Table 5. Selected patents that were subject to litigation related to rituximab in the United States.
| Publication No | Priority date | Assignee/Alias | Subject matter | Claims as filed/Granted | Lawsuit |
|---|---|---|---|---|---|
| US5500362 | Jan 08, 1987 | Xoma | compound | chimeric IgG1 antibody comprising two HC and two LC, each of which comprising a human C region and a V region, being produced in a eukaryotic host, and having specificity for the antigen bound by the antibody produced by hybridoma HB9303 deposited with the ATCC, and having cytolytic activity, wherein said cytolytic activity is ADCC or CDC | |
| US6652852 | Oct 27, 1986 | Xoma | compound + 2nd medical use | method for treating a B-cell disorder comprising administering to a patient an antibody comprising two LC and two HC, wherein the antibody molecule comprises a V region having specificity for a CD20 antigen bound by an antibody produced by hybridoma HB9303 as deposited with the ATCC, and a human C region and wherein the antibody is capable of mediating ADCC or CDC | |
| US4987084 | Feb 21, 1989 | Dana Farber | method of testing the effect of an agonist or an antagonist to B lymphocyte cell surface protein CD20 on B lymphocyte function comprising (i) determining Ca ion flux across the membrane of said B lymphocyte, contacting said B lymphocyte with said agonist or antagonist, and (iii) determining the change in Ca ion flux across said membrane after exposure of said B lymphocyte to said agonist or antagonist | ||
| US5595721 | July 16, 1993 | Coulter, now GSK | compound + method of treatment | method for immunotherapy of B-cell lymphoma, which comprises: (i) administering to a patient an imaging effective amount of ananti-CD20 antibody, or a Fab, Fab' or F(ab')2 portion thereof, trace labeled with a first radiolabel; (ii) imaging the distribution of said labeled antibody or portion thereof within the body of the patient; (iii) administering to the patient an amount of the antibody or portion thereof in unlabelled form, and (iv) administering a radioimmunotherapeutically effective amount of said antibody, or portion thereof, which is labeled with said first radiolabel or with a different radiolabel wherein the amount of radioactivity is less than the the dose which causes myelosuppression severe enough to require the reintroduction of hematopoietic stem cells | Idec vs. Corixa |
| US6015542 | July 16, 1993 | Coulter, now GSK | compound | composition comprising (1) a radioactively labeled monoclonal anti-CD20 antibody or fragment in an amount providing 1 to 200 mCi of radioactivity and providing irradiation in a dose range of 10 to 200 cGy to the whole body of a human patient, wherein the amount of radioactivity that labels the antibody or antibody fragment is less than the amount which causes myelosuppression severe enough to require the reintroduction of hematopoietic stem cells, and (2) a pharmaceutically acceptable carrier | Idec vs. Corixa |
| US6287537 | July 16, 1993 | Coulter, now GSK | compound + method of treatment | method for immotherapy of B-cell lymphoma, which comprises: (i) administering an imaging effective amount of an anti-CD20 antibody or portion thereof trace-labeled with a first radiolabel; (ii) imaging the distribution of said antibody or portion within a patient's body, (iii) administering a second antibody or portion, said amount of said second antibody or said second antibody portion effective for blocking non-tumor binding sites for a third anti-CD20 antibody or portion; and (iv) administering a radioimmunotherapeutically effective amount for treating B-cell lymphoma of said third antibody or portion which is labeled with said first radiolabel or with a different radiolabel, wherein the amount of radioactivity is less than that which causes myelosuppression severe enough to require the reintroduction of hematopoietic stem cells | |
| US6090365 | July 16, 1993 | Coulter, now GSK | compound + 2nd medical use | method for the treatment of lymphoma which comprises: first administering to a patient an unlabelled anti-CD20 antibody or fragment; and subsequently administering a radioimmunotherapeutically effective amount of an anti-CD20 antibody or a fragment having a radioactive label, wherein the amount of radioactivity is less than the amount that causes myelosuppression severe enough to require the reintroduction of hematopoietic stem cells | Idec vs. Corixa |
| US6331415 | Apr 8, 1983 | Genentech/ Cabilly | enablement technology | process for producing an Ig molecule or fragment comprising at least the V domains of the Ig HC and LC in a single host cell, comprising the steps of: (i) transforming said host cell with a first DNA encoding at least the V domain of the Ig HC and a second DNA encoding at least the V domain of the Ig LC, and (ii) independently expressing said first DNA and said second DNA so that said Ig HC and LC are produced as separate molecules in said transformed single host cell | Many |
| US7682612 | Nov 9, 1998 | Genentech | compound + 2nd medical use | method of treating CLL, comprising administering an anti-CD20 antibody to the patient, wherein the method does not include treatment with a radiolabeled anti-CD20 antibody | Genentech/ Biogen vs. GSK |
| RE40070 | Feb 22, 1994 | GSK | enablement technology | method for purifying monomeric IgG antibody from a mixture comprising said monomeric antibody and at least one of immunoglobulin aggregates, misfolded species, host cell protein or protein A comprising contacting said mixture with a hydrophobic interaction chromatographic support and selectively eluting the monomer from the support | GSK vs. Genentech |
| RE41555 | Feb 22, 1994 | GSK | enablement technology | method for purifying monomeric IgG antibody from a mixture comprising said monomeric IgG antibody and at least one of immunoglobulin aggregates, misfolded species, host cell protein orand protein A comprising, wherein said method comprises the steps of: (i) contacting said mixture with a hydrophobic interaction chromatographic support and (ii) selectively eluting the monomeric IgG antibody from the support | Genentech vs. GSK |
| US4399216 | Feb 25, 1980 | Columbia/Axel | enablement technology | process for inserting foreign DNA I into a suitable eukaryotic cell which comprises cotransforming said cell with said DNA I and with unlinked foreign DNA II which codes for a selectable phenotype not expressed by said cell, said cotransformation being performed under suitable conditions permitting survival or identification of cells which have acquired said selectable phenotype, said DNA I being incorporated into the chromosomal DNA of said eukaryotic cell | Genentech vs. Columbia |
| US4634665 | Feb 25, 1980 | Columbia/Axel | enablement technology | process for inserting foreign DNA I into a suitable eukaryotic cell which comprises cotransforming said cell with said DNA I and with unlinked foreign DNA II which codes for a selectable phenotype not expressed by said cell, said cotransformation being performed under suitable conditions permitting survival or identification of cells which have acquired said selectable phenotype, said DNA II being attached to bacterial plasmid or phage DNA | Genentech vs. Columbia |
| US5179017 | Feb 25, 1980 | Columbia/Axel | enablement technology | transformed CHO cell which comprises amplified foreign DNA I corresponding to a gene of interest stably incorporated into the chromosomal DNA of the transformed cell and amplified DNA II encoding a dominant selectable phenotype not expressed by the transformed cell prior to transformation | Genentech vs. Columbia |
| US6455275 | Feb 25, 1980 | Columbia/Axel | enablement technology | transformed CHO cell comprising a DNA construct comprising DNA I encoding a proteinaceous material foreign to the CHO cell and linked thereto DNA II encoding an amplifiable dominant selectable phenotype not expressed by such cell prior to transformation with the construct, the construct being effective for producing the proteinaceous material when the construct is introduced into the cell, wherein the construct is stably incorporated into the chromosomal DNA of the transformed cell | Genentech vs. Columbia |
| US5654403 | Oct 28, 1991 | Glaxo Wellcome/ Smith | enablement technology | Ig composition of IgG1 containing Cu ions in an amount sufficient to degrade the immunoglobulin, wherein the improvement comprises the addition of an amount of a chelator of Cu ions sufficient to bind the Cu ions present in the composition and protect the Ig from degradation by the Cu ions and thus stabilize the IgG1 composition | Genentech vs. GlaxoWellcome |
| US5792838 | Oct 28, 1991 | Glaxo Wellcome/ Smith | enablement technology | method of making a stabilized IgG1 composition comprising adding to a starting composition comprising (i) IgG1 and (ii) Cu ions in an amount sufficient to degrade said IgG1, an amount of a chelator of Cu ions sufficient to stabilize said IgG1 against Cu ion-mediated degradation, so that said stabilization IgG1 composition is made | Genentech vs. GlaxoWellcome |
| US5545403 | Oct 17, 1990 | Glaxo Wellcome/ Page | enablement technology | a method for treating comprising administering a whole glycosylated recombinant human chimeric or CDR-grafted or bispecific antibody effective in treating a disease or disorder in a human, wherein the improvement comprises an antibody glycosylated by a CHO cell | Genentech vs. GlaxoWellcome |
| US5545405 | Oct 17, 1990 | Glaxo Wellcome/ Page | enablement technology | method for treating cancer by administering a whole glycosylated recombinant human, chimeric, CDR grafted or bispecific antibody effective in treating said cancer, wherein the improvement comprises an antibody glycosylated by a CHO cell | Genentech vs. GlaxoWellcome |
Abbreviations: ADCC, antibody-dependent cell-mediated cytotoxicity; ATCC, American Type Culture Collection; C, constant region; CDC, complement-dependent cytotoxicity; CDR, complementarity-determining region; CHO, Chinese hamster ovary; CHOP, cyclophosphamide, doxorubicin, oncovin, and prednisone or prednisolone; CLL, chronic lymphocytic leukemia; Cu, copper; CVP, cyclophosphamide, vincristine, and prednisone or prednisolone; DLCL, diffuse large cell lymphoma; HC, heavy chain; Ig, immunoglobulin; LC, light chain; MTX, methotrexate; NHL, non-Hodgkin lymphoma; RA, rheumatoid arthritis; TNF, tumor necrosis factor; V, variable region.