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ASTRAZENECA PHARMACEUTICALS v. MAYNE PHARMA

November 2, 2005.

ASTRAZENECA PHARMACEUTICALS LP and ASTRAZENECA PHARMACEUTICALS UK LTD., Plaintiffs,
v.
MAYNE PHARMA (USA) INC., Defendant.



The opinion of the court was delivered by: WILLIAM PAULEY III, District Judge

OPINION AND ORDER

AstraZeneca Pharmaceuticals LP and AstraZeneca Pharmaceuticals UK Ltd. (collectively, "AstraZeneca") allege patent infringement by Mayne Pharma (USA) Inc. ("Mayne"), formerly known as Faulding Pharmaceutical Company. In particular, AstraZeneca accuses Mayne of infringing U.S. Patent Nos. 5,714,520 (the "`520 patent"), 5,731,355 (the "'355 patent") and 5,731,356 (the "'356 patent") (collectively, the "asserted patents") by filing Abbreviated New Drug Application ("ANDA") No. 76-452 with the United States Food and Drug Administration ("FDA").

This action arises under 35 U.S.C. § 271(e) and this Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a). Venue is proper under 28 U.S.C. §§ 1391(b)-(c) and 1400(b). This Court conducted an eleven-day bench trial. Insofar as the Court exercises its prerogative as finder of fact to determine the weight and credibility of the evidence, the discussion herein is limited to the evidence that this Court credits. Further, this Court recites only those findings of fact that are relevant to its conclusions of law. FINDINGS OF FACT

  AstraZeneca owns the asserted patents. Those patents have a common specification and relate to a pharmaceutical composition of propofol and edetate. AstraZeneca alleges that by filing ANDA No. 76-452, Mayne infringed one or more claims of the asserted patents under 35 U.S.C. § 271(e)(2)(A).*fn1 ANDA No. 76-452 was filed by ESI Lederle ("ESI"), formerly a division of Wyeth Pharmaceuticals, Inc. ("Wyeth") and later a division of Baxter Healthcare Corporation ("Baxter"). Mayne acquired ANDA No. 76-452 from Baxter and is now the applicant of record.

  I. Procedural History

  By letter dated August 20, 2002, Wyeth provided notice to AstraZeneca pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) that ESI was seeking FDA approval of ANDA No. 76-452, which it filed on June 28, 2002. (Plaintiffs' Exhibit ("PX") 121.) ANDA No. 76-452 indicated Wyeth's intention to commercially manufacture, use or sell its "generic propofol emulsion, 20 mL vial." (Joint Pretrial Order ("JPTO") ¶ VI.B.24.) On October 4, 2002, AstraZeneca filed the first of these consolidated actions, No. 02 Civ. 7936 (WHP), alleging patent infringement by Wyeth based on the August 20, 2002 notice. (JPTO ¶ VI.B.25.) On February 3, 2003, Mayne, was substituted as the defendant and Wyeth was dismissed from the action. (JPTO ¶ VI.B.26.)

  By letter dated July 15, 2003, Mayne notified AstraZeneca pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) that it was seeking FDA approval for its amended ANDA No. 76-452, filed on July 7, 2003, to engage in the commercial manufacture, use or sale of its generic propofol emulsion in 50 and 100 mL vials. (JPTO ¶ VI.B.27.) On August 6, 2003, AstraZeneca filed the second action, No. 03 Civ. 6487 (WHP), alleging patent infringement by Mayne based on its July 15, 2003 notice. (JPTO ¶ VI.B.28.) This Court consolidated the actions on October 24, 2003.

  II. Background of the Claimed Inventions

  By way of background, propofol is an injectable anesthetic that has hypnotic properties and can be used as a general anesthetic for sedation. AstraZeneca markets propofol under the trademark DIPRIVAN® for use in treating humans and under the trademark RAPINOVET® for veterinary use. (PX 1, Col. 1, lines 7-13.) Microbial contamination of propofol compositions can cause nosocomial infection among intensive care unit ("ICU") patients. As a result, the "giving set"*fn2 used to administer the earlier propofol compositions had to be changed every six to twelve hours. (PX 1, Col. 2, line 62 — Col. 3, line 3.)

  AstraZeneca's approved New Drug Application ("NDA") No. 19-627 is directed to the manufacture and sale of a "propofol injectable emulsion for use in anesthesia and sedation" ("Original Diprivan"). (JPTO ¶ VI.B.2.) Original Diprivan was an oil-in-water emulsion containing one-percent 2,6-diisopropylphenol (i.e., propofol) for intravenous administration. (Trial Transcript ("Tr.") at 246-47, 259-60.) Original Diprivan did not contain an antimicrobial additive. (Tr. at 783.) Original Diprivan was launched in the United States in November 1989, following use in Europe for five to seven years. (Tr. at 59-60, 73, 349.) Soon after its launch in the United States, AstraZeneca received reports of post-operative infection among patients given Original Diprivan. AstraZeneca sought to improve Original Diprivan. In June 1990, AstraZeneca added instructions on proper handling procedures in its "package insert" and sent a special mailing to doctors regarding those instructions. In early 1991, AstraZeneca revised these procedures and recommended that unused portions. In early Original Diprivan vial be discarded six hours after opening. (Tr. at 75-83; see also Tr. at 350-51; Joint Exhibit ("JX") 33 at AZ081112.)

  At that time, AstraZeneca's scientists recognized that the oil in the emulsion allowed the growth of microbes introduced into the water phase of the emulsion through improper handling. (Tr. at 50-51, 350, 354; JX 33.) Soon thereafter, the inventors of the asserted patents concluded that retarding microbial growth would resolve the issue. (Tr. at 361-72; JX 32 at AZ041069-70.) The inventors came to believe that adding a small amount of disodium edetate (0.005% by weight) would provide broad antimicrobial protection for at least twenty-four hours without disrupting the oil-in-water emulsion. (Tr. at 369-77.) Thus, AstraZeneca modified Original Diprivan by adding disodium edetate to the formulation ("Modified Diprivan"). Notably, all Original Diprivan ingredients are present in Modified Diprivan, and the anesthetic properties of Original Diprivan are identical to Modified Diprivan. (Tr. at 56-58.)

  The inventors filed a patent application covering their invention with the United States Patent and Trademark Office (the "USPTO") on March 22, 1995. AstraZeneca submitted a supplemental New Drug Application ("sNDA") for Modified Diprivan on December 22, 1995. The FDA approved the sNDA on June 11, 1996, and granted AstraZeneca three years of "marketing exclusivity" for Modified Diprivan. (Tr. at 101-02; PX 160 at AZ014136, AZ014140-43.) At the same time, AstraZeneca applied to withdraw FDA approval for Original Diprivan; the FDA approved this request in 1998. (Tr. at 101-03.)

  Net sales for Modified Diprivan from 1997 through 2004 have exceeded $2 billion. Despite competition from similar products on the market, AstraZeneca's sales have exceeded $200 million per year. (Tr. at 106-08; PX 257A; see Tr. at 631, 959-60.)

  III. The Asserted Patents

  AstraZeneca received three patents for Modified Diprivan. The '520 patent, titled "Propofol Composition Containing Edetate," was issued on February 3, 1998. Thereafter, the '355 and '356 patents, each titled "Pharmaceutical Compositions of Propofol and Edetate," issued on March 24, 1998. The '355 and '356 patents are divisional applications based on the '520 patent's disclosure. (PX 1-3.) The asserted patents have a common specification and concern a pharmaceutical composition of propofol and edetate. (JPTO ¶ VI.B.5.) The asserted claims are Claims 1-14, 16-32 and 34 of each asserted patent and Claims 38-39 of the '520 patent. (JPTO ¶ VI.B.6.)

  A. The Specification

  The asserted patents relate to formulaic variations of sterile propofol pharmaceutical compositions for anesthetic use. These compositions comprise an oil-in-water emulsion of propofol containing sufficient amount of edetate to retard the growth of microorganisms for over twenty-four hours if the composition becomes contaminated. (PX 1, Col. 4, lines 38-45.) The oil-in-water emulsion is a distinct two-phase system in equilibrium that is kinetically stable, but thermodynamically unstable. (PX 1, Col. 4, lines 46-50.) During their experiments which led to the patented inventions, the inventors noted that "the addition of small amounts of a selected agent to `Diprivan' will enable the formulation to be administered in `giving sets' that require changing significantly less frequently than is presently the case." (PX 1, Col. 3, lines 20-25.) The inventors experimented with various additives to Original Diprivan and "unexpectedly found that edetate, which is not regarded as a broad spectrum antimicrobial agent was the only agent that would meet [their] requirements." (PX 1, Col. 4, lines 22-34.) The specification defines "edetate" as "ethylenediaminetetraacetic acid (EDTA) and derivatives thereof." (PX 1, Col. 4, lines 51-52.) The specification contains no indication that the inventors intended a narrow definition for edetate. Indeed, it states: "The nature of the edetate is not critical, . . . [as long as it] fulfils [sic] the function of preventing significant growth of microorganisms for at least 24 hours in the event of adventitious extrinsic contamination." (PX 1, Col. 4, lines 57-61.)

  The inventors performed tests to determine their preferred composition for Modified Diprivan. (PX 1, Col. 7, line 1 — Col. 11, line 12.) They tested comparative microbiological activity of Original Diprivan with and without 0.005% disodium edetate. While the Original Diprivan formulation without disodium edetate failed the microbiological test, the formulation with disodium edetate passed. (PX 1, Col. 9, line 64 — Col. 10, line 32.) The specification also describes tests of comparative microbiological activity of an oil-in-water emulsion with the same formulation as Original Diprivan but containing no propofol. Here, too, the formulation without disodium edetate failed the microbiological test, while the formulation with disodium edetate passed. (PX 1, Col. 10, line 39 — Col. 11, line 10.) B. The Asserted Claims

  Claim 1 of the '520 patent is as follows:
A sterile pharmaceutical composition for parenteral administration which comprises an oil-in-water emulsion in which propofol dissolved in a water-immiscible solvent, is emulsified with water and stabilized by means of a surfactant, and which further comprises an amount of edetate sufficient to prevent a no more than 10-fold increase in growth of each of Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027 and Candida albicans ATCC 10231 for at least 24 hours as measured by a test wherein a washed suspension of each said organism is added to a separate aliquot of said composition at approximately 50 colony forming units per ml, at a temperature in the range 20° 25° C., whereafter said aliquots are incubated at 20° 25° C. and are tested for viable counts of said organism after 24 hours, said amount of edetate being no more than 0.1% by weight of said composition.
(PX 1, Col. 11, lines 33-48.) Claim 38 is identical to Claim 1 but includes the additional requirement that the edetate not destabilize the emulsion. Claims 2 and 20 specify that the edetate is disodium edetate, and Claim 34 specifies the amount of disodium edetate as 0.005%. (PX 1, Col. 11, line 33 — Col. 14, line 36.) Claims 3-14 specify the various constituents of the Claim 1 formulation, and Claims 16-19, 21-32 and 39 address the molar concentrations of edetate.

  The asserted claims of the '355 patent are directed to "[a] method for producing anaesthesia in a warm-blooded animal which comprises parenterally administering" a sterile pharmaceutical composition of the type set forth in the claims of the '520 patent. The asserted claims of the '356 patent are directed to "[a] method for limiting the potential for microbial growth" in a sterile pharmaceutical composition of the type described in the claims of the '520 patent.

  Highly pertinent to the infringement analysis below, each asserted claim includes "edetate." In its Markman ruling, this Court defined "edetate" as follows: EDTA as well as compounds structurally related to EDTA regardless of how they are synthesized, and which can prevent a no more than 10-fold increase in growth of each of Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027 and Candida albicans ATCC 10231 for at least 24 hours.

 AstraZeneca Pharmas., LP v. Mayne Pharma (USA), Inc., 352 F.Supp. 2d 403, 419 (S.D.N.Y. 2004).

  IV. The Accused Formulation

  AstraZeneca accuses Mayne of infringing the asserted patents by filing ANDA No. 76-452 which describes Mayne's generic propofol emulsion. Mayne's formulation, generic versions of Original Diprivan and later of Modified Diprivan, were developed by ESI. Dr. Martin Joyce led the ESI work, starting in September 1994. In 1995, ESI researchers learned about the risk of microbial infection from the improper handling of Original Diprivan. In June 1996, when ESI's researchers learned that AstraZeneca had reformulated Original Diprivan to include an antimicrobial additive, ESI also changed its generic propofol formulation to include an additive. (Tr. at 906, 928-30.) ESI filed an ANDA on the formulation in December 1996 with a "Paragraph III Certification."*fn3 (Tr. at 906, 908-09.)

  In February 1998, ESI learned that AstraZeneca had received a patent on its Modified Diprivan formulation. (Tr. at 906.) Dr. Joyce and his colleagues read the '520 patent while continuing their work. (Tr. at 930-33, 945; PX 97.) ESI then started screening antimicrobial agents for its generic composition. (Tr. at 907.) Dr. Joyce's team considered the option of "initiating new formulation efforts" to replace Modified Diprivan's EDTA with a different agent. (Tr. at 935.)

  In an August 5, 1998 memorandum, Dr. Mary George, the senior formulator on the project, identified the calcium trisodium salt of diethylenetriaminepentaacetate ("DTPA"),*fn4 as a promising antimicrobial candidate for ESI's generic formulation. (Tr. at 912-13, 941-44; JX 4; JX 12.) Calcium trisodium DTPA was chosen for a number of reasons. First, the compound appeared in the FDA Inactive Ingredient Guide, which lists excipients in approved products. (Tr. at 913; JX 4.) Second, with this compound, ESI's generic formulation matched the characteristics and stability profile of Modified Diprivan, and thus was capable of being approved as an ANDA without additional clinical or safety studies. (Tr. at 944; JX 4.) Third, Dr. George believed that the addition of calcium trisodium DTPA to ESI's generic formulation did not infringe the '520 patent. (Tr. at 944-47; JX 4.) Finally, the compound satisfied the microbiological test set forth in the '520 patent. (Tr. at 947-48; JX 4.)

  Mayne's generic propofol emulsion is an "intravenous sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation in a human patient." (JPTO ¶ VI.B.20.) Mayne's formulation, a sterile pharmaceutical composition for parenteral administration, "is an oil-in-water emulsion in which propofol dissolved in a water-immiscible solvent, is emulsified with water and stabilized by means of egg lecithin as a surfactant." (JPTO ¶¶ VI.B. 8-10.) Mayne's formulation "contains 1% by weight of propofol." (JPTO ¶ VI.B.11.) In addition, it contains 10% by weight of soybean oil as a water immiscible solvent. (JPTO ¶¶ VI.B. 12-13.) The emulsion also contains water, sodium hydroxide and "12 mg/ml (or 1.2% by weight) of egg lecithin, a naturally occurring phosphatide, as a surfactant." (JPTO ¶¶ VI.B.14-15, 17.) The generic propofol emulsion is "made isotonic with blood by incorporation of 22.5 mg/ml (or 2.25% by weight) of glycerol." (JPTO ¶¶ VI.B. 18-19.) Its pH is between 7.0 and 8.5. (JPTO ¶ VI. B. 16.)

  More important to the infringement analysis below, Mayne's generic propofol emulsion "contains 0.008 mg/ml (or 0.0008% by weight) of calcium trisodium DTPA as an antimicrobial agent." (JPTO ¶¶ VI.B.21, 23.) The amount of calcium trisodium DTPA is

 
sufficient to prevent a no more than 10-fold increase in growth of each of Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027 and Candida albicans ATCC 10231 for at least 24 hours as measured by a test wherein a washed suspension of each said organism is added to a separate aliquot of said composition at approximately 50 colony forming units per ml, at a temperature in the range 20°-25° C., whereafter said aliquots are incubated at 20°-25°C. and are tested for viable counts of said organism after 24 hours.
(JPTO ¶ VI.B.22.)

  ESI filed ANDA No. 76-452 for its proposed generic formulation on June 28, 2002. The ANDA included a "Paragraph IV Certification" that the asserted patents were "invalid, or unenforceable, or will not be infringed" by the proposed generic. (PX 21 at FPC221273, FPC221283.) Further, ESI filed a patent application for its propofol formulation that included DTPA, which matured into U.S. Patent No. 6,028,108 ("the '108 patent") on February 22, 2000. (Defendant's Exhibit ("DX") 152.)

  V. Comparison of the Asserted Claims to the Accused Formulation

  AstraZeneca contends that Mayne's filing of ANDA No. 76-452 on its generic propofol composition infringes Claims 1-14, 16-32 and 34 of each asserted patent as well as Claims 38 and 39 of the '520 patent. Each asserted claim includes "edetate." The parties principally disagree over whether Mayne's formulation contains the edetate recited in the claims. That is, the parties dispute whether the calcium trisodium DTPA in Mayne's generic propofol emulsion qualifies as the edetate in the asserted claims.

  Claim 1 of the '520 patent is as follows:
[a]*fn5 A sterile pharmaceutical composition for parenteral administration which comprises
[b] an oil-in-water emulsion in which propofol dissolved in a water-immiscible solvent, is emulsified with water and stabilized by means of a surfactant,
[c] and which further comprises an amount of edetate sufficient to prevent a no more than 10-fold increase in growth of each of Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027 and Candida albicans ATCC 10231 for at least 24 hours as measured by a test wherein a washed suspension of each said organism is added to a separate aliquot of said composition at approximately 50 colony forming units per ml, at a temperature in the range 20°-25° C., whereafter said aliquots are incubated at 20°-25°C, and are tested for viable counts of said organism after 24 hours,
[d] said amount of edetate being no more than 0.1% by weight of said composition.
(PX 1, Col. 11, lines 32-48.) This Court previously construed three disputed claim terms as follows: Claim Term Meaning
 
"Edetate" EDTA as well as compounds structurally related to EDTA regardless of how they are synthesized, and which can prevent a no more than 10-fold increase in growth of each of Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027 and Candida albicans ATCC 10231 for at least 24 hours.
"Propofol" 2, 6-diisopropylphenol.
 
"an amount of edetate. . ." An amount of edetate, greater than 0% but less than or equal to 0.1% by weight of the pharmaceutical composition, which is sufficient to meet the microbiological test recited in the claim phrase.
AstraZeneca, 352 F. Supp. 2d at 419.
A. Analysis for Literal Infringement
  As discussed below, Mayne's generic propofol emulsion includes each limitation recited in Claims 1, 3-14 of each asserted patent and Claim 38 of the '520 patent.

  1. Claims 1 and 3-14 of the '520 Patent

  Limitation [a] of Claim 1 calls for "a sterile pharmaceutical composition for parenteral administration." Likewise, Mayne's generic propofol emulsion is also a sterile pharmaceutical composition for parenteral administration. (JPTO ¶¶ VI.B.8, 10; see also PX 21 at FPC221394, FPC221418.) Thus, the accused formulation meets this limitation.

  Limitation [b] is "an oil-in-water emulsion in which propofol dissolved in a water-immiscible solvent, is emulsified with water and stabilized by means of a surfactant." As stipulated by the parties, Mayne's generic propofol emulsion is also an oil-in-water emulsion, which includes propofol at a concentration of 10 mg/ml (or 1% by weight) and soybean oil at a concentration of 100 mg/ml (or 10% by weight). The propofol is dissolved in soybean oil, which is emulsified with water and stabilized by a surfactant, egg lecithin. (JPTO ¶¶ VI.B.9, 11-13; see also PX 21 at FPC221292, FPC221394, FPC221418.) Thus, the accused formulation meets this limitation. Limitation [c] is "an amount of edetate sufficient to [pass the recited microbiological test]." Mayne's formulation contains 0.0008% by weight of calcium trisodium DTPA. (JPTO ¶¶ VI.B.21-23.) As noted above, the calcium trisodium DTPA in Mayne's generic propofol emulsion passes the microbiological test recited in Claim 1. (JPTO ¶ VI.B.22.) Thus, the key question is whether the calcium trisodium DTPA in Mayne's formulation is structurally related to EDTA (i.e., whether it is an edetate).

  The EDTA free acid structure may be depicted as follows:

  (Tr. at 1063-64; see also Tr. at 1381-82.) The DTPA free acid structure may be illustrated as:

  (Tr. at 1072; see also Tr. at 1381-82; PX 281 at FPC255811.) DTPA cannot "easily" be synthesized from EDTA in a laboratory (Tr. at 292-93); however, it can theoretically be synthesized from EDTA (Tr. at 284-86), because both DTPA and EDTA are members of a class of structurally analogous compounds known as polyaminopolycarboxylic acids (Tr. at 1363-65). AstraZeneca's expert, Dr. Jack Norton,*fn6 testified on the topic of whether DTPA and EDTA are structurally related. (Tr. at 281-86.) Dr. Norton concluded that, based on his knowledge of the "chemical literature," DTPA and EDTA were structurally related. (Tr. at 285-88.) AstraZeneca's other expert, Thomas Foster,*fn7 also testified that DTPA and EDTA are structurally related. (Tr. at 156-59, 1297-98.) Similarly, Mayne's expert, Dr. Norman Weiner,*fn8 testified that "DTPA is a structural analog of EDTA." (Tr. at 869.) Although Mayne's other expert, Dr. Harold Hopfenberg,*fn9 resisted conceding that DTPA was structurally related to EDTA, he acknowledged that the two are structural analogs and belong to the same structurally analogous polyaminopolycarboxylic acid family of compounds. (Tr. at 1363-64.) Thus, as compounds in the same family of chemical structures, this Court finds that DTPA is a structural analog of EDTA. Further, as this Court stated in its Markman ruling, "the proper definition of edetate includes EDTA as well as . . . structural analogs of EDTA." AstraZeneca, 352 F. Supp. 2d at 417. That is, as EDTA's structural analog, DTPA is structurally related to EDTA and is an edetate as that term is used in Claim 1. See AstraZeneca, 352 F.Supp. 2d at 417. That does not end the inquiry, however, because the compound in Mayne's formulation is calcium trisodium DTPA not DTPA.

  Calcium trisodium DTPA may be depicted as follows:

  (See Tr. at 863, 865-66.) As this depiction illustrates, calcium trisodium DTPA contains the following chemical groups: ethylene (CH2CH2), amino (N) and carboxylic acid (also called acetic acid) (CH2COO). In particular, calcium trisodium DTPA contains two ethylene, three amino and five carboxylic acid groups. Dr. Weiner testified that calcium trisodium DTPA is a salt of DTPA. (Tr. at 863.) Because calcium trisodium DTPA is a salt instead of an acid, it includes one calcium ion and three sodium ions instead of the four hydrogen ions present in DTPA. (Tr. at 856-66, 1299-1301, 1359-61; PX 281 at FPC255811; PX 437-2.) Dr. Hopfenberg testified that all salts of DTPA have the basic structure of DTPA. (Tr. at 1361.) Thus, calcium trisodium DTPA has the basic structure of DTPA. (Tr. at 863, 865-66, 1361; PX 281 at FPC255811.) Moreover, as a salt of DTPA, this Court finds that calcium trisodium DTPA is a derivative of DTPA. (Tr. at 860-61; DX 152, Col. 2, lines 1-5 (Mayne's patent stating that calcium trisodium DTPA is a derivative of DTPA).) Finally, because calcium trisodium DTPA is structurally related to DTPA (i.e., calcium trisodium DTPA is a derivative of DTPA), it is structurally related to EDTA. (Tr. at 156-59 (discussing the calcium trisodium DTPA additive in Mayne's generic propofol emulsion, although imprecisely referring to it simply as DTPA); JX 4 (noting that calcium trisodium DTPA is "structurally similar to edetate"); PX 437-2; see Tr. at 944, 1297-1302; PX 21 at FPC221291-96 (Mayne's ANDA submission discussing the similarities between calcium trisodium DTPA and EDTA).) In fact, calcium trisodium DTPA is a member of the polyaminocarboxylic family, like EDTA and DTPA. (Tr. at 1300-01; PX 437-2; see Tr. at 856-66, 1299-1301, 1359-61; PX 281 at FPC255811; PX 437-1; PX 437-2.) As members of the same family, calcium trisodium DTPA and EDTA are structurally related (i.e., calcium trisodium DTPA is a derivative of EDTA). (See Tr. at 1363-64). See AstraZeneca, 352 F. Supp. 2d at 417. Thus, this Court finds that the accused formulation meets limitation [c].

  Limitation [d] of Claim 1 requires that the edetate be no more than 0.1% by weight of the composition. Because the amount of calcium trisodium DTPA in Mayne's generic propofol formulation, 0.0008% by weight, is less than 0.1% by weight of the formulation, Mayne's composition meets this limitation. (JPTO ¶¶ VI.B.21, 23; see Tr. at 159; PX 433-3.)

  Claims 3-14 of the '520 patent depend on Claim 1, thereby incorporating all the limitations of Claim 1. Claims 3-14 add further limitations relating to various attributes of the components of the claimed compositions other than the disputed "edetate" limitation. Because Mayne's formulation includes these additional limitations (JPTO ¶¶ VI.B. 11-13, 15-19; see Tr. at 160-64; PX 433-4 — 433-15), the accused formulation meets all the limitations in Claims 3-14 of the '520 patent. 2. Claim 38 of the '520 Patent

  Independent Claim 38 of the '520 patent is identical to Claim 1, but adds that "the edetate does not physically destabilise [the] emulsion." Similarly, calcium trisodium DTPA does not destabilize Mayne's generic propofol formulation. (Tr. 164-66; PXs 433-16, 433-17, 433-18; see Tr. 952-53; JX 12 at FPC205490; PX 21 at FPC221415-16, ...


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