Functional Language in Claim

In general, a claim with functional language is very often objected by the Examiner in Korean patent practice. Examiners usually consider functional wordings or expressions used in claims rendering the scope or constitution of the claimed invention unclear and indefinite. Further, they seem to surely have the opinion that such functional expressions make the scope of the functional language claim to be unduly broader than the subject matter supported by the specification.

However, functional wordings or functional expressions are surely allowed under Korean patent practice when no alternative and effective expressions that can clearly and definitely describe the claimed subject matter; the meanings of the functional expressions are fully supported by the detailed description of the invention; and the functional expressions do not pose any problems in defining the scope of the claimed invention. For example, for the specifications of electronic technology field, functional wordings are usually and often allowed in claims. An examiner who is in charge of examinations for chemistry, biotechnology or pharmaceutical patent applications, has relatively high tendency to reject functional language claims.

Recently the Supreme Court held that the scope of protection for an invention is limited to the embodiments clearly specified in the detailed description and drawings when means-plus-function features are exceptionally allowed. The detailed descriptions and drawings of the invention are critical factors to be considered in narrowly interpreting functional claims for purposes of determining the scope of protection. Therefore, it is advisable to keep in mind that many examples should be described in the detailed description when the applicant files an application for a functional claim.

Denied Patent Term Extension for Novartis' Exelon® Patch in Korea

Novartis' Exelon® Patch has been used to treat mild to moderate dementia of the Alzheimer's type and mild to moderate dementia associated with Parkinson's disease. The active ingredient is rivastigmine.

Novartis obtained the first MA for Exelon® Capsule and the second MA for Exelon® Patch in Korea. Exelon® Patch uses a new formulation that allows rivastigmine to be administered in a transdermal therapeutic system (TTS).

Novartis listed two patents in the Green List (http://medipatent.kfda.go.kr) of KFDA pursuant to the linkage system of patent and market approval. The first patent is Korean Patent No. 133,686 that claims chemical compounds including rivastigmine, its pharmaceutical use. The term of the compound patent expired on December 23, 2012. The second patent is Korean Patent No. 569,051 that claims inventions of TTS formulation. The second patent will expire on January 8, 2019.

Novartis has another patent in issue that claims rivastigmine compound for transdermal administration and compositions for them. The patent in issue is Korean Patent No. 121,596 that has actually lmost the same scope of protection that of the basic compound patent of Korean Patent No. 133,686. The background between two patents is somewhat complicated because Korean Patent No. 121,596 stems from transient measure in 1987.

The Patentee and NDA holder, Novartis filed a petition for patent term extension of the basic compound patent on April 23, 2012. In Korea, the patent term extension system was first introduced on July 1, 1987. Under the 1987 Act that applied to the patent in issue, a petition for patent term extension may be filed only during the last three (3) years of the original term of the patent. Upon filing a PTE request, the term of the subject patent shall be extended automatically and shall be terminated on the expiry date retroactively in case the petition has been denied.

KIPO denied Novartis’ petition. Novartis appealed to the Seoul Administrative Court. On September 26, 2013, the court rejected Novartis’ arguments and denied PTE for Exelon Patch patent. The Patentee and NDA holder, Novartis appealed the lower court decision to the Seoul High Court again. The current PTE system has been based on 1990 amendment and the first PTE regulations of 1987 are quite different from those of the current PTE regulations. The PTE regulations of 1987 that must applied to Exelon Patch case had much more narrow scope than those of the current regulations in subject patents and gourds for PTE. Exelon Patch falls in such unfortunate cases during transient period between 1987 and 1990.

Physicochemical Data Addition to the Specification during Prosecution

In general, the specification for a new chemical compound should describe physicochemical data of the claimed compound to such an extent that persons skilled in the art could clearly understand, recognize and reproduce the invention without any additional specific knowledge. However, as for addition of physicochemical data during prosecution, the Patent Court has somewhat differentiated a new compound invention from a new medicinal use invention. The Patent Court held that adding physicochemical data through an amendment does not constitute new matter if examples of a process for preparing claimed chemical compounds are described in detail in the specification. In principle, Korean patent practice requires that all patent applications for novel chemical compounds include physicochemical data in its original specification so as to confirm the production of the compounds. Physicochemical data refers to element analysis data, NMR data, melting point, boiling point, refraction rate, ultraviolet or infrared spectrum, viscosity, crystal type, color or the like. In case a specification fails to contain these data, the application was rejected on the grounds of (i) being an incomplete invention or (ii) failing to meet the description requirement.

The Patent Court decision is significant in that it somewhat relaxes the strict standard applied to all chemical compound inventions that are without physicochemical data. Here is an example. A patent application for novel chemical compounds was rejected by KIPO on the ground that the specification failed to meet the description requirement for a specification. In response, the applicant filed an amendment by incorporating physicochemical data on the claimed compounds, such as structural formulae, melting points and NMR data, into the specification. KIPO rejected the amendment on the ground that the incorporated physicochemical data constituted new matter. The issue was whether the physicochemical data later incorporated into the specification were essential to the confirmation of the production of the claimed compounds, in addition to the initial disclosure in the specification. The Patent Court found that the physicochemical data were not necessary since the production of the claimed compounds was confirmed from the initial disclosure based on the following: (1) chemical names and molecular formulae of substituents for the claimed compounds described in the specification can confirm structural formulae, molecular weights and chemical formulae of the claimed compounds; (2) the description "by crystallization" confirms that the compounds produced are in a solid state; and (3) reaction conditions and processes for preparing the claimed compounds are described in detail to be easily reproduced. The Patent Court has thus held that if the production of the claimed compounds can be adequately confirmed from the initial disclosure in the specification, adding such data to the specification does not constitute new matter.

Really Strict Description Requirement on Pharmacological Effect in Korea

In principle, the pharmacological effect should be described to such an extent that persons skilled in the art could clearly understand, recognize and reproduce the invention without any additional specific knowledge in the specification for a medicinal use invention at the filing stage. It is paramount to understand that under Korean patent practice the specification for pharmaceuticals or medicinal use inventions must quantitatively describe their pharmacological effects. The Korea Supreme Court specifically held that (1) if a pharmacological mechanism by which a certain pharmacological effect is provided has been clearly known, a simple description of the pharmacological effect would suffice; however, (2) in case such a pharmacological mechanism has not been known, the specification should include quantitative experimental data or the specific development of confirmation the pharmacological effect, i.e., when specific experiments were conducted, experimental methods, experimental results or the like, so that others could also confirm such a pharmacological effect.

For example, a new pharmaceutical composition with an enhanced anti-emetic effect in which the composition comprises two known anti-emetic agents, i.e., ondansetron and dexamethasone was claimed but the specification only described in connection with the pharmacological effect of the claimed composition that “the anti-emetic properties of one anti-emetic agent (i.e., ondansetron) are enhanced by administering with the second anti-emetic agent (i.e., dexamethasone).” No quantitative data supporting the enhanced effect was included in the original specification. The application was finally rejected on the ground that the specification violated the description requirement and that the claimed invention had not been completed.

Furthermore, it is not permitted to add quantitative pharmacological data to the specification through an amendment during prosecution. For example, there was a real case that an applicant submitted a declaration which was prepared before the application filing date, describing experimental data supporting the synergistic effect of the composition during the examination and trial proceedings. In that case, KIPO and the Patent Court did not allow the applicant to add data based on the ground that the addition of experimental data is new matter to the specification. Therefore, it is required to have such data or descriptions contained within the original specification at the filing stage.

Pfizer v. Hanmi re: Infringement Litigation on Viagra Trademark for Diamond Shape and Blue Color in Korea

Pfizer’s blockbuster drug, Viagra tablet has known worldwide for its blue color and diamond shape. Right after expiry of a compound patent in Korea, many Korean companies launched generic versions of Viagra in local market. Among them, in particular, Hanmi Pharmaceutical decided to adopt their product’s shape and color as similar as possible to the original drug Viagra. As a result, Hanmi’s generic pill has almost a carbon-copy design with blue color and diamond shape with round edges. Through such a good price and clever marketing strategy, Hanmi could take nearly half the market in about 5 months after Pfizer's patent lapsed.

As an anticipated course, Pfizer filed a trademark infringement lawsuit against Hanmi but lost the first instance case. Pfizer appealed to the Seoul High Court and won the second instance case. Hanmi appealed the case to the Supreme Court late last year.

Pfizer obtained a trademark registration for Viagra’s diamond shape with blue color on February 17, 2005. (Korean TM Reg. No. 608,773) Hanmi contended that any diamond shape and blue color for drug tablets is common or conventional and thus does not have distinctiveness. Also Hanmi’s products have their own Trademark on the surface of tablet and on their package. The package is totally different from Viagra’s.

Hanmi argued that there is no likelihood of confusion between Viagra and Hanmi’s generic drug because (1) two products have their own TMs respectively on product itself as well as its package; (2) the subject drug must be distributed through doctor’s careful prescription and pharmacist’s delivery; (3) Hanmi used the diamond shape and blue color as design elements for drug tablets; and (4) such a diamond shape with blue color has been applied to drug tablets conventionally.

The Seoul Central District Court agreed with Hanmi’s arguments. However, on October 17, 2013, the Seoul High Court reversed the lower court’s decision and held that Hanmi infringed Viagra’s registered TM in diamond shape and blue color. The High Court held that the diamond shape with blue color had become a famous TM and there is likelihood of confusion about source of products having the same shape and color even though they have further TM on their surfaces and packages.

Hanmi appealed the decision to the Supreme Court. The case is pending. Pfizer has not brought the second lawsuit for damage compensation yet.