眾律國際法律事務所

專利法中提到的生物相關發明，並非指所有的生物或任意形式的生物生產方法，而是必須依專利法第24條所規定，將動植物、生產動植物的主要生產方法、人類或動物之診斷、治療或外科手術方法以及妨害公共秩序或善良風俗者排除在外。

專利法於83年修正時，刪除了有關微生物不予發明專利的規定，自此微生物可作為發明專利的標的，但因學術界和專利法中界定的「微生物」定義略有不同，為避免爭議，便將「生物材料」一詞引進專利法。

生物材料是指包括遺傳訊息，並可自我複製或於生物系統中複製的物質。專利法中所指的生物材料包括載體、質體、嗜菌體、病毒、細菌、真菌、動物細胞株、植物細胞株、動物組織培養物、植物組織培養物、原生動物、單細胞藻類等等。除了生物材料本身之外，與生物材料相關的方法或利用生物材料的發明，亦可作為發明專利申請的標的。

不同於其他領域的發明，有關生物材料或利用生物材料之發明，若生物材料為該發明不可或缺的部分，且所使用的生物材料並非該發明所屬技術領域中具有通常知識者容易取得者，使得該發明所屬技術領域中具有通常知識者無法據說明書中所揭露的內容以及通常知識據以實現該發明，則申請人須依專利法第27條的規定，將該生物材料寄存於專利專責機關指定的國內寄存機構。應寄存生物材料而未寄存者，可視為違反專利法第26條第1項之規定「說明書應明確且充分揭露，使該發明所屬技術領域中具有通常知識者，能瞭解其內容，並可據以實現。」而不予專利(註[1])。

「專利連結」（patent linkage）概念上係指將學名藥（generic drug）的上市審查程序，與其參考的原開發藥廠藥品（the originator reference product）的專利權利狀態連結（patent-registration linkage）在一起；進一步言，一旦首個新藥通過藥物主管機關的審查上市後，只要在該新藥相關的專利有效期間，主管機關不應核准該新藥之仿製藥品上市。在藥品上市審查之過程中連結到專利權利狀態之目的，係為確保學名藥不得在原開發藥廠之專利到期前上市，同時藉此降低學名藥一旦於上市後被控侵權敗訴，因藥品回收銷除且不得繼續販賣製造的結果，反而造成藥品供給面的問題，影響病患用藥之權益[1]。

2010年間，美國國會即通過Biologics Price Competition and Innovation Act of 2009 （BPCIA法案），規範生物相似藥（biosimilar）監管措施與上市程序，期達降低藥價並促進市場競爭之目的[2]。有別於Drug Price Competition and Patent Term Restoration Act of 1984（即Hatch-Waxman法案），BPCIA法案所採措施為生物相似性藥品申請人（biosimilar applicant）與生物藥品發起人(reference product sponsor），在訴訟開始前，在保密情況下，進行相互交換產品和專利資料的程序，通稱為專利舞蹈(Patent dance)。

[1] 黃慧嫺(2009), 專利連結(Patent Linkage)－藥品研發與競爭之阻力或助力？談藥品查驗登記程序與專利權利狀態連結之發展(上),科技法律透析,第21卷第2期
[2] http://www.pitdc.org.tw/member/knowledge/knowledge.asp?id=579
[3] http://www2.itis.org.tw/ITRIWeb/News.aspx?sqno=2&nsqno=54
[4] http://www.pharmacompliancemonitor.com/bpcia-patent-dance-waiting-music-begin/8352/
 

一、前言
隨著科技進步與醫學的發展，人工生殖技術的進步，為求子多年的不孕夫妻帶來希望。為健全人工生殖的發展，保障不孕夫妻、人工生殖子女與捐贈人之權益，維護國民之倫理與健康，於民國96年3月21日公布施行人工生殖法。因代理孕母是否開放議題在當時社會未達成共識，致與代理孕母相關之部分未通過立法。然而，代理孕母的存在仍有一定的社會需求，代理孕母是否合法化的議題，近來再度被拿出來討論[1]。本文僅就98年度竹簡字第281號判決內容，加以整理。

二、案例事實簡化
甲與乙原互不認識，經丙介紹，始知乙因不孕而欲請人幫忙擔任孕母，原告自認身體尚稱健康，曾有生產經驗，願收費幫忙乙達成心願，遂96年12月於由乙指定之醫師將乙與其夫丙之受精卵植入原告體內，惟不久即告流產，該次孕母報酬，乙已陸續支付完畢。
甲於97年1月間與已約定在擔任代理孕母，且由乙按月給付2萬元做為報酬。惟植入胚胎後，不久確知懷有八胞胎，隨後經過數次減胎手術，甲之身體陸續發生不適狀況，甲於97年7月中下旬陸續分娩出胚胎，曾大量出血，僥倖撿回一命，惟嗣後仍因身體不適而就持續就醫，經醫師診斷為不孕症。甲身心受創，對乙事後置之不理感到不平。遂而起訴請求乙給付約定之報酬。

三、主要爭點
甲乙間約定由甲受植入乙之受精卵代乙懷孕生子（即代理孕母），並由乙給付報酬予甲之協議是否違反禁止規定或公序良俗(民法第71條或民法第72條)？
(一)甲主張
1.96年3 月21日公布之「人工生殖法」中就「代理孕母」並無明文禁止
2.從法哲學及憲法學之觀點切入，國家不應也沒有權力禁止代理孕母的施行（見顏厥安著，國家不應禁止代理孕母的法哲學與憲法學根據）

(一)前言
某地主甲早年喪妻，死後留下遺產五千萬，其嫁出去的女兒乙因生活困頓，表示希望能繼承遺產。遭到兄長丙反對，丙表示甲於乙出嫁時，聲明乙不得回娘家繼承其遺產，並有乙所簽寫之拋棄繼承書為證。丙認為乙是嫁出去的女兒，不應該再回娘家分產。請問乙可繼承甲之遺產嗎?

(二)相關法條
民法第1138條
遺產繼承人，除配偶外，依左列順序定之：
一、直系血親卑親屬。
二、父母。
三、兄弟姊妹。
四、祖父母。

民法第1145條

Due diligence is one of the procedure to investigate a business or person which normally occurs after the parties have decided to form an agreement but before a binding contract is signed.

Due diligence can be accomplished successfully by careful planning. Including the assessment of available resources, selection of management, estimation of risk, the recognition of the consequences of failure, definition of the deal’s scope, identification of possible obstacles to deal with and all of which lead to the crucial decisions essential to produce the results one wants to achieve.

Many investors, investment funds and lending institutions have essential criteria for business that they will invest. An overview of the business gained from the basic information enables an investor to plan the due diligence. All financial information, both public and private, constitutes the most basic information studied in due diligence. Such criteria includes financial ratios, historical earnings, projected earning potential, tangible book value in relation to price, type of business and quality management. These criteria give an indication of what investors hope to get for their money, such as income to offset losses, increased market capability or new facilities.

While planning the scope and nature of a due diligence, an investor must implement a risk assessment to determine the degree of business and legal risk that he/she will accept. Scope in this context includes the depth of questioning on any subject and the quantity of original documents to be reviewed. Nevertheless, well-run due diligence program cannot guarantee success for investors.

When an investor seriously considers a business opportunity, a list of information and documents may be required to contain all essential data yet avoid the superfluous. Due diligence will be involved in almost every aspects of business transactions and all business persons, including the professionals representing them or be involved in the transaction. It is crucial to conduct proper due diligence or otherwise could lead to other implications, such as liability to third parties or criminal liability. Additionally, any persons such as attorneys, accountants, broker/dealers, appraisers and other professionals may also find themselves being sued by their clients or by third parties not conducting a proper due diligence.

Questions to be asked:

1. What is the legal name of the business?

2. What is the address, telephone and FAX number of the business’s headquarters and/or the owner?

3. What are the names, telephone numbers and addresses of the principals involved in negotiating this transaction?

4. Review the following documents:

日前報載國內C型肝炎患者因新藥價格過於昂貴，自海外申購學名藥，甚有代購業者協助代辦。以下簡單介紹何謂原廠藥?何謂學名藥?個人輸入自用藥品申請、及代購業者可能涉及的法律規範。

(一) 原廠藥與學名藥

(1)原廠藥：原開發公司之母廠或子廠所生產之同一成分、劑型及劑量之產品，或具有原開發公司以書面授權在本國委託製造或共同販售，且在授權期間所產、售之同一成分、劑型及劑量之產品。

(2)學名藥：依「藥品查驗登記審查準則」第4條第2款之規定，係指與國內已核准之藥品具同成分、同劑型、同劑量、同療效之製劑。又名為非專利藥，是指原廠藥的專利權過期後，由合格廠商依照原廠藥申請專利時所公開的資訊，生產製作相同化學成分的藥品，即以相同方式複製該藥品[1]。

由於原廠藥經過研發及臨床試驗階段，投入相當龐大的資金及人力，因此到消費者端的價格通常較昂貴。而學名藥於專利期過後，藥廠利用原廠專利藥申請專利時所公開的資訊，生產相同成分的藥品，因此學名藥的成本較原廠藥低廉，消費者取得的價格自然也比較便宜。

(二) 個人輸入自用藥品申請

依據衛生福利部食品藥物管理署，個人輸入自用藥品規範專區所提供的資料[2]，C肝病患欲從海外購入個人自用藥品，須依據藥品樣品贈品管理辦法第2條第4款、第4條、第14條規定辦理。填寫貨品進口同意書及備齊相關附件(如：身分證影本、國際包裹招領單或海關提單影本、貨品外盒、說明書(仿單)或目錄、醫院出具之診斷證明書及處方、個人自用切結書)，向食品藥物管理署提出申請進口同意文件，再憑該進口同意書辦理通關事宜。

(三)代購業者

代購業者若不具藥商資格，依藥事法第27條規定，沒有藥商執照不得販售相關藥品，違者依藥事法第92條規定處新臺幣三萬元以上二百萬元以下罰鍰。若代購業者不具藥商資格，在醫院廣告兜售藥物，依藥事法第65條規定，違者依藥事法第91條規定處新臺幣二十萬元以上五百萬元以下罰鍰。

參考資料:

一、前言

乙居住的公寓大廈，欲成立管理委員會，籌組程序是否因該公寓大廈之建造執照取得的時間點在公寓大廈管理條例施行前後而有所不同?

二、籌組程序

依公寓大廈管理條例(下稱本條例)成立管理委員會籌組程序[1]，如下:

(一)依規定召開區分所有權人會議

(1)新建公寓大廈:本條例第28條之規定，由起造人代表擔任召集人，起造人應於三個月內召集區分所有權人召開區分所有權人會議。

(2)本條例施行前已取得建造執照之公寓大廈:依本條例第55條第1項之規定，其區分所有權人應依第二十五條第四項規定，互推一人為召集人，並召開第一次區分所有權人會議。

(二)決議籌組管理委員會的組織規範

依本條例第31條之規定，區分所有權人會議之決議，除規約另有規定外，應有區分所有權人三分之二以上及其區分所有權比例合計三分之二以上出席，以出席人數四分之三以上及其區分所有權比例占出席人數區分所有權四分之三以上之同意行之。

(三)依組織規範成立管理委員會

一、前言

甲在中南部有連棟透天厝一戶，平日素來熱心公益，為提升居住品質，欲依公寓大廈管理條例之規定成立管理委員會加強透天厝周邊的管理維護。於此情況，是否能成立管理委員會?

二、相關規定

公寓大廈管理條例乃為加強公寓大廈之管理維護，提昇居住品質，所制定的特別法。對於建築物的型態並無限制，然而是否符合公寓大廈的定義，依公寓大廈管理條例第三條第一款之規定，係指構造上或使用上或在建築執照設計圖樣標有明確界線，得區分為數部分之建築物及其基地。又按內政部九十二年五月十五日台內營字第○九二○○八五八○六號函示說明「公寓大廈之定義公寓大廈管理條例第三條第一款定有明文，依該條款規定，在構造上或使用上或在建築執照設計圖樣標有明確界線加以認定，惟其是否為公寓大廈尚需同時具有『得區分為數部分之建築物及其基地』之要件。至建築物之登記型態，如為同一建號，屬同一權利主體所有，已非屬區分所有建物，自無共同使用部分者，即無區分數部分之情形，應非屬公寓大廈，自無公寓大廈管理條例之適用。」

三、小結

若甲的透天厝如經地方主管建築機關依公寓大廈管理條例第三條第一項規定認定，應非屬公寓大廈者，自無公寓大廈管理條例之適用，亦無成立管理委員會必要之建築物。反之，若甲的透天厝，該集合住宅如經地方主管建築機關依公寓大廈管理條例第三條第一項規定認定，應屬公寓大廈者，應依公寓大廈管理條例第二十九條第一項之規定應成立管理委員會或推選管理負責人。(內政部93.2.24內授營建管字第0930082158號函參照)

因此，甲須先請地方主管建築機關認定甲的透天厝建築物是否屬公寓大廈，若該住宅經地方主管建築機關依法認定應屬公寓大廈者，則可適用公寓大廈管理條例之規定，成立管理委員會。

Compensation for improper caveat[1]

Pursuant to s 130(1) of the Land Title Act 1994, a person who lodges or continues a caveat without reasonable cause must compensate anyone else who suffers loss or damage as a result. Section 130(2) of the Land Title Act 1994 specifically provides that a court of competent jurisdiction, when determining the compensation in such a proceeding, may include a component for exemplary damages. It is presumed that a caveat has been lodged or continued without reasonable cause until the person who lodged or continued it proves that there was reasonable cause (s 130(3) of the Land Title Act 1994).[2]

This is because it might be proved later that the caveat is unmeritorious and the other party suffered financial loss because of the caveat.[3] There are two main ways by which a registered owner can remove the caveat: removal by application to the Registrar General and removal by order of the Supreme Court. Therefore, if the registered owner contests the caveat, the caveator must be prepared to incur legal expenses to defend his interest on the property. The removal of the caveat that is found to be lodged without merit may result also to compensation of legal costs incurred by the registered owner. Furthermore, if a party fails to prove his interest in the property he is forever precluded from lodging a caveat on the same property.

The party who is considering lodging a caveat must first seek legal advice. The need to protect one’s interest on a property must be balanced with the danger of being ordered to pay damages as a consequence of filling an unmeritorious caveat.

List of Sources:

1. Land Title Act 1994 (QLD) – current as at 1 December 2014 – revised version-Queensland legislation.
2. Secondary Resource: - accessed on 1^st August 2016
3. http://www.onerfamilylaw.com.au/Sites/2251/Images%20Files/FLNA%20caveat%20article.pdf>
3. Secondary Resource: Aussie Divorce Est. 2005 - accessed on 1^st August 2016
4. http://www.aussiedivorce.com.au/familylawinformation/lodging-a-caveat-on-matrimonial-real-property.html>
4. Land Title Practice Manual  - Department of Natural Resources and Mines – accessed on 1^st August 2016 –

<https://www.dnrm.qld.gov.au/__data/assets/pdf_file/0003/97149/ltpm-part-11.pdf >

Case Law Persons Who May Lodge a Caveat

A Person Claiming an Interest in a Lot

What Happens after a Caveat is lodged?

1. Notification:  Once the caveat has been lodged, the registered owner will receive a letter from the Department of Natural and Mines advising that the caveat has been registered. The titles office will send notices to each person whose interests are affected by the lodgement of the caveat.[1] The registered owner’s consent is not required for the lodgement of a caveat.
2. Court Proceedings: Once the caveat has been lodged, court proceedings must be investigated to support your interest under the caveat.  These proceedings must be filed by you either:[2]

• Within 3 months[3] from the date the caveat is lodged; or
• Within 14 days[4] from receipt of a notice from the registered proprietor of the property under section 126 of the Land Title Act.

Once a caveat has been registered, and a Notice is not served by the registered owner as detailed above, then the caveat will remain in place, but only for three months. If property settlement matters are not resolved within that three month period, the only way to keep the caveat “alive” and registered against the property is to start Court proceedings for property settlement. Such proceedings must be commenced before three months have lapsed. Once that has taken place, the caveat will remain registered against the property indefinitely until both parties reach mutual agreement.

Removing a caveat[5]

Pursuant to s 127 of the Land Title Act 1994 or 389H of the Land Act 1994, a caveatee may apply at any time to the Supreme Court for an order that a caveat be removed. The caveat remains in force until the matter is determined by the court or the caveat is withdrawn.[6] A registered caveat may be withdrawn by the caveator by lodging a Form 14 – Request to Withdraw (s 125 of the Land Title Act 1994 or s 389G of the Land Act 1994). The Supreme Court may make the order whether or not the caveator has been served with the application, and may make the order on the terms it considers appropriate.[7]

Pursuant to s 128 of the Land Title Act 1994 or s 389I of the Land Act 1994, the Registrar may cancel a caveat upon receipt of a request to cancel if the Registrar is satisfied that:

• the interest claimed by the caveator has ceased or the claim to it has been abandoned or withdrawn; or

• the claim of the caveator has been settled by agreement or otherwise satisfied; or

• the nature of the interest claimed does not entitle the caveator to prevent registration of an instrument or document that has been lodged.

The Registrar must notify the caveator of the Registrar’s intention to cancel the caveat at least seven days before it is cancelled (s 128(2) of the Land Title Act 1994 or s 389I (3) of the Land Act 1994). If no response is received within seven days, the caveat will be cancelled. If an instrument or document that has been lodged will, on registration, give effect to the interest claimed in the caveat, the Registrar may remove the caveat immediately before registering the instrument (s 128(3) of the Land Title Act 1994 or document s 389I (4) of the Land Act 1994).

Lapsing a Caveat[8]