Belcher Pharm., LLC. v. Hospira, Inc.

• Decision Date: 31 March 2020
• Docket Number: C.A. No. 17-775-LPS
• Citation: 450 F.Supp.3d 512
• Parties: BELCHER PHARMACEUTICALS, LLC., Plaintiff, v. HOSPIRA, INC., Defendant.
• Court: U.S. District Court — District of Delaware

450 F.Supp.3d 512

BELCHER PHARMACEUTICALS, LLC., Plaintiff,

v.HOSPIRA, INC., Defendant.

C.A. No. 17-775-LPS

United States District Court, D. Delaware.

Signed March 31, 2020

Unsealed on April 3, 2020

Stephen B. Brauerman, BAYARD, P.A., Wilmington, DE, Stefan V. Stein, Cole Carlson, William Stein, GRAYROBINSON, P.A., Tampa, FL, Attorneys for Plaintiff.

John C. Phillips, Megan C. Haney, PHILLIPS, GOLDMAN, MCLAUGHLIN & HALL, P.A., Wilmington, DE, Thomas J. Meloro, Matthew Freimuth, Ronald A. Lee, Devon W. Edwards, WILLKIE FARR & GALLAGHER LLP, New York, NY, Attorneys for Defendant.

OPINION

STARK, U.S District Judge:

Belcher Pharmaceuticals, LLC. ("Belcher" or "Plaintiff") sued Hospira, Inc. ("Hospira" or "Defendant") under the Hatch-Waxman Act, see 35 U.S.C. § 271(e), for Hospira's attempts to bring to market a bioequivalent of Belcher's Epinephrine Injection USP. (D.I. 1 at ¶ 8) Belcher alleges that Hospira's bioequivalent product infringes U.S. Patent No. 9,283,197 ("the '197 Patent") under the doctrine of equivalents. (D.I. 1 at ¶¶ 17-26; D.I. 201 at ¶ 3) Hospira contends that it does not infringe the '197 Patent and, further, that the Patent is invalid and/or unenforceable. (See D.I. 156) In June 2019, the Court held a two-day bench trial. (See D.I. 217-19) ("Tr.") Thereafter, the parties submitted post-trial briefing (D.I. 222, 225, 230, 232, 235, 236), proposed findings of fact (D.I. 223-24, 231), and notices of supplemental authorities (D.I. 240-42).

Pursuant to Federal Rule of Civil Procedure 52(a), and having considered the entire record in this case and the applicable law, the Court concludes that: (1) Hospira does not infringe the '197 Patent under the doctrine of equivalents, (2) the '197 Patent is invalid as obvious in view of the prior art and for improper inventorship, and (3) the '197 Patent is unenforceable due to inequitable conduct.

The Court's findings of fact and conclusions of law are set forth in detail below.

FINDINGS OF FACT

This section contains the Court's findings of fact ("FF") on disputes raised by the parties during trial, as well as the facts stipulated to by the parties. The Court adopts the parties' Stipulated Facts (D.I. 201-1 Ex. 1) ("SF"), which are repeated in part below. Certain findings of fact are also provided in connection with the Court's legal analysis later in this Opinion.

I. Introduction

1. This patent infringement action arises out of Hospira's submission of New Drug Application ("NDA") No. 209359 to the U.S. Food and Drug Administration ("FDA") pursuant to 21 U.S.C. § 355(b). Hospira's NDA seeks FDA approval of a 0.1 mg/mL injectable l-epinephrine formulation ("Hospira's NDA Product"). (SF ¶¶ 20-21, 28)

2. Belcher is the holder of NDA No. 205029, which was approved by FDA on July 29, 2015 for a 1 mg/mL injectable l-epinephrine formulation ("Belcher's NDA Product"). (D.I. 1 at ¶ 13; see also JTX-59/DTX-137)

3. The FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations – commonly referred to as the "Orange Book" – lists the '197 Patent for Belcher's NDA No. 205029. (D.I. 1 at ¶ 15; Rubin Tr. at 149)¹

4. Hospira's NDA included a certification ("Paragraph IV certification"), pursuant to 21 U.S.C. § 355(b)(2)(A)(iv), that the claims of the '197 Patent are invalid, unenforceable, and/or will not be infringed by the manufacture, use, importation, sale or offer for sale of Hospira's NDA Product. (SF ¶ 21)

5. On June 16, 2017, Belcher sued Hospira for infringing the '197 Patent pursuant to 35 U.S.C. § 271(a), (b), (c) and (e)(2), based on the filing of Hospira's NDA and the accompanying Paragraph IV certification as to Hospira's NDA Product. (D.I. 1 at ¶¶ 22-26)

6. Belcher and Hospira stipulated that Hospira's NDA Product does not literally infringe claims 6 and 7 of the '197 Patent. (SF ¶ 35)

7. Trial proceeded on Belcher's theory of infringement under the doctrine of equivalents and Hospira's affirmative defenses and counterclaims of non-infringement, invalidity, and unenforceability. (See D.I. 201 at ¶¶ 3-5)

II. Patent-in-Suit

8. The '197 Patent, entitled "More Potent and Less Toxic Formulations of Epinephrine and Methods of Medical Use," issued on March 15, 2016 from U.S. Application No. 14/460,845 ("the '845 Application"). (SF ¶¶ 3, 5; see also JTX-1)

9. The '197 Patent lists Jugal K. Taneja as the sole inventor. (SF ¶ 4; see also JTX-1)

10. The '197 Patent is assigned to Belcher. (SF ¶ 6)

11. Belcher asserts claims 6 and 7 of the '197 Patent. (D.I. 1 at ¶ 20; D.I. 201 at ¶ 2)

12. Claim 7 depends from claim 6. (JTX-1 at cl. 7)

13. Claim 6 recites:

An injectable liquid pharmaceutical formulation of l-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 l-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,² 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.

(JTX-1 at cl. 6)

14. Claim 7 recites:

The said injectable liquid pharmaceutical formulation of claim 6 further having a concentration of 1 mg per mL l-epinephrine.

(JTX-1 at cl. 7)

15. The Court construed the claim limitation "said injectable liquid pharmaceutical formulation compounded in an aqueous solution as 1.0 to 1.06 mg/mL l-epinephrine" as a product-by-process limitation, such that "1.0 to 1.06 mg/mL l-epinephrine" must be present in the solution after the compounding step has been completed. (D.I. 96 at 5; D.I. 97; D.I. 204 at 4-5; D.I. 205)

16. The Court construed "in an aqueous solution" to mean "in a homogenous mixture of one or more substances dissolved in a solvent that is mainly water." (D.I. 96 at 10; D.I. 97)

17. The Court construed "said liquid formulation having a pH between 2.8 and 3.3" as referring to the pH of the final product. (D.I. 204 at 2; D.I. 205)

III. Witnesses

A. Belcher's Expert Witness

18. Dr. Shyam Mohapatra earned his Ph.D. in molecular biology and genetics before joining the College of Medicine, Internal Medicine Department, at the University of South Florida, where he has earned the title of distinguished health professor. (Mohapatra Tr. at 294) Dr. Mohapatra is a named inventor on more than 39 U.S. patents, including patents related to drug development, formulation, and delivery, and has collaborated with pharmaceutical companies such as Pfizer, Merck, Bristol-Myers-Squibb, and Astra-Zeneca, to improve their pharmaceutical products. (Id. at 295-96)

B. Hospira's Expert Witness

19. Dr. Rodolfo Pinal earned his bachelor's degree in pharmaceutical chemistry from the National Autonomous University of Mexico. (Pinal Tr. at 225) From 1990 to 2003, he worked on pre-formulations, sterile products (including their manufacture), and solid pharmaceuticals at Hoffman LaRoche. (Id. at 225-26) He is currently an Associate Professor in Industrial and Physical Pharmacy at Purdue University, where he has taught parenteral products to both undergraduate and graduate students since 2004. (Id. )

C. Fact Witnesses

20. Brian McHugh was a program manager of several epinephrine programs at Hospira, including the Abboject project. (McHugh Tr. at 58-59)

21. Xifeng Zhang is a product manager in the Regulatory Affairs Division at Hospira and was responsible for filing the NDA for Hospira's NDA Product. (X. Zhang Tr. at 76)

22. Eric Zhang has been an employee of Hospira since 2004 and is an associate researcher fellow who worked extensively on Hospira's NDA Product. (E. Zhang Tr. at 94)

23. Jugal Taneja is the Chief Executive Officer of Belcher and the sole named inventor of the '197 Patent. (J. Taneja Tr. at 114-15) He graduated with a degree in petrochemical mining in 1966 from a university in India. (Id. at 115) After moving to the United States in 1972, he held a series of positions in various fields before earning his Master of Business Administration from Rutgers University in 1978. (Id. at 116) He subsequently worked at a series of banks involved in petrochemicals, and then joined a nutraceutical company that produced vitamins. (Id. at 117) In 2005, his company began producing generic drugs. (Id. at 117-18)

24. Darren Rubin is the Chief Science Officer of Belcher. (Rubin Tr. at 145-46) He graduated summa cum laude with a degree in biology before earning a Master's degree in medical sciences, specializing in biochemistry and molecular biology and a Master of Business Administration, specializing in finance.³ (Id. at 145) Rubin has also been referred to as the "Head of [Intellectual Property]" at Belcher and helped draft and prosecute the '197 Patent. (Id. at 149; see also M. Taneja Tr. at 218) Rubin is neither a patent agent nor patent attorney. (Rubin Tr. at 146)

25. Mihir Taneja is Belcher's Vice President of Sales and Marketing at Belcher and was involved in Belcher's interactions with Sintetica SA ("Sintetica") concerning epinephrine formulations. (M. Taneja Tr. at 209-11) He is the son of Jugal Taneja. (Id. at 210)

26. Fabio Lanzieri was a salesperson associated with Belcher. (Lanzieri Tr. at 384)

IV. Person of Ordinary Skill in the Art

27. A person of ordinary skill in the art ("POSA") in relation to the '197 Patent is a person with a PharmD or Ph.D. in pharmaceutical sciences or a related discipline, with at least three years of experience formulating and/or manufacturing commercial scale drug products, or a Master's or Bachelor's degree and five to eight years of experience. (D.I. 224 at ¶ 30) The POSA would also have experience in the development of parenteral (injectable) drugs, specifically including solutions for injection, formulating such solutions for human or animal use, and would have the skills necessary to perform the testing and evaluation necessary to obtain regulatory approval of such formulations.⁴ (Id. ; Pinal Tr at 250-51)

28. Hospira's...