 patent, claims 1 and 2; '146 patent, claim 1. in general, "rapamycin" may refer to a class of compounds. While the patents-in-suit use the term "rapamycin," the parties agree that the shared specification discloses only one rapamycin species called sirolimus. Sirolimus is naturally produced by a bacterium called Streptomyces hygroscopicus. The structure of sirolimus appears below and includes a substituent group at and beyond the C-37 position (dashed circle) and a macrocy-clic triene ring (macrocyclic ring) indicated by the C-1 to C-36 positions.
The parties do not dispute that the effective filing date of both patents is January 9, 1992. At that time, it was known that sirolimus acts in part by binding two proteins at sites within the macrocyclic ring. It was also known that there were four additional compounds with the same macrocyclic ring as sirolimus, but different substituent groups beyond the C-37 position.
The parties also do not dispute that the specification discloses the immunosuppressive and antirestenotic properties of sirolimus. The specification discloses in vitro test data indicating that sirolimus inhibits rat smooth muscle cell proliferation. See 781 patent col. 5 l. 1–col. 6 l. 2. It also discloses in vivo test data indicating that intraperitoneal injection of sirolimus in rats reduced the thickening of the arterial wall following vascular injury. See id. col. 6 ll. 39–65, col. 8 l. 17–col. 10 l. 16.
In two separate actions, Wyeth sued the defendants for infringement of the patents-in-suit. The defendants market stent products that elute everolimus and zotarolimus, two drugs that have the same macrocyclic ring as sirolimus but different substituents at the C-42 position. After briefing and a hearing, the district court adopted Wyeth's proposed construction of "rapamycin" as "a compound containing a macrocyclic triene ring structure produced by Streptomyces hygroscopicus, having immunosuppressive and anti-restenotic effects." Wyeth, 2012 WL 175023, at *3. Based in part on that construction, thecourt granted defendants' joint motions for summary judgment of invalidity for nonenablement and lack of written description. Id. at *17-18. Wyeth appeals. We have jurisdiction under 28 U.S.C. § 1295(a)(1).
We review a grant of summary judgment under the law of the regional circuit. Grober v. Mako Prods., Inc., 686 F.3d 1335, 1344 (Fed. Cir. 2012). The Third Circuit reviews a grant of summary judgment without deference. Healy v. New York Life Ins. Co., 860 F.2d 1209, 1210 (3d Cir. 1988). Summary judgment is appropriate if "the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." FED. R. CIV. P. 56(a). "The evidence of the nonmovant is to be believed, and all justifiable inferences are to be drawn in his favor." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).
A patent's specification must describe the invention and "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 . . . to make and use the same." 35 U.S.C. § 112(a) (2012). Claims are not enabled when, at the effective filing date of the patent, one of ordinary skill in the art could not practice their full scope without undue experimentation. MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1380- 81 (Fed. Cir. 2012). Enablement is a question of law based on underlying facts. Id.
The central issue on appeal is whether practicing the full scope of the claims requires excessive—and thus undue—experimentation. The district court held that it does. Wyeth, 2012 WL 175023, at *17-18. It found that the claims cover any structural analog of sirolimus that exhibits immunosuppressive and antirestenotic effects.Id. The court also found that, while the specification describes assays to ascertain whether a potential rapamycin compound exhibits the recited functional effects, the only species disclosed is sirolimus. Id. In further support of its holding of nonenablement, the court relied on the unpredictability of the chemical arts, the complexity of the invention, and the limited knowledge of treatment of restenosis using sirolimus at the time of the invention. Id.
Wyeth argues that the district court ignored evidence that practicing the full scope of the claims would have required only routine experimentation. It contends that the claims do not cover a new genus of compounds, but rather a new use for an existing class of compounds. Wyeth argues that its experts opined that one of ordinary skill would readily know how to practice the full scope of the claims using two steps. First, a skilled artisan could ascertain whether a candidate rapamycin compound has the same macrocyclic ring as sirolimus. Second, a skilled artisan could routinely determine whether a candidate has immunosuppressive and antirestenotic effects using the assays disclosed in the specification.
Regarding the amount of experimentation, Wyeth acknowledges that one of its experts testified that there could be millions of compounds made by varying the substituent groups outside of sirolimus's macrocyclic ring. Wyeth counters that the same expert testified that the number of compounds that would exhibit the recited functional effects would be significantly smaller. According to Wyeth's expert, one of ordinary skill would have understood two relevant facts. First, in order to exhibit the recited functional effects, a compound must be permeable across cell membranes. Second, such permeability typically occurs in compounds having molecular weights below 1,000-1,200 Daltons (sirolimus's molecular weight is approximately 914 Daltons), which further limits the universe of potential rapamycin compounds.
Appellees respond that practicing the full scope of the claims would have required excessive experimentation, even if routine. They argue that the specification is silent on how to structurally modify sirolimus to yield a compound having the recited functional effects. Appellees disagree that one of ordinary skill would have known to select only compounds with a molecular weight below 1,200 Daltons. Even accepting Wyeth's molecular weight argument, however, Appellees respond that there are still tens of thousands of potential compounds that require screening. They emphasize that Wyeth's own witnesses testified that even minor alterations to the sirolimus molecule could impact its immunosuppressive and an-tirestenotic properties. Appellees argue that one of ordinary skill would thus need, at a minimum, to engage in a laborious iterative process to determine what candidates fall within the claimed genus, and that there is no contrary evidence in the record.
We agree with App...
To continue reading
Request your trial
-
Promega Corp. v. Life Techs. Corp.
...Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1381 (Fed.Cir.2012). Our previous decisions in MagSil and Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380 (Fed.Cir.2013), are instructive. In MagSil, a patentee asserted infringement of a claim directed to a device used in computer har......