Simple-Combination "Trick Patent" Didn't Work... Bronchitis-Treatment Combination Drug Patent Invalidated

Eight pharmaceutical companies filed the patent invalidation trial

The patent authorities have ruled that a new drug made by simply bundling into a single formulation drugs that were already widely co-prescribed in hospitals cannot obtain a patent. The Intellectual Property Trial and Appeal Board found that it was difficult to recognize either novelty or inventive step, based on existing prescription practices and clinical data.

According to the industry and the legal community on the 23rd, the 63rd Panel of the Intellectual Property Trial and Appeal Board on the 2nd upheld the claim in a patent invalidation trial for a "pharmaceutical composition for the prevention and treatment of respiratory diseases," filed by eight pharmaceutical companies including Company A against Pharmaceutical Company B.

Pharmaceutical Company B developed and registered a patent for a bronchitis-treatment combination drug that blended the Pelargonium sidoides extract used in existing cold medicines (the ingredient of Umckamin syrup) and four cough/phlegm medicine ingredients (the ingredients of Cough syrup).

In response, Company A and others argued that there was no novelty or inventive step, saying that the two drugs had been frequently co-prescribed to bronchitis patients in hospitals even before the patent application.

Pharmaceutical Company B, on the other hand, countered that it was a new invention that developed drugs previously taken separately into a single pharmaceutical composition, and that a superior synergistic effect appears when blended in a specific ratio.

The Intellectual Property Trial and Appeal Board accepted the claimants' argument. Based on the Health Insurance Review and Assessment Service's co-prescription database, the Board judged, "It is confirmed that, even before the patent application, the two drugs were co-prescribed to bronchitis patients in tens of thousands of cases or more," adding, "The mixing ratio stated in the patent also includes, as is, the drug ratio used in existing co-prescriptions."

The Board also found that making drugs previously prescribed together into a single formulation is a level that an ordinary skilled person could easily derive.

The synergistic effect claimed by Pharmaceutical Company B was also not recognized. The Board denied inventive step, saying, "Looking at the respondent's clinical trial results, the effect when the two drugs were blended together showed a subtractive effect lower than the effect expected when each was administered separately."

Daeryun Patent & Law Firm, which jointly represented the claimants, said, "This is a meaningful decision that put the brakes on an attempt to build a patent barrier by simply combining drugs already widely used in clinical settings," adding, "By comprehensively analyzing the Health Insurance Review and Assessment Service's prescription data and the clinical trial results, we proved that there was no novelty or inventive step."

Reporter Hwang Jung-won (garden@sidae.com)

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Simple-Combination "Trick Patent" Didn't Work... Bronchitis-Treatment Combination Drug Patent Invalidated (Go to link)