Belcher Pharms., LLC v. Hospira, Inc.

Case Name: Belcher Pharms., LLC v. Hospira, Inc., No. 17-775-LPS, 2020 WL 1650535 (D. Del. Mar. 31, 2020) (Stark, J.)

Drug Product and Patent(s)-in-Suit: epinephrine injection; U.S. Patent No. 9,283,197 (“the ’197 patent”)

Nature of the Case and Issue(s) Presented: Belcher sued Hospira resulting from Hospira’s attempts to market a bioequivalent version of Belcher’s epinephrine injection product. Belcher alleged infringement of the ’197 patent under the doctrine of equivalents. Hospira argued that it did not infringe, and that the ’197 patent was invalid and unenforceable. The court held a two-day bench trial, and ultimately found that: (i) Hospira did not infringe the ’197 patent under the doctrine of equivalents; (ii) the ’197 patent was invalid as obvious and for improper inventorship; and (iii) the ’197 patent was unenforceable due to inequitable conduct.

Why Hospira Prevailed: The court first addressed the issue of infringement, ultimately finding that the concentration of 0.10 mg/mL l-epinephrine in Hospira’s NDA product did not perform substantially the same function in substantially the same way to obtain substantially the same result as the claimed 1.0-1.06 mg/mL l-epinephrine in claim 6 of the ’197 patent. Because Belcher had not proven infringement of independent claim 6, it also could not prove infringement of dependent claim 7. The formulation of claims 6 and 7 was compounded at 1.0-1.06 mg/mL l-epinephrine to allow for minor losses due to subsequent production steps to produce a final concentration of 1 mg/mL. Hospira’s NDA product was compounded at a concentration 0.1 mg/mL—one-tenth that of the claimed invention—without any overages, to produce a final concentration of 0.1 mg/mL. While the total amount of l-epinephrine delivered to a patient was the same for both the Belcher (i.e. as-claimed) and Hospira NDA products, and there was also no substantial difference between the products in terms of concentration of l-epinephrine after diluting for administration, neither the total amount of l-epinephrine delivered to a patient nor the diluting step was claimed in asserted claims 6 or 7.

The court next addressed the issues of anticipation and obviousness. The two critical pieces of prior art were JHP’s Adrenalin Product and Hospira’s Ampul Product. JHP’s Adrenalin Product was an injectable liquid formulation of 1-epinephrinis that had a concentration of 1 mg/mL l-epinephrine, and was supplied in a 1 mL vial single-dose container. Hospira’s Ampul Product was a sterile, injectable liquid formulation of 1 mg/mL l-epinephrine, which was supplied in a 1 mL ampule single-dose container. The court found that while neither JHP’s Adrenalin Product nor Hospira’s Ampul Product anticipated the claims, due to their higher post-compounding concentrations, it would have been obvious to reduce those products’ overages in light of the general knowledge of a POSA. Due to the FDA’s enforcement strategies, a POSA would have been motivated to minimize the overage in any epinephrine product in order to obtain FDA approval. Moreover, the court found that Belcher failed to show that its NDA product was an unexpected solution to a long-felt need for preservative-free, low-overage epinephrine products. Rather, it was, instead, an obvious and inevitable response to FDA policy.

The court also found in favor of Hospira’s argument that Inventor Taneja—the sole named inventor—neither conceived of nor reduced to practice the alleged invention, as his sole contribution was to suggest a pH of between 2.8 and 3.3, which was known in the prior art.

Finally, the court addressed the issue of inequitable conduct. Belcher’s chief scientific officer, Mr. Rubin, played an active role in the prosecution of the ’197 patent, often serving as a liaison between the inventor and prosecution counsel, and owed a duty of candor and good faith to the PTO. Despite this duty, he admitted that he withheld information from Belcher’s patent prosecution attorney, including JHP’s Adrenalin Product reference and other material prior art. At trial, Mr. Rubin testified that he withheld those references because he considered them irrelevant because they were directed to formulations that contained preservatives, used epinephrine bitartrate base, or had high overages. The court also found that his testimony “raised serious questions as to his credibility.” “That, in combination with express statements made during prosecution, persuaded the Court by clear and convincing evidence that Rubin engaged in inequitable conduct.” Accordingly, the court found the ’197 patent unenforceable.