J&J Lawyers Admit Cypher Stent Is Risky
1 CommentBy Ed Silverman // September 25th, 2007 // 8:17 am
File this under ‘Nice try, but…’ For months now, Johnson & Johnson has insisted its Cypher stent is safe, despite repeated studies suggesting these drug-coated devices can cause blood clots. In fact, the latest claim from the health care giant was made less thant two weeks ago. But when its suits J&J, the company is more than ready to concede the risks. And that’s apparently just what J&J lawyers did in hopes of winning a long-running patent fight with Boston Scientific.
In what appears to be a rather foolish move, J&J lawyers tried to highlight the Cypher’s safety concerns. The hope was to persuade a federal judge in Delaware that, because the Cypher was linked in clinical trials to blood clots, it somehow was beyond the safety profile of a Boston Scientific patent, The New York Times reports. Remember that J&J has repeatedly tried to convince doctors and the public that its drug-coated stent is no more likely to cause clots than bare-metal stents.
Did the judge buy the argument? Nope. Judge Sue Robinson refused to throw out a jury verdict that the Cypher infringed on a Boston Scientific patent covering drug coatings. And she also upheld a jury verdict against J&J a separate patent case involving the design of the underlying metal stent. During the course of back-to-back trials over two years, juries decided that each company had infringed patents owned by the other.
As the paper writes, the goal of the J&J legal team was to convince the judge that the Boston Scientific patent covers stents with a “non-thrombogenic” coating - one that doesn’t cause clots. And so the reasoning went that evidence indicating Cypher has a significant clotting problem might suggest it doesn’t infringe on the patent.
Judge Robinson’s ruling noted that while federal regulators had been concerned about studies showing potential medical risks in using Cypher and the Taxus stent from Boston Scientific, the only drug-coated stents on the US market, they also concluded it wasn’t clear whether the drug-coating or some other aspect of the devices was at fault. Robinson said the evidence cited by J&J’s lawyers was “too speculative” for her to dismiss Boston Scientific’s patent claim or order a new trial into whether J&J infringed, according to the Times.
Follow-up trials in which potential damages were to be weighed have been postponed while the two companies sought to overturn the infringement verdicts. Judge Robinson made all the verdicts final yesterday. Both companies said last night that they would now proceed to appeal the verdicts against them to the United States Court of Appeals for the Federal Circuit in Washington.
Christopher Allman
Ed: I want to provide some addition thoughts on this story today from our perspective.
One of Judge Robinson’s rulings yesterday concerned a Boston Scientific patent for a stent coating that the inventor claims is non-thrombogenic. That means it theoretically prevents thrombosis. Since thrombosis has been demonstrated to occur with all currently marketed stents — bare metal and drug-eluting from all manufacturers — we hold that no currently marketed stent could be infringing a patent for a non-thrombogenic coating. That’s why we intend to appeal.
The drug-coating process at issue in this case is not in use by any manufacturer at this time, nor has it ever been.
Cordis argued at trial that any drug-eluting stent for which thrombosis has been demonstrated can’t infringe a patent that claims a non-thrombogenic coating. We lost at trial and made a motion for that decision to be overturned as more data were presented that confirmed that thromboses do occur with drug-eluting stents, both Cordis’ CYPHER Sirolimus-eluting Coronary Stent and Boston Scientific’s Taxus. Yesterday’s ruling by Judge Robinson denied that motion, and we are disappointed because we continue to hold that we are not infringing a patent for a non-thrombogenic coating. We expect to argue for that position on appeal.
Our legal strategy in this case is not inconsistent with any position we have held in any other venue. We continue to believe that the CYPHER Stent offers important advantages in terms of efficacy and safety over bare metal stents and the Taxus stent when used in appropriate patients. A growing body of clinical evidence supports this position.
Thanks
Christopher Allman
Cordis Corporation