North American Vaccine, Inc. And National Research Council of Canada v. American Cyanamid Company and Praxis Biologics, Inc.

7 F.3d 1571
CourtCourt of Appeals for the Federal Circuit
DecidedDecember 8, 1993
Docket93-1076
StatusPublished
Cited by142 cases

This text of 7 F.3d 1571 (North American Vaccine, Inc. And National Research Council of Canada v. American Cyanamid Company and Praxis Biologics, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
North American Vaccine, Inc. And National Research Council of Canada v. American Cyanamid Company and Praxis Biologics, Inc., 7 F.3d 1571 (Fed. Cir. 1993).

Opinions

LOURIE, Circuit Judge.

National Research Council of Canada and its exclusive licensee, North American Vaccine (collectively NRC), appeal from the judgment of the United States District Court for the Southern District of New York holding claims 12 and 25 of U.S. Patent 4,356,170 invalid for indefiniteness under 35 U.S.C. § 112, ¶ 2 (1988), and not infringed by American Cyanamid Co. and Praxis Biologies, Inc. (collectively Cyanamid). North American Vaccine, Inc. v. American Cyanamid Co., 24 USPQ2d 1898, 1992 WL 234591 (S.D.N.Y.1992). We affirm-in-part and reverse-in-part.

BACKGROUND

On February 28, 1991, NRC brought an action against Cyanamid alleging infringement of the 170 patent. That patent, entitled “Immunogenic Polysaccharide-Protein Conjugates,” relates to human infant vaccines against bacterial infections such as meningitis. The principal components of the vaccines are polysaccharide-protein conjugates. The polysaccharide, which is derived from the bacteria against which immunization is sought, has antigenic properties that elicit an immune response. Infant immune systems, however, do not respond well to the polysaccharide unless it is linked to a protein.

While linking of the polysaccharide and protein enhances infants’ immune response to the antigenic polysaccharide, the immune response is hampered by “crosslinking.” The parties indicate that crosslinking obstructs the antigenic sites of the polysacchar-ide, precluding an effective immune response. The amount of crosslinking increases with the number of proteins that are linked to the polysaccharide. The claimed invention purports to avoid the problem associated with crosslinking by linking the protein only to a terminal portion of the polysaccharide, thereby preserving the antigenic properties of the polysaccharide and producing an immune response in infants. The meaning of the expression “a terminal portion” in the claims is a key issue in this ease. The meaning of the term “crosslinking” is also contested.

Trial was limited to the issues of infringement and validity of claims 12 and 25, which are directed, respectively, to a polysacchar-ide-protein conjugate and a human infant vaccine comprising that conjugate. Both are dependent upon claim 11, which reads:

11. An antigenic-polysaccharide-protein conjugate wherein the polysaccharide and protein are covalently linked through a
CH2-NH-protein
linkage to a terminal portion of the poly-saccharide without significant crosslink-ing, said antigenic polysaccharide having a MW [molecular weight] above about 2,000.

(emphasis added). Claims 12 and 25 read as follows:

12. The conjugate of claim 11 wherein the antigenic polysaccharide is selected from the group derived from meningococci, Hae-mophilus influenza, pneumococci, beta-he-molytic streptococci, and E. eoli.
25. A human infant vaccine comprising the conjugate of claim 11 wherein the poly-saccharide comprises at least one of men-[1574]*1574ingococcal polysaccharide and Haemophi-lus influenza polysaccharide.

(emphases added).

A polysaccharide is a sugar molecule having a carbon backbone with hydroxy groups attached, to which proteins may be linked. Linking a protein to a polysaccharide generally involves modifying the hydroxy groups to create one or more active sites and covalently linking the activated polysaccharide to a free amino group of a protein. The result is a polysaccharide-protein conjugate.

Cyanamid’s accused product, “HibTITER,” is a vaccine against Haemophilus influenza (H. flu) type b (Hib) bacteria that can cause meningitis. HibTITER consists of Hib polysaccharides linked to one or more proteins. Specifically, it is comprised of three components referred to as “monomers,” “dimers,” and “trimers.” Monomers, which constitute 50% of the polysaccharide-protein molecules of HibTITER, consist of a single protein linked to a terminal end of one or more polysaccharides; dimers consist of two proteins linked together by polysaccharide; and trimers consist of three proteins linked together by polysaccharides. The protein linkage in each of these components is at a terminal portion of the Hib polysaccharide; none has a protein linkage along the backbone of the polysaccharide. Monomers, having a protein linkage at only one terminal, are referred to as monofunctional. Dimers and trimers, having linkages at both terminals of the polysaccharide, are referred to as difunctional and exhibit what has been called end-to-end crosslinking.

The district court entered judgment for Cyanamid, holding that claims 12 and 25 were not infringed and were invalid for indefiniteness under 35 U.S.C. § 112, second paragraph. NRC appeals from that judgment.

DISCUSSION

A. Infringement

A determination of patent infringement requires a two-step analysis. First, a claim must be interpreted to determine its proper scope and meaning; second, it must be determined whether an accused device is within the scope of the properly interpreted claim. ZMI Corp. v. Cardiac Resuscitator Corp., 844 F.2d 1576, 1578, 6 USPQ2d 1557, 1559 (Fed.Cir.1988). The first step is an issue of law and the second a question of fact. Minnesota Mining & Mfg., Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559, 1570, 24 USPQ2d 1321, 1330 (Fed.Cir.1992) (citations omitted). A determination of literal infringement requires that each limitation in the asserted claims be present in the accused device. Hi-Life Products., Inc. v. American Nat’l Water-Mattress Corp., 842 F.2d 323, 325, 6 USPQ2d 1132, 1133 (Fed.Cir.1988). Only the issue of literal infringement is before us in this case.

Whether HibTITER, which includes monomers, dimers, and trimers, infringes claims 12 and 25, turns on our interpretation of the limitation “linkage to a terminal portion of the polysaccharide without significant crosslinking” in claim 11. It is not disputed that the monomer components in HibTITER meet this limitation. Thus, if, contrary to what the district court decided,1 the monomers themselves meet all the other limitations of the claims, including being a conjugate, infringement of the claims would be established because they contain “linkage to a terminal portion of the polysaccharide without significant crosslinking” and they are quantitatively a significant component of the product. However, at oral argument, counsel for NRC stated that NRC is not contesting this aspect of the court’s decision.2 The [1575]

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7 F.3d 1571, Counsel Stack Legal Research, https://law.counselstack.com/opinion/north-american-vaccine-inc-and-national-research-council-of-canada-v-cafc-1993.