IP Newsletter | Spring 2015
	PATENT
	Patent for Top-Selling Drug in Korea Upheld
	Starting the year in pharmaceutical patents off with a bang, the Intellectual Property Tribunal ("IPT") of the Korean Intellectual Property Office (KIPO) upheld the validity of a patent covering the active ingredient (entecavir) of the top selling drug in Korea, BMS' hepatitis B drug Baraclude®. Seeking to launch their generic versions of the drug before the expiry of Korean Patent No. 160523, an entecavir compound patent, the two generics Hanmi and Daewoong had challenged the inventiveness of the patent. Notably, the IPT's ruling comes in the wake of a 2014 U.S. Federal Circuit decision invalidating the counterpart U.S. patent for obviousness. The person of ordinary skill would not have been motivated to combine the prior art The main issue disputed in the case related to the lead-compound approach. The generics argued that a person skilled in the art would have selected a certain lead compound from the prior art, and then combined it with a second compound embodying the functional groups for the necessary modification, with a reasonable expectation of success at conceiving an effective antiviral compound. The IPT disagreed, noting that the significant difference in mechanism-of-actions between the lead compound and second compound meant that there would have been no motivation for a person of ordinary skill to combine such prior art to arrive at entecavir. Entecavir's "remarkable" effects The inventiveness question also hinged on whether data prepared after the patent filing could be cited by the patentee to support entecavir's inventive effects. While entecavir was shown to have 13.3 times greater anti-HBV activity over the lead compound, the generics argued this evidence should not be allowed because the data was generated after the patent filing date. The IPT also rejected this argument, citing Supreme Court precedent that even without an explicit disclosure or corresponding data in the patent, any inferences of such effects in the patent should allow the use of post-filing data to support inventiveness, particularly for a chemical compound invention. BMS' 2013 annual report noted that the worldwide sales of Baraclude® were US$1.5 billion. Due to its blockbuster sales, the patent has had no shortage of generic challengers. Hanmi and Daewoong were the first two of seventeen generics to file challenges to the validity of the patent. BMS was represented by Kim & Chang.
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