Therasense and Abbott Labs v. Becton, Dickinson and Company, Nova Biomedical, and Bayer Healthcare (2008-1511, -1512, -1513, -1514, -1595) precedential

Obviousness

4,545,382 and 4,225,410 were the killers of '551.

The central question with respect to obviousness is whether the prior art disclosed a glucose sensor without a membrane for use in whole blood. The district court found after trial that the prior art '382 patent disclosed electrochemical sensors in which "a protective membrane was optional in all cases except the case of live blood, in which case the protective membrane was preferred--but not required." Trial Opinion, 565 F. Supp. 2d at 1103.

The first two named inventors of the '382 patent were in on the '551 patent. '382 was cited prior art to '551.

Abbott cited the claims of '382 as the patent's scope of disclosure, and that was supposed to mean that a critical feature, of not using a membrane, which '551 embodies, would not have been obvious.

At the outset, it is important to understand the scope and context of the '382 patent. The claims of a prior art patent are part of its disclosure. In re Brenno, 768 F.2d 1340, 1346 (Fed. Cir. 1985) ("[I]t is true . . . that 'a claim is part of the disclosure' . . . ."); In re Smolak, 88 F.2d 838, 841 (CCPA 1937) ("[T]he disclosures in [prior art] specifications . . . include the claims, the written specification, and the drawings." (quotation omitted)); see also Gabrielidis v. Prince Sports Group, Inc., Nos. 99-1469, 99-1490, 2000 WL 1648134, at *7 (Fed. Cir. Nov. 1, 2000). The claims of the '382 patent are plainly directed in part to sensors without a membrane, as is made clear by the dependent claims that specifically include a membrane as an additional feature of the device.

Abbott tried to shade the '382 disclosure by contending "that in the case of blood--as opposed to other fluids--a membrane is required." The word connoisseurs known as the CAFC observed: "The use of the term "preferably" implies that such a membrane is not necessary."

Abbott was disbelieving that that patent-reading hoopleheads would believe what they read, as it went against conventional wisdom.

Abbott, however, contends that a person having ordinary skill in the art would not have read the '382 specification that way. Abbott asserts that the conventional wisdom of those skilled in the art was that a membrane was necessary when testing with blood, and that skilled artisans would not have read the patent's disclosure literally when it said that a membrane was not necessary with blood.

The district court found that incredible, and the CAFC concurred.

Enablement plays into the punch that prior art has: not individually, but collectively.

In order to render a claimed apparatus or method obvious, the cited prior art as a whole must enable one skilled in the art to make and use the apparatus or method. Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989). An individual prior art reference, on the other hand, "need not be enabled; it qualifies as a prior art, regardless, for whatever is disclosed therein." Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1357 (Fed. Cir. 2003); see also Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1578 (Fed. Cir. 1991); Beckman Instruments, 892 F.2d at 1551.

The argument over enablement went to the issue of oxygen sensitivity, and left Abbott out of breath: the courts rejected Abbott's argument on that count.

Abbott argued that there was no motivation to combine references, but the courts weren't motivated to agree.

Abbott cited the product which flew under the banner of '551 as evidence of commercial success that overcomes obviousness.

In order to overcome a finding of obviousness by demonstrating commercial success, "[a] nexus between commercial success and the claimed features is required." Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000). "[T]he asserted commercial success of the product must be due to the merits of the claimed invention beyond what was readily available in the prior art." J.T. Eaton & Co. v. Atl. Paste & Glue Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997).

But the CAFC observed:

This is not a situation where the success of a product can be attributed to a single patent, because Abbott's Exactech product embodied at least two patents: the '382 patent and the '551 patent.

The defendants presented uncontroverted evidence demonstrating that the Exactech product's success was due to features already present in prior art such as the '382 patent.

'551 dead one time.

Inequitable Conduct

Non-disclosure leads to exposure of inequitable conduct. Abbott went buck naked* in Europe.

* The American Heritage Dictionary conjectures that the term was originally "butt naked", but was cleaned up to "buck naked" for use in polite company, as if polite company is expounding on nakedness. (But here we are.) Wordsmith Michael Quinon pondered the posterior portion contrary to the putative. "Buck" and "buff" connote nudity, derived respectively from buckskin and buffalo hides. Thomas Dekker, in 1602, went on the record using "buff" to mean naked. Quinon's assumption is that "buck" is simply an alternative to "buff," no cleansing required for the colloquialism. Now, back to our regularly scheduled court ruling.

Following the bench trial, the district court also held the '551 patent unenforceable for inequitable conduct based on a failure to disclose statements made to the European Patent Office ("EPO") during a revocation proceeding of the European counterpart to the '382 patent. Trial Opinion, 565 F. Supp. 2d at 1127.

"[I]nequitable conduct includes affirmative misrepresentation of a material fact, failure to disclose material information, or submission of false material information, coupled with an intent to deceive." Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1378 (Fed. Cir. 2008) (quoting Pharmacia Corp. v. Par Pharm., Inc., 417 F.3d 1369, 1373 (Fed. Cir. 2005)) (quotation marks omitted). "The party asserting inequitable conduct must prove a threshold level of materiality and intent by clear and convincing evidence. The court must then determine whether the questioned conduct amounts to inequitable conduct by balancing the levels of materiality and intent, 'with a greater showing of one factor allowing a lesser showing of the other.'" Digital Control, Inc. v. Charles Mach. Works, 437 F.3d 1309, 1313 (Fed. Cir. 2006) (quoting Union Pac. Res. Co. v. Chesapeake Energy Corp., 236 F.3d 684, 693 (Fed. Cir. 2001)) (citations omitted).

The penalty for inequitable conduct is severe, as an entire patent is rendered unenforceable. Therefore it is important that courts maintain a high standard. "Just as it is inequitable to permit a patentee who obtained his patent through deliberate misrepresentations or omissions of material information to enforce the patent against others, it is also inequitable to strike down an entire patent where the patentee only committed minor missteps or acted with minimal culpability or in good faith." Star Scientific, 537 F.3d at 1366.

The district court found that Abbott had made directly contradictory representations to the EPO concerning the teaching of the '382 patent in European Patent EP 0 078 636 ("the '636 patent")--a counterpart to the '382 patent with virtually identical specifications--and that Abbott had not disclosed those contradictory representations to the PTO.

In determining whether a failure to disclose material information was intentional, "the involved conduct, viewed in light of all the evidence, including evidence indicative of good faith, must indicate sufficient culpability to require a finding of intent to deceive." Kingsdown, 863 F.2d at 876. Because direct evidence of deceptive intent is rarely available, such intent can be inferred from indirect and circumstantial evidence. Star Scientific, 537 F.3d at 1366.

The credibility of Lawrence Pope ("Pope"), Abbott's patent attorney, and Dr. Sanghera, Abbott's Director of Research and Development, were crucial to evading inequitable conduct. The district court found them incredible, and the CAFC panel majority found those findings "amply supported."

'551 dead two times.

Dissent

Judges DYK and Friedman were the panel majority.

Judge Linn dissented on inequitable conduct. On materiality, Linn thought that the district court, and the majority, had taken only the damning inference when a more innocent inference was possible.

The majority invokes the familiar adage that "[c]lose cases should be resolved by disclosure." LaBounty Mfg., Inc. v. U.S. Int'l Trade Comm'n, 958 F.2d 1066, 1076 (Fed. Cir. 1992) (emphasis added). It is sage advice, and practitioners should take it to heart, so that they may avoid even being accused of inequitable conduct, much less being found to have committed it. But this adage is not a legal rule. We have never recognized a "close case" standard for materiality. The majority, however, believes that if this is such a case, then the duty of disclosure "requires that the material in question be submitted to the examiner." Maj. Op. 26 (emphasis added). Our circuit already entertains five different standards for materiality. See Digital Control, Inc. v. Charles Mach. Works, 437 F.3d 1309, 1315-16 (Fed. Cir. 2006). I do not think that we need a sixth.

Linn put up a stiff defense that Pope and Sanghera were harshly considered, and so intent was not the slam dunk that the majority made it out to be in backing the district court.

In my view, Attorney Pope and Dr. Sanghera's good faith explanations are entirely consistent with the alternative reasonable interpretation of the EPO submissions that renders them immaterial. Indeed, as demonstrated by the myriad footnote citations to the trial record, supra, this alternative reasonable interpretation is the one that the individuals' themselves presented to the district court. Coupled with the fact that these individuals were unaware of the Suzuki patent (or any other contrary teachings), their explanations are certainly plausible.

While agreeing with prior art invalidity, Linn found relying on prior art claims bad form.

The descriptive portions of the prior art patents are alone sufficient to invalidate the claims-in-suit. It is therefore unnecessary, and I believe improper in this case, to look to the claims of the prior art patents as a measure of what the prior art discloses for purposes of obviousness and anticipation. See In re Benno, 768 F.2d 1340, 1346 (Fed. Cir. 1985) ("The scope of a patent's claims determines what infringes the patent; it is no measure of what it discloses.").