State Of The Art Could Not Fill The Gaps In Disclosure For Written Description Support Where The Specifications Indicated Unpredictability And A Lack Of Knowledge In The Art

This article previously appeared in Last Month at the Federal Circuit Newsletter, July 2011

Judges: Bryson, Gajarsa (concurring-in-part), Moore (author)

[Appealed from D. Del., Judge Robinson]

In Boston Scientific Corp. v. Johnson & Johnson, Inc., Nos. 10-1230, -1231, -1233, -1234 (Fed. Cir. June 7, 2011), the Federal Circuit affirmed the district court's grant of SJ that the asserted claims were invalid for lack of written description under 35 U.S.C. § 112, ¶ 1.

Johnson & Johnson, Inc. ("J&J"), and Cordis Corp. ("Cordis") own U.S. Patent Nos. 7,217,286; 7,223,286; and 7,229,473 (collectively "the 1997 patents") and, along with Wyeth, own U.S. Patent No. 7,300,662 ("the '662 patent") (collectively "the patents-in-suit"). The patents-in-suit relate to drug-eluting stents for use in treating coronary artery disease ("CAD"). Bare metal stents, traditionally inserted in an artery to prevent collapse following angioplasty, did not adequately address restenosis (narrowing of the artery) caused by neointimal proliferation (an increase in smooth muscle cells of the artery over time in response to injury caused by angioplasty). Attempts to prevent restenosis led researchers to test numerous oral drugs and drug-eluting stents. Prior to 1997, orally administered rapamycin was known to inhibit restenosis in rats. Several analogs of rapamycin were also known in the art, including everolimus, which is both a macrocyclic lactone and triene analog of rapamycin. Cordis's Cypher® stent, which uses rapamycin as a therapeutic agent, was the first drug-eluting stent approved by the FDA and sold in the United States.

The 1997 patents, which share a common specification, claim drug-eluting stents using either rapamycin or a macrocyclic lactone analog of rapamycin as the therapeutic agent. The 1997 patents contain only a single reference to macrocyclic lactones under the heading "Experiments," but the experiments disclosed therein do not use or provide a single example of a macrocyclic lactone analog. Cordis added the phrase "macrocyclic lactone analog" in a 2006 claim amendment shortly after a competitor, Guidant, received European approval to sell a drug-eluting stent containing everolimus.

The '662 patent was filed in 2004, but J&J, Cordis, and Wyeth (collectively "Appellants") asserted that the claims were entitled to an effective filing date of 2001. The '662 patent claims drug-eluting stents using either rapamycin or a macrocyclic triene analog of rapamycin...