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Generic Version of Wonder Drug under Legal Spotlight

The public interest in incentivising research into new pharmaceuticals, and the rights of doctors and pharmacists to prescribe and dispense the cheapest available drugs, collided head-on in a High Court test case.

Company A manufactured a highly successful drug which was used to treat epilepsy, generalised anxiety disorder and neuropathic pain. Patent protection in relation to the first two uses had expired, but not in respect of the third. Company B was in the process of seeking market authorisation for a generic version of the drug.

Company B agreed to take steps, including the adoption of particular packaging instructions, in order to meet company A’s concerns that the generic drug would be prescribed and dispensed for the treatment of pain. However, company A argued that those measures did not go far enough.

Company A asked the Court to order company B to write to all pharmacists, requiring them to agree as a matter of contract that they would not dispense the generic drug for the purpose of pain management. In rejecting that application, however, the Court expressed doubt that such a measure would be effective. In practice, pharmacists had a strong commercial incentive to dispense cheaper, generic, drugs where they would be just as effective as a patented version.

Whilst recognising the importance of company A’s rights, the Court found that granting the order sought would ‘create a greater risk of injustice’ than refusing it. Company A had failed to establish a seriously arguable case that company B would infringe the patent by marketing the generic drug and the latter would suffer ‘substantial unquantifiable harm’ if prevented from doing so.