Imagine needing a drug to save your life, finding one that is likely to work, and then realizing you can’t afford it. This was the ironic situation that recently confronted a research physician who was diagnosed with leukemia, the very disease he had devoted his life to studying. Fortunately, the doctor’s friends raised the money to buy him this medicine; once administered, it put his disease into remission. Many of the newest generation of drugs are unbelievably expensive, with a course of treatment running tens to hundreds of thousands of dollars. Even with insurance, a twenty percent co-pay on one of these prescriptions could easily cost more than a new car. Why are so many new medicines so high-priced?
Some drugs are costly because they were designed to treat rare [orphan] diseases that have few patients. However, a more general explanation for high drug prices is because the majority of these medicines have a short window of time to recoup their development costs as a result of patent limitations. Patents are one of the critical cornerstones on which the biotechnology industry was built. Many people wrongly believe that owning a drug patent gives the patent holder the right to make and sell that medicine. In actuality, patents give their holders the right to prevent others from practicing their invention, which in this case means selling their drugs. Essentially, this grants them a monopoly for as long as the patent is in place. U.S. patents currently last for 20 years, affording a considerable period of time to earn a return on investment while competitors are kept out of the marketplace. A substantial amount of money can be earned during this time interval. Pfizer’s atorvastatin (Lipitor) holds the record for most total revenues earned by a drug, pulling in more than $125 billion during the 14.5-year period that this drug was sold under patent. Like many Olympic records, experts believe it will be a very long time, if ever, before this total is bested.
The effective lifespan of a drug patent can theoretically be cut in half if it takes 10 years to bring the medicine to market. In practice, several strategies act to mitigate this problem. Patents are usually awarded a number of years after they are filed. A common strategy among companies seeking pharmaceutical patents is to move their applications along at a tortoise-like pace, thereby providing more patent coverage time once their drug is approved for sale. Drug companies have also developed a variety of techniques that effectively extend their patents on drugs. One such approach involves manufacturing new (and separately patentable) medicines that simply further purify the active chemical substance, or they make minor changes to its structure, a strategy known as evergreening. The Drug Price Competition and Patent Term Restoration Act (also known as the Hatch-Waxman Act) of 1984 provides patent holders of FDA approved drugs with a lengthened term of patent protection to compensate for the time involved in running clinical trials as well as obtaining FDA review and approval. This can add as many as five years of extended patent protection. The intention of the Act was to encourage drug industry innovation by guaranteeing that patented drugs could be sold for a long enough period of time to make them profitable for drug makers. Calculating how long it will take for a drug to become profitable before it even comes to market remains more art than science, and some poor selling drugs likely never recoup their development costs.
Patent coverage extensions can play a significant role in protecting drug revenue streams. In a well-documented case, The Medicines Company missed a patent extension deadline by a couple of days in 2001 for their blood thinner bivalirudin (Angiomax). This legally permissible extension was meant to compensate for the patent time used up while the FDA reviewed their drug application. Unfortunately, this minor clerical error (by outside counsel) had the potential of costing the firm almost five years of patent protection and nearly a billion dollars in lost drug sales. The Company spent millions of dollars lobbying Congress to pass legislation (sarcastically referred to as “The Dog Ate My Homework Act”) that would retroactively correct for the filing mistake. The Company commissioned studies that purported to show that a longer patent life for Angiomax would actually save the health care system billions of dollars because the drug is associated with a lower risk of bleeding than a competing medicine that sells for a significantly lower price. However, an independent analysis by the Congressional Budget Office came to the opposite conclusion. They estimated that extending the patent would actually cost hospitals (and thereby consumers) an extra $1B over a seven-year period. In 2012 The Medicines Company finally obtained their patent extension, which will enable them to reap a very large return on the money they spent on lobbying and litigation.
You may have noticed that biopharmaceutical firms seldom miss an opportunity to report just how expensive it is to develop new medicines. While many question industry-provided numbers, there can be little doubt that this lengthy and laborious process really can cost big bucks. However, individual drug prices do not appear to be directly tied to their development costs. According to an analysis by pharmaceutical analyst Richard Evans (as quoted in a Forbes article), drug price increases accounted for nearly half of U.S. pharma sales growth since 1980, and 145% of U.S. sales growth over the last half decade. Price increases, and not new, innovative medicines, accounted for a significant percentage of the profits earned by drug companies. This illustrates the tremendous pricing power that monopolies provide.
It has been suggested that drug prices would be considerably lower if patent holders (i.e. drug companies) had a significantly longer period of time to recover their considerable investments in bringing their medicines to market. I’m not an economist, but you don’t need to know the difference between Adam Smith and Adam Sandler to get a sense that lengthening drug patents might not really lead to decreased drug prices. My expectation: biopharmaceutical companies will simply keep prices high and milk their cash cows for a longer time period. These arguments regarding patent length have mostly been hypothetical because drug patents generally aren’t extendable to a large degree. Having said that, we now have a real-world opportunity to observe what at least one company did after receiving a significant (15 year) extension to their patent coverage. The company is Amgen, and the patent is on the blockbuster rheumatoid arthritis drug etanercept (Enbrel). How has this situation come about?
Amgen acquired Enbrel when they purchased the biotechnology company Immunex in 2002. U.S. sales of this drug are currently running approximately $4.2 billion per year. Immunex’s original patent on Enbrel was issued in 1996 and is due to expire in 2013. The drug itself was not approved for sale in the US until late 1998, and Amgen didn’t acquire the rights to this drug until they purchased Immunex. Revenues on the drug have been shared with their partner Wyeth (now part of Pfizer), although this profit-sharing arrangement ends in October 2013, at which time all profits will accrue to Amgen.
In late 2011, however, Amgen received a new U.S. patent on etanercept (via a patent application that Immunex had licensed from Roche) that extended its legal protection until 2028. This newly issued patent effectively hinders the future entry into the U.S. marketplace of biosimilar (i.e. generic) versions of this blockbuster from companies that include Celltrion, LG Life Sciences, Merck/Hanwha Chemical, and Mycenex. These drug makers may choose to fight this new patent, or attempt to develop derivatives of this medicine that will enable them to get around it. This will be costly, however, because alternative versions of Enbrel will likely need to undergo clinical trials before the FDA would approve them for sale.
The lengthy patent extension—which could end up giving Amgen a 30-year monopoly—raised an obvious question: would it lead Amgen to lower the price of Enbrel? I can imagine that the response from any drug company in this situation would be to say that they couldn’t reduce drug prices because:
1) Their patent could be declared invalid or found to infringe another patent.
2) Competitors could develop a better product and take away market share, so they need to keep the price high.
3) Their company needs the income to recoup additional legal expenses that were incurred in order to get the longer patent coverage.
4) New rules in places like India and China allow the government to award compulsory licenses to competitors to make and sell patented drugs, potentially putting future revenues derived from other portfolio drugs sold in those countries at risk.
5) Sales were originally shared with another company, so revenues to their company were not “maximized” and therefore need to be recouped going forward.
Each of these rationalizations sounds logical, and all but the last one would clearly apply to nearly every drug already on the market. These same explanations could also be trotted out to justify why drug prices on products with theoretically longer patent lives (30, 40, or even 50 years, for example) could not be lowered.
Drug pricing is an extremely complicated topic, and figuring out the “correct price” of a particular drug can be challenging. Check out some of the proposed new rules associated with the Affordable Care Act to see just how problematic this can be. What exactly defines a drug’s price? Are we talking about the retail price in a pharmacy? The price paid by Medicare? By hospitals? The average wholesale price? Does “bundling” this drug’s sales with other medications affect the price that patients will pay? How do Big Pharma’s “Payment Assistance” and new co-pay coupon programs factor into these numbers? What percentage of patients actually qualifies for these discounts?
Drug prices have deliberately been made difficult to find, with obfuscation trumping clarity as the industry standard. Buying drugs, it turns out, most closely resembles the process for purchasing airline tickets and hotel rooms: there appears to be no real set price. What you shell out is different from what your neighbor pays, and few people really fork over the full (unlisted) price. The AWP (Average Wholesale Price) is the most often used cost benchmark, but because this number differs significantly from the real prices that are often paid for a drug, it is often derisively referred to as “ain’t what’s paid”.
Enbrel faces considerable competition in the marketplace from other anti-inflammatory medicines that bind with the TNF molecular target, as well as drugs that act through different mechanisms. One competitor, Abbott’s adalimumab (Humira), is poised to become the best selling drug in the world now that Lipitor has gone off patent. A product that might drive down the price of all injectable TNF inhibiting biologics, including Enbrel and Humira, would be an orally active rheumatoid arthritis medicine. Pfizer’s experimental drug tofacitinib (which has a unique mechanism of action) was recently recommended for approval in this disease indication by an FDA advisory panel, and awaits a final decision from the agency. Its price (compared to currently marketed drugs), in addition to its relative safety, efficacy, and convenience, will likely factor into whether or not this oral medication will be widely adopted if it is approved.
Let me answer the question that I posed above: Did Amgen lower the price of Enbrel, a core constituent of its drug portfolio, once they were awarded the extended patent coverage? Obtaining this information took considerable effort, as drug-pricing data is almost as tightly guarded as US nuclear launch codes. Several local pharmacists couldn’t supply the answer, and major drug distributors Cardinal Health and McKesson wouldn’t share the information. Numerous calls to various Amgen customer information numbers were unproductive, but perseverance paid off and a helpful Amgen representative finally provided me with the number: The average sales price of Enbrel actually increased by 9.8 percent from 2011 to 2012.
Anyone shocked by this news clearly hasn’t been paying attention to healthcare issues in general and drug prices in particular. Any scientist will tell you that it’s always better to have more than a single data point when evaluating information, even in pharmaceutical economics. If you know of other drugs that received extended patent coverage for some reason, please cite the example and let us know whether the price increased or decreased thereafter. The cost of our medicines are derived from a complex formula that combines elements of innovation, perceived value, rationalization, regulation, competition, duration, and good old-fashioned greed. The trend, however, is ever upward at an unsustainable rate, and despite all of the chatter about the “patent cliff”, the industry remains highly profitable. The current crisis that is reshaping the biopharmaceutical industry is due to a number of different factors, but the length of drug patents does not appear to be one of them.
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