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】
【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。
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。
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.