High Court of Justice Issues Ruling in Erythropoietin Patent Litigation

Apr 11, 2001, 01:00 ET from Transkaryotic Therapies, Inc.

    CAMBRIDGE, Mass., April 11 /PRNewswire/ -- Transkaryotic Therapies, Inc.
 (Nasdaq: TKTX) today announced the High Court of Justice in London has issued
 an opinion in a patent infringement suit TKT and Aventis brought against
 Kirin-Amgen, Inc., involving Dynepo(TM), the companies' Gene-Activated(R)
 erythropoietin for the treatment of anemia.
     Mr. Justice Neuberger of the English High Court of Justice presided over
 the case and ruled that one of four claims of European Patent No. 0 148 605 B2
 asserted in the case against TKT and Aventis was not infringed on a literal
 basis but would be infringed when the claim is construed on a purposive basis
 (essentially under the U.K. version of the U.S. doctrine of equivalents).  The
 other three claims asserted were found to be invalid and even if valid,
 incapable of infringement.
     "We believe we made significant progress in this initial case and are
 confident we have strong grounds to appeal the remaining issue," said Richard
 F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT.  "The
 Judge found critical facts in our favor, and we look forward to resolution of
 this case in mid-2002."
     Dynepo is a human erythropoietin for the treatment of anemia.  Clinical
 development testing Dynepo as a treatment for anemia of renal failure in
 dialysis and pre-dialysis patients has been completed, and Aventis is pursuing
 marketing authorization in both the U.S. and Europe.
     Transkaryotic Therapies, Inc. (TKT) is a biopharmaceutical company
 dedicated to the development and commercialization of products based on its
 three proprietary development platforms: Gene-Activated(R) proteins, Niche
 Protein(TM) products, and Gene Therapy.  The Company's gene activation
 technology is a proprietary approach to the large-scale production of
 therapeutic proteins, which does not require the cloning of genes and their
 subsequent insertion into non-human cell lines. TKT's Niche Protein product
 platform is based on protein replacement for the treatment of rare genetic
 diseases, a group of disorders characterized by the absence of certain
 metabolic enzymes.  The Company's Gene Therapy technology, known as
 Transkaryotic Therapy(TM), is focused on the commercialization of non-viral,
 ex vivo gene therapy products for the long-term treatment of chronic protein
 deficiency states.
 
     This press release contains forward-looking statements that involve a
 number of risks and uncertainties.  For this purpose, any statements contained
 herein that are not statements of historical fact may be deemed to be forward-
 looking statements.  Without limiting the foregoing, the words, "believes,"
 "anticipates," "plans," "expects,"  "estimates," "intends," "should," "could,"
 "will," "may," and similar expressions are intended to identify forward-
 looking statements. There are a number of important factors that could cause
 the Company's actual results to differ materially from those indicated by such
 forward-looking statements set forth under the caption "Certain Factors That
 May Affect Future Results" in the Company's Annual Report on Form 10-K for the
 year ended December 31, 2000 which is on file with the Securities and Exchange
 Commission and incorporated herein by reference.   These include, without
 limitation, the following: (1) whether any of the Company's Gene-Activated
 protein, Niche Protein or gene therapy product candidates will advance in the
 clinical trial process, (2) whether such clinical trials will proceed in a
 timely manner, (3) whether the clinical trial results will warrant continued
 product development, (4) whether the required regulatory filings, such as
 Investigational New Drug applications and Biologics License Applications, are
 made in a timely manner, (5) whether the Company's products will receive
 approval from the U.S. Food and Drug Administration or equivalent foreign
 regulatory agencies, (6) if such products receive approval, whether they will
 be successfully distributed and marketed, (7) whether patent litigation in
 which the Company is involved or may become involved are resolved in a manner
 adverse to the Company, (8) the effects of competitive products on the
 Company's proposed products, and (9) the Company's dependence on third
 parties, including collaborators, manufacturers and distributors.
 
     Gene-Activated(R) is a registered trademark and Niche Protein(TM),
 TKT(TM), and Transkaryotic Therapy(TM) are trademarks of Transkaryotic
 Therapies, Inc.  Dynepo(TM) is a trademark of Aventis Pharma.
 
     Please visit our web site at www.tktx.com for additional information about
 Transkaryotic Therapies, Inc.
 
      CONTACT:
      Justine E. Koenigsberg
      Director, Corporate Communications
      (617) 349-0271
 
 

SOURCE Transkaryotic Therapies, Inc.
    CAMBRIDGE, Mass., April 11 /PRNewswire/ -- Transkaryotic Therapies, Inc.
 (Nasdaq: TKTX) today announced the High Court of Justice in London has issued
 an opinion in a patent infringement suit TKT and Aventis brought against
 Kirin-Amgen, Inc., involving Dynepo(TM), the companies' Gene-Activated(R)
 erythropoietin for the treatment of anemia.
     Mr. Justice Neuberger of the English High Court of Justice presided over
 the case and ruled that one of four claims of European Patent No. 0 148 605 B2
 asserted in the case against TKT and Aventis was not infringed on a literal
 basis but would be infringed when the claim is construed on a purposive basis
 (essentially under the U.K. version of the U.S. doctrine of equivalents).  The
 other three claims asserted were found to be invalid and even if valid,
 incapable of infringement.
     "We believe we made significant progress in this initial case and are
 confident we have strong grounds to appeal the remaining issue," said Richard
 F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT.  "The
 Judge found critical facts in our favor, and we look forward to resolution of
 this case in mid-2002."
     Dynepo is a human erythropoietin for the treatment of anemia.  Clinical
 development testing Dynepo as a treatment for anemia of renal failure in
 dialysis and pre-dialysis patients has been completed, and Aventis is pursuing
 marketing authorization in both the U.S. and Europe.
     Transkaryotic Therapies, Inc. (TKT) is a biopharmaceutical company
 dedicated to the development and commercialization of products based on its
 three proprietary development platforms: Gene-Activated(R) proteins, Niche
 Protein(TM) products, and Gene Therapy.  The Company's gene activation
 technology is a proprietary approach to the large-scale production of
 therapeutic proteins, which does not require the cloning of genes and their
 subsequent insertion into non-human cell lines. TKT's Niche Protein product
 platform is based on protein replacement for the treatment of rare genetic
 diseases, a group of disorders characterized by the absence of certain
 metabolic enzymes.  The Company's Gene Therapy technology, known as
 Transkaryotic Therapy(TM), is focused on the commercialization of non-viral,
 ex vivo gene therapy products for the long-term treatment of chronic protein
 deficiency states.
 
     This press release contains forward-looking statements that involve a
 number of risks and uncertainties.  For this purpose, any statements contained
 herein that are not statements of historical fact may be deemed to be forward-
 looking statements.  Without limiting the foregoing, the words, "believes,"
 "anticipates," "plans," "expects,"  "estimates," "intends," "should," "could,"
 "will," "may," and similar expressions are intended to identify forward-
 looking statements. There are a number of important factors that could cause
 the Company's actual results to differ materially from those indicated by such
 forward-looking statements set forth under the caption "Certain Factors That
 May Affect Future Results" in the Company's Annual Report on Form 10-K for the
 year ended December 31, 2000 which is on file with the Securities and Exchange
 Commission and incorporated herein by reference.   These include, without
 limitation, the following: (1) whether any of the Company's Gene-Activated
 protein, Niche Protein or gene therapy product candidates will advance in the
 clinical trial process, (2) whether such clinical trials will proceed in a
 timely manner, (3) whether the clinical trial results will warrant continued
 product development, (4) whether the required regulatory filings, such as
 Investigational New Drug applications and Biologics License Applications, are
 made in a timely manner, (5) whether the Company's products will receive
 approval from the U.S. Food and Drug Administration or equivalent foreign
 regulatory agencies, (6) if such products receive approval, whether they will
 be successfully distributed and marketed, (7) whether patent litigation in
 which the Company is involved or may become involved are resolved in a manner
 adverse to the Company, (8) the effects of competitive products on the
 Company's proposed products, and (9) the Company's dependence on third
 parties, including collaborators, manufacturers and distributors.
 
     Gene-Activated(R) is a registered trademark and Niche Protein(TM),
 TKT(TM), and Transkaryotic Therapy(TM) are trademarks of Transkaryotic
 Therapies, Inc.  Dynepo(TM) is a trademark of Aventis Pharma.
 
     Please visit our web site at www.tktx.com for additional information about
 Transkaryotic Therapies, Inc.
 
      CONTACT:
      Justine E. Koenigsberg
      Director, Corporate Communications
      (617) 349-0271
 
 SOURCE  Transkaryotic Therapies, Inc.