Case Name: Ferring Pharms. Inc. v. Par Pharm., Inc., Civ. No. 1:15-cv-173-RGA, 2017 U.S. Dist. LEXIS 106491 (D. Del. July 11, 2017) (Andrews, J.)
Drug Product and U.S. Patent: Prepopik® (sodium picosulfate, magnesium oxide, and anhydrous citric acid); U.S. Patents Nos. 8,450,338 (“the ’338 patent”) and 8,481,083 (“the ’083 patent”)
Nature of the Case and Issue(s) Presented: Par filed an ANDA seeking to engage in the commercial manufacture, use, and sale of a generic version of Ferring’s Prepopik product. Ferring filed suit alleging infringement of the patents-in-suit. Prepopik is a treatment used as preparation for colonoscopy. Prior to trial, Par dismissed all invalidity defenses with prejudice. The court held a two-day bench trial on whether Par’s proposed ANDA product and process infringed the patents-in-suit. The court held that it did.
Why Ferring Prevailed: The parties agreed that Par’s ANDA product met all of the claimed limitations except for one. Thus, the only disputed issue for trial was whether Par’s ANDA product comprises a “spray-coated layer of sodium picosulfate coating a potassium bicarbonate core.”
Par argues that Ferring has not proven that: (i) Par’s ANDA product has a layer of sodium picosulfate coating a bicarbonate core; and (ii) Par’s ANDA product is produced using a spray-coating process. The parties’ disputes as to both limitations revolved around the plain and ordinary meaning of the terms “coated,” “coating,” and “layer.” During the claim construction phase of the litigation, the court declined to construe “coated” and “coating,” holding instead that the parties should present expert opinions at trial as to what a skilled artisan would understand those terms to mean. Ultimately, the court adopted Ferring’s expert’s opinion that those terms meant “a layer of a substance, which is on the outer surface of another substance or material” because his expertise was more closely aligned with the technology at issue and because he provided a more persuasive explanation for his proposal.
Next, the court decided whether Par’s manufacturing process involved spray-coating or wet granulation. While both processes can be performed using the same equipment, they are distinct processes that produce different sized particles. Ferring’s expert opined that Par’s ANDA product is made using a spray-coating process. Par argued in response that its product was manufactured by “agglomeration via a wet granulation process.” The court found in favor of Ferring. First, calling it “wet granulation” “was neither dispositive, nor even persuasive in the face of substantial evidence that its process employs spray-coating rather than wet granulation.” In any event, some of Par’s own lab notebooks referenced using a spray-coating process. Second, Par’s configuration of its manufacturing equipment did not prove anything about whether its process results in wet granulation or spray-coating, particularly when its expert admitted that the “top-spray” configuration can do both. Third, Par’s reliance on a single scientific publication that showed that certain parameters indicated that the process was wet granulation was misplaced. The process must be considered as a whole, rather than looking to each process setting individually, in order to determine whether the process was spray-coating or wet granulation. Next, employing a drying step was not necessarily evidence that the process was wet granulation.
Defendant next argued that the separate drying step it employed was evidence that its process was wet granulation. (D.I. 181 at 18). The court was not persuaded. Dr. Augsburger did not opine that a spray-coating process never involved a separate drying step. Rather, he testified that "it's not uncommon in a granulation to have a step like that." (Tr. 471:18-10). This was insufficient to rebut Dr. Johnson's credible testimony that Defendant's ANDA process, viewed as a whole, was spray-coating rather than wet granulation.
Defendant attempted to discredit Dr. Johnson by arguing that he did no physical [*16] analysis on Defendant's products, his opinions were not supported by the scientific literature, and there were "gaps" in his reasoning process. (Di. 181 at 19-22). Defendant suggested that it was "improper" for Dr. Johnson to base his opinion on the information in Defendant's ANDA and his knowledge and experience as a person of ordinary skill in the art. (Id. at 19). The court disagreed. As Dr. Johnson explained, the information he needed to form his opinion was present in the batch processing records. (Tr. 206:22-207:7). Furthermore, Plaintiffs' other expert, Dr. Davies, did conduct physical testing and Dr. Johnson referred to the results of those tests as evidence supporting his infringement opinion. (Tr. 236:18-237:4). Ultimately the court credited Ferring’s expert over Par’s and found that Par’s process employed spray-coating.
The court next decided the issue of whether Par’s ANDA product had a “layer of sodium picosulfate.” Par argued that the Raman images presented at trial showed the presence of sodium picosulfate inside the potassium bicarbonate core, rather than only on the surface of the core. In response, Ferring’s expert testified that evidence of sodium picosulfate inside the granule suggested that sodium picosulfate was actually on the surface because the granules were not smooth. Rather, they had crevices and cracks in which sodium picosulfate could lodge. Given Ferring’s expert’s qualifications in Raman spectroscopy, the court credited Ferring’s expert’s testimony and held that Par’s ANDA product contained a layer of sodium picosulfate.
