On July 6, the Department of Justice (DOJ) filed a brief in the U.S. Court of Appeals for the 2nd Circuit expressing a new DOJ view on pay-for-delay settlements. The brief urges the 2nd Circuit to regard pay-for-delay settlements as “presumptively unlawful under Section 1 of the Sherman Act.” While the DOJ has not always supported a presumption against legality for these settlements, the Federal Trade Commission (FTC) has long been adamant that such settlements are unlawful. Now, more than ever before, the DOJ and the FTC seem to have a similar perspective on pay-for-delay settlements.

The July 6, 2009 brief filed by the DOJ signifies a stark departure from the Bush administration’s position. In 2006 and 2007, the DOJ urged the Supreme Court to refuse to hear two cases involving pay-for-delay settlements, involving the drugs K-Dur and Tamoxifen, because the DOJ felt these settlements were legal. In its latest brief, the DOJ states that “[r]everse payments are scarcely essential to the voluntary settlement of patent disputes.” The DOJ brief then goes on to discuss how such settlements have reduced the affordability of prescription drugs for consumers. The DOJ emphasized that it was not taking a stance on the specific settlement in the case at bar, involving the antibiotic drug Cipro, but made a more general statement about settlements including payments to the alleged patent infringer to keep the generic drug off of the market. The brief echoed earlier statements of Christine Varney, the new Assistant Attorney General, who announced during her confirmation hearings an intent to “align” the position of the DOJ with that of the FTC.

During a speech last month at the Center for American Progress, FTC Chairman Jon Leibowitz estimated that prohibiting pay-for-delay settlements would save consumers $3.5 billion per year. The anti-pay-for-delay sentiment in the FTC and DOJ has also reached Congress. Two bills in Congress, S.369 (introduced by Sens. Herb Kohl (D-WI.) and Chuck Grassley (R-IA)) and H.R. 1706 (introduced by Rep. Bobby Rush (D-IL-1.)) would help bring generic drugs to market sooner. These bills would prohibit brand name and generic drug companies from entering into agreements in which the brand name company pays off the generic company in return for the delay of the generic onto market. You can find out more about this legislation here.

The European Union also recently investigated the legality of pay-for-delay settlements. The EU study found that it took an average of seven months after expiration of the brand name company’s patent for a generic drug to come to market. This delay cost consumers about 3 billion euros (roughly U.S. $4.2 billion) from 2000 to 2007. You can read more about the EU investigation in the NY Times. http://www.nytimes.com/2009/07/09/business/global/09drug.html

Readers of this blog know that we here at PAL are no fans of Nexium, AstraZeneca’s [NYSE:AZN] blockbuster drug for erosive esophagitis, heartburn and Gastroesophageal Reflux Disease (GERD). Nexium, a so-called “proton pump inhibitor,” is the successor to Prilosec, and is essentially no better than Prilosec. Nexium is the brand name for the chemical known as esomeprazole. It is the “S-enantiomer,” or chemical mirror of Prilosec, or omeprazole. The main difference is that Nexium has three yellow stripes. But it’s more than 8 times more expensive than Prilosec, which is now available Over-the-Counter. (Today, the price on drugstore.com for 30 tablets of Nexium 20 mg was $164.31, and a box of 42 tablets of Prilosec was $26.99 – that’s $5.47 per pill for Nexium, compared to 64 cents a pill for Prilosec, meaning you could get 8.54 Prilosec pills for the same price as one Nexium.)

The bottom line is that millions of people take Nexium, and pay dearly for the privilege, when they would do just as well with a cheaper generic Proton Pump Inhibitor, over-the-counter Prilosec, or another over-the-counter heartburn medication like Pepcid, Zantac or plain ol’ Tums. And why do they take Nexium? Overwhelmingly because of the aggressive marketing that Astra Zeneca pours into it, directed at both consumers (TV ads, magazine ads for “The healing purple pill”) and physicians (through pharmaceutical salespeople).

In 2005, we here at Prescription Access Litigation gave Astra Zeneca one of our Bitter Pill Awards for Nexium, the “The Least Extreme Makeover Award: For Dressing Up an Old Drug with a New Name and a New Price Tag.” A number of PAL member are also involved in lawsuits against AstraZeneca for allegedly deceptively marketing Nexium as an improvement over Prilosec.

So we regard last week’s news that Ranbaxy Laboratories got tentative approval from the FDA to market generic Nexium (esomeprazole) with some amazement. Does the world need a generic version of Nexium? If it’s the same as Prilosec, isn’t it unnecessary? Aren’t the seemingly innumerable numbers of heartburn drugs on the market enough, particularly since they don’t differ all that much in terms of how effective they are?

The answer is, that’s beside the point. A generic will be introduced because the market for Nexium is huge — $5.2 billion in annual global sales, according to a Reuters article. If and when generic Nexium comes on the market, there are millions of people with prescriptions for Nexium who will have that prescription automatically substituted with a generic, saving them money, and giving them exactly the same level of relief. So isn’t that a good thing?

Perhaps. Generics are terrific. Consumers should use generics more than they already do. The obstacles that brand-name drug companies put in the way of generics coming to market (frivolous patent lawsuits, frivolous FDA petitions, authorized generics, reverse payment settlements, etc.) should be prohibited. Generic drug companies should challenge bogus patents. While that’s all true, a generic version of a drug that the world never needed in the first place feels like a hollow victory. I’d rather see the pharmaceutical industry focus on genuinely innovative treatments that don’t just duplicate — often exactly — treatments that already exist, or yet another “extended relief”/once a day/once a month version that’s just aimed at preserving market share. Then I’d like to see generic versions of those truly breakthrough treatments become available as soon as valid patents on them expire, without unnecessary interference by the brand-name holder of the patent.

My worries of course are probably premature. The FDA only granted tentative approval, not final approval. Astra Zeneca has no intention of letting its cash cow go without a fight. If and when the FDA grants final approval, you can be sure that Astra Zeneca will sue Ranbaxy for patent infringement before the final approval letter is even out of the envelope. As AZ’s CEO said recently:

“Our position has been we have strong intellectual property and we intend to defend it and stand behind it. Obviously, we have options available to us. We always explore options that are available but it’s clear to us that we have an intellectual property argument to make and we are making it.”

So, dear Readers, what do you think? Does the world need a generic Nexium? Post your thoughts in the comments.