Novartis Pharms. Corp. v. Noven Pharms., Inc.
| Decision Date | 31 August 2015 |
| Docket Number | Civil Action No. 13-527-RGA,Civil Action No. 14-111-RGA |
| Parties | NOVARTIS PHARMACEUTICALS CORPORATION, NOVARTIS AG, NOVARTIS PHARMA AG, NOVARTIS INTERNATIONAL PHARMACEUTICAL LTD., and LTS LOHMANN THERAPIE-SYSTEME AG, Plaintiffs; v. NOVEN PHARMACEUTICALS, INC., Defendant. |
| Court | U.S. District Court — District of Delaware |
TRIAL OPINION
Michael P. Kelly, Esq., Daniel M. Silver, Esq., MCCARTER & ENGLISH, LLP, Wilmington, DE; Nicholas N. Kallas, Esq., Charlotte Jacobsen, Esq., Dominick A. Conde, Esq., Christopher E. Loh, Esq., Daniel J. Minion, Esq., FITZPATRICK, CELLA, HARPER & SCINTO, New York, NY.
Attorneys for Plaintiffs Novartis Pharmaceuticals Corp., et al.
John C. Phillips, Jr., Esq., Megan C. Haney, Esq., PHILLIPS, GOLDMAN & SPENCE, PA., Wilmington, DE; Steven J. Lee, Esq., Michael K. Levy, Esq., Christopher J. Coulson, Esq., KENYON & KENYON LLP, New York, NY.
Attorneys for Defendant Noven Pharmaceuticals, Inc.
Plaintiffs Novartis Pharmaceuticals Corporation, Novartis AG, Novartis Pharma AG, Novartis International Pharmaceutical Ltd., and LTS Lohmann Therapie-Systeme AG (collectively, "Novartis") brought this suit against Defendant Noven Pharmaceuticals, Inc., alleging infringement of U.S. Patent Nos. 6,335,031 ("the '031 patent") and 6,316,023 ("the '023 patent"). (D.I. 1).1 The '023 patent is no longer at issue. (D.I. 137). The parties stipulated that Noven's ANDA products infringe claims 7 and 16 of the '031 patent. (D.I. 146). Noven argues, however, that the asserted claims are invalid as obvious under 35 U.S.C. § 103(a) and invalid under obviousness-type double patenting. The Court held a three day bench trial beginning on December 1, 2014 on the issue of validity. (D.I. 154, 155 & 156). The parties filed post-trial briefing (D.I. 161, 168 & 170) and proposed statements of fact. (D.I. 162, 169 & 171).2 For the reasons stated below, I find that Noven failed to prove by clear and convincing evidence that the asserted claims are invalid as obvious. I also find that the asserted claims are not invalid under obviousness-type double patenting.
Claims 7 and 16 of the '031 patent depend on non-asserted independent claims 1 and 15, which are drawn to a pharmaceutical composition and a stabilization method, respectively. Claim 1 of the '031 patent recites:
(D.I. 1-1 at 6, col. 8:14-21). In the claim language "Compound A" refers to rivastigmine, the "S" enantiomer of the racemic compound RA7.3 Claim 7 recites a "transdermal device comprising a pharmaceutical composition as defined in claim 1, wherein the pharmaceutical composition is supported by a substrate." (Id., col. 8:49-51). Claim 15 recites:
A method of stabilizing (S)-N-ethyl-3-{(1-dimethylamino)ethyl}-N-methyl-phenyl-carbamate in free base or acid addition salt form (Compound A), wherein the method comprises forming a composition by combining Compound A with an amount of antioxidant effective to stabilize Compound A from degradation.
(Id. at 7, col. 9:10-15). Claim 16 limits the method's antioxidant to "tocopherol, esters thereof, ascorbic acid, butylhydroxytoluene, butylhydroxyanisole or propyl gallate." (Id., col. 10:1-3).
The presumption that all patents are valid is the starting point for any obviousness determination. 35 U.S.C. § 282 (2012). A patent claim is invalid as obvious under 35 U.S.C. § 103 "if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains." Id. § 103(a); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406-07 (2007).Obviousness is a question of law that depends on the following factual inquiries: (1) the scope and content of the prior art; (2) the differences between the claims and the prior art; (3) the level of ordinary skill in the relevant art; and (4) any objective considerations such as commercial success, long felt but unsolved need, and the failure of others. See KSR, 550 U.S. at 406; see also Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1347 (Fed. Cir. 2012). The improvement over prior art must be "more than the predictable use of prior art elements according to their established functions." KSR, 550 U.S. at 417.
To prove obviousness, a party must show that a person having ordinary skill in the art (PHOSITA) would be motivated to combine the claimed combinations with a reasonable expectation of success. Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1291 (Fed. Cir. 2013). Evidence of obviousness, especially when that evidence is proffered in support of an "obvious-to-try" theory, is insufficient unless it indicates that the possible options skilled artisans would have encountered were "finite," "small," or "easily traversed," and "that skilled artisans would have had a reason to select the route that produced the claimed invention." In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1072 (Fed. Cir. 2012). Obviousness must be proven by clear and convincing evidence. Id. at 1078.
"Obviousness-type double patenting is a judicially-created doctrine designed to prevent claims in separate applications or patents that do not recite the 'same' invention, but nonetheless claim inventions so alike that granting both exclusive rights would effectively extend the life of patent protection." In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013) (internal quotationmarks omitted).4 Under this doctrine, the court must determine "whether the claimed invention in the application for the second patent would have been obvious from the subject matter of the claims in the first patent, in light of the prior art." In re Longi, 759 F.2d 887, 893 (Fed. Cir. 1985). In order to do so, the court applies a two-step analysis: Abbvie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366, 1374 (Fed. Cir. 2014) (internal quotation marks omitted). "A later claim that is not patentably distinct from . . . an earlier claim is invalid for obviousness-type double patenting." Id. (internal quotation marks omitted).
1. The PHOSITA is an individual, or team of individuals, with an advanced degree in chemistry, pharmacy, or a related field with at least two years of practical experience, or a master's or bachelor's degree in those disciplines and at least four or six years of practical experience, respectively.
2. The following are all prior art references: Sasaki (DTX 12); Carey & Sundberg (DTX 32); Ansel (DTX 91); Modern Pharmaceutics (PTX 153); Physician's Desk Reference (PTX 157 ); Remington's Pharmaceutical Sciences (JTX 5); Handbook of Pharmaceutical Excipients (JTX 8); the '480 patent (JTX 9); Sramek (JTX 11); the '807 patent (JTX 17); GB '040 (JTX 19); the '176 patent (JTX 20); Elmalem (JTX 21); Formulary (JTX 25); Ebert (JTX 28); Weinstock 1981 (JTX 30); Linnell (JTX 32); Weinstock 1994 (PTX 175); and Enz 1991 (PTX 174).
3. A PHOSITA would not have known rivastigmine was susceptible to oxidative degradation based on its chemical structure.
4. Comparing rivastigmine to nicotine would not have informed a PHOSITA that rivastigmine was susceptible to oxidative degradation.
5. None of the prior art references teach a PHOSITA that rivastigmine is susceptible to oxidative degradation.
6. Rivastigmine was not known to be susceptible to oxidative degradation.
7. It would not have been obvious to a PHOSITA to combine an antioxidant with rivastigmine in a transdermal patch.
Noven argues that claims 7 and 16 of the '031 patent are invalid for obviousness. In a previous case involving the '031 and '023 patents, where claims 7 and 16 of the '031 patent were at issue, I stated that:
[T]he obviousness determination in this case turns on whether a PHOSITA in January 1998, looking at all of the prior art, would have known rivastigmine was susceptible to oxidative degradation. If the answer is yes, the asserted claims of the '023 and '031 patents are invalid because the addition of an antioxidant to a pharmaceutical composition that oxidatively degrades is one of several known, obvious solutions. If the answer is no, then the discovery that rivastigmine oxidatively degrades and the solution to that problem are an inventive contribution worthy of patent protection.
Novartis Pharm. Corp. v. Par Pharm., Inc. ("Watson"), 48 F. Supp. 3d 733, 758 (D. Del. 2014), aff'd sub nom., Novartis Pharm. Corp. v. Watson Labs., Inc., 2015 WL 2403308 (Fed. Cir. May 21, 2015) (internal citations omitted).5 Noven has introduced new evidence that was not beforethe Court in Watson. Nevertheless, my analysis reaches the same conclusion as in the prior case.
Noven argues that a PHOSITA in 1998 would have examined the chemical structure of rivastigmine and recognized that it is susceptible to oxidative degradation. (D.I. 161 at 8). Noven cites the Ansel reference, which states that "one of the most important activities of preformulation work is the evaluation of the physical and chemical stability of the pure drug substance." (DTX 91 at 91 [Howard C. Ansel, Introduction to Pharmaceutical Dosage Forms 91 (4th ed. 1985)]). Ansel...
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