By Kevin E. Noonan —
The diplomats negotiating the Trans Pacific Partnership (TPP) agreement have done the seemingly impossible: they have kept the details of the draft agreement secret from the press and public in the United States, Canada, Mexico, Australia, Singapore, Malaysia, Japan, Chile, Peru, Vietnam, New Zealand, and Brunei Darussalam (as well as the rest of the world over six years of deliberations. Secrecy has not been absolute, of course, with the Wikileaks website periodically publishing purported drafts of the agreement. With the announcement on October 5th that the parties have come to substantial agreement, Wikileaks once again released portions of the agreement. Relevant here are the purported provisions regarding intellectual property (see “TPP Treaty: Intellectual Property Rights Chapter”).
The IP portion of the agreement is contained in provisionally numbers Section QQ. The Objectives of the agreement with regard to IP are stated as follows:
The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.
The substantive IP portions of the Agreement govern copyrights, trademarks and patents, and Section QQ.E.20 is specifically drawn to biologic drugs. Consistent with the efforts of the Obama administration to reduce the term of market exclusivity of biologic drugs from 12 years as provided by the Biologic Price and Competition and Innovation Act (BPCIA) to 7 years (even at the risk of scuttling agreement over passage of the omnibus healthcare reform legislation termed “Obamacare”), the TPP provides that the signatory nations will provide “effective market protection  for a period of at least 8 years from the date of first marketing approval of that product” or, in the alternative “a period of at least 5 years from the date of first marketing approval.” These provisions don’t mandate protection of less than 12 years under current U.S. law but provide a pathway for reducing the term.
In like vein, the Agreement defines patentable subject matter as being “any invention, whether a product or process, in all fields of technology, provided that the invention is new, involves an inventive step, and is capable of industrial application” (Section QQ.E.1). But before the U.S. patent community anticipates that ratification of the TPP will return the U.S. to status quo ante of the Mayo/Myriad/Alice trilogy of recent Supreme Court cases, the Agreement also provides that “Each Party may also exclude from patentability: diagnostic, therapeutic, and surgical methods for the treatment of humans or animals; animals other than microorganisms; and essentially biological processes for the production of plants or animals, other than non-biological and microbiological processes.” (Section QQ.E.1.3).
More worrisome (for those who believe that developing a harmonized worldwide IP regime providing predictable rights, the drafters of the TPP have learned the lessons of the GATT/TRIPS agreement and its later modification by the WTO, inter alia by the Doha Declaration. Thus, Section QQ.A.Y provides:
1. Parties may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Chapter.
2. Appropriate measures, provided that they are consistent with the provisions of this Chapter, may be needed to prevent the abuse of intellectual property rights by rights holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.
Congress granted the President so-called “fast-track authority” for the TPP, which means that Congress can ratify the agreement, or not, but cannot amend the agreement or filibuster Senate consideration. Opposition to the TPP has been voiced by putative Democratic Party Presidential nominee Hillary Clinton and her nearest challenger, Sen. Bernie Sanders (I-VT), as well as groups like the Electronic Frontier Foundation, Public Citizen and several unions. Ratification of the TPP might be the crowning achievement of the Obama Presidency, which includes normalizing relations with Cuba, reducing U.S. military presence on Iraq and Afghanistan, and Obamacare. But there is sufficient opposition to the agreement that its ratification is not assured and provides a juicy target for political shenanigans as the 2016 election cycle approaches.
Patent Docs will provide a more in-depth review when the official version of the TPP is released.