Free Claim Construction Chart - District Court of Delaware - Delaware

Case 1:04-cv-00968-GMS

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ALLERGAN, INC., ALLERGAN SALES, LLC, Plaintiffs, v. ALCON, INC., ALCON LABORATORIES, INC., and ALCON RESEARCH, LTD., Defendants. Civil Action No. 04-968-GMS

JOINT CLAIM CHART '337 Patent Asserted Claim Claim 1 1. A therapeutically effective ophthalmic composition comprising:

Agreed Upon Construction The claim requires a therapeutically effective ophthalmic composition, and the term "therapeutically effective" is used in its ordinary sense. The claimed composition must contain an alpha-2adrenergic agonist component in an amount that is effective to provide a therapeutic benefit to a patient. The parties dispute the construction of this limitation.

Allergan's Proposed Construction The parties do not dispute the construction of this limitation.

Alcon's Proposed Construction The parties do not dispute the construction of this limitation.

an alpha-2adrenergic agonist component in an amount effective to provide a therapeutic benefit to a patient in whom the composition is administered; and a solubility enhancing component other than a cyclodextrin

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

The claimed composition contains a solubility

The claimed composition must contain an anionic component, other than a cyclodextrin, in an

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Asserted Claim in an amount effective to increase the solubility of the alpha-2-adrenergic agonist component in the composition relative to the solubility of an identical alpha-2adrenergic agonist component in a similar composition without the solubility enhancing component.

Agreed Upon Construction

Allergan's Proposed Construction enhancing component, which is a component that enhances the solubility of the alpha-2adrenergic agonist component, and any solubility enhancing component other than a cylclodextrin is covered by the claim. The solubility enhancing component must be present in such an amount that the solubility of the alpha-2adrenergic agonist component in the composition is increased relative to its solubility in a similar composition without the solubility enhancing component. Support for proposed construction: '337 patent, abstract, col. 2, lines 13-20, col. 4, lines 60-65, col. 6, lines 1741, '337 patent file history, Reply to Office Action, Dated June 16, 2003. 2

Alcon's Proposed Construction amount effective to increase the solubility of the alpha-2-adrenergic agonist component in the composition relative to the solubility of the alpha-2-adrenergic agonist component in an otherwise identical composition without the anionic component. In addition, the "solubility enhancing component" cannot be polyvinyl alcohol, povidone (polyvinylpyrrolidone), hydroxypropylcellulose, poloxamers or hydroxymethylcellulose. Support for proposed construction: Application No. 09/904,018 (parent application of the application which issued as the '337 patent): Office Action mailed September 18, 2002; Response to Restriction Requirement received by PTO on October 22, 2002; Office Action dated January 9, 2003; Interview Summary, mailed 3/3/03; Reply to Office Action, received by the PTO March 17, 2003 including Declaration of Orest Olejnik; '337 patent, Office Action, mailed March 13, 2003; Reply to Office Action, dated June 16, 2003.

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Asserted Claim Claim 2 2. The composition of claim 1 wherein the alpha-2adrenegic component is selected from the group consisting of iminoimidazolines, imidazolines, imidazoles, azepines, thiazines, oxazolines, guanidines, catecholamines, derivatives thereof, and mixtures thereof.

Agreed Upon Construction Claim 2 contains all the limitations of claim 1, with the additional requirement that the alpha-2adrenergic agonist component must be: an iminoimidazoline, imidazoline, imidazole, azepine, thiazine, oxazoline, guanidine, catecholamine, derivative of one of the foregoing, or a mixture of one of the foregoing. Claim 3 includes all the limitations of claim 1, with the further requirement that the composition must contain a quinoxaline component. Claim 4 includes all the limitations of claims 1 and 3, with the further requirement that the quinoxaline component must be a quinoxaline, a derivative of quinoxaline, or mixture of two or more of the foregoing.

Allergan's Proposed Construction The parties do not dispute the construction of this limitation.

Alcon's Proposed Construction The parties do not dispute the construction of this limitation.

Claim 3 3. The composition of claim 1 wherein the therapeutically active component includes a quinoxaline component.

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

Claim 4 4. The composition of claim 3 wherein the quinoxaline component is selected from the group consisting of quinoxaline, derivatives thereof, and mixtures thereof.

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

3

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Asserted Claim

Agreed Upon Construction

Claim 6 6. The composition The parties dispute of claim 1 wherein the construction of the solubility this limitation. enhancing component is effective to increase the solubility in a biological environment of the alpha-2-adrenergic agonist component relative to the solubility in a biological environment of an identical alpha-2adrenergic agonist component in a similar composition without the solubility enhancing component.

Allergan's Proposed Construction Claim 6 includes all the limitations of claim 1, with the further requirement that the solubility enhancing component is effective to increase the solubility in a biological environment of the alpha-2adrenergic agonist component relative to its solubility in a similar composition without the solubility enhancing component. Support for proposed construction: ' 337 patent, col. 1, lines 58-64, col. 4, lines 4147.

Alcon's Proposed Construction Claim 6 contains all the limitations of claim 1, with the further requirement that the "solubility enhancing component" must be effective to increase the solubility in a biological environment of the alpha2-adrenergic agonist component relative to the solubility in the same biological environment of the alpha-2-adrenergic agonist component in an otherwise identical composition without the "solubility enhancing component." Support for proposed construction: As relevant to the construction of claim 6, Alcon incorporates its comment to claim 1.

Claim 9 The composition of claim 1 which further comprises an effective amount of a preservative.

Claim 9 includes all the limitations of claim 1 with the further requirement that the composition must contain a component that assists in the preservation of the composition.

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

4

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Asserted Claim Claim 10 The composition of claim 6 which further comprises an effective amount of a preservative.

Agreed Upon Construction Claim 10 includes all the limitations of claim 6 with the further requirement that the composition must contain an effective amount of a component that assists in the preservation of the composition.

Allergan's Proposed Construction The parties do not dispute the construction of this limitation.

Alcon's Proposed Construction The parties do not dispute the construction of this limitation.

'834 Patent Asserted Claim Claim 1 1. A therapeutically effective aqueous ophthalmic composition comprising:

Agreed Upon Construction The claim requires a therapeutically effective ophthalmic composition, and the term " therapeutically effective" is used in its ordinary sense.

Allergan's Proposed Alcon's Proposed Construction Construction The parties do not dispute the construction of this limitation. The parties do not dispute the construction of this limitation.

up to about 0.15% The parties dispute (w/v) of 5-bromo-6- the construction of (2-imidozolin-2this limitation. ylamino) quinoxaline tartrate,

The claimed composition contains up to approximately 0.15% (w/v) brimondine tartrate. Support for proposed construction: The term " about" is used in its ordinary sense, meaning " approximately." See Merck & Co. v. Teva Pharms., Inc., 395 F.3d 1364 (Fed. Cir. 2005). See also ' 834 patent, Figure 1, col. 1, lines 33-53, col. 2, lines 48-52, col. 3, lines 23-36, col. 6, lines 8-16, col. 11, lines 1-6, 5

The claimed composition must contain up to 0.155% (w/v) (the upper limit of 0.15 ± 0.005% (w/v)) of brimondine tartrate. The specification (including the claims as originally filed) and prosecution history of the ' 834 patent only reflect testing of brimonidine tartrate solutions at concentrations of 0.5% (w/v) and 0.2% (w/v) and thus provide no teaching or

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Asserted Claim

Agreed Upon Construction

Allergan's Proposed Construction Example 2 and descriptive text, Table IV and descriptive text, Application No. 09/904,018 (parent application of the application which issued as the ' 834 patent, including the original claims), ' 834 patent file history, Reply to Office Action, dated Mar. 24, 2003.

Alcon's Proposed Construction guidance supporting the terms " up to about 0.15% (w/v)," " up to 0.15% (w/v)," or " about 0.15% (w/v)" nor do they disclose that such compositions are within the scope of the alleged invention. In Merck & Co. v. Teva Pharms., Inc., 395 F.3d 1364 (Fed. Cir. 2005), the court rejected the patentee' s attempt to define the terms " about 70 mg" and " about 35 mg" as limited to the precise numerical values disclosed, without any surrounding range. Thus, in order to supply a range, but in light of the absence of any teaching in the specification as guidance for the same, Alcon proposes that the term " about" be interpreted to encompass the full range of values that would normally be rounded up or down to 0.15%. The composition must have a pH of 6.95 (the lower limit of 7.0 + 0.05) or greater. The specification (including the

the composition The parties dispute having a pH of the construction of about 7.0 or greater, this limitation.

The claimed composition has a pH of approximately 7.0 or greater. Support for proposed construction: The term " about" is used 6

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Asserted Claim

Agreed Upon Construction

Allergan's Proposed Construction in its ordinary sense, meaning " approximately." See Merck & Co. v. Teva Pharms., Inc., 395 F.3d 1364 (Fed. Cir. 2005). See also ' 834 patent, Figure 1, col. 4, lines 22-33, col. 11, lines 1-6, Example 2 and descriptive text, Application No. 09/904,018 (parent application of the application which issued as the ' 834 patent, including the original claims), ' 834 patent file history, Reply to Office Action, dated Mar. 24, 2003. The brimonidine tartrate must be soluble in the composition at approximately 21° C. Support for proposed construction: The term " about" is used in its ordinary sense, meaning " approximately." See Merck & Co. v. Teva Pharms., Inc., 395 F.3d 1364 (Fed. Cir. 2005). See also ' 834 patent, Figure 1, Example 2 and descriptive text, Application No. 09/904,018 (parent application of the application which issued as the ' 834 patent, including the original claims), ' 834 7

Alcon's Proposed Construction claims as originally filed) and the prosecution history of the ' 834 patent provide no teaching regarding the scope of the pH limitation. Thus, Alcon proposes that the term " about" be interpreted to encompass the full range of values that would normally be rounded up or down to pH 7.0.

and the 5-bromo-6(2-imidozolin-2ylamino) quinoxaline tartrate being soluble in the composition at about 21° C.

The parties dispute the construction of this limitation.

The brimondine tartrate must be soluble in the composition at 21 ± 0.5C The specification (including the claims as originally filed) and the prosecution history of the ' 834 patent provide no teaching regarding the scope of the temperature limitation. Thus, Alcon proposes that the term " about" be interpreted to encompass the full range of values that would normally be rounded up or down to a temperature of 21°C.

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Asserted Claim

Agreed Upon Construction

Allergan's Proposed Alcon's Proposed Construction Construction patent file history, Reply to Office Action, dated Mar. 24, 2003. The parties do not dispute the construction of this limitation. The parties do not dispute the construction of this limitation.

Claim 2 2. The composition of claim 1 which includes up to 0.15% (w/v) of 5bromo-6-(2imidozolin-2ylamino) quinoxaline tartrate.

Claim 2 includes all the limitations of claim 1, with the additional requirement that the composition must include up to 0.15% (w/v) brimonidine tartrate.

Claim 3 3. The composition The parties dispute of claim 1 which the construction of includes about this limitation. 0.15% (w/v) of 5bromo-6-(2imidozolin-2ylamino) quinoxaline tartrate.

Claim 3 includes all the limitations of claim 1, with the additional requirement that the composition must include approximately 0.15% brimonidine tartrate. Support for proposed construction: The term " about" is used in its ordinary sense, meaning " approximately." See Merck & Co. v. Teva Pharms., Inc., 395 F.3d 1364 (Fed. Cir. 2005). See also ' 834 patent, Figure 1, col. 1, lines 33-53, col. 2, lines 48-52, col. 3, lines 23-36, col. 6, lines 8-16, col. 11, lines 1-6, Example 2 and descriptive text, Table IV and descriptive text, Application No. 09/904,018 (parent application of the application which 8

Claim 3 contains all the limitations of claim 1, with the additional requirement that the composition must include 0.15% ± 0.005% (w/v) brimondine tartrate. Support for proposed construction: As relevant to the construction of claim 3, Alcon incorporates its comments to claim 1.

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Asserted Claim

Agreed Upon Construction

Allergan's Proposed Alcon's Proposed Construction Construction issued as the ' 834 patent, including the original claims), ' 834 patent file history, Reply to Office Action, dated Mar. 24, 2003.

Claim 4 4. The composition of claim 1 which included 0.15% (w/v) of 5-bromo-6(2-imidozolin-2ylamino) quinoxaline tartrate. Claim 5 5. The composition of claim 1 having a pH of 7.0 or greater.

Claim 4 includes all the limitations of claim 1, with the additional requirement that the composition must include 0.15% (w/v) brimonidine tartrate. Claim 5 includes all the limitations of claim 1, with the additional requirement that the pH of the composition must be 7.0 or greater. Claim 6 includes all the limitations of claim 1 and further requires that the composition must contain either an oxy-chloro or quaternary ammonium preservative in an amount effective to assist in preserving the composition.

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

Claim 6 6. The composition of claim 1 which further comprises a preservative selected from the group consisting of an oxy-chloro component and a quaternary ammonium compound in an amount effective to at least assist in preserving the composition. Claim 8 8. The composition of claim 1 which is substantially free of anionic cellulosic derivatives.

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

Claim 8 includes all the limitations of claim 1 and further requires that the composition is 9

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

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Asserted Claim

Agreed Upon Construction substantially free of anionic cellulosic derivatives. Claim 9 includes all the limitations of claim 1 and further requires that the composition is substantially free of carboxymethyl cellulose. The claim requires a therapeutically effective ophthalmic composition, and the term " therapeutically effective" is used in its ordinary sense.

Allergan's Proposed Alcon's Proposed Construction Construction

Claim 9 The composition of claim 1 which is substantially free of carboxymethyl cellulose.

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

Claim 10 10. A therapeutically effective aqueous ophthalmic composition comprising:

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

up to about 0.15% The parties dispute (w/v) of a the construction of component selected this limitation. from the group consisting of 5bromo-6-(2imidozolin-2ylamino) quinoxaline, salts of 5-bromo-6-(2imidozolin-2ylamino) quinoxaline, esters of 5-bromo-6-(2imidozolin-2ylamino) quinoxaline and mixtures thereof,

The claimed composition contains up to approximately 0.15% (w/v) brimondine, salts of brimonidine, esters of brimonidine, or mixtures of the foregoing. Support for proposed construction: The term " about" is used in its ordinary sense, meaning " approximately." See Merck & Co. v. Teva Pharms., Inc., 395 F.3d 1364 (Fed. Cir. 2005). See also ' 834 patent, Figure 1, col. 1, lines 33-53, col. 2, lines 48-52, col. 3, lines 23-36, col. 6, lines 8-16, col. 11, lines 1-6, Example 2 and 10

The claimed composition must contain up to 0.155% (w/v) (the upper limit of 0.15 ± 0.005% (w/v)) of brimondine, salts of brimonidine, esters of brimonidine, or mixtures of two or more of the foregoing. The specification (including the claims as originally filed) and prosecution history of the ' 834 patent only reflect testing of brimonidine tartrate solutions at concentrations of 0.5% (w/v) and 0.2% (w/v) and thus provide no teaching or

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Asserted Claim

Agreed Upon Construction

Allergan's Proposed Construction descriptive text, Table IV and descriptive text, Application No. 09/904,018 (parent application of the application which issued as the ' 834 patent, including the original claims), ' 834 patent file history, Reply to Office Action, dated Mar. 24, 2003.

Alcon's Proposed Construction guidance supporting the terms " up to about 0.15% (w/v)," " up to 0.15% (w/v)," or " about 0.15% (w/v)" nor do they disclose that such compositions are within the scope of the alleged invention. In Merck & Co. v. Teva Pharms., Inc., 395 F.3d 1364 (Fed. Cir. 2005), the court rejected the patentee' s attempt to define the terms " about 70 mg" and " about 35 mg" as limited to the precise numerical values disclosed, without any surrounding range. Thus, in order to supply a range, but in light of the absence of any teaching in the specification as guidance for the same, Alcon proposes that the term " about" be interpreted to encompass the full range of values that would normally be rounded up or down to 0.15%. The claimed composition must have a pH of 6.95 (the lower limit of 7.0 + 0.05) or greater. The specification (including the

the composition The parties dispute having a pH of the construction of about 7.0 or greater, this limitation.

The claimed composition has a pH of approximately 7.0 or greater. Support for proposed construction: The term " about" is used 11

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Asserted Claim

Agreed Upon Construction

Allergan's Proposed Construction in its ordinary sense, meaning " approximately." See Merck & Co. v. Teva Pharms., Inc., 395 F.3d 1364 (Fed. Cir. 2005). See also ' 834 patent, Figure 1, col. 4, lines 22-33, col. 11, lines 1-6, Example 2 and descriptive text, Application No. 09/904,018 (parent application of the application which issued as the ' 834 patent, including the original claims), ' 834 patent file history, Reply to Office Action, dated Mar. 24, 2003. The brimonidine tartrate must be soluble in the composition at approximately 21° C. Support for proposed construction: The term " about" is used in its ordinary sense, meaning " approximately." See Merck & Co. v. Teva Pharms., Inc., 395 F.3d 1364 (Fed. Cir. 2005). See also ' 834 patent, Figure 1, Example 2 and descriptive text, Application No. 09/904,018 (parent application of the application which issued as the ' 834 patent, including the original claims), ' 834 patent file history, 12

Alcon's Proposed Construction claims as originally filed) and the prosecution history of the ' 834 patent provide no teaching regarding the scope of the pH limitation. Thus, Alcon proposes that the term " about" be interpreted to encompass the full range of values that would normally be rounded up or down to pH 7.0.

and the component being soluble in the composition at about 21° C.

The parties dispute the construction of this limitation.

The component must be soluble in the composition at 21 ± .5ºC. The specification (including the claims as originally filed) and the prosecution history of the ' 834 patent provide no teaching regarding the scope of the temperature limitation. Thus, Alcon proposes that the term " about" be interpreted to encompass the full range of values that would normally be rounded up or down to a temperature of 21°C.

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Asserted Claim

Agreed Upon Construction

Allergan's Proposed Alcon's Proposed Construction Construction Reply to Office Action, dated Mar. 24, 2003. The parties do not dispute the construction of this limitation. The parties do not dispute the construction of this limitation.

Claim 11 11. The composition of claim 10 which includes up to 0.15% (w/v) of the component.

Claim 11 includes all the limitations of claim 10, with the additional requirement that the composition must include up to 0.15% (w/v) of the component selected from the group described in claim 10. The parties dispute the construction of this limitation.

Claim 12 12. The composition of claim 10 which includes about 0.15% (w/v) of the component

Claim 12 includes all the limitations of claim 10, with the additional requirement that the composition must include approximately 0.15% (w/v) of the component selected from the group described in claim 10. Support for proposed construction: The term " about" is used in its ordinary sense, meaning " approximately." See Merck & Co. v. Teva Pharms., Inc., 395 F.3d 1364 (Fed. Cir. 2005). See also ' 834 patent, Figure 1, col. 1, lines 33-53, col. 2, lines 48-52, col. 3, lines 23-36, col. 6, lines 8-16, col. 11, lines 1-6, Example 2 and descriptive text, 13

The claimed composition must include all the limitations of claim 10, with the additional requirement that the composition must include 0.15 ± 0.005% (w/v) of the component listed in claim 10. As relevant to the construction of claim 12, Alcon incorporates its comments to claim 10.

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Asserted Claim

Agreed Upon Construction

Allergan's Proposed Alcon's Proposed Construction Construction Table IV and descriptive text, Application No. 09/904,018 (parent application of the application which issued as the ' 834 patent, including the original claims), ' 834 patent file history, Reply to Office Action, dated Mar. 24, 2003. The parties do not dispute the construction of this limitation. The parties do not dispute the construction of this limitation.

Claim 13 13. The composition of claim 10 which includes 0.15% (w/v) of the component

Claim 13 includes all the limitations of claim 10, with the additional requirement that the composition must include 0.15% (w/v) of the component selected from the group described in claim 10. Claim 14 includes all the limitations of claim 10, with the additional requirement that the pH of the composition must be 7.0 or greater. Claim17 includes all the limitations of claim 10 and further requires that the composition is substantially free of anionic cellulosic derivatives. Claim 18 includes all the limitations of claim 10 and further

Claim 14 14. The composition of claim 10 having a pH of 7.0 or greater.

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

Claim 17 17. The composition of claim 10 which is substantially free of anionic cellulosic derivatives.

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

Claim 18 18. The composition of claim 10 which is

The parties do not dispute the construction of this 14

The parties do not dispute the construction of this

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Asserted Claim substantially free of carboxymethyl cellulose.

Agreed Upon Construction requires that the composition is substantially free of carboxymethyl cellulose. Claim 20 includes all the limitations of claim 10 and further requires that the composition must contain either an oxy-chloro or quaternary ammonium preservative in an amount effective to assist in preserving the composition.

Allergan's Proposed Alcon's Proposed Construction Construction limitation. limitation.

Claim 20 20. The composition of claim 10 which further comprises a preservative selected from the group consisting of an oxy-chloro component and a quaternary ammonium compound in an amount effective to at least assist in preserving the composition.

The parties do not dispute the construction of this limitation.

The parties do not dispute the construction of this limitation.

FISH & RICHARDSON P.C. By: /s/ William J. Marsden, Jr._________ William J. Marsden, Jr. (#2247) Sean P. Hayes (#4413) 919 N. Market Street, Suite 1100 P.O. Box 1114 Wilmington, DE 19899-1114 (302) 652-5070 Jonathan E. Singer Michael J. Kane Deanna J. Reichel 3300 Dain Rauscher Plaza 60 South Sixth Street Minneapolis, MN 55402 Juanita Brooks W. Chad Shear 12390 El Camino Real San Diego, CA 92130

YOUNG CONAWAY STARGATT & TAYLOR, LLP By:/s/ Josy W. Ingersoll___________ Josy W. Ingersoll (#1088) The Brandywine Building, 17th Floor 1000 West Street P.O. Box 391 Wilmington, DE 19899-0391 (302) 571-6600 Brian D. Coggio, Esq. Orrick, Herrington & Sutcliffe LLP 666 Fifth Avenue New York, NY 10103-0001

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