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January 11, 2012

Bleeding

Streck sued Research & Diagnostic Systems (R&D) for infringing hematology control patents 6,200,500 and 6,221,668. R&D counterclaimed a declaratory judgment action of noninfringement and invalidity. The two competitors were innovating in stride, but Streck had the edge, at least with the favor of the courts, which is really all that matters.

Streck v. Research & Diagnostic Systems (CAFC 2011-1044) precedential; Judges Newman, O'Malley (author) and Reyna

R&D's DJ, focused on 112 issues, got trashed. The DJ had included claims that Streck had not asserted. After the appearance of waffling by the district court, the judge refused to consider them, as not representing an actual controversy.

On October 28, 2009, the jury found that: (1) R&D had not proven, by clear and convincing evidence, that it was the first to invent; and (2) R&D had not willfully infringed Streck's patents. The jury found that Streck was entitled to a royalty for R&D's infringing sales and awarded damages of 12.5%, which amounted to $92,298.88 plus costs and interest. The court entered judgment in favor of Streck on October 29, 2009.

Meanwhile, on a dual track of interference at the USPTO, the patent office found that R&D had priority of invention, the opposite of what had been determined at district court. The district court ignored the PTO.

The CAFC, as it normally does, lacking abuse of discretion, backed the district court. Withstanding the typical court bias exemplified here, the case law issue is the threshold by which declaratory judgment may gain jurisdiction.

It is well-established that, in patent cases, the existence of a "case or controversy must be evaluated on a claim-by-claim basis." Jervis B. Webb Co. v. So. Sys., Inc., 742 F.2d 1388, 1399 (Fed. Cir. 1984) (citations omitted). A party claiming declaratory judgment jurisdiction has the burden of showing "that the facts alleged, 'under all the circumstances, show that there is a substantial controversy, between the parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.'" Benitec Austl., Ltd. v. Nucleonics, Inc., 495 F.3d 1340, 1343 (Fed. Cir. 2007) (quoting MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 (2007)). The party seeking a declaratory judgment must establish that jurisdiction "existed at the time the claim for declaratory relief was filed and that it has continued since." Id. at 1344. (citing Steffel v. Thompson, 415 U.S. 452, 459 n.10 (1974)). In other words, jurisdiction must exist "at all stages of review, not merely at the time the complaint [was] filed." Id. at 1345 (quoting Steffel, 415 U.S. at 459 n.10).

After MedImmune, courts must look at "all the circumstances" to determine whether a declaratory judg-ment plaintiff has shown a case or controversy between the parties. As this court has explained, moreover, al-though the Supreme Court rejected the reasonable appre-hension of suit test as the sole test for jurisdiction, "it did not completely do away with the relevance of a reasonable apprehension of suit." Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1329, 1336 (Fed. Cir. 2008) (citing Caraco Pharm. Labs., Ltd. v. Forest Labs, Ltd., 527 F.3d 1278, 1291 (Fed. Cir. 2008)).

Looking at "all the circumstances" means merely rationalizing however a court wants to rule. A long list of patent rulings by the Supreme Court on down in the past decade have scrubbed objectivity as a necessity, substituting subjectivity as a ruse for the rule of law. MedImmune set a subjective standard for DJs. eBay for injunctive relief. KSR blatantly did so with obviousness.

By ignorning the interference, which does create a controversy, the courts became free to exercise their bias against R&D, and not allow the DJ to proceed. But then, ignoring the PTO has long been a matter of court discretion. The scratchy random competence of the patent office helps make that an easier call. (More uproar would likely ensue over courts ignoring the PTO if the PTO were reliably competent. But that is far from reality.)

The interpretation of § 112 ¶1 is another subjective evaluation. Courts can decide as a matter of law if they can only see one view of the facts. It all sounds so reasonable.

It is well-established that the "hallmark of written description is disclosure." Ariad, 598 F.3d at 1351. The level of detail required to satisfy the written description requirement depends, in large part, on the nature of the claims and the complexity of the technology. Id. As we explained in Ariad, the written description requirement "does not demand either examples or an actual reduction to practice; a constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement." Id. at 1352 (citing Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366-67 (Fed. Cir. 2006)). That said, a "mere wish or plan" to obtain the claimed invention is not sufficient. Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011) (citing Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566 (Fed. Cir. 1997)). "Compliance with the written description requirement is a question of fact but is amenable to summary judgment in cases where no reasonable fact finder could return a verdict for the nonmoving party." PowerOasis, Inc. v. T-Mobile, Inc., 522 F.3d 1299, 1307 (Fed. Cir. 2008).

In this case, R&D's view of the facts was readily brushed aside.

R&D asserts that: (1) "Ryan was unable to locate any description of the use of true reticulocytes in his own patents" when asked to do so during his deposition; (2) Ryan did not consider true reticulocytes to be part of his invention; and (3) "Streck had never attempted to make a true reticulocyte integrated control." Appellants' Br. 36.

Here the CAFC lowers the bar to written description; but just this once, or at least until the next time it decides to grant such favor.

Streck is not required to prove an actual reduction to practice as to all disclosures.

The CAFC carved precedent of case law on enablement here, ending on the note, once again, that subjectivity is the standard; there are no objective metrics, only considerations.

Enablement "is a legal determination of whether a patent enables one skilled in the art to make and use the claimed invention." Hybritech Inc. v. Monoclonal Antibod-ies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986) (citation omitted). To be enabling, a patent's specification must "teach those skilled in the art how to make and use the full scope of the claimed invention without 'undue ex-perimentation.'" Alza Corp. v. Andrx Pharm., LLC, 603 F.3d 935, 940 (Fed. Cir. 2010) (citations omitted). It is well-established, however, that a specification need not disclose what is well-known in the art. See Hybritech, 802 F.2d at 1384 ("[A] patent need not teach, and preferably omits, what is well known in the art."). It is true, how-ever, that, "the rule that a specification need not disclose what is well known in the art is merely a rule of supple-mentation, not a substitute for a basic enabling disclo-sure." Alza, 603 F.3d at 940-41 (quoting Auto. Techs. Int'l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1282 (Fed. Cir. 2007)).

The enablement requirement is met where one skilled in the art, having read the specification, could practice the invention without "undue experimentation." In re Wands, 858 F.2d 731, 736-37 (Fed. Cir. 1988) ("Enablement is not precluded by the necessity for some experimentation such as routine screening."). Whether undue experimentation is required "is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." Alza, 603 F.3d at 940 (citing Wands, 858 F.2d at 737). In Wands, this court set forth the following factors to consider when determining whether a disclosure requires undue experimentation:

(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.

858 F.2d at 737. "[I]t is not necessary that a court review all the Wands factors to find a disclosure enabling. They are illustrative, not mandatory." Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1213 (Fed. Cir. 1991).

All of R&D's objections, some quite provacative, were slapped away as "without merit."

Affirmed.

Posted by Patent Hawk at January 11, 2012 2:02 PM | § 112