Teva Pharmaceuticals USA, Inc. et al v. Doctor Reddys Laboratories, Ltd. et al
ORDER Construing the Terms of U.S. Patent Nos. 9,155,775 ("the '775 Patent") and 9,763,993 ("the '993 Patent"). Signed by Judge Gregory M. Sleet on 12/1/2017. (mdb)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
IN RE: COPAZONE '775 PATENT
Civil Action No. 16-1267-GMS
ORDER CONSTRUING THE TERMS OF U.S. PATENT NOs. 9,155,775 ("the '775
Patent") and 9,763,993 ("the '993 Patent"). 1
After considering the submissions of the parties and hearing oral argument on the matter,
IT IS HEREBY ORDERED, ADJUDGED, and DECREED that, as used in the asserted claims of
U.S. Patent Nos. 9,155,775 ("the '775 Patent") and 9,763,993 ("the '993 Patent"):
The term "controlled room temperature" in the '775 patent is construed to mean
"includes at least the range of greater than or equal to 17.8° C_to less than or equal to
All docket citations refer to Civil Action NO. 16-1267-GMS. The abbreviation "Tr." refers to the transcript
from the Markman Hearing on November 2, 2017, D.I. 157.
The parties' dispute centers on whether the person having ordinary skill in the art ("POSA") would know
to consult the United States Pharmacopeia ("USP"), which is extrinsic to the patent, to determine the appropriate
temperature during filtration. Markman Hr'g Tr. 36:3-4. The court adopts Defendants' construction of the term
because its construction comports with the description of the term in the asserted patent and the intrinsic evidence.
Phillips v. AWH Corp., 415 F.3d 1303, 1317, 1320-21 (Fed. Cir. 2005) (explaining that extrinsic evidence is "less
significant than the intrinsic record in determining the legally operative meaning of claim language."') (citing C.R.
Bard, Inc. v. US. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004)).
Plaintiffs' proposed construction relies solely on evidence extrinsic to the patent, namely the USP. First,
Plaintiffs argue that "controlled room temperature" should have its plain and ordinary meaning as found in the USP.
(D.I. 118 at 4.) To support this position, Plaintiffs argue that the USP-NF guidelines state that "controlled room
temperature" means "[t]he temperature maintained at the usual and customary working environment of 20° to 25°
(68° to 77° F)." (D.I. 118 at Ex. A.) Plaintiffs, argue that the Federal Food, Drug, and Cosmetic Ac(("FDCA") tells
the skilled artisan that the USP is where to look for the definition of "controlled room temperature" and that Abbott
Labs. v. Lupin Ltd., shows the USP decides the issue. (D.I. 118 at Ex. A); Markman Hr'g Tr. 37:21-25, 38: 1-8, 11 :2025, 27:14-25; Abbott Labs. v. Lupin Ltd., 753 F.Supp.2d 382, 418 (D. Del. 2010). Second, Plaintiffs argue that
"controlled room temperature" has a specific definition because when the patent recites a temperature other than a
controlled room temperature, it provides a numerical range. Markman Hr'g Tr. 16:11-14. Plaintiffs argue that it is a
misreading of the range from Table 2 to include 17.8° to 24.6° C because the proper reading is the plain and ordinary
meaning, in accordance with the USP, at 20°to 25° C. Markman Hr'g Tr. 17:8-24. Defendants cite to various
The term "filtering the aqueous pharmaceutical solution at a temperature of
above 0° C to 17.5° C to produce a filtrate" in the '775 patent and the terms "(iii)
filtering the first filtrate at a temperature of above 0° C. to 17.5° C. through a
second filter to produce a second filtrate" and "(ii) filtering the aqueous
pharmaceutical solution at a temperature of above 0° C. to 17.5° C. to produce
a filtrate" in the '933 patent are construed to mean "filtering the aqueous
pharmaceutical solution, wherein the temperature of the aqueous pharmaceutical
solution is between 0° C and 17.5° C, inclusive of 17.5° C."3
pharmacopeias, including Europe and Japan, to show that the definition of "controlled room temperature" is not
uniform. (D.I. 125-1, Ex. 5 at 2); Markman Hr'g Tr. 30:20-23.
The court agrees with Defendants for three main reasons. First, the provision of the USP that Plaintiffs cite
defines controlled room temperature in terms of storage and shipping conditions, not the temperature at which the
solution is filtered. (D.I. 118, Ex. A at 317.) Indeed, the FDCA tells the POSA to refer to the USP-NF only where no
storage requirements for a prescription drug are established. 21 C.F.R. § 205 .50( c)(1 ). Second, the specification shows
the controlled room temperature to include 17.8° to 24.6° C. '775 Patent at 11 :35-65. The specification, therefore,
explains that an improved filtration process was necessary to avoid the pressure buildup on the second filter. '775
Patent at 10:5-15; (D.I. 128 at JA23, 11 :45-58.) Also, Table 2 for Experiment Number 1 identifies 17.8° to 24.6° C as
the temperature of the solution held in the receiving vessel for the controlled room temperature at 13 hours. '775
Patent at 11 :35-65. The range in Table 2 is the only place in the specification that indicates the temperatures
encompassed by the control room temperature. Markman Hr'g Tr. 23:22-25. The court remains unconvinced that a
POSA would look to the USP storage conditions for the filtration temperature. Finally, as noted above, the definition
of "controlled room temperature" seems to vary among pharmacopeias which begs the question, what is the plain
meaning of the term? Phillips, 415 F.3d at 1318. "[E]xtrinsic evidence may be useful to the court, but it is unlikely to
result in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence."
Phillips, 415 F.3d at 1319.
The intrinsic record fully supports Defendants' proposed construction. Markman Hr' g Tr. 26: 16-17. The
specification explicitly states that controlled room temperature includes the range 17.8° to 24.6° C and that filtration
in that range is undesirable because of the pressure buildup in the second filter. Markman Hr'g Tr. 22:18-21.
The parties' dispute centers on: (1) whether the reduced temperature filtration, 0° to 17.5° C is maintained
for the entirety of the filtration process; and (2) whether there was a clear disclaimer of all processes without "improved
filterability" in the '775 parent that carries over to the '993 continuation. Markman Hr'g Tr. 61: 1-7, 17-24.
First, Defendants argue that Plaintiffs' proposed construction broadens the claim by allowing filtration at
virtually any temperature. Markman Hr'g Tr. 64: 16-19. In contrast, Defendants claim their construction accounts for
the POSA's understanding that the temperature is maintained throughout filtration. Markman Hr'g Tr. 62: 18-25.
Plaintiffs argue that when the patentee chose to use the words "is maintained" they did so. Markman Hr' g Tr. 49: 1114. Specifically, these words appear in Claim 14, not Claim 1 of the '775 Patent and do not appear in Claims 1 or 19
of the '993 Patent. Markman Hr'g Tr. 49:18-22. The court will, therefore, not read the limitation into the '993 Patent.
Second, Defendants argue that the '993 child must include the "improved filterability" steps in the '775
Parent. Markman Hr'g Tr. 72:1-2, 6-12; (D.1. 156 at JA6174-82.) Specifically, Defendants argue when the parent and
child share related subject matter, the child applicant cannot recapture claim scope previously disclaimed without
notifying the examiner they are rescinding the disclaimer. Markman Hr'g Tr. 73:1-9, 18-25. The close relation of
subject matter, however, does not conclusively answer the question of whether the disclaimer travels between
generations of patents. Ormco Corp. v. Align Tech., Inc., 498 F.3d 1307, 1314 (Fed. Cir. 2007). At least one court
The term "wherein the filterability of the aqueous pharmaceutical solution is
improved as compared to the filterability of the solution at controlled room
temperature" in the '775 patent is construed to mean "wherein the filterability of
the aqueous pharmaceutical solution is improved as compared to the filterability of
the solution ifthe solution were at controlled room temperature, as measured by, e.g.,
a lower increase in pressure on the filter. " 4
has determined that the disclaimer in the parent does not apply to the child when the parent's claim scope changed as
a result of an amendment. Sanofi v. Glenmark Pharm. Inc., USA, 204 F. Supp. 3d 665, 703 (D. Del. 2016). In that
case, the disclaimer made during prosecution of the parent did not carry over to the child because the amendment
occurred through explicit claim language rather than arguments about the meaning of any common claim language.
Markman Hr'g Tr. 58:24-25 - 59:1-11. The Court of Appeals for the Federal Circuit recently affirmed the district
court's determination explaining that:
Sanofi did not argue during prosecution that the unamended claim language of the
[parent] patent, or the disclosed invention generally, excluded [the limitation]. In
these circumstances, the process in this case fit a similar pattern: an applicant
adopts an explicit claim-narrowing limitation to achieve immediate issuance of a
patent containing the narrowed claims and postpones to the prosecution of a
continuation application further arguments about claims that lack the narrowing
limitation. Without more than exists here, that process does not imply a disclaimer
as to claims, when later issued in the continuation, that lack of the first patents'
express narrowing limitation.
Sanofiv. Watson Labs., Inc., 2017 WL 5180716 at *25 (Fed. Cir. Nov. 9, 2017). Here, the claims in the '993 and '775
Patents are similar, but not identical. (D.1. 149 at 5.) For example, Claim 1 of the '775 Patent is not limited to 40milligrams, while Claim 19 of the '993 Patent is. Markman Hr' g Tr. 59:21-24. Because the disclaimer in the parent
patent occurred through an amendment and the child does not contain identical language, as the parent the disclaimer
should not apply to the child.
Moreover, Defendants argue in their letter to the court dated November 11, 2017, that Plaintiffs' "opening
claim construction brief states that 'improved filterability' is the 'central and novel teaching' of the patents' common
specification." (D.I. 159 at 2.) The '933 Patent, however, was not mentioned one time in Plaintiffs' Opening Claim
Construction Brief-likely because the '993 Patent issued over two weeks after Plaintiffs brief was filed. (D.1. 118.)
Defendants, therefore, improperly assert that statements made in Plaintiffs' Opening Claim Construction Brief about
the '775 Patent apply to the '933 child.
The parties' dispute centers on whether the construction should include the word "significantly" before the
phrase "improved filterability." Markman Hr'g Tr. 85: 18-20. The specification discloses "improved filterability"
without the qualifier "significantly." '775 Patent at 18: 19-24, 12:29-32. Specifically, the '775 Patent states that:
Reducing the temperature of the bulk solution during the compounding stage or
before passing through Filter A or reducing the temperature of Filter A also
improves the filterability of GA 40 mg/mL solution ...
'775 Patent at 18:19-24. During the Markman Hearing, Defendants made an indefiniteness argument to explain that
"significantly" should be included. Markman Hr'g Tr. 95:18-21. The court will not entertain indefiniteness at this
stage in the proceedings, and will therefore adopt the Plaintiffs' proposed construction.
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