UNITED STATES PATENT AND TRADEMARK OFFICE
`
`———————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`———————
`
`ETON PHARMACEUTICALS, INC.,
`
`Petitioner
`
`v.
`
`EXELA PHARMA SCIENCES, LLC,
`
`Patent Owner
`
`———————
`
`U.S. PATENT NO. 10,653,719
`
`DECLARATION OF HARRY “WARREN” JOHNSON
`
`1
`
`
`
`Eton Ex. 1116
`1 of 8
`
`
`
`———————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`———————
`
`ETON PHARMACEUTICALS, INC.,
`
`Petitioner
`
`v.
`
`EXELA PHARMA SCIENCES, LLC,
`
`Patent Owner
`
`———————
`
`U.S. PATENT NO. 10,653,719
`
`DECLARATION OF HARRY “WARREN” JOHNSON
`
`1
`
`
`
`Eton Ex. 1116
`1 of 8
`
`
`
`1.
`
`My name is Harry “Warren” Johnson. I am over 21 years of age. I
`
`submit this declaration on behalf of Eton Pharmaceuticals, Inc. (hereinafter “Eton”)
`
`in connection with the above-captioned matter, which I understand concerns U.S.
`
`Patent No. 10,653,719 (“the ’719 patent”). I am not being compensated for my time,
`
`although, as noted below, I have an indirect, potential financial interest in this matter.
`
`2.
`
`I previously submitted a declaration dated May 15, 2020, in connection
`
`with a PGR concerning U.S. Patent No. 10,478,453 (“the ’453 patent”), which I
`
`understand is related to the ’719 patent.
`
`3.
`
`In connection with this Declaration, I reviewed certain business records
`
`of Allergy Laboratories, Inc. (hereinafter “Allergy Labs”) and AL Pharma, Inc.
`
`(hereinafter “AL Pharma”). These records were created and maintained in the
`
`ordinary course of Allergy’s and AL Pharma’s business.
`
`4.
`
`I also held discussions with individuals who provided information that
`
`I also relied upon in preparing this declaration.
`
`5.
`
`Based on my personal knowledge and the results of my investigation, I
`
`am informed and understand that the facts stated in this Declaration are true.
`
`Background
`
`6.
`
`From January 2001 to approximately January 2017, I served as Vice
`
`President and was a 49% owner of Allergy Labs. My wife owned the remaining
`
`shares. In or around January 2017, Allergy Labs sold some of its assets and business
`
`2
`
`
`
`Eton Ex. 1116
`2 of 8
`
`
`
`activities, including the Allergy Laboratories name, to ALK. Allergy Labs (which
`
`changed its name to AL Pharma, Inc. (“AL Pharma”) following the sale) retained
`
`the real estate, including its Oklahoma City plant, and the cysteine products, which,
`
`as discussed below, Allergy Labs previously manufactured for Sandoz Inc.
`
`(“Sandoz”). ALK currently leases AL Pharma’s Oklahoma City plant. My wife and
`
`I own all outstanding shares of AL Pharma. I have served as Vice President of AL
`
`Pharma since January 2017.
`
`7.
`
`AL Pharma has a profit sharing arrangement with Eton in connection
`
`with Eton’s proposed L-Cysteine Hydrochloride Injection drug product that is the
`
`subject of Eton’s Abbreviated New Drug Application (ANDA). I understand that
`
`Eton’s ANDA has prompted a suit for alleged patent infringement by Exela Pharma
`
`Sciences, LLC (“Exela”). I am advised that Exela contends the manufacture, use
`
`and/or sale of Eton’s proposed ANDA product would infringe one or more claims
`
`of the ’453 patent, the ’719 patent, and U.S. Patent No 10,583,155 (“the ’155
`
`patent”), which I understand is related to the ’453 and ’719 patents.
`
`The Sandoz L-Cysteine Product
`
`8.
`
`In addition to serving as Vice President, my job responsibilities at
`
`Allergy Labs during the time frame of January 2001 through January 2017 included
`
`manufacturing, sales, accounting, inventory and purchasing. My wife, a chemist and
`
`pharmacist, was primarily responsible for quality assurance and quality control.
`
`3
`
`
`
`Eton Ex. 1116
`3 of 8
`
`
`
`9.
`
`Prior to approximately 2008, Allergy Labs contract-manufactured an
`
`L-Cysteine Hydrochloride Injection, USP drug product for Parenta Pharmaceuticals
`
`(“Parenta”). Allergy Labs manufactured the Parenta L-Cysteine Product at
`
`Allergy’s manufacturing plant in Oklahoma City, Oklahoma.
`
`In or about 2008, I
`
`understand that Parenta was acquired by Sandoz. From that time until 2016, Allergy
`
`Labs contract-manufactured the L-Cysteine Hydrochloride Injection Product (50
`
`mg/mL product and available in both single dose vials and pharmacy bulk package)
`
`for Sandoz (the “Sandoz L-Cysteine Product” or “Sandoz product”).
`
`10. Allergy Labs contract-manufactured the Sandoz L-Cysteine Product
`
`pursuant to Sandoz’s specifications and sold the finished product to Sandoz pursuant
`
`to purchase orders. Among other things, the specifications for the Sandoz product
`
`required that the finished product was a clear colorless solution free of visible
`
`particulate matter from the time of manufacture until the product’s expiration date,
`
`which was two years after manufacture.
`
`11. Compliance with the above-referenced free of visible particulate matter
`
`specification was evaluated by visually inspecting the product shortly after
`
`manufacture and by storing samples for each lot of Sandoz product at approximately
`
`25 °C and approximately 60% relative humidity and visually inspecting the samples
`
`at 3, 6, 9, 12, 18 and 24-month time intervals. Allergy Labs contracted a third-party,
`
`KABS Pharmaceutical Services (“KABS”), to assist in evaluating the Sandoz
`
`4
`
`
`
`Eton Ex. 1116
`4 of 8
`
`
`
`product samples for compliance with the free of visible particulate matter
`
`specification.
`
`12.
`
`The Sandoz product consistently met the free of visible particulate
`
`matter specification, remaining free of visually detectable particulate matter for at
`
`least 24 months after manufacture.
`
`13.
`
`Pursuant to its agreement with Sandoz, various regulatory obligations,
`
`and as part of its ordinary business practices, Allergy Labs made, received and kept
`
`records associated with its manufacture of the Sandoz L-Cysteine Product and
`
`compliance with product specifications. These records included, but were not
`
`limited to, maintaining records demonstrating compliance with the free of visible
`
`particulate matter specification for each lot of Sandoz L-Cysteine Product.
`
`14. Attached as Exhibit A is a true and correct copy of a record relating to
`
`Sandoz product lot #2081915, which was manufactured on August 19, 2015. As
`
`was Allergy’s practice at the time, the date on which the product was manufactured
`
`is reflected by the lot number assigned to the product. Consistent with that practice,
`
`the numbers in the lot # that I have shown in bold represent the manufacture date
`
`(#2081915) of 08/19/15 and the “2” stands for manufacturing line 2 at the Oklahoma
`
`City plant. It is my understanding and belief that this record was made by KABS at
`
`or near the time of the events recorded therein by technicians who had knowledge
`
`and were responsible for making records of the testing of the Sandoz product
`
`5
`
`
`
`Eton Ex. 1116
`5 of 8
`
`
`
`samples for Allergy Labs, including but limited to establishing compliance with the
`
`1 free of visible pmticulate matter specification. KABS would send records of the
`
`type attached as Exhibit A to Allergy Labs, and it was Allergy Labs' regular practice
`
`to rely upon and maintain these records in the ordinary course of its business.
`
`l 5.
`
`l hereby declare under penalty of pe1jury under the laws of the Unjted
`
`States of America that the foregoing is true and con·ect, and that all statements made
`
`ofmy own knowledge are true and that all staten1ents made on information and belief
`
`are believed to be true. 1 understand that willful false statements are punishable by
`
`fine or imprisonment or both. See 18 U .S.C. § 1001.
`
`Date: /-tv<7 :2 i, .)o.2..o
`
`&r
`
`;
`
`Respectfully submitted,
`
`
`
`Eton Ex. 1116
`6 of 8
`
`
`
`Exhibit A
`
`
`
`Eton Ex. 1116
`7 of 8
`
`
`
`Confidential
`ICABS Laboratories Inc.
`
`DocuShale/SpedalProJKts/Olcmts/A/Alle,cy/Cystdne/StablHtyFollow-Up/StllbRlty follow up (lot 2081915)
`
`2017 SEP 2 2 ff'
`
`(49.JmgfmL)
`9K.6,.LC
`
`(49.4mgfmL)
`9K.7~" LC
`
`(4H.KmgfmL)
`97.6~•1.C
`
`(49.0mgfmL)
`9K.I~. LC
`
`(4K.SmglmL)
`96.9•;. LC
`
`(49.2mglmL)
`911.mLC
`
`(4H.2mg/mL)
`96.4°.LC
`
`KS.0 • I IS.0~. LC
`
`KABS-134K.t.C
`
`Assay
`
`10.6
`
`I.)
`
`N.App.
`
`I.)
`
`10.K
`
`I.)
`
`N.:App.
`
`N.'App.
`
`N.'App.
`
`N.IApp.
`
`To deliver NLT 10.0 ni.
`
`USP'-'I>
`
`I.)
`
`I.J
`
`1.4
`
`1.3
`
`1.0 • 2.S
`
`USP<791>
`
`Fill volume
`
`pH
`
`Padatgillg: Conform
`
`Padcagillg: Conform Pldm;ing: Conform
`
`Padcaging: Confonn
`
`Paclcllgmg: Ccnfonn
`
`p0'Mb on the rmbcr Slapper
`Padcagmg: Prmnce of \Wile
`
`Pacbgmg: Confonn
`
`Padcagi~ No appara11 lralcage or ph)'sical
`
`allcrallon
`
`Product: Confann
`
`Product: Confonn
`
`Product: Conform
`
`Pnxlucl: Confonn
`
`Product: Confonn
`
`Product: Confonn
`
`Product: Confonn
`
`ProdUd: Clear colorless liquid frcc from
`
`visible peniculale !Mttcr
`
`Visual
`
`Dcsaiption
`
`CN 1397S9
`24 Months
`
`CN 136493
`18Moa1lls
`
`CN 133221
`12 Months
`
`CN 131SJS
`9Months
`
`CN 129674
`6Months
`
`CN 12n36
`J Months
`
`CN 125929
`
`lmtbl
`
`Speclflcadon
`
`Method
`
`Test
`
`Tame Point
`
`l'PRICHT
`
`2S°CU°C ~,RH:t:S~.RH
`
`201S'AuBf28
`
`208191S
`
`Date orEalJy Into &ability:
`&ability Condldom:
`Lor:
`
`CystrJnt HCI lnitttlon (SO mg/mL) 10 mL fill
`
`LBM<ocnpute,•313
`2017/Sep/22
`
`2SC_60%RH Upri&ht
`
`-~----------
`
`.._ __ -------
`
`Stability follow up (lot 2081915)
`
`
`
`Eton Ex. 1116
`8 of 8
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
