Business Drugmakers Cliffhanger
商业 制药企业 悬念
Big Pharma struggles to protect its blockbusters as they lose patent protection
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.
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.
In all, blockbusters with a combined $170 billion in annual sales will go off-patent by 2015.
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.
Patients and health-care payers should reap the benefit.
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).
But generics makers may face delays getting their cheaper versions to market.
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.
More important, research-based drug firms are using a variety of tactics to make the patent cliff slope more gently.
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.
In the year to October the FTC identified what it believes to be 28 such settlements.
American and European regulators are looking into these deals.
However, legal challenges against them have faltered, and a bill to ban them is stuck in Congress.
To encourage generics makers to challenge patents on drugs, and introduce cheaper copies,
an American law passed in 1984 says that the first one to do so will get a 180-day exclusivity period,
in which no other generics maker can sell versions of the drug in question, as Ranbaxy supposedly won with Lipitor.
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.
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.
More unusual, Pfizer has cut the price of its original version, and will keep marketing it vigorously.
So Ranbaxy faces not one, but two competitors.
This strategy has precedent, says David Risinger of Morgan Stanley, but the scale and structure of Pfizer's scheme is unmatched.
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.
Pfizer is also offering Lipitor for a generic price to big firms such as Medco, which manage health schemes' prescription costs.
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.
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).
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.
Express Scripts is advising the health plans it works for to reject Pfizer's deals for Lipitor.
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.