Tuesday, January 10, 2012

Streck v. Research Diagnostic

Bottom line: we affirm the district court’s judgment against R&D and its decision granting a permanent injunction in favor of Streck.

As to the disputed issues:

For the reasons set forth below, we find that: (1) the district court did not err in limiting the action to the claims Streck asserted, given R&D’s failure to establish a case or controversy with respect to the other claims; (2) the patents-in-suit satisfy the written description requirement as a matter of law, because the specification clearly discusses true reticulocytes as well as analogs; (3) R&D’s evidence failed to create a jury question on the issue of whether the patents-in-suit failed to enable one skilled in the art to make the claimed integrated controls using true reticulocytes; (4) the priority issue is controlled by this court’s ruling in Appeal No. 2011-1045, and R&D’s related evidentiary challenges are without merit; and (5) properly construed, the language in the permanent injunction is not overbroad. Accordingly, we affirm the district court in full.

Salient points:

It is well-established that, in patent cases, the exis- tence 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 reference to DNJ: Post-MedImmune, at least one district court has found that it lacked declaratory judgment jurisdiction over patent claims that were initially asserted in a broad complaint and subsequently not included in the narrower scope of claims alleged to be infringed. See Hoffman-La Roche Inc. v. Mylan Inc., No. 2:09cv1692, 2009 U.S. Dist. LEXIS 114784, at *17-18 (D.N.J. Dec. 9, 2009).

Of written description: The written description “must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citation and quota- tions omitted). The test is whether the disclosure “con- veys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. This test requires an “objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. Given this per- spective, in some instances, a patentee can rely on infor- mation that is “well-known in the art” to satisfy written description. Boston Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1366 (Fed. Cir. 2011). Where, however, the “four corners of the specification directly contradict infor- mation that the patentee alleges is ‘well-known’ to a person of skill at the effective filing date, no reasonable jury could conclude that the patentee possessed the invention.” Id.

A mere wish or plan is not enough to satisfy written description: It is well-established that the “hallmark of written de- scription 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)). “Com- pliance 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).

Here: Streck is not required to prove an actual reduction to practice as to all disclosures. See Ariad, 598 F.3d at 1352. Instead, to satisfy written description, Streck need only show that the specification itself demonstrates “a constructive reduction to practice that in a definite way identifies the claimed invention.” See Id. at 1352. The relevant inquiry, therefore, is whether a person of ordi- nary skill in the art would reasonably find that the patent sufficiently described the invention using true reticulo- cytes. R&D’s expert, Dr. Simson, testified that, in this case, a person of ordinary skill in the art is “someone with an advanced degree like an M.D. or a Ph.D. and with experience in the field.” J.A. 46608:10-12.
Looking to the specifications, the patents-in-suit refer to several types of true reticulocytes: (...)

Note the use of the PRESENT tense: The reticulocyte component is prepared in any suitable manner. See, e.g. U.S. Pat. No. 5,432,089, incorporated by reference. Alterna- tively, it is possible to obtain suitable reticulocytes by obtaining blood from an anemic animal (e.g., a pig, goat, rabbit or the like).

As to enablement: 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.”).


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).

Of evidence issues: importantly, R&D failed to offer evidence to the contrary.
R&D also failed to produce adequate evidence that the experimentation required to create a true reticulocyte integrated control would be unduly laborious for one of ordinary skill in the art. R&D relies primarily on its own expert, Dr. Simson, who testified that “the patents do not enable a person of ordinary skill in the art to make . . . an integrated control preparation containing naturally occurring reticulocytes.” J.A. 46613:9-12. Simson further testified that “there is no real description in the patent itself enabling one to do it” and there were no examples “of how to make this material using natural occurring reticulocytes” in the patents. J.A. 46610:25-46611:5. As Streck argues, however, conclusory expert assertions do not give rise to a genuine issue of material fact. Although Simson testified that “a large amount of experimentation” would be necessary, on cross-examination he admitted, after he was presented with his own conflicting deposition testimony, that he has never been involved in developing controls. See J.A. 46611:19-24; 46621:13-46622:20.


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