Depomed

Evergreening and Nucynta Pain Medication

As we announced on this blog a few days ago, we’re making draft inter partes review (IPR) documents available for anyone who wishes to use them to challenge patents for certain drugs that we find overpriced and protected by seemingly invalid patents.

An IPR is an administrative procedure at the United States Patent and Trademark Office (USPTO) to challenge the validity of a patent. The Patent Trials & Appeals Board (PTAB) is the particular administrative body at the USPTO that handles the review of IPRs. We now know from a recent ruling that anyone can file an IPR – the filer’s motives, intent, status as a competitor, lack of altruism and all the other specious arguments raised by pharma are simply irrelevant.   Now we know “anyone” actually means anyone.

The first draft IPR document we’re releasing is for Nucynta and Nucynta ER — medications used in the treatment of chronic pain that are currently marketed by DepoMed, Inc. It’s available here.

Nucynta was approved in 2008, and the “extended release” version was approved in 2011. Today, these medications cost about $7,000 per year — up from less 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% per year.

Depomed’s Business Strategy

Depomed’s business strategy is to buy lesser-known drugs and then massively increase the price of those drugs immediately after acquisition.

When Depomed bought the rights to Nucynta and Nucynta ER in 2015 from Johnson & Johnson, the first thing the company did was raise the price by 44%.

Pharmaceutical companies love to argue that high drug prices are critical to support research. But of the five medications currently offered by Depomed, only one was developed internally.

According to the company’s 2014 Annual Report, Depomed slashed spending on R&D from $15m in 2012 to $7m in 2014 — while revenues have gone up from $90m to $390m.

Revenues up, research down. That’s not the way pharmaceutical companies say it’s supposed to work, but from a business perspective, it makes a lot of sense: why spend time and money on tedious research to invent something new to benefit the public when you can buy up old drugs, jack up the prices, and pocket the profits?

Nucynta’s Patent Protection

The FDA’s Orange Book is a list of approved drugs. The information in the database includes which patents supposedly protect each drug and when they expire.

Nucynta is protected by three Orange Book patents. Nucynta ER (the extended release version) is protected by eight Orange Book patents.

The longest-dated patent currently claimed to cover Nucynta expires in June 2025 and is designated as US Patent No. 7,994,364 (the ‘364 patent).  The ‘364 patent is probably invalid. There is one patent with a later expiration date than the ‘364 that covers Nucynta ER, but we’ll discuss that in a future post.

As discussed in the draft IPR petition attached, inconsistent statements were made during the prosecution of the ‘364 patent in the US and in Europe with respect to the active ingredient in Nucynta and Nucynta ER. We caught this, had experiments conducted, and confirmed this deception. It will now likely come back to bite DepoMed.

Draft IPR

The draft petition is available in Word format here and a PDF version is available here. Feel free to use this free of charge for any purpose.

If you’re so inclined, make comments in the comments section below.

You can also send comments to us at info@nxn.com with “Nucynta” in the subject line.

Or you can create your own community to deal with this issue and leave us out of it.

If you’re interested in filing the IPR petition, we can make available two expert declarations and related experimental data in support of the petition.

If you’re a law firm or expert that would like to help put an end to evergreening and other bullshit practices like buying old drugs and implementing huge price increases, we are happy to connect you with interested filers.

The ideal filer would be a charitable organization, law school, or consumer-focused action group — but perhaps someone will come up with other ideas.

To be clear—I do not hold a long or short position in Depomed. I’m not asking for – nor will I accept – compensation from anyone for this petition or related declarations: it’s all now public property.

I’m hoping that additional IPR filings will help stop the US Patent Office from continuing to over-indulge the pharmaceutical industry — at the expense of patients and the American taxpayers.

If the United States Patent Office would do its job and stop bending its knee to pharma by permitting evergreening and holding pharma IPRs to higher legal standards than other technologies, drug prices would fall. As politicians look for ways to lower drug prices, let’s hope they keep this in mind and encourage the US patent office and the PTAB to do its job.

Our guess is that few Americans are familiar with the USPTO, and even fewer have heard of the PTAB—but perhaps as more become familiar with evergreening they will reach out and let politicians, the USPTO, and the PTAB know they are not fans of evergreening, and that it needs to stop.

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September 29th, 2015|Categories: Pharma|Tags: , |1 Comment