Procter & Gamble Co. v. Teva Pharmaceuticals Usa

• Decision Date: 13 May 2009
• Docket Number: No. 2008-1404.,No. 2008-1405.,No. 2008-1406.,2008-1404.,2008-1405.,2008-1406.
• Citation: 566 F.3d 989
• Parties: The PROCTER & GAMBLE COMPANY, Plaintiff-Appellee, v. TEVA PHARMACEUTICALS USA, INC., Defendant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

566 F.3d 989

The PROCTER & GAMBLE COMPANY, Plaintiff-Appellee, v. TEVA PHARMACEUTICALS USA, INC., Defendant-Appellant.

No. 2008-1404.

No. 2008-1405.

No. 2008-1406.

United States Court of Appeals, Federal Circuit.

May 13, 2009.

William F. Lee, Wilmer Cutler Pickering Hale & Dorr LLP, of Boston, MA, argued for plaintiff-appellee. With him on the brief were Vinita Ferrera and Allen C. Nunnally. Also on the brief were David B. Bassett and Christopher J. Meade, of New York, NY.

James Galbraith, Kenyon & Kenyon LLP, of New York, NY, argued for defendant-appellant. With him on the brief were Maria Luisa Palmese, and A. Antony Pfeffer.

Before MAYER, DYK, Circuit Judges, and HUFF,^* District Judge.

HUFF, District Judge.

Teva Pharmaceuticals USA, Inc. ("Teva") appeals from a final judgment of the United States District Court for the District of Delaware in favor of The Procter & Gamble Company ("P & G") in three cases upholding the validity of P & G's U.S. Patent 5,583,122 (the "'122 patent"). Proctor & Gamble Co. v. Teva Pharmaceuticals USA, Inc., 536 F.Supp.2d 476 (D.Del.2008). After a bench trial and a stipulation for judgment in the related cases, the district court rejected Teva's invalidity defenses of obviousness and obviousness-type double patenting. We affirm.

I. BACKGROUND

The '122 patent claims the compound risedronate, the active ingredient of P & G's osteoporosis drug Actonel®. In August 2004, P & G sued Teva for infringement of the '122 patent after Teva notified P & G that it planned to market risedronate as a generic equivalent of Actonel®. Specifically, P & G alleged that Teva's proposed drug infringed claim 4 of the '122 patent for the compound risedronate, claim 16 for pharmaceutical compositions containing risedronate, and claim 23 for methods of treating diseases using risedronate. In its defense, Teva argued that the '122 patent was invalid as obvious in light of P & G's expired U.S. Patent 4,761,406 (the "'406 patent"), filed on June 6, 1985 and issued on August 2, 1988. Alternately, Teva argues that the '122 patent is invalid for obviousness-type double patenting.

Risedronate, the subject of the contested claims, is a member of a group of compounds referred to as bisphosphonates. Bisphosphonates, in general, are active in inhibiting bone resorption. The first two promising bisphosphonates studied for the treatment of metabolic bone diseases, etidronate (EHDP) and clodronate, had clinical problems which prevented their commercialization. P & G conducted a significant amount of experimentation involving hundreds of different bisphosphonate compounds, but could not predict the efficacy or toxicity of the new compounds. Eventually, researchers at P & G identified risedronate as a promising drug candidate.

On December 6, 1985, risedronate's inventors applied for a patent on the compound. P & G is the owner by assignment of the '122 patent, entitled "Pharmaceutical Compositions Containing Geminal Diphosphonates," which issued on December 10, 1996.

Risedronate is neither claimed nor disclosed in the '406 patent. Instead, the '406 patent, entitled "Regimen for Treating Osteoporosis," claims an intermittent dosing method for treating osteoporosis. As the trial court noted, the '406 patent "addresses the central problem seen in bisphosphonates at the time, namely that they inhibited bone mineralization, by teaching the use of a cyclic administrative regimen to achieve a separation of the benign effect of anti-resorption from the unwanted side effect of anti-mineralization in patients." Proctor & Gamble, 536 F.Supp.2d at 492. The '406 patent lists thirty-six polyphosphonate molecules as treatment candidates and eight preferred compounds for intermittent dosing, including 2-pyr EHDP. Teva contends that the structural similarities between risedronate and 2-pyr EHDP render the challenged claims of the '122 patent obvious.

From the testimony at trial, the district court concluded that the '406 patent would not have led a person of ordinary skill in the art to identify 2-pyr EHDP as the lead compound. In light of the extremely unpredictable nature of bisphosphonates at the time of the invention, the district court also found that a person of ordinary skill in the art would not have been motivated to make the specific molecular modifications to make risedronate. The district court concluded that unexpected results of risedronate's potency and toxicity rebut a claim of obviousness. The district court found that secondary considerations of non-obviousness supported its conclusions. Similarly, the court found that the '122 patent was not invalid for obviousness-type double patenting. This consolidated appeal followed. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).

II. DISCUSSION

I. Standard of Review

"On appeal from a bench trial, this court reviews the district court's conclusions of law de novo and findings of fact for clear error." Golden Blount, Inc. v. Robert H. Peterson Co., 365 F.3d 1054, 1058 (Fed.Cir.2004). Whether the subject matter of a patent is obvious is a question of law and is reviewed de novo. PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1359 (Fed.Cir.2007). Factual determinations underlying the obviousness issue are reviewed for clear error. Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed.Cir.2006). The evidentiary burden to show facts supporting a conclusion of invalidity is one of clear and convincing evidence. AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1238-39 (Fed.Cir.2003). Non-statutory double patenting is a legal question reviewed without deference. Georgia-Pacific Corp. v. U.S. Gypsum Co., 195 F.3d 1322, 1326 (Fed.Cir. 1999).

II. Patent Obviousness—Legal Standard

Under the U.S. Patent Act, an invention cannot be patented if "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 to which said subject matter pertains." 35 U.S.C. § 103(a). Patents are presumed to be valid. Kao Corp. v. Unilever U.S., Inc., 441 F.3d 963, 968 (Fed.Cir.2006). A party seeking to invalidate a patent based on obviousness must demonstrate "by clear and convincing evidence that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed.Cir.2007). Clear and convincing evidence places in the fact finder "an abiding conviction that the truth of [the] factual contentions are highly probable." Colorado v. New Mexico, 467 U.S. 310, 316, 104 S.Ct. 2433, 81 L.Ed.2d 247 (1984) (quotation marks omitted).

The obviousness determination turns on underlying factual inquiries involving: (1) the scope and content of prior art, (2) differences between claims and prior art, (3) the level of ordinary skill in pertinent art, and (4) secondary considerations such as commercial success and satisfaction of a long-felt need. Graham v. John Deere Co., 383 U.S. 1, 17, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966). The Supreme Court has explained that the Federal Circuit's "teaching, suggestion or motivation" test provides helpful insight into the obviousness question as long as it is not applied rigidly. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 127 S.Ct. 1727, 1741, 167 L.Ed.2d 705 (2007). Accordingly, under KSR, "it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound." Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed.Cir. 2007).

If a patent challenger makes a prima facie showing of obviousness, the owner may rebut based on "unexpected results" by demonstrating "that the claimed invention exhibits some superior property or advantage that a person of ordinary skill in the relevant art would have found surprising or unexpected." In re Soni, 54 F.3d 746, 750 (Fed.Cir.1995). We consider the relevant factors in turn.

III. Identification of a Lead Compound

An obviousness argument based on structural similarity between claimed and prior art compounds "clearly depends on a preliminary finding that one of ordinary skill in the art would have selected [the prior art compound] as a lead compound." Takeda, 492 F.3d at 1359; see also Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353, 1359 (Fed.Cir.2008) (stating that "post-KSR, a prima facie case of obviousness for a chemical compound still, in general, begins with the reasoned identification of a lead compound" in the prior art). Teva argues that the '406 patent identifies 2-pyr EHDP as the most promising molecule for the inhibition of bone resorption. The trial court disagreed and concluded from the evidence that a person of ordinary skill in the art would not have identified 2-pyr EHDP as a lead compound for the treatment of osteoporosis.

We need not reach this question because we conclude that even if 2-pyr EHDP was a lead compound, the evidence does not establish that it would have been obvious to a person of ordinary skill at the time of the invention to modify 2-pyr EHDP to create risedronate.

IV. Obviousness of Risedronate in Light of the Prior Art

To decide whether risedronate was obvious in light of the prior art, a court must determine whether, at the time of invention, a person having ordinary skill in the art would have had "reason to attempt to make the composition" known as risedronate and "a reasonable expectation of success in doing so." PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1360 (Fed.Cir.2007).

The district court concluded that, even if 2-pyr EHDP were a lead compound, it would not render the '122 patent's claims on risedronate obvious because a person having ordinary skill in the art would not have had reason to make risedronate based...