Full article reprinted from "The Gray Sheet" - September 2, 2008
Find out why device firms Medtronic and AngioScore are fighting an effort by Abbott to extend the life of its valuable "rapid-exchange" catheter patent, set to expire Oct. 29.
Full article reprinted from "The Gray Sheet" - September 2, 2008
Device firms Medtronic and AngioScore are fighting an effort by Abbott to extend the life of its valuable "rapid-exchange" catheter patent, set to expire Oct. 29.
AngioScore, maker of the AngioSculpt scoring balloon catheter, claims in a petition to FDA that Abbott is misusing a law that allows companies to gain back the patent-protected marketing time lost during clinical testing and FDA pre-market review.
Drug-eluting stent maker Medtronic is taking another approach, challenging Abbott's patent extension request in federal court.
In its Aug. 19 1citizen petition, Fremont, Calif.-based AngioScore urges FDA to deny Abbott's request to extend a patent on the rapid-exchange catheters and delivery system used in certain models of Abbott's Xience V everolimus-eluting coronary stent system.
According to AngioScore, Abbott's patent term extension (PTE) application, filed July 25, is "fatally flawed in several key areas."
Namely, the company says Abbott is taking advantage of Xience V's recent approval to extend the catheter patent well beyond the time limits set forth in the 1984 Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act.
Under Hatch-Waxman, companies have 60 days after product approval to apply for a patent extension. The patent in question - 25,451,233 - was granted to Dr. Paul G. Yock in September 1995. Devices that utilize this patent, AngioScore claims, were approved in 2003 and 2004 as part of then Guidant's and now Abbott's Multi-Link Vision and Mini Vision bare-metal coronary stent systems.
"The Hatch-Waxman Act was created by Congress to provide a mechanism for compensating patent holders and their licensees for the time period a product claimed in the patent was under review by the FDA and not commercially available," AngioScore CEO Thomas R. Trotter says in an Aug. 25 statement.
"In this particular case, far from being deprived of the commercial value of this patent due to FDA review, Abbott and their licensees have enjoyed unprecedented commercial success for over a decade," he added.
Is Xience "Claimed" By Catheter Patent?
Under the law, in order to be eligible for extension, the patent must "claim" a recently approved product or a method of using or manufacturing that product.
But Abbott and AngioScore disagree on whether Xience V is "claimed" by the catheter patent or not.
AngioScore argues that patent '233 applies to the catheter delivery system only, not to Xience's drug component or drug-device combination product.
"The term 'stent' never appears in the '233 patent specification and no drugs are identified" in the patent, the petition states.
The Xience V system, approved July 2, is a combination product consisting of an everolimus-coated stent and either a rapid-exchange or over-the-wire stent delivery system.
The rapid-exchange models that are part of the Xience V system are clearly intended to be used in the method described in the 1995 Yock patent, Abbott indicates in its PTE application. In particular, the elongated balloon dilation catheter, catheter shaft, guidewire openings and other specs described in the patent correspond to features in the Xience V models.
Abbott is requesting patent extension until May 24, 2011. Over-the-wire models would not be affected by the patent extension, Abbott noted.
"We are confident in the validity of our request for a patent term extension," a spokesman for the firm said. "We believe we are entitled to this extension."
Medtronic Files Motion To Lift Catheter Injunction
Medtronic, meanwhile, filed a 3motion Aug. 15 in the U.S. District Court of the Northern District of California that also questions the validity and fairness of Abbott's patent extension request.
Since May 2000, Medtronic has been enjoined from manufacturing or marketing rapid-exchange catheters, after former Guidant unit Advanced Cardiovascular Systems filed a complaint in 1995 alleging that Medtronic's Falcon catheter delivery system infringed on the '233 patent.
Once the Yock patent expires, the injunction will be lifted and Medtronic can sell rapid-exchange products in the U.S. The firm's motion seeks to challenge any attempts to extend the injunction past that date.
Medtronic asserts that Abbott and its predecessors have collectively received more than 100 PMA and PMA supplement approvals in the last 18 years for products that use Yock's delivery system.
"One could hardly expect to find a patent owner less deserving of the benefits the Hatch-Waxman Act was intended to provide," the motion states.
If the patent is extended, Medtronic argues that the scope of enforcement should be limited to drug-eluting stents that are "identical" to Xience V.
The motion is set to be heard by Judge D. Lowell Jensen on Oct. 3, a Medtronic spokesman said.
Firms Look To Expiration For Product Launches
The expiration of Yock's patent has been "eagerly anticipated across the industry," AngioScore's Trotter told "The Gray Sheet."
About 70%-80% of coronary angioplasty procedures in the U.S. utilize rapid-exchange catheters, according to AngioScore and Medtronic estimates. But only Abbott, along with Johnson & Johnson/Cordis and Boston Scientific, which have sub-licenses to the technology, have access to that market.
AngioScore is waiting for the patent to expire to launch a rapid-exchange version of its AngioSculpt catheter.
"In the United States, we only sell it in an over-the- wire variety," Trotter said. "We actually did our clinical trial for our PMA three years ago on rapid-exchange technology. It's already approved, so it's obviously quite disconcerting to see this thing transpire here at the last minute."
Medtronic's Endeavor zotarolimus-eluting stent and Driver bare-metal stent are also FDA-approved for use on the rapid-exchange delivery system. The firm says it has PMA supplement approvals pending for other, non-drug-eluting-stent products that use the rapid-exchange system.
While Medtronic's motion states that "an extension of the Yock patent and the Falcon injunction would adversely and irreparably harm" the company, CEO Bill Hawkins is downplaying the significance of rapid-exchange, or "RX," catheters for the business.
"We haven't put into our models that we need RX to be able to maintain our share," he said during the firm's Aug. 19 first-quarter earnings call.
Medtronic offers an alternative delivery system, as well. Its Zipper multi-exchange delivery system, which allows physicians to use shorter guidewires and change them without removing the catheter, has been "very well received," Hawkins said.
Device Makers Chart Unfamiliar Territory
Though the 1984 patent extension legislation applies to all medical products, many still view patent restoration as the drug companies' domain.
"Hatch-Waxman exclusivity is vitally important to the pharmaceutical industry," said Minneapolis-based drug and device lawyer Mark DuVal. "On the device side, the product life cycle is so short that getting [extended] patent protection has not been as important."
Patent extension remains a gray area, AngioScore agrees, and CEO Trotter worries the lack of clarity may work in Abbott's favor.
PTE applications are processed jointly by the U.S. Patent and Trademark Office and FDA. FDA helps PTO determine whether a patent is eligible for extension, and how long that extension should be, based on the regulatory review period (the length of the clinical testing phase plus the approval phase).
On July 30, PTO requested confirmation from FDA on the regulatory review dates cited in Abbott's application. Otherwise, PTO wrote to FDA, "Our review of the application to date indicates that the subject patent would be eligible for extension."
If FDA has not completed its part of the review by Oct. 29, "the PTO has the authority to grant an interim extension," the patent office's Mary Till told "The Gray Sheet."
AngioScore and Medtronic oppose any interim fix.
- Jessica Bylander
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