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2013/07/24

大製藥廠與智權之關係/從威而剛專利到期談起

【郭史蒂夫/北美智權 教育訓練處 歐洲專利律師/中文翻譯 陳宜誠律師/北美智權教育訓練處處長/首席研究員】
輝瑞(Pfizer)藥廠在歐洲地區擁有眾多專利,其中之一的藥品威而剛(Viagra,學名sildenafil citrate)的專利已於2013年6月到期(即其合法壟斷期已經結束)。輝瑞早就知道威而剛將會是一個非常成功的商品,並試圖藉由不同的方式,來延長其各種智財權的壟斷期。他們
【郭史蒂夫/北美智權 教育訓練處 歐洲專利律師/中文翻譯 陳宜誠律師/北美智權教育訓練處處長/首席研究員】
輝瑞(Pfizer)藥廠在歐洲地區擁有眾多專利,其中之一的藥品威而剛(Viagra,學名sildenafil citrate)的專利已於2013年6月到期(即其合法壟斷期已經結束)。輝瑞早就知道威而剛將會是一個非常成功的商品,並試圖藉由不同的方式,來延長其各種智財權的壟斷期。他們所做的努力中,有些是成功的(例如延長威而鋼有關肺動脈高壓的小兒劑量治療和SPC延展保護時間計6個月),而另一些則沒有(例如EPO T1212/01決定,認為一更具體描述威而剛對勃起功能障礙之醫學效果的專利為無效,而使其不能藉此專利來延長威而鋼於歐洲的壟斷期)。涉及威而剛的類似專利無效判決,也發生在加拿大和中國。至於在美國,由於美國專利法的某些特殊規定,輝瑞藥廠能夠有效延長它的威而剛專利之保護期直到2019年。
威而鋼的故事是一個能善用專利制度(獎勵研發成果的公開)的好例子。輝瑞藥廠自發現並銷售威而鋼,已經有長達15年的時間,可以充分回收其投資。但是,時間已經到了!
以營收來算,輝瑞藥廠是目前世界上最大的製藥公司之一。它藉由發現、開發、專利化和商業化藥物,如威而鋼,來達成如此成就。另一種屬於輝瑞藥廠的藥物,立普妥(Lipitor),是迄今為止全球最暢銷的藥物,至1996年為止,其總營收就超過1,250億美元。輝瑞藥廠有時候是自己開發這些藥物,如威而鋼,有時候會以收購或合併其他藥廠的方式,來取得其已受智慧財產權保護的藥物,如立普妥。立普妥原由華納 - 蘭伯特藥廠所開發,現在已成為輝瑞藥廠的一部分。
就像所有的大製藥廠,輝瑞藥廠在過去幾年曾經歷過一個動盪的歷程。一方面,他們受益於來自受專利保護之暢銷藥品,如立普妥和威而鋼,而獲得令人難以置信的巨大收入。另一方面,開發這些產品(研發支出)和商品化這些藥物(嚴格的測試如臨床試驗等尤其昂貴)的支出,以及同時開發新產品與取得智財(IP)保護之需求,對這些公司已經造成資金壓力。這意味著,製藥公司已經看到了藉由互相合併,變成越來越大的公司是有利可圖的 - 不但可以減少他們的支出成本,更可以有效的減少他們的研發費用。由許多製藥公司附聚成較大的公司群,就可以看出這種合併的趨勢。在上世紀90年代開始時,計有40 ~ 60家製藥公司,現在則只有幾個較大規模的仍然存在 - 其中值得注意的是輝瑞(Pfizer)、葛蘭素史克(GSK)、賽諾菲(Sanofi)、羅氏(Roche)、諾華(Novartis)、嬌生(J&J)、阿博特實驗室(Abbot Labs)和阿斯利康(AstraZeneca)。即使是具有顯著歷史,曾開發出偉大藥品(如第一支零售避孕藥物,烯雌酮)的惠氏(前為美國家用產品)藥廠,在2009年也被納入輝瑞藥廠旗下。
整體分析這些大製藥廠之發現新藥以及將其商業化的結果,似乎表明這些大藥廠並不能再生產出如威而剛和立普妥等能獲取巨大利益的藥物。這個結果是由於許多因素而產生的,其中包括研究的方式與受調查產品的類型。像輝瑞藥廠於2012年就宣布,它將放棄可治療阿滋海默症的試用藥物bapineuzumab,而它花了很多的錢(與嬌生合作)才發展到那個階段。
這是否代表我們曾看過之大型藥廠商業模式的結束呢?我認為事實並非如此。可滿足藥廠胃口之巨大市場仍然存在,例如如何治療阿滋海默症或其他新疾病將變得越來越重要(需要新的抗生素這事情,讓許多國家的主管機關開始有所警覺)。問題是,怎麼找到那個正確的藥物。
在這方面,我認為製藥公司應繼續執行他們的慣行。他們先發現可能由其本身或由較小的公司開發之具潛力候選藥物,並盡可能以智慧財產權保護之。然後,他們運用他們的專業知識去開發、製造與推廣藥物於市場,並獲得臨床試驗許可。在進行這些活動時,藥廠本身是一家大型跨國公司如輝瑞藥廠,而不是由某大學分拆出來的一小製藥公司,可能效能會較佳。
還有一個顯著的變化,是藥廠在研發部分的變化。以前藥廠的研發重點是尋找能改進醫療狀況的新化學物質,而現在強調的是更量身客製的生物技術產品,特別是抗體。在這方面,大型製藥公司不是轉移自己研究部門的研究重心,就是四處尋找較小的生物技術公司合作、將其合併或買斷其智財(IP)。當然,這些企業確定一個前瞻性研發項目之可行性的標準,仍置基於其智慧財產權,特別是其專利能否成功的保護該產品。



The state of Big-Pharma and its relationship to IP
Stefano John NAIP Education & Training Group / European Patent Attorney
It has been widely reported that in Europe in June 2013, one of the patents owned by Pfizer that best covers the pharmaceutical Viagra (sildenafil citrate), is coming "off-patent" (i.e. its allowable lifetime as a monopoly is finished). Pfizer knew that Viagra would be a great commercial success and tried to extend their monopoly in different ways, using different forms of IP available. Some of them worked (6 months extension for pulmonary hypertension in pediatric dosages only and SPC extensions) where extensions were allowable, while others did not (EPO decision T1212/01, which invalidated a patent with more specific medical indication of Viagra towards erectile dysfunction that would have meant longer coverage period in Europe). Similar cases involving Viagra have occurred in Canada and China. In the US, Pfizer are effectively able to extend their patent protection on Viagra until 2019 thanks to certain differences in US patent Law.
The story of Viagra is a great example of the patent system working as it should. Pfizer, the company that discovered and has been marketing Viagra, has had 15 years to make a return on its investment. But that time is up!
Pfizer is currently one of the world’s largest pharmaceutical company by revenue. It achieved this by having discovered, developed, patented and commercialized drugs such as Viagra. Another drug belonging to Pfizer is Lipitor, which generated by 1996 over 125 billion USD and was the best-selling drug to date. Pfizer sometimes developed these drugs on their own, such as Viagra, and sometimes used their incoming capital to acquire/merge with companies where the drug has been protected by IP, such as Lipitor. Lipitor was previously owned by Warner-Lambert Company, now part of Pfizer.
Pfizer, like all Big-Pharma, has had a turbulent history in the last few years. On the one hand, they have benefited incredibly from the very high revenues coming in from best–selling pharmaceuticals having patent protection such as Lipitor and Viagra. On the other, the money required to develop these products (R&D expenditure) and to commercialize these drugs (strict tests such as clinical trials are particularly expensive) have put financial pressure on these companies, while the need to continue developing new products to protect with IP remained. This has meant that pharmaceuticals companies have seen it as profitable to merge themselves into ever larger companies - to reduce their outgoing costs and to better streamline their R&D expenses. This trend to merge can be seen by the agglomeration of many pharmaceutical companies into larger groups. Where at the start of the 90’s there were 40-60 companies, now only a large few remain – notable among them being Pfizer, GSK, Sanofi, Roche, Novartis, J&J, Abbot Labs and AstraZeneca. Even Wyeth (previously known as American Home Products), a company with a notable history in developing great pharmaceuticals (first OTC contraceptive drugs such as equilin) was subsumed by Pfizer in 2009.
An overall analysis of new drugs being discovered and commercialized by these large companies would seem to indicate that these companies are not able to produce pharmaceuticals with the same financial success of Viagra and Lipitor. This is due to many factors which include the manner of research and the type of product being investigated. As an example, Pfizer announced in 2012 that it would abandon a trial drug for treating Alzheimer’s disease, bapineuzumab, which it had spent a lot of money (in conjunction with J&J) to develop to that stage.
Is this the end of the business model of large pharmaceutical companies that we have seen before? I would argue it is not. Large markets to satisfy for pharmaceutical companies to exploit still exist, such a treating diseases such as Alzheimer’s and new ones are becoming ever more important (the need for new antibiotics is starting to alarm many country national agencies). The issue is finding that right drug.
In this respect I would argue that the pharmaceutical companies perform as they always have. They find hopeful candidate drugs, either by themselves or developed by smaller entities, and protect the IP as much as possible. They then apply their expertise in developing the drug for market and obtaining clinical trial clearance. In this respect, being a large multinational company such as Pfizer, instead of a university spin-out, could be very useful.
One area of notable change is the change in R&D. The emphasis in R&D before was on finding new chemical entities to help with medical conditions, now the emphasis is much more directed to tailored biotechnological products, especially antibodies. In this respect, the large pharmaceutical companies are either shifting the emphasis of their own research departments or are looking around for smaller biotechnology companies with which to collaborate with or merge with or buy outright. Of course, the underlying criteria by which these companies determine the feasibility of a prospective project remains that IP, especially patent, cover the product successfully.
【完整內容請見《北美智權報》第88期】


轉貼來源:UDN新聞網

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