Free Claim Construction Chart - District Court of Delaware - Delaware

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 1 of 62

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

IN RE: BRIMONIDINE PATENT LITIGATION MDL Docket No. 07-md-01866 GMS

JOINT CLAIM CHARTS '078 patent1 Asserted Claim of '078 patent Claim 1 1. A method for preserving an aqueous ophthalmic formulation so as to enhance the shelf life thereof comprising incorporating into said aqueous ophthalmic formulation stabilized chlorine dioxide in an amount effective to act as the sole preservative in said aqueous ophthalmic formulation, Allergan's Proposed Construction2 Apotex's Proposed Construction

Agreed-upon construction: The claim requires a method for preserving an aqueous ophthalmic formulation to enhance the shelf life of the formulation. The claimed method requires incorporation into the aqueous ophthalmic formulation of stabilized chlorine dioxide in an amount effective to act as the sole preservative in the formulation. The claimed method requires incorporation into the aqueous ophthalmic formulation of stabilized chlorine dioxide in an amount effective to act as the sole preservative in the formulation. "stabilized chlorine dioxide in an amount effective to act as the sole preservative in said aqueous ophthalmic

1

2

Allergan and Apotex agree on the construction for many of the claim terms. There are, however, a few where Allergan and Apotex agree as to a portion of the construction but the remainder is in dispute. To facilitate the Court's review of this joint claim chart, where a portion of the construction of the term is in dispute but not the entire construction, the disputed portion is in bold. Because the claim language itself is clear and unambiguous, no resort to the specification and prosecution history is necessary, therefore, the best evidence that the plain and ordinary meaning of the claim terms controls is the claims themselves. For brevity, citation to the claim language itself will not be repeated each time as the claim language is provided in Column 1.

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 2 of 62

Asserted Claim of '078 patent

Allergan's Proposed Construction2

Apotex's Proposed Construction formulation" means an amount so that a 99.9% reduction of microbes challenge occur within 14 days of contact with the product being tested; and that no growth of yeast and fungi occur.

at least one ophthalmically acceptable buffer component in an amount effective to maintain said aqueous ophthalmic formulation at a pH in the range of about 6.8 to about 8, and at least one ophthalmically acceptable tonicity component in an amount effective to maintain said aqueous ophthalmic formulation at an osmolality of at least about 200 mOsmol/kg,

See. e.g., Col. 2:35-36; 61-66; See, e.g., `078 patent, column 3:13-21; and 4:1-23, 8, lines 40-43. Examples I-VIII; `078 Prosecution History, Amendment February 29, 1992 Agreed-upon construction: The claimed method requires incorporation into the aqueous ophthalmic formulation of at least one ophthalmically acceptable buffer component in an amount effective to maintain the formulation at a pH in the range of approximately 6.8 to approximately 8.

The claimed method requires incorporation into the aqueous ophthalmic formulation of at least one ophthalmically acceptable tonicity component in an amount effective to maintain the formulation at an osmolality of at least approximately 200 mOsmol/kg. Allergan disagrees with Apotex that the language "Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components "provided that such component or components are compatible

The claimed method requires incorporation into the aqueous ophthalmic formulation of at least one ophthalmically acceptable tonicity component in an amount effective to maintain the formulation at an osmolality of at least approximately 200 mOsmol/kg. "Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components "provided that such component or components are compatible with the other ingredients of the ophthalmic formulation

2

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 3 of 62

Asserted Claim of '078 patent

Allergan's Proposed Construction2 with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye," is necessary. The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). See, e.g., '078 patent, col. 2, lines 38-42; col. 5, lines 1344; Examples V-VIII. 078 Prosecution History, Amendment dated February 27, 1992; Appellant's Brief dated September 18, 1992.

Apotex's Proposed Construction and do not have deleterious or toxic properties which could harm the eye." The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). The limitation of " at least about 200 mOsmol/kg" is supported by the written description at column 5, lines 13-23. The definition of " ophthalmically acceptable tonicity component" is at column 5, lines 24-33.

provided that said aqueous ophthalmic formulation is ophthalmically acceptable and no germicidally effective amounts of any positively charged, nitrogen-containing cationic polymers are incorporated into said aqueous ophthalmic formulation. Claim 2 2. The method of claim 1 wherein said stabilized chlorine dioxide is present in said aqueous ophthalmic formulation in an amount in

Agreed-upon construction: The claimed method requires that the aqueous ophthalmic formulation is ophthalmically acceptable and that it includes no germicidally effective amounts of any positively charged, nitrogen-containing cationic polymers.

Agreed-upon construction: Claim 2 contains all the limitations of claim 1, with the further requirement that the stabilized chlorine dioxide is present in the formulation in an amount in the range of approximately 0.0002 to approximately 0.02 weight/volume percent.

3

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 4 of 62

Asserted Claim of '078 patent the range of about 0.0002 to about 0.02 weight/volume percent. Claim 3 3. The method of claim 1 wherein said stabilized chlorine dioxide is present in said aqueous ophthalmic formulation in an amount in the range of about 0.004 to about 0.01 weight/volume percent. Claim 4 4. The method of claim 1 wherein said at least one ophthalmically acceptable buffer component is present in an amount effective to maintain said aqueous ophthalmic formulation at a pH in the range of about 7 to about 7.5. Claim 5 5. The method of claim 1 wherein said at least one ophthalmically acceptable tonicity component is present in an amount effective to maintain said aqueous ophthalmic formulation at an osmolality in the range of about 200 to about 400 mOsmol/kg.

Allergan's Proposed Construction2

Apotex's Proposed Construction

Agreed-upon construction: Claim 3 includes all the limitations of claim 1, with the further requirement that the stabilized chlorine dioxide is present in the formulation in an amount in the range of approximately 0.004 to approximately 0.01 weight/volume percent.

Agreed-upon construction: Claim 4 includes all the limitations of claim 1, with the further requirement that at least one ophthalmically acceptable buffer component is present in an amount effective to maintain the formulation at a pH in the range of approximately 7 to approximately 7.5.

Claim 5 includes all the limitations of claim 1, with the further requirement that at least one ophthalmically acceptable tonicity component is present in an amount effective to maintain the formulation at an osmolality in the range of approximately 200 to approximately 400 mOsmol/kg. Allergan disagrees with Apotex that the language " Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components " provided that such component or

Claim 5 includes all the limitations of claim 1, with the further requirement that at least one ophthalmically acceptable tonicity component is present in an amount effective to maintain the formulation at an osmolality in the range of approximately 200 to approximately 400 mOsmol/kg. " Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of

4

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 5 of 62

Asserted Claim of '078 patent

Allergan's Proposed Construction2 components are compatible with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye," is necessary. The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). See, e.g., ' 078 patent, col. 2, lines 38-42; col. 5, lines 1344; Examples V-VIII. See citations for Claim 1 above.

Apotex's Proposed Construction the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye." The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). The limitation of " effective to maintain the formulation at an osmolality in the range of approximately 200 to about 400 mOsmol/kg" is supported by the written description at column 5, lines 13-23. The definition of " ophthalmically acceptable tonicity component" is at column 5, lines 24-33.

Claim 6 6. The method of claim 1 wherein said aqueous ophthalmic formulation is a solution. Claim 7 7. A method for preserving an aqueous ophthalmic solution so as to enhance the shelf life thereof comprising

Agreed-upon construction: Claim 6 includes all the limitations of claim 1 with the further requirement that the aqueous ophthalmic formulation is a solution.

Agreed-upon construction: The claim requires a method for preserving an aqueous ophthalmic solution to enhance the shelf life of the solution.

5

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 6 of 62

Asserted Claim of '078 patent incorporating into said aqueous ophthalmic solution stabilized chlorine dioxide in an amount effective to act as the sole preservative in said aqueous ophthalmic solution in the range of about 0.002 to about 0.02 weight/volume percent,

Allergan's Proposed Construction2 The claimed method requires incorporation into the aqueous ophthalmic solution of stabilized chlorine dioxide in an amount effective to act as the sole preservative in the solution in the range of approximately 0.0002 to approximately 0.02 weight/volume percent. Allergan disagrees Apotex that the language " `stabilized chlorine dioxide in an amount effective to act as the sole preservative in said aqueous ophthalmic solution' means an amount so that a 99.9% reduction of microbes challenge occur within 14 days of contact with the product being tested; and that no growth of yeast and fungi occur." is necessary.

Apotex's Proposed Construction The claimed method requires incorporation into the aqueous ophthalmic solution of stabilized chlorine dioxide in an amount effective to act as the sole preservative in the solution in the range of approximately 0.0002 to approximately 0.02 weight/volume percent. "stabilized chlorine dioxide in an amount effective to act as the sole preservative in said aqueous ophthalmic solution" means an amount so that a 99.9% reduction of microbes challenge occur within 14 days of contact with the product being tested; and that no growth of yeast and fungi occur. The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). See, e.g., `078 patent, column 8, lines 40-43.

The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). See. e.g., col. 2, lines 35-36; 61-66; col. 3, lines 13-21; and 4:15-23; Examples I-VIII

6

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 7 of 62

Allergan's Proposed Apotex's Proposed 2 Construction Construction See citations for Claim 1 above. at least one ophthalmically Agreed-upon construction: acceptable buffer component The claimed method requires incorporation into the aqueous in an amount effective to ophthalmic solution of at least one ophthalmically acceptable maintain said aqueous buffer component in an amount effective to maintain the ophthalmic solution at a pH in solution at a pH in the range of approximately 6.8 to the range of about 6.8 to about approximately 8. 8, and at least one ophthalmically acceptable tonicity component in an amount effective to maintain said aqueous ophthalmic solution at an osmolality in the range of about 200 to about 400 mOsmol/kg, The claimed method requires incorporation into the aqueous ophthalmic solution of at least one ophthalmically acceptable tonicity component in an amount effective to maintain the solution at an osmolality in the range of approximately 200 mOsmol/kg to approximately 400 mOsmol/kg. Allergan disagrees that the language " Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye," is necessary. The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., The claimed method requires incorporation into the aqueous ophthalmic solution of at least one ophthalmically acceptable tonicity component in an amount effective to maintain the solution at an osmolality in the range of approximately 200 mOsmol/kg to approximately 400 mOsmol/kg. " Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye." The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order

Asserted Claim of '078 patent

7

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 8 of 62

Asserted Claim of '078 patent

Allergan's Proposed Construction2 No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). See, e.g.,' 078 patent, Col. 2, lines 38-42; col. 5, lines 1344; Examples V-VIII. See citations for Claim 1 above.

Apotex's Proposed Construction construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). The limitation of " an amount effective to maintain the formulation at an osmolality in the range of about 200 to about 400 mOsmol/kg" is supported by the written description at column 5, lines 13-23. The definition of " ophthalmically acceptable tonicity component" is at column 5, lines 24-33.

provided that said aqueous ophthalmic solution is ophthalmically acceptable and substantially no germicidally effective amounts of any positively charged, nitrogencontaining cationic polymers are incorporated into said aqueous ophthalmic solution. Claim 8 8. A preserved ophthalmic formulation comprising an ophthalmically acceptable aqueous medium and,

Agreed-upon construction: The claimed method requires that the aqueous ophthalmic solution is ophthalmically acceptable and that it includes substantially no germicidally effective amounts of any positively charged, nitrogen-containing cationic polymers.

Agreed-upon construction: The claim requires a preserved ophthalmic formulation. Agreed-upon construction: The claimed formulation requires an ophthalmically acceptable aqueous medium. The claimed formulation requires the inclusion of stabilized chlorine dioxide in an amount effective to act as the sole preservative in the ophthalmically acceptable aqueous medium. The claimed formulation requires the inclusion of stabilized chlorine dioxide in an amount effective to act as the sole preservative in the ophthalmically acceptable aqueous medium.

included therein, stabilized chlorine dioxide in an amount effective to act as the sole preservative in said ophthalmically acceptable aqueous medium,

8

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 9 of 62

Asserted Claim of '078 patent

Allergan's Proposed Construction2

Apotex's Proposed Construction "stabilized chlorine dioxide in an amount effective to act as the sole preservative in said ophthalmically acceptable aqueous medium" means an amount so that a 99.9% reduction of microbes challenge occur within 14 days of contact with the product being tested; and that no growth of yeast and fungi occur.

See. e.g., col. 2, lines 35-36; 61-66; col. 3, lines 13-21; and 4:15-23. See citations for Claim 1 above. at least one ophthalmically acceptable buffer component in an amount effective to maintain said ophthalmically acceptable aqueous medium at a pH in the range of about 6.8 to about 8,

See, e.g., `078 patent, column 8, lines 40-43.

Agreed-upon construction: The claimed formulation requires the inclusion of at least one ophthalmically acceptable buffer component in an amount effective to maintain the ophthalmically acceptable aqueous medium at a pH in the range of approximately 6.8 to approximately 8.

and at least one ophthalmically acceptable tonicity component in an amount effective to maintain said ophthalmically acceptable aqueous medium at an osmolality of at least about 200 mOsmol/kg,

The claimed formulation requires the inclusion of at least one ophthalmically acceptable tonicity component in an amount effective to maintain the ophthalmically acceptable aqueous medium at an osmolality of at least approximately 200 mOsmol/kg. Allergan disagrees with

The claimed formulation requires the inclusion of at least one ophthalmically acceptable tonicity component in an amount effective to maintain the ophthalmically acceptable aqueous medium at an osmolality of at least approximately 200 mOsmol/kg. " Ophthalmically acceptable

9

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 10 of 62

Asserted Claim of '078 patent

Allergan's Proposed Construction2 Apotex that the language " Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye." is necessary. The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). See, e.g., ' 078 patent, col. 2, lines 20-58; col. 2, lines 6168; col. 4, lines 1-23; col. 5, lines 13-44; Examples I-VIII. See citations for Claim 1 above.

Apotex's Proposed Construction tonicity component" is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye." The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). The limitation of " at least about 200 mOsmol/kg" is supported by the written description at column 5, lines 13-23. The definition of " ophthalmically acceptable tonicity component" is at column 5, lines 24-33.

provided that said preserved Agreed-upon construction: ophthalmic formulation is The claimed formulation is ophthalmically acceptable and free ophthalmically acceptable and of germicidally effective amounts of any positively charged, is free of germicidally nitrogen-containing cationic polymers. effective amounts of any positively charged, nitrogencontaining cationic polymers.

10

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 11 of 62

Asserted Claim of '078 patent Claim 9 9. The preserved ophthalmic formulation of claim 8 wherein said stabilized chlorine dioxide is present in said preserved ophthalmic formulation in an amount in the range of about 0.0002 to about 0.02 weight/volume percent. Claim 10 10. The preserved ophthalmic formulation of claim 8 wherein said stabilized chlorine dioxide is present in said preserved ophthalmic formulation in an amount in the range of about 0.004 to about 0.01 weight/volume percent. Claim 11 11. The preserved ophthalmic formulation of claim 8 wherein said at least one ophthalmically acceptable tonicity component is selected from the group consisting of alkali metal chlorides and alkaline earth metal chlorides and mixtures thereof.

Allergan's Proposed Construction2

Apotex's Proposed Construction

Agreed-upon construction: Claim 9 contains all the limitations of claim 8, with the further requirement that the stabilized chlorine dioxide is present in the formulation in an amount in the range of approximately 0.0002 to approximately 0.02 weight/volume percent.

Agreed-upon construction: Claim 10 contains all the limitations of claim 8, with the further requirement that the stabilized chlorine dioxide is present in the formulation in an amount in the range of approximately 0.004 to approximately 0.01 weight/volume percent.

Claim 11 contains all the limitations of claim 8, with the further requirement that at least one ophthalmically acceptable tonicity component is selected from the group consisting of alkali metal chlorides and alkaline earth metal chlorides and mixtures thereof. Allergan disagrees with Apotex that the language " Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of the ophthalmic formulation

Claim 11 contains all the limitations of claim 8, with the further requirement that at least one ophthalmically acceptable tonicity component is selected from the group consisting of alkali metal chlorides and alkaline earth metal chlorides and mixtures thereof. " Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which

11

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 12 of 62

Asserted Claim of '078 patent

Allergan's Proposed Construction2 and do not have deleterious or toxic properties which could harm the eye." is necessary.

Apotex's Proposed Construction could harm the eye."

The definition of " ophthalmically acceptable tonicity component" is at See., e.g., ' 078 patent, col. 5, lines 23-44; Examples V-VIII. column 5, lines 24-33. See citations for Claim 1 above.

Claim 12 12. The preserved ophthalmic formulation of claim 8 wherein said at least one ophthalmically acceptable tonicity component comprises sodium chloride.

Claim 12 contains all the limitations of claim 8, with the further requirement that at least one ophthalmically acceptable tonicity component comprises sodium chloride. See citations for Claim 1 above.

Claim 12 contains all the limitations of claim 8, with the further requirement that at least one ophthalmically acceptable tonicity component comprises sodium chloride. " Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye." The definition of " ophthalmically acceptable tonicity component" is at column 5, lines 24-33.

Claim 13 13. The preserved ophthalmic formulation of claim 8 wherein said at least one ophthalmically acceptable tonicity component comprises an alkaline earth metal salt selected from the group consisting of calcium chloride and magnesium chloride and

Claim 13 contains all the limitations of claim 8, with the further requirement that at least one ophthalmically acceptable tonicity component comprises an alkaline earth metal salt selected from the group consisting of calcium chloride and magnesium

Claim 13 contains all the limitations of claim 8, with the further requirement that at least one ophthalmically acceptable tonicity component comprises an alkaline earth metal salt selected from the group consisting of calcium chloride and magnesium

12

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 13 of 62

Asserted Claim of '078 patent mixtures thereof.

Allergan's Proposed Construction2 chloride and mixtures thereof. Allergan disagrees with Apotex that the language " Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye." is necessary.

Apotex's Proposed Construction chloride and mixtures thereof. " Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye."

The definition of " ophthalmically acceptable See., e.g., ' 078 patent, col. 5, tonicity component" is at lines 13-44; Examples V-VIII. column 5, lines 24-33. See citations for Claim 1 above.

Claim 14 14. The preserved ophthalmic formulation of claim 8 wherein said at least one buffer component is selected from the group consisting of potassium phosphates, boric acid, sodium borate, sodium phosphates and mixtures thereof. Claim 15 15. The preserved ophthalmic formulation of claim 8 wherein said at least one ophthalmically acceptable buffer component is present in an amount effective to maintain said ophthalmically acceptable aqueous medium at a pH in the range of about 7 to about 7.5. Claim 16

Agreed-upon construction: Claim 14 contains all the limitations of claim 8, with the further requirement that at least one buffer component is selected from the group consisting of potassium phosphates, boric acid, sodium borate, sodium phosphates and mixtures thereof.

Agreed-upon construction: Claim 15 contains all the limitations of claim 8, with the further requirement that at least one ophthalmically acceptable buffer component is present in an amount effective to maintain the ophthalmically acceptable aqueous medium at a pH in the range of approximately 7 to approximately 7.5.

13

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 14 of 62

Asserted Claim of '078 patent 16. The preserved ophthalmic formulation of claim 8 wherein said at least one ophthalmically acceptable tonicity component is present in an amount effective to maintain said ophthalmically acceptable aqueous medium at an osmolality in the range of about 200 to about 400 mOsmol/kg.

Allergan's Proposed Construction2 Claim 16 contains all the limitations of claim 8, with the further requirement that at least one ophthalmically acceptable tonicity component is present in an amount effective to maintain the ophthalmically acceptable aqueous medium at an osmolality in the range of approximately 200 to approximately 400 mOsmol/kg. Allergan disagrees with Apotex that the language " Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye." is necessary. See, e.g., ' 078 patent, col. 2, lines 20-58; col. 2, lines 6168; col. 4, lines 1-23; col. 5, lines 13-44; Examples I-VIII. The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S.

Apotex's Proposed Construction Claim 16 contains all the limitations of claim 8, with the further requirement that at least one ophthalmically acceptable tonicity component is present in an amount effective to maintain the ophthalmically acceptable aqueous medium at an osmolality in the range of approximately 200 to approximately 400 mOsmol/kg. " Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye." The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). The limitation of " an amount effective to maintain the formulation at an osmolality in the range of about 200 to

14

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 15 of 62

Asserted Claim of '078 patent

Allergan's Proposed Construction2 patent nos. 6,673,337 and 6,641,834). See citations for Claim 1 above.

Apotex's Proposed Construction about 400 mOsmol/kg" is supported by the written description at column 5, lines 13-23. The definition of " ophthalmically acceptable tonicity component" is at column 5, lines 24-33.

Claim 17 17. The preserved ophthalmic formulation of claim 8 which is a solution. Claim 18 18. A preserved ophthalmic solution comprising an ophthalmically acceptable aqueous solution and,

Agreed-upon construction: Claim 17 contains all the limitations of claim 8, with the further requirement that the formulation is a solution. Agreed-upon construction: The claim requires a preserved ophthalmic solution. Agreed-upon construction: The claim requires an ophthalmically acceptable aqueous solution. The claimed solution requires the inclusion of stabilized chlorine dioxide in an amount effective to act as the sole preservative in the ophthalmically acceptable aqueous solution in the range of approximately 0.002 to approximately 0.02 weight/volume percent. Allergan disagrees with Apotex that the language " `stabilized chlorine dioxide in an amount effective to act as the sole preservative in said ophthalmically aqueous acceptable solution' means an amount so that a 99.9% The claimed solution requires the inclusion of stabilized chlorine dioxide in an amount effective to act as the sole preservative in the ophthalmically acceptable aqueous solution in the range of approximately 0.002 to approximately 0.02 weight/volume percent. "stabilized chlorine dioxide in an amount effective to act as the sole preservative in said ophthalmically aqueous acceptable solution" means an amount so that a 99.9% reduction of microbes challenge occur within 14

included therein, stabilized chlorine dioxide in an amount effective to act as the sole preservative in said ophthalmically aqueous acceptable solution in the range of about 0.002 to about 0.02 weight/volume percent,

15

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 16 of 62

Asserted Claim of '078 patent

Allergan's Proposed Construction2 reduction of microbes challenge occur within 14 days of contact with the product being tested; and that no growth of yeast and fungi occur." is necessary or appropriate. The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). See e.g., col. 2, lines 35-36; 61-66; col. 3, lines 13-21; and 4:15-23; Examples I-VIII

Apotex's Proposed Construction days of contact with the product being tested; and that no growth of yeast and fungi occur. The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). See, e.g., `078 patent, column 8, lines 40-43.

See citations for Claim 1 above. at least one ophthalmically Agreed-upon construction: acceptable buffer component The claimed solution requires the inclusion of at least one in an amount effective to ophthalmically acceptable buffer component in an amount maintain said ophthalmically effective to maintain the ophthalmically acceptable aqueous acceptable aqueous solution at solution at a pH in the range of approximately 6.8 to a pH in the range of about 6.8 approximately 8. to about 8, and at least one ophthalmically acceptable tonicity component in an amount effective to maintain said ophthalmically acceptable aqueous solution at an osmolality in the range of about 200 to about 400 mOsmol/kg, The claimed solution requires the inclusion of at least one ophthalmically acceptable tonicity component in an amount effective to maintain the ophthalmically acceptable aqueous solution at an osmolality in the range of approximately 200 The claimed solution requires the inclusion of at least one ophthalmically acceptable tonicity component in an amount effective to maintain the ophthalmically acceptable aqueous solution at an osmolality in the range of approximately 200

16

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 17 of 62

Asserted Claim of '078 patent

Allergan's Proposed Construction2 mOsmol/kg to approximately 400 mOsmol/kg. Allergan disagrees with Apotex that the language " `Ophthalmically acceptable tonicity component' is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye." is necessary or appropriate. The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). See, e.g., ' 078 patent, col. 2, lines 20-58; col. 2, lines 6168; col. 4, lines 1-23; col. 5, lines 13-44; Examples I-VIII See citations for Claim 1 above.

Apotex's Proposed Construction mOsmol/kg to approximately 400 mOsmol/kg. " Ophthalmically acceptable tonicity component" is defined in the specification as any tonicity component or components " provided that such component or components are compatible with the other ingredients of the ophthalmic formulation and do not have deleterious or toxic properties which could harm the eye." The ordinary meaning of the term " about" is " approximately." See Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1377 (Fed. Cir. 2005); Allergan Inc. v. Alcon Inc., No. 04-968 (GMS) (D. Del. July 26, 2005) (order construing the terms of U.S. patent nos. 6,673,337 and 6,641,834). The limitation of " an amount effective to maintain the formulation at an osmolality in the range of about 200 to about 400 mOsmol/kg" is supported by the written description at column 5, lines 13-23. The definition of " ophthalmically acceptable tonicity component" is at column 5, lines 24-33.

provided that said preserved

Agreed-upon construction:

17

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 18 of 62

Asserted Claim of '078 Allergan's Proposed Apotex's Proposed 2 patent Construction Construction ophthalmic solution is The claimed solution is ophthalmically acceptable and free of ophthalmically acceptable and germicidally effective amounts of any positively charged, is free of germicidally nitrogen-containing cationic polymers. effective amounts of any positively charged, nitrogencontaining polymers.

18

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 19 of 62

'873 patent3 Asserted Claim of '873 Patent Claim 1. 1. A composition comprising: a therapeutically active component selected from the group consisting of alpha-2adrenergic agonists and mixtures thereof, and being present in an amount effective to provide a desired therapeutic benefit to a patient to whom the composition is administered; Allergan's Proposed Construction4 The claimed composition contains a component selected from the group consisting of an alpha-2-adrenergic agonist and mixtures thereof, and that component is present in an amount that is effective to provide a therapeutic benefit to a patient to whom the composition is administered. Allergan disagrees with Apotex that the language " with respect to brimonidine tartrate, at the time of filing, included the range of .2% to .5%" is necessary or proper for claim construction. Apotex's Proposed Construction The claimed composition contains a component selected from the group consisting of an alpha-2-adrenergic agonist and mixtures thereof, and that component is present in an amount that is effective to provide a therapeutic benefit to a patient to whom the composition is administered. "being present in an amount effective to provide a desired therapeutic benefit to a patient to whom the composition is administered" with respect to brimonidine tartrate, at the time of filing, included the range of .2% to .5%. See `873 patent, Table I (0.5%); Table III (0.2%). a solubility enhancing component, other than a cyclodextrin, in an amount effective to increase the solubility of the therapeutically active
3

The claimed composition contains a solubility enhancing component, which is a component other than a cylclodextrin that enhances the solubility of the

The claimed composition contains an amount of a solubility enhancing component, which is a component other than a cylclodextrin that solubilizes

4

Allergan and Apotex agree on the construction for many of the claim terms. There are, however, a few where Allergan and Apotex agree as to a portion of the construction but the remainder is in dispute. To facilitate the Court' s review of this joint claim chart, where a portion of the construction of the term is in dispute but not the entire construction, the disputed portion is in bold. Because the claim language itself is clear and unambiguous, no resort to the specification and prosecution history is necessary, therefore, the best evidence that the plain and ordinary meaning of the claim terms controls is the claims themselves. For brevity, citation to the claim language itself will not be repeated each time as the claim language is provided in Column 1. 19

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 20 of 62

Asserted Claim of '873 Patent component in the composition relative to the solubility of an identical therapeutically active component in a similar composition without the solubility enhancing component;

Allergan's Proposed Construction4 therapeutically active component relative to its solubility in a similar composition without the solubility enhancing component.

Apotex's Proposed Construction more of the therapeutically active component relative to a similar composition without the solubility enhancing component.

an oxy-chloro component in an effective amount to at least aid in preserving the composition; and a liquid carrier component. Claim 2. 2. The composition of claim 1 wherein the therapeutically active component is selected from the group consisting of imino-imidazolines, imidazolines, imidazoles, azepines, thiazines, oxazolines, guanidines, catecholamines, and mixtures thereof. Claim 3. 3. The composition of claim 1 wherein the therapeutically active component includes a quinoxaline component. Claim 4. 4. The composition of claim 3 wherein the quinoxaline component is selected from the group consisting of quinoxalines, quinoxaline derivatives, and mixtures thereof. Claim 5. 5. The composition of claim 3

See e.g., ' 873 patent, col. 1, See `873 patent, Column 16, lines 13-18; col. 1, lines 43lines 20-62, Table IV, Fig. 1. 53; col. 2, lines 3-6; col. 3, lines 1-9; col. 4, lines 38-52; col. 5, lines 3-10. Agreed-upon construction: The claimed composition contains an oxy-chloro component in an effective amount to at least aid in preserving the composition Agreed-upon construction: The claimed composition contains a liquid carrier component. Agreed-upon construction: Claim 2 includes all of the limitations of claim 1, with the further requirement that the therapeutically active component is selected from the group consisting of imino-imidazolines, imidazolines, imidazoles, azepines, thiazines, oxazolines, guanidines, catecholamines, and mixtures thereof.

Agreed-upon construction: Claim 3 includes all of the limitations of claim 1, with the further requirement that the therapeutically active component includes a quinoxaline component. Agreed-upon construction: Claim 4 includes all of the limitations of claim 3, with the further requirement that the quinoxaline component is selected from the group consisting of quinoxalines, quinoxaline derivatives, and mixtures thereof.

Claim 5 includes all of the 20

Claim 5 includes all of the

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 21 of 62

Asserted Claim of '873 Patent wherein the quinoxaline component is selected from the group consisting of quinoxaline, (2-imidozolin-2ylamino) quinoxaline, 5bromo-6-(2-imidozolin-2ylamino) quinoxaline, and tartrate of 5-bromo-6-(2imidozolin-2-ylamino) quinoxaline, and mixtures thereof.

Allergan's Proposed Construction4 limitations of claim 3, with the further requirement that the quinoxaline component is selected from the group consisting of quinoxaline, (2imidozolin-2-ylamino) quinoxaline, brimonidine, and brimonidine tartrate, and mixtures thereof. Allergan disagrees with Apotex that the language " "being present in an amount effective to provide a desired therapeutic benefit to a patient to whom the composition is administered" as recited in claim 1, with respect to a tartrate of 5-bromo-6-(2imidozolin-2-ylamino) quinoxaline, as recited in claim 5, at the time of filing, included the range of .2% to .5%." is necessary or proper for claim construction. Claim 6 includes all of the limitations of claim 1, with the further requirement that the therapeutically active component comprises brimonidine tartrate. Allergan disagrees with Apotex that the language " being present in an amount effective to provide a desired therapeutic benefit to a patient to whom the composition is administered" as recited in claim 1, with respect to a tartrate of 5-bromo-6-(2imidozolin-2-ylamino)

Apotex's Proposed Construction limitations of claim 3, with the further requirement that the quinoxaline component is selected from the group consisting of quinoxaline, (2imidozolin-2-ylamino) quinoxaline, brimonidine, and brimonidine tartrate, and mixtures thereof. "being present in an amount effective to provide a desired therapeutic benefit to a patient to whom the composition is administered" as recited in claim 1, with respect to a tartrate of 5-bromo-6-(2imidozolin-2-ylamino) quinoxaline, as recited in claim 5, at the time of filing, included the range of .2% to .5%. See `873 patent, Table I (0.5%); Table III (0.2%). Claim 6 includes all of the limitations of claim 1, with the further requirement that the therapeutically active component comprises brimonidine tartrate. "being present in an amount effective to provide a desired therapeutic benefit to a patient to whom the composition is administered" as recited in claim 1, with respect to a tartrate of 5-bromo-6-(2imidozolin-2-ylamino) quinoxaline, as recited in

Claim 6. 6. The composition of claim 1 wherein the therapeutically active component comprises a tartrate of 5-bromo-6-(2imidozolin-2-ylamino) quinoxaline.

21

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 22 of 62

Asserted Claim of '873 Patent

Allergan's Proposed Construction4 quinoxaline, as recited in claim 6, at the time of filing, included the range of .2% to .5%." is necessary or proper for claim construction. Claim 7 includes all of the limitations of claim 1, with the further requirement that the therapeutically active component has increased diffusion through a lipid membrane relative to an identical therapeutically active component in a similar composition without the solubility enhancing component. Allergan does not agree with Apotex that the language " `increased diffusion through a lipid membrane' means increased movement through a biological membrane composed of lipid molecules, including cell membranes, is necessary or appropriate as the claim is clear on it face. See e.g. Claim 7; col. 5, lines 3-31; col. 8, lines 11-18. Claim 8 includes all of 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 therapeutically active component relative to the solubility in a biological

Apotex's Proposed Construction claim 6, at the time of filing, included the range of .2% to .5%. See `873 patent, Table I (0.5%); Table III (0.2%). Claim 7 includes all of the limitations of claim 1, with the further requirement that the therapeutically active component has increased diffusion through a lipid membrane relative to an identical therapeutically active component in a similar composition without the solubility enhancing component. "increased diffusion through a lipid membrane" means increased movement through a biological membrane composed of lipid molecules, including cell membranes. `873 patent, column 5, lines 317, column 8, lines 11-18.

Claim 7. 7. The composition of claim 1 wherein the therapeutically active component has increased diffusion through a lipid membrane relative to an identical therapeutically active component in a similar composition without the solubility enhancing component.

Claim 8. 8. The composition of claim 1 wherein the solubility enhancing component is effective to increase the solubility in a biological environment of the therapeutically active component relative to the solubility in a biological environment of an identical

Claim 8 includes all of the limitations of claim 1, with the further requirement that the solubility enhancing component is effective to solubilize more in a biological environment of the therapeutically active component relative to the solubility in a biological environment of an identical therapeutically active

22

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 23 of 62

Asserted Claim of '873 Patent therapeutically active component in a similar composition without the solubility enhancing component.

Allergan's Proposed Construction4 environment of an identical therapeutically active component in a similar composition without the solubility enhancing component.

Apotex's Proposed Construction component in a similar composition without the solubility enhancing component.

a "biological environment" means an portion of the patient's body being treated Allergan does not believe that by the therapeutically active the additional language sought component, including the cornea of an eye. by Apotex; " a "biological environment" means an `873 patent, column 5, lines 3portion of the patient' body s 17, column 8, lines 11-18. being treated by the therapeutically active component, including the cornea of an eye," is necessary as the claim is unambiguous on its face. `873 patent, column 5, lines 3-17, column 8, lines 11-18; Claim 8.

Claim 9. 9. The composition of claim 1 wherein the solubility enhancing component comprises a polyanionic component. Claim 10. 10. The composition of claim 9 wherein said polyanionic components is selected from the group consisting of anionic cellulose derivatives, anionic polymers derived from acrylic acid, anionic polymers derived from methacrylic acid, anionic polymers derived from alginic acid, anionic polymers derived from amino acids and mixtures thereof. Claim 11. 11. The composition of claim

Agreed-upon construction: Claim 9 includes all of the limitations of claim 1, with the further requirement that the solubility enhancing component comprises a polyanionic component. Agreed-upon construction: Claim 10 includes all of the limitations of claim 9, with the further requirement that the said polyanionic component is selected from the group consisting of anionic cellulose derivatives, anionic polymers derived from acrylic acid, anionic polymers derived from methacrylic acid, anionic polymers derived from alginic acid, anionic polymers derived from amino acids and mixtures thereof.

Agreed-upon construction:

23

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 24 of 62

Asserted Claim of '873 Patent 1 wherein the solubility enhancing component comprises an anionic cellulose derivative. Claim 12. 12. The composition of claim 1 wherein the solubility enhancing component comprises a carboxymethylcellulose. Claim13. 13. The composition of claim 1 wherein the solubility enhancing component is present in an amount in a range of about 0.1% (w/v) to about 30% (w/v). Claim 14. 14. The composition of claim 1 wherein the solubility enhancing component is present in an amount in a range of about 0.2% (w/v) to about 10 (w/v). Claim 15. 15. The composition of claim 1 wherein the solubility enhancing component is present in an amount in a range of about 0.2% (w/v) to about 0.6% (w/v). Claim 16. 16. The composition of claim 1 wherein the oxy-chloro component is selected from the group consisting of hypochlorite components, perchlorate components, chlorite components and mixtures thereof. Claim 17. 17. The composition of claim 1 wherein the oxy-chloro component comprises a

Allergan's Proposed Apotex's Proposed 4 Construction Construction Claim 11 includes all of the limitations of claim 1, with the further requirement that the solubility enhancing component comprises an anionic cellulose derivative. Agreed-upon construction: Claim 12 includes all of the limitations of claim 1, with the further requirement that the solubility enhancing component comprises a carboxymethylcellulose. Agreed-upon construction: Claim 13 includes all of the limitations of claim 1, with the further requirement that the solubility enhancing component is present in an amount in a range of approximately 0.1% (w/v) to approximately 30% (w/v). Agreed-upon construction: Claim 14 includes all of the limitations of claim 1, with the further requirement that the solubility enhancing component is present in an amount in a range of approximately 0.2% (w/v) to approximately 10 (w/v). Agreed-upon construction: Claim 15 includes all of the limitations of claim 1, with the further requirement that the solubility enhancing component is present in an amount in a range of approximately 0.2% (w/v) to approximately 0.6% (w/v). Agreed-upon construction: Claim 16 includes all of the limitations of claim 1, with the further requirement that the oxy-chloro component is selected from the group consisting of hypochlorite components, perchlorate components, chlorite components and mixtures thereof.

Agreed-upon construction: Claim 17 includes all of the limitations of claim 1, with the further requirement that the oxy-chloro component comprises a 24

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 25 of 62

Asserted Claim of '873 Patent chlorite component. Claim 18. 18. The composition of claim 1 wherein the oxy-chloro component comprises stabilized chlorine dioxide. Claim 19. 19. The composition of claim 1, wherein the oxy-chloro component is present in an amount of about 500 ppm (w/v) or less. Claim 20. 20. The composition of claim 1 wherein the oxy-chloro component is present in an amount in a range of about 10 ppm (w/v) to about 200 ppm (w/v). Claim 23. 23. The composition of claim 1 wherein the liquid carrier is an aqueous liquid carrier component. Claim 24. 24. The composition of claim 1 which is a solution. Claim 25. 25. The composition of claim 1 which has a pH of about 7 or greater.

Allergan's Proposed Construction4 chlorite component.

Apotex's Proposed Construction

Agreed-upon construction: Claim 18 includes all of the limitations of claim 1, with the further requirement that the oxy-chloro component comprises stabilized chlorine dioxide. Agreed-upon construction: Claim 19 includes all of the limitations of claim 1, with the further requirement that the oxy-chloro component is present in an amount of approximately 500 ppm (w/v) or less. Agreed-upon construction: Claim 20 includes all of the limitations of claim 1, with the further requirement that the oxy-chloro component is present in an amount in a range of approximately 10 ppm (w/v) to approximately 200 ppm (w/v). Agreed-upon construction: Claim 23 includes all of the limitations of claim 1, with the further requirement that the liquid carrier is an aqueous liquid carrier component. Agreed-upon construction: Claim 24 includes all of the limitations of claim 1, with the further requirement that the composition of claim 1 is a solution. Agreed-upon construction: Claim 25 includes all of the limitations of claim 1, with the further requirement that has a pH of approximately 7 or greater.

Claim 26. 26. The composition of claim Agreed-upon construction: 1 which has a pH in a range of Claim 26 includes all of the limitations of claim 1, with the about 7 to about 9. further requirement that the composition has a pH in a range of approximately 7 to approximately 9. Claim 27. 27. The composition of claim Agreed-upon construction: 1 which is ophthalmically Claim 27 includes all of the limitations of claim 1, with the acceptable. further requirement that the composition is ophthalmically acceptable. 25

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 26 of 62

Asserted Claim of '873 Patent Claim 28. 28. A composition comprising: a therapeutically active component selected from the group consisting of alpha-2adrenergic agonists and mixtures thereof in an amount effective to provide a therapeutic benefit to a patient to whom the composition is administered; an anionic cellulose derivative in an amount effective to increase the solubility of the therapeutically active component;

Allergan's Proposed Construction4

Apotex's Proposed Construction

Agreed-upon construction: The claimed composition contains a therapeutically active component selected from the group consisting of alpha-2adrenergic agonists and mixtures thereof in an amount effective to provide a therapeutic benefit to a patient to whom the composition is administered.

The claimed composition contains an anionic cellulose derivative in an amount effective to increase the solubility of the therapeutically active component.

The claimed composition contains an anionic cellulose derivative in an amount effective to solubilize more of the therapeutically active component.

a chlorite component in an effective amount to at least aid in preserving the composition; and an aqueous liquid carrier component. Claim 29. 29. The composition of claim 28 wherein the therapeutically active component comprises a tartrate of 5-bromo-6-(2imidozolin-2-ylamino) quinoxaline.

See e.g., ' 873 patent, col. 1, lines 13-18; col. 1, lines 4353; col. 2, lines 3-6; col. 3, lines 1-9; col. 4, lines 38-52; col. 5, lines 3-10; Examples I and II including the figure and tables. Agreed-upon construction: The claimed composition contains a chlorite component in an effective amount to at least aid in preserving the composition Agreed-upon construction: The claimed composition contains an aqueous liquid carrier component. Claim 29 includes all of the limitations of claim 28, with the further requirement that the therapeutically active component comprises brimonidine tartrate. Allergan disagrees with Apotex that the language Claim 29 includes all of the limitations of claim 28, with the further requirement that the therapeutically active component comprises brimonidine tartrate. "being present in an amount effective to provide a

26

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 27 of 62

Asserted Claim of '873 Patent

Allergan's Proposed Construction4 " being present in an amount effective to provide a desired therapeutic benefit to a patient to whom the composition is administered" as recited in claim 28, with respect to a tartrate of 5-bromo-6-(2imidozolin-2-ylamino) quinoxaline, as recited in claim 29, at the time of filing, included the range of .2% to .5%." is necessary or proper for claim construction.

Apotex's Proposed Construction desired therapeutic benefit to a patient to whom the composition is administered" as recited in claim 28, with respect to a tartrate of 5-bromo-6-(2imidozolin-2-ylamino) quinoxaline, as recited in claim 29, at the time of filing, included the range of .2% to .5%. See `873 patent, Table I (0.5%); Table III (0.2%).

Claim 30. 30. The composition of claim 28 wherein the anionic cellulose derivative comprises carboxymethylcellulose. Claim 31. 31. The composition of claim 28 wherein the anionic cellulose derivative is present in an amount in a range of about 0.2% to about 0.6% (w/v). Claim 32. 32. A composition comprising: a tartrate of 5-bromo-6-(2imidozolin-2-ylamino) quinoxaline in an amount effective to provide a therapeutic benefit to a patient to whom the composition is administered;

Agreed-upon construction: Claim 30 includes all of the limitations of claim 28, with the further requirement that the anionic cellulose derivative comprises carboxymethylcellulose. Agreed-upon construction: Claim 31 includes all of the limitations of claim 28, with the further requirement that the anionic cellulose derivative is present in an amount in a range of approximately 0.2% to approximately 0.6% (w/v).

The claimed composition contains brimonidine tartrate in an amount effective to provide a therapeutic benefit to a patient to whom the composition is administered. Allergan disagrees with Apotex that the language "an amount effective to provide a desired therapeutic benefit to a patient to whom the composition is administered" of a tartrate of 5-bromo-6-(2imidozolin-2-ylamino)

The claimed composition contains brimonidine tartrate in an amount effective to provide a therapeutic benefit to a patient to whom the composition is administered. "an amount effective to provide a desired therapeutic benefit to a patient to whom the composition is administered" of a tartrate of 5-bromo-6-(2-imidozolin2-ylamino) quinoxaline, at

27

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 28 of 62

Asserted Claim of '873 Patent

Allergan's Proposed Construction4 quinoxaline, at the time of filing, included the range of .2% to .5%." is necessary or appropriate for claim construction. The claimed composition contains a solubility enhancing component in an amount effective to increase the solubility of brimonidine tartrate. Allergan disagrees with Apotex that the language " Additional solubility enhancing components, such as cyclodextrins, are not excluded by this claim language," is necessary or appropriate for claim construction.

Apotex's Proposed Construction the time of filing, included the range of .2% to .5%. See `873 patent, Table I (0.5%); Table III (0.2%). The claimed composition contains a solubility enhancing component in an amount effective to solubilize more of brimonidine tartrate. Additional solubility enhancing components, such as cyclodextrins, are not excluded by this claim language.

a solubility enhancing component in an amount effective to increase the solubility of the tartrate of 5bromo-6-(2-imidozolin-2ylamino) quinoxaline;

a chlorite component in an effective amount to at least aid in preserving the composition; and an aqueous liquid carrier component. Claim 33. 33. The composition of claim 32 wherein the solubility enhancing component comprises a carboxymethylcellulose. Claim 34. 34. The composition of claim 32 which is ophthalmically acceptable. Claim 35. 35. A composition comprising:

Agreed-upon construction: The claimed composition contains a chlorite component in an effective amount to at least aid in preserving the composition. Agreed-upon construction: The claimed composition contains an aqueous liquid carrier component. Agreed-upon construction: Claim 33 includes all of the limitations of claim 32, with the further requirement that the solubility enhancing component comprises a carboxymethylcellulose. Agreed-upon construction: Claim 34 includes all of the limitations of claim 32, with the further requirement that the composition of claim 32 is ophthalmically acceptable.

28

Case 1:07-md-01866-GMS

Document 42

Filed 05/16/2008

Page 29 of 62

Asserted Claim of '873 Patent a therapeutically active component in an amount effective to provide a desired therapeutic benefit to a patient to whom the composition is administered; an oxy-chloro component in an effective amount to at least aid in preserving the composition; and a liquid carrier component, wherein the composition is substantially free of cyclodextrins. Claim 36. 36. The composition of claim 35 wherein the therapeutically active component is selected from the group consisting of antibacterials, antihistamines, decongestants, antiinflammatories, antiparasitics, miotics, anticholinergics, adrenergics, antivirals, local anesthetics, antifungals, amoebicidals, trichomonocidals, analgesics, mydriatics, antiglaucoma drugs, carbonic anhydrase inhibitors, ophthalmic diagnostic agents, ophthalmic agents used as adjuvants in surgery, chelating agents, antineoplascics, antihypertensives, muscle relaxants, diagnostics, and mixtures thereof. Claim 37. 37. The composition of claim 35 wherein the therapeutically active component is selected from the group consisting of

Allergan's Proposed Apotex's Proposed 4 Construction Construction Agreed-upon construction: The claimed composition contains a therapeutically active component in an amount effective to provide a desired therapeutic benefit to a patient to whom the composition is administered.

Agreed-upon construction: The claimed composition contains an oxy-chloro component in an effective amount to at least aid in preserving the composition. Agreed-upon construction: The claimed composition contains a liquid carrier component, wherein the composition is substantially free of cyclodextrins. Agreed-upon construction: Claim 36 includes all of the limitations of claim 35, with the further requirement that the therapeutically active component is selected from the group consisting of antibacterials, antihistamines, decongestants, antiinflammatories, antiparasitics, miotics, anticholinergics, adrenergics, antivirals, local anesthetics, antifungals, amoebicidals, trichomonocidals, analgesics, mydriatics, antiglaucoma drugs, carbonic anhydrase inhibitors, ophthalmic diagnostic agents, ophthalmic agents used as adjuvants in surgery, chelating agents, antineoplascics, antihypertensives, muscle relaxants, diagnostics, and mixtures thereof.

Agreed-upon construction: Claim 37 includes all of the limitations of claim 35, with the further requirement that the therapeutically active component is selec