Boston Scientific Corp.. v. Johnson & Johnson (also Known As Johnson & Johnson Inc.)

• Decision Date: 07 June 2011
• Docket Number: 2010–1233,2010–1231,Nos. 2010–1230,2010–1234.,s. 2010–1230
• Citation: 99 U.S.P.Q.2d 1001,647 F.3d 1353
• Parties: BOSTON SCIENTIFIC CORPORATION and Boston Scientific Scimed, Inc., Plaintiffs–Appellees,v.JOHNSON & JOHNSON (also known as Johnson & Johnson, Inc.), Cordis Corporation, and Wyeth, Defendants–Appellants.
• Court: U.S. Court of Appeals — Federal Circuit

647 F.3d 1353

99 U.S.P.Q.2d 1001

BOSTON SCIENTIFIC CORPORATION and Boston Scientific Scimed, Inc., Plaintiffs–Appellees,

v.JOHNSON & JOHNSON (also known as Johnson & Johnson, Inc.), Cordis Corporation, and Wyeth, Defendants–Appellants.

Nos. 2010–1230

2010–1231

2010–1233

2010–1234.

United States Court of Appeals, Federal Circuit.

June 7, 2011.

Matthew M. Wolf, Arnold & Porter LLP, of Washington, DC, argued for plaintiffs-appellees.

With him on the brief were Edward Han and John E. Nilsson.David T. Pritikin, Sidley Austin LLP, of Chicago, IL, argued for defendants-appellants. With him on the brief were Constantine L. Trela, Jr., William H. Baumgartner, Jr., Russell E. Cass and Justin B. Weiner.Sandra A. Frantzen, McAndrews, Held & Malloy, Ltd., of Chicago, IL, for amicus curiae Abbott Cardiovascular Systems Inc. With her on the brief were Edward A. Mas, II, Stephanie F. Samz and Kathleen A. Dorton.Before BRYSON, GAJARSA, and MOORE, Circuit Judges.Opinion for the court filed by Circuit Judge MOORE. Circuit Judge GAJARSA concurs-in-part.MOORE, Circuit Judge.

Johnson & Johnson, Inc. (J & J), Cordis Corp. (Cordis) and Wyeth (collectively, Appellants) appeal the decision of the United States District Court for the District of Delaware granting summary judgment that certain claims of U.S. Patent Nos. 7,217,286 (the '7286 patent), 7,223,286 (the ' 3286 patent), 7,229,473 (the '473 patent), and 7,300,662 (the '662 patent) (collectively, the patents-in-suit) are invalid for failure to comply with 35 U.S.C. § 112, ¶ 1. Boston Scientific Corp. v. Johnson & Johnson, Inc., 679 F.Supp.2d 539 (D.Del.2010). The district court determined that the asserted claims of the '7286 patent, the '3286 patent, and the '473 patent (collectively, the 1997 patents) are invalid for lack of adequate written description and lack of enablement, and that the asserted claims of the '662 patent are invalid for lack of adequate written description. Because no finder of fact could reasonably determine that the asserted claims of the patents-in-suit contained an adequate written description, we affirm.

Background

I. Drug–Eluting Stents

The patents-in-suit relate to drug-eluting coronary stents used in the treatment of coronary artery disease. Coronary artery disease is caused, in part, by atherosclerosis, a build-up of arterial plaque. Atherosclerosis limits the flow of blood and oxygen to the heart and can result in chest pain, blood clots, heart attacks, and other ailments.

In 1977, physicians first used a procedure called balloon angioplasty to reopen arteries closing because of atherosclerosis. During the procedure, the physician inserts a balloon catheter into an artery near the patient's groin and threads the catheter through the artery to the site of the blockage. The physician then inflates the balloon to reopen the narrowed artery. In many balloon angioplasty patients, the opened artery narrows again—a process known as restenosis. One of the key components of restenosis is a phenomenon called neointimal proliferation, wherein the smooth muscle cells of the artery multiply over time in response to injury caused by the inflation of the balloon. The result of neointimal proliferation is the renarrowing of the artery.

In the 1980s, physicians began using bare metal coronary stents to support the artery after the physician deflates the balloon. Although these bare metal coronary stents prevented the collapse of the artery and constriction due to scarring, restenosis remained a problem because the bare metal stents did not prevent neointimal proliferation.

Researchers turned to a myriad of techniques in an attempt to prevent restenosis following balloon angioplasty. For example, researchers tested numerous oral drugs for the treatment of restenosis. J.A. 14732–39. One of Appellants' experts characterized the number and variety of drugs tested as “reflect[ing] the lack of any clear path or direction toward a particular drug therapy for restenosis.” J.A. 14732. Researchers also experimented with drug-eluting stents in an effort to prevent restenosis. Researchers believed that the drugs contained on such stents could help prevent neointimal proliferation. Cordis's Cypher® stent was the first drug-eluting stent approved by the United States Food and Drug Administration (FDA) and sold in the United States.

II. The Patents–In–Suit

The 1997 patents claim drug-eluting stents using either rapamycin or a macrocyclic lactone analog of rapamycin as the therapeutic agent. The ' 662 patent claims drug-eluting stents using either rapamycin or a macrocyclic triene analog of rapamycin.¹ The rapamycin molecule has a number of structural features including lactone and triene moieties. Thus, rapamycin is both a macrocyclic triene and a macrocyclic lactone. Rapamycin is depicted below with the macrocyclic ring, the lactone group, and the triene group identified:

Image 1 (3.37" X 2.14") Available for Offline Print

Appellees' Br. 10.

Cordis's Cypher® drug-eluting stent utilizes rapamycin as a therapeutic ingredient. Rapamycin (also called sirolimus) is a naturally occurring compound produced by the bacterium Streptomyces hygroscopicus. Scientists at Ayerst Research Laboratories (which later became part of Wyeth) isolated rapamycin, and the compound was first publicly described in articles published in 1975.

Researchers first investigated rapamycin as a potential antifungal. Later, researchers discovered that rapamycin exhibited other properties, including anti-tumor activity and immunosuppressant activity. In the early 1990s, researchers at Stanford University discovered that rapamycin inhibited restenosis after oral administration to rats.

Prior to the filing of the 1997 patents, some analogs of rapamycin were disclosed in the prior art. For example, PCT application WO 94/09010 (the Cottens publication) describes “novel alkylated derivatives of rapamycin having pharmaceutical utility, especially as immunosuppressants.” J.A. 11059–11100. The Cottens publication specifically describes twenty-eight “preferred novel compounds,” twenty-five of which contain the same macrocyclic ring as rapamycin. J.A. 11063–64. These preferred analogs include everolimus. Everolimus is made by modifying rapamycin at a single location and is both a macrocyclic lactone and triene analog of rapamycin. Boston Scientific Corp., 679 F.Supp.2d at 543 n. 3. Similarly, U.S. Patent No. 5,362,718 (the Skotnicki patent) claims and describes macrocyclic analogs of rapamycin and provides examples of fourteen specific structures. J.A. 10595–608.

A. The 1997 Patents

The '7286 patent, the '3286 patent and the '473 patent all descend from a provisional application filed in April 1997. The 1997 patents share a common specification and generally claim drug-eluting stents utilizing “rapamycin, or a macrocyclic lactone analog thereof” as the therapeutic agent. Cordis first added the phrase “macrocyclic lactone analog” to the claims during an April 7, 2006 claim amendment during prosecution of the '3286 patent. J.A. 20328–36. Cordis added these claims shortly after a competitor, Guidant, received European approval to sell a drug-eluting stent containing everolimus.

The 1997 patents' “Summary of the Invention” describes “[a] stent designed to include reservoirs ... [,] a new approach which offers several important advantages over existing technologies.” '7286 patent col.3 ll.43–45. The “Summary of the Invention” does not mention any particular therapeutic agent or any particular polymer coatings. The shared specification discloses that the reservoirs could be loaded with drugs and “[a] coating or membrane of biocompatible material could be applied over the reservoirs [to] control the diffusion of the drug from the reservoirs to the artery wall.” Id. col.3 ll.61–65.

Later, in the “Detailed Description of Illustrative Embodiments,” the shared specification discusses rapamycin for the first time. The specification identifies rapamycin as one of the “[n]umerous agents [that] are being actively studied as antiproliferative agents for use in restenosis and [that] have shown some activity in experimental animal models.” Id. col.5 ll.8–10, 33. The 1997 patents indicate that rapamycin is of particular interest because it “is capable of inhibiting both the inflammatory response known to occur after arterial injury and stent implantation, as well as the [smooth muscle cell] hyperproliferative response.” Id. col.5 ll.47–51. However, the specification also states that “the precise mechanism of rapamycin is still under active investigation,” id. col.5 ll.36–38, and that “the ideal agent for restenosis has not yet been identified,” id. col.5 ll.59–60.

The specification of the 1997 patents contains only a single reference to the claimed macrocyclic lactones. Under a subheading “Experiments,” the specification states, “Agents: Rapamycin (sirolimus) structural analogs (macrocyclic lactones) and inhibitors of cell-cycle progression.” Id. col.6 ll.4–5. The experiments disclosed under this subheading, however, only use rapamycin. The specification does not include any experiments using a macrocyclic lactone analog or even provide a single example of a macrocyclic lactone analog.

B. The '662 Patent

Cordis filed the application that issued as the '662 patent in 2004, but asserts that the claims are entitled to an effective filing date of January 25, 2001. The '662 patent defines rapamycin broadly to include “rapamycin, rapamycin analogs, derivatives and congeners that bind FKBP12 and possess the same pharmacologic properties as rapamycin.” See, e.g., '662 patent col.5 ll.48–51. The '662 patent, like the 1997 patents, does not identify any specific species of rapamycin analogs.

Furthermore, the '662 patent does not identify what constitutes the claimed “macrocyclic triene analogs” of rapamycin, and provides no examples of “macrocyclic triene analogs.” In fact, the only time the term “macrocyclic triene” is used in the...