Personalised medicine, medical indication patents and patent infringement: emergency treatment required

This contribution provides for the first time an in-depth analysis of the scope of protection of medical indication claims. This analysis leads to the inevitable conclusion that virtually all players in the chain, i.e. the generic drug manufacturers, the drug wholesalers, the physician and the pharmacists, run a credible and documented risk of committing patent infringement in the case of an off-label use by producing drugs for the use in medical treatment, by prescribing them and by dispensing those drugs. The introduction of a therapeutic freedom exception for clinicians and pharmacists is advised. Such an introduction is not sufficient to guarantee full therapeutic freedom at a reasonable cost for both patients and the healthcare system at large. It is evidenced that medical indication patents do not only come very close to the therapeutic activities of the clinician, and present serious risks from that perspective; other players in the pharmaceutical product chain also run the risk of committing patent infringements which they cannot necessarily control. It is likely that under the current state of the law, generic manufacturers will be liable for patent infringement, knowing that their drugs, which are not authorised and offered for sale for patented medical indications, will be used off-label by physicians for the use in the treatment of a patented medical indication. Such a situation is not desirable, as it will expel generics from the pharmaceutical product market, even in markets which are no longer patent protected. This can come at a potentially very high cost for the healthcare system, which is already under financial pressure in most countries. This article puts forward a number of solutions to prevent this from happening.