Science Minister, David Willetts, is expected to announce plans to amend UK patent laws to include a specific exemption for clinical trials from patent infringement actions. Backed by an existing EU directive, this exemption already applies in the majority of EU member states, but not in the UK. The amendments are expected to be passed in October 2013.
John Dean, partner and patent attorney at Withers & Rogers, said:
“Research conducted prior to seeking market approval for a new drug is necessarily long-winded and expensive. Even before research gets underway, pharma companies will have invested millions of pounds in development just getting to this point.
“When it comes to clinical trials, pharma companies simply can’t afford to take any risks. As a result, most have been choosing to conduct such trials in other European countries rather than run the risk of a patent infringement action in the UK.”
While examples of infringement actions linked to clinical trials are relatively few and far between – largely because drug companies choose not to sue - they can and do happen. Most drug companies will recall the case of ‘rapamycin’, an immunosuppressant drug owned by American Home Products (now Wyeth). American Home Products was sued for alleged patent infringement prior to the new drug’s market entry and the case reached appeal stage before being rejected.
According to Withers & Rogers, the risk of being sued for patent infringement while undertaking basic drug discovery research in the UK is often ignored by academics but does nevertheless represent a real threat. John Dean comments:
“Drug research scientists in the UK tend to be unaware of the risks associated with conducting experiments that involve the use of third party drugs. However, the risks are real and, if infringement actions are brought, the new drug’s passage to market could be blocked by an injunction and significant costs incurred.”
For research scientists, any move to make clinical trials exempt from patent infringement claims, would help to clarify the law in this area.
John Dean concluded:
“Currently, pharma companies and scientists undertaking research work to obtain market approval, particularly when finding a new use for an existing drug, are likely to be taking a significant risk. By planning to take action to remove this risk, the Government is taking positive action to support the pharma sector and encourage companies to stay and invest in the UK.”