Kasan Insight :: 과학, 기술 그리고 법

- 제약/화학/바이오 분야의 실용적 법률정보와 해결방안

의료법인이 보건복지부를 상대로 과징금부과처분취소 소송 - 과징금 부과 조치에 앞서 위반행위를 조사했던 조사기관이 시정조치를 통해 추가적인 위반행위를 막을 수 있었는데도 이를 방치해 과도한 과징금이 부과된 경우 재량권을 일탈한 징계조치로 본 서울행정법원 판결

사안의 개요

건강보험공단: 2015년 8월 대상 병원의 급여비용 적정 청구 관련 위법사항 확인

보건복지부: 2016년 9월 대상 병원의 급여비용 적정 청구 여부에 대한 현지조사

조사 대상기간: 2015년 5월 ~ 2015년 7월, 2016년 5월 ~ 2016년 7월, 총 6개월, 2015년 8월 ~ 2016년 4월 총 9개월 조사대상기간에서 제외

보건복지부 제재처분: 2018년 4월 요양급여비용 부당청구에 따른 1억2790만원, 같은 해 7월 의료급여비용 부당청구에 따른 3345만원 등 합계 1억6135만원의 과징금 부과 처분

의료법인의 과징금 부과처분 불복 행정소송 제기 및 주장의 요지

보건복지부가 급여비용 부당청구를 현지 조사하는 경우 그 조사대상 기간을 1년으로 하거나 '2015년 5월부터 2016년 7월까지'로 하는 것이 합리적인데, 보건복지부는 이미 현지 확인을 통해 병원의 착오 청구가 확인된 2015년 7월은 조사대상기간에 포함하는 한편, 그 이후부터 2016년 4월까지의 기간은 조사대상기간에서 임의적으로 제외하여, 결과적으로 과징금 처분의 근거가 된 월평균 부당금액과 부당비율, 업무정지기간이 과도하게 산정한 것은 위법, 부당함.

서울행정법원의 판단 요지 – 재량권 일탈 남용 인정 + 과징금부과처분 위법, 취소 판결

“공단의 현지확인 시점은 2015년 8월 11일경인데 당시 병원의 2015년 7월분 급여비용은 청구만 됐을 뿐 건강보험심사평가원의 심사가 종료되지 않아 지급되기 이전이었다. 공단은 현지확인 후 병원의 2015년 7월분 급여비용의 지급이 이뤄지기 전에 그 청구를 철회하게 하거나 잘못된 급여비용 청구의 근거를 직접 시정하는 방법으로 급여비용의 부당지급이 이뤄지지 않도록 할 수 있었는데도 그렇게 하지 않았다.

보건복지부의 현지조사 대상기간은 현지조사 시행시기에 근접한 3개월을 제외하면 단 3개월에 불과해 위반기간인 1개월에 비해 지나치게 짧다. 보건복지부는 이 사건의 구체적 사정을 고려하지 않고 과도한 월 평균 부당금액과 부당비율을 산정함으로써 재량권을 적절히 행사하지 못했다.”

KASAN_의료보험 부당 청구로 인한 과징금부과처분 불복 행정소송 - 서울행정법원 2018구합70943 판결 조사기간 임의선택의 위법성 및 시정조치 없어 추가 위반기간 포함 과도한 과징금 부과는 .pdf

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당연 위법 사항 - per se illegal

► price fixing, ► output restraint, ► market division, ► group boycott, ► resale price maintenance

경쟁제한성과 합리성 판단 사항 - Rule of Reason 적용대상

Safeguards against the anticompetitive concerns 

► horizontal restraints

► tying arrangements (package licensing)

► exclusive dealing (territory, field of use, components, alternatives, etc.)

► cross-licensing and pooling arrangements

           . fair, reasonable and non-discriminatory terms and conditions

           . limiting to technically essential patents, not including alternatives

            . free to be licensed individually or in a package

            . worldwide non-exclusive

            . royalties on actual use of the patents

  . free to develop and use alternatives

           . grant back under non-exclusive, non-discriminatory licenses

  . no joint defense

► grant-back

► acquisition (exclusive licensing) of IPR

판단요소

1. Whether the restraint is likely to have anticompetitive effects?

2. Whether, under the relevant market context, the restraint is reasonably necessary to achieve pro-competitive efficiencies that outweigh anticompetitive effects?

Qualcomm 퀄컴 특허라이선스 계약의 불공정사항 수정 명령 - 미국법원 FTC v. Qualcomm 사건 2019. 5. 21. 선고 1심 판결 내용

(1) Qualcomm must not condition the supply of modem chips on a customer’s patent license status and Qualcomm must negotiate or renegotiate license terms with customers in good faith under conditions free from the threat of lack of access to or discriminatory provision of modem chip supply or associated technical support or access to software.

(2) Qualcomm must make exhaustive SEP licenses available to modem-chip suppliers on fair, reasonable, and non-discriminatory ("FRAND") terms and to submit, as necessary, to arbitral or judicial dispute resolution to determine such terms.

(3) Qualcomm may not enter express or de facto exclusive dealing agreements for the supply of modem chips.

(4) Qualcomm may not interfere with the ability of any customer to communicate with a government agency about a potential law enforcement or regulatory matter.

KASAN_기술이전, 특허라이선스 계약에서 공정거래법, Anti-trust & Fair Competition Law 관련 실무적 개요.pdf

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2017년 미 연방통신위원회(FTC)에서 퀄컴을 상대로 제기한 소송에서 2019. 5. 21. 퀄컴 패소 취지의 판결이 선고되었다는 뉴스입니다. 해당 판결문은 링크: 19-05-21 FTC v. Qualcomm Ju...에서 찾아볼 수 있습니다.

판결문에서 퀄컴의 특허 라이선스 및 판매 정책이 반도체 시장에서 경쟁을 저해하고, 휴대폰 제조업체와 경쟁회사뿐 아니라 소비자에게도 피해를 주었다고 판단하였습니다. 우리나라 기업들에게도 영향을 미칠 것으로 보입니다.

미국법원은 퀄컴에게 휴대폰 제조사들과 라이선스 계약을 전면 재협상해 가격과 판매 관행을 다음과 같이 변경할 것을 명령하고, 그 후 7년 동안 FTC로부터 그 이행여부 관련 모니터링을 받아야 한다는 의무까지 부과하였습니다.

FTC Act, and has ordered the following remedies:

(1) Qualcomm must not condition the supply of modem chips on a customer’s patent license status and Qualcomm must negotiate or renegotiate license terms with customers in good faith under conditions free from the threat of lack of access to or discriminatory provision of modem chip supply or associated technical support or access to software.

(2) Qualcomm must make exhaustive SEP licenses available to modem-chip suppliers on fair, reasonable, and non-discriminatory ("FRAND") terms and to submit, as necessary, to arbitral or judicial dispute resolution to determine such terms.

(3) Qualcomm may not enter express or de facto exclusive dealing agreements for the supply of modem chips.

(4) Qualcomm may not interfere with the ability of any customer to communicate with a government agency about a potential law enforcement or regulatory matter.

(5) In order to ensure Qualcomm's compliance with the above remedies, the Court orders Qualcomm to submit to compliance and monitoring procedures for a period of seven (7) years. Specifically, Qualcomm shall report to the FTC on an annual basis Qualcomm’s compliance with the above remedies ordered by the Court.

KASAN_미국 Qualcomm 퀄컴의 특허 라이선스 – 불공정거래행위로 판단한 미국법원 판결 뉴스 – 미국법원 FTC v. Qualcomm 사건 1심 판결.pdf

실무적 포인트

·         진술 및 보증 조항 Rep. & Warranty

Ø  소유권/license허여권 보증 (○)

Ø  계약대상 IP의 권리 유효성 보증 (적법 등록유지 ○, 절대적 유효성 ×)

Ø  제3자의 지재권 비침해 보증 (고의침해 ○, 기타 △)

·         면책 Indemnification

Ø  지재권 침해 claim시 면책규정은 license, 공동연구발 계약협상에서 쟁점이 많은 규정

Ø  특허를 제외한 copyright등 기타 권리에 대해서는 indemnification을 대부분 수용하는 편이나, 특허에 대해서는 면책보장의 수용이 어려운 경우가 많음. 

Ø  전세계 특허의 사전조사는 현실적으로 불가능하고, 고의적으로 copy한 경우가 아니더라도 유사성이 존재하는 한 침해를 구성  

Ø  반면, 저작권 등의 경우는 제3자의 저작물을 copy한 경우가 아니라면, 독자개발에 의해 발명/발견된 경우는 유사성이 존재하더라도 침해를 구성치 않음.  

Ø  고의침해 경우(punitive damage대상이 됨) - 무제한 배상 보장 가능

Ø  기타 지재권 침해 claim경우 - 지불금액 총액 한도내에서 합의가 합리적  

Ø  제외: - 허여 용도 외 사용, 제공기술/제품의 임의 수정, 제공 외 기술/제품과 결합, 합성 등으로 인해 침해가 발생한 경우         

계약조항 영문 샘플

23. INDEMNIFICATION; INSURANCE; LIMITATION OF LIABILITY. 

23.1 General Indemnification by Licensor. Licensor CyDex shall defend, indemnify and hold Licensee Hospira and its Affiliates and Sublicensees, and each of their respective directors, officers, agents and employees, harmless from and against any and all losses, judgments, damages, liabilities, settlements, penalties, fines, costs and expenses (including the reasonable costs and expenses of attorneys and other professionals) (collectively “Losses”) incurred as a result of any claim, demand, action or other proceeding (each, a “Claim”) by a Third Party, to the extent such Losses arise out of: (a) the manufacture, use, handling, promotion, marketing, distribution, importation, sale or offering for sale of Captisol by CyDex, its Affiliates or any of their agents, or (b) CyDex’s breach of this Agreement, including without limitation any of its representations and warranties set forth in Section 8, or (c) any negligent or willful misconduct by CyDex or its Affiliates or any of their respective distributors, officers, directors employees or agents, in each case to the extent that such Losses are not due to Hospira’s or any of its Affiliates’ or Sublicensees’, or any of their respective directors’, officers’, agents’ or employees’ breach of this Agreement or negligence or willful misconduct.

23.2 General Indemnification by Licensee. Licensee Hospira shall defend, indemnify and hold Licensor CyDex and its Affiliates, and each of their respective directors, officers, agents and employees, harmless from and against any and all Losses incurred as a result of any Claim by a Third Party, to the extent such Losses arise out of: (a) the manufacture, use, handling, promotion, marketing, distribution, importation, sale or offering for sale of the Finished Product by Hospira, its Affiliates and Sublicensees, or (b) Hospira’s breach of this Agreement, including without limitation any of its representations and warranties set forth in Section 8, or (c) any negligent or willful misconduct by Hospira or its Affiliates or any of their respective distributors, officers, directors employees or agents, in each case to the extent that such Losses are not due to CyDex’s or any of its Affiliates’ or any of their respective directors’, officers’, agents’ or employees’ breach of this Agreement or negligence or willful misconduct.

23.4 Procedure.

(a) The person intending to claim indemnification under Section 9 (an “Indemnified Party”) shall promptly notify the other party (the “Indemnifying Party”) of any Claim in respect of which the Indemnified Party intends to claim such indemnification, and a reasonable explanation of the basis for the Claim and the amount of alleged Losses to the extent of the facts then known by the Indemnified Party. (Notwithstanding the foregoing, no delay or deficiency on the part of the Indemnified Party in so notifying the Indemnifying Party will relieve the Indemnifying Party of any liability or obligation under this Agreement except to the extent the Indemnifying Party has suffered actual prejudice directly caused by the delay or other deficiency.) The Indemnifying Party shall assume the defense thereof; provided, however, that if the Indemnifying Party assumes the defense, the Indemnified Party shall have the right to employ counsel separate from counsel employed by the Indemnifying Party in any such action and to participate in the defense thereof, but the fees and expenses of such counsel employed by the Indemnified Party shall be at the sole cost and expense of the Indemnified Party unless the Indemnifying Party consents to the retention of such counsel or unless the named parties to any action or proceeding include both the Indemnifying Party and the Indemnified Party and a representation of both the Indemnifying Party and the Indemnified Party by the same counsel would be inappropriate due to the actual or potential differing interests between them. And provided further that, if the Indemnifying Party shall fail to assume the defense of and reasonably defend such Claim, the Indemnified Party shall have the right to retain or assume control of such defense and the Indemnifying Party shall pay (as incurred and on demand) the fees and expenses of counsel retained by the Indemnified Party.

(b) The Indemnifying Party shall not be liable for the indemnification of any Claim settled (or resolved by consent to the entry of judgment) without the written consent of the Indemnifying Party (which shall not be unreasonably withheld or delayed). Also, if the Indemnifying Party shall control the defense of any such Claim, the Indemnifying Party shall have the right to settle such Claim; provided, that the Indemnifying Party shall obtain the prior written consent (which shall not be unreasonably withheld or delayed) of the Indemnified Party before entering into any settlement of (or resolving by consent to the entry of judgment upon) such Claim unless (A) there is no finding or admission of any violation of law or any violation of the rights of any Third Party by an Indemnified Party, no requirement that the Indemnified Party admit fault or culpability, and no adverse effect on any other claims that may be made by or against the Indemnified Party and (B) the sole relief provided is monetary damages that are paid in full by the Indemnifying Party and such settlement does not require the Indemnified Party to take (or refrain from taking) any action.

(c) Regardless of who controls the defense, the other party hereto shall reasonably cooperate in the defense as may be requested. Without limitation, the Indemnified Party, and its directors, officers, advisers, agents and employees, shall reasonably cooperate with the Indemnifying Party and its legal representatives in the investigations of any Claim.

23.5 Insurance. CyDex will procure and maintain, at its own expense, for the duration of the Agreement, and for [*] thereafter if written on a claims made or occurrence reported form, the types of insurance specified below with carriers rated [*]. Best or like rating agencies:

  a. Workers’ Compensation accordance with applicable statutory requirements and shall provide a waiver of subrogation in favor of Hospira; 

  b. Employer’s Liability with a limit of liability in an amount of not less than $[***]; 

  c. Commercial General Liability including premises operations, products & completed operations, blanket contractual liability, personal injury including fire legal liability for bodily injury and property damage in an amount not less than $[***]; 

  d. Commercial Automobile Liability for owned, hired and non-owned motor vehicles with a combined single limit in an amount not less than $[*];  

  e. Excess Liability including product liability with a combined single limit in an amount of not less than $[*]; 

  f. Commercial Crime or Fidelity Bond in an amount of not less than $[*] including an endorsement for Third Party liability without the requirement of a conviction. 

  g. Cargo Legal Liability insurance covering all risks of physical loss or damage to cargo handled by CyDex. The limit of liability shall not be less than $[*]. 

23.6 Limitation of Liability. EXCEPT FOR (1) PERSONAL INJURY, INCLUDING DEATH, (2) TANGIBLE PROPERTY DAMAGE, (3) EACH PARTY’S INDEMNIFICATION OBLIGATIONS, (4) DAMAGES ARISING OUT OF AN INTENTIONAL BREACH OF THE CONFIDENTIALITY OBLIGATIONS HEREIN, (5) DAMAGES ARISING OUT OF CYDEX’S BREACH OF SECTION 2.4, AND (6) DAMAGES FOR WHICH CYDEX IS RESPONSIBLE PURSUANT SECTION 3.6, 3.7 OR 6.4.

KASAN_특허실시, 기술이전, 라이선스 영문계약서에서 진술보증, 면책조항 관련 실무적 포인트 몇 가지 면책조항 INDEMNIFICATION, INSURANCE, LIMITATION OF LIABILITY 계약조항 샘플.pdf

KASAN_특허실시, 기술이전 라이선스, 공동연구개발계약에서 추가 연구개발 결과물, 개량발명 관련 계약조항 샘플, 법적 쟁점 및 실무적 대응방안 몇 가지.pdf

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