IP Navigation Group founder and owner Erich Spangenberg made good on his pledge to publish substantially complete petitions for inter partes review of weak drug patents today with one targeted at Depomed Inc.’s Nucynta pain medication.
The draft IPR petition was published on Spangenberg’s Spangenblog under a post titled “Evergreening and Nucynta Pain Medication—Here’s How to Drop the Price of Nucynta Sooner.”
Evergreening is the practice of drug companies filing patents for incremental innovations designed to extend the life of previous patents that would otherwise expire. Rather than representing a novel innovation, they typically involve a different dosage level or something similar.
The Coalition for Affordable Drugs, which is led by billionaire J. Kyle Bass and his hedge fund Hayman Capital Management and Spangenberg, has made evergreening a cause for criticism in two IPR petitions against Biogen Idec and one against Vimovo.
The patent at issue in the draft IPR petition is U.S. Patent No. 7,994,364, which is the base patent for Nucynta. Depomed bought Nucynta and the underlying patents from Johnson & Johnson earlier this year and promptly raised the price by 44%, according to Spangenberg.
Chris Keenan, a spokesman for Depomed, wasn't aware of the draft IPR and declined to comment.
“Nucynta was approved in 2008, and the ‘extended release’ version was approved in 2011,” Spangenberg said in his blog post. “Today, these medications cost about $7,000 per year — up from more than $3,000 when the medication was first launched. That’s a 133% increase in seven years — at a time when inflation’s been running about 2% a year.
Depomed’s business strategy of not investing in developing new drugs and buying old ones and raising prices flies in the face of what pharmaceutical companies preach about high drug prices being needed to foster expensive and risky research.
Spangenberg noted that of the five medications currently offered by Depomed, only one was developed internally.
“As discussed in the draft IPR petition attached inconsistent statement were made during the prosecution of the ‘364 patent in the U.S. and Europe, wirth respect to the active ingredient in Nucynta and Nucynta ER,” Spangenberg said. “We caught this, had experiments conducted, and confirmed this deception. It will now likely come back to bite Depomed.”
Soangenberg said the draft IPR will not be filed or funded by him or the coalition.
“Feel free to use this free of charge. If you’re so inclined, make comments in the comments section below. You can also send comments to us at firstname.lastname@example.org.”
He also promises to make available expert declarations and related experimental data to support the IPR.
“If you’re a law firm or expert that would like to help put an end to ever greening and other bullshit practices like buying old drugs and implementing huge price increases, we are happy to connect you with interested filers.”
He added that the ideal filer would be a charitable organization, law school, or consumer focused action group, which would be able to avoid the accusations of filing the IPR for a profit as has been hurled at Bass, Spangenberg and the coalition.
Spangenberg also noted that he doesn't have a long or short position in Depomed.
In an emailed statement, Spangenberg said Hayman Capital is not involved in any way.
"No one is trading for/with me," he said. "I have been in contact with two foundations and one law school clinic [not giving out names]."
Patent market observers said the draft IPR crusade was novel and would be interesting to watch.
"I have never seen anything like this before," said Brian Pandya, a partner with Wiley Rein LLP in Washington, D.C. in an interview. "Evergreening has been the subject of criticism for years but so far no one's had any luck challenging it. With PTAB judge's expertise it will be interesting to see if they carry the day."
Carrying the day may be difficult, however, without a profit motive, according to Ashley Keller, a managing director of Gerchen Keller Capital in Chicago.
"Is someone else going to fund the prosecution of theIPR and pay the filing fees? It's not going to be me. I only do things for a profit. I'm a capitalist. Every patent that gets invalidated is challenged by someone with a financial interest."
Asked whether a profit motive might be necessary to get the draft filed, Spangenberg said "cost will not stand in the way of getting this done. To be clear—someone with a profit motive could file — I would prefer a foundation/clinic, but it is free for anyone to use."
—To reach the reporter responsible for this story please contact Dan Lonkevich at 707 318-7899 or at email@example.com