Forest Laboratories, Inc. v. Ivax Pharmaceuticals, Inc.
| Decision Date | 13 July 2006 |
| Docket Number | No. CIV.A. 03-891-JJF.,CIV.A. 03-891-JJF. |
| Citation | 438 F.Supp.2d 479 |
| Parties | FOREST LABORATORIES, INC., Forest Laboratories Holding, Ltd. and H. Lundbeck A/S, Plaintiffs, v. IVAX PHARMACEUTICALS, INC., and Cipla Ltd., Defendants. |
| Court | U.S. District Court — District of Delaware |
Melanie K. Sharp, Esquire and Andrew Lundgren, Esquire of Young Conaway Stargatt & Taylor, Wilmington, DE, Of Counsel: John M. Desmarais, Esquire; Peter J. Armenio, Esquire; Gerald J. Flattman, Jr., Esquire and Maxine Y. Graham, Esquire of Kirkland & Ellis LLP, New York, NY, for Plaintiffs.
Richard D. Kirk, Esquire of the Bayard Firm, Wilmington, DE, Of Counsel: Jeffrey S. Ward, Esquire; Thomas P. Heneghan, Esquire; Shane A. Brunner, Esquire; Edward J. Pardon, Esquire and Charlene L. Yager, Esquire of Michael Best & Friedrich LLP, Madison, WI, for Defendants.
This action was brought by Plaintiffs, Forest Laboratories, Inc., Forest Laboratories Holdings, Ltd. and H. Lundbeck A/S (collectively, "Plaintiffs"), against Defendants Ivax Pharmaceuticals, Inc. ("Ivax") and Cipla Ltd. ("Cipla") (collectively, "Defendants") alleging infringement of U.S. Patent No. Re. 34,712 (the "'712 patent") based on IVAX's submission of Abbreviated New Drug Application ("ANDA") 76-765 to the Food and Drug Administration and CIPLA's role in assisting IVAX with the submission of ANDA 76-765 and serving as a future importer and manufacturer of the generic product contemplated by ANDA 76-765. For purposes of this action, the parties have stipulated to a specific claim construction for the primary disputed term in the '712 patent. Based on this agreed upon claim construction, the parties have further stipulated that the proposed generic products defined by ANDA 76-765 infringe claims 1,3,5,7 and 9 of the '712 patent. (PTX 189). The parties have also stipulated that Defendants' process for making the proposed generic products will infringe claim 11 of the '712 patent. (PTX 782).
Because the parties have stipulated to infringement for purposes of this litigation, the only issues remaining for adjudication by the Court are Defendants' counterclaims of invalidity and unenforceability. Specifically, Defendants seek a declaratory judgment that (1) claim 1 of the '712 patent is invalid as anticipated under 35 U.S.C. § 102; (2) claims 1,3,5,7,9 and 11 of the '712 patent are invalid as obvious under 35 U.S.C. § 103; and (3) claim 11 of the '712 patent is invalid as an improperly broadened reissued claim under 35 U.S.C. § 251. In addition, Defendants seek a declaratory judgment that the '712 patent is unenforceable due to inequitable conduct.
This action arises under the patent laws of the United States, Title 35 of the United States Code and the Abbreviated New Drug Application provisions of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(j). Accordingly, the Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. §§ 1331 and 1338.1
The Court conducted a five day bench trial on the issues presented by the parties. This Opinion constitutes the Court's findings of fact and conclusions of law on Defendants' counterclaims of invalidity and unenforceability.
Plaintiff H. Lundbeck A/S ("Lundbeck") is a Danish corporation with a principal place of business in Copenhagen, Denmark. (D.I. 526, Attachment 1 "Admitted Facts" at ¶3, 35). Lundbeck is the sole owner of the 2 Drug Application (NDA) 21-323 on LEXAPRO® brand escitalopram oxalate products. (Admitted Facts at ¶ 37).
Defendant Ivax is a Florida corporation with a principal place of business in Miami, Florida. (Admitted Facts at ¶ 5). Ivax submitted ANDA 76-765 seeking approval to market generic tablets containing 5, 10 or 20 milligrams of escitalopram oxalate. (Admitted Facts at ¶ 39). Defendant Cipla is an Indian corporation with a principal place of business in Mumbai, India. (Admitted Facts at ¶ 6). Cipla provided information to IVAX that was included in the submission of ANDA 76-765 to the FDA, and under ANDA 76-765, Cipla will manufacture the escitalopram oxalate used in the proposed generic drugs. (Admitted Facts at ¶ 42).
The '712 patent is a reissue of U.S. Patent No. 4,943,590 (the "'590 patent"). (Admitted Facts at ¶ 12). The '590 patent originally issued on July 24, 1990. (Admitted Facts at ¶ 13). On August 30, 1994, the '712 patent was issued. (Admitted Facts at ¶ 9; DTX 1). The '712 patent is entitled "Pharmaceutically Useful (+)-1-(3-dimethylaminoproply)-1-(4'-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile And Non-Toxic, Acid Additional Salts Thereof." (DTX-1). The named inventors of the '712 patent are Klaus P. Bogeso and Jens K. Perregaard. The '712 patent covers substantially pure (+)-citalopram, also known as "S-citalopram" or "escitalopram," in the oxalate salt form, which is the active ingredient in LEXAPRO®, an antidepressant drug, from the class of compounds known as selective serotonin reuptake inhibitors ("SSRIs").
The '712 patent is set to expire on June 8, 2009; however, Lundbeck has timely requested a patent term extension of 827 days. (Admitted Facts at ¶ 14, 16). Lundbeck's request for an extension has not been challenged, and therefore, the '712 patent will not expire until September 13, 2011. In addition to this extension period, LEXAPRO® brand escitalopram oxalate products covered by the '712 patent are subject to a pediatric extension of six months. (Admitted Facts at ¶ 15). Thus, generic versions of the LEXAPRO® products covered by the '712 patent are precluded from being marketed in the United States until March 13, 2012. (Admitted Facts at ¶ 18).
Once a patent is issued by the United States Patent and Trademark Office ("PTO") it is cloaked with a presumption of validity. 35 U.S.C. § 282. This presumption of validity also applies to reissued patents. 35 U.S.C. § 252. To overcome this presumption, the party challenging the patent must demonstrate by clear and convincing evidence that the patent is invalid. U.S. Gypsum Co. v. Nat'l Gypsum Co., 74 F.3d 1209, 1212 (Fed.Cir. 1996).
Pursuant to 35 U.S.C. § 102(g), a patent is invalid as anticipated if "the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant' for patent ...." To anticipate a patent, a prior printed publication must contain each and every limitation of the claimed invention, either expressly or inherently, such that a person of ordinary skill in the art could practice the claimed invention without undue experimentation. Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed.Cir.2000).
Defendants contend that claim 1 of the '712 patent is anticipated by Donald F. Smith, The Stereoselectivity of Serotonin Uptake in Brain Tissue and Blood Platelets: The Topography of the Serotonin Uptake Area, Neuroscience and Behavioral Reviews, Vol. 10, pp. 37-46 (1986) (DTX 871) ("Smith" or the "Smith reference"). Specifically, Defendants cite to a portion of Smith which provides:
[C]italopram ... is a racemic drug with potent inhibitory effect on 5-HT [serotonin] uptake. Although effects of the individual enantiomers of citalopram have never been studied, the model predicts that the (R)-enantiomer is far more potent that the (S)-enantiomer as a 5-HT uptake inhibitor. Thus, the present model can be tested by determining whether these predications are correct.
(DTX 871 at DS000200) (internal citations omitted).
To contain each and every element of the claimed invention, a prior art printed publication need not recite the elements of the patent claim in language identical to the language used in the Claim, so long as the reference teaches the entirety of the invention. Structural Rubber Prods. Co. v. Park Rubber Co., 749 F.2d 707, 716 (Fed.Cir.1984). "Anticipation of inventions set forth in product claims cannot be predicated on mere conjecture respecting the characteristics of products that might result from the practice or processes disclosed in references." W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 1554 (Fed.Cir.1983); see also Mentor HIS, Inc. v. Med. Device Alliance, Inc., 244 F.3d 1365, 1376 (Fed.Cir.2001) (). In addition, references that have the same general features as the invention do not anticipate the invention, and one skilled in the art cannot supply missing elements through his or her knowledge. Stated another way, "[t]here must be no difference between the claimed invention and the reference disclosure, as viewed by a person of ordinary skill in the field of the invention." Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565, 1576 (Fed.Cir. 1991). Whether a step or element is expressly or inherently disclosed in a prior art reference is a question of fact. Tegal Corp. v. Tokyo Electron Am., Inc., 257 F.3d 1331, 1345-1346 (Fed.Cir.2001).
Claim 1 of the '712 patent claims substantially pure (+)-citalopram which the parties have agreed, for purposes...
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