TKT under fire again over gene activation technology
that gene activation technology used in the production of
Transkaryotic Therapies' biological drugs contravenes a US patent.
While the suit does not mention any drugs by name, TKT uses gene activation technologies in the production of its Replagal (agalsidase alfa), a treatment for Fabry disease with sales currently running at around $15 million a quarter, and candidate anaemia drug Dynepo (epoetin delta).
A spokesperson for TKT confirmed that Serono's suit was a wide-ranging assault on the gene activation technology, but would not be drawn on the potential impact on TKT's products if it were to be successful.
Serono's subsidiary - Applied Research Systems - has filed an amended complaint in the US District Court of Massachusetts against TKT alleging patent infringement on certain methods of gene activation. Serono is claiming infringement of one of its US patents - No 5,272,071 - that covers the activation of normally dormant genes in cells in order to get them to produce desired proteins.
However, Serono has tried to take on TKT over its gene activation activities in Europe as well as the US, but without success. Last year, the Technical Board of Appeals of the European Patent Office (EPO) invalidated a corresponding European Patent - No 0 505 500 - owned by ARS - after Serono brought suit against TKT claiming that its activities relating to Replagal infringed the patent.
Meantime, TKT has travelled a rocky road trying to bring Dynepo to market, with a string of challenges from US biotechnology company Amgen, which is looking to provide protection for its own blockbuster anaemia drug Epogen (epoetin alfa).
That ongoing litigation is product-specific rather relating to TKT's production platform, and is being held up as a key test of the ability of companies to bring so-called biosimilar drugs to market - the biologics equivalent of a generic drug.
In the latest suit Serono alleges that "by making, using, selling and/or offering for sale the methods, cell lines, and/or DNA constructs claimed therein," TKT is infringing the '071 patent.
Earlier this month, TKT entered into a manufacturing agreement whereby Lonza Biologics will make Dynepo at its current Good Manufacturing Practice (cGMP)-standard production facility in Slough, UK.
At the time, David Pendergast, chief operating officer of TKT, said: "With the signing of this contract, we expect to complete the necessary manufacturing and regulatory requirements to support a commercial launch in the European Union in late-2005 or early-2006."
