A federal appeals court last week declined to revisit its decision to uphold the invalidation of patents covering drug-eluting stent technology.
The U.S. Court of Appeals for the Federal Circuit declined a re-hearing request from plaintiffs Wyeth Pharmaceuticals and Johnson & Johnson‘s (NYSE:JNJ) Cordis Corp. subsidiary to revisit the case against Abbott (NYSE:ABT), Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT).
The lawsuit concerns a coating drug called rapamycin. In June, a 3-member panel of judges for the Federal Circuit ruled to invalidate patents held by Cordis and Wyeth, a subsidiary of Pfizer Inc. (NYSE:PFE).
That decision hinged on whether the patents in question described an invention that a skilled practitioner could reasonably make and use without "undue experimentation," a measure that’s intended to ensure that "the invention is communicated to the interested public in a meaningful way," according to the U.S. Patent & Trademark Office.
The Federal Circuit judges ruled, like their lower court counterparts, that the Wyeth patents, as written, did require undue experimentation due to the "need to engage in a systematic screening process for each of the many rapamycin candidate compounds," according to the filed decision.
J&J’s Cypher stent, the 1st drug-eluting stent to hit the U.S. market, is coated in sirolimus (also called rapamycin and rapamune), the patents for which are held by Wyeth.
J&J and Wyeth claimed that Abbott’s Xience V DES and Medtronic’s Endeavor stent were using related drugs without permission. The drug coatings help prevent scarring in the blood vessels that can occur after angioplasty procedures, keeping the vessels from re-narrowing.
Boston Scientific got pulled into the lawsuit because its Promus stent is a private-label version of the Xience V, licensed from Abbott. The Xience V and Promus stents are coated in everolimus.
Medtronic’s Endeavor is coated in zotarolimus. Both everolimus and zotarolimus are made by modifying the sirolimus molecule at a single location.