Alza Corp. v. Mylan Laboratories, Inc.

• Decision Date: 06 September 2006
• Docket Number: No. 06-1019.,06-1019.
• Citation: 464 F.3d 1286
• Parties: ALZA CORPORATION Plaintiff-Appellant, v. MYLAN LABORATORIES, INC. and MYLAN PHARMCEUTICALS, INC. Defendants-Appellees.
• Court: U.S. Court of Appeals — Federal Circuit

464 F.3d 1286

ALZA CORPORATION Plaintiff-Appellant, v. MYLAN LABORATORIES, INC. and MYLAN PHARMCEUTICALS, INC. Defendants-Appellees.

No. 06-1019.

United States Court of Appeals, Federal Circuit.

September 6, 2006.

COPYRIGHT MATERIAL OMITTED

Gregory L. Diskant, Patterson, Belknap, Webb & Tyler LLP, of New York, New York, argued for plantiff-appellant. With him on the brief were Jeffrey I.D. Lewis, and Richard J. McCormick.

John B. Wyss, Wiley, Rein, & Fielding LLP, of Washington, DC, argued for defendants-appellees. With him on the brief were James H. Wallace, Jr., Kevin P. Anderson, and Robert J. Scheffel.

Before GAJARSA, Circuit Judge, CLEVENGER, Senior Circuit Judge, and PROST, Circuit Judge.

GAJARSA, Circuit Judge.

Alza Corp. ("Alza") appeals from the district court's judgment, after a bench trial, of noninfringement and invalidity of claims 1-3, 11, 13 and 14 of U.S. Patent No. 6,124,355¹ ("the '355 patent") in favor of Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc. (collectively, "Mylan"). Alza Corp. v. Mylan Labs., Inc., 388 F.Supp.2d 717 (N.D.W.Va.2005) ("Alza II"). The infringement arose from Mylan's filing of two Abbreviated New Drug Applications ("ANDAs") for a generic version of the once-a-day extended release formulation of the anti-incontinence drug oxybutynin, id. at 720, which Alza has been marketing as Ditropan XL®. Id. at 738. This court has jurisdiction pursuant to 28 U.S.C. § 1295(a)(1). For the reasons stated below, we affirm the district court's judgment of noninfringement and invalidity.

I. BACKGROUND

This litigation arose from Mylan's and Impax's filings of ANDAs for once-daily, controlled-release oxybutynin formulations. Oxybutynin is a drug used to treat urinary incontinence. Once-a-day dosing provides the usual benefits of convenience, steady-dosing, and in addition, possibly reduced absorption of a metabolite that leads to side-effects. Claim 2 of the '355 patent is representative.

2. A sustained-release oxybutynin formulation for oral administration to a patient in need of treatment for urge incontinence comprising a therapeutic dose of an oxybutynin selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that delivers from 0 to 1 mg in 0 to 4 hours, from 1 mg to 2.5 mg in 0 to 8 hours, from 2.75 to 4.25 mg in 0 to 14 hours, and 3.75 mg to 5 mg in 0 to 24 hours for treating urge incontinence in the patient.

col. 17, ll. 31-38 (emphasis added).

The district court construed the '355 patent claims in its Markman Order, reported at Alza Corp. v. Mylan Labs., Inc., 349 F.Supp.2d 1002 (N.D.W.Va.2004) ("Alza I"). The court construed the word "deliver" to refer to the rate of in vivo release in the gastrointestinal ("GI") tract. See id. at 1019.

Alza did not present direct evidence that Mylan's ANDA formulation released drug in the GI tract at the rates claimed by the '355 patent. However, it did offer two other types of evidence: 1) the rate at which the generic product released oxybutynin in an in vitro dissolution apparatus, and 2) the rate at which the ANDA product resulted in the accumulation of oxybutynin in the bloodstream.

The district court found that Alza had failed to meet its burden of proof on infringement. The district court also found the asserted claims of the '355 patent to be invalid as both anticipated and obvious in light of the prior art. For the reasons stated below, we affirm the invalidity holding on obviousness grounds, and consequently, we do not need to reach Alza's arguments regarding anticipation. We also affirm the holding of noninfringement.

II. DISCUSSION

A. Standard of review

Infringement is a question of fact that, after a bench trial, we review for clear error. See, e.g., Ferguson Beauregard/Logic Controls, Div. of Dover Res., Inc. v. Mega Sys., LLC, 350 F.3d 1327, 1338 (Fed.Cir.2003). Under the clear error standard, a reversal is permitted only when this court is left with a definite and firm conviction that the district court was in error. Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1164 (Fed.Cir.2006).

As for obviousness, a claimed invention is unpatentable if the differences between it and the prior art are "such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art." 35 U.S.C. § 103(a) (2000); In re Kahn, 441 F.3d 977, 985 (Fed.Cir.2006) (citing Graham v. John Deere Co., 383 U.S. 1, 13-14, 86 S.Ct. 684, 15 L.Ed.2d 545, (1966)). Obviousness is a question of law, reviewed de novo, based upon underlying factual questions which are reviewed for clear error following a bench trial. Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1275 (Fed.Cir.2004). These "underlying factual inquiries includ[e]: (1) the scope and content of the prior art; (2) the level of ordinary skill in the prior art; (3) the differences between the claimed invention and the prior art; and (4) objective evidence of nonobviousness." In re Dembiczak, 175 F.3d 994, 998 (Fed.Cir.1999). Similarly, "[t]he presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact," In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir.2000); accord Winner Int'l Royalty Corp. v. Wang, 202 F.3d 1340, 1348 (Fed. Cir.2000), as is the presence or absence of a "reasonable expectation of success" from making such a combination, Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed.Cir.2006). Because "a patent retains its statutory presumption of validity, see 35 U.S.C. § 282, ... the movant retains the burden to show the invalidity of the claims by clear and convincing evidence as to underlying facts." McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1349 (Fed.Cir. 2001) (internal quotations omitted).

In Graham, the Court held that that the obviousness analysis begins with several basic factual inquiries: "[(1)] the scope and content of the prior art are to be determined; [(2)] differences between the prior art and the claims at issue are to be ascertained; and [(3)] the level of ordinary skill in the pertinent art resolved." 383 U.S. at 17, 86 S.Ct. 684. After ascertaining these facts, the Court held that the obviousness vel non of the invention is then determined "against th[e] background" of the Graham factors. Id. at 17-18, 86 S.Ct. 684 (emphasis added). Clearly, the Court recognized the importance of guarding against hindsight, as is evident in its discussion of the role of secondary considerations as "serv[ing] to guard against slipping into use of hindsight and to resist the temptation to read into the prior art the teachings of the invention in issue." Id. at 36, 86 S.Ct. 684.

The Court of Appeals for the Federal Circuit's and its predecessor's "motivation to combine" requirement likewise prevents statutorily proscribed hindsight reasoning when determining the obviousness of an invention. Kahn, 441 F.3d at 986 ("[T]he `motivation-suggesting-teaching' requirement protects against the entry of hindsight into the obviousness analysis."); In re Fridolph, 30 C.C.P.A. 939, 942, 134 F.2d 414 (1943) ("[I]n considering more than one reference, the question always is: does such art suggest doing the thing the [inventor] did."). According to the "motivation-suggesting-teaching" test, a court must ask "whether a person of ordinary skill in the art, possessed with the understandings and knowledge reflected in the prior art, and motivated by the general problem facing the inventor, would have been led to make the combination recited in the claims." Kahn, 441 F.3d at 988 (citing Cross Med. Prods., Inc., v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1321-24 (Fed.Cir.2005)).

This requirement has been developed consistent with the Supreme Court's obviousness jurisprudence as expressed in Graham and the text of the obviousness statute that directs us to conduct the obviousness inquiry "at the time the invention was made" 35 U.S.C. § 103. As we explained in Kahn,

The motivation-suggestion-teaching test picks up where the analogous art test leaves off and informs the Graham analysis. To reach a non-hindsight driven conclusion as to whether a person having ordinary skill in the art at the time of the invention would have viewed the subject matter as a whole to have been obvious in view of multiple references, the Board must provide some rationale, articulation, or reasoned basis to explain why the conclusion of obviousness is correct. The requirement of such an explanation is consistent with governing obviousness law ....

441 F.3d at 987. We further explained that the "motivation to combine" requirement "[e]ntails consideration of both the `scope and content of the prior art' and `level of ordinary skill in the pertinent art' aspects of the Graham test." Id. at 986.

At its core, our anti-hindsight jurisprudence is a test that rests on the unremarkable premise that legal determinations of obviousness, as with such determinations generally, should be based on evidence rather than on mere speculation or conjecture. Our court's analysis in Kahn bears repeating:

A suggestion, teaching, or motivation to combine the relevant prior art teachings does not have to be found explicitly in the prior art, as "the teaching, motivation, or suggestion may be implicit from the prior art as a whole, rather than expressly stated in the references.... The test for an implicit showing is what the combined teachings, knowledge of one of ordinary skill in the art, and the nature of the problem to be solved as a whole would have suggested to those of ordinary skill in the art." However, rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness. This requirement is as much rooted in the Administrative Procedure Act [for our review of Board determinations], which ensures due process and...