Despite its global status as one of the most active countries for the development of intellectual property, South Korea has a reputation for being less friendly in terms of patent protection and enforcement compared to other major jurisdictions. For example, South Korea has been notorious for its strict examination requirements concerning pharmaceutical-related inventions, e.g., clinical data requirement, non-recognition of patentability for second medical use claims, etc.
South Korea’s patent litigation procedures have also been known to be poorly equipped for discovering evidence to prove patent infringement and damages, and sometimes unfavourable to foreigners. In this regard, South Korean courts have been trying to change the environment for patent protection and patent litigation, specifically by rendering decisions that are more favourable to the protection of pharmaceutical-related inventions. Additionally, the courts have implemented an improved discovery process and established an international panel that provides foreigners with more convenient patent litigation procedures.
Inventive step of second medical use inventions recognized by the Supreme Court.
The novelty of a second medical use invention for a new dosage regimen was first recognized by the Supreme Court (en banc case) in 2015, overruling an earlier Supreme Court decision holding that a second medical use could not be a patentable invention. Despite the en banc decision, the standard for the inventive step of a second medical use invention had not been clearly defined by the court.
Recently, the Supreme Court acknowledged the inventive step of a second medical use invention relating to a new route of administration. That case involved South Korean Patent No. 121596, relating to a pharmaceutical composition for systemic transdermal administration, and comprising an (S) optical isomer of rivastigmine, RA7. The Supreme Court specifically held that “one of ordinary skill in the art could not easily anticipate the effect of the transdermal administration of RA7 or an optical isomer thereof from the properties of the racemate compound disclosed in the prior art reference because: (1) the reference discloses the oral or non-oral administration of the racemate compound and the effect of oral administration, but does not disclose the effect of transdermal absorption; and (2) the reference discloses the properties of racemate compounds such as high lipid solubility, low melting point, short half-life, small molecular weight, lower dose, narrow therapeutic window, etc., which might be also shown in the compounds having superior transdermal absorptivity, but it cannot be deemed that all the compounds having such properties exhibit superior transdermal absorptivity. Therefore, the claimed invention could not be easily conceived from the prior art and is acknowledged to have an inventive step.”
The Supreme Court has recognized the technical significance of second medical use inventions and the necessity of their protection to promote the pharmaceutical industry. Based on these recent court decisions, it now appears that various types of second medical use inventions, not limited to dosage regimen and administration route, will be patentable, based on their effects that are not easily conceivable from the prior art.
Distinguishing the enablement and support requirements in medical use inventions. Under South Korean pharmaceutical practice, clinical data or its equivalent have been required to be presented in the disclosure of medical use inventions from the filing date. South Korea’s Intellectual Property Office (KIPO) has strictly applied this standard, both for the enablement requirement and the support requirement of medical use inventions.
However, recently the Patent Court held that the criteria for the support requirements of claims under article 42(4)(i) of the Patent Act should be distinguished from the criteria for the enablement requirement under article 42(3)(i) of the Patent Act.
Previously, in a case involving a patent application in the technical field of computer communications, the Supreme Court had held that the two requirements are different in terms of their purpose. Thus, different criteria should be applied in determining compliance with the requirements. Notwithstanding this ruling, examiners and trial judges of the KIPO had taken the position that, in the case of a medical use invention, the criteria for determining compliance with the enablement requirement can exceptionally be applied to determine compliance with the support requirement. They did this based on the premise that inventions in the medical use field are much less predictable and reproducible than inventions in other technical fields.
The Patent Court has now made it clear that the two requirements should be separately determined, even in the case of a medical use invention. Specifically, the lack of clinical data or its equivalent in the specification cannot be used as a basis for determining non-compliance with the support requirement. The court ruled that the support requirement should be determined based on whether the specification has corresponding descriptions to the claims in it, and if the claimed inventions can be expanded or generalized from the descriptions in the specification. This decision is expected to generate a substantial change in the practice of determining compliance with the support requirement for medical use inventions based on the presence or absence of clinical data or its equivalent in the specification.
Reinforced obligations of submitting evidence in a patent infringement suit. Under the South Korean Code of Civil Procedure, discovery generally is not permitted. Thus, proving infringement or damages is difficult where an accused product or process is not publicly available, or where key evidence is exclusively in the possession of an alleged infringer. In such cases, the civil procedure code allows a party to ask the court to order an adverse party to produce certain specifically-identified relevant materials. However, under the pre-revised Patent Act, even when the court ordered the adverse party to produce such materials, the ordered party could typically avoid producing them by asserting that the requested items contain trade secret information.
Under revised article 132 of the Patent Act, if certain evidence is deemed necessary to verify infringement or damages, the alleged infringer is not permitted to refuse production by asserting that the evidence requested is a trade secret. If the alleged infringer does not respond to the court’s order to submit such evidence without a justifiable reason, the requesting party’s arguments that could be proved based on the requested evidence may be deemed to have been proved. The court will, however, attempt to prevent trade secrets from being disclosed to the extent possible by limiting the scope of the evidence to be disclosed and limiting who will have access to the evidence.
Furthermore, the revised Patent Act expands the type of evidence that the court can order to be produced in a patent infringement action from “documents” to “any materials”, which now captures digital materials.
Revisions to the Patent Act are expected to ease the patentee’s burden of proving patent infringement and in assessing damages in patent infringement actions.
New international panel established for IP cases in the courts. As the number of lawsuits involving foreign parties has been continuously increasing in South Korean courts each year (i.e. more than 40% of cases filed in 2016), there has been a recognized need to establish an international panel to resolve international patent disputes.
In June 2018, an international panel was established in the courts for IP actions. Under the revised Court Organization Act, which was passed on 24 November 2017, the Seoul District Court, which tries initial patent infringement actions, and the Patent Court, which tries the second level of such cases, including appeals of patent infringement actions or appeals of Intellectual Property Trial and Appeal Board (IPTAB) decisions, each will have an international panel to hear international disputes in English.
Before the revision, the Korean language was the only language used in the courts. The revision allows parties to submit briefs and evidence, and make oral arguments in a foreign language (English) upon consent of the parties. The international panel also provides an official English translation of its decision.
This new panel will provide foreign entities with smooth and fair trial proceedings and reduced trial expense, including translation costs. It is expected that an increasing number of IP disputes will be brought to courts by foreign IP holders, and that courts will become a popular venue for resolving international disputes.
Based on the efforts discussed above, it is anticipated that South Korea will soon be perceived as having a friendlier environment for protecting and enforcing patent rights.
LEE INTERNATIONAL IP & LAW GROUP
Poongsan Bldg, 23 Chungjeongro
Seoul 03737, South Korea
Tel: +82 2 2262 6000 Fax: +82 2 2279 5020
Email: [email protected]
+82 2 369 1212