February 1, 2018

Case Name: iCeutica Pty v. Lupin Ltd., Civ. No. MJG-17-0394, 2018 U.S. Dist. LEXIS 16526 (D. Md. Feb. 1, 2018) (Garbis, J.) 

Drug Product and Patent(s)-in-Suit: Vivlodex® (meloxicam); U.S. Patents Nos. 9,526,734 (“the ’734 patent”) and 9,649,318 (“the ’318 patent”)

Nature of the Case and Issue(s) Presented: Vivlodex is approved for the treatment of osteoarthritis pain. iCeutica sued Lupin alleging patent infringement based on the filing of Lupin’s ANDA for generic meloxicam. Lupin moved for summary judgment of non-infringement on both asserted patents. The court granted Lupin’s motion.

Why Lupin Prevailed: Both asserted patents claim formulations of meloxicam milled to meet a specified nanoparticulate size distribution profile. Specifically, the claims required a particle size distribution with a D(0.9) of between 1200 nm and either 3000 or 4000 nm. iCeutica conceded that Lupin’s ANDA products did not literally meet the claimed particle size distributions—Lupin’s ANDA products had a D(0.9) of less than 800 nm—but asserted infringement under the doctrine of equivalents.

Lupin argued that iCeutica surrendered during prosecution particle size distributions with a D(0.9) below 1200 nm during prosecution through both amendment-based and argument-based estoppel. Thus, Lupin argued that iCeutica was estopped from asserting the doctrine of equivalents against Lupin’s ANDA products.

The court found that during prosecution of the asserted patents, the examiner rejected iCeutica’s claims as obvious in view of a reference referred to as Cooper. Cooper disclosed a formulation of meloxicam with a narrow particle size distribution. To overcome the rejection, the applicant amended the claims to recite a broader particle size distribution. The examiner allowed the claims after an amendment to recite a particle size distribution with a median particle size, D(0.5), of 100-500 nm and a D(0.9) of 1200-3000 nm.

Additionally, the court found that the applicant made several arguments during prosecution regarding the particle size distribution. The applicant argued that the claims had a broader particle size distribution than Cooper. The applicant also argued that the claimed particles had a D(0.9) above 900 nm, while Cooper disclosed particles with a D(0.9) below 300 nm. Thus, the applicant argued that there was a substantial difference in particle size between the claimed particles and the particles disclosed by Cooper. With respect to amendment-based estoppel, the court found that iCeutica clearly narrowed its D(0.9) values through amendments during prosecution and that those amendments were made to overcome a § 103 rejection. The court found that the examiner required the applicant to amend its D(0.9) value to 1200 nm in order to create a sufficiently broad particle size distribution to overcome Cooper.

The court also found that iCeutica surrendered D(0.9) values below 1200 nm through argument-based estoppel. The applicant repeatedly argued to the examiner that its invention required a higher D(0.9) value in order to demonstrate a broader particle size distribution than Cooper’s.