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Friday, December 8, 2023 | Back issues
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Johnson & Johnson Sinks Stent Patent Verdict

(CN) - The Federal Circuit reversed a $593 million verdict against Johnson & Johnson to a radiologist who claimed infringement of his patents for drug-eluting stents.

A federal judge in Marshall, Texas, has initially sided with Dr. Bruce Saffran in his complaint over Cypher stents made by Johnson & Johnson subsidiary Cordis. The three-judge panel of the Federal Circuit concluded Thursday, however, that "the district court erred in construing the asserted claims of the '760 patent."

"Because the accused products do not satisfy those claims as correctly construed, Cordis is entitled to a judgment of noninfringement as a matter of law," the 27-page opinion states.

In particular, the majority found that infringement is impossible since the defendants constructed their device without a sheet covering open mesh holes between struts in the stents.

"The accused Cordis stents all exhibit a metallic mesh structure, their struts coated with a thin layer comprising polymer and sirolimus," Judge Alan Louirie wrote for the majority. "But that layer is akin to paint on a chain link fence, not a continuous sheet wrapped around the mesh, and open holes remain between the struts of the accused devices - as Saffran has acknowledged."

Furthermore, the lack of a drug affixed to the surface via hydrolyzable bonds is grounds for noninfringement in construing "release means," according to the ruling.

"As construed, each of the asserted apparatus and method claims requires a treating material attached to the substantially impermeable sheet via hydrolyzable bonds or an equivalent thereof, but the sirolimus provided by the Cordis products is not attached by hydrolyzable bonds," Louirie wrote. "It is instead embedded within the polymer layer and held in place by intermolecular 'hydrophobic' interactions that facilitate its slow diffusion through the polymer matrix. Saffran has not argued otherwise."

Though the opinion does not include dissents, Louirie's colleagues on the panel each declined to join in certain parts of the ruling.

In a concurring opinion, Judge Kimberly Moore disagreed that the trial court incorrectly construed "release means."

"The district court concluded that the corresponding structure was 'chemical bonds and linkages.' I agree," Moore wrote. "The specification is clear: '[t]he rate of healing can be . . . accelerated by attachment of a treating material, either mechanically or by chemical bond, to the inner surface of the device,' which includes a 'method of medicine release by chemical bond.' This passage directly associates the claimed 'release means' with the chemical bond structure, which is sufficiently specific."

She added: "I simply cannot fathom what more the patentee must do 'to link or associate structure to function' so as to provide 'sufficient specificity.' By limiting the structure to 'hydrolyzable bonds,' my colleagues punish the patentee for providing a detailed description of his preferred embodiment."

In a separate concurring opinion, Judge Kathleen O'Malley agreed with the majority's "release means" construction, but disagreed with the construction of "device" as a continous sheet with no open mesh holes.

"The claim language is broad and the written description, while focused on the treatment of fractured bones with a sheet, discloses a host of other embodiments and treatment applications," O'Malley wrote. "Several of those embodiments cannot fairly be characterized as sheets. And, I find no clear and unambiguous disclaimer of those embodiments in the prosecution history. Accordingly, I would affirm the district court's construction of "device" as something which comprises the limitations set out in the body of the claim."

Saffran has sued other medical device companies in the past. The law firm Dickstein Shapiro noted that he filed a similar federal complaint against Boston Scientific over its drug-eluting cardiac stent in 2008 and ultimately won $500.9 million in damages and interest.

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