I still see the TPP as a significant threat to our rights

[AntiBank]

101. Impact Of The TPP On The Pharma Industry (showing EXACTLY that the TPP puts evergreening into play)

http://www.ip-watch.org/2015/12/02/impact-of-the-tpp-on-the-pharma-industry/


The final text of the Trans-Pacific Partnership confirms beyond doubt the apprehensions expressed by civil society, academia and the generic industry about new barriers to access to medicines. The TPP has done away with several flexibilities provided under the TRIPS Agreement and the Doha Declaration on Public Health. Though the text mentions “nothing in this [IPR] Chapter limits a Party’s rights and obligations under Article 31 of the TRIPS Agreement,” the TPP Investment Chapter overrides these flexibilities, says D G Shah.

Executive Summary

The final text of the Trans-Pacific Partnership confirms beyond doubt the apprehensions expressed by civil society, academia and the generic industry about new barriers to access to medicines. The TPP has done away with several flexibilities provided under the TRIPS Agreement and the Doha Declaration on Public Health. Though the text mentions “nothing in this [IPR] Chapter limits a Party’s rights and obligations under Article 31 of the TRIPS Agreement,” the TPP Investment Chapter overrides these flexibilities, says D G Shah.


The key elements in the TPP and their likely impact on pharmaceutical industry – both innovative and generic – are noted below:

Patentability Criteria

The TPP member states have surrendered their sovereign right to define ‘patentability’ criteria. Not only have they have surrendered their right, they have agreed to grant patents for:

a) new uses of a known product;
b) new methods of using a known product, or;
c) new processes of using a known product.


This would lead to the “evergreening” of patents and result in an average extension of monopoly by at least five years. Some can stretch it beyond five years, as was done by Novartis AG for Gleevec (imatinib). This would encourage innovators to go for low-hanging fruits at the cost of more difficult-to-succeed efforts. Generics will slow down and patients will have to wait longer for affordable treatments.

Patent Term Extension

The TPP member states have agreed to adjust the term of the patent for “unreasonable” delays in the issuance of patents. The “unreasonable” period is defined as “more than five years from the date of filing of the patent application”. Likewise, any delay in granting marketing approval for a drug will entitle the rights holder to extension of the patent term.

The patent term adjustment provision has several implications. First, it would enable the rights holder to delay launch of the product in relatively low-priced markets, particularly developing countries. Secondly, to delay the launch, the innovators may furnish even incomplete data to the drug regulator to show the approval process look tardy and inefficient.

Thirdly, it would thus deny access to a new medicine in the lower priced markets. Fourthly, even after the expiry of a patent in the developed countries, the product would retain monopoly status in the developing countries. This could on an average give at least two years of extended monopoly, further impacting generic growth and patient access.

snip



Under the TPP, America’s insanely high drug prices will be an unappreciated export

http://qz.com/543385/under-the-tpp-americas-insanely-high-drug-prices-will-be-an-unappreciated-export/


US drugs already have strong patent protections

US patents on traditional drugs last 20 years; once they expire, competitors can apply for permission to market a generic version. Generic manufacturers don’t have to repeat the entire costly process of clinical trials, though; a 1984 law called the Hatch-Waxman Act lets them rely on the brand-name drug’s clinical data if they can prove their generic drug is an equivalent.

Brand-name drug makers were aghast at the idea of allowing rivals to use their expensive clinical data to start robbing them of market share, of course. So Hatch-Waxman also contains a compromise: five years of “data exclusivity” after the 20-year patent expires, during which no one else can use brand-name clinical data to get a drug approved.

Generic drugs developed under this system have helped consumers in the US and around the world. But there is a strong case that 25 years of protection for traditional drugs is too long—and ultimately, a way for investors to extract rents (like the infamous case of Martin Shkreli, who bought a drug and raised the price 5,000%) rather than an incentive for innovation.
Obamacare made some protections even stronger

Nonetheless, certain kinds of drug patents ended up even better protected under the Obama administration’s Affordable Care Act (ACA).


The president and his team knew well that to pass a comprehensive overhaul of the health-care system, they’d need the health industry’s powerful players—big hospital chains and pharmaceutical makers, mainly—on their side, even as they found ways to spend less money on them.

To gain pharma’s support, the administration not only agreed not to use the government’s negotiating power to drive down drug prices, but also endorsed a 12-year period of data exclusivity for “biologics”—a class of drugs based not on inert chemical compounds but instead created from living cells, and seen as the next big thing in medical research. This concession was made despite arguments in a 2009 Federal Trade Commission report that biologics don’t need that kind of protection (pdf) because generic versions of them, known as biosimilars, are more difficult to develop than traditional generics.
Now the TPP is exporting those protections

The US sought to accomplish a half-dozen sometimes conflicting goals with the TPP: Open new markets for US exports and especially services; deepen economic linkages with Pacific states in a bid to contain China; convince China to continue liberalizing its economy; and generally raise economic standards, such as labor rights and environmental regulations, at a time when the main forum for doing this, the World Trade Organization, was deeply deadlocked.

Even supporters of the pact in America concede that it will result in low-skilled manufacturing jobs leaving the US for other countries. Though US negotiators included worker protections in the treaty, including the right to unionize, the wage gap between the US and, say, Vietnam or Peru, is just too large for many manufacturers to ignore.



But that sacrifice will be balanced out by benefits to US service industries, particularly those that make their money off intellectual property. When it comes to tech companies or Hollywood films, the higher prices these protections bring can be onerous to consumers, but arguably a lot more so when they involve prices not for entertainment but for health and medicines.
With Republicans in control of Congress, gaining approval of the TPP would in part be contingent on the support of pharma. So US negotiators presented demands opposed by every other country in the talks. The 12-year data exclusivity proposal for biologics was the most controversial, since it was new, well beyond global norms, and considered unnecessary by well-respected authorities. In the end, it was wrangled down to a range of five to eight years.