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Allergan Sales, LLC v. Teva Pharmaceuticals USA Inc.

United States District Court, E.D. Texas, Marshall Division

July 12, 2017




         In these consolidated patent infringement lawsuits, Allergan Sales, LLC (“Allergan”) and Qualicaps Co., LTD. (“Qualicaps”) allege that Teva Pharmaceuticals USA, Inc. (“Teva”), Mylan Pharmaceuticals, Inc., Mylan Laboratories Limited, and Mylan, Inc. (collectively “Mylan”) are seeking FDA approval to market and sell a generic version of Allergan's branded Delzicol drug product in violation of U.S. Patent No. 6, 649, 180 (“the '180 patent”). Before the court is the matter of claim construction. The parties submitted technology tutorials and claim construction briefs, and the Court held a claim construction hearing on August 30, 2016.


         The '180 patent was filed April 13, 2000, issued November 18, 2003, and is scheduled to expire April 13, 2020. See '180 patent, Dkt. 1-2; 35 U.S.C. § 154(a)(2). The background of the patent describes problems with hard gelatin capsules used in the pharmaceutical and health food fields. Id. at 1:10-11. Gelatin capsules are films formed from gelatin, a plasticizer, opacifying agent, dye, pigment, and other ingredients. Id. at 1:12-14. The capsules are made by dipping a pin (or mold) into an aqueous solution of the capsule forming ingredients, drawing the pin out of solution, allowing the solution adhering to the pin to dry, and, once the solution forms a hard shell, separating the shell from the pin. Id. at 1:15-20; 4:54-5:4. The shell is then cut to size and mated with a complementary shell to form a capsule. Id. at 4:67-5:4.

         Gelatin capsules made in this way are affected by residual water content. Id. at 1:21-34. A capsule with too little water is not flexible enough to withstand the stress encountered when the capsule is filled with drug. Id. at 1:22-24. Problems associated with too little water may worsen over time as a capsule dries and loses water during storage, resulting in contraction of the capsule. Id. at 1:24-26. A capsule may contract to the point where the shell cap disengages from the shell body. Id. To prevent these problems, maintaining a water content of about 13 to 15% by weight is optimal. Id. at 1:26-28.

         Such a relatively high amount of water content limited the use of gelatin capsules to certain drugs. Id. at 1:28-35. A hygroscopic or water-absorbing drug, for example, would draw too much water from the capsule, thus leading to problems associated with drying. Id. Gelatin capsules worked best with hydrophobic or non-water-absorbing drugs. Id.

         It was known in the prior art that capsules made from cellulose ether compositions were more versatile. Id. at 1:38-42. Capsules made of hydroxypropyl methyl cellulose (HPMC) were known to maintain sufficient strength even with low water content while otherwise performing similarly to conventional gelatin capsules. Id. at 1:47-50. HPMC capsules could be manufactured using the dipping method. Id. 1:50-52.

         Capsules made from cellulose ether compositions nevertheless had their own problems. Chief among them was the tendency of the gelling agent to precipitate out of the capsule film during long-term storage, causing cloudiness and making the capsule “unpleasant to look at it.” Id. at 1:53-56, 2:1-6. When a polysaccharide such as HPMC was used in combination with potassium chloride or calcium chloride as a gelling aid, for example, residual potassium or calcium ions would precipitate out onto the film surface as water content dropped during long-term storage. Id. at 1:57-67.

         The purpose of the invention claimed in the '180 patent is “to provide a novel and improved cellulose ether film of a composition comprising a cellulose ether as a base, a gelling agent, and a gelling aid, which prevents the gelling aid from precipitating out and maintains a favorable outer appearance during long-term storage.” Id. at 2:9-15. The inventors' discovery, according to the patent, is that precipitation of the gelling aid can be prevented with a cellulose ether that has no more than 37.6% cellulosic alkyl or hydroxyalkyl groups substituted in place of cellulosic hydroxyl groups. Id. at 2:26-32. By limiting the amount of cellulosic alkyl or hydroxyalkyl groups, the inventors believed that there were enough hydrophilic hydroxyl groups to ensure the film held enough water, thus preventing potassium or calcium from precipitating. Id. at 2:41-49.

         The '180 patent has one independent claim (claim 1), and it recites:

A hard capsule formed of a film composition comprising a hydroxypropyl methyl cellulose as a base, a gelling agent, and a gelling aid, wherein said hydroxypropyl methyl cellulose has a content of hydroxypropoxyl groups of at least 4% by weight of the hydroxypropyl methyl cellulose and a content of methoxyl groups and hydroxypropoxyl groups combined of 23 to 37.6% by weight of the hydroxypropyl methyl cellulose.

Id. at 6:38-45. In other words, the HPMC used in the film composition has at least 4% by weight hydroxypropoxyl groups (a type of hydroxyalkyl group), and the combined amount of hydroxypropxyl and methoxyl groups is 23 to 37.6% by weight. Id. at 6:38-45, 2:62-3:7. The other claim at issue for purposes of claim construction is claim 4, which depends from claim 1 and specifies, “the content of methoxyl and hydroxypropoxyl groups combined is 29 to 37% by weight of the hydroxypropyl methyl cellulose.” Id. at 6:55-58.


         The ultimate claim construction inquiry is a question of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837 (2015) (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 388-91 (1996)). “It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (internal quotation marks omitted). “[T]here is no magic formula or catechism for conducting claim construction.” Id. at 1324. Instead, the court is free to attach the appropriate weight to appropriate sources “in light of the statutes and policies that inform patent law.” Id.

         “[T]he words of a claim are generally given their ordinary and customary meaning . . . [which is] the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Id. at 1312-13 (internal citations and quotation marks omitted). “[T]he ordinary meaning of a claim term is its meaning to the ordinary artisan after reading the entire patent.” Id. at 1321 (internal quotation marks omitted). The patent specification “is always highly relevant to the claim construction analysis. ...

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