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Q&A

PATENTS | July 18, 2007

A Thorn in Pharma's Side

Patent watchdog Dan Ravicher touts the need for patent reform after getting the U.S. government to review Gilead's patents for its leading HIV drug.

DANIEL S. LEVINE

Patent reform efforts are threatening to make it harder for pharmaceutical companies to win protections for the products they develop, but a nonprofit legal services firm is not waiting for reforms. It's seeking to invalidate patents it feels should never have been granted in the first place.

The Public Patent Foundation is challenging the validity of four patents on Gilead Sciences' tenofovir, a leading drug used to treat HIV and AIDS. On Wednesday the group said the U.S. Patent and Trademark Office granted its request to review the patents. If successful, the challenge could end Gilead's exclusive rights to produce the drug well before the 2017 expiration of the patents. Marketed as Viread, tenofovir is also part of the Foster City, California-based company's combination therapy Atripla.

The New York-based nonprofit legal services firm mounting the challenge argues that the patents should not have been granted because there was existing work that would have allowed someone skilled in the area to have developed the drug.

Gilead investors seemed unshaken by the news. Shares in Gilead closed at $39.34, up 11 cents on Nasdaq on Wednesday. In a prepared statement, the company called the PTO's move a technical matter that it would be able to resolve with the office. "We don't believe it threatens the substance of our intellectual property protection for Viread or our other HIV products, " the company said. The patent office's review can take up to two years and if it decides to overturn the patents, Gilead could then mount a legal challenge, which could take another two years.

The latest challenge follows a high-profile case in which the Public Patent Foundation last year brought a challenge to three Wisconsin Alumni Research Foundation's stem cell patents on behalf of the Foundation for Taxpayer and Consumer Rights. In 2005, the foundation challenged one of the patents underlying Pfizer's blockbuster cholesterol-lowering Lipitor.

Dan Ravicher, executive director of the Public Patent Foundation, spoke with The Journal of Life Sciences web editor Daniel S. Levine about the reexamination of the Gilead patents, what he sees as problems with the patent system, and the likelihood of reforms. Edited excerpts follow.


Q: What's the concern here? Is it that because these patents may have wrongly been issued it's preventing access to these drugs?


A: The patent system is supposed to incentivize and reward innovation and innovation isn't just doing something new, it's actually doing something that is not obvious, even if it is new. If you give patents to people who haven't done innovation, they get the benefit of the patent, but society doesn't get any benefit of innovation. I'm a firm believer in the patent system, but for it to work correctly, you have to make sure it rewards the people it's supposed to reward and doesn't reward the people who don't deserve it. On this basis, patents are undeserved by Gilead and therefore they shouldn't exist. They should have no monopoly over tenofovir.


Q: Do you think patents in the pharmaceutical industry have been issued too easily?


A: Patents across the board have been issued in the last decade or so under increasingly lax standards and that's because the special interest who benefit from patents have captured not only Congress, but also the courts, to get very favorable law, which basically over time has eroded the bars to getting a patent and made it easier and easier and easier and that's been across all technological subject matter.


Q: I think the pharmaceutical industry would argue that patents are critical to allowing for innovation and ensuring that there are adequate incentives for taking the type of risks needed to develop new drugs?


A: To some extent I completely agree. There are plenty of patents out there that we don't challenge. But if someone's got a patent on the No. 2 pencil or aspirin that they don't deserve, you can't say that patent incentivized innovation.


Q: In terms of the patent system, what would you say is wrong and how do you fix it?


A: The biggest overarching problem with the patent system is that it takes into account too much the interest of the patent holders and the patent attorneys and does not take into account enough the effect it has on the public. Basically, it puts the private benefit from the patent system above the public benefit. In my view, the patent system's goal ultimately is to benefit the public. Although you may need to benefit private entities as an intermediate step, that's not the ultimate goal. I think today's patent system sees its ultimate goal is to make companies rich and if it makes companies rich, than it's working just fine.


Q: What would you do to change it?


A: There's lot of things. I've testified to Congress twice and I have a long laundry list. There's no one single quick fix. There are lots of different things to do. There's this thing called continuations. It allows applicants who get their application rejected to simply pay a fee to force the patent office, the patent examiner, to withdraw the rejection. They can do this an unlimited number of times. That's just ridiculous. That's a big problem. The patent office is trying to do something now. They received a lot of push back from patent holders.


Q: I take it damages are another concern?


A: Damages are out of whack. Patent holders deserve to get paid a fair amount for innovation, but they don't deserve to rob people blind. If someone invented the MP3 format and someone is selling software that does all sorts of thing—word processing, surfing the Internet and yes, it plays MP3s for $100, I don't think that patent holder deserves $10 or $20 dollars of every $100. But our patent system's current damage awards are quite perverse in that way in giving people more money than they actually deserve. I'm not saying they don't deserve anything, but it should just be fair.


Q: My sense is that the high-tech industry and the pharmaceutical industry have been at odds here on the issue of patent reform.


A: Generally speaking, that's right. There are several high-tech companies that are actually on the side of the pharmaceutical companies like GE and Philips Electronics. And there are some life sciences companies like small biotech on the IT side, but generally that's correct.


Q: Why is that?


A: The two industries products have vastly different numbers of patents, which apply to each product. On the pharmaceutical side, you can have three or four patents that apply to each product. In the IT industry, you can have thousands of patents, which means patents are less important to the IT industry.

The other issue is that it's easier for a greedy, arbitrageur to get a patent related to information technology. They can sit at home and one weekend and write some code and say I invented a method of buying things in one click and I'm going to get a patent. It's much harder for that same guy in a weekend to come up with some new pharmaceutical compositions.


Q: How close do you think we are to seeing major patent reform?


A: Nowhere close. It won't happen. The best that will happen is they'll get some compromise in some ways that will be of little value that will be presented as significant reform, but won't be. The biggest area they are making reform on now is litigation reforms, venue and stuff like that. There may be constitutional issues about whether or not what Congress is trying to pass would comply with the constitution. I have no faith. I'm a skeptic about legislation.

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