商业 制药企业 悬念

　　Big Pharma struggles to protect its blockbusters as they lose patent protection

　　大型制药企业艰难保护着专利失效的"重磅炸弹"药物

　　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.

　　多年来，大型制药企业一直担心"专利悬崖"出现——最畅销药品的专利到期或专利因诉讼而中止，而市场上鲜有新的"重磅炸弹"药物，这时企业的销售额将会锐减。

　　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，史上最畅销的药物"立普妥"（Lipitor）专利到期，这种降胆固醇药去年就为辉瑞公司赚了近110亿美元。

　　In all, blockbusters with a combined $170 billion in annual sales will go off-patent by 2015.

　　到了2015年，多种"重磅炸弹"药物（年销售额总计达1170亿美元）的专利都将失效。

　　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.

　　很多仿制药公司现在大概正忙着推出与立普妥的非专利药（即化学结构相同的药物），价格仅为立普妥的1/5。

　　Patients and health-care payers should reap the benefit.

　　病人和医疗费用支付方会收益，而辉瑞的收入会缩水。

　　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).

　　同样的事件将反复上演，因为其他畅销药也要临近"专利悬崖"（见图）。

　　But generics makers may face delays getting their cheaper versions to market.

　　然而，非专利制药企业却发现仿制药上市一拖再拖。

　　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.

　　兰伯西（Ranbaxy）这家日本制药企业历尽艰辛，获得了立普妥非专利药的生产许可，但该许可要到专利失效那天才生效。

　　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，以研发为基础的制药公司正使用各种方法缓冲"专利悬崖"效应。

　　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.

　　美国联邦贸易委员会（Federal Trade Commission，FTC）主席Jon Leibowitz注意到，制药商们千方百计地为产品增加后续专利，以延缓保护的失效，但其实那些专利没什么价值。

　　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.

　　另一种战术是"有偿延迟"协议，也就是说在专利诉讼时，制药企业会付给未来竞争对手一笔钱，以延迟价钱更低的仿制药进入市场。

　　In the year to October the FTC identified what it believes to be 28 such settlements.

　　截止到10月，FTC就发现了28起类似事件。

　　American and European regulators are looking into these deals.

　　美国和欧洲的监管部门也开始调查这些协议。

　　However, legal challenges against them have faltered, and a bill to ban them is stuck in Congress.

　　然而，反对这些协议的诉讼一再搁浅，而美国国会也未能通过禁止此类事件的一项法案。

　　To encourage generics makers to challenge patents on drugs, and introduce cheaper copies,

　　为了鼓励非专利制药企业挑战药品专利、生产价钱更低的仿制药，

　　an American law passed in 1984 says that the first one to do so will get a 180-day exclusivity period,

　　美国于1984年通过一项法案，其中提到"第一个挑战成功的仿制药企能获得180天市场独占期，

　　in which no other generics maker can sell versions of the drug in question, as Ranbaxy supposedly won with Lipitor.

　　在此期间其他仿制药企不能贩售同一专利药的其他仿制药，就像兰伯西获得立普妥仿制药的生产权一样。"

　　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，辉瑞钻了这个法案的空子，它让第二家授权仿制药企业——华生制药公司（Watson，美国公司）来仿制。

　　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.

　　根据BernsteinResearch的分析，在此交易期间，华生公司获得立普妥的仿制权，辉瑞将获得华生公司年收入的70%。

　　More unusual, Pfizer has cut the price of its original version, and will keep marketing it vigorously.

　　更为不同的是，辉瑞将降低立普妥专利药的价格，并对其采取积极的营销策略。

　　So Ranbaxy faces not one, but two competitors.

　　所以说，兰伯西的对手是两个，而非一个。

　　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认为，这项策略虽有先例，但就规模和结构而言绝对不能与辉瑞的计划相比。

　　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.

　　辉瑞的患者，若使用一种特殊打折卡，通过共同支付方式（在健康计划中他们对药物成本的贡献），只花4美元就可以获得一个月用量的立普妥专利药，而其他仿制品需要花费约10美元。

　　Pfizer is also offering Lipitor for a generic price to big firms such as Medco, which manage health schemes' prescription costs.

　　辉瑞还以仿制药价格向美可保健（Medco）等大型公司（负责管理健康计划处方的成本）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认为，所有这些举措将使得辉瑞2012年上半年的销售额比不采取措施时增加近5亿美元，总收入在180天市场独占期后会下降。

　　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).

　　美可保健公司辩解说，辉瑞的项目是为各方省钱，并保证稳定供货（兰伯西批准受挫也引起类似的忧虑）。

　　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.

　　也有人担心，由于共同支付计划很复杂，辉瑞的战术会增加雇主门支付健康计划的成本，也让患者们在数年内都不明白仿制药的重要意义。

　　Express Scripts is advising the health plans it works for to reject Pfizer's deals for Lipitor.

　　快捷药方公司（Express Scripts）正建议其所属的健康计划反对辉瑞的立普妥交易。

　　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.

　　他们最担心，如若辉瑞的做法被仿制，那么180天专有期的价值会缩水，而仿制药公司挑战专利的动力也会在初期被抑制。