Case 1:17-cv-00775-LPS Document 178-1 Filed 04/12/19 Page 60 of 157 PageID #: 5618
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`BELCHER PHARMACEUTICALS, LLC,
`
`v.
`
`HOSPIRA, INC.,
`
`Plaintiff,
`
`Defendant.
`
`_______________ )
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`C.A. No. 17-cv-775-LPS
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`EXPERT REPORT OF SHY AM MOHAPATRA, PH. D., IN SUPPORT OF BELCHER
`PHARMACEUTICALS, LLC'S INFRINGEMENT POSITION
`
`I, Shyam Mohapatra, Ph.D., declare as follows:
`
`I. Background and Qualifications
`
`a. Credentials
`
`1.
`
`I am a Distinguished Professor at the University of South Florida ("USP")
`
`Institute for Advanced Innovation and Discovery and the Associate Dean of Graduate Programs
`
`at USF College of Pharmacy. Over the past 20 years, I have assisted in numerous scientific
`
`publications, with topics ranging from drug delivery methods to anti-cancer treatments. I have
`
`over 40 US patents and patent applications, some of which include methods of drug delivery and
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`drug compositions for treating infections.
`
`2.
`
`I received my Ph.D. at Australian National University in Canberra in
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`Botany in the field of Genetics in 1984. Prior to this, I received a Master' s Degree in Genetics
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`from G.B. Pant University of Agriculture and Technology in Pantnagar, India in 1978, and my
`
`Bachelor of Science Degree from Orissa University of Agriculture and Technology in
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`1
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`Bhubaneswar, India in 1976. Following my Ph.D. I trained in Genomics Sciences in Bielefeld,
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`Germany, then worked as Research Associate at the McGill University, Montreal, Canada and
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`then appointed as Assistant Professor and then Associate Professor in Immunology, at the
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`University of Manitoba, Winnipeg, Canada during 1988 to 1995. In 1996, I became an Associate
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`Professor in Internal Medicine at the University of South Florida ("USF''). I also received my
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`Masters in Business Administration from USF in 1999. At USF, I became a full professor in
`
`2000 and awarded a Distinguished Health Professor in 2011.
`
`3.
`
`I am also currently a Distinguished Professor at the USF Institute for
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`Advanced Innovation and Discovery, Director of the USF Center for Research and Education in
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`Nanobioengineering, Director of the Division of Translational Medicine for the Department of
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`Internal Medicine at the USF Morsani College of Medicine, and a Research Career Scientist and
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`Principal Investigator for the James A Haley VA Hospital in Tampa, Florida.
`
`4.
`
`I have also served as the Associate Dean of Graduate Programs and a
`
`professor of Pharmaceutical Sciences at the University of South Florida College of Pharmacy
`
`since 2013. I teach both undergraduate and graduate courses in cellular and molecular
`
`immunology, medicine, and pharmacy at the University of South Florida. I have authored or co(cid:173)
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`authored over 200 research papers, reviews, and book chapters. I regularly act as referee for a
`
`variety of journals in the fields of medicine, pharmacy and engineering and specialized areas
`
`such as molecular medicine and pharmacy, among others. I have been a reviewer of such
`
`journals as Biodrugs, Pharmaceutical Sciences, Genetic Vaccines and Therapy (Editor-in-Chief
`
`Molecular and Clinical Allergy), Associate Editor Gene Therapy (Nature Journals) Mucosal
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`Immunity, Journal of Allergy and Clinical Immunology, Immunology Today, Journal of Clinical
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`Investigations, International Journal of Cancer, Allergy Journal of Immunology Journal,
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`International Archives of Allergy and Immunology and others.
`
`5.
`
`I have regularly spoken to the medical and pharmacy community and
`
`lectured at universities throughout the country on a variety of topics in related fields.
`
`6.
`
`My industry experience includes working as a consultant and performing
`
`contract research over more than 25 years. I have consulted with industries on an as-needed basis
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`in the areas of pharmaceutical biotechnology and nanotechnology. For example, I have consulted
`
`with industries such as Connaught Labs, Merck, AstraZeneca, Bristol Myer Squibb, Genetics
`
`Institute and others involving the development and formulation of pharmaceutical drug products.
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`I was personally involved in post-marketing research and development projects and large-scale
`
`manufacture of pharmaceutical drugs, when I did this consulting work.
`
`7.
`
`I was previously a member of the Canadian Society of Allergy and
`
`Immunology and the European Academy of Allergology and Clinical Immunology. I am a
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`Fellow of the American Academy of Allergy, Asthma and Clinical Immunology and an
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`Honorary Member of the Mexican Society of Allergy and Immunology, the USF Academy of
`
`Inventors, the American Thoracic Society, the American Academy of Allergy and Clinical
`
`Immunology, the American Association of Immunologists and American Association of
`
`Pharmaceutical sciences. I have been elected as a Fellow of several Learned Societies, including
`
`the American Association for the Advancement of Science (AAAS), the National Academy of
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`Inventors, the American Institute of Medical and Biological Engineers and a Fellow of the
`
`prestigious National Academy of Inventors.
`
`8.
`
`I have received national and international recognition for my contributions
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`to the development and characterization of pharmaceuticals in the immunological and allergy
`
`3
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`field, excipients and solid materials, including being the recipient of prestigious Alexander Von
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`Humboldt Research Fellowship, Bonn, Germany; The Pharmacia Allergy and Immunology
`
`Foundation, Upsala, Sweden; The Global Corporate Award in Nanotechnology and was inducted
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`to the 'Florida Inventor Hall of Fame' for contributions to biomedical and pharmaceutical
`
`nanotechnology.
`
`9.
`
`I have 36 granted U.S. Patents as well as a number of pending
`
`applications. These patents generally concern immunotherapy, methods of gene transfer, and
`
`prevention of viral diseases, novel diagnostic methods, novel devices for treatment, discovery of
`
`anti-inflammatory and anti-cancer, anti-viral and anti-bacterial drugs, methods of treatment of
`
`diseases, and novel drug formulation methods.
`
`10.
`
`Additional information about my credentials are listed in my curriculum
`
`vitae attached as Exhibit A.
`
`b. Compensation
`
`11.
`
`I am being compensated at a rate of $450 per hour plus expenses for my
`
`consulting services. My compensation is not contingent on the opinions expressed in this
`
`declaration, my testimony at deposition or trial, or the outcome of this case.
`
`II. Opinions to Be Expressed
`
`a. Retention & Assignment
`
`12.
`
`I have reviewed U.S. Patent No. 9,283,197 ("the ' 197 Patent") and its
`
`prosecution history. The ' 197 Patent is attached as Exhibit B to this declaration. I have also
`
`reviewed Hospira's NDA No. 20-9359 (''the Hospira NDA") as well as Judge Stark's 9/28/18
`
`Claim Construction Ruling (D.l. 97).
`
`4
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`13.
`
`I have been asked by counsel to provide my op1mons m this case
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`regarding Hospira' s infringement of the ' 197 Patent.
`
`b. Legal Standards
`
`14.
`
`I understand that, in order to infringe a patent in the United States, an actor
`
`must perform each element of a claim within a patent either literally or under the Doctrine of
`
`Equivalents.
`
`15.
`
`I understand that the Doctrine of Equivalents is a legal rule that allows a
`
`court to hold a party liable for patent infringement even though the infringing device or process
`
`does not fall within the literal scope of a patent claim, but nevertheless is equivalent to the
`
`claimed invention.
`
`16.
`
`I understand that any analysis done under the Doctrine of Equivalents is
`
`applied to individual claim limitations and not the invention as a whole. Infringement may be
`
`found under the Doctrine of Equivalents if every limitation of the asserted claim, or i1s
`
`"equivalent," is found in the accused subject matter, where an "equivalent" differs from the
`
`claimed limitation only insubstantially. One way of determining whether a claim limitation has
`
`been met under the Doctrine of Equivalents is called the "triple-identity" test. Under the triple(cid:173)
`
`identity test, the difference between the feature in the accused device and the limitation literally
`
`recited in the patent claim may be found to be equivalent if the feature in the accused device: 1)
`
`performs substantially the same function, 2) In substantially the same way, and 3) to yield
`
`substantially the same result as the limitation literally recited in the patent claim. What
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`constitutes equivalency must be determined against the context of the patent, the prior art, and
`
`the particular circumstances of the case.
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`5
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`17.
`
`I understand that a defense to an allegation of infringement under the
`
`Doctrine of Equivalents is prosecution history estoppel, which can occur either by making a
`
`narrowing amendment to a claim or surrendering claim scope through argument to the patent
`
`examiner. It is also my understanding the Judge Stark has ruled that the amendments and
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`arguments made during prosecution of the '197 Patent do not give rise to estoppel such that the
`
`Doctrine of Equivalents may apply (D.I. 100).
`
`18.
`
`I understand that another defense to an allegation of infringement under
`
`the Doctrine of Equivalents is ensnarement. I understand this defense may be used to prevent a
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`patentee from asserting a scope of equivalency that would encompass, or ensnare, or the prior
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`art. I also understand that Judge Stark has ruled that there is a genuine dispute of material fact
`
`regarding whether ensnarement should apply (D.I. 100).
`
`c. Level of Ordinary Skill in the Art
`
`19.
`
`I understand from counsel that the definition of a Person of Ordinary Skill
`
`in the Art ("POSA") for the '197 Patent is based on the following factors: (1) the type of
`
`problems encountered in the art; (2) the prior art solution to those problems; (3) the rapidity with
`
`which innovations are made; ( 4) the sophistication of the technology; and (5) the educational
`
`level of workers in the field.
`
`20.
`
`I also understand from counsel that the inventor of the '197 Patent, Dr.
`
`Jugal Taneja, has a university degree and a minimum of three years' experience in the
`
`pharmaceutical industry in the field of pharmaceutical preparation.
`
`21.
`
`Based on this understanding, it is my opinion that a POSA is someone
`
`with a minimum of a Bachelor of Science Degree in Pharmacy or Chemical Engineering, or
`
`6
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`related field, and a mlilllllum of three years' experience in the field of pharmaceutical
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`preparation and drug formulation technology or similar technical field of study.
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`III.
`
`INFRINGEMENT ANALYSIS
`
`a. The '197 Patent
`
`22.
`
`The claims of the '197 Patent are directed to a liquid pharmaceutical
`
`formulation of I-epinephrine sterile solution.
`
`23.
`
`It is my understanding that only Claims 6 and 7 of the '197 Patent are
`
`being asserted against Hospira.
`
`24.
`
`Claim 6 of the ' 197 Patent recites:
`
`6. An injectable
`liquid pharmaceutical formulation of 1-
`epinephrine
`sterile
`solution;
`said
`liquid pharmaceutical
`formulation having a pH between 2.8 and 3.3; said injectable
`liquid pharmaceutical formulation compounded in an aqueous
`solution as 1.0 to 1.06 mg/mL I-epinephrine, and further
`including a tonicity agent; said liquid pharmaceutical formulation
`including no more than about 6% d-epinephrine and no more
`than about 0.5% adrenalone at release, and no more than about
`12% d-epinephrine and no more than about 0.5% adrenalone
`over a shelf-life of at least 12 months.
`
`25.
`
`Claim 7 of the ' 197 Patent recites:
`
`7. The said injectable liquid pharmaceutical formulation of claim
`6 further having a concentration of 1 mg per mL I-epinephrine.
`
`26.
`
`Based on my experience in the pharmaceutical industry, the ' 197 Patent
`
`represents a unique and novel approach to formulating a particular epinephrine product due to
`
`the low overage during compounding, low pH, and low amount of impurities at release and over
`
`the shelf-life.
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`7
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`b. The Court's Claim Construction
`
`27.
`
`It is my understanding that the Court interpreted a number of terms from
`
`Claim 6 of the '197 Patent. These constructions are summarized below and were used in my
`
`determination of infringement by Hospira.
`
`Claim Term
`
`Court's Construction
`
`"compounded in an aqueous solution as
`1.0 to 1.06 mg/mL I-epinephrine"
`
`"having 1.0 to 1.06 mg/mL I-epinephrine in an
`aqueous solution after the compounding step has
`been completed"
`
`"said injectable liquid pharmaceutical
`formulation compounded"
`
`"the injectable liquid pharmaceutical formulation
`formed by combining the active ingredients and
`excipients"
`
`"in an aqueous solution"
`
`"as 1.0 to 1.06 mg/mL I-epinephrine"
`
`"in a homogenous mixture of one or more
`substances dissolved in a solvent that is mainly
`water"
`
`"the concentration of I-epinephrine in the
`compounded solution being within the range of
`1.0 to 1.06 mg/mL"
`
`"and further including a tonicity agent" No construction necessary
`
`c. Claim Terms Literally Infringed
`
`28.
`
`Hospira filed a 505(b )(2) application (the "Hospira NDA") for
`
`Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL), Single-Use, Abboject™ Syringe (the
`
`"Hospira NDA Product") with the Food and Drug Administration ("FDA") to get its product
`
`approved as a generic drug product. Per FDA guidelines, drug products that are approved in
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`these types of applications are generally considered by the FDA to be therapeutically equivalent
`
`to the Reference Listed Drug ("RLD").
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`8
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`29.
`
`Hospira referenced Belcher's Epinephrine Injection USP, 1 mg/mL, 1 mL
`
`as the RLD for the Hospira NDA.
`
`30.
`
`31.
`
`Many limitations contained within Claim 6 have been literally infringed.
`
`Claim 6 requires an injectable formulation. Eric Zhang, the research and
`
`development lead on the Hospira NDA Product, stated that the Hospira NDA Product is
`
`injectable. Eric Zhang Deposition Transcript at 41 :23-42:3.
`
`32.
`
`Claim 6 also requires that the formulation be liquid. Mr. Zhang stated that
`
`the Hospira NDA Product is liquid. Eric Zhang Deposition Transcript at 111 :3-5.
`
`33.
`
`Claim 6 also requires a pharmaceutical formulation. Mr. Zhang stated that
`
`the Hospira NDA Product is a phannaceutical preparation, which is the same as a pharmaceutical
`
`formulation. Eric Zhang Deposition Transcript at 11 I :3-13.
`
`34.
`
`Claim 6 also requires that the formulation be sterile. Mr. Zhang stated that
`
`the Hospira NDA Product is sterile. Eric Zhang Deposition Transcript at 111 :3-7.
`
`35.
`
`Claim 6 also requires a tonicity agent in the formulation. Mr. Zhang stated
`
`that
`
`. Eric Zhang Deposition Transcript
`
`at 98;21-24. Therefore, the Hospira NDA Product includes a tonicity agent.
`
`36.
`
`Claim 6 requires a pH between 2.8 to 3.3. Based on the specification of
`
`the '197 Patent, this appears to relate to the in-process pH, which generally refers to the pH of
`
`the formulation before initial filtration, filling, and sterilization.
`
`37.
`
`When discussing an engineering batch performed to get FDA approval,
`
`Mr. Zhang admitted that
`
`137:6-11.
`
`. Eric Zhang Deposition Transcript at
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`9
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`38.
`
`Claim 6 also requires that the formulation be "compounded." Based on the
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`Court's construction, "compounding" is "combining active ingredients and excipients." Mr.
`
`Zhang confirmed that the formulation is formed by combining the active ingredients and
`
`excipients. Eric Zhang Deposition Transcript at 129:9-137:12.
`
`39.
`
`Claim 6 also requires that the formulation be compounded "in an aqueous
`
`solution." Based on the Court's construction, an aqueous solution is a "homogenous mixture of
`
`one or more substances dissolved in a solvent that is mainly water." Mr. Zhang confirmed that
`
`the solution,
`
`is assumed to be homogenous and that the
`
`solvent for the mixture is water. Eric Zhang Deposition Transcript at 132: 19-133 :7.
`
`40.
`
`Claim 6 also requires no more than about 6% d-epinephrine at release.
`
`When discussing a comparison between Hospira's engineering batches and the RLD, Mr. Zhang
`
`stated that, at release, the Hospira NDA Product has
`
`. Eric Zhang
`
`Deposition Transcript at 119:8-13.
`
`41.
`
`Claim 6 also requires nor more than about 0.5% adrenalone at release.
`
`Similarly, Mr. Zhang agreed that the Hospira NDA Product has
`
`-
`
`Zhang Deposition Transcript at 119:14-19.
`
`42.
`
`43.
`
`The proposed shelf-life of the Hospira NDA Product is 15 months.
`
`Claim 6 requires no more than 12% d-epinephrine over a shelf-life of at
`
`least 12 months. Mr. Zhang agreed that the Hospira NDA Product
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`. Eric Zhang Deposition Transcript at 120:1-
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`7.
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`10
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`44.
`
`Finally, Claim 6 also requires no more than 0.5% adrenalone over a shelf-
`
`life of at least 12 months. Mr. Zhang agreed that
`
`Eric Zhang Deposition Transcript at 120: 1-18.
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`45.
`
`To the extent Mr. Zhang is discussing any Hospira documents as it relates
`
`to his statements, those documents only serve to further establish literal infringement of those
`
`limitations.
`
`46.
`
`Additionally, Table l, reproduced below, was included as part of Section
`
`3.2.P.5. 1 of the Hospira NDA. This table further indicates that d-epinephrine and adrenalone
`
`levels are below the amounts indicated in Claim 6 both at release and over a shelf-life of at least
`
`12 months.
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`47.
`
`The product insert included in the Hospira NDA further confi1ms literal
`
`infringement of several of the claim limitations above. HOS BPI_ 00000298-3 07.
`
`48.
`
`Mr. Zhang's testimony, including the documents discussed during his
`
`testimony and the documents cited above, clearly demonstrate infringement of the claim
`
`limitations described.
`
`49.
`
`The only limitation not literally infringed is the requirement that the
`
`formulation have " 1.0 to 1.06 mg/rnL I-epinephrine ... after the compounding step has been
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`completed" as required by the Court's construction of the claim limitation "compounded in an
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`aqueous solution as 1.0 to 1.06 mg/mL I-epinephrine."
`
`d. Infringement Under the Doctrine of Equivalents
`
`50.
`
`Products classified as therapeutically equivalent can be substituted with
`
`the full expectation that the generic product will produce the same clinical effect and safety
`
`profile as the RLD under the conditions specified in the labeling. See FDA' s Approved Drug
`
`Products with Therapeutic Equivalents (the Orange Book), preface to the 36th edition, at page
`
`Vll.
`
`51 .
`
`A generic combination product classified as therapeutically equivalent to
`
`the RLD can be expected to produce the same clinical effect and safety profile as the RLD under
`
`the conditions specified in labeling. This does not mean, however, that the proposed generic
`
`combination product and its RLD need to be identical in all respects. The fact that FDA
`
`tentatively approved Hospira's NOA Product shows that the FDA classified Hospira' s NDA
`
`Product as therapeutically equivalent to Belcher' s product.
`
`52.
`
`The Hospira NDA Product
`
`as an indication of use. That is
`
`also an indication of the RLD.
`
`53.
`
`The "active ingredient" in a pharmaceutical formulation is the component
`
`that is intended to furnish pharmacological activity or other direct effects in the diagnosis, cure,
`
`mitigation, treatment, or prevention of disease, or to affect the structure or any function of the
`
`body of man or other animals. The term includes those components that may undergo chemical
`
`change in the manufacture of the drug product and be present in the drug product in a modified
`
`form intended to furnish the specified activity or effect. 21 C.F.R. § 2 10.3(b)(7).
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`54.
`
`The drug product described in the ' 197 Patent essentially contains two
`
`elements: the active pharmaceutical ingredient ("API''), which is I-epinephrine, and excipients.
`
`55.
`
`Hospira's NDA Product contains essentially two elements: the API of 1-
`
`epinephrine and excipients.
`
`56.
`
`57.
`
`Concentration is a measure of mass per volume.
`
`It is my understanding Hospira contends that the concentration of ](cid:173)
`
`epinephrine in the Hospira NDA Product after the compounding step has been completed is not
`
`equivalent to that claimed by the '197 Patent. I disagree with this contention. In my opinion, the
`
`differences between the Hospira NDA Product and the formulation described in the '197 Patent
`
`are insubstantial.
`
`58.
`
`Based on the batch records included in the Hospira NDA,
`
`the
`
`concentration of the Hospira NDA Product after the compounding step has been completed must
`
`be
`
`This is confirmed by Mr. Zhang when discussing the batch records. Eric
`
`Zhang Deposition Transcript at 128:12-129:1 , 135:22-136:5 (reciting batch size, amount of
`
`epinephrine used for each batch, and the concentration of each batch). Any variation over this
`
`amount would be an overage that would fall in the 0-6% range contemplated by the '197 Patent.
`
`59.
`
`A concentration of
`
`is equivalent to the concentration range of 1.0 - 1.06 mg/mL I-epinephrine
`
`as described in the '197 Patent because the same amount of API is being used to treat the
`
`indication provided for in the Hospira NDA Product and the formulation described by ' 197
`
`Patent as embodied by the RLD. 1 milligram of I-epinephrine is present in both the Hospira
`
`NDA Product and the formulation described by '197 Patent as embodied by the RLD.
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`•
`
`•
`
`I
`
`I
`
`62.
`
`This position is reinforced by the '197 Patent specification. In particular,
`
`the '197 Patent states "A sealed 2 mL glass ampule served as the container for the 1 mL drug
`
`product that was tested. However, the drug product solution of the present invention can be made
`
`in larger volumes in other sterile containers, including glass vials and bottles, and syringes and
`
`autoinjectors; including autoinjectors conducive with the preservative-free formulation." ' 197
`
`Patent at 5:8-14. This implies that one skilled in the art could also compound the I-epinephrine
`
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`liquid formulation in the form of 0.1 mg/mL in 10 mL, or 0.2 mg/mL in 5 mL, or 0.4 mg/mL in
`
`2.5 mL. This is depicted in the figure below.
`
`Concentration of L-epinephrine
`
`l
`
`0.4/ml
`
`l
`
`0.2mg/m
`
`I
`
`O.lmg/ml
`
`1 mg
`
`!
`
`m
`
`1 ml - - -
`
`0.0
`
`..... V'l
`
`:I .... o_
`o E
`.....
`C1l
`c::
`....
`:I .!:!>
`0
`:::: E E
`<( c::
`Cii :.::..
`.....
`t-2
`
`lmg
`
`1 mg
`
`Sml
`
`10mL
`
`Reducing Concentration
`
`63.
`
`The primary reason for having a concentration of 1.0 to 1.06 mg/mL in the
`
`' 197 Patent is to have a reduced overage.
`
`See
`
`Eric Zhang Deposition Transcript at 79:15-22.
`
`64.
`
`Instead of "having 1.0 to 1.06 mg/mL I-epinephrine in an aqueous solution
`
`after the compounding step has been completed," the Hospira NDA Product has
`
`While the
`
`Hospira NDA Product has a difference in concentration by a factor of ten, it still uses -
`
`-
`
`delivers 1 mg of I-epinephrine to the patient. 1 Use of either product will result in a
`
`patient recovering from septic shock.
`
`65.
`
`The function of the
`
`and the
`
`formulation described in the '197 Patent is to maintain a high amount of I-epinephrine content at
`
`1 That the Hospira NDA Product is titrated to effect in a patient is irrelevant because the formulation described in the
`would receive the same amount of
`'197 Patent is likewise titrated to effect. A patient
`epinephrine-containing IV fluid if their physician were to use the Hospira NDA Product or the RLD which embodies
`the claims of the '197 Patent.
`
`16
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`Page 16 of 19
`
`

`

`Case 1:17-cv-00775-LPS Document 178-1 Filed 04/12/19 Page 76 of 157 PageID #: 5634
`
`the end of the shelf-life. Both the Hospira NDA Product and the formulation described in the
`
`'197 Patent achieve this high I-epinephrine content by using a lower pH with a tonicity agent in
`
`combination with
`
`Finally, the Hospira NDA Product and the formulation
`
`described in the '197 Patent deliver I milligram of API to the patien
`
`rn
`
`combination with lower pH and a tonicity agent as the means of treating an ill patient.
`
`66.
`
`The differences between the concentration of the formulation at the end of
`
`the compounding step in the Hospira NDA Product and concentration of the formulation at the
`
`end of the compounding step described in the '197 Patent are insubstantial. Further, the function,
`
`way, and means of having no to low overage in terms of concentration at the end of the
`
`compounding step are equivalent for the Hospira NDA Product and the formulation described in
`
`the '197 Patent.
`
`67.
`
`The Hospira NDA further confirms the equivalency of the Hospira NDA
`
`Product and the formulation described in the ' 197 Patent.
`
`17
`
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`Page 17 of 19
`
`

`

`Case 1:17-cv-00775-LPS Document 178-1 Filed 04/12/19 Page 77 of 157 PageID #: 5635
`
`68.
`
`A summary of the equivalency between the '197 Patent and the Hospira
`
`Hos ira NOA
`Epinephrine Injection USP, 0.1
`mg/ml (10 ml), single-use
`s rin e
`I-epinephrine (1 mg)
`
`NDA Product is provided below.
`
`Features
`Product
`
`'197 & RLD
`Epinephrine Injection USP 1
`mg/ml, single-dose ampules
`
`L-epinephrine
`dose
`T onicit agent
`Formulation
`Dosa e form
`Route
`Strength/cone
`for admin to the
`
`I-epinephrine (1 mg)
`
`Sodium Chloride
`
`ln'ectable form
`Intravenous Infusion thru IV ba
`1mg/1001 ml of a 0.5% dextrose
`solution (0.9901 mcg/ml)
`
`0-6%
`Isotonic sodium chloride
`
`18
`
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`Page 18 of 19
`
`

`

`Case 1:17-cv-00775-LPS Document 178-1 Filed 04/12/19 Page 78 of 157 PageID #: 5636
`
`H
`Intended use
`Label Warning
`
`2.8-3.3
`
`Do not use the solution if it is
`colored or cloudy or if it contains
`particulate matter
`
`Storage
`
`Store between 20-25 C (68 -77F)
`Protect from light. Do not Freeze
`
`1 mg/ml
`
`0.1 mg/ml
`
`1 mg in 1 ml in 2 ml ampule
`
`0.1 mg in 1 O ml in Abboject
`S rin e
`
`IV. Conclusion
`
`69.
`
`70.
`
`correct.
`
`It is my opinion that the Hospira NDA Product infringes the '197 Patent
`
`I declare, under penalty of perjury, my belief that the foregoing is true and
`
`Date: February 22, 2019
`
`By:
`
`Shyam Mohapatra, Ph.D.
`
`19
`
`ADAMIS EXHIBIT 1023
`Page 19 of 19
`
`