生技製藥產業專利技術之價值評估模式與投資策略

Patent Evaluation and Patent Investment of Biopharmaceutical Industry

李奇峰(Chi-Feng Lee)

指導教授 ： 李存修

國立臺灣大學/管理學院/財務金融組/碩士(2010年)

https://doi.org/10.6342/NTU.2010.02264

摘要

生技製藥產業不論是在產品的開發或後續的行銷均有許多難題尚待突破，尤其是創新技術的取得、生產設備的提升、以及人力或資金的投入等更是維持公司營運的要素。 生技製藥公司為求企業的永續生存，必須不斷推出產品以維持營收的成長。 除自行開發新產品或購併外，如何縮短產品推出時程以促進公司成長也是重要競爭策略之一。 尤其新藥開發是一項高風險的投資，新藥研發時間長、研發費用高昂，所開發的產品一旦順利上市，往往能藉由智慧財產的保護取得市場獨占性，因而獲得倍數的報酬回收。 生技製藥業如何應用專利佈局與投資經營之知識管理策略來增加企業競爭力，實是一個值得深入探討的主題。
本論文首先以五力理論及強弱危機綜合分析工具進行個案分析發現，受到2008年金融風暴影響，全球製藥產業策略聯盟的總件數不增反減，但生技公司參與聯盟的件數逐年增加，顯示生技公司發展產品或專利技術的佈局已日趨重要，生技公司在專利權策略聯盟的互補競爭已逐漸顯現優勢。 尤其生技製藥公司若能與產業外部互補者創新的技術進行專利佈局投資策略之授權合作，對企業而言不僅可帶來資金，同時也分攤了許多產品開發的風險。
因此，為提昇產業競爭力，本論文以生技製藥產品開發階段進行專利策略的研究，提出可行專利申請模式與其全球專利佈局投資策略方向包括: 第一、由專利權擁有者自行研發生產製造; 第二、由專利權擁有者授權策略聯盟夥伴生產製造; 第三、以所持有專利權進行特定的專利地雷佈局; 第四、與策略聯盟夥伴交互授權以持有專利權技術; 以及第五、將所持有專利權全部轉讓出售予第三者。 從跨國生技公司之企業營運策略個案分析顯示，所開發產品愈接近上市風險愈低，報酬可能也愈高； 為解決生技製藥產業自行開發產品無法短期內推出產品上市之窘境，建議可採行彼此風險較低候選藥物的技術交互授權與合作開發，以求專利產品能加速進入上市。 在全球產業策略聯盟的風潮帶動下，生技製藥企業亦應積極以產品技術授權、技術引進、委託生產及行銷合作等各類型的策略佈局，以進入海外市場或縮短產品開發時程，而產業界的全球聯盟或整合亦為現階段突破中小型生技製藥企業困境的重要發展模式。
專利評價方法雖多，卻無一個可以放諸四海而準的模式。 為建立策略性專利投資決策之評價工具，本論文應用財務金融鑑價觀念，從個案研究分析生技專利價值評估模式，建議可藉由投資期望值、風險淨現值、實質選擇權，以及複合選擇權等四種模式完成新藥專利組合之價值評估。 尤其從財務面分析研究發現，專利投資佈局之關鍵成功因子主要在於具有聚焦專利新藥產品的開發、擁有足夠數量的專利產品組合、充裕的合作開發資金投入新藥開發生產、積極的佈局全球以建構合作聯盟營運模式，以及政府政策暨國際法規趨勢的配合等五項關鍵成功因素，以建立合宜且彈性的專利佈局投資策略模式。 因此，需先募集充足的資金才得以聚焦完成專利產品組合的臨床試驗；且新藥開發過程中，固定成本如果過高將是企業優先要解決的重要的議題，如何節省營運成本以彌補面臨的營收短缺更是當務之急；唯有據以建立明確的目標、區隔服務的對象，以及具體推出國際商業價值的創新產品，企業才有機會持續發展。
本研究以生技製藥產業之價值鏈與產業專利技術之價值評估理論為基礎，進行生技製藥產業專利技術之價值評估模式與產品投資策略探討。 希望由此一系列之研究能提供生技製藥產業攸關專利權佈局較具綜效投資之策略參考。

關鍵字

專利價值評估 ； 專利投資 ； 生技製藥產業 ； 策略聯盟 ； 專利佈局 ； 競爭策略 ； 關鍵成功因素 ； 專利授權 ； 專利策略 ； 價值鏈 ； 投資策略

並列摘要

Biopharmaceutical industries have encountered many difficulties that need to overcome such as research and development or subsequent marketing. In particular, acquisition of innovative technology, upgrading of machinery, capital funds and human resources are the key element to operate a biopharmaceutical companies. Hence, for them to survive, they must constantly develop new products to increase the revenue. Other than developing new products or incorporating with others, shortening the launch time for new products is one of important competitive strategy for facilitating company growth. Developing new drugs is a high risk investment that requires a long period of time and large amount of funds. Once the developed products launch to the market successfully, these products will monopolize the market under the protection of intellectual property law. Consequently, the returned profit will be multiplied. Therefore, it is an interested topic to discuss how biopharmaceutical industries apply patent layout and knowledge of investment and management on increasing enterprise competitive
According to Porter’s five forces theory and SWOT analysis on case studies reveal that due to financial crisis in 2008, the total number of global pharmaceutical industry policy in strategic alliance has declined. However, the number of biotech companies participating in the alliance is increasing every year. This indicates biotech companies play an important role in product developments and patent technology layout. The biotech companies have greater advantages in complementary competition of patent strategy alliance. Thus, if the biotech companies could incorporated with others with innovated technology and investing strategy on patent layout and authorizing cooperation, it not only brings more funds but also shares many risks on enterprise developing.
To enhance competitiveness, during the research and development phase in biopharmaceutical production, patent application mode and global patent layout investing strategy can be proposed in several directions. Firstly, both researching and manufacturing are performed by the patent holder. Secondly, partners, in the strategic alliance, manufacture with authorized license from the patent holder. Thirdly, the patent holder constructs a specific landmine for patent layout. Fourth, the patented technology can be exchanged among the strategic alliance partners. Lastly, the patent license can be sold to a third party. A case study on global biopharmaceutical industry operating strategy shows that the developed product close to launch time, the risk is lower and the revenue might be higher. To accelerate patented product to be on the market, it is suggested to develop low risk candidate drugs, obtain patented technology transferring and cooperate with others in order to solve the problem for biopharmaceutical industrial are not capable to launch product in a short period of time. Following the trend of global industrial strategic alliance, the domestic biotech industry should be actively seeking product licensing, technology transfer, authorized manufacturing, and collaborative marketing. To open the oversea market or shortening the product development timeline, the global strategic alliance is an important developmental model for small and medium sized biopharmaceutical enterprises to breakthrough.
Although there are plenty hypothesis of patent evaluations, there is no such a standard evaluation model for biopharmaceutical industry. In order to establish strategically patent investing evaluation tool, according to concept of financial and economic evaluation, the analysis of case study on biotech patent evaluation model suggests investment expectations, risk adjusted net present value, real option, and compound option are combined to form evaluation process on new drug patent. In particular, from financial analysis discovers key success factors for the successful patent investments are focused on new drug development, enough number of patented product combinations, investing abundant resources, establishing cooperative alliance operating model from global layout, and incorporation with government policy and international regulation. With all above, a suitable and reflex patent layout investing strategy can be built. Thus, enough fund raise must be achieved in order to complete on patented clinical trials. Nevertheless, if fixed costs were higher than expected during new drug developments, it would be the priority subject to resolve for the enterprise. Cost down, for instance, can be performed to make up revenue shortages. Establishing specific targets, targeting distinct service segments, and launching international business values containing products are essential for a long lasting enterprise to operate.
The theory of value chain and the evaluation of patented technology serve as a basis for analyzing the case studies on the patent evaluation of the biopharmaceutical companies and product investing strategies. Hopefully, a series of analysis from above can provide beneficial references on constructing the patent layout and investment strategy.

並列關鍵字

patent evaluation ； patent investment ； biopharmaceutical industry ； patent layout ； strategic alliance ； competitive strategy ； key success factors ； patent license ； patent strategy ； value chain ； investment strategy

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