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IP Newsletter | Winter 2018/19
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PATENT
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Korean Supreme Court Overrules Lower Tribunal to Recognize that a Patent for a Sustained Release Pharmaceutical Composition Satisfies the Description Requirements
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The Korean Supreme Court recently overturned the Patent Court's (2nd level Court of Appeals) decision to invalidate a Novartis patent for a sustained release formulation invention where the pharmacological data was described based on animal testing for failing to meet description requirements (Supreme Court Decision No. 2016 Hu 601 rendered on October 25, 2018). In its decision, the Supreme Court clarified what kind of data in the specification would be sufficient to satisfy the description requirements for a sustained release formulation invention by applying legal principles regarding description requirements for a product invention.
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Background
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Novartis obtained a patent directed to a sustained release pharmaceutical composition comprising octreotide or a pharmaceutically-acceptable salt thereof as an active ingredient and two different polylactide-co-glycolide polymers (PLGAs) as further defined in the claims. Octreotide is used for the treatment of acromegaly and symptom relief of carcinoid syndromes associated with gastroentero-pancreatic carcinoid tumors. The pharmacological effects of octreotide were already known before the priority date of Novartis' patent. The claimed composition continuously releases octreotide for about 3 months without large fluctuations in the plasma level.
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The patent specification describes that the claimed pharmaceutical composition allows a sustained release of the active ingredient over a period of more than three months, preferably between three and six months and that during the release of the active ingredient, the plasma levels of octreotide are within the therapeutic range. The specification also provides working examples regarding the method for an experiment where the compositions were administered to rabbits and the plasma levels of octreotide were measured for 96 days, as well as data obtained from the experiment.
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Procedural History
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Dongkook Pharmaceutical filed an invalidation action with the Intellectual Property Trial and Appeal Board (IPTAB) against Novartis' patent arguing lack of novelty, lack of inventiveness and failure to meet description requirements. The IPTAB held that Novartis' patent is novel and inventive and that both the specification and the claims met the description requirements.
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Dongkook Pharmaceutical appealed the IPTAB's decision to the Patent Court. The Patent Court held that a person skilled in the art could not have properly understood the long term treatment effect of the patented invention from the rabbit data in the specification unless undue experimentation was carried out or special knowledge was added. Thus, the Patent Court found that Novartis' patent should be invalidated for failing to meet the description requirements prescribed in Article 42(3) of the Korean Patent Act. In its decision, the Patent Court indicated that a person skilled in the art could not have estimated the human plasma level profile from the rabbit data and determined the therapeutic effect in humans based on such estimation. In other words, the Patent Court had determined that the animal test data disclosed in the specification was not enough to meet the description requirements.
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The Supreme Court reversed the Patent Court decision and found the patent to be valid. Specifically, the Supreme Court held that (i) according to the rabbit data described in the working examples, octreotide is continuously released for 89 days within a stable range of plasma level; (ii) the sustained pharmacological effect can be verified by confirming whether the plasma level of the active ingredient is continuously maintained after the sustained release formulation is administered; (iii) the method of predicting the plasma level in humans through test results regarding measurement of the plasma level of a specific active ingredient in animals had been widely used in the field of sustained release formulations at the time of the priority date; (iv) as described in the specification, if the plasma level of octreotide measured after administration at the appropriate dose of octreotide in rabbits was constantly maintained over a certain level for about 3 months, then a person skilled in the art could have predicted that the plasma level of octreotide in humans would be constantly maintained for a similar period based on the rabbit test results; and (v) as long as a person skilled in the art could manufacture and use the sustained release pharmaceutical composition of the patent and also could have predicted the effect of the patented invention on the basis of technology level at the time of the filing date of Novartis' patent application, even if clinical trial data was not provided in the specification, it is recognized that the description requirements have been satisfied.
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Significance
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The Supreme Court decision explicitly rejects the Patent Court's application of an unreasonably strict description requirement to Novartis' patent which is in conflict with the Korean patent practice, and provides legal principles regarding description requirements for a sustained release formulation invention, which are largely consistent with the legal principles established by the Supreme Court for a product invention.
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