Patent Baristas » Medical Devices

Court To Boston Scientific: Your Patent Is Invalid if We Say It Is

Stephen Jenei — Wed, 28 Jan 2009 22:51:56 +0000

Cordis and Johnson & Johnson tried to get a new trial and judgment as a matter of law (JMOL) following a jury verdict finding that they infringed Boston Scientific’s patent. Boston Scientific v. Cordis Corp. (08-1073). The U.S. Court of Appeals for the Federal Circuit said that “because the court erred … in failing to hold the ’536 patent to have been obvious, we reverse the judgment.”

Cordis makes the Cypher drug-eluting expandable stent, which has two coatings: an undercoat containing the drug and a topcoat. Early in the manufacturing process, the Cypher stent’s topcoat is drug-free. The topcoat is sprayed on as a solution containing no drug but containing a polymer and two solvents. The solvents dissolve the drug, allowing it to diffuse from the undercoat into the topcoat. Thus, when the Cypher stent is sterilized, removing any remaining solvent, the drug has moved into the topcoat to such an extent that the topcoat and undercoat contain the same concentration of drug.

U.S. Patent 6,120,536 relates to a drug-eluting expandable stent with a coating that has a non-thrombogenic surface. Boston Scientific sued Cordis alleging that Cordis’s Cypher stent infringed claim 8 of the ’536 patent.

The patent covers:

[An expandable stent comprising a tubular body having open ends and an open lattice sidewall structure] wherein at least a part of the device portion is metallic and at least part of the metallic device portion is covered with a coating for release of at least one biologically active material, wherein said coating comprises an undercoat comprising a hydrophobic elastomeric material incorporating an amount of biologically active material [and] a topcoat … comprising a biostable, non-thrombogenic material which provides long term non-thromobogenicity to the device portion during and after release of the biologically active material, and wherein said topcoat is substantially free of an elutable material [and wherein the coating conforms to said sidewall structure in a manner that preserves said open lattice].

The district court construed the phrase “non-thrombogenic material which provides long term non-thrombogenicity to the device portion during and after release of the biologically active material” in claim 1 as meaning “a material that does not promote thrombosis for a period of time that extends both during and after release of the biologically active material.” The court relied on medical dictionary definitions for the meaning of “thrombogenic” (“causing thrombosis or coagulation of the blood”) and “thrombolytic” (“break[ing] up or dissolv[ing] a thrombus”).

The court rejected Cordis’s proposed definition of “non-thrombogenic,” which required a “significant reduction in thrombogenicity over that experienced with bare metal stents.” The court also construed the phrase “substantially free of an elutable material” to mean “largely or approximately free of an elutable material.”

At trial, the jury found that claim 8 of the ’536 patent would not have been obvious based on, among other prior art references, U.S. Patent 5,545,208 (Wolff) and U.S. Patent 5,512,055 (Domb). The jury also found that the Cypher stent infringed claim 8.

The court reasoned that Domb, which discloses esophageal stents, does not suggest the use of metal in a stent, and that there was no evidence of motivation to combine Domb with other references. The court reasoned that Wolff does not teach a metallic stent having a two-layer coating, and the failure of Wolff’s assignee to create the claimed stent after more than a decade of work evidenced a lack of motivation to combine the features of its various prior art stents with each other.

The court found support for the jury’s infringement finding in a witness’s testimony that the topcoat is drug-free when applied and “has about 1 to 2% drug . . . after manufacturing is completed,” finding that 1 to 2% drug may be considered “substantially free.” The court also pointed to evidence that a stent need not be sterilized to be implantable and thus that the stent could infringe during manufacture, when the topcoat was first applied and was then drug-free.

Finally, the court found that the ’536 patent specifically contemplates that the drug will move into the topcoat prior to implantation, implying that the “substantially free” limitation does not preclude the topcoat from containing 23% of the drug.

On appeal, Cordis argued that the district court erred by declining to construe the “non-thrombogenic” limitation to require less thrombogenicity than an uncoated metal stent. Cordis asserted that that Cypher stents and bare-metal stents were equally thrombogenic.

A little like politician, Cordis publicly said that its stents were non-thrombogenic, thus meeting the claim language and infringing, all while arguing that its public statements used the term in a different sense from the patent and that its stents do not infringe.

The Federal Circuit had their own thoughts:

To determine the meaning of “non-thrombogenic,” we begin by considering the language of the claims. See Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc). The language of claim 1 requires that the non-thrombogenic topcoat material “provide[] . . . non-thrombogenicity” to the stent, but it does not require a comparison to any other stent, either bare metal or coated. ’536 patent col.13 ll.22–26. As the claims themselves provide no other insight into the meaning of “non-thrombogenic,” we turn to the specification in order to determine if it provides a clearer indication of the scope of “non-thrombogenic.”

“[C]laims must be read in view of the specification, of which they are a part.” Phillips, 415 F.3d at 1315 (quotation marks omitted). The abstract of the invention states that the “non-thrombogenic surface . . . is provided with sites . . . which aid in . . . reduc[ing] thrombogenic activity.” ’536 patent abstract; see also id. at col.2 ll.36–46 (using heparin “to impart a non-thrombogenic surface to the material”). Thus, we can discern that the non-thrombogenic material must reduce thrombogenic activity because of its particular properties.

Cordis argued that the ’536 patent invalid for obviousness. According to Cordis, the Wolff patent alone renders the invention of claim 8 obvious since it shows a polymer stent made of a drug-eluting polymer with a barrier topcoat, and Wolff also refers to the stent and topcoat as separate “layers.” Cordis also argued that Domb alone also rendered it obvious because Domb teaches every limitation except that the stent can be made of metal and have an open lattice.

Boston Scientific countered that KSR is irrelevant to this obviousness inquiry because Cordis urged no particular combination of references. Also, had it been so obvious, Boston Scientific argues, Medtronic would have made the claimed invention.

Ultimately, the Court said the patent was dead:

We agree with Cordis that Wolff alone renders claim 8 of the ’536 patent obvious and therefore invalid. Because we hold the claim obvious based on Wolff alone, we do not address Cordis’s arguments for obviousness based on Domb or any other reference.

As we have discussed above, claim 8 recites a metallic stent with an open lattice structure. The stent includes an undercoat and a topcoat. The undercoat contains a drug, and the topcoat is drug-free and non-thrombogenic.

Wolff also discloses a stent including an undercoat and a topcoat, where the undercoat contains a drug. … Wolff also discloses that the topcoat is drug-free, as layer 15 in figure 3B “may be a simple barrier which limits diffusion of drugs” and “could be as simple as a silicone or polyurethane.” Wolff also discloses that the topcoat is non-thrombogenic.

Reversed.

Update: Boston Scientific and Medtronic agreed to settle two patent-infringement lawsuits over stents and put three others on hold. Boston Scientific said it will continue to pursue patent-infringement claims against Abbott Labs. It’s not personal, it’s just business.

Hatch-Waxman Safe Harbor Doesn’t Apply to Device Not Subject to FDA Approval

Stephen Jenei — Fri, 08 Aug 2008 01:35:45 +0000

The U.S. Court of Appeals for the Federal Circuit ruled that the manufacture, marketing, or sale of a medical device, which is used in the development of FDA regulatory submissions, but is not itself subject to the FDA premarket approval process, is not entitled to the protection of the Hatch-Waxman Act section 271(e)(1) safe harbor provision. Proveris Scientific Corp. v. Innovasystems (07-1428).

Innova makes and sells a device known as the Optical Spray Analyzer (OSA). The OSA itself is not subject to FDA approval. It is, however, used in connection with FDA regulatory submissions. In that setting, the device measures the physical parameters of aerosol sprays used in nasal spray drug delivery devices.

Proveris filed suit against Innova for infringing U.S. Pat. No. 6,785,400. The ’400 patent is directed to a system and apparatus for characterizing aerosol sprays commonly used in various drug delivery devices, such as nasal spray pumps and inhalers. According to the ’400 patent, spray characterization also plays an important role in the regulatory approval process of the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act (FDCA).

As part of its defense, Innova invoked the safe harbor provision of the so-called “safe harbor” provision of the Drug Price Competition and Patent Term Restoration Act of 1984, known as the “Hatch-Waxman Act.” The safe harbor provision is codified at 35 U.S.C. § 271(e)(1), which states in relevant part:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

Innova argued that its allegedly infringing activities are immunized by the safe harbor provision because its OSA devices are used by third parties solely for the development and submission of information to the FDA.

After a district court found Innovasystems infringed the ‘400 patent, Innovasystems appealed arguing that the district court erred in ruling that the does not immunize its accused activity from infringement of the ’400 patent.

Under section 156, the Act seeks to eliminate de facto patent term reduction by providing patent term extension for those patents claiming a “product” subject to regulatory delays caused by the FDA premarket approval process. The term “product” means a “drug product” and “[a]ny medical device, food additive, or color additive subject to regulation under the [FDCA.]”

Then, section 271(e)(1), provides a safe harbor that immunized competitors from infringement on account of making, using, offering to sell, or selling within the United States or importing into the United States a “patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” The basic idea behind this provision was to allow competitors to begin the regulatory approval process while the patent was still in force, followed by market entry immediately upon patent expiration.

Here, Innova argued that it is entitled to the benefit of the section 271(e)(1) safe harbor because it only offered to sell the OSA to pharmaceutical companies and the FDA and the OSA was used exclusively in applications for regulatory approval in accordance with the requirements of the FDCA. Innova pushed the idea that “Congress wrote § 271(e)(1) extremely broadly” when it said that it was not an act of infringement to sell a “patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

Proveris countered that section 271(e)(1) extends only to the infringement of patents that claim “products” as that term is defined in section 156(f) and to other patented inventions that are inherent to the development of “products.” The Federal Circuit sided with Proveris:

… Innova’s OSA device is not subject to FDA premarket approval. Rather, FDA premarket approval is required only in the case of the aerosol drug delivery product whose spray plume characteristics the OSA measures. In short, Innova is not a party seeking FDA approval for a product in order to enter the market to compete with patentees. Because the OSA device is not subject to FDA premarket approval, and therefore faces no regulatory barriers to market entry upon patent expiration, Innova is not a party who, prior to enactment of the Hatch-Waxman Act, could be said to have been adversely affected by the second distortion. For this reason, we do not think Congress could have intended that the safe harbor of section 271(e)(1) apply to it.

… At the same time, because Innova’s OSA device also is not subject to a required FDCA approval process, it does not need the safe harbor protection afforded by 35 U.S.C. § 271(e)(1).

FDA Panel Gives Mixed Review on Coated Stents

Stephen Jenei — Wed, 13 Dec 2006 22:13:32 +0000

A panel of experts put together by the U.S. Food and Drug Administration looked at the safety concerns surrounding the more than $5 billion drug-coated stent industry. These so-called drug-eluting stents are small metal tubes implanted into blood vessels to help prop up clogged heart arteries after they have been cleared. By coating the stents with a drug, it can reduce the growth of scar tissue that can gradually clog arteries and lead to a heart attack. Recently, researchers are finding that drug coated stents increase the odds of a blood clot when compared to bare metal ones.In response, the FDA convened a panel of experts in Washington to look at recent data suggesting a small but significant increase in the rate of death and myocardial infarction — a heart attack — that may be due to stent thrombosis — a blood clot in the stent — in patients treated with drug. The panel conclusions about the drug-coated stents were mixed, however. The studies show that most patients with drug-coated stents have some increased risk of heart attacks and death but it’s unclear whether this is due to poor health or the devices themselves.

It seems that about 40% of the situations in which the stents are used, the blockage involves just one artery, and the patient’s heart is not significantly damaged. That’s what the FDA envisioned when it approved the use of stents. And in those cases, the panel says the benefits of the stents outweigh any clotting danger.

But the remaining 60% are cases where multiple arteries are blocked, the patient has already suffered a serious heart attack, or other complications are involved. In these more complex cases, the panelists were not confident the benefits outweigh the risk of blood clots. These included cases not originally studied before the devices received FDA approval such as patients whose arteries are narrower or more damaged, or who receive overlapping or multiple stents in a single blood vessel — so-called off-label uses.

The panel concluded that the drug-coated stents are safe when used with healthier patients with less complex problems but may put patients at risk for blood clots. Therefore, the panelists recommended stent patients take blood-thinning drugs for at least a year. They also recommended that the labels on the devices should be updated to warn doctors that off-label use won’t give the same results as seen in generally simpler cases involving healthier patients.