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Business Drugmakers Cliffhanger
商業 制藥企業 懸念
Big Pharma struggles to protect its blockbusters as they lose patent protection
大型制藥企業艱難保護著專利失效的"重磅炸彈"藥物
FOR some years the big drugmakers have been dreading an approaching "patent cliff"—a slump in sales as the patents on their most popular pills expire or are struck down by legal challenges, with few new potential blockbusters to take their place.
多年來，大型制藥企業一直擔心"專利懸崖"出現——最暢銷藥品的專利到期或專利因訴訟而中止，而市場上鮮有新的"重磅炸彈"藥物，這時企業的銷售額將會銳減。
This week the patent on the best-selling drug in history expired—Lipitor, an anti-cholesterol pill which earned Pfizer nearly $11 billion in revenues last year.
本周，史上最暢銷的藥物"立普妥"（Lipitor）專利到期，這種降膽固醇藥去年就為輝瑞公司賺了近110億美元。
In all, blockbusters with a combined $170 billion in annual sales will go off-patent by 2015.
到了2015年，多種"重磅炸彈"藥物（年銷售額總計達1170億美元）的專利都將失效。
What is supposed to happen now is that lots of copycat firms rush in with "generic" (ie, chemically identical) versions of Lipitor at perhaps one-fifth of its price.
很多仿制藥公司現在大概正忙著推出與立普妥的非專利藥（即化學結構相同的藥物），價格僅為立普妥的1/5。
Patients and health-care payers should reap the benefit.
病人和醫療費用支付方會收益，而輝瑞的收入會縮水。
Pfizer's revenues should suffer. The same story will be repeated many times, as other best-selling drugs march over the patent cliff (see chart).
同樣的事件將反復上演，因為其他暢銷藥也要臨近"專利懸崖"（見圖）。
But generics makers may face delays getting their cheaper versions to market.
然而，非專利制藥企業卻發現仿制藥上市一拖再拖。
Ranbaxy, a Japanese-owned drugmaker, struggled to get regulators' approval for its generic version of Lipitor, and only won it on the day the patent expired.
蘭伯西（Ranbaxy）這家日本制藥企業歷盡艱辛，獲得了立普妥非專利藥的生產許可，但該許可要到專利失效那天才生效。
More important, research-based drug firms are using a variety of tactics to make the patent cliff slope more gently.
更重要的是，以研發為基礎的制藥公司正使用各種方法緩沖"專利懸崖"效應。
Jon Leibowitz, chairman of America's Federal Trade Commission (FTC), is concerned by drugmakers filing frivolous additional patents on their products to put off the day when their protection expires.
美國聯邦貿易委員會（Federal Trade Commission，FTC）主席Jon Leibowitz注意到，制藥商們千方百計地為產品增加后續專利，以延緩保護的失效，但其實那些專利沒什么價值。
Another tactic is "pay-for-delay", in which a drugmaker facing a legal challenge to its patent pays its would-be competitor to put off introducing its cheaper copy.
另一種戰術是"有償延遲"協議，也就是說在專利訴訟時，制藥企業會付給未來競爭對手一筆錢，以延遲價錢更低的仿制藥進入市場。
In the year to October the FTC identified what it believes to be 28 such settlements.
截止到10月，FTC就發現了28起類似事件。
American and European regulators are looking into these deals.
美國和歐洲的監管部門也開始調查這些協議。
However, legal challenges against them have faltered, and a bill to ban them is stuck in Congress.
然而，反對這些協議的訴訟一再擱淺，而美國國會也未能通過禁止此類事件的一項法案。
To encourage generics makers to challenge patents on drugs, and introduce cheaper copies,
為了鼓勵非專利制藥企業挑戰藥品專利、生產價錢更低的仿制藥，
an American law passed in 1984 says that the first one to do so will get a 180-day exclusivity period,
美國于1984年通過一項法案，其中提到"第一個挑戰成功的仿制藥企能獲得180天市場獨占期，
in which no other generics maker can sell versions of the drug in question, as Ranbaxy supposedly won with Lipitor.
在此期間其他仿制藥企不能販售同一專利藥的其他仿制藥，就像蘭伯西獲得立普妥仿制藥的生產權一樣。"
However, Pfizer is exploiting a loophole in the 1984 law, which lets it appoint a second, authorised copycat—in this case, Watson, another American firm.
然而，輝瑞鉆了這個法案的空子，它讓第二家授權仿制藥企業——華生制藥公司（Watson，美國公司）來仿制。
According to BernsteinResearch, under the deal between the two drugmakers Pfizer will receive about 70% of Watson's revenues from its approved copy of Lipitor.
根據BernsteinResearch的分析，在此交易期間，華生公司獲得立普妥的仿制權，輝瑞將獲得華生公司年收入的70%。
More unusual, Pfizer has cut the price of its original version, and will keep marketing it vigorously.
更為不同的是，輝瑞將降低立普妥專利藥的價格，并對其采取積極的營銷策略。
So Ranbaxy faces not one, but two competitors.
所以說，蘭伯西的對手是兩個，而非一個。
This strategy has precedent, says David Risinger of Morgan Stanley, but the scale and structure of Pfizer's scheme is unmatched.
摩根士丹利的David Risinger認為，這項策略雖有先例，但就規模和結構而言絕對不能與輝瑞的計劃相比。
Patients with a special discount card from Pfizer will make co-payments (their contribution to the pills' costs under their health plan) of just $4 for a month's worth of the original Lipitor, compared with about $10 for many generic medicines.
輝瑞的患者，若使用一種特殊打折卡，通過共同支付方式（在健康計劃中他們對藥物成本的貢獻），只花4美元就可以獲得一個月用量的立普妥專利藥，而其他仿制品需要花費約10美元。
Pfizer is also offering Lipitor for a generic price to big firms such as Medco, which manage health schemes' prescription costs.
輝瑞還以仿制藥價格向美可保健（Medco）等大型公司（負責管理健康計劃處方的成本）提供立普妥。
All this may raise Pfizer's sales by nearly $500m in the first half of 2012 compared with what they would otherwise have been, says Tim Anderson of BernsteinResearch, with revenues then falling after the 180 days are over.
BernsteinResearch的Tim Anderson認為，所有這些舉措將使得輝瑞2012年上半年的銷售額比不采取措施時增加近5億美元，總收入在180天市場獨占期后會下降。
Medco argues that Pfizer's scheme will save money for all parties, and ensure a steady supply of the drug (Ranbaxy's regulatory struggles are bound to have caused some concern).
美可保健公司辯解說，輝瑞的項目是為各方省錢，并保證穩定供貨（蘭伯西批準受挫也引起類似的憂慮）。
Others fear that Pfizer's tactics may drive up costs for the employers who sponsor health plans, thanks to the complexities of co-payment schemes, and confuse patients lectured for years about the merits of generics.
也有人擔心，由于共同支付計劃很復雜，輝瑞的戰術會增加雇主門支付健康計劃的成本，也讓患者們在數年內都不明白仿制藥的重要意義。
Express Scripts is advising the health plans it works for to reject Pfizer's deals for Lipitor.
快捷藥方公司（Express Scripts）正建議其所屬的健康計劃反對輝瑞的立普妥交易。
The biggest worry is that Pfizer's strategy, if copied, will make the 180-day exclusivity period worth far less, and thus discourage generics firms from challenging patents in the first place.
他們最擔心，如若輝瑞的做法被仿制，那么180天專有期的價值會縮水，而仿制藥公司挑戰專利的動力也會在初期被抑制。
