Aventis Pharma S.A. v. Hospira, Inc.

• Decision Date: 09 April 2012
• Docket Number: No. 2011–1018.,2011–1018.
• Citation: 675 F.3d 1324,102 U.S.P.Q.2d 1445
• Parties: AVENTIS PHARMA S.A. and Sanofi–Aventis U.S., LLC, Plaintiffs–Appellants, v. HOSPIRA, INC., Defendant–Appellee,andApotex Inc. and Apotex Corp., Defendants–Appellees.
• Court: U.S. Court of Appeals — Federal Circuit

102 U.S.P.Q.2d 1445

675 F.3d 1324

AVENTIS PHARMA S.A. and Sanofi–Aventis U.S., LLC, Plaintiffs–Appellants,

v.HOSPIRA, INC., Defendant–Appellee,andApotex Inc. and Apotex Corp., Defendants–Appellees.

No. 2011–1018.

United States Court of Appeals, Federal Circuit.

April 9, 2012.

George F. Pappas, Covington & Burling, LLP, of Washington, DC, argued for plaintiffs-appellants Aventis Pharma S.A., et al. With him on the brief were Christopher N. Sipes, Kevin B. Collins, Michael N. Kennedy, and Roger A. Ford.

James F. Hurst, Winston & Strawn, LLP, of Chicago, IL, argued for defendant-appellee, Hospira, Inc. With him on the brief was Imron T. Aly. Of counsel on the brief were Steffen N. Johnson, Geoffrey P. Eaton, and Jacob R. Loshin, of Washington, DC. Of counsel was Andrew Nichols.

Richard T. Ruzich, Duane Morris LLP, of Washington, DC, argued for defendants-appellees, Apotex Inc., et al. With him on the brief were Arthur M. Dresner, Kerry B. Mctigue, Kristina Caggiano and Matthew C. Mousley. Of counsel on the brief was Shashank Upadhye, Apotex, Inc., of Toronto, Ontario, Canada.

Before LINN, DYK, and PROST, Circuit Judges.

PROST, Circuit Judge.

Aventis Pharma S.A. and Sanofi–Aventis U.S., L.L.C. (collectively “Sanofi”) filed suit against Hospira, Inc. (“Hospira”) and Apotex Inc. and Apotex Corp. (collectively “Apotex”) under 35 U.S.C. § 271(e) for infringement of U.S. Patent Nos. 5,750,561 (“'561 patent”) and 5,714,512 (“'512 patent”). After a bench trial, the district court found, inter alia, that claim 5 of the '561 patent and claim 7 of the '512 patent were invalid for obviousness under 35 U.S.C. § 103, that claim 7 of the '512 patent was not infringed, and that both the '561 and '512 patents were unenforceable for inequitable conduct. Sanofi has appealed. For the reasons set forth below, we affirm.

I. Background

The '561 and '512 patents are pharmaceutical patents related to the administration of the chemotherapy cancer drug docetaxel, which is marketed under the brand-name Taxotere. The patents are assigned to Aventis Pharma S.A., and Sanofi–Aventis U.S., L.L.C. is the holder of the New Drug Application for Taxotere. Docetaxel is a successor to the cancer drug paclitaxel, marketed as Taxol, and the composition for docetaxel was covered by now-expired U.S. Patent No. 4,814,470 (“'470 patent”). Both docetaxel and paclitaxel belong to the class of compounds known as taxanes.

Taxanes are administered through an intravenous infusion, accomplished by slowly delivering the drug in a diluted aqueous solution called a “perfusion.” Taxanes, however, have low solubility in water and tend to precipitate, i.e., form solid clumps, and come out of solution. To delay precipitation, taxanes are mixed with additives like surfactants and ethanol; these additives stabilize the perfusion and delay the amount of time before precipitation occurs. The taxane is combined with the additives to form a “stock solution” which is then mixed into an injectable aqueous solution, such as saline, to form a perfusion.

In the prior art, the surfactant Cremophor was used with taxanes to form the stock solution, but it was known to trigger serious allergic reactions, including anaphylactic shock. '561 patent col.1 ll.59–63; '512 patent col.2 ll.31–35. The '561 and '512 patents relate to using surfactants other than Cremophor with docetaxel and decreasing the amount of ethanol to reduce alcohol intoxication and anaphylactic effects in patients. After Hospira and Apotex applied for U.S. Food and Drug Administration (“FDA”) approval to market generic versions of Taxotere, Sanofi filed suit against them for infringement of the '561 and '512 patents. Only claim 5 of the ' 561 patent and claim 7 of the '512 patent are at issue on appeal.

The '561 patent is titled “Compositions containing taxane derivatives” and describes taxane compositions, including a perfusion that avoids anaphylactic and alcohol intoxication manifestations. Claim 5 of the '561 patent recites:

5. A perfusion, which contains approximately 1 mg/ml or less of compound of formula as defined in claim 1, and which contains less than 35 ml/1 of ethanol and less than 35 ml/1 of polysorbate, wherein said perfusion is capable of being injected without anaphylactic or alcohol intoxication manifestations being associated therewith.

The '512 patent is titled “New compositions containing taxane derivatives,” and discloses taxane compositions with reduced ethanol. Claim 7 depends from claims 1 and 6. As corrected by a Certificate of Correction, those claims recite:

1. A composition comprising a compound of the formula

Image 1 (2.83" X 1.49") Available for Offline Print in which Ar is unsubstituted phenyl, R7 is phenyl or tert butoxy, R6 is hydrogen, R5 is acetyloxy or hydroxy, R3 and R4 taken together form an oxo radical, R1 is hydroxy and R2 is hydrogen, said composition being dissolved in a surfactant selected from polysorbate, polyoxyethylated vegetable oil, and polyethoxylated castor oil, said composition being essentially free or free of ethanol.

6. The composition of claim 1, wherein R5 is hydroxy and R7 is tert butoxy.

7. The composition of claim 6, wherein said surfactant is polysorbate.

After a bench trial, the court found that claim 7 of the '512 patent was invalid as obvious and not infringed by Hospira or Apotex. With respect to claim 5 of the '561 patent, the court found that Hospira and Apotex did infringe but concluded that the claim was obvious. The court also determined that the '512 and '561 patents were unenforceable for inequitable conduct.

II. Discussion

On appeal, Sanofi challenges the district court's construction of two claim terms: “perfusion” in claim 5 of the '561 patent and “essentially free or free of ethanol” in claim 7 of the '512 patent. Based on the district court's constructions, Sanofi argues that the court erred in finding that both claims were invalid for obviousness under 35 U.S.C. § 103 and that Apotex's and Hospira's accused products did not infringe claim 7 of the '512 patent. Additionally, Sanofi contends that the court erred in finding that the '561 and '512 patents were unenforceable for inequitable conduct. We have jurisdiction under 28 U.S.C. § 1295(a)(1).

A. Claim 5 of the '561 Patent

Claim construction is a question of law reviewed de novo. Cybor Corp. v. FAS Techs., 138 F.3d 1448, 1454–55 (Fed.Cir.1998) (en banc). Claim terms generally are construed in accordance with the ordinary and customary meaning they would have to one of ordinary skill in the art in light of the specification and the prosecution history. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.Cir.2005) (en banc).

Before the district court, the parties initially agreed to construe “perfusion” in claim 5 of the '561 patent as “a solution suitable for infusion into patients including at least active pharmaceutical ingredient and an aqueous infusion fluid such as physiological saline or glucose.” Aventis Pharma S.A. v. Hospira, Inc., 743 F.Supp.2d 305, 332 (D.Del.2010). The parties, however, later realized that they did not agree on the meaning of the phrase “suitable for infusion into patients” in their proposed construction, leading Sanofi to ask the district court to require that the claimed “perfusion” also be effective for treatment, safe, and stable (i.e., not precipitate) for at least eight hours. The court declined to impose these additional limitations and instead construed “perfusion” to mean “an injectable solution containing the active pharmaceutical ingredient and an aqueous infusion fluid.” Id. at 333. On appeal, Sanofi argues that the district court erred in not construing “perfusion” to include these additional efficacy, safety, and stability limitations.

We can easily dispose of Sanofi's first two limitations. Neither the claims, the specification, nor the prosecution history suggest that the claimed perfusion must satisfy certain safety or efficacy standards. We previously have refused to impose such limitations when not required by the language of the claims or the specification, see Mitsubishi Chem. Corp. v. Barr Labs., Inc., 435 Fed.Appx. 927, 934–35 (Fed.Cir.2011); Iovate Health Scis., Inc. v. Bio–Engineered Supplements & Nutrition, Inc., 586 F.3d 1376, 1382 (Fed.Cir.2009), and decline to do so here.

Regarding Sanofi's eight-hour stability limitation, Sanofi does not contend that “perfusion,” as that term is normally understood in the art, includes such a limitation. Instead, Sanofi argues that based on how the term is used in the context of the '561 patent, the claimed “perfusion” must demonstrate at least eight hours of stability. See Oral Argument 3:05–3:10, available at http:// www. cafc. uscourts. gov/ oral– argument– recordings/ 2011– 1018/ all. This court recently reiterated the stringent standard for narrowing a claim term beyond its plain and ordinary meaning in Thorner v. Sony Computer Entertainment America L.L.C., 669 F.3d 1362 (Fed.Cir.2012). There, we explained that we will only interpret a claim term more narrowly than its ordinary meaning under two circumstances: “1) when a patentee sets out a definition and acts as [its] own lexicographer, or 2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution.” Id. at 1365.

“To act as its own lexicographer, a patentee must ‘clearly set forth a definition of the disputed claim term’ other than its plain and ordinary meaning.” Id. (quoting CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed.Cir.2002)). In other words, “the patentee must ‘clearly express an intent’ to redefine the term.” Id. This clear expression need not be in haec verba but may be inferred from clear limiting descriptions of the invention in the specification or prosecution history. Similarly, to disavow claim scope, “[t]he patentee may demonstrate intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification...