Case Name: Warner Chilcott Labs Ireland Ltd. v. Mylan Pharma. Inc., Civ. Nos. 2:08-06304-WJM; 2:09-02073-WJM; 2:09-01233-WJM, 2012 U.S. Dist. LEXIS 60386 (D.N.J. April 30, 2012) (Martini, J.)
Drug Product and Patent(s)-in-Suit: Doryx® (doxycycline hyclate) Delayed Release Capsules; U.S. Pat. No. 6,958,161 ("the '161 patent").
Nature of the Case and Issue(s) Presented: The first issue presented was whether Mylan's or Impax's proposed generic product contained a stabilizing coat as the patent claims required. Unlike the patented product, the proposed generic products do not contain a stabilizing coat. To demonstrate infringement, Warner Chilcott relied on a single test, "a humidity test", to show that the generic products contained a stabilizing coat. After a bench trial, the Court found that defendants did not apply a stabilizing coat during its manufacturing process, five widely-accepted scientific testing methods did not show the presence of a stabilizing coat in the proposed generic products and that the novel test that Warner Chilcott relied on failed to demonstrate a stabilizing coat in the generic products. Thus, the Court found that the generic products did not infringe the patent-in-suit. The second issue presented was whether the '161 patent was inherently anticipated by U.S. 5,413,777 ("the '777 patent") and/or rendered obvious in light of the '777 patent in view of other prior art references. The Court found that '777 patent fails to disclose each and every element of the '161 patent. The '777 patent does not inherently disclose the dissolution storage stability limitations of the claims. The Court further found that the defendants failed to present any evidence that the '777 patent disclosed the stabilizing coat limitation. With respect to obviousness, the Court found that the additional prior art references failed to teach the claim limitations missing from the '777 patent.
Why Mylan and Impax Prevailed: Mylan and Impax prevailed because the patent requires a stabilizing coat and the proposed generic products did not contain one. The Court construed the phrase "stabilising coat between each core element and its modified release coating" to mean "[A] layer of material(s) between each core element and its modified release coating, which keeps the migration of core materials to a minimum such that the interaction of core materials with coating materials is reduced or prevented." It was undisputed that Mylan and Impax did not apply a stabilizing coat to their generic products during the manufacturing process. The Court reviewed, in detail, five widely-accepted scientific testing methods: (i) Raman spectroscopy; (ii) Time of Flight Ion Mass Spectrometry; (iii) Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy; (iv) Atomic Force Microscopy and (v) Scanning Electronic Microscopy. All of those tests did not show the presence of a stabilizing coating. Warner Chilcott relied on a single test, a humidity test, to demonstrate a stabilizing coating. The Court found that the humidity test did not meet the Daubert standard and even if it had, the test did not support a finding of a stabilizing coat. The Court analyzed the humidity test applying the eight factors in deciding whether to admit evidence under Rule 702 and Daubert. The Court found that the humidity test was not subject to peer-review, did not have a known or potential rate of error, only had nebulous standards for controlling the operation of the humidity test, was not generally accepted in the scientific community for the purpose of determining the presence of a coating, does not have a relationship to reliable testing methods and has never been put to any non-judicial use. The Court also determined that if the humidity test would meet the Daubert standard, the humidity test would not support a finding of a stabilizing coat. Mylan and Impax presented different interpretations of the humidity test results. The Court found that those different interpretations evaluated in light of the other tests conducted, demonstrate that the humidity test is insufficient to demonstrate infringement of the stabilizing-coat limitation.
