Courts Toss Johnson & Johnson’s Stent Patents

(CN) - Medical device maker Cordis, a Johnson & Johnson company, lost its claim to four patents behind stents implanted after an angioplasty, the Federal Circuit affirmed.

Wyeth, as a co-owner of the patents, also lost out in the long-running dispute with Boston Scientific and its subsidiary Boston Scientific Scimed.

The patents involve technology behind drug-eluting coronary stents used in the treatment of coronary artery disease. After angioplasty opens a restricted artery in a patient, the artery can narrow again in a process known as restenosis. Doctors began implanting stents to prevent restenosis, and Cordis's Cypher stent was the first drug-eluting stent approved by the U.S. Food and Drug Administration and sold in the United States.

The active ingredient behind Cypher is a bacteria-produced compound known as rapamycin.

After Abbott Cardiovascular Systems came out with a stent system called Xience V that uses a modified rapamycin analog known as everolimus, Boston Scientific released a private labeled version called Promus.

Cordis, Johnson & Johnson and Wyeth asserted its four patents against Abbott in separate federal actions in the New Jersey, while Boston Scientific sued seeking declaratory judgments to invalidate those four patents. Cordis, Johnson & Johnson and Wyeth counterclaimed for infringement.

When the parties filed for summary judgment, a Delaware federal judge had granted summary judgment to Boston Scientific, ruling that four of Cordis' patents were invalid for lack of adequate written description or lack of enablement.

A three-judge panel of the Washington-based Federal Circuit affirmed on June 7.

"At the effective filing date, very little knowledge existed regarding the use of drug-eluting stents to inhibit restenosis," Judge Kimberly Moore wrote for the court. "In fact, Cordis's Cypher stent, which employs the patented technology, was the first drug-eluting stent marketed and approved in the United States. Appellants' own expert declarations detail the failure of others to develop drug-eluting stents to inhibit restenosis and evidenced the 'highly unexpected' and 'remarkable clinical results seen in Cordis's Cypher stent.'"

"Indeed, the shared specification of the 1997 patents acknowledges the uncertainties surrounding rapamycin, restenosis, and drug-eluting stents as of the effective filing date of the patents," Moore added.

Ultimately the patents, three of which were filed in 1997 and one of which Cordis claims has been effective since 2001, cannot correlate the function and strucure of rapamycin and its analogs enough for an adequate written patent description, according to the 28-page opinion.

"Given the absence of information regarding structural characteristics of macrocyclic lactone analogs or examples of macrocyclic lactone analogs in the specification, the unpredictability of the art and the nascent state of using drug-eluting stents to inhibit restenosis, we affirm the district court's grant of summary judgment," Moore wrote. "The patent laws do not reward an inventor's invitation to other researchers to discover which of the thousands of macro-cyclic lactone analogs of rapamycin could conceivably work in a drug-eluting stent. Because we affirm the district court's holding that no reasonable jury could conclude that the 1997 patents contained sufficient written description support, we need not separately address Appellants' arguments regarding enablement."

Judge Arthur Gajarsa wrote a separate opinion, concurring in part, saying that his colleagues should have tossed the 1997 patents for enablement only, not description.

"The claimed invention is a combination of a stent, polymeric carrier, and therapeutic agent," Gajarsa wrote. "The majority focuses solely on the written description aspect of whether the therapeutic agent's analogs were adequately described and ignores that in nearly all of the asserted claims, the agents must effectively inhibit neointimal proliferation. Because undue experimentation was required to practice the 1997 patents, the district court's grant of summary judgment of invalidity should have been affirmed on enablement grounds."

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