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Novartis Pharmaceuticals Corporation v. Par Pharmaceutical, Inc.

United States District Court, D. Delaware

August 29, 2014


Michael P. Kelly, Esq., and Daniel M. Silver, Esq., Mccarter & English, LLP, Wilmington, DE; Nicholas N. Kallas, Esq., Charlotte Jacobsen, Esq., Fitzpatrick, Cella, Harper & Scinto, New York, NY, Attorneys for Plaintiffs Novartis Pharmaceuticals Corporation, et al.

Steven J. Fineman, Esq., and Katharine C. Lester, Esq., Richards, Layton & Finger, P.A., Wilmington, DE; Daniel G. Brown, Esq., Latham & Watkins LLP, New York, NY; Roger J. Chin, Esq., Latham & Watkins LLP, San Francisco, CA; Jennifer Koh, Esq., Latham & Watkins LLP, San Diego, CA; Michelle Ma, Esq., Latham & Watkins LLP, Menlo Park, CA. Attorneys for Defendant Par Pharmaceutical, Inc.


RICHARD G. ANDREWS, District Judge.

Novartis Pharmaceuticals Corporation, Novartis AG, Novartis Pharma AG, Novartis International Pharmaceutical Ltd., and LTS Lohmann Therapie-Systeme AG (collectively, "Novartis" or "Plaintiff') brought this suit against Watson Laboratories, Inc., Watson Pharma, Inc., Watson Pharmaceuticals, Inc. (collectively "Watson"), and Par Pharmaceutical, Inc ("Par" or "Defendant")[1] alleging infringement of U.S. Patents Nos. 6, 335, 031 ("the '031 patent") and 6, 316, 023 ("the '023 patent") (collectively, "the patents in suit"). Both patents share the same specification.[2]

Novartis sells an Exelon® transdermal patch for the treatment of Alzheimer's disease that contains rivastigmine. (D.I. 374-1at4).[3] Novartis listed the '031 and '023 patents in the Food and Drug Administration's "Approved Drug Products with Therapeutic Equivalence Evaluations, " frequently referred to as the "Orange Book, " as covering the Exelon® patches. Par's Abbreviated New Drug Application 202, 339 ("ANDA") seeks approval to engage in the commercial manufacture, importation, use, or sale of a rivastigmine transdermal system, in 4.6 mg/24 hr, 9.5 mg/24 hr, and 13.3 mg/24hr dosage strengths. The basic design of the drug is depicted[4] below:

Novartis asserts that Par's ANDA products infringe claim 7 of the '031 Patent because acetaldehyde meets claim 7's antioxidant requirement. (D.I. 403 at 5). Par counters that if acetaldehyde is found to be an antioxidant, then claim 7 fails to meet the requirements of 35 U.S.C. § 112, as the claim is both indefinite and the claim does not meet the written description requirement.

The Court held a two day bench trial on May 1 and 2, 2014. (D.I. 398, 399 (collectively referred to as Tr.)). As explained below, Novartis failed to prove that Par's ANDA products infringe by a preponderance of the evidence, and thus the Court does not reach the issue of invalidity.[5]


The one asserted claim in the '031 patent, claim 7, depends from non-asserted independent claim 1. Claim 1 of the '031 patent recites:

A pharmaceutical composition comprising:

(a) a therapeutically effective amount of (S)-N-ethyl-3-((1-dimethylamino)ethyl}-N-methyl-phenyl-carbamate in free base or acid addition salt form (Compound A);
(b) about 0.01 to about 0.5 percent by weight of an antioxidant, based on the weight of the composition, and
(c) a diluent or carrier.

'031 patent, claim 1. In the claim language "Compound A" refers to rivastigmine, the "S" enantiomer of the racemic compound RA1. Claim 7 narrows claim 1 by limiting it to a specific delivery method. Claim 7 reads:

A transdermal device comprising a pharmaceutical composition as defined in claim 1, wherein the pharmaceutical composition is supported by a substrate.

Id. , claim 7.

Claim 7 is a "presence" claim, and thus requires proof that Compound A and an antioxidant are present. The Court defined "antioxidant" as an "agent that reduces oxidative degradation." (D.I. 250, pp. 1-2). There is no additional requirement that the antioxidant function with respect to Compound A because that is specifically required in the function claims. (Id., p. 2 ("The patents repeatedly disclose the combination of Compound A and the antioxidant without specifically requiring that the antioxidant affect Compound A. It would be improper to preclude those embodiments by limiting antioxidant' to require that interaction." (internal citations omitted))).

The parties agree that whether Par's ANDA product infringes raises only two issues: (1) whether an antioxidant is present and (2) whether that antioxidant will be present in Par's ANDA products in the amount claimed by the '031 patent. (D.1. 403 at 5; D.I. 410 at 6). Novartis argues both that acetaldehyde is an antioxidant and that it is present in the patch in sufficient quantities to infringe the '031 Patent. Par maintains that acetaldehyde is not an ...

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