North American Vaccine, Inc. v. American Cyanamid Co.
| Decision Date | 06 October 1993 |
| Docket Number | No. 93-1076,93-1076 |
| Citation | 28 USPQ2d 1333,7 F.3d 1571 |
| Parties | NORTH AMERICAN VACCINE, INC. and National Research Council of Canada, Plaintiffs-Appellants, v. AMERICAN CYANAMID COMPANY and Praxis Biologics, Inc., Defendants-Appellees. |
| Court | U.S. Court of Appeals — Federal Circuit |
Stephen R. Smith, Morgan & Finnegan, New York City, argued for plaintiffs-appellants. With him on the brief were John A. Diaz and Arnold I. Rady. Also on the brief were Mark J. Abate, Tony V. Pezzano and Bruce D. Radin, of counsel.
Donald R. Dunner, Finnegan, Henderson, Farabow, Garrett & Dunner, Washington, DC, argued for defendants-appellees. With him on the brief were Brian G. Brunsvold, Thomas H. Jenkins and Thomas W. Banks. Daniel J. Thomasch, Donovan, Leisure, Newton & Irvine, of counsel.
Before LOURIE, Circuit Judge, SKELTON, Senior Circuit Judge, and RADER, 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, p 2 (1988), and not infringed by American Cyanamid Co. and Praxis Biologics, 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.
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 polysaccharide, 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 case. 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 polysaccharide-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
CH sub2 -NH-protein
linkage to a terminal portion of the polysaccharide without significant crosslinking, 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, Haemophilus influenza, pneumococci, beta-hemolytic streptococci, and E. coli.
25. A human infant vaccine comprising the conjugate of claim 11 wherein the polysaccharide comprises at least one of meningococcal (emphases added).
polysaccharide and Haemophilus influenza polysaccharide.
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.
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 The district court construed this phrase as being limited to linkage at only one terminal portion of the polysaccharide, excluding all crosslinking, even end-to-end crosslinking. Accordingly, the court held that the claims did not cover the dimers and trimers in HibTITER. NRC argues that the court's claim interpretation was erroneous and that the limitation requiring "linkage to a terminal portion of the polysaccharide without significant crosslinking" in claim 11 is not limited to linkage at only a single terminal, but includes linkages at either one or both terminals of the polysaccharide. According to NRC, end-to-end crosslinking which involves linkages at both terminal portions of the polysaccharide is not "significant crosslinking" for purposes of the asserted claims since it achieves the intended purpose of the invention by avoiding crosslinking along the backbone of the polysaccharide. NRC also argues that the inclusion of references to Haemophilus influenza in dependent claim 12 and the specification indicate that claim 11 was intended to be interpreted to include end-to-end crosslinking because polysaccharides from that organism lead to end-to-end crosslinking. Thus, NRC asserts, the properly interpreted claims cover the dimers and trimers in HibTITER. We disagree and conclude that the contested phrase does not include polysaccharide-protein linkages at both terminal portions of the polysaccharide.
only issue before us, therefore, is whether the other components of the vaccine, the dimers and trimers which have protein linkages at both terminal portions of the Hib polysaccharides and exhibit end-to-end crosslinking, come within the meaning of the above-quoted language, in which case the totality of the accused product would be infringing.
A determination as to the scope and meaning of a claim is a question of law which we review de novo. ZMI, 844 F.2d at 1578, 6 USPQ2d at 1559. Therefore, we need not defer to the district court's claim interpretation. Specialty Composites v. Cabot Corp., 845 F.2d 981, 986, 6 USPQ2d 1601, 1604 (Fed.Cir.1988) (citation omitted). Cyanamid characterizes these issues as questions of fact, imposing on us a "clearly erroneous" standard of review. It argues that the meaning of claim language raises factual questions. We agree that a genuine evidentiary conflict underlying the meaning of claim terms raises a question of fact, but the questions before us in this case go to the heart of what the claims mean. Resolution of disputed issues regarding the meaning of contested language is ultimately a determination of what claims mean and what they cov...
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