More experimental freedom - but who wins?
The US Supreme Court's 13 June 2005 decision in Merck v Integra provides welcome news for both large researchers and those awaiting the benefits of scientific research.
The court held that an existing exception to patent infringement (35 U.S.C section 27(1) (e)) covering trials solely relating to submissions for regulatory clearance (here, the Food and Drug Adminstration) also applies to early preclinical trials which could lead to the development of new drugs - if there is reasonable basis for belief that the outcome of the tests would be used for regulatory submission.
The case involved work on cancer treatments on animals. It had been argued that the exemption should be limited to later stage tests to enable generic products to be brought to market as quickly as possible after the patent term.
The question of what commercial research and testing is exempt from patent infringement is complex - for example there are differing positions in the UK and Germany, which are both members of the European Patent Convention. A broad exemption is in the public interest, increasing the prospects of important products being developed (and coming to market after the relevant patent term). Smaller companies which own key patents, however, will likely be concerned at loss of royalty income as others use their innovation to move forward.
The court held that an existing exception to patent infringement (35 U.S.C section 27(1) (e)) covering trials solely relating to submissions for regulatory clearance (here, the Food and Drug Adminstration) also applies to early preclinical trials which could lead to the development of new drugs - if there is reasonable basis for belief that the outcome of the tests would be used for regulatory submission.
The case involved work on cancer treatments on animals. It had been argued that the exemption should be limited to later stage tests to enable generic products to be brought to market as quickly as possible after the patent term.
The question of what commercial research and testing is exempt from patent infringement is complex - for example there are differing positions in the UK and Germany, which are both members of the European Patent Convention. A broad exemption is in the public interest, increasing the prospects of important products being developed (and coming to market after the relevant patent term). Smaller companies which own key patents, however, will likely be concerned at loss of royalty income as others use their innovation to move forward.
posted by Dr Abbe Brown at 8:21 am
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