« When the Chips are Down | Main | Sanctioned »

January 7, 2008

Unstenting

Cordis separately sued Medtronic and Boston Scientific for infringing "patents covering vascular stents that are used to treat coronary artery disease;" winning both cases. Losers appealed. In the blowup, Cordis had a claim invalidated, so appealed that. All appeals were consolidated, resulting in one long ruling focused on claim construction and prosecution estoppel.

Cordis v. Medtronic and Boston Scientific; Medtronic v. Cordis; Boston Scientific v. Cordis (CAFC 2006-1393, -1394, 1395, -1396, -1415, -1416

The asserted patents were 4,739,762 & 5,195,984.

'762 disclosed a coronary stent mounted on an angioplasty balloon, delivered via blood vessel using a catheter. Once in place, the balloon is inflated to expand the stent to desired size.

'984 disclosed a flexible stent.

Unusually, Cordis requested reexamination during litigation, in light of prior art; narrowing scope of some claims in the outcome, but also with new claims.

The Medtronic case went through summary judgment of literal non-infringement, jury verdict of doctrine of equivalents (DOE) infringement, post-trial JMOL non-infringement under DOE by prosecution estoppel, appeal reversing claim construction and prosecution estoppel, retrial of literal infringement, denial post-trial for a new trial; hence, appeal by Medtronic.

Medtronic had lots of argument on appeal, but the CAFC bought none of it. Most interesting was Medtronic arguing that jury instruction was incorrect in light of KSR; the CAFC in reply nuancing KSR.

[Medtronic] AVE argues that it should not be penalized for requesting an instruction based on the state of the law before KSR, because in its view KSR resulted in a significant change in the law. The Supreme Court, however, stated that “[t]here is no necessary inconsistency between the idea underlying the TSM test and the Graham [v. John Deere Co., 383 U.S. 1 (1966)] analysis.” KSR, 127 S. Ct. at 1741. This court’s error, the Supreme Court explained, was to “transform[] the general principle into a rigid rule that limit[ed] the obviousness inquiry.” Id.; see also Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007) (“As long as the [TSM] test is not applied as a ‘rigid and mandatory’ formula, that test can provide ‘helpful insight’ to an obviousness inquiry.” (quoting KSR, 127 S. Ct. at 1731)). In any event, even in the case of a change in the law, the Supreme Court has held that the plain error standard applies to a jury instruction to which no objection was made. See Johnson v. United States, 520 U.S. 461, 465-66 (1997). Under that standard, AVE has not remotely demonstrated that it is entitled to a new trial on obviousness.

Boston Scientific lost at trial in 2000 under DOE, but got a new trial based on jury instruction regarding prosecution estoppel, stayed pending Cordis's successful claim construction appeal, resulting a a second trial in 2005 finding infringement; denied post-trial anything (JMOL or a new trial), appeal.

Boston Scientific also had lots of argument on appeal, with the CAFC taking a bite of the bait. The case was remanded over the definition of what constitutes a "smooth surface."

[Boston Scientific] BSC is correct, of course, that the definition of “smooth surface” that applies to the infringement analysis must also apply to the issue of obviousness. Whether, on the facts of this case, the broader definition requires any further proceeding with respect to the issue of obviousness, however, is not a matter that the parties have addressed in any detail on appeal and is best left for the district court to resolve on remand, particularly in light of the district court’s intimate familiarity with the extensive and complex proceedings in this difficult case.

Boston Scientific argued prosecution estoppel from the Cordis reexam. Though the argument went nowhere, how it went nowhere is precedential.

[A]n applicant can make a binding disavowal of claim scope in the course of prosecuting the patent, through arguments made to distinguish prior art references. Such argument-based disavowals will be found, however, only if they constitute clear and unmistakable surrenders of subject matter. Conoco, Inc. v. Energy & Envtl. Int’l, L.C., 460 F.3d 1349, 1364 (Fed. Cir. 2006); Pharmacia & Upjohn Co. v. Mylan Pharms., Inc., 170 F.3d 1373, 1376 (Fed. Cir. 1999); Litton Sys., Inc., 140 F.3d at 1458. Moreover, the scope of such a disavowal will depend on the nature of the argument made by the patentee. As the court explained in Omega, 334 F.3d at 1324, even in the case of an unequivocal disavowal of claim scope, the court must construe the claim “congruent with the scope of the surrender.” In order to constitute binding surrenders of claim scope, the statements in question must be such that “a competitor would reasonably believe that the applicant had surrendered the relevant subject matter.” Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1457 (Fed. Cir. 1998) (en banc). If the court finds that the patentee made a clear disavowal of the subject matter that is subsequently asserted to be equivalent to the limitation in question, it will preclude the patentee from asserting equivalency as to that subject matter. See Bayer AG v. Elan Pharm. Res. Corp., 212 F.3d 1241, 1252 (Fed. Cir. 2000).

[T]here is no reason to treat Cordis’s definitional explanation in the prosecution history as having the effect of surrendering all equivalents that would otherwise have been available under the patent.

Cordis's appeal was from the district court invalidating a new claim granted during reexam. The appeals court agreed with Cordis.

[T]he [district] court concluded that ['762] claim 44 was “added solely to cover competitors’ stents, and not for a permissible reason under § 305.

In holding claim 44 invalid, the district court incorrectly interpreted section 305. The portion of section 305 on which the district court relied permits a patentee to add claims (1) that distinguish the invention from the prior art cited under section 301 and (2) that are added in response to an office action adverse to the patentability of a claim. Claims added under either clause must satisfy section 305’s substantive limitation, which prevents patent owners from adding new claims that enlarge the scope of the patent’s coverage.

Cordis specifically stated that the changes it made in its July 21, 1998, submission to the PTO, including the addition of claims 44 through 59, were “[r]esponsive to” the office action that had rejected all but two of the claims of the ’762 patent in light of prior art references. Moreover, Cordis was free to include the new claims even apart from the office action if they were added to distinguish the invention from prior art cited under section 301. Section 305 does not require the patent owner to include an express statement that the new claims distinguish the prior art or remarks indicating how the new claims distinguish the prior art references. If the claims fail to distinguish the prior art, the claims will be rejected on the appropriate grounds; for that reason, it may frequently be in the patent owner’s interest to include such remarks, but they are not necessary to satisfy section 305. For purposes of assessing validity under section 305, the MPEP directs the examiner to determine only whether any added claims impermissibly “enlarge the scope of the original claims.” 37 C.F.R. § 1.552(b). Here, the district court acknowledged, and BSC concedes, that claim 44 does not broaden the scope of coverage of the ’762 patent.

Back to district court for another round.

Posted by Patent Hawk at January 7, 2008 6:56 PM | Claim Construction

Comments

This is kind of sad. So much research dollars and then legal expenses for a failed technology. Science News reported in their June 23, 2007 issue that stents were falling out of favor among doctors. They said, "This April, another study showed that oral drug therapy may be just as good as stent implantation in treating mild artery blockage. Also in April, researchers reported that in patients with severe arterial disease, drug-coated stents offered no benefit over heart-bypass surgery." ... " FDA acknowledged an acute need for more data but issued a statement maintaining that 'concerns about thrombosis [i.e., blood clots] do not outweigh the benefits' of drug-coated stents when the stents are used for 'approved indications.' And there's the rub. The agency approved the stents for only a specific group of low-risk patients—those with one small blockage in one artery. But according to two studies in the May 9 Journal of the American Medical Association (JAMA), about half of patients who receive drug-coated stents do not fall in that category." ... "For drug-coated stents, 'there was off-label use like you've never seen,' says Michael J. Mack, director of the Cardiopulmonary Research Science and Technology Institute in Dallas. '"I think this was mainly due to the marketing hype.'" ... "Observers predict a continuing decline in the use of drug-coated stents. Says Eisenberg: 'This is one of those situations where we thought there was no downside. But now that there is a serious downside, even if the risk is tiny, most of us are very risk averse. So I need to be convinced now by hard data that a drug-coated stent is the right way to go.'"

Posted by: Len at January 10, 2008 9:44 PM