Shire Dev. LLC v. Watson Pharms., Inc.
| Decision Date | 09 May 2013 |
| Docket Number | Case No. 12-60862-CIV-MIDDLEBROOKS/BRANNON |
| Parties | SHIRE DEVELOPMENT LLC, et al., Plaintiffs, v. WATSON PHARMACEUTICALS, INC., et al., Defendants. |
| Court | U.S. District Court — Southern District of Florida |
THIS CAUSE comes before the Court for final disposition of the issues presented during a bench trial held from April 8, 2013, through April 12, 2013, with closing arguments held on April 26, 2013. Plaintiffs1 (collectively, "Plaintiffs" or "Shire") assert that Defendants2 (collectively, "Defendants" or "Watson") infringe Claims 1 and 3 of United States Patent 6, 773, 720 (the '"720 Patent"). Defendant Watson Florida counterclaims for a declaration that their product does not infringe the '720 Patent, as well as a declaration that the '720 Patent is invalid under 35 U.S.C. § 112(a), for lack of written description and enablement.
This Opinion constitutes the Court's findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a). All proposed findings of fact and conclusions of law inconsistent with those set forth herein are rejected.
The '720 Patent is listed in the FDA's publication titled "Approved Drug Products with Therapeutic Equivalence Evaluations" (commonly known as the "Orange Book") as covering Lialda®. Shire Development is the owner of New Drug Application ("NDA") No. 22000, and is FDA-approved for the manufacture and sale of mesalamine delayed-release tablets containing 1.2 g mesalamine, which are commercialized under the tradename Lialda®. Lialda® is indicated for the induction of remission in adults with active, mild-to-moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.
On May 8, 2012, Plaintiffs filed this action for infringement of the '720 Patent against Defendants under the Hatch-Waxman Act (the "Hatch-Waxman Act" or the "Act"), 35 U.S.C. § 271.3
The Hatch-Waxman Act permits a generic drug manufacturer to obtain approval to market a generic version of a previously approved pharmaceutical product without conducting expensive and time-consuming tests to establish the safety and effectiveness of that product. In place of these safety and efficacy tests, the generic manufacturer must submit an Abbreviated New DrugApplication ("ANDA") to the Federal Drug Administration ("FDA") and demonstrate that its product is bioequivalent to the branded product. 21 U.S.C. § 355(j)(2)(A)(iv). The Hatch-Waxman Act requires that an ANDA applicant submit a "Paragraph IV" certification in its ANDA that the product it seeks FDA approval to market will not infringe any valid U.S. patent. Id. § 355(j)(2)(A)(vii)(IV). The Act also requires that an ANDA applicant submit a detailed notice to the patent owner explaining the factual and legal basis for the opinion that the patent is invalid or that the generic product will not infringe the patent. Id. § 355(j)(2)(B); see also 21 C.F.R. § 314.95(c)(6). The patent owner may file a suit for patent infringement within forty-five days of receipt of a Paragraph IV notice. If the owner files suit, then the FDA may not approve the ANDA for thirty months or until a United States court finds for the defendant based on non-infringement, patent invalidity, or patent unenforceability. Id. § 355(j)(5)(B)(iii).
Defendant Watson Florida submitted Watson's ANDA number 203817 ("ANDA Product") to the FDA seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of Watson's ANDA Product. Watson's ANDA Product is a generic mesalamine delayed-release tablet and contains 1.2 g mesalamine as the active ingredient.
Watson's ANDA included a "Paragraph IV" certification seeking FDA approval before the expiration of the '720 Patent. On March 26, 2012, pursuant to 21 U.S.C. § 355(j)(2)(B)(iv), Watson sent the Paragraph IV certification to Cosmo Technologies Limited, Young & Thompson, Shire US Inc., and "Shire." Watson's notice indicates that Watson Florida seeks FDA approval to market Watson's ANDA Product before the '720 Patent expires.
Plaintiffs filed their Complaint against Defendants on May 8, 2012, within forty-five days of receipt of the Paragraph IV notice letters, and filed an Amended Complaint (DE 43) on August3, 2012. Plaintiffs allege infringement of one or more claims of the '720 Patent against all Defendants (Count I), and induced and/or contributory infringement of the '720 Patent by Watson Pharmaceuticals (now Actavis) (Count II). With regard to Count II, Plaintiffs allege that Watson Pharmaceuticals knowingly induced Watson Pharma, Watson Laboratories, and/or Watson Florida to infringe and/or contributed to Watson Pharma's, Watson Laboratories', and/or Watson Florida's infringement of the ' 720 Patent. They also allege that Watson Pharmaceuticals actively induced, encouraged, aided, or abetted Watson Pharma's, Watson Laboratories', and/or Watson Florida's preparation, submission, and filing of Watson's ANDA with a paragraph IV certification to the '720 Patent. Plaintiffs assert that these acts constitute infringement under 35 U.S.C. § 271.
On August 23, 2012, Defendants filed their Answer (DE 52). Within the Answer, Watson Florida asserts two counterclaims for declaratory relief: (1) a declaration that their ANDA product would not infringe any claim of the '720 Patent, (see DE 52 at 15-16); and (2) a declaration that the '720 Patent and its claims are invalid under 35 U.S.C. § 112, for lack of written description and lack of enablement, to the extent the claims are alleged to cover any products set forth in the Watson ANDA. (See DE 52 at 16-17).
Plaintiffs are asserting infringement of only Claims 1 and 3 of the '720 Patent. Claim 1 is the Patent's only independent claim, and provides:
(DE 202-1 at 4). Claim 3, which is dependent on Claim 1, provides: "Compositions as claimed in [C]laim 1, in the form of tablets, capsules, mintablets." (Id.).4
At the request of the Parties, and following claim construction briefing and a Markman hearing on December 20, 2012, see Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995), the Court issued an Order dated January 16, 2013 (DE 147), construing certain disputed claims of the '720 Patent. The Court's claim constructions are as follows:
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