Protection for research or manufacturing?
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Rulings from District Courts in the United States can often be taken with a pinch of salt, as they are frequently overturned at Federal level. However, a recent decision by the District Court of Delaware over the use of screening technologies has surprised many and could have far-reaching implications. In case Civ. A. No. 01-148-SLR, the Court upheld the right of Bayer to use screening processes that were patented by Housey Pharmaceuticals for research that led to the development of novel pharmaceuticals, as long as these processes were not used for subsequent manufacturing of any drugs in the United States. Housey alleged that Bayer's use of their technologies infringed their patents protected under section 271g of US Code 35, which states that a product cannot be sold or used within the United States if it has been made by a process patented in the United States. But Chief Judge Sue L. Robinson decided in favour of Bayer, writing that “These processes of identification and generation of data are not steps in the manufacturing of final drug products”. The fact that Bayer conducted its screening programme outside the United States most probably contributed to the decision, but nevertheless the message given by the court's decision is that 'screening' technologies are not part of the manufacturing process, but rather part of a separate 'pre-manufacturing' R & D phase.
OGT array patent still standing after 6 years of opposition
After 6 years of legal wrangling, a microarray patent held by Oxford Gene Technology (OGT) has emerged almost entirely unchanged from a 3-day hearing at the European Patent Office (EPO). OGT was established to commercialize microarray technology that arose from research in Ed Southern's laboratory at Oxford University. OGT's patent, granted by the EPO in 1994, covers most oligonucleotide arrays that are on the market at present, whether they are made by in situ synthesis or deposition of pre-synthesized oligonucleotides. In mid-November, the EPO conducted an oral hearing to consider arguments raised by a number of companies. They argued that although Southern had invented microarrays of many different types, similar work had already been done by others using conventional blotting techniques, in which an array of known oligonucleotides is bound to filter paper in order to detect labelled sequences. The one thing, however, that was new and inventive about Southern's invention was his idea of using a smooth impermeable surface, such as glass, for the array support. Therefore, OGT introduced amendments to limit the patent's coverage to oligonucleotides that are covalently attached to smooth impermeable surfaces — amendments that were accepted by the Opposition Division of the EPO. OGT are delighted with the EPO's decision and with the broad claims that still emerge from their patent. OGT intends to continue to pursue licensing opportunities.
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ICT Pharmaceuticals US patent 4,980,281
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Oxford Gene Technology European patent EP373203 United States patent database
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News Analysis. Nat Rev Drug Discov 1, 11 (2002). https://doi.org/10.1038/nrd719
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DOI: https://doi.org/10.1038/nrd719