Posts Tagged: "Trans Pacific Partnership"

President-Elect Donald Trump has announced that he will withdraw the United States from the Trans-Pacific Partnership (TPP) agreement on his first day in office. So ends more than five years of often heated negotiations led by President Barack Obama’s administration as part of an overall strategy to strengthen the US position in the Pacific Rim region… Pulling out of the TPP is a missed opportunity for the US to pursue its IPR agenda in the Pacific Rim economies.

Given the importance of intellectual property rights to economic growth and technological development, as well as the wider benefits of biopharmaceutical research, the provisions found in the recently negotiated Trans-Pacific Partnership (TPP) Agreement to protect biologic medicines are disappointing… As clinical trials become increasingly costly, these costs are increasingly born by the biopharmaceutical industry. A recent study from the Johns Hopkins Bloomberg School of Public Health calculates that the biopharmaceutical drug and medical device industry now funds six times more clinical trials than the federal government.

Now it is time for Trump to call for a vigorous debate on the Trans Pacific Partnership Treaty (“TPP”) to demonstrate his expertise on matters of strategic national and international economic importance. The TPP, now pending before Congress, makes many changes to the US patent system and some in Congress such as Senators Orrin Hatch (R-UT) and Rob Portman (R-OH) have already expressed opposition because of how it weakens American intellectual property rights. Trump should challenge Senators Rubio and Ted Cruz to debate the TPP with their Senate colleagues now rather than wait for the lame duck Congress, when many politicians newly unaccountable to voters could do strange things.

Patents, intellectual property, innovation and technology policy may not decide who will become the next President of the United States, but the positions the candidates hold will greatly impact the industry, and a U.S. economy that is increasingly an innovation based digital economy.

The language of the Trans-Pacific Partnership’s ostensible provision on Government Use of Software (Article QQ.H.11) is short and relatively straight-forward. This article examines the Trans-Pacific Partnership (TPP) Intellectual Property (IP) Chapter Article QQ.H.11, “Government Use of Software,” now available via WikiLeaks.

It is already a criminal act in the United States to intercept and/or decode an encrypted satellite signal. See 18 U.S.C. §2511. Many in the United States may not realize that similar provisions criminalizing interception of an encrypted program-carrying satellite signal are included in Free Trade Agreements already concluded by the U.S., including the North American Free Trade Agreement. With Article QQ.H.9, one might be tempted to read Paragraph 1 as permitting the possession and use of a device which can receive and de-crypt a program-carrying satellite signal (without authorization of the signal’s lawful distributor), although any of the nefarious activities enumerated in Paragraph 1(a) would be criminal. However, Footnote 153 makes clear that receipt and use, or receipt and decoding of the signal are also distinct, criminal activities.

Globally there are approximately 7,000 medicines in development to treat and cure a wide variety of diseases. Of these, more than 5,000 are in development in the United States. It’s difficult to argue that the strength and success of the U.S. biopharmaceutical industry is uncorrelated with the IP protection available here. It is, therefore, disappointing that the recently negotiated Trans-Pacific Partnership (TPP) Trade Agreement fails to deliver sufficient IP protection for biologics. Much of the continuing controversy plaguing the TPP Agreement surrounds data exclusivity protection for biologic medicines and the future of the agreement may hinge on precisely this issue.

Trade partners negotiating the Tans-Pacific Partnership trade deal have reached an agreement. The agreement details have not been released, and likely will not be submitted to Congress for a mandatory review for at least a month, perhaps longer… Presently the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement reportedly knocks that term of protection down to 5 years. While the term of data exclusivity is not one in the same with reducing the term of market exclusivity, there is little doubt that more limited data exclusivity would likely lead to significant negative consequences for the bio-pharma industry.

An October 5, 2015 version of the Trans Pacific Partnership (TPP) Intellectual Property (IP) Chapter is now available on WikiLeaks. This article includes the entire text of the WikiLeaks-referenced TPP Section C: Trademarks. This article offers accompanying commentary together on the TPP’s trademark provisions together with thoughts on portions of the TPP text regarding Geographical Indications (GIs).

In order to reach an agreement the United States granted a key concession relating to biologics, which are advanced medicines made from living organisms. Presently the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement knocks that term down to 5 years. Sources have confirmed to me that a TPP deal that so substantially reduced biologic data exclusivity will face an uphill battle in Congress.

While patents protect innovations that are novel, nonobvious and useful, data exclusivity protects the extensive preclinical and clinical trial data required to establish new therapies as safe and effective. Regulatory data protection safeguards this data for a limited period of time, preventing competing firms from free-riding on the data that was generated at great expense. Specifically, biosimilar firms seeking regulatory approval are required to produce their own preclinical and clinical trial data to establish safety and efficacy, or wait the set period of time after which they are able to utilize the innovator’s prior approval in an abbreviated regulatory approval, eliminating the need for independently generated data.

The controversy swirling around the Trans-Pacific Partnership (TPP) Trade Agreement sheds light on two critically important but divisive issues: international trade and intellectual property protection for pharmaceuticals. One of the most significant sticking points in the negotiations is the issue of intellectual property protection for pharmaceuticals, specifically data exclusivity. Data exclusivity is a means of correcting a free-riding market failure, providing the innovative firms with a limited period of time in which data from clinical trials and other required testing cannot be used by competing firms to secure market access.

To listen to the critics, one would believe that the Trans-Pacific Partnership (TPP) Trade Agreement marks the end of the world for global health, especially for the poor. They are, in a word, wrong. Admittedly, the TPP Agreement is extremely contentious, but the TPP Agreement contains important provisions regarding intellectual property (IP) rights, especially the standards of protection for pharmaceuticals. If the global community is to truly benefit from the promise of medical progress, we must stop the attack on the IP protections that incentivize innovation and turn our attention to the issues that genuinely inhibit access to medicines.