Novartis Pharm. Corp. v. W.-Ward Pharm. Int'l Ltd.
287 F. Supp. 3d 505
| D. Del. | 2017

Background

  • Plaintiffs (Novartis) sued Roxane/West‑Ward after Roxane filed an ANDA to market generic everolimus (Afinitor). Parties stipulated the ANDA would infringe asserted claims of U.S. Pat. Nos. 8,410,131 (claims 1–3) and 9,006,224 (claim 1).
  • The '131 patent claims methods of administering everolimus to inhibit growth of solid excretory system tumors, including advanced renal cell carcinoma (RCC). Priority date: Feb. 19, 2001.
  • The '224 patent claims everolimus monotherapy to treat advanced pancreatic neuroendocrine tumors (PNETs) after failure of cytotoxic chemotherapy. Priority date: Nov. 21, 2005.
  • Defendant asserted obviousness under 35 U.S.C. § 103 based on prior art including Hidalgo 2000, Hutchinson, the '772 and '973 patents (for the '131' challenge) and Duran, Dancey, Tabernero, von Wichert, and publication '541 (for the '224' challenge).
  • Bench trial held; Court analyzed the Graham factors (scope/content of prior art, differences, level of ordinary skill, and secondary considerations) and ruled the asserted claims of both patents were not proven invalid for obviousness by clear and convincing evidence.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Obviousness of '131 claims to treat advanced RCC '131 nonobvious because prior art did not teach everolimus for RCC and clinical/pharmacologic uncertainties removed expectation of success Prior art (temsirolimus phase I data, rapamycin biology, dosing info in '772/'973) would have motivated POSA to try everolimus with reasonable expectation of success Court held defendant failed to prove obviousness: POSA would not have been motivated to select everolimus and would not have had a reasonable expectation of success as of 2001
Obviousness of '224 claim for everolimus monotherapy in advanced PNETs post‑chemo '224 nonobvious: prior art lacked direct anticancer clinical evidence for everolimus in PNETs; models cited (BON, CA20948) were not convincing PNET surrogates; secondary considerations support nonobviousness Prior art (Duran, Dancey, Tabernero, '541, von Wichert) shows temsirolimus/rapamycin activity and everolimus dosing so a POSA would substitute everolimus with expectation of success Court held defendant failed to prove obviousness: deficiencies in prior art models/data and pharmacologic differences undermined motivation and expectation of success; secondary considerations (long‑felt need, failure of others) weigh against obviousness
Role of secondary considerations Plaintiffs: long‑felt need and failures of others support nonobviousness (esp. for PNETs) Defendant: secondary considerations do not overcome technical/prior‑art showing Court: for '131 no relevant secondary evidence presented; for '224 long‑felt need and failures of others supported nonobviousness but plaintiffs failed to prove unexpected results
Proper scope of prior art and POSA definition Plaintiffs: POSA would consider many non‑mTOR approaches; defendant's expert limited analysis to mTOR art (hindsight) Defendant: prior art reasonably suggested mTOR inhibitors and oral everolimus as an option; need not show everolimus was the preferred compound Court: rejected overly narrow prior‑art scope and found defendant’s expert suffered from hindsight bias; POSA need not have mTOR expertise and would consider broader field, undermining defendant's motivation/expectation arguments

Key Cases Cited

  • KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (framework for obviousness and combining prior art)
  • Graham v. John Deere Co., 383 U.S. 1 (1966) (Graham factors for obviousness)
  • In re Cyclobenzaprine Hydrochloride Extended‑Release Capsule Patent Litig., 676 F.3d 1063 (Fed. Cir. 2012) (importance of objective indicia as check against hindsight)
  • Western Union Co. v. MoneyGram Payment Sys., Inc., 626 F.3d 1361 (Fed. Cir. 2010) (reciting Graham inquiries)
  • Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342 (Fed. Cir. 2012) (obviousness is legal question with factual underpinnings)
  • Prometheus Labs., Inc. v. Roxane Labs., Inc., 805 F.3d 1092 (Fed. Cir. 2015) (secondary considerations evidence not required but if presented must meet evidentiary threshold)
  • Apple Inc. v. Samsung Elec. Co., Ltd., 839 F.3d 1034 (Fed. Cir. 2016) (standard for proving secondary considerations)
  • Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) (burden of persuasion remains with challenger despite secondary considerations)
  • Amgen Inc. v. F. Hoffman‑La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009) (reasonable expectation of success measured at date of invention)
  • Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005) (prior art disclosing all claim elements with only minor dosage difference may render claim obvious where patent offers no reason for deviation)
  • PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342 (Fed. Cir. 2007) (new promising field of experimentation in prior art does not render invention obvious if only general guidance given)
  • Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989 (Fed. Cir. 2009) (unexpected results analysis requires comparison to closest prior art)
  • Kao Corp. v. Unilever U.S. Inc., 441 F.3d 963 (Fed. Cir. 2006) (compare claimed invention to closest prior art for unexpected results)
  • Bristol‑Myers Squibb Co. v. Teva Pharm. USA, Inc., 752 F.3d 967 (Fed. Cir. 2014) (differences in kind vs. degree in unexpected results analysis)
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