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Sanofi v. Lupin Atlantis Holdings S.A.

United States District Court, D. Delaware

October 23, 2017

SANOFI and SANOFI-AVENTIS U.S. LLC, Plaintiffs,
v.
LUPIN ATLANTIC HOLDINGS S.A., LUPIN LTD. and LUPIN PHARMACEUTICALS INC., Defendants.

          Jack B. Blumenfeld, Derek J. Fahnestock, Stephen J. Kraftshik, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE; William E. Solander, Daniel J. Minion, James R. Tyminski, Zachary L. Garrett, Anna E. Dwyer, FITZPATRICK, CELLA, HARPER & SCINTO, New York, NY. Attorneys for Plaintiffs.

          John M. Seaman, ABRAMS & BAYLISS LLP, Wilmington, DE; Maureen L. Rurka, Julia M. Johnson, Loren G. Rene, WINSTON & STRAWN LLP, Chicago, IL. Attorneys for Defendant Sandoz Inc.

          Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLP, Wilmington, DE; Natalie C. Clayton, Christopher L. McArdle, Yi Wen Wu, ALSTON & BIRD LLP, New York, NY. Frank G. Smith, ALSTON & BIRD LLP, Atlanta, GA. Attorneys for Defendants Watson Laboratories, Inc.

          TRIAL OPINION

          ANDREWS, U.S. DISTRICT JUDGE

         Plaintiffs Sanofi and Sanofi-Aventis U.S. LLC (collectively, "Plaintiffs") bring this consolidated patent infringement case against Defendants Watson Laboratories, Inc. and Sandoz Inc. (collectively, "Defendants"). (C.A. No. 15-415-RGA, D.I. 188 at pp. 1, 3).[1] This opinion addresses allegations of infringement and invalidity with respect to U.S. Patent No. 9, 107, 900 (the "'900 patent").

         I held a two-day bench trial relating to this patent. ("Tr."). The parties filed post-trial briefing with respect to infringement (D.I. 201; D.I. 203; D.I. 206) and invalidity. (D.I. 200; D.I. 204; D.I. 205). Having considered the documentary evidence and testimony, I make the following findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a).

         I. BACKGROUND

         Sanofi-Aventis U.S. LLC is the holder of approved New Drug Application No. 022425 for dronedarone tablets, 400 mg, which are prescribed under the trademark Multaq®. (D.I. 188, Exh. 1 at p. 2). The active ingredient in Multaq® tablets is N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-l -benzofuran-5-yl]methanesulfonamide hydrochloride, also known as dronedarone hydrochloride. (D.I. 188, Exh. 1 at p. 2). Plaintiffs make and sell Multaq® in the United States. (D.I. 188 at p. 1).

         The '900 patent, entitled "Use of Dronedarone for the Preparation of a Medicament for Use in the Prevention of Cardiovascular Hospitalization or Mortality, " issued on August 18, 2015. (D.I. 188, Exh. 1 at p. 2). The '900 patent is listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") in connection with NDA No. 022425. (D.I. 188 at p. 1).

         Plaintiffs are asserting claims 1, 6-9, and 14 of the '900 patent against Defendants. (D.I. 188, Exh. 2 at p. 1, Exh. 3 at p. 2). There are three independent claims: 1, 6, and 9. Claim 7 depends from claim 1. Claim 8 depends from claim 6. Claim 14 depends from claim 9. Defendants assert that claims 1, 7, 9, and 14 of the '900 patent are invalid as obvious.

         The asserted claims read as follows.

         Claim 1

1. A method of reducing a risk of cardiovascular hospitalization in a patient, said method comprising administering to said patient an effective amount of dronedarone or a pharmaceutically acceptable salt thereof, twice a day with a morning and an evening meal, wherein said patient does not have severe heart failure, (i) wherein severe heart failure is indicated by: a) NYHA Class IV heart failure or b) hospitalization for heart failure within the last month; and (ii) wherein said patient has a history of, or current, paroxysmal or persistent non-permanent atrial fibrillation or flutter, and (iii) wherein said patient has structural heart disease, wherein said structural heart disease is coronary heart disease; and (iv) wherein the patient has (a) an age greater than or equal to 75 or (b) an age greater than or equal to 70 and at least one cardiovascular risk factor selected from the group consisting of:
i. hypertension;
ii. diabetes;
iii. a history of cerebral stroke or of systemic embolism;
iv. a left atrial diameter greater than or equal to 50 mm; and
v. a left ventricular ejection fraction less than 40%.

         Claim 6

6. A method of reducing a risk of cardiovascular hospitalization in a patient, said method comprising administering to said patient an effective amount of dronedarone or a pharmaceutically acceptable salt thereof, twice a day with a morning and evening meal, (i) wherein said patient has a history of, or current, paroxysmal or persistent non-permanent atrial fibrillation or flutter; and (ii) wherein said patient has congestive heart failure defined as NYHA class III; and (iii) wherein said patient has not been hospitalized for heart failure within the last month.

         Claim 7

7. The method according to claim 1, wherein the administration of said effective amount of dronedarone or pharmaceutically acceptable salt thereof is maintained for at least 12 months.

         Claim 8

8. The method according to claim 6, wherein the administration of said effective amount of dronedarone or pharmaceutically acceptable salt thereof is maintained for at least 12 months.

         Claim 9

9. A method of reducing a risk of cardiovascular hospitalization for atrial fibrillation in a patient, said method comprising administering dronedarone, or a pharmaceutically acceptable salt thereof, twice a day with a morning and an evening meal to a patient in need of reduction of said risk, wherein said patient does not have severe heart failure, (i) wherein severe heart failure is indicated by: a) NYHA Class IV heart failure or b) hospitalization for heart failure within the last month; and (ii) wherein said patient has a history of, or current, paroxysmal or persistent non-permanent atrial fibrillation, and (iii) wherein said patient has structural heart disease, wherein said structural heart disease is coronary heart disease; and (iv) wherein the patient has (a) an age greater than or equal to 75 or (b) an age greater than or equal to 70 and at least one cardiovascular risk factor selected from the group consisting of:
i. hypertension;
ii. diabetes;
iii. a history of cerebral stroke or of systemic embolism;
iv. a left atrial diameter greater than or equal to 50 mm; and
v. a left ventricular ejection fraction less than 40%.

         Claim 14

14. The method according to claim 9, wherein the administration of said dronedarone or pharmaceutically acceptable salt thereof is maintained for at least 12 months.

(JTX-1).

         II. LEGAL STANDARDS

         A. Infringement

         A patent is infringed when a person "without authority makes, uses, offers to sell, or sells any patented invention, within the United States .. . during the term of the patent... ." 35 U.S.C. § 271(a). A two-step analysis is employed in making an infringement determination. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). First, the court must construe the asserted claims to ascertain their meaning and scope. See Id. The trier of fact must then compare the properly construed claims with the accused infringing product. See Id. This second step is a question of fact. Bai v. L&L Wings, Inc., 160F.3d 1350, 1353 (Fed. Cir. 1998).

         "Literal infringement of a claim exists when every limitation recited in the claim is found in the accused device." Kahn v. Gen. Motors Corp., 135 F.3d 1472, 1477 (Fed. Cir. 1998). "If any claim limitation is absent from the accused device, there is no literal infringement as a matter of law." Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000). If an accused product does not infringe an independent claim, it also does not infringe any claim depending thereon. See Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed. Cir. 1989). However, "[o]ne may infringe an independent claim and not infringe a claim dependent on that claim." Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 1359 (Fed. Cir. 2007). A product that does not literally infringe a patent claim may still infringe under the doctrine of equivalents if the differences between an individual limitation of the claimed invention and an element of the accused product are insubstantial. See Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 39-40 (1997). The patent owner has the burden of proving infringement by a preponderance of the evidence. See SmithKline Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988).

         B. Obviousness

         The presumption that all patents are valid is the starting point for any obviousness determination. 35 U.S.C. § 282. Apatent 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. Tele/lex 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 indicia of nonobviousness. 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). A court is required to consider secondary considerations, or objective indicia of nonobviousness, before reaching an obviousness determination, as a "check against hindsight bias." See In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1078-79 (Fed. Cir. 2012). Relevant secondary considerations include commercial success, long felt but unsolved needs, failure of others, praise, unexpected results, and copying, among others. Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966); Ruiz v. A.B. Chance Co., 234 F.3d 654, 662-63 (Fed. Cir. 2000); Tex. Instruments, Inc. v. U.S. Int'l Trade Comm'n, 988 F.2d 1165, 1178 (Fed. Cir. 1993).

         "Generally, a party seeking to invalidate a patent as obvious must demonstrate ... that a skilled artisan would have had reason to combine the teaching of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success from doing so." In re Cyclobenzaprine Hydrochloride, 676 F.3d at 1068-69. "The Supreme Court has warned, however, that, while an analysis of any teaching, suggestion, or motivation to combine known elements is useful to an obviousness analysis, the overall obviousness inquiry must be expansive and flexible." Id. at 1069. 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. Evidence of obviousness, however, 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, 676 F.3d at 1072. Obviousness must be proven by clear and convincing evidence. Id. at 1078.

         III. DISCUSSION

         A. Infringement

         I. Findings of Fact

         1. The person of ordinary skill in the art ("POSA") with respect to the '900 patent is someone having a medical degree who is board certified in cardiology or electrophysiology with at least two years of clinical practice who also has knowledge of the design, implementation, and analysis of clinical studies.

         2. The Indications and Usage section (section 1) of Defendants' labels indicates dronedarone tablets for reducing "the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation." This section directs a POSA to review, and a POSA would review, the Clinical Studies section (section 14) of the labels.

         3. The Clinical Studies sections teach that dronedarone could be used for some patients with coronary heart disease.

         4. The ATHENA study (section 14.1) discloses that "[d]ronedarone reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24.2%." A POSA would recognize that dronedarone's indicated benefit extended to the 60% of ATHENA patients who had structural heart disease. A POSA would recognize that approximately half of the patients with structural heart disease would have coronary heart disease. A POSA would therefore understand that dronedarone's indicated benefit extended to some patients with coronary heart disease. In the context of Defendants' labels, a POSA would understand that "structural heart disease" is a term that includes coronary heart disease.

         5. The EURIDIS/ADONIS study (section 14.2) provides further encouragement to a POSA that dronedarone's indicated benefit extended to some patients with coronary heart disease.

         6. Defendants' labels encourage a POSA to administer dronedarone to some patients within the Age Criteria.[2]

         7. Approximately 20-25% of the uses of dronedarone infringe claims 1, 7, 9 and 14 of the '900 patent.

         8. Defendants' labels instruct a POSA to administer dronedarone to patients with coronary heart disease and who meet the Age Criteria. It is readily apparent from the Clinical Studies section that the use of dronedarone for these patients would reduce the risk of cardiovascular hospitalization. Defendants' labels induce infringement of claims 1, 7, 9 and 14 of the '900 patent.

         9. The first page of Defendants' labels is a "Black Box" warning that discourages physicians from using dronedarone in patients with decompensated heart failure. Doctors would see this warning as a "flashing red light" in determining whether to prescribe dronedarone to NYHA ("New York Heart Association") Class III congestive heart failure ("CHF") patients, whether decompensated or not. The Black Box warning strongly teaches away from the use of dronedarone in Class III patients generally.

         10. The Contraindications section (section 4), along with the Cardiovascular Death in NYHA Class IV or Decompensated Heart Failure section (section 5.1) and ANDROMEDA study (section 14.4), of Defendants' labels discourage a physician from prescribing dronedarone to Class III patients generally.

         11. Many authoritative guidelines also discourage physicians from prescribing dronedarone to Class III patients generally.

         12. The ATHENA study and Figure 4 of the Defendants' labels provide a POSA with very little encouragement to prescribe dronedarone to stable Class III patients. A POSA would remain skeptical, after combing through the Clinical Studies sections, of the safety of prescribing dronedarone to stable Class III patients because the label fails to make it clear that it is safe to do so.

         13. Approximately 3% of the uses of dronedarone infringe claims 6 and 8 of the '900 patent.

         14. Defendants' labels do not instruct a POSA to administer dronedarone to stable Class III patients. Defendants' labels do not induce infringement of claims 6 and 8 of the '900 patent.

         2. Conclusions of Law

         Plaintiffs argue that Defendants' product labels will induce infringement of the asserted claims.[3] 35 U.S.C. § 271(b) provides that "[w]hoever actively induces infringement of a patent shall be liable as an infringer." 35 U.S.C. § 271(b). "In order to prevail on an inducement claim, the patentee must establish first that there has been direct infringement, and second that the alleged infringer knowingly induced infringement and possessed specific intent to encourage another's infringement." ACCO Brands, Inc. v. ABA Locks Mfrs. Co., 501 F.3d 1307, 1312 (Fed. Cir. 2007). In other words, "inducement requires evidence of culpable conduct, directed to encouraging another's infringement, not merely that the inducer had knowledge of the direct infringer's activities." DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1306 (Fed. Cir. 2006) (en banc). "[S]pecific intent may be inferred from circumstantial evidence where a defendant has both knowledge of the patent and specific intent to cause the acts constituting infringement." Ricoh Co. v. Quanta Computer Inc., 550 F.3d 1325, 1342 (Fed. Cir. 2008). "[Liability for induced infringement can only attach if the defendant knew of the patent and knew as well that 'the induced acts constitute patent infringement.'" Commil USA, LLC v. Cisco Sys., Inc., 135 S.Ct. 1920, 1926 (2015) (quoting Global-Tech Appliances, Inc. v. SEB S.A., 131 S.Ct. 2060, 2068 (2011)). The knowledge requirement may be satisfied by showing actual knowledge or willful blindness. See Global-Tech, 131 S.Ct. at 2068 (2011).

         In Hatch-Waxman cases alleging that a proposed drug label will induce infringement by physicians, "The pertinent question is whether the proposed label instructs users to perform the patented method." AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed. Cir. 2010). "The label must encourage, recommend, or promote infringement." Takeda Pharm. USA, Inc. v. West-Ward Pharm. Corp., 785 F.3d 625, 631 (Fed. Cir. 2015). "The mere existence of direct infringement by physicians, while necessary to find liability for induced infringement, is not sufficient for inducement." Id. Rather, "specific intent and action to induce infringement must be proven." Id.

         a) Claims 1, 7, 9, 14

         Defendants argue that they do not induce infringement of claims 1, 7, 9, and 14. Those four claims are directed to patients with coronary heart disease and who meet the Age Criteria.

         The person of ordinary skill in the art is someone having a medical degree who is board certified in cardiology or electrophysiology with at least two years of clinical practice who also has knowledge of the design, ...


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