UNITED STATES DISTRICT COURT
`MIDDLE DISTRICT OF FLORIDA
`TAMPA DIVISION
`
`
`
`ADAMIS PHARMACEUTICALS
`CORPORATION,
`
`Plaintiff,
`
`
`
`
`
`
`
`
`
`v.
`
`
`
`
`
`
`
`
`
`
`
`
`
`BELCHER PHARMACEUTICALS, LLC,
`
`
`
`
`
`
`
`
`
`
`
`Defendant.
`
`
`
`
`
`
`
`CASE No: 8:18-cv-02379-WFJ-AAS
`
`
`
`
`/
`
`
`
`
`
`
`
`PLAINTIFF BELCHER PHARMACEUTICALS, LLC’S
`INITIAL INFRINGEMENT CONTENTIONS
`
`
`
`
`Pursuant to the Scheduling Order entered December 19, 2018, [Dkt. 18], Defendant
`
`Belcher Pharmaceuticals, LLC (“Belcher”) provides the following Initial Infringement
`
`Contentions for Plaintiff Adamis Pharmaceuticals Corporation (“Adamis”). These contentions
`
`are preliminary and based solely on information in Belcher’s possession, custody, or control.
`
`Belcher reserves the right to supplement these contentions as appropriate based upon further
`
`discovery and the schedule of this case.
`
`
`
`
`
`
`
`
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`
`
`
`
`ADAMIS EXHIBIT 1020
`Page 1 of 11
`
`

`

`Dated: January 7, 2019
`
`
`
`
`
`
`
`/s/ Stefan V. Stein
`
`
`
`
`
`
`
`Stefan V. Stein
`Florida Bar No. 300527
`Cole Carlson
`Florida Bar No. 112863
`William V. Stein
`Florida Bar No. 1004226
`GrayRobinson, P.A.
`401 East Jackson Street, Suite 2700
`P.O. Box 33324
`Tampa, Florida 33602
`Tel: 813-273-5000
`Fax: 813-273-5145
`stefan.stein@gray-robinson.com
`cole.carlson@gray-robinson.com
`william.stein@gray-robinson.com
`
`
`
`
`
`
`
`ADAMIS EXHIBIT 1020
`Page 2 of 11
`
`

`

`INITIAL INFRINGEMENT CONTENTIONS
`
`With regard to the various elements contained within Claims 6 and 7 of U.S. Patent
`Number 9,283,197 (the “’197 Patent”), below is a chart indicating where each of the relevant
`limitations can be found in publicly available documents.
`
`’197 Patent Claim 6
`
`Evidence of Infringement
`
`injectable
`An
`formulation
`of
`solution;
`
`liquid pharmaceutical
`l-epinephrine
`sterile
`
`Inject SYMJEPI intramuscularly or subcutaneously
`into the anterolateral aspect of the thigh with the
`needle facing downwards. It can be
`injected
`through clothing if necessary.
`
`said liquid pharmaceutical formulation
`having a pH between 2.8 and 3.3;
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 2.
`
`injection, USP)
`(epinephrine
`Each SYMJEPI
`syringe contains 0.8 mL of sterile aqueous solution
`of epinephrine for intramuscular or subcutaneous
`administration. The syringe is overfilled: more than
`half of the solution remains in the syringe after use
`and CANNOT BE REUSED.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6.
`
`Belcher disputes Adamis’ contention that this claim
`requires an in-process pH between 2.8 and 3.3. The
`plain language of the claim states that “said liquid
`pharmaceutical formulation” has the stated pH
`range which logically and grammatically refers to
`the final product.
`
`The pH range is 2.2-5.0.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/nd
`a/2017/207534Orig1s0000ChemR.pdf at 12. This
`document is heavily redacted and the final pH is
`obscured. As such, on information and belief, the
`final product has a pH in the claimed range.
`
`
`
`
`
`ADAMIS EXHIBIT 1020
`Page 3 of 11
`
`

`

`liquid pharmaceutical
`injectable
`said
`formulation compounded in an aqueous
`solution as 1.0
`to 1.06 mg/mL
`l-
`epinephrine,
`
`and further including a tonicity agent;
`
`injection, USP)
`(epinephrine
`Each SYMJEPI
`syringe contains 0.8 mL of sterile aqueous solution
`of epinephrine for intramuscular or subcutaneous
`administration. The syringe is overfilled: more than
`half of the solution remains in the syringe after use
`and CANNOT BE REUSED.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6.
`On information and belief, the product must be
`compounded in an aqueous solution if the final
`product is an aqueous solution.
`
`Further, the Chemistry Review from the publicly
`available portions of the SYMJEPI NDA as
`summarized by the FDA states that the drug is sold
`as 1 mg/mL.
`https://www.accessdata.fda.gov/drugsatfda_docs/nd
`a/2017/207534Orig1s0000ChemR.pdf at 29.
`
`Each 0.3 mL in SYMJEPI 0.3 mg contains 0.3 mg
`epinephrine, 1.8 mg sodium chloride, 0.5 mg
`sodium metabisulfite, hydrochloric acid to adjust
`pH, and Water for Injection. The pH range is 2.2-
`5.0.
`
`Each 0.3 mL in SYMJEPI 0.15 mg contains 0.15
`mg epinephrine, 1.8 mg sodium chloride, 0.3 mg
`sodium metabisulfite, hydrochloric acid to adjust
`pH, and Water for Injection. The pH range is 2.2-
`5.0.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6.
`
`said liquid pharmaceutical formulation
`including no more than about 6% d-
`epinephrine and no more than about 0.5%
`adrenalone at release,
`
`Based on stability data, Adamis is requesting a
`shelf-life (expiry date) of 18 months when stored at
`room temperature 77ºF in the plastic case provided.
`The Stability data support an 18-month expiry.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/nd
`a/2017/207534Orig1s0000SumR.pdf at 4.
`
`Protect from light. Epinephrine is light sensitive
`and should be stored in the case provided to protect
`it from light . . . Before using, check to make sure
`the solution in the syringe is clear and colorless.
`
`ADAMIS EXHIBIT 1020
`Page 4 of 11
`
`

`

`Replace the product if the solution is discolored
`(pinkish or brown color), cloudy, or contains
`particles.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 8.
`
`On information and belief, the SYMJEPI liquid
`pharmaceutical formulation includes no more than
`about 6% d-epinephrine and no more than about
`0.5% adrenalone at
`release based on
`these
`indications.
`
`than about 12% d-
`and no more
`epinephrine and no more than about 0.5%
`adrenalone over a shelf-life of at least 12
`months.
`
`Based on stability data, Adamis is requesting a
`shelf-life (expiry date) of 18 months when stored at
`room temperature 77ºF in the plastic case provided.
`The Stability data support an 18-month expiry.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/nd
`a/2017/207534Orig1s0000SumR.pdf at 4.
`
`Protect from light. Epinephrine is light sensitive
`and should be stored in the case provided to protect
`it from light . . . Before using, check to make sure
`the solution in the syringe is clear and colorless.
`Replace the product if the solution is discolored
`(pinkish or brown color), cloudy, or contains
`particles.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 8.
`
`On information and belief, the SYMJEPI liquid
`pharmaceutical formulation includes no more than
`about 12% d-epinephrine and no more than about
`0.5% adrenalone over a shelf-life of at least 12
`months based on these indications.
`
`
`
`
`
`
`
`
`
`
`ADAMIS EXHIBIT 1020
`Page 5 of 11
`
`

`

`’197 Patent Claim 7
`
`Evidence of Infringement
`
`The said injectable liquid pharmaceutical
`formulation of claim 6 further having a
`concentration of 1 mg per mL
`l-
`epinephrine.
`
`Inject SYMJEPI intramuscularly or subcutaneously
`into the anterolateral aspect of the thigh with the
`needle facing downwards. It can be
`injected
`through clothing if necessary.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 2.
`
`injection, USP)
`(epinephrine
`Each SYMJEPI
`syringe contains 0.8 mL of sterile aqueous solution
`of epinephrine for intramuscular or subcutaneous
`administration. The syringe is overfilled: more than
`half of the solution remains in the syringe after use
`and CANNOT BE REUSED.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6.
`
`The Chemistry Review from the publicly available
`portions of the SYMJEPI NDA as summarized by
`the FDA states
`that
`the drug
`is 1 mg/mL.
`https://www.accessdata.fda.gov/drugsatfda_docs/nd
`a/2017/207534Orig1s0000ChemR.pdf at 29.
`
`“Labeled active content is 1.0 mg/mL, formulation
`includes REDACTED overage.” Id. at 53.
`
`
`
`With regard to the various elements contained within Claims 1-7 of U.S. Patent Number
`10,004,700 (the “’700 Patent”), below is a chart indicating where each of the relevant limitations
`can be found in publicly available documents.
`
`
`’700 Patent Claim 1
`
`Evidence of Infringement
`
`A method of treating allergic reaction,
`anaphylaxis, anaphylactic shock, or a
`combination thereof
`
`SYMJEPI is indicated in the emergency treatment
`of allergic reactions (Type I) including anaphylaxis
`to stinging insects (e.g., order Hymenoptera, which
`include bees, wasps, hornets, yellow jackets and
`fire ants) and biting
`insects (e.g.,
`triatoma,
`mosquitoes), allergen immunotherapy, foods, drugs,
`diagnostic testing substances (e.g., radiocontrast
`media) and other allergens, as well as idiopathic
`anaphylaxis or exercise-induced anaphylaxis.
`
`http://www.adamispharmaceuticals.com/wp-
`
`ADAMIS EXHIBIT 1020
`Page 6 of 11
`
`

`

`by an injection of at least one dosage of an
`injectable
`liquid
`pharmaceutical
`formulation
`of
`l-epinephrine
`sterile
`solution
`
`syringe
`administered by a prefilled
`containing said at least one dosage of said
`injectable
`liquid
`pharmaceutical
`formulation;
`
`liquid pharmaceutical
`injectable
`said
`formulation compounded in an aqueous
`solution
`
`and further including a tonicity agent;
`
`content/uploads/2018/10/prescribing-info.pdf at 2.
`
`Inject SYMJEPI intramuscularly or subcutaneously
`into the anterolateral aspect of the thigh with the
`needle facing downwards. It can be
`injected
`through clothing if necessary.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 2.
`
`injection, USP)
`(epinephrine
`Each SYMJEPI
`syringe contains 0.8 mL of sterile aqueous solution
`of epinephrine for intramuscular or subcutaneous
`administration.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6.
`
`DOSAGE FORMS AND STRENGTHS
`
`Injection: Single-dose pre-filled syringe for manual
`injection, containing 0.3 mg/0.3 mL epinephrine
`sterile solution for injection, USP
`
`Injection: Single-dose pre-filled syringe for manual
`injection, containing 0.15 mg/0.3 mL epinephrine
`sterile solution for injection, USP
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 2.
`
`injection, USP)
`(epinephrine
`Each SYMJEPI
`syringe contains 0.8 mL of sterile aqueous solution
`of epinephrine for intramuscular or subcutaneous
`administration. The syringe is overfilled: more than
`half of the solution remains in the syringe after use
`and CANNOT BE REUSED.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6.
`On information and belief, the product must be
`compounded in an aqueous solution if the final
`product is an aqueous solution.
`
`Each 0.3 mL in SYMJEPI 0.3 mg contains 0.3 mg
`epinephrine, 1.8 mg sodium chloride, 0.5 mg
`sodium metabisulfite, hydrochloric acid to adjust
`pH, and Water for Injection. The pH range is 2.2-
`
`ADAMIS EXHIBIT 1020
`Page 7 of 11
`
`

`

`5.0.
`
`Each 0.3 mL in SYMJEPI 0.15 mg contains 0.15
`mg epinephrine, 1.8 mg sodium chloride, 0.3 mg
`sodium metabisulfite, hydrochloric acid to adjust
`pH, and Water for Injection. The pH range is 2.2-
`5.0.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6
`(emphasis added).
`
`liquid pharmaceutical
`injectable
`said
`formulation containing up to 1.1 mg of l-
`epinephrine per prefilled syringe
`
`Each SYMJEPI 0.3 mg pre-filled syringe delivers a
`single dose of 0.3 mg of epinephrine from
`epinephrine injection, USP (0.3 mg/0.3 mL).
`
`and having a pH between 2.8 and 3.3;
`
`Each SYMJEPI 0.15 mg pre-filled syringe delivers
`a single dose of 0.15 mg of epinephrine from
`epinephrine injection, USP (0.15 mg/0.3 mL).
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6.
`
`Belcher disputes Adamis’ contention that this claim
`requires an in-process pH between 2.8 and 3.3. The
`plain language of the claim states that “said liquid
`pharmaceutical formulation” has the stated pH
`range which logically and grammatically refers to
`the final product.
`
`The pH range is 2.2-5.0.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/nd
`a/2017/207534Orig1s0000ChemR.pdf at 12. This
`document is heavily redacted and the final pH is
`obscured. As such, on information and belief, the
`final product has a pH in the claimed range.
`
`said liquid pharmaceutical formulation
`including no more than about 6% d-
`epinephrine and no more than about 0.5%
`adrenalone at release,
`
`Based on stability data, Adamis is requesting a
`shelf-life (expiry date) of 18 months when stored at
`room temperature 77ºF in the plastic case provided.
`The Stability data support an 18-month expiry.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/nd
`
`ADAMIS EXHIBIT 1020
`Page 8 of 11
`
`

`

`a/2017/207534Orig1s0000SumR.pdf at 4.
`
`Protect from light. Epinephrine is light sensitive
`and should be stored in the case provided to protect
`it from light . . . Before using, check to make sure
`the solution in the syringe is clear and colorless.
`Replace the product if the solution is discolored
`(pinkish or brown color), cloudy, or contains
`particles.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 8.
`
`On information and belief, the SYMJEPI liquid
`pharmaceutical formulation includes no more than
`about 6% d-epinephrine and no more than about
`0.5% adrenalone at
`release based on
`these
`indications.
`
`than about 12% d-
`and no more
`epinephrine and no more than about 0.5%
`adrenalone over a shelf-life of at least 12
`months.
`
`Based on stability data, Adamis is requesting a
`shelf-life (expiry date) of 18 months when stored at
`room temperature 77ºF in the plastic case provided.
`The Stability data support an 18-month expiry.
`
`https://www.accessdata.fda.gov/drugsatfda_docs/nd
`a/2017/207534Orig1s0000SumR.pdf at 4.
`
`Protect from light. Epinephrine is light sensitive
`and should be stored in the case provided to protect
`it from light . . . Before using, check to make sure
`the solution in the syringe is clear and colorless.
`Replace the product if the solution is discolored
`(pinkish or brown color), cloudy, or contains
`particles.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 8.
`
`On information and belief, the SYMJEPI liquid
`pharmaceutical formulation includes no more than
`about 12% d-epinephrine and no more than about
`0.5% adrenalone over a shelf-life of at least 12
`months based on these indications.
`
`
`
`
`
`ADAMIS EXHIBIT 1020
`Page 9 of 11
`
`

`

`’700 Patent Claim 2
`
`Evidence of Infringement
`
`The method of claim 1 wherein said
`injectable
`liquid
`pharmaceutical
`formulation is compounded in an aqueous
`solution with up
`to 1.1 mg/mL
`l-
`epinephrine.
`
`Each SYMJEPI 0.3 mg pre-filled syringe delivers a
`single dose of 0.3 mg of epinephrine from
`epinephrine injection, USP (0.3 mg/0.3 mL).
`
`Each SYMJEPI 0.15 mg pre-filled syringe delivers
`a single dose of 0.15 mg of epinephrine from
`epinephrine injection, USP (0.15 mg/0.3 mL).
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6.
`
`Since each SYMJEPI syringe is either 0.3 mg or
`0.15 mg, the liquid pharmaceutical formulation
`must be compounded in an aqueous solution with
`1.1 mg/mL l-epinephrine or less.
`
`
`
`’700 Patent Claim 3
`
`Evidence of Infringement
`
`The method of claim 1 wherein said
`injectable
`liquid
`pharmaceutical
`formulation has a concentration of 1 mg
`per mL l-epinephrine.
`
`The Chemistry Review from the publicly available
`portions of the SYMJEPI NDA as summarized by
`the FDA states
`that
`the drug
`is 1 mg/mL.
`https://www.accessdata.fda.gov/drugsatfda_docs/nd
`a/2017/207534Orig1s0000ChemR.pdf at 29.
`
`“Labeled active content is 1.0 mg/mL, formulation
`includes REDACTED overage.” Id. at 53.
`
`
`
`’700 Patent Claim 4
`
`Evidence of Infringement
`
`The method of claim 1 wherein said
`injectable
`liquid
`pharmaceutical
`formulation is stored in a container with
`an inert gas prior to use.
`
`“The pre-filled syringe consists of a 1 mL standard
`glass syringe barrel sealed at one end by a rubber
`plunger stopper, and at the other end fitted with a
`25 G5/8” injection needle, covered by a rigid needle
`shield.”
`https://www.accessdata.fda.gov/drugsatfda_docs/nd
`a/2017/207534Orig1s0000ChemR.pdf at 12.
`
`liquid
`the
`belief,
`and
`information
`On
`pharmaceutical container must be filled with an
`inert gas to prevent degradation.
`
`
`
`ADAMIS EXHIBIT 1020
`Page 10 of 11
`
`

`

`’700 Patent Claim 5
`
`Evidence of Infringement
`
`The method of claim 1 wherein said
`injection is intramuscular or subcutaneous
`injection and is administered by a syringe
`assist device/autoinjector containing said
`prefilled syringe.
`
`Inject SYMJEPI intramuscularly or subcutaneously
`into the anterolateral aspect of the thigh with the
`needle facing downwards. It can be
`injected
`through clothing if necessary.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 2.
`
`injection, USP)
`(epinephrine
`Each SYMJEPI
`syringe contains 0.8 mL of sterile aqueous solution
`of epinephrine for intramuscular or subcutaneous
`administration. The syringe is overfilled: more than
`half of the solution remains in the syringe after use
`and CANNOT BE REUSED.
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6.
`
`
`On information and belief, the SYMJEPI syringe
`can be administered using a syringe assist
`device/autoinjector
`containing
`said
`prefilled
`syringe.
`
`
`’700 Patent Claim 6
`
`Evidence of Infringement
`
`The method of claim 1 wherein said at
`least one dosage of an injectable liquid
`pharmaceutical
`formulation
`is
`approximately 0.15 mg l-epinephrine.
`
`Each SYMJEPI 0.15 mg pre-filled syringe delivers
`a single dose of 0.15 mg of epinephrine from
`epinephrine injection, USP (0.15 mg/0.3 mL).
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6.
`
`
`’700 Patent Claim 7
`
`Evidence of Infringement
`
`The method of claim 1 wherein said at
`least one dosage of an injectable liquid
`pharmaceutical
`formulation
`is
`approximately 0.30 mg l-epinephrine.
`
`Each SYMJEPI 0.3 mg pre-filled syringe delivers a
`single dose of 0.3 mg of epinephrine from
`epinephrine injection, USP (0.3 mg/0.3 mL).
`
`http://www.adamispharmaceuticals.com/wp-
`content/uploads/2018/10/prescribing-info.pdf at 6.
`
`
`
`
`ADAMIS EXHIBIT 1020
`Page 11 of 11
`
`