U.K. amends patent law to ease restrictions for innovative trials
The amendment gives the same level of protection against lawsuits to companies running the trials on innovative products with patented active ingredients as it does to companies running trials on generics, BioCentury reports.
"As a whole, we feel these changes are a step towards ensuring the U.K. patent system continues to encourage and support those innovative businesses who recognize the economic value which can be gained through granted patent rights, whilst ensuring legal certainty for third parties," the Intellectual Property Office said, BioCentury reports.
The section of the law covers the use of a patented drug as an active comparator or as part of a drug combination in a clinical trial of another product. Prior to the amendment, the law prevented a patent owner from suing a company that uses a drug in a generic drug trial. The law did not previously provide protection to companies running trials of innovative products that contain patented active ingredients such as combination products or oral formulations of patented IV antibiotics.
Clinical trial activities are considered exempt in most European Union countries under patent law. The Hatch-Waxman act protects clinical trial activities in the United States.
The Intellectual Property Office proposed the amendment in October, BioCentury reports.