由浩鼎生技公司案論內線交易之重大消息與明確性

An Analysis of the Requirements for Material Information and Precision in Insider Trading Using the OBI Pharma Case

基於對市場公平交易的維護，促進證券市場效率等原因，避免資訊的不對稱，我國於1988年增訂證券交易法第157條之1，明文禁止內線交易行為。生技及新藥業者為試驗新藥，以憑取得藥證上市，但新藥試驗期漫長，投資金額龐大，新藥試驗過程，何者為對股價有影響的「重大消息」﹖應如何認定？2010年新修訂之證券交易法第157條之1第1項增列「明確性」的要件，該「明確性」之要件為何，實務如何認定，亦成為新藥及生技業者關注焦點。浩鼎生技公司係台灣第一宗因「新藥解盲」起訴的內線交易案，檢察官起訴主要理由是：該公司新藥「OBI-822」第二及第三期合併臨床實驗的「惡化人數」未達289人，勢必影響該實驗的「Power檢定值」小於0.05（5％），造成該實驗的檢定力不足；其次，該新藥臨床試驗僅執行「單一樞紐實驗」，且試驗過程將「惡化人數」的判讀，由中央判讀（Central Reading）改為由醫師檢視病人惡化情形的「醫師判讀」（Local Reading），此種判讀的改變，影響實驗的正確性，檢察官認為解盲前半年的「專家會議」結論，被告等即已知悉該試驗通過新藥藥證機率微乎其微，「推論」2015年8月28日專家會議的結論屬於證券交易法第157之1條的「重大消息」，被告張○○等五人於明知在新藥藥證不可能通過之下，從2015年8月28日專家會議結束這天開始，到隔年2016年2月21日解盲當天，被告張○○等五人買賣浩鼎的股票都屬於證券交易法第157條之1第1項的「內線交易」？一審審理時，法院先釐清檢察官所指的「重大消息」內涵是甚麼？該專家會議的「結論」是否屬於我國證券交易法第157條之1條規定影響股價的「重大消息」？是否符合2010年6月2日證券交易法第157條之1立法修正後於重大消息「在該消息」、「明確性」的要件？檢方起訴認定之「重大消息」是否有立論基礎？一審判決直指檢察官以臨床實驗的「惡化人數」未達289人，取得藥證機會「微乎其微」，因而認定被告等五人涉有「內線交易」，該起訴理由之論點「係屬錯誤推論」（一審判決書第62頁），且以2013年12月31日即已下架之法規非難被告，「而有錯誤」（一審判決書第62頁），試驗過程是否由「中心判讀」或「醫生判讀」，係「不瞭解科學法規的變遷」（一審判決書第62頁），更認為「檢察官自行臆測」（一審判決書第62頁），更認為檢察官因該判讀方法的改變，「將導致數據判讀偏差、影響試驗數據可信度，影響試驗資料品質之結論，「全無根據」（一審判決書第62頁），法院認為：任何人在解盲前，都無法得知試驗是否成功與否，檢察官起訴認定之「重大消息」其內涵，在科學試驗中未必發生，況且根本不是「重大」消息，起訴理由係檢察官「自行臆測」（一審判決書第62頁），判決結論直指：「檢察官起訴之『重大消息』無法得出具有相當『高度』地發生可能性機率，自無所謂『重大消息』之成立，更無『重大消息』」之成立始點可言。」（一審判決書第62頁），判決被告全數無罪。本文先扼要介紹我國證券交易法對於內線交易重大消息之認定標準，其後將討論國際間及美國食品藥物管理局（FDA）新藥實驗的標準作業和規範，說明新藥臨床試驗必需嚴格遵守的作業規範，再檢視浩鼎公司新藥「OBI-822」是否合乎該規範？再者，就本案的專家及臨床醫師具結證言，探討檢方起訴「內線交易」的三大爭點有無理由？是否構成證券交易法第157條之1第1項的「重大消息」？檢方上述三大爭點，檢視是否合於2010年6月2日新修正證券交易法第157條之1第1項規定的「明確性」？本文評釋本案台灣士林地方法院106年度金重訴字第2號判決，能釐清新藥試驗暨發展過程與證券交易法「內線交易」錯綜複雜的關係。

Based on the protection of fair trade in the market, the promotion of efficiency in the securities market, and the avoidance of asymmetric information, Taiwan added Article 157-1 of the Securities Exchange Act in 1988, which explicitly prohibits insider trading. Biotech and pharmaceutical companies are testing new drugs to obtain drug licenses, but the new drug trial time is long and the required investment capital is significant. What is “material information,” which would affect the stock price during the trial process of a new drug? And how is it identified? In the new amendment to the first paragraph of Article 157-1 of the Securities and Exchange Act in 2010, it added a specific requirement that the material information be precise. How to define the “precise” requirement as well as how the courts will identify that requirement have gained the attentions of the biotech and pharmaceutical companies. OBI Pharma, Inc. is the first case to be charged with insider trading of “unblinding” of new drug trial process in Taiwan. The main reason for its prosecution is that the PD in the second and third phase of the company's new drug, OBI-822, was less than 289 people, which would inevitably affect the p-value (criterion is p < 0.05), resulting in insufficient verification power of the experiment. Secondly, the new drug clinical trial only performed a “single pivot trial”, and the identification of the PD was changed from “Central Reading” to “Local Reading,” which doctors would examine the deterioration of the patients instead. The change affected the validity of the experiment. The prosecutor believed that the defendants had already known that the chance of getting the new drug approved was small, according to the conclusions of the experts meeting which was held a half year prior to the unblinding and, therefore, assumes the conclusion of the experts meeting on August 28, 2015 was material information regarding Article 157-1 of the Securities Exchange Act. The defendants had known that new drug would not be approved on the date of the experts meeting, and all the transactions of OBI Pharma’s stocks from August 28, 2015 to the unblinding date, February 21, 2016, were subject to the insider trading of Article 157-1 of the Securities Exchange Act. During the trial, the court first clarified what the definition of material information was, as referred by the prosecutor. Whether the conclusions of the experts meeting were in fact the material information defined in the Article 157-1 of the Securities Exchange Act. Additionally, what also needed further clarity was whether it met the requirement of being “precise” after the amendment of the Article 157-1 of the Securities Exchange Act on June 2, 2010 and whether the material information identified by the prosecutor could stand its ground. In the trial court decision, it directly pointed out that it is a wrong assumption that the prosecutor alleged that due to the PD of clinical trials did not reach 289, the chances of obtaining the drug approval were very small, and therefore, the defendants violated the insider trading law. Also, there was no ground to reach the conclusion that the change from Central Reading to Local Reading would affect the credibility and the quality of the test data. The court held that no one could know whether the trial was successful or not before the unblinding process. The material information charged by the prosecutor was not necessarily occurring in a scientific trial. Moreover, it was not even material information at all; the allegations were the assumption of the prosecutor. The court directly pointed out that the material information charged by the prosecutor could not lead to a high probability of occurrence, and therefore, there was no such thing as material information. The court held that all the defendants were not guilty. This paper first introduces the criteria for meeting the material information requirements in Taiwan's Securities Exchange Act for insider trading and then discusses the standard operations and specifications of the US Food and Drug Administration (FDA) new drug trials, indicating that new drug clinical trials must strictly adhere to the above operations and specifications. This paper will additionally examine whether OBI Pharma’s new drug, OBI-822, met the above requirements. Furthermore, with the testimony of the experts and clinicians in this case, this paper will discuss whether the three disputes regarding insider trading, as raised by the prosecutors, meet the requirements of material information and whether the three disputes meet the requirement of being precise, as provided in Paragraph 1 of Article 157-1 of the newly amended Securities Exchange Act on June 2, 2010. This paper will analyze the trial court decision of OBI Pharma case and further clarify the complicated relationship between new drug trials and development and insider trading in the Securities Exchange Act.