672 F.3d 1350 (Fed. Cir. 2012), 2010-1548, Marine Polymer Technologies, Inc. v. HemCon, Inc.
|Citation:||672 F.3d 1350, 102 U.S.P.Q.2d 1161|
|Opinion Judge:||LOURIE, Circuit Judge.|
|Party Name:||MARINE POLYMER TECHNOLOGIES, INC., Plaintiff-Appellee, v. HEMCON, INC., Defendant-Appellant.|
|Attorney:||Brian M. Poissant, Jones Day, of New York, NY, for plaintiff-appellee on rehearing en banc. With him on the brief were Julie M. Baher, Lynda Q. Nguyen and Ognian V. Shentov. Of counsel was Gregory A. Castanias, of Washington, DC. Raymond A. Kurz, Hogan Lovells U.S. LLP, of Washington, DC, for def...|
|Judge Panel:||Before RADER, Chief Judge, NEWMAN, LOURIE, BRYSON, GAJARSA, LINN, DYK, PROST, REYNA, and WALLACH, Circuit Judges.  Opinion for the court in part filed by Circuit Judge LOURIE, in which Chief Judge RADER and Circuit Judges NEWMAN, BRYSON, and PROST join in full, and in which Circuit Judge LI...|
|Case Date:||March 15, 2012|
|Court:||United States Courts of Appeals, Court of Appeals for the Federal Circuit|
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Defendant-Appellant HemCon, Inc. (" HemCon" ) appeals from a judgment of the United States District Court for the District of New Hampshire holding that HemCon infringed U.S. Patent 6,864,245 (" the '245 patent" ) assigned to Plaintiff-Appellee Marine Polymer Technologies, Inc. (" Marine Polymer" ). On September 26, 2011, a panel of this court reversed the district court's decision, concluding that HemCon had acquired intervening rights in the '245 patent based on actions taken by Marine Polymer during a parallel reexamination proceeding. Marine Polymer Techs., Inc. v. HemCon, Inc., 659 F.3d 1084 (Fed.Cir.2011) (" Panel Opinion " ), vacated, __ Fed.Appx. __, 2012 WL 255331 (Fed.Cir. Jan. 20, 2012). Upon reconsideration en banc, we affirm the judgment of the district court by an equally divided court. Although the district court did not have the reexamination before it or decide the effect of that issue on its decision, we also consider HemCon's arguments with respect to the reexamination and a majority of this court concludes as an alternative ground for affirmance that intervening rights do not apply to claims that have not been amended and are not new.
Marine Polymer owns the '245 patent, which discloses and claims preparations of poly-‹ ‹ beta› › -1 4-N-acetylglucosamine (" p-GlcNAc" ), a naturally occurring polysaccharide polymer produced by organisms such as arthropods, fungi, and microalgae. Purified p-GlcNAc has utility in various industrial, pharmaceutical, and bio-medical applications. For example, p-GlcNAc promotes hemostasis ( i.e., stoppage of bleeding or hemorrhage) and is therefore useful in trauma units for treating serious wounds.
The '245 patent places particular emphasis on " biocompatible" compositions of p-GlcNAc. In this context, biocompatibility relates to a compound's biological reactivity or tendency to elicit deleterious reactions— e.g., necrosis, erythema, edema, cellular degeneration-upon exposure to living cells or tissues. E.g., '245 patent col.42 ll.36-38, col.44 ll.15-16. The specification describes four tests that can be used to assess the biocompatibility of a substance: an elution test, an implantation test, an intracutaneous injection test, and a systemic injection test. Id. col.42 ll.1-3.
The disclosed elution test involves exposing a test substance to a solution to create an extract, exposing cultured test cells to the extract, and then observing the cells for signs of cytotoxicity. See id. col.42 ll.6-62. The implantation test involves implanting a sample of the test substance into an animal's muscle tissue and scoring the severity of any adverse local reactions. See id. col.42 l.64— col.43 l.64. The intracutaneous injection test calls for preparing an extract of the test substance, injecting small volumes of the extract into the skin of an animal, and monitoring the injection sites for reactivity. See id. col.43 l.65— col.44 l.56. Finally, in the systemic injection test, animals are monitored for weight changes and other overt signs of toxicity after receiving intravenous or intraperitoneal injections of a test substance extract. See id. col.44 l.57— col.45 l.42.
In describing these biocompatibility tests, the specification indicates that their requirements are met if a given test substance shows no more than mild or slight reactivity. For example, scores on the elution test range from zero to four on a scale of biological reactivity, where zero represents no reactivity, one represents slight reactivity, two represents mild reactivity, and three or four represent moderate or severe reactivity, respectively, and a substance can satisfy the elution test " if none of the cultures treated with the test article show a greater than mild reactivity." Id. col.42 ll.41-62. But with regard to the claimed p-GlcNAc compositions, the specification also states that " the p-GlcNAc of the invention exhibits no detectable biological reactivity, as assayed by elution tests, intramuscular implantation in rabbits, intracutaneous injection in rabbits, and systemic injections in mice." Id. col.41 l.66— col.42 l.3; see also col.45 l.44— col.49 l.66 (reporting biocompatibility test results for p-GlcNAc showing zero reactivity on each test).
The '245 patent issued with 22 claims, all of which recite " biocompatible" compositions of p-GlcNAc. A majority of those claims recite the " biocompatible" limitation generically. Independent claim 6 is representative:
A biocompatible poly-‹ ‹ beta› › -1 4-N-acetylglucosamine comprising up to about 150,000 N-acetylglucosamine monosaccharides covalently attached in a ‹ ‹ beta› › -1 4 conformation and having a molecular weight of up to about 30 million daltons in which at least one N-acetylglucosamine monosaccharide has been deacetylated.
Id. col.72 ll.5-10 (emphasis added). In addition, the '245 patent contains several dependent claims that recite specific scores on the elution test. For example, claim 12 claims: " The biocompatible poly-‹ ‹ beta› › -1 4-N-acetylglucosamine of any one of claims 6-11 which has an elution test score of 0. " Id. col.72 ll.33-35 (emphasis added). Claims 3 and 20 also specify zero scores on the elution test; analogous claims 4, 5, 13, 14, 21, and 22 require elution test scores of one or two. E.g., id. col.72 ll.33-41.
Marine Polymer sued HemCon in March 2006, alleging that HemCon infringed the ' 245 patent. During subsequent Markman proceedings, Marine Polymer argued that " biocompatible" p-GlcNAc should be construed to mean " biomedically pure [p-GlcNAc] that reproducibly exhibits acceptably low levels of adverse bioreactivity, as determined by biocompatibility tests." Marine Polymer Techs., Inc. v. HemCon, Inc., No. 06-CV-100, 2008 WL 1995454, at *1 (D.N.H. May 6, 2008). HemCon countered that " biocompatible" should be read as limiting the claims to p-GlcNAc that had been " harvested from plant microalgae," or, in the alternative, should be interpreted broadly to mean " suited for biomedical applications." Id. at *1-2. The district court considered, and ultimately
rejected, each of the parties' proposed constructions after reviewing the '245 patent's claim language, written description, and prosecution history. Instead, the district court concluded that " biocompatible" p-GlcNAc, as claimed in the '245 patent, means p-GlcNAc " with low variability, high purity, and no detectable biological reactivity as determined by biocompatibility tests." Id. at *10.
Marine Polymer then moved for summary judgment that HemCon literally infringed claims 6, 7, 10-12, 17, and 20 of the '245 patent. Applying its claim construction, the district court granted Marine Polymer's motion and held that HemCon had infringed all seven asserted claims. A jury trial followed to determine validity and damages. The jury made factual findings relating to obviousness and determined that the '245 patent was not anticipated by the cited prior art. With respect to damages, the jury found that Marine Polymer was entitled to a reasonable royalty of $29,410,246. After the jury verdict, HemCon filed motions for judgment as a matter of law (" JMOL" ) on anticipation, on the jury's factual findings relating to obviousness, and challenging the damages award...
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