A U.S. Supreme Court refusal to hear Boston Scientific’s appeal in a long-running cardiac device patent infringement case with St. Jude Medical will have international implications for devicemakers, experts say.
The high court’s decision last week leaves standing a 2009 ruling by the full U.S. Court of Appeals for the Federal Circuit. “Under that ruling, device companies can export products made in the U.S. that are capable of performing a patented method outside the U.S. without infringing the U.S. patent,” Kelsey Nix, a partner in the intellectual property and litigation departments of Wilkie Farr & Gallagher, told D&DL.
The appeal — which stems from a case filed by Cardiac Pacemakers, now part of Boston Scientific, in 1996 — focused on the ’288 method patent for Cardiac’s implantable cardioverter defibrillator. The Federal Circuit ruled that while the patent was valid and enforceable, using that method outside the U.S. does not infringe the patent.
The method at issue in the court’s decision concerns using a device — not the method of manufacturing it, Nix said.
The majority of the appellate court determined that Section 271(f) of the 1984 Patent Law Amendments does not cover method patents. That section prohibits an unauthorized company from shipping the components of a patented product from the U.S. to another country for assembly.
As a result of the ruling, devicemakers may be more confident in expanding their international cardiac rhythm management divisions, which would increase competition and lower prices, Dan Whalen, an analyst for Millennium Research Group, told D&DL.
On the other hand, the decision could chill innovation, Gregory Piche, a partner at Holland & Hart, told D&DL. “It takes away the reward of people who are successful in developing concepts and applications,” he said.
Devicemakers could ask Congress to update patent law to extend international protection to U.S. method patents, Piche said. However, such a move would face strong opposition from major software companies, such as Microsoft, that benefit from the current patent language, he added.
Several software companies filed amicus briefs siding with St. Jude, which was accused of infringing Cardiac’s method patent, arguing against a broad construction of Section 271(f). Their arguments were based, in part, on the fact that some countries do not permit patenting of medical procedures, according to court documents.
Ormco, an orthodontic devicemaker, filed the only amicus brief on the side of Cardiac.
In the lone dissent to the appellate court’s decision, Judge Pauline Newman takes issue with the other 11 judges for “dumping” the patent statute entirely as an overreaction to the facts of one case.
The Federal Circuit remanded Cardiac Pacemakers, Inc. et al. v. St. Jude Medical, Inc., and Pacesetter, Inc. to the U.S. District Court for the Southern District of Indiana to determine damages for any infringement in the U.S. — Virgil Dickson
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