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Did Orexigen Have The Right To File Its Controversial Patent?

This article is more than 8 years old.

Shares in Orexigen Therapeutics, the maker of a weight-loss drug called Contrave, have dropped 24%  to $5 since Tuesday, when news came out that data that the drug maker had originally presented as showing Contrave prevented heart attacks and strokes were part of a study that, in the end, showed no such thing.

The news was initially disclosed in a patent that was granted and published on March 3, which caused the stock to jump from $5.94 to $8.50 in a day. But the trial's lead investigator, Steven Nissen of the Cleveland Clinic, and the Food and Drug Administration both complained publicly that the release was improper and premature and that the data were likely to be misleading. They were: the supposed cardiovascular benefit went from 41% to just 12%, and was no longer statistically significant, as the trial continued. It will never finish: Nissen and its leadership recommended stopping it because Orexigen released the early data publicly.

Orexigen was publicly critical of my reporting, but has not returned multiple requests for comment. I contacted the company for this story at 3:41 p.m. yesterday and have not received any response. But Mike Narachi, Orexigen's chief executive, has been talking to Wall Street analysts, explaining why investors should not be concerned about these new developments.

In particular, Narachi spoke with Simos Simeonidis, the biotechnology analyst at RBC Capital markets. From a note Simeonidis sent to investors:

We spoke with Orexigen's CEO, Mike Narachi, who told us he "adamantly refutes the assertions that the company misled investors and patients." He was defiant in regards to today's news and defended Orexigen's handling of the LIGHT trial data. He told us that there was a data access plan in place, it was followed, and it actually had provisions for filing of patents; in fact, Orexigen had notified the FDA in advance and "the filing of the patent that unblinded the study was not a surprise to anyone."

In other words, Narachi argues, Orexigen was allowed to file the patent under the data access plan, and so Nissen and the other experts involved in the clinical trial have no right to be angry.

I asked Nissen about this. He said that there was a short mention of filing a patent in the 14-page document, and then went to check with Thomas Fleming, the meticulous University of Washington statistician who ran the trial's data safety monitoring board, charged with protecting patients as the trial progressed. Here is what Nissen said:

[Thomas Fleming] reminded me of what the actual discussion was. They said look, we want to be able to file a patent related to the ruling out of 2.0, what Fleming said with the discussions was yes, you can have access to the data, and once you have submitted, if you want to make a claim related to ruling out a doubling of risk that is acceptable because that is not revealing any data that is not in the public domain.

You can make any claim that is related to what is actually allowed on the understanding that your data have to rule out 2.0. It was absolutely clear, it came up, it was discussed, and that was the entire extent of it. He said, I don’t know how many times we said to them you cannot release the interim data.

Nissen says that what the statement really referred to was verifying "knowledge of threshold" -- that the first 25% of the study had ruled out Contrave doubling the risk of heart attacks and strokes -- or worse. This analysis did that, but was meant to be kept secret, according to public statements made by Nissen and Fleming at an FDA meeting that Orexigen representatives attended. But Nissen says it just meant that Orexigen could file for a patent based on excluding a doubling of risk. "It doesn’t mean the exact data in the trial can be published," Nissen says. "We work with industry with the expectation that there is not an effort to game the system."

Neither Nissen nor Orexigen (which was sent Nissen's exact statements) was willing to make public the actual text of the data access agreement. But Nissen argues that a reading of the document that would allow Orexigen to publish all of its data in a patent would go against the rest of its 14 pages. “The document doesn’t let them share it with business partners or with their own board," Nissen says. "Why would we allow them to publicly release it in a patent?”

It seems worth noting that, before the data were released publicly, Orexigen did share them with more than 100 people, according to the FDA. This, not the later disclosure, was what led the FDA to say the trial was no longer scientifically rigorous enough to satisfy a requirement that the company test Contrave's cardiovascular safety.

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