The Korean Supreme Court Case - "The phrase 'consisting essentially of' cannot be used in the claims"(Case No. 2007hu1442, decided on October 11, 2007)

During the prosecution of Korean Patent Application No. 1999-7002853 titled "[I]solated nucleic acid molecule encoding cancer associated antigen, the antigen itself, and uses thereof," one of the claims, which is directed to an isolated nucleic acid molecule that encodes a cancer associated antigen, the complementary sequence of which hybridizes to the nucleic acid molecule having a particular nucleotide sequence, has been amended to an isolated nucleic acid molecule which encodes a cancer associated antigen, the complementary sequence of which hybridizes to the nucleic acid molecule consisting essentially of a particular nucleotide sequence. In the Argument, the applicant maintained that "consisting essentially of" occupies a middle ground between "comprising" and "consisting of" and that it excludes additional unspecified ingredients which would affect the novel characteristics of the claims; further, it allows some "reading on" additional unspecified substance. However, the KIPO finally rejected the application.

In the appeal to the Korean Intellectual Property Tribunal (KIPT), the Tribunal affirmed the rejection holding that: "The claims are not clear because the location, dimension, or details of unspecified ingredients, which do not affect the novel characteristics of the element, are not described and the hybridization condition, alone, is not sufficient to identify the unspecified sequence. Although an English wording is added in parentheses it does not render the claims clear."

The applicant filed an appeal with the Patent Court. The Patent Court stated that the U.S. standard for constructing claims cannot be applied to the Korean practice because the legal systems of the U.S. and Korea are not the same. However, it held that the expression "consisting essentially of" is not unclear by explaining that it is an expression emphasizing "consisting of."

The Korean Supreme Court reversed the Patent Court decision and held that:
"[a]s a result of the addition of the word 'essentially' to a claim, which must be defined only the features indispensable for the construction of the invention, it is not clear whether it means that 'the element consists essentially only of the nucleotide sequence recited in the claim' or it means that 'it includes elements recited in the claims and allows an addition of other elements.' The applicant seems to consider the semi-open format of 'consisting of' during the prosecution, and later he maintained that it means 'consisting of.' The English wording 'consisting essentially of,' which is put in parentheses and follows the Korean wording, renders the unclear Korean wording more unclear."

Huge Reduction in Patent and Utility Model Registration Fee

As of January 1, 2008, the Korean Intellectual Property Office (KIPO) decided to hugely reduce the registration fee for patent and utility model. An average reduction of 11 % will be expected in the patent and utility model registration fees (year 1 through 3) and yearly maintenance fees (year 4 through 9). It is estimated that the reduction will help the patent owners in saving, as a total, approximately 11.4 billion Won.

Patent Trial Decision Processing Time will be reduced to within 6 months

According to the KIPO, the total number of patent and utility model trial filing (such as, trials against ruling of refusal or invalidation trials) was 10,867 at the end of November in 2007. This is an increase of 11% compared to last year. The KIPO had expected that the trial decision processing time will eventually be reduced to within 6 months at the end of 2007 through a steady decrease from 14 months in 2003, 12 months in 2004, 9.1 months in 2005, and 8.1 months in 2006.

The KIPO explained that they expect to reduce the trial decision processing time by way of increasing the number of trial examiners from 49 in 2005 to 99 in 2007 to expedite the issuance of patent trial decisions and making efficient improvements to the trial process and policy. Further, in 2007, the KIPO adopted "the intensive trial procedure" wherein both parties participate and sort out the main issues at an early stage for a swift judgment instead of a documentary examination and it will apply to all inter-party trials. By restricting unnecessary extensions of the trial due dates so as to cut off the intentional delay of the trial processing time and expanding the subjects of the preferential trials, the reduction of the trial decision processing time has been accomplished.

Examination Guideline for medical diagnosis technology has been revised

An invention relating to a medical diagnosis method may be patentable in Korea.

According to the revised guideline, an invention relating to a medical diagnosis method may be patentable if the method does not include a direct clinical diagnosis of a doctor. The KIPO also stated that the revision reflected an international trend that a medical diagnosis method excluding decision of a doctor can be patentable.

Under the former guideline pertaining to the medical field, an invention relating to a treating method and a diagnosing method for a human body was not allowed for patent because the patent could restrict a citizen's right from getting proper medical treatment.

180- Day Market Exclusivity to "First"Generic Drug that prevails in an infringement trial

The Korea Food and Drug Administration (KFDA) gave a presentation on the topic, 'plan to introduce the drug approval-patent connection system,' at the forum, "Strategies for drug patent disputes following FTA," that was held on November 30, 2007.

According to the plan, the patent holder of an original drug is informed within 7 days from the date an application for marketing approval for a generic drug is filed. The patent holder may file a patent infringement suit within 30 days from the notice.

A generic drug, the opposite concept of 'branded drug,' generally means a drug that is produced and distributed without patent protection. In a narrower meaning, a generic drug means 'a replica of the original drug whose patent has expired' and is equivalent to the original branded drug in terms of safety, route of administration, quality, performance and the use which is intended from the drug.

If the patent holder files a lawsuit against the generic developer, the production and import of the generic drug is restricted for a certain period of time as long as 12 months. However, in some exceptional cases, for example, if the patent of the original drug expires or if the generic drug is proved not within the scope of the patent, the generic drug can be produced or imported even during said period of time.

The plan also offers 180 days of market exclusivity to the "first" generic applicant who challenges a listed patent if there is a trial or judicial decision finding the patent invalid or not infringed by the generic drug.

Preventive Order can be requested against sale of a generic drug based on explicit plan for sale.

Recently, the Korean Intellectual Property Tribunal (KIPT) held that "[i]n case a generic drug is explicitly being planned for sale, although it is not being sold, it could be a subject of preventive order for infringement. Therefore, it could be subject to a trial to confirm the scope of right." (Case No.: 2007dang1221, decided on October 31, 2007)

As Kukje Pharmaceuticals went through the approval procedures for "Kukje Amlodipin" with the Health Insurance Review & Assessment Service, Pfizer Inc. filed for a trial on May 11, 2007 to confirm the scope of a right. Pfizer asserted that "Kukje Amlodipine is within the scope of patent related to Norvasc" in order to prevent Kukje's product from being put on the market.

In the past, such trials to determine the scope of right were dismissed if the subject invention was not being practiced.

However, the KIPT in this case held that if there was an explicit plan for sale, a trial to determine the scope of a right by patentee may be filed even before the commence of sale.

The KIPT reviewed as to the scope of right under the assumption that Pfizer's patent is valid, and an invalidation trial against Pfizer's patent regarding Amlodipine besylate is now pending in the Supreme court.

Patent Prosecution Highway Pilot Program between KIPO and USPTO commences on January 28, 2008.

The KIPO and the United States Patent and Trademark Office (USPTO) announced that a Patent Prosecution Highway (PPH) pilot program between the KIPO and the USPTO that will last for a period of one year will commence on January 28, 2008. The KIPO and the USPTO will evaluate the results of the pilot program to determine whether the program should be fully implemented after said period.

Under the PPH, an applicant who receives a patent allowance from either Office for the same invention filed in both offices may request for the PPH in the other Office. The website of the USPTO (http://www.uspto.gov/web/patents/pph/pph_kipo.html) provides information about the PPH.

Korean Language Added to the List of International Patent Publication Languages

The Korean language was formally adopted as an international patent publication language of the Patent Cooperation Treaty (PCT). In the 43rd WIPO general assembly held in Geneva, Swiss, the Korean language was added to the list of languages of publication for international patent applications by unanimous consent of the 183 member nations. Until now, the list of languages of publication included English, French, German, Japanese, Russian, Spanish, Chinese and Arabic. Korean and Portuguese have just been added to increasing the languages of publication to 10 languages.

Introducing HANYANG's new patent attorney, Hank Moon

Patent attorney, Moon, Hank, has joined Hanyang International starting this year as part of an effort to enforce client legal services.

Mr. Moon has a B.S. and M.S. from Yonsei University in Physics. He also finished Ph.D. coursework in the systems engineering field from Ajou University.

Mr. Moon worked for Samsung Electronics Co., Ltd. as a member of the process development team and a project leader of materials characteristics analysis team from 1988 to 1992. He also worked in the Institute for Advanced Engineering as a project leader of information and communication laboratory from 1993 to 1999. He taught in the University College at Yonsei university and also was an academic and career path advisor since 2000.

As an amateur marathoner, he published a book titled, "Journey into myself, Marathon." He also co-wrote the book, "Science newspaper from a historical viewpoint: Physics and Chemistry."