AstraZeneca said the U.S. District Court for New Jersey has ruled that U.S. Patent No. 7,524,834, protecting pulmicort respules in the U.S. is invalid.
Link: http://www.nasdaq.com/article/astrazeneca-us-court-rules-pulmicort-respules-patent-invalid-20150216-00028#ixzz3RvL8GU5d
The opinion was by District Judge RENÉE MARIE BUMB. The claims at issue were to a powder and to a suspension:
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Claims 1 and 50 of the
'834 Patent,
the independent claims at issue, teach a powder and suspension,
respectively, comprising a "micronized powder composition."
Specifically, claim 1 recites:
A
pharmaceutically acceptable, micronized powder composition at least
98.5% by weight of which is pure budesonide or an ester, acetal or salt
thereof, wherein the composition meets the criteria of sterility
according to the US Pharmacopoeia [sic] 23/NF18, 1995, pages 1686-1690
and 1963-1975.
'834 Patent col.11 11.48-52 (emphasis added). Claim 50 recites:
A
pharmaceutically acceptable suspension consisting of a micronized
powder composition at least 98.5% by weight of which is pure budesonide
or an ester, acetal or salt thereof, suspended in an aqueous solution,
wherein the suspension meets the criteria of sterility [*6] according to the US Pharmacopoeia [sic] 23/NF18, 1995, pages 1686-1690 and 1963-1975.
'834 Patent
col.13 11.54-60 (emphasis added). The dependent claims - claims 2 and
51 - include the additional limitation that 98.5% of the "micronized
powder composition" is pure budesonide.
'834 Patent col.11 ll.53-54 & col.13 11.61-63.
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This case had taken a trip to the CAFC:
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On appeal, the Federal Circuit
reversed this Court's claim construction, construing the disputed term
"micronized powder composition" to mean "finely divided dry particles" without requiring any particular process for sterilizing the particles. AstraZeneca
,
542 F. App'x at 976-78. In light of the broadened claim construction,
much of the remand proceedings centered on what was known in the art
regarding the five conventional sterilization techniques. Defendants
contend [*7] that now that AstraZeneca
successfully
obtained a broader claim construction not limited to a particular
process, the so-construed patent is vulnerable to invalidity challenges
based upon a significantly greater selection of prior art. See Sandoz
Br., Docket No. 908, at 1, 8 ("AstraZeneca
paid a steep price for its victory in the Federal Circuit.").
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Reduction to practice arose in the discussion of prior art:
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"To antedate (or establish
priority) of an invention, a party must show either an earlier reduction
to practice, or an earlier conception followed by a diligent reduction
to practice." See Purdue Pharma L.P. v. Boehringer Ingelheim GmbH, 237 F.3d 1359, 1365 (Fed. Cir. 2001)
(citation omitted). "In order to establish an actual reduction to
practice, the inventor must prove that: (1) he constructed an embodiment
or performed a process that met all the limitations of the interference
count; and (2) he determined that the invention would work for its
intended purpose. . . . The inventor must also 'contemporaneously
appreciate that the embodiment worked and that it met all the
limitations of the interference count." Henkel Corp. v. Procter & Gamble Co., 560 F.3d 1286, 1289 (Fed. Cir. 2009) (citation omitted); see also Purdue Pharma, 237 F.3d at 1365-66.
The patentee bears the burden of producing evidence supporting an
earlier invention date but the burden of proof remains on the defendant
"to establish by clear and convincing evidence that the patentee's
invention date does not precede the date of the ostensible prior art
reference." Power Integrations, Inc. v. Fairchild Semiconductor Int'l, Inc., 585 F. Supp. 2d 568, 575-76 (D. Del. 2008) (citing Spectralytics, 576 F. Supp. 2d at 1045).5 AstraZeneca
points
to laboratory-reports, dated March 1997, demonstrating inter alia that
heating the substance for 60 minutes at 110 ° C would result in more
than a 7 log reduction in [*13] Bacillus subtilis spores. See PTX 1034 at 1335867; PTX 1527. Redacted versions of these laboratory reports were submitted with AstraZeneca's
Rule 131 Declaration. PTX 5A. Dr. George Zhanel, an expert for AstraZeneca,
and Dr. Cheryl Larrivee-Elkins, one of the named inventors on the '834 Patent,
testified that a six or seven log reduction was the "standard" used to
define the goal of a sterilizing process because it indicates a 1/1
million sterility assurance level. See 2012 Trial Tr. 615:2-11; id. at
4213:9-16. Dr. Zhanel further testified that a POSA would understand
from the laboratory data that this experiment would result in a sterile
product as it demonstrates rapid spore reduction. Id. at 4276:9-4277:16.
Although Defendants' expert, Dr. Scott Sutton, testified that this data
only demonstrates spore reduction and not a sterilized product, he
acknowledged that he was the "wrong person to ask" how the spore
reduction translated into sterility. Id. at 2463:14-18, 2465:20-23.
However, while the conclusion expressed in the documents was that
heating for 60 minutes at 110 ° C "will give" more than a 7 log
reduction, PTX 1034 clearly demonstrates that the samples were not
actually heated at that time and [*14] temperature. PTX 1034 at 1335866-67; cf. Purdue Pharma, 237 F.3d at 1365
("To prove actual reduction to practice, 'an inventor must establish
that he actually prepared the composition . . . ." (citing Estee Lauder Inc. v. L'Oreal, S.A., 129 F.3d 588, 592 (Fed. Cir. 1997))).
Similarly, PTX 1527 provides no information regarding sterility of the
heat-treated samples, and the testing conducted was not intended to even
address sterility. See PTX 1527 at 1339829.
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As to obviousness:
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A patent is invalid as
obvious if the differences between the claimed invention and prior art
are such that the invention as a whole would have been obvious to a
person of ordinary skill in the art at the time the invention was made. Sciele Pharma, 684 F.3d at 1259 (quoting 35 U.S.C. § 103(a)).
Whether a patent claim is obvious is a question of law based on four
underlying facts: 1) the scope and content of the prior art; (2) the
level of ordinary skill in the pertinent art; (3) the differences
between the prior art and the claims at issue; and (4) such secondary
considerations as commercial success, long-felt but unsolved need, and
the failure of others. Id. (quoting Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966)); see also KSR Int'l. Co. v. Teleflex, Inc., 550 U.S. 398, 406 (2007).
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The court used an AstraZeneca response against AstraZeneca:
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AstraZeneca's
response to Defendants' evidence actually serves to confirm this Court's obviousness finding. Importantly, AstraZeneca
does
not dispute that sterile filtration was a known sterilization process.
Nor does it dispute that a POSA had a reasonable expectation of
successfully performing [*59]
a sterile filtration of a budesonide solution. Trial Tr. 2284:16-20
(Akers) ("Q. And I think we agreed the. sterilization step, you have no
problem with that, the skilled person could reasonably expect success in
performing a sterile filtration of the budesonide solution, correct? A.
They could reasonably expect success . . . ."). And their own witness,
Dr. Akers, agreed that the steps in the 1994 FDA Inspection Guide were
typical in 1997. See PTX 2110 at 54 ("The preparation of sterile solids
typically includes a sterile filtration, followed by crystallization,
filtration, washing, drying, milling, and blending, all of which are
carried out under sterile conditions.");
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The CAFC decision was mentioned:
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Yet, as the Federal Circuit
has ruled, the patent is not limited to a process (a practical way), but
rather it covers a product. The fact that AstraZeneca
admitted
to the PTO that there existed a (arguably) less practical way to make
the product in and of itself, it seems, should end the obviousness
analysis. Notably, in Orthopedic Equipment Co. v. United States, 702 F.2d 1005 (Fed. Cir. 1983), the Federal Circuit recognized that while a POSA may not combine two [*78] prior art apparatuses for "economic feasibility" reasons, that decision is not relevant to nonobviousness. 702 F.2d at 1013
("In other words, the fact that the two disclosed apparatus would not
be combined by businessmen for economic reasons is not the same as
saying that it could not be done because skilled persons in the art felt
that there was some technological incompatibility that prevented their
combination. Only the latter fact is telling on the issue of
nonobviousness."). Similarly, while a drug manufacturing company may not
have ultimately utilized sterile filtration in combination with aseptic
processing to manufacture sterilized budesonide in bulk due to the
associated high costs of maintaining an aseptic environment at that
scale, that is not to say that a POSA would not be motivated to employ
these well-known sterilization processes in a laboratory with a
reasonable expectation of successfully preparing the claimed sterilized
budesonide compositions.
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The district court notes some deference is due to the examiner's conclusion:
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The Court is
well aware that it must give great deference to the Examiner's ultimate
decision to allow the asserted claims notwithstanding
the Jakupovic/Ansel references. However, it is evident that what was
not considered by the Examiner is the evidence Defendants have
persuasively put forth in this proceeding. In 1997, a POSA would have
known how to dry and mill crystallized budesonide to form a
finely-divided (micronized) powder. Indeed,
AstraZeneca 
concedes
this point. PRFOF ¶ 23. Moreover, a POSA would have known how to
routinely conduct aseptic processing to preserve the sterility of the
micronized budesonide composition, for the reasons set forth above. See,
e.g.,
Sciele Pharma, 684 F.3d at 1260 (recognizing Court may afford less weight to references that were before the PTO) .
Finally,
AstraZeneca 
argues that both parties' "experts agree" that
U.S. Patent No. 3,962,430,
filed on July 14, 1975 by Joseph L. O'Neill ("O'Neill"), entitled
"Sterilization of Solid Non-Electrolyte Medicinal Agents Employing
Sodium Chloride," teaches that aseptic recrystallization is problematic
due to the formation of needle-shaped crystals. DTX 848. The Court finds
that
AstraZeneca 
has
taken the deposition testimony of Ms. Jeanne Moldenhauer, Defendants'
expert, out of context as counsel for Sandoz aptly pointed out. See
Trial Tr. 2221:19-2222:5, 2439:6-2442:3. In demonstrating the value
of his invention, O'Neill addresses problems in the prior art,
including the fact that aseptic recrystallization resulted in the
formation of needle-shaped crystals unsuitable for parenteral
suspensions. DTX 848 at col.3 11.3 6-40. This was a recognized potential
disadvantage of the prior art, as Defendants' expert, Ms. Moldenhauer,
indicated. However, O'Neill then provided his salt saturation method,
which as explained below, resulted in no change in crystal form. Ms.
Moldenhauer thus concluded that a POSA would be motivated to try the
O'Neill process and would have a reasonable expectation of success that
the O'Neill process would result in a sterile budesonide product that
would satisfy the asserted claims. Dr. Akers, who read Ms. Moldenhauer's
deposition testimony, expressed no opinions disagreeing with her
conclusion. See Trial Tr. 2441:17-2442:3.
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Bottom line on obviousness:
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For the reasons set forth
above, the evidence clearly and convincingly demonstrates that a POSA
would have had a reasonable expectation of successfully preparing the
claimed
sterile budesonide compositions (the powder set forth in claims 1 and
2, and the suspensions set forth in claims 50 and 51) using four of the
five conventional sterilization techniques (i.e., sterile
filtration/crystallization, moist heat, EO, and irradiation). Moreover,
there is insufficient evidence of secondary considerations of
nonobviousness. See Wyers v. Master Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010)
("[S]econdary considerations of nonobviousness . . . simply cannot
overcome a strong prima facie case of obviousness."). As such, the
asserted claims are invalid as obvious.
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