Biosimilars Council Opposes IP Provisions in Trans-Pacific Partnership

The provisions in the Trans-Pacific Partnership (TPP) dealing with patent exclusivity periods are diametrically opposed to the main goals originally outlined in the Biologics Price Competition and Innovation Act of 2009 in the Patient Care Protection and Affordable Care Act, the Biosimilars Council wrote in an open letter to President Obama on July 27, 2015.

The council said that an item in the TPP granting pharmaceutical manufacturers 12 years of patent protection for biologics unfairly promotes branded medications over generic drugs and would restrict consumer access to affordable medications on a worldwide scale. Citing Senate Finance Committee estimates, the New York Times reports that among the 12 TPP countries, there are 5600 drugs currently in development-900 of which are biologics.

"The current text only advances the interests of the brand industry, preventing market entry for lower-dose pharmaceuticals in a number of ways, including patent linkage, patent extensions, and increased exclusivity periods,” the letter said. “As we work to promote trade around the world, we simply cannot let this flawed framework stand and potentially serve as a precedent for future agreements." At its conclusion, the letter requests that the TPP contain language regarding patent linkage, patent extensions, and exclusivity.

Earlier this month, Reps. Rosa DeLauro (D, CT) and Jan Schakowsky (D, ILL) also expressed concern about the TPP, saying that proposed changes to the drug approval process delineated in the TPP have the potential to delay generic drugs from being released in the market. The representatives are concerned the TPP would promote the practice of evergreening, a process through which pharmaceutical companies can extend the life of their patents by making slight formulation changes to products-changes which some opponents of the practice say do not often translate into clinically meaningful therapeutic benefits. Additionally, there is some concern that the TPP partners-consisting of Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam-will not comply with all of the rules set forth by the TPP agreement. Congresswoman DeLauro wrote in a separate letter to the President on July 29, 2015 that, “even if Congress were to pass implementing legislation for the TPP, it would not go into effect unless and until the other nations conform their laws, policies, and practices to the US understanding of the TPP requirements.”

Reps. DeLauro and Schakowsky, along with Rep. Louise Slaughter (D, NY), released the following statement about the leaked intellectual property section of the TPP: “The text proves that the Administration has essentially worked as a lobbying arm of Big Pharma, working to extend some of the patents and cripple the generic-drug industry with unnecessary regulation. We will continue to demand that this agreement be released from the shadows into the light of day so that the American people can see what is being negotiated on their behalf, against their interest.”