Local pharmaceutical companies may no longer be able to avoid patent claims with base-altering strategies, as the Supreme Court has remanded the case regarding the patent infringement lawsuit filed by Astellas against Core Pharm Bio in favor of the plaintiffs on Thursday.
Core Pharm Bio had released A-care before the patent expired in December 2016, by base-altering Solifenacin succinate of Vesicare’s, the original drug made by Astellas, to Solifenacin Fumarate.
At the time, the Korean company claimed that A-care does not fall within the scope of the extended patents as it has a different base compound. With the strategy, the company won all lawsuits related to patent infringement and scope of passive rights for the patent filed by Astellas. The Patent Court agreed with Core Pharm and ruled in favor of the company in its first ruling.
The Patent Court ruled that the Patent Law’s Article 95, which states that "the effect of the extension patent is limited to the object of the patented invention," does not affect the entire scope of the invention described in the claims, but extends only to the scope of the license for which the extension is registered.
The ruling meant that since Solifenacin Fumarate differs from Solifenacin succinate, companies can release such base-altered drugs before the extended patent expiration date.
Korean and Japanese firms have adopted such “main component” theory to release their product before the patent expiration date.
However, the Supreme Court ruled that the effect of the extended patent rights is not restricted to the implementation of the target “item,” but also the criteria for the therapeutic effect and use.
“The extent to which an extended patent is valid is based on whether the medicinal product licensed under the Pharmaceutical Affairs Law has the same specific active ingredients, therapeutic effects and uses expected to produce therapeutic effects,” the Supreme Court said in its ruling. “Although A-care has a different base compound, it can be easily selected by ordinary technicians.”
If the therapeutic effect or the use of the active ingredient absorbed by the human body is substantially the same, the product should be regarded as a patent-infringing product, it added.
With the latest ruling, local firms and experts expect that it will become harder for local companies to use the base-altering strategy as a means of avoiding patents that have an extended duration.