Some of Judge Sleet's reasoning in Cubist v. Hospira, D. Delaware, C.A. No. 12-367-GMS

Judge Sleet found issues with four of the five Cubist patents related to daptomycin.

As to the '967 patent:


The court notes initially that several of Cubist's counterarguments as to why
the Woodworm article does not anticipate are more appropriately directed at an
obviousness inquiry. Questions concerning the motivations of one skilled in the
art, or whether the Woodworm article teaches away from the '967 Patent do not
weigh on anticipation. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
246 F.3d 1368,1378 (Fed. Cir. 2001) ("[A] reference is no less anticipatory if,
after disclosing the invention, the reference then disparages it. Thus, the
question whether a reference 'teaches away' from the invention is inapplicable
to an anticipation analysis." (quoting Celeritas Techs., Ltd. v. Rockwell Int'l
Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998))); see also Cohesive Techs., Inc. v.
Waters Corp., 543 F.3d 1351, 1364 (Fed. Cir. 2008) ("The tests for anticipation
and obviousness are different. . . . [O]bviousness requires analysis of
secondary considerations of nonobviousness, while secondary considerations are
not an element of a claim of anticipation.").



AND


Turning first to the question of whether the Woodworm article discloses all of
the claimed elements, the court notes that Cubist also spends considerable time
discussing the experiments conducted in the Woodworm article, rather than
focusing on the particular disclosure at issue, which was a prediction or
suggestion for future study. But Hospira is correct that "anticipation
does not require actual performance of suggestions in a disclosure." See
Bristol-Myers Squibb, 246 F.3d at 1379. Thus, the only element Cubist contests
is whether the Woodworm article inherently discloses "minimizing skeletal muscle
toxicity." The court finds that it does. Regardless of whether one skilled in
the art would be aware of it, following the suggestion disclosed by the
Woodworth article (4-6 mg/kg/day) would have the physiological effect of
minimizing skeletal muscle toxicity. (Tr. at 1028 (Guglielmo).) This
cause-and-effect was the same at the time of the '967 priority date as it was
when the Woodworth article was published. Cubist's expert Dr. Guglielmo conceded
that he had difficulty grasping the concept of inherent disclosures when
multiple suggestions are offered in the prior art reference. (Id. at 1028-32.)
Nonetheless, the law is clear that the "disclosure of multiple examples" does
not "render[] one example less anticipatory." Leggett & Platt, Inc. v. VUTEk,
Inc., 537 F.3d 1349, 1356 (Fed. Cir. 2008). "Under the principles of inherency,
if the prior art necessarily functions in accordance with, or includes, the
claimed limitations, it anticipates." In re Cruciferous SproutLitig., 301 F.3d
1343,1349 (Fed. Cir. 2002). The court finds that minimizing skeletal muscle
toxicity was a necessary accompaniment to the other disclosed claimed
limitations and therefore was inherently disclosed by the Woodworm article.




As to enablement


Cubist's primary argument, however, is that, even if Woodworm discloses the
necessary elements of the '967 Patent claims, they are not enabled by the
disclosure. "An anticipating reference must be enabling; that is, the
description must be such that a person of ordinary skill in the field of the
invention can practice the subject matter based on the reference, without undue
experimentation." Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed.
Cir. 2008). The patentee, however, bears the burden of overcoming the
presumption of prior art enablement by a preponderance of the evidence. See
Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355-56 (Fed. Cir.
2003).10 In overcoming this presumption, the patent holder should address
several factors: the quantity of experimentation that was actually needed, the
amount of guidance provided in the reference, the presence or absence of actual
examples of the experimental procedure, the state of the knowledge already
available concerning the subject matter at issue, and the predictability or
unpredictability in the specific area of science or technology. See id. at 1085.

10 Although it concedes that prior art patents have a presumption of enablement,
Cubist argues there should be no presumption of [*36] enablement for prior art
printed publications. (D.I. 126 at 8 n.7.) The Federal Circuit in Amgen never
squarely addressed this question, although it indicated that there should be no
distinction between patents and printed publications. See Amgen, 314 F.3d at
1355 n.22 ("We note that by logical extension, our reasoning here might also
apply to prior art printed publications as well, but as Sugimoto is a patent we
need not and do not so decide today."). The court finds this logical extension
appropriate. Whereas the claims of a valid patent must be enabling by statute,
35 U.S.C. § 112, the additional disclosures in the specification need not. Amgen
nonetheless held that both the claimed and unclaimed disclosures are presumed
enabling. Id. at 1355. The court finds that printed publications should receive
the same treatment as unclaimed disclosures. Moreover, patent examiners already
apply a presumption of enablement to printed publications during the prosecution
process. See In re Antor Media Corp., 689 F.3d 1282, 1289 (Fed. Cir. 2012).
10 Although it concedes that prior art patents have a presumption of enablement,
Cubist argues there should be no presumption of [*36] enablement for prior art
printed publications. (D.I. 126 at 8 n.7.) The Federal Circuit in Amgen never
squarely addressed this question, although it indicated that there should be no
distinction between patents and printed publications. See Amgen, 314 F.3d at
1355 n.22 ("We note that by logical extension, our reasoning here might also
apply to prior art printed publications as well, but as Sugimoto is a patent we
need not and do not so decide today."). The court finds this logical extension
appropriate. Whereas the claims of a valid patent must be enabling by statute,
35 U.S.C. § 112, the additional disclosures in the specification need not. Amgen
nonetheless held that both the claimed and unclaimed disclosures are presumed
enabling. Id. at 1355. The court finds that printed publications should receive
the same treatment as unclaimed disclosures. Moreover, patent examiners already
apply a presumption of enablement to printed publications during the prosecution
process. See In re Antor Media Corp., 689 F.3d 1282, 1289 (Fed. Cir. 2012).


10 Although it concedes that prior art patents have a presumption of enablement,
Cubist argues there should be no presumption of [*36] enablement for prior art
printed publications. (D.I. 126 at 8 n.7.) The Federal Circuit in Amgen never
squarely addressed this question, although it indicated that there should be no
distinction between patents and printed publications. See Amgen, 314 F.3d at
1355 n.22 ("We note that by logical extension, our reasoning here might also
apply to prior art printed publications as well, but as Sugimoto is a patent we
need not and do not so decide today."). The court finds this logical extension
appropriate. Whereas the claims of a valid patent must be enabling by statute,
35 U.S.C. § 112, the additional disclosures in the specification need not. Amgen
nonetheless held that both the claimed and unclaimed disclosures are presumed
enabling. Id. at 1355. The court finds that printed publications should receive
the same treatment as unclaimed disclosures. Moreover, patent examiners already
apply a presumption of enablement to printed publications during the prosecution
process. See In re Antor Media Corp., 689 F.3d 1282, 1289 (Fed. Cir. 2012).



Bottom line as to the '967 patent


The novelty requirement of patent law embodies the policy that private entities
should not be able to obtain patents "whose effects are to remove existent
knowledge from the public domain, or to restrict free access to materials
already available." See Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489
U.S. 141, 146, 109 S. Ct. 971, 103 L. Ed. 2d 118 (1989) (quoting Graham v. John
Deere Co. of Kan. City, 383 U.S. 1, 6, 86 S. Ct. 684, 15 L. Ed. 2d 545 (1966)).
The court finds that Hospira has demonstrated by clear and convincing evidence
that the Woodworth article disclosed each of the elements of the claims of the
'967 Patent, expressly or inherently. Cubist has not shown by a preponderance of
the evidence that the Woodworth article was not enabling. Thus, Woodworth
anticipates the '967 Patent and renders it invalid, pursuant to 35 U.S.C. § 102.



As a point of law, anticipation is not the epitome of obviousness:


A finding that a patent is anticipated under § 102 often--but not
necessarily--indicates that the patent is obvious under § 103. Cohesive Techs.,
543 F.3d at 1364 & n.2 (Fed. Cir. 2008) ("[O]ur precedent has rejected reliance
on the 'legal homily' that 'anticipation is the epitome of obviousness.'"
(quoting Mendenhall v. Cedarapids, Inc., 5 F.3d 1557, 1563 (Fed. Cir. 1993))).


The tests for anticipation and obviousness are different. Obviousness
can be proven by combining existing prior art references, while
anticipation requires all elements of a claim to be disclosed within a
single reference. Moreover, obviousness requires analysis of secondary
considerations of nonobviousness, while secondary considerations are
not an element of a claim of anticipation. And although anticipation
can be proven inherently, proof of inherent anticipation is not the
same as proof of obviousness.


Id. at 1364 (internal citations omitted). Therefore, although the court found
the '967 Patent to be anticipated, a separate obviousness analysis is still
required.




As to secondary considerations:


As Hospira points out, however, the claims of the '967 and '689 Patents are not
truly commensurate with the long-felt need Cubist puts forth--treatment of
serious infections like SAE. The claims cover bacterial infections generally. As
Cubist's [*50] expert testified, Eli Lilly had previously been successful using
daptomycin to treat some infections. (Id.) Moreover, vancomycin was the standard
treatment for many of these same infections. (Tr. at 949-50 (Guglielmo).) Thus,
for much of what the dosing patents claim, there was no long-felt need. See
Muniauction, 532 F.3d at 1328 n.4 ("[C]laims which are broad enough to read on
obvious subject matter are unpatentable even though they also read on nonobvious
subject matter." (quoting In re Lintner, 458 F.2d 1013, 1015, 59 C.C.P.A. 1004
(C.C.P.A. 1972))).

(...)

Thus, there is a disconnect between what the dosing patents actually claim and
the secondary considerations Cubist offers. The court is not convinced that the
objective indicia cited by Cubist are entitled to significant weight; and any
weight certain factors may have does not overcome Hospira's prima facie showing
of obviousness. See Muniauction, 532 F.3d at 1327 ("[T]o the extent that some of
the factors arguably meet the nexus requirement, their relationship to the
claims is simply too attenuated to overcome the strong prima facie demonstration
by Thomson that the claims are obvious."); see also Pfizer, 480 F.3d at 1372
("Even if Pfizer showed that amlodipine besylate exhibits unexpectedly superior
results, this secondary consideration does not overcome the strong showing of
obviousness in this case."). Hospira has shown by clear and convincing evidence
that the '967 and '689 Patents are obvious and therefore invalid under 35 U.S.C.
§ 103.


Independent and parallel inventions:


Finally, Hospira asserts Eli Lilly's ability to produce 98% pure daptomycin over
a decade before the priority date of Cubist's purity patents weighs in favor of
an obviousness finding. See Geo. M. Martin Co. v. Alliance Mach. Sys. Int'l LLC,
618 F.3d 1294, 1305 (Fed. Cir. 2010) ("Independently made, simultaneous
inventions, made 'within a comparatively short space of time,' are persuasive
evidence that the claimed apparatus 'was the product only of ordinary mechanical
or engineering skill.'" (quoting Concrete Appliances Co. v. Gomery, 269 U.S.
177, 184, 46 S. Ct. 42, 70 L. Ed. 222, 1926 Dec. Comm'r Pat. 284 (1925))). The
clinical studies conducted by Eli Lilly (discussed in the previous section) used
daptomycin batches with purity levels reaching upwards of 98%. (DTX-079.) The
court agrees with Hospira that Eli Lilly's production of similarly pure
daptomycin lots--not just simultaneous with, but considerably prior to Cubist's
patented invention--is objective support for an obviousness determination.

Ultimately, the court finds that secondary considerations do not upset Hospira's
prima facie showing that the asserted claims of the purity patents are obvious.
Hospira has made this showing by clear and convincing evidence. The '238 and
'342 Patents are invalid as obvious under § 103.



The bottom line


For the reasons stated above, the court concludes that: (1) the [*72]
Certificate of Correction issued for the RE'071 Patent is not invalid, and
therefore Hospira's products infringe the RE'071 Patent; (2) the RE'071 Patent
is not invalid for lack of written description; (3) the RE'071 Patent is not
invalid for improper recapture; (4) a revision to the court's claim construction
of the term "daptomycin" in the '967, '689, '238, and '342 Patents is not
warranted, and therefore Hospira's products infringe the '967, '689, '238, and
'342 Patents; (5) the '967, '689, '238, and '342 Patents are not invalid for
lack of written description; (6) the asserted claims of the '967 Patent are
invalid due to anticipation; (7) the asserted claims of the '967 and '689
Patents are invalid due to obviousness; (8) claim 98 of the '238 Patent is
invalid as anticipated; (9) the asserted claims of the '238 and '342 Patents are
invalid due to obviousness; (10) Hospira's § 102(f) derivation defense is
untimely and precluded; and (11) each of the parties' Rule 52(c) motions are
granted in part and denied in part.