CAPA: Strengthening Patent Quality Key to Lowering Prescription Drug Costs, Protecting Legitimate Patent Holders

Commends Senator Tillis and the Senate Judiciary Subcommittee on Intellectual Property for holding hearing & shining a light on the important issue of low-quality and invalid patents.

WASHINGTON, D.C. –  The Coalition Against Patent Abuse, a diverse coalition of healthcare providers, consumer groups, patient advocacy organizations, free market advocates and others released the following statement commending U.S. Senator Thom Tillis (R-NC) and the Senate Judiciary Subcommittee on Intellectual Property for holding today’s hearing on preventing the spread of low-quality and invalid patents.  CAPA is also calling on Congress to reform the current system by strengthening the inter partes review (IPR) process, which would protect legitimate patent holders while benefitting patients who are being harmed by high drug prices. 

The following statements are attributable to Mathew Lane, Executive Director of the Coalition Against Patent Abuse:

“CAPA commends Senator Tillis and the Senate Judiciary Subcommittee on Intellectual Property for holding this hearing on the critical topic of eliminating low-quality patents.  Brand-name drug companies routinely make use of low-quality patents to game the patent system and protect their drug monopolies and profits at the cost of the taxpayer and patients.”

“As we saw in the cases of Namenda and Zytiga, when low-quality patents are challenged, they can be found invalid, benefiting American patients, the market, and the patent system.  But patients shouldn’t have to wait, and at today’s hearing we’ve heard proposals that would reduce bad patents from issuing in the first place.  This was an important hearing but now it’s incumbent on Congress to take real action and reform this broken system.”

Under the current system, it often takes a long time and great expense to invalidate a low-quality patent. Patients do not get the benefit of generic competition during that time.  In short, patients pay more.  Here are two examples:

1. Namenda – Forest Labs began Hatch-Waxman proceedings against generic patent challenges to the extended release version of their Alzheimer’s drug on February 2, 2014.  The Federal Circuit found several claims of at least 5 patents invalid on December 11, 2017. The first generic came to market shortly after on February 21, 2018.  Today, a month’s supply of maximum strength Namenda XR costs $468 for the brand and $87 for the generic.

2. Zytiga – On December 4, 2015, the first IPR petition was filed on a new patent obtained to block entry of generic competition on a prostate cancer medicine.  Two more IPR proceedings and a court case were filed and all found the asserted claims invalid as obvious.  The last decision in the case found for the generics on May 14, 2019, clearing the way for generic entry.  The original drug patent expired in December 2016, and Baltimore issuing to recover damages from the use of a “sham” patent.  Today a month’s supply of the brand goes for $10,786 while the generic goes for $1,836.

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