Case Name: Shire Development, LLC v. Mylan Pharms., Inc., No: 12-1190-T-36AEP, 2017 U.S. Dist. LEXIS 11441 (M.D. Fla. Jan. 27, 2017) (Honeywell, J.) 

Drug Product and Patent(s)-in-Suit: Lialda® (mesalamine); U.S. Patent No. 6,773,720 (“the ’720 patent”)

Nature of the Case and Issue(s) Presented:  Lialda is a delayed-release formulation of mesalamine indicated for treating ulcerative colitis. The ’720 patent is listed in the Orange Book. Mylan submitted an ANDA for a generic version of the drug. The ’720 patent claims a controlled-release formulation of the API 5-amino-salicylic acid having, inter alia, an inner lipophilic matrix and an outer hydrophilic matrix, wherein the API is dispersed in both matrices. As construed by the court, a matrix is a “macroscopically homogeneous structure in all its volume.” The court held a four-day bench trial on the issue of infringement. The court found that Shire has established by a preponderance of the evidence that Mylan’s ANDA Product infringed claims 1 and 3 of the ’720 patent, literally, and that Shire had established secondary liability by Mylan on the theory of induced and contributory infringement.

Why Shire Prevailed:  The nature of the matrices was disputed. Mylan argued that because certain excipients were present throughout its product, the product did not have separate matrices. However, the court found that Shire’s testing demonstrated the presence of two portions of the product having separate composition characteristics. These characteristics include the viscosity level and water penetration resistance.

Shire’s evidence of the “macroscopically homogeneous” limitation for each matrix’s structure, admittedly, consisted of microscopic but not macroscopic images. The court found that there was nothing to refute the fact that Shire’s experts could have reasonably inferred from the microscopic images that the matrices were macroscopically homogeneous.

Ultimately, the court credited Shire’s experts’ testimony over those of Mylan on each of the disputed infringement proofs. The court found that Shire was entitled to a judgment that the ANDA filing constituted infringement, that the effective date of any approval be no earlier than the expiration date of the ’720 patent, and that Mylan be enjoined from commercial manufacture, use, sale, or importation of its ANDA product.