Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Bial - Portela & CA, S.A. v. Torrent Pharmaceuticals Ltd.

United States District Court, D. Delaware

October 17, 2019

BIAL - PORTELA & CA S.A., BIAL -HOLDING, S.A., and SUNOVION PHARMACEUTICALS INC., Plaintiffs,
v.
TORRENT PHARMACEUTICALS LTD. and TORRENT PHARMA INC., Defendants. BIAL - PORTELA & CA S.A., BIAL -HOLDING, S.A., and SUNOVION PHARMACEUTICALS INC., Plaintiffs,
v.
ALKEM LABORATORIES LIMITED and S&B PHARMA, INC., Defendants. BIAL - PORTELA & CA S.A., BIAL -HOLDING, S.A., and SUNOVION PHARMACEUTICALS INC., Plaintiffs,
v.
LUPIN LIMITED and LUPIN PHARMACEUTICALS, INC., Defendants. BIAL - PORTELA & CA S.A., BIAL - HOLDING, S.A., and SUNOVION PHARMACEUTICALS INC., Plaintiffs,
v.
JUBILANT LIFE SCIENCES LIMITED, JUBILANT PHARMA LIMITED, JUBILANT GENERICS LIMITED, JUBILANT LIFE SCIENCES (USA) INC., and JUBILANT CADISTA PHARMACEUTICALS INC., Defendants. BIAL - PORTELA & CA S.A., BIAL - HOLDING, S.A., and SUNOVION PHARMACEUTICALS INC., Plaintiffs,
v.
DR. REDD Y'S LABO RA TORIES, LTD. and DR. REDDY'S LABORATORIES, INC., Defendants. BIAL - PORTELA & CA S.A., BIAL - HOLDING, S.A., and SUNOVION PHARMACEUTICALS INC., Plaintiffs,
v.
HETERO LABS LIWTED, HETERO LABS LIMITED UNIT-V, and HETERO USA INC., Defendants. BIAL - PORTELA & CA S.A., BIAL - HOLDING, S.A., and SUNOVION PHARMACEUTICALS INC., Plaintiffs,
v.
APOTEX INC. and APOTEX CORP., Defendants. BIAL - PORTELA & CA S.A., BIAL - HOLDING, S.A., and SUNOVION PHARMACEUTICALS INC., Plaintiffs,
v.
SPH SHANGHAI ZHONGXI PHARMACEUTICAL CO., LTD., Defendant.

          MEMORANDUM ORDER

          Colm F. Connolly United States District Judge.

         Before me is the matter of claim construction of terms found in six patents asserted in this case: U.S. Patent Nos. 5, 753, 646 ("the #646 patent"), 8, 372, 431 ("the #431 patent"), 9, 206, 135 ("the #135 patent"), 9, 566, 244 ("the #244 patent"), 9, 643, 929 ("the #929 patent"), and 9, 750, 747 ("the #747 patent). Oral argument regarding claim construction was held on October 11, 2019.

         At the heart of this Hatch-Waxman case is Aptiom®, an anti-epileptic drug approved by the Food and Drug Administration (FDA) for the treatment of partial-onset seizures. Plaintiffs Bial-Portela & CA S.A. and Bial-Holding, S.A. developed Aptiom® and own the asserted patents. Plaintiff Sunovion Pharmaceuticals is the holder of the Aptiom® New Drug Application and the exclusive licensee of the asserted patents, all of which Sunovion listed in the FDA's Orange Book. The asserted patents cover the active pharmaceutical ingredient in Aptiom®, eslicarbazepine acetate; pharmaceutical compositions and formulations containing eslicarbazepine acetate; and methods of treatment in certain patient subpopulations using eslicarbazepine acetate.

         Defendants are eight manufacturers that filed Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic eslicarbazepine acetate tablets prior to the expiration of the asserted patents. Plaintiffs allege that Defendants' filing of their respective AND As constitute infringement under 35 U.S.C. § 271(e).

TERM A: "stereoisomer" in claim 1 of the #646 patent
1. Plaintiffs' proposed construction: "the compound having the same molecular formula, but being arranged differently in space"
2. Defendants' proposed construction: "either S(-) or R() enantiomer of the recited compounds in the genus"
3. Court's Construction: "the compound having the same molecular formula, but being arranged differently in space"

         Claim 1 of the #646 patent recites: "A compound of general formula I, or stereoisomer thereof, wherein:... R is hydrogen, alkyl, aminoalkyl, halogenalkyl, aralkyl, cycloalkyl, cycloalkylalkyl, alkoxy, aryl or pyridyl...." #646 patent at claim 1 (8:50-66). I construe "stereoisomer" in claim 1 of the #646 patent as "a compound having the same molecular formula, but being arranged differently in space" because that is the term's plain and ordinary meaning to a person of ordinary skill in the art (POSIT A) at the time of the invention and the intrinsic record does not otherwise define or limit the term.

         A court should construe claim terms according to the plain and ordinary meaning that the term would have to a POSITA when read in the context of the specification and prosecution history. Thorner v. Sony Comput. Entm't Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). "There are only two exceptions to this general rule: 1) when a patentee sets out a definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of the claim term either in the specification or during prosecution." Id. In either event, the lexicography or disavowal must be clear and unmistakable. See Id. at 1367-68. Here, the claims, written description, and prosecution history do not specifically define or limit the meaning of the term stereoisomer. Thus, the term must be construed according to its plain and ordinary meaning.

         The plain and ordinary meaning of the term stereoisomer to a POSITA at the time of the invention was "a compound having the same molecular formula, but being arranged differently in space." According to Organic Chemistry, isomers are "different compounds that have the same molecular formula" and stereoisomers are "[t]he particular kind of isomers that are different from each other only in the way the atoms are oriented in space (but are like one another with respect to which atoms are joined to which other atoms)." Robert Thornton Morrison & Robert Neilson Boyd, Organic Chemistry, 125 (6th ed. 1992). (The parties agree that it is appropriate for me to rely on this definition set forth in Organic Chemistry. See D.I. 58[1] at 6; Markman Hr'g Tr. 24:2-9.)

         Instead of using the plain and ordinary meaning, Defendants seek to limit the term stereoisomer to only the S(-) or R() enantiomers of the recited compounds. D.I. 58 at 5. Nothing in the specification or prosecution history, however, limits or specially defines the term to include only the S(-) and R() enantiomers of the compound. Instead, the written description supports a broader reading of the term. It states: "The invention ... relates to new compounds of general formula I, including all possible stereoisomers ...." #646 patent at 1:36-39 (emphasis added). Moreover, Defendants' proposed construction would exclude embodiments of claim 1: specifically, compounds 16 and 31 of claim 2. D.I. 58 at 8 (citing #646 patent at 9:41-42, 10:12-13). An interpretation that excludes a preferred embodiment "is rarely, if ever, correct and would require highly persuasive evidentiary support" that does not exist here. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996).

         Defendants' argument relies, in part, on the figure in claim 1 that follows the word "thereof." See #646 patent at claim 1 (8:53-63). Defendants claim that the wavy line in the figure identifies the location of the chiral center of the stereoisomers. D.I. 58 at 10. In Defendants' view, the patentees "limited themselves to [the] set of stereoisomers located at the chiral center, not all possible stereoisomers." Id. Nothing in the text of the written description or claims, however, states that the wavy line is the only potential location of the chiral center.

         Finally, Defendants assert that the prosecution history supports its construction. Claim 1 of the #646 patent originally recited "[c]ompounds of general formula I, including all possible stereoisomers." D.I. 58 at 10 (citing D.I. 59 at Appxl31). That claim language was rejected by the patent examiner, and the patentees amended the claim to recite "[a] compound of general formula I, or stereoisomer thereof." Id. (citing D.I. 59 at Appxl38).

         The prosecution history can inform the claim construction analysis. Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005). "Yet because the prosecution history represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation, it often lacks the clarity of the specification and thus is less useful for claim construction purposes." Id. at 1317. Thus, "it is inappropriate to limit a broad definition of a claim based on prosecution history that is itself ambiguous." Inverness Med. Switz. GmbH v. Warner Lambert Co., 309 F.3d 1373, 1382 (Fed. Cir. 2002).

         Here, the prosecution history is too ambiguous to justify reliance on it in construing the disputed term. It is not clear if the change to "a compound, or stereoisomer thereof was made for grammatical reasons (as Plaintiffs contend), to limit the types of stereoisomers claimed for validity purposes (as Defendants contend), or for some other reason. Without a clear explanation of the amendment, the change does not limit the plain meaning of the term.

         Furthermore, the new language of the amended (and final) claim-"a compound ... or stereoisomer thereof-does not limit the term stereoisomers to two kinds of enantiomers. The language "a compound, or stereoisomer thereof would cover multiple types of stereoisomers based on the plain meaning of those words.

         Because the written description and prosecution history do not unmistakably limit the scope of the term "stereoisomers," I construe the term according to its plain and ordinary meaning to a POSITA at the time of the invention. That plain and ordinary meaning is "the compound having the same molecular formula, but being arranged differently in space."

TERMS "10-acetoxy-10, 11-dihydro-5H-dibenz/b, f/azepine-5-carboxamide" in claim 2 of the #646 patent
1. Plaintiffs' proposed construction: "licarbazepine acetate, including R-licarbazepine acetate, S-licarbazepine acetate, or a mixture of R-licarbazepine acetate and S-licarbazepine acetate in any proportion"
2. Defendants' proposed construction: "licarbazepine acetate, i.e. a racemic mixture consisting of the S(-)-10-acetoxy-10, 11-dihydro-5H-dibenz/b, f/azepine-5-carboxamide and R()-10-acetoxy-10, 11-dihydro-5H-dibenz/b, f/azepine-5-carboxamide individual enantiomers"
3. Court's Construction: "licarbazepine acetate, including R-licarbazepine acetate, S-licarbazepine acetate, or a mixture of R-licarbazepine acetate and S-licarbazepine acetate in any proportion"

         The parties agree that 10-acetoxy-10, 11-dihydro-5H-dibenz/b, f/azepine-5-carboxamide is the compound licarbazepine acetate. They dispute, however, whether the claimed compounds include the R-enantiomer, the S-enantiomer, and mixtures thereof in any proportion (as Plaintiffs contend) or only racemic mixtures of the R- and S-enantiomers (as Defendants contend).

         I construe "10-acetoxy-10, 11-dihydro-5H-dibenz/b, f/azepine-5-carboxamide" as "licarbazepine acetate, including R-licarbazepine acetate, S- licarbazepine acetate, or a mixture of R-licarbazepine acetate and S-licarbazepine acetate in any proportion." Nothing in the intrinsic record limits 10-acetoxy-10, 11-dihydro-5H-dibenz/b, f/azepine-5-carboxamide to a specific form. Thus, I construe the term to include all stereoisomeric forms in accordance with its plain and ordinary meaning in the context of the written description and prosecution history.

         The language of claim 2 and the written description of the #646 patent show that the claimed licarbazepine acetate in claim 2 includes all of its stereoisomers, not just its racemic stereoisomer. Claim 2 recites: "A compound as defined in claim 1 which is: (1) 10-acetoxy-10, 11-dihydro-5H-dibenz/b, f/azepine-5-carboxamide ...." #646 patent at claim 2 (9:7-9). And claim 1 recites: "A compound of general formula I, or stereoisomer thereof...." Id. at claim 1 (8:50-51). Thus, claim 1 recites a compound and all of its stereoisomeric forms and claim 2 lists preferred compounds of the compound defined in claim 1. Furthermore, the written description of the #646 patent states: "The invention ... relates to new compounds of general formula I, including all possible stereoisomers" Id. at 1:36-39 (emphasis added). Finally, Example 4 describes a method of preparing ()-10-acetoxy-10, 11-dihydro-5H-dibenz/b, f/azepine-5-carboxamide, and ()-10-acetoxy-10, 11-dihydro-5H-dibenz/b, f/azepine-5-carboxamide is not a racemic mixture. Id. at 6:52-54; D.I. 58 at 20, 22. Claim terms are normally not interpreted "in a way that excludes disclosed examples in the specification." Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (2007).

         Defendants assert that the prosecution history shows that the patentee disclaimed the S- and R-enantiomers because, in a declaration submitted to the United Stated Patent and Trademark Office, the patentee identified the S- and R-enantiomers with the nomenclature "S(-)" and "R()" and that nomenclature does not appear in the disputed term in claim 2. D.I. 58 at 22-23. I disagree. The prosecution history cannot be used to limit the scope of a claim unless it shows that the patentee "clearly disavowed" the claim scope during prosecution. IMS Tech., Inc. v. Haas Automation, Inc., 206 F.3d 1422, 1439 (Fed. Cir. 2000). Denoting the S- and R-enantiomers during prosecution and not in the claim language is not a clear disavowal of claim scope that limits the compound to the S- and R-enantiomers. The patentee's failure to use the S(-) and R() nomenclature could also be interpreted as showing that the patentee intended the claimed compound to include more than just the S- and R-enantiomers instead of excluding those stereoisomeric forms. Furthermore, Defendants' own reasoning would exclude Defendants' construction. Defendants insist that I construe the disputed compound term as racemic only, but in the same declaration Defendants cite, the patentee also identified racemic licarbazepine acetate with the term "racemic" in front of the compound name, see D.I. 59 at Appx 147, and the term racemic does not appear in the disputed term in claim 2, see #646 patent at claim 2. Thus, using Defendants' logic, because the term racemic does not appear before the compound term in dispute, the compound cannot include the racemic form.

         The Federal Circuit has required "convincing intrinsic evidence [to confine] otherwise-unrestricted claims to racemic mixtures." Sumitomo Dainippon Pharma Co. v. Emcure Pharms. Ltd., 887 F.3d 1153, 1158 (Fed. Cir. 2018). Yet here, nothing in the intrinsic record supports limiting the claim to racemic mixtures. The term "racemic" does not appear in the #646 patent. See #646 patent. And the prosecution history does not show that the compound is limited to racemic mixtures. Because the patent does not limit the licarbazepine acetate compound to particular stereoisomeric forms, I construe the disputed term to include the S-and R-enantiomers and mixtures of those two enantiomers in any proportion.

TERMC "licarbazepine acetate" in claims 8, 12, and 13 of the #431 patent and claims 1 and 2 of the #244 ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.