眾律國際法律事務所

Abuse of Dominance in the EU Competition law (Article 102 TFEU)

As mentioned in previous articles, competition law exists to ensure competition in a free market and is believed to bring efficiency, low prices and innovation. Article 102 of the Treaty on Functioning of the European Union (TFEU), together with Article 101 TFEU, promotes this competitiveness and are meant to prevent anti-competitive behaviour. In particular, a company can restrict competition if it is very strong on a given market. A dominant position is not itself anticompetitive, but if the company exploits this position to eliminate competition its behaviour can be considered abusive. The Article states:

Any abuse by one or more undertakings of a dominant position within the internal market or in a substantial part of it shall be prohibited as incompatible with the internal market in so far as it may affect trade between Member States.

Therefore, for Article 102 to be applicable four requirements must be met: (1) one or more undertakings must be in a dominant position, (2) such position must be held within the common market or substantial part of it. (3) There must be abuse, and (4) this must have an effect on inter-State trade.

Definition of ‘Dominant Position’

In one of the most important ‘abuse of dominance’ cases, Hoffman-La Roche, the European Court of Justice gave the definition of dominant position: “[The dominant position] relates to a position of economic strength enjoyed by an undertaking, which enables it to prevent effective competition being maintained on the relevant market by affording it the power to behave to an appreciable extent independently of its competitors, its customers and ultimately of the consumers”. The process employed by the Commission to assess dominance of a undertaking follows a two-stage procedure:

1. Evaluation of the market on which the undertaking is operating (‘the Relevant Market’). Competition takes place on markets, so that’s why it is necessary to determine the behaviour and status of the undertaking in the ‘relevant market’. In order to define it, the Commission has to define:

• Product/Service Market. Refers to the material scope of the market, the main products or services delimiting the relevant market.
• Geographic Market. A geographic delimitation is also necessary to define the relevant market (which may be EU-wide, national or even local).
• Temporal Market. It is less important, but it can also influence the relevant market and market positions.

2. The undertakings position on this particular market. Once the relevant market has been determined, the Commission must decide at what point the undertaking has sufficient power over this market to be considered as “dominant”. Generally, market share is the principal element to assess dominance, since only companies which have won a large part of one market can be deemed to be in a dominant position. Usually, a company is unlikely to be dominant if it has a market share of less than 40%.  However, market share is not determinative and other factor indicating dominance can also be taken into account, such as the existence of any barriers to entry and the extent of any countervailing buyer power.

Definition of ‘Abusive Conduct’

As mentioned above, holding a dominant position is not itself unlawful. However, where a company has a dominant position, it will be in breach of the EU competition if it “abuses” of that position. Article 102 includes a non-exhaustive list of examples of abusive conduct:

• directly or indirectly imposing unfair purchase or selling prices or other unfair trading conditions;
• limiting production, markets or technical development to the prejudice of consumers;
• applying dissimilar conditions to equivalent transactions with other trading parties, thereby placing them at a competitive disadvantage;
• making the conclusion of contracts subject to acceptance by other parties of supplementary obligations which, by their nature or according to commercial usage, have no connection with the subject of such contracts.

生技專利說明書之撰寫 實質篇(四)／黃怡然律師
五、專利要件
生物技術專利於專利要件上，須注意之處：
(一)產業利用性
應具體說明在產業上如何利用，不能僅想當然耳羅列其功能，舉例如下：
1.蛋白質除說明其活性外，要具體說明用途。例如：具有分解脂質之活性的蛋白質X，可做為預防心血管疾病的保健用途，應用於健康食品中。而不能僅描述其有分解脂質之功能。
2.專利請求項為分離血液中特定蛋白質之方法，應說明分離出該蛋白質可以檢測某項疾病，或做為某種指標之用。而不可僅提及該特定蛋白質名稱。
3.經重組改造的特定cDNA片段，可大量產生某種蛋白質，該蛋白質可用於治療改善某種疾病。
(二)新穎性
生物技術發明於新穎性之特殊判斷舉例：

前面稍微介紹了「擬制喪失新穎性」的概念以後，本篇將會開始討論擬制喪失新穎性的一些形式要件以及注意事項。若發現審查意見並沒有依循此些規定的話，就可以據此跟審查委員爭執先前技術不能使用，作為答辯的手段之一。

首先，讓我們來看看擬制喪失新穎性的形式要件。

在經過反覆的校稿以及討論以後，事務所終於把專利送進專利局後，事情並沒有就此告一段落。約莫一年半載以後，申請人就會開始收到官方發給的審查意見。審查意見會列舉一些審查委員認為相近的前案（引證資料），意見書會指出此些引證資料單獨或是結合起來就跟申請案的全數技術內容一樣。

但，稍等一下，在埋頭研究這些前案之前，筆者建議稍微先稍微分神看一下是否這些引證文件真的可以用嗎？（比較專業的說法就是，這些引證資料是否具有適格性）如果審查委員引用這些文件不合法，那即便這些前案內容與申請案激似也不構成威脅。

一般而言，所謂的引證資料需要符合申請前已公開且能為公眾得知之訊息此項條件[註1]。簡單來說，這些資料公開、發表的時間需要早於申請案的申請日才可以拿來引用。但有一個例外情況，我國專利法為了避免將相同發明或新型先後授予專利的情況，特別法律擬制（legal fiction）[註2]將申請在先公告在後的先申請案也納入新穎性的考量之中。實務上稱此作法為擬制喪失新穎性。簡單來說，法律上規定審查新穎性的時候申請在前公開在後的前案也視為申請案的前案之一。

還是有點不懂嘛？來一起看看下方圖式。

三、不符合可據以實現要件之情形舉例

授予專利權的三要件(或稱專利三性)為產業利用性、新穎性、進步性，但除此之外，尚有一項重要的要件必須符合，即是「可據以實現要件」。這個要件的內涵為希望透過說明書的充分揭露，使相關領域之技術人員能瞭解內容並據以實施專利。

以下情形將會遭智財局判定為「不符合可據以實現要件」，撰寫說明書時應盡量避免類似情況發生：

1. 申請專利之DNA片段過長，除具標的功能之基因外，其餘無關之片段夾雜其中：此情況可能導致實施專利者須經「過度實驗」方能篩選出有標的功能之片段，即為所謂「不符合可據以實現要件」。
2. 申請專利的化合物是經由隨機篩選之方式得來，而非於確知其活性或作用機制後分析而來：實施專利者若須經由大量實驗、隨機產生的方式才能得到該產物，亦被認為不符合可據以實現要件。
3. 說明書未提供該生物方法可重複實施之證據，或該方法之結果並不穩定：「可據以實現要件」的基本精神即是希望節省實施專利者的時間，使其不必大量重複實驗，故若方法本身再現性太低，即不得已此申請專利。

四、請求項不能為說明書所支持之情形舉例

說明書必須詳盡至「可作為專利實施者的操作protocol」，所謂請求項不能為說明書所支持，簡而言之就是說明書說明不足的情況，亦須盡量避免：

(一)未揭露申請專利DNA片段之的調節元件(如promoter, enhancer)以及未轉譯區域。

(二)僅揭露cDNA全長，未提供其open reading frame (ORF)資訊，無法得知其與蛋白質產物之關聯。

(三)未提供雜交(Hybridization)的條件。須詳細至溫度及buffer濃度等，例如：6倍SSC，65℃。

(四)專利請求項為蛋白質變異體(原本之胺基酸序列發生取代、刪除、插入或加入其他胺基酸)時，須明確表示究為何種變異方式，亦需說明具體的變異實例，不能籠統的以「蛋白質變異體」略之。

Application of article 101 TFEU: anticompetitive agreements

Article 101 of the Treaty on the Functioning of the European Union (TFEU) prohibits anticompetitive agreements, which are:

All agreements between undertakings, decisions by associations of undertakings and concerted practices which may affect trade between Member States and which have as their object or effect the prevention, restriction or distortion of competition within the internal market.

Article 101(1) TFEU lists a non-exhaustive list of prohibited practices:

• directly or indirectly fix purchase or selling prices;
• limit or control production, markets, technical development or investment;
• share markets or source of supply;
• apply dissimilar conditions to equivalent transactions with other trading parties;
• make the conclusion of contracts conditional on acceptance of unrelated obligations.

Article 101 applies only to ‘undertaking’, which is defined broadly by the Court of Justice and can be extended to any legal or natural person engaged in an economic or commercial activity. Therefore, this concept includes individuals, partnerships, corporations, limited partnerships, trusts, charities, co-operatives, nationalised firms, state-owned commercial organisations and non-profit making organisations.

Article 101 requires an appreciable effect on trade between Member States in order for the Commission to have jurisdiction. Otherwise, then national competition rules are likely to apply. The regime extends to agreements, decisions and concerted practices concluded between undertakings which are not located in the EU, but which have an effect and affect trade between Member States.

To come within the scope of article 101 there must be two or more undertakings involved. Agreements made between companies within the same corporate group will generally not be caught by the competition rules, since they are considered as part of the same economic entity.

The term ‘agreement’ is widely construed and includes not only written agreements, but also oral agreements, whether they are or not intended to be legally binding. Informal agreements are also caught, it is sufficient that the undertakings have expressed their joint intention to conduct the market in a specified way.

This way, according to EU case law, four elements must be presented for the prohibition in article 101(1) to apply:

EU Competition law

The primary purpose of the competition law is to remedy some of the situations in which the free market system breaks down.

European Union competition law applies to all companies and individuals doing business within the Member States or which may affect trade between de Member States of the European Economic Area (EEA) regardless of whether these companies are established in one of these countries or not.

The Treaty on the Functioning of the EU (TFEU) provides for a single internal market, one of the basic goals of the EU, which has been described by the European Commission (the core of the EU competition policy) as one of the ‘EU’s biggest assets’ which it is determined to protect. This single market refers to the EU as one territory without any internal borders or other regulatory obstacles to the free movement of goods and services. A functioning single market stimulates competition and trade. In order to achieve this, the TFEU includes rules to ensure that competition within the EU is not restricted or distorted by cartels or anti-competitive agreements, abuses of market power, mergers and acquisitions, unfair State aid… The TFEU is supported by a number of regulations and directives intended to be observed by all members.

As mentioned above, competition rules are applicable not only to EU companies, but also to those carrying on business in Europe or whose business conduct may have effects in Europe.

The main rules

• Competition law and policy of the EU rules are set out mainly at Articles 101 and 102 TFEU. Article 101 controls agreements or concerted practice which is made between two or more independent business which may affect trade between the EU. It catches secret price-fixing or market-sharing cartels or any other agreements between business that have the object or effect of restricting competition (e.g. including exclusive dealing provision or territorial restrictions).
• In accordance to Article 102 TFEU, business may not abuse a dominant position in a particular market to squeeze out smaller competitors.
• In addition, the EU competition rules contain special rules aimed at preventing Member States rom distorting competition through the grant of State aid or other support. The following, for example, are forbidden unless they comply with certain criteria: loans and grants; tax breaks, goods and services provided at preferential rates, government guarantees which enhance the credit rating of a company compared to its competitors. Furthermore, there are special rules applicable to State monopolies and which seek to encourage the liberalisation of markets within the EU.
• Also, competition law and policy in the EU also controls mergers through the EU Merger Regulation, which complements articles 101 and 102. Business are not allowed to merge if that would put them in a position to control the market (in particular as a result of the creation or strengthening of a dominant position) and larger companies cannot merge without prior approval from the European Commission, even if they are based outside the EU.

　　一、前言

　　專利權固然是為保護發明人而賦予其合法排他之權利，惟立法政策上仍有必要就各種權益之平衡加以考量。於是，在保護專利權人合法權益之前提下，同時維護技術使用者及社會公眾的利益，以及維持正常的交易秩序及研發秩序之情況下，我國專利法特別對於專利權效力不及之情事進行規定。

　　二、專利權效力不及的情事

　　按我國專利法第59條係對於專利權效力不及的七款情事進行規定，包括：

　　(1).非出於商業目的之未公開行為：

　　本款規定的目的在避免專利權的行使過於影響非商業目的使用之行為，然而此種非商業使用行為在本質上仍為對於專利權的侵害，故，此類型為即使免責，仍不宜公開，而造成專利權人太大的損失。

　　(2).以研究或實驗為目的而實施發明之必要行為：

　　從事研究或實驗，通常要在原有技術的基礎上進行，如果都需要取得專利權人的同意才可以進行，將造成研發人員裹足不前，反而妨礙研發，不利技術之創新。因此，很多國家之專利法中均有研究實驗免責之規定或透過判例承認其為免責事由。規範研究實驗免責之目的，係保障以發明專利標的為對象之研究實驗行為，以促進發明之改良或創新。

　　一、前言

　　為鼓勵創作，促進產業利用發展，必須賦予專利權人在一定期間內對其發明創作享有競爭上之優勢，任何人未經專利權人同意，不得實施其發明，這就是專利權。專利申請案經過專利專責機關之審查，符合可專利性之要件，由國家授予有一定期限之排他權利，即所謂「排他權」，其意涵在於專利申請人取得專利權後，專有排除他人實施其專利之權，因專利權屬於無形存在之權利，非一般有體財產，故稱為無體財產權。專利權具有經濟上、商業上之利益與價值，得為讓與、繼承或設定質權之標的。

　　二、發明專利權之權利，其區分為：

　　(1).物品專利權：

　　物品專利權人，除專利法另有規定外，專有排除他人未經同意而製造、為販賣之要約、販賣、使用或為上述目的而進口該物品之權。

　　(2).方法專利權：

　　方法專利權人，除專利法另有規定外，專有排除他人未經同意而使用該方法及使用、為販賣之要約、販賣或為上述目的而進口該方法直接製成之物品之權。

　　三、實施發明的專利權，亦包括有三種情況：

二、生物科技專利說明書記載注意事項

除一般專利說明書記載時須注意之事項外，生物科技專利說明書還有以下記載之要點：

(一)專利內容涉及核酸序列或胺基酸序列時，需附上序列表。

(二)涉及微生物時，應描述其拉丁文學名，以及其菌學特徵性質相關資料(描述方式可參考Bergy’s Manual)、必要之基因圖譜或圖式。若為新菌株，則須描述其與同種菌其他菌株不同之處，必要時補充選擇性產生代謝產物之能力、培養條件、培養方法或分離來源等資訊。若該微生物非生物科技領域一般知識者可輕易取得者，尚需寄存該微生物。

(三)分離或重組之DNA或基因、載體(vector)、重組載體，則需說明來源、獲得所使用之載體的方法、使用之試劑、反應條件、回收、分離及純化之步驟、鑑定方法。

(四)涉及轉形株(transformant)，需說明導入之基因或重組載體、宿主、基因或重組載體導入宿主之方法、篩選轉形株之方法、鑑定方法。

(五)融合細胞則需說明親代細胞之預處理方法、融合條件、篩選融合細胞之方法、鑑定方法。

(六)專利標的為重組蛋白質(recombinant  protein)，應描述獲得編碼該重組蛋白質之基因的方法、使用之表現載體、獲得宿主之方法、將基因導入宿主之方法、自業已導入基因之轉形株回收及純化該重組蛋白質之步驟、鑑定所製得之重組蛋白質的方法。

(七)單株抗體(monoclonal antibodies)需說明獲得或生產抗原之方法、免疫接種方法、篩選抗體生產細胞的方法、鑑定單株抗體之方法。必要時補充其鑑定特徵，如：抗原、抗體重鏈/輕鏈及/其亞型（subclass）、抗原-抗體親和常數、交叉反應、等電點、分子量、抗原專一性分析（如EIA, RIA, Western blot, Immunoprecipitation等）、融合細胞寄存號碼等資訊。

(八)涉及低分子量物質者，可依發明之特徵適當記載下列部分特性作為該產物與習知者得以鑑定區分用之辨識特徵。舉例而言，如元素分析值、分子量、熔點、比旋光度、紫外線吸收光譜、紅外線吸收光譜、核磁共振光譜、質譜、對溶劑之溶解度、呈色反應、酸鹼性質、物質之色澤等物理或化學特性等。