« It's a Dud, Dude | Main | Money Matters »

February 12, 2008

Stent for Rent

Over a decade ago, radiologist Dr. Bruce Saffran invented a drug-eluting porous sheet, and was granted 5,653,760. Boston Scientific liked the idea. Imitation resulted in flattery costing $431.9 million, an 8% royalty on U.S. sales, and 6% on foreign sales, from 2004 through last September. The award was reputedly the sixth largest in history. Hard-nosed BS will try to get presiding Eastern District of Texas Judge T. John Ward to overturn the jury verdict; barring that, appeal.

Gary Hoffman of Dickstein Shapiro, lead attorney for Saffron:

The big companies have attitudes in which they'll fight things to the last breath. Boston Scientific had a reputation for being extremely aggressive in litigation and putting out all the stops. Yet we were successful in overcoming those attempts.

Saffran's patent claims have application to bone or coronary stents. Bone stents accelerate healing from a fracture. Heart stents are mesh tubes that prop open coronary arteries after they have been surgically cleared of fatty plaque. Boston Scientific and a Cordis, a unit of Johnson & Johnson, dominate the market for stents, coated with drugs which release to accelerate healing and prevent post-surgical scar tissue from creating new coronary blockages. Patent disputes over stents are common; the claims are over small differences in stent design and the drugs they are coated with.

Saffran has a similar suit pending against Cordis in the same court. Cordis has a coronary stent patent suit going against Boston Scientific that went to appeal and was remanded back to Delaware district court.

Saffran did not request an injunction; a smart move, in that he would not have gotten one.

Posted by Patent Hawk at February 12, 2008 6:31 PM | Damages

Comments

Hawk, you say "would not have gotten" an injunction. Tell me, this is a dumb question, I know, but how does USA reconcile its (eBay) domestic law of patents, on the matter of injunctive relief, with the essential international concept of the patent as exclusive right, and in particular TRIPS Art 28 which provides:

A patent shall confer on its owner the following exclusive rights:
(a) ....to prevent third parties not having his consent from the acts of: making, using....etc

Posted by: MaxDrei at February 13, 2008 2:43 AM

Max,

We still haven't figured that one out. In many minds, Ebay was a travesty.

Legally, it comes down to the difference between courts sitting in Equity or in Law. Injunctions have always been deemed the sphere of Equitable jurisdiction, which has quite different issues to consider. Here's a situation where stare decisis worked against the patent law that had been in existence for a couple of centuries.

Posted by: bierbelly at February 13, 2008 5:31 AM

Max,

Bierbelly is right, we still have the "English" common law concepts of law and equity. Injunctions are equitable relief. Also, SCOTUS is very adverse to treating any area of the law, including IP law, as having any exceptions to the general rules, including the standards for granting injunctions. What is irksome is not the opinion of SCOTUS by Thomas in eBay (which is actually quite reasonable and even cautions the need to follow the Continental Paper Bag precedent that a patent owner can still get an injunction, even if the patent isn't licensed or practiced by the patentee), but the unfortunate and unnecessary comments by Kennedy's concurring opinion about certain "types of patents" (there is only one type of utility patent in the U.S.) and certain alleged practices of "abuse" which are far fewer than the concurring opinion would leave you to believe, and which (why is this a surprise) are supported by absolutely no evidence in the eBay record, or at least any evidence in the eBay record cited by the Kennedy concurring opinion.

Posted by: EG at February 13, 2008 6:39 AM

Thanks guys, now that I come to look, I see that UK law (at least in July 2000) was still categorising an injunction, that restrains the infringer from doing it again, as "a discretionary remedy". In reciting the availability of injunctive relief, the UK Statute also avoids using "shall". One can rationalise with TRIPS, I suppose, on the basis that the grant of a UK or US patent does indeed confer an exclusive right but it just might be, in special circumstances, that a court in the exercise of its inherent discretion declines to deliver that exclusive right. Maybe that's not such a disaster, after all, provided the special circumstances are confined to the court's idea of some higher ideal of natural justice.

Posted by: MaxDrei at February 13, 2008 8:47 AM

J. Kennedy is an idiot. So are Brier (sp?), Scalia, Roberts, and Alito.

Posted by: JD at February 13, 2008 2:35 PM

JD,

It's spelled Breyer, and yes, Justice Breyer leaves much to be desired when it comes to IP law generally and patent law specifically. First we have the Breyer Patch (that's what I call his statements) talking about "raccoon inventions" in KSR International, and recently "bicycle pedals" in Quantum Computer. Clearly a technologically challenged individual, but too egotistically to admit it, or try to improve

Posted by: EG at February 13, 2008 3:03 PM

Oh yeah, I'd much rather have Thomas "writing" the majority opinion, after having read his thoroughly incisive decision in Warner Jenkinson...they're all bozos on the SCOTUS now, bending and swaying to the political winds.

Posted by: bierbelly at February 14, 2008 5:09 AM

EG,

Thanks. J. Breyer is certainly challenged when it comes to technology.

What's that old expression about SCOTUS? "We're not final because we're infallible, we're infallible because we're final."

Let's hope President Obama can put some better people on the bench.

Posted by: JD at February 14, 2008 5:44 AM

The jury was sold the usual story that the inventor pioneered, in this case, drug coated stents, and the evil corporation stole the invention from him.

However, there is no evidence whatsoever that Dr. Saffran played any part in the development of drug coated stents developed and sold by Boston Scientific, J&J, Abbott or Medtronic. Dr. Saffran never developed any way of coating a stent or any particular drugs that might be efficacious for use in drug coated stents. None are disclosed in his patents. I am not affiliated with any of these companies but am knowledgeable of the history of stent development.

Fundamentally, it comes down to the fact that if the claims of the `760 patent can be read on the accused drug coated stents, then they read on the prior art drug coated stents. Since the patent examiner did not cite any such prior art, it is a safe bet that the examiner never thought of the claims in the context of a stent that did not have a sheet around it.

If you actually take the time to read the `760 patent, you will see that the one embodiment of a stent that is described bears no resemblance to the accused drug coated stents, but to a stent wrapped with a fabric sheet that purportedly is capable of blocking passage of a substantial portion of "macromolecules" (size not described) through it and also can be impregnated with a drug. If Claim 1 was asserted, you will see that it does not expressly recite this configuration but does include recitations to the blocking and drug releasing capabilities of a "layer" of a "device". The claims also recite device characteristics enabling manual shaping, which of course is never done to a stent by hand but might have been construed to read on balloon catheter expansion in situ, though that construction is not described in the specification. That limitation in the specification is particular to the manual placement of other, larger scale, device embodiments around a fractured bone where the fabric sheet can be manually extended around the bone and stretched to fit.

Now, you will also see that while stent "coating" is mentioned once in the specification, there is no explicit recitation of a coating on a stent in a way that would make the stent capable of "substantially restricting the through passage of at least one type of macromolecule", which in the context of a stent would be from the expanded tissue into the lumen of the stent. The relatively large spaces between the drug coated struts of a typical stent are still wide open to such passage of macromolecules, which was known in the prior art. So, the claims should have been construed to only cover a sheet surrounding the stent to effect that restriction as disclosed in the specification. I have no information as to how the judge construed that last limitation of Claim 1.

Suppose the judge construed that limitation to mean the coating on the stent struts was itself capable of restricting the through passage. Well, many prior art drug coated stents would have had the same inherent capability, as nothing could pass through the coating and the underlying metal struts to reach the stent lumen.

Speaking of prior art, the specification discloses prior art stents that include the fabric sheet around the stent (Figs. 8a - 8d) and also admits that the prior art teaches loading the sheet with drugs that elute in situ. The inventive sheet 1 around the stent struts 29 depicted in Figs. 8e - 8h is characterized as possessing a drug emitted at 12 and more importantly having minute pores enabling passage of certain small metabolites 16 while blocking passage of large macromolecules 8 through the sheet 1 into the lumen.

So, one difference of the invention over the admitted prior art stent of Fig. 8d recited in independent Claims 1, 8 and 15 appears to be this selective passage of small metabolites and blocking of large macromolecules, not the capability of eluting drugs that is also recited in the claims. While the cited prior art US 5,383,928 patent may have been silent as to the ability of the sheet to "substantially" restrict the through passage of large macromolecules, a non-porous sheet would logically inherently have that capability. The only difference over the admitted prior art would be having pores sized to pass the “small metabolites.” But that is not claimed!

Another difference that may have emphasized in prosecution is the recitation that the "treating material" is released "in a directional manner". The "direction" is not recited in the claims, but any drug on a drug coated stent is released outward or away from the stent strut. It cannot be released into the underlying stent strut! So, this is a meaningless limitation that is also inherently met by the prior art drug coated stents.

Without reviewing the file history, it appears to me that the patent examiner never considered any drug coated stent prior art, e.g., US Patents 5,464,650 and 5,102,417, for example. Early 90s publications also describe stent drug coatings, and those authors are responsible for the development of drug coated stents, not Dr. Saffran's later disclosures.

These claims are a classic example of "inventing" new ways of describing the prior art by claiming characteristics not expressed in the same words in the prior art the examiner is relying on. Restoring the ability of the patent examiner to rely on common sense in construing the inherent disclosures of the prior art is long overdue. And, this litigation is a poster child of the excesses that the CAFC and US Supreme Court are reigning in.

Posted by: Joe Breimayer at February 23, 2008 4:17 PM

It is interesting that the very same rationales adopted by the CAFC in the Medtronic v. Brainlab decision could be applied to the Saffran patent claims in the litigation with Boston Scientific and J & J to void the recent district court/jury verdict. Saffran's one word reference to stent drug coating is "a minimal dropping of an unenabled reference to an undeveloped system does not support a claim to it."

Posted by: JFB at February 26, 2008 7:32 AM