특허권자의 역지급화해에 대한 경쟁법의 적용 연구 (Applying Competition Law in the Context of Reverse Payments Settlements)

서지정보

· 발행기관 : 한국경영법률학회
· 수록지 정보 : 경영법률 / 26권 / 3호 / 405 ~ 456페이지
· 저자명 : 김두진

초록

제약산업에서 특허권자와 특허권의 침해자라고 주장되는 자 사이에 체결되는, 전자가 후자에 대하여 일정한 대가를 지급하는 협정에 대하여 ‘역지급화해’라는 용어가 사용된다. 여기에서 ‘역지급’이란 그 지급이, 통상의 권리침해에서의 그것과 상반되게, 피해자라 주장되는 특허권자로부터 침해자에게 행해지는 점에서 붙여진 이름이다. 역지급화해에 있어서, 브랜드 약품의 특허권을 보유하는 선두제약사는 복제약 제조사에게 복제약의 시장진입을 특정일까지 지연시키기 위하여 일정 대가를 지급한다. 따라서 역지급화해에 대하여 ‘지연을 위한 지급 화해’라는 용어도 사용되고 있다.
이 글은 특허권자의 역지급화해에 대하여 그 의의 및 산업적·법제적 발생배경을 고찰하고, 미국과 EU에서의 역지급화해 관행에 대한 경쟁법적용의 사례를 소개하며, 우리 공정거래위원회와 법원이 최근 글락소 그룹 사건에서 이 관행에 대하여 공정거래법을 적용함에 있어서 채택한 접근방법에 대하여 비판적으로 분석한 후, 장래에 우리 경쟁당국과 법원이 구체적인 특정 역지급화해 관행에 대하여 공정거래법을 적용함에 있어서 거쳐야 하는 지적재산권의 정당한 행사에 대한 공정거래법 적용면제의 관문에 대한 접근방법, 해당 관행의 부당한 공동행위로서의 위법성 판단기준 등에 관하여 제언하는 것을 목적으로 하는 것이다.
특허권자의 역지급화해는 발명과 혁신을 장려하여 소비자후생을 증대시키기 위한 지식재산권법과 독점금지법의 보완관계가 정립된 지식기반사회에서 지식재산권의 남용의 하나로서 경쟁법에 의하여 위법한 것으로서 규율되어야 하는 반경쟁적 사업관행일 수 있다. 예컨대, 해당 관행이 복제약의 진입을 지연시켜 시장의 잠재적 경쟁을 저해하며 결과적으로 소비자에게 보다 높은 가격을 지급하도록 하여 특허권자의 경쟁수준을 초과하는 위법한 착취남용을 가능하게 한다면 공정거래법이 적절히 발동되어 저지하여야 한다. 역지급화해는 종래 제약산업에서 시도된 관행이었다. 그러나 상품의 원료나 제조공정에 특허권이 부여되는 산업이라면 이론적으로 어떤 산업이라도, 마찬가지로 특허권만이 아니라 저작권과 같은 다른 지재권과 관련해서도 역지급화해가 이용될 가능성은 열려 있다. 그러한 경우 그 산업 및 지재권의 특성을 감안한 적절한 변용을 통하여 반경쟁적 역지급화해에 대한 경쟁법 적용이 행해질 수 있을 것이다.

영어초록

The term “reverse payment settlements (RPSs)” has been used as to characterize an agreements between patent holder and alleged infringers that involve a transfer of consideration from the patent owner to the alleged infringer. “Reverse payment” is so called because it is a payment by the alleged victim, the patent holder, to the alleged patent violator. In RPSs, the originator companies who have patent or patents for brand-name pharmaceutical product pay the generic manufacturers to delay entry into the market until a specific future date. So the term “pay-for-delay settlements” is also used to refer to RPSs. RPSs may allow invalid or weak patents to restrict competition unfairly. By restricting competition, RPSs may often significantly increase consumer prices for pharmaceutical drugs and allow the settled parties share resulted supercompetitive profit. The purpose of this article is to discuss which approach should be properly applied to the RPSs under the competition law. For that ends, in Part II of this Article, the meaning of the RPSs and pharmaceutical sectoral background are observed.
Part Ⅲ of this Article looks into the experiences of applying competition law to the RPSs in U.S. E.U. and South Korea. On June 17, 2013, the U.S. Supreme Court decided FTC v. Actavis, Inc., et al., 133 S.Ct. 2223, holding that the parties entering into RPSs may have antitrust liability if the payments are designed to delay competition between a brand-name and a generic pharmaceutical manufacturer. Under this ruling, the Supreme Court ordered lower courts proceed by applying the “rule of reason,” rather than under a “quick look” approach to reverse payment settlements, independent of examinations of the validity of the relevant patents. And On June 19, 2013, the European Commission also decided that Danish pharmaceutical company Lundbeck and other generic companies settled for delaying market entry of generic medicines and their RPSs violated EU competition rules that prohibit anticompetitive agreements (Article 101 of the Treaty on the Functioning of the European Union). On December 23, 2011, the Korea Fair Trade Commission (hereinafter “KFTC”) made a Decision (No. 2011-300) that the RPS between Glaxo Group Ltd. and GlaxoSmithKlein (hereinafter “Glaxo Group”) and Dong-A Pharm Co. condemned as an unfair collaborative act under the Korea Monopoly regulation and the Korea Fair Trade Act (hereinafter “Fair Trade Act”). On February 27, 2014, the Korea Supreme Court also decided Glaxo Group v. KFTC, 2012Du24498 upholding the Seoul High Court’s decision that the parties of the RPS violated the prohibition of unfair collaborative acts but reversing the part of the judgment of the lower court because of its failure of requiring the KFTC to fix the structure of the RPS in that case.
In Part Ⅳ, I discuss on the general exemption from the Fair Trade Act. The article 59 of the Fair Trade Act provides that the Act shall not apply to any lawful acts which is deemed as an exercise of the right under the intellectual property law, such as the Patent Act. The rationale of article 59 is the exemption intent of the Parliament in virtue of intellectual property policies for promoting inventions and innovations, meaning that the Fair Trade Act should apply to the abuse of the IP but does not apply to lawful exercise of it. So I suggest that whether the exercise of the IP is lawful or abused should be reviewed not through the eye of competition law but under the viewpoint of the IP law. And the RPS at issue passes this threshold, then whether it violates the prohibition of unfair collaborative act under the article 19(1) of the Fair Trade Act should be reviewed. Part Ⅴ analyses how to find and prove the illegality of RPSs under the Fair Trade Act, observing the commentators’ discussion and the lower courts’ approach to that issue after the FTC v. Actavis case in U.S.A. To encourage competitive markets to promote consumer welfare, the structured and circumscribed rule-of-reason approach will be the most adequate approach we can choose, given the degree of anticompetitiveness of the RPSs and efficient antitrust enforcement. In that approach, the KFTC as plaintiff should prove the character of the settlement, its potential anticompetitive effects through the reverse payment’s size, its percentage to the payer’s anticipated future litigation costs, its independence from other services for which it might represent payment, and the burden of providing any other convincing justification should be shifted to the defendants.
Lastly in Part Ⅵ, I conclude by summarizing my observations and suggesting brief policy suggestions that follow from my analysis.

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