Shire Development LLC. v. Watson Pharma

Case Name: Shire Development LLC. v. Watson Pharma., Civ. No. 12-60862-Middlebrooks/Brannon, 2013 U.S. Dist. LEXIS 43782 (S.D. Fla. March 20, 2013) (Middlebrooks, J.)

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

Nature of the Case and Issue(s) Presented:  Watson asserted two defenses in this Hatch-Waxman litigation: non-infringement and invalidity for lack of written description and non-enablement. The parties filed summary judgment motions. Shire moved the Court to declare that its patent was not invalid for lack of written description and non-enablement. Shire claimed that Watson’s invalidity argument is improper and fails as a matter of law because the claim is conditioned upon infringement. The Court denied Shire’s motion because Shire failed to provide any case law that held that the mere assertion of invalidity conditioned upon infringement is improper.

Watson filed a motion for summary judgment of non-infringement. Because Watson did not raise the doctrine of equivalents, the Court found that Watson’s motion only concerned literal infringement. The asserted claims were directed to a controlled-release oral pharmaceutical composition containing mesalazine, comprising an inner lipophilic matrix, and an outer hydrophilic matrix. The inner lipophilic matrix must contain ingredients with melting points below 90°C. The active ingredient is dispersed in both the lipophilic and hydrophilic matrix. Watson argued that its generic product did not infringe for three reasons: (i) Watson’s product does not have an “inner lipophilic matrix” in which mesalamine is dispersed; (ii) Watson’s product does not have an “outer hydrophilic matrix” in which mesalamine is dispersed; and (iii) Watson’s product does not contain a lipophilic substance with a melting point below 90°C. The Court rejected all of Watson’s arguments and denied the summary judgment motion.

Watson also moved to strike four expert declarations based on late disclosure. The Court struck one declaration as untimely. The Court allowed the other three declarations, finding that the late disclosure was harmless and did not prejudice Watson.

Why the Court denied both parties’ motions for summary judgment:  The Court denied the parties’ summary judgment motions for very distinct reasons. The Court found that Shire’s motion was not supported by the law. Shire failed to provide the Court with a case to support its argument that the mere assertion of invalidity conditioned upon infringement is improper. The Court denied Watson’s summary judgment motion because questions of material fact still exist. Watson claimed that its product did not have an inner matrix because that product’s “compressed core” contains one lipophilic substance—magnesium stearate—and only as a lubricant in the subsequent tablet-compression step. Shire presented expert opinion and test results that showed magnesium stearate throughout the ANDA product. The Court found that this expert testimony and test results created an issue of material fact. Second, Watson argued that it cannot infringe because no mesalamine is contained in its mesalamine granules dispersed in the outer matrix. Shire countered by introducing evidence showing that a hydrophilic substance is present at the surface of the granules is in contact with and dispersed with the mesalamine in that region. Outside of the granules there are fines that exist throughout the ANDA product. Shire provided evidence indicating that those fines contain mesalamine. Shire also claimed that the hydrophilic material will swell massively after ingestion of the tablet and as a result of that expansion, the outer hydrophilic matrix will be homogeneously dispersed with mesalamine as it continues to transit and release in the gastrointestinal tract. The Court found that a genuine issue of material fact remained since Shire provided adequate evidence indicating that a hydrophilic matrix is present in the ANDA product and mesalamine is dispersed within it. Finally, Watson argued that the magnesium stearate in its product would not melt below 90°C by provided evidence from a supplier. Shire claimed that Watson was using a different supplier and claimed that the magnesium stearate product would melt below 90°C. The Court found that this also raised a genuine issue of material fact for determination at trial.