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Abraxis Bioscience, Inc. v. Mayne Pharma Inc.

Abraxis Bioscience, Inc. v. Mayne Pharma Inc.

United States Court of Appeals for the Federal Circuit

November 15, 2006, Decided

06-1118

Opinion

 [***1705]   [*1372]  LOURIE, Circuit Judge.

Mayne Pharma (USA), Inc. ("Mayne") appeals from the decision of the United States District Court for the Southern District of New York granting judgment of infringement of U.S. Patents 5,714,520 ("the '520 patent"), 5,731,355 ("the '355 patent"), and 5,731,356 ("the '356 patent"), both literally and under [***1706]  the doctrine of equivalents, in favor of AstraZeneca Pharmaceuticals LP and AstraZeneca UK Ltd. (collectively "AstraZeneca"). AstraZeneca Pharms. LP v. Mayne Pharma (USA)  [**2]   Inc., 2005 U.S. Dist. LEXIS 26196, No. 02-7936, 03-6487 (S.D.N.Y. Nov. 2, 2005) ("Nov. 2, 2005 Opinion"). Because the district court erred in its construction of "edetate," which was the basis upon which it found literal infringement, we reverse the court's claim construction and the court's finding  [*1373]  of literal infringement. However, because the court did not clearly err in determining that the accused product infringes under the doctrine of equivalents, we affirm the district court's judgment.

BACKGROUND

In November 1989, AstraZeneca launched in the United States an original pharmaceutical composition used to induce and maintain general anesthesia and sedation in patients. The product was marketed and sold under the trade name DIPRIVANA(R) for treatment in humans and RAPINOVETA(R) for veterinary use. The composition consists of an injectible oil-in-water emulsion containing propofol, or 2,6-diisopropylphenol, as its active ingredient.

Typically, DIPRIVANA(R) is administered to patients by infusion, which involves the use of a "giving set." '520 patent, col.2 ll.56-61. A giving set involves connecting a reservoir containing the propofol emulsion with the patient's vein via the appropriate tubing. In 1990,  [**3]  AstraZeneca became aware that patients using DIPRIVANA(R) were increasingly suffering from post-operative infections. It was determined that the infections were linked to the microbial contamination of fluids contained in the DIPRIVANA(R) giving set. As a result, the Food and Drug Administration ("FDA") imposed a requirement that the giving sets be "changed at least every 6 or 12 hours dependent on the presentation being used." Id., col.3 ll.2-3.

AstraZeneca researchers began developing an improved formulation that would allow giving sets to be changed less frequently. The inventors of the patents in suit recommended the use of preservatives in DIPRIVANA(R). They experimented with a number of preservatives, but discovered that most were ineffective. The inventors ultimately discovered that one preservative in particular, disodium edetate, was unexpectedly effective in retarding microbial growth in the propofol formulation without disrupting the oil-in-water emulsion for at least twenty-four hours. AstraZeneca subsequently developed an improved version of the original DIPRIVANA(R) formulation consisting of edetate, as well as all of the ingredients in the original formulation.  [**4]  The original DIPRIVANA(R) formulation and the improved formulation have identical anesthetic properties. Nov. 2, 2005 Opinion, 2005 U.S. Dist. LEXIS 26196, [slip op.] at 4.

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467 F.3d 1370 *; 2006 U.S. App. LEXIS 28199 **; 80 U.S.P.Q.2D (BNA) 1705 ***

ABRAXIS BIOSCIENCE, INC. (formerly known as ASTRAZENECA PHARMACEUTICALS LP and ASTRAZENECA UK LTD.), Plaintiffs-Appellees, v. MAYNE PHARMA (USA) INC. (formerly known as Faulding Pharmaceutical Company), Defendant-Appellant.

Prior History:  [**1]  Appealed from: United States District Court for the Southern District of New York. Judge William H. Pauley, III.

AstraZeneca Pharms. LP v. Mayne Pharma (USA) Inc., 2005 U.S. Dist. LEXIS 26196 (S.D.N.Y., Nov. 2, 2005)

Disposition: AFFIRMED.

CORE TERMS

edetate, derivatives, patent, calcium, trisodium, infringement, district court, patentees, salts, specification, antimicrobial, propofol, doctrine of equivalents, chelation, analogs, metal, invention, generic, literal, inventors, improved, disodium, composition, compounds, microbial, sodium, asserted claim, asserts, argues, polyaminocarboxylates

Patent Law, Jurisdiction & Review, Standards of Review, De Novo Review, Infringement Actions, Claim Interpretation, Fact & Law Issues, Clearly Erroneous Review, General Overview, Civil Procedure, Appeals, Construction Preferences, Infringing Acts, Doctrine of Equivalents, Elements, Equivalence, Defenses, Estoppel & Laches, Elements