Trans-Pacific Partnership Agreement Leaked by WikiLeaks

The apparent final version of the Trans-Pacific Partnership Agreement (TPP) has been leaked by WikiLeaks.  A copy can be found, here.  While I have not reviewed the entire agreement in depth, here is the section concerning biologics that was apparently holding up the agreement, in part:

Article QQ.E.20: {Biologics}

1. With regard to protecting new biologics, a Party shall either: (a) with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic62,63, provide effective market protection through the implementation of Article QQ.E.16.1 and Article QQ.E.16.3 mutatis mutandis for a period of at least 8 years from the date of first marketing approval of that product in that Party; or alternatively (b) with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic, provide effective market protection: Without Prejudice

(i) through the implementation of Articles QQ.E.16.1 and QQ.E.16.3 mutatis mutandis for a period of at least 5 years from the date of first marketing approval of that product in that Party;

(ii) through other measures; and (iii) recognizing that market circumstances also contribute to effective market protection to deliver a comparable outcome in the market.

2. For the purposes of this Section, each Party shall apply this provision to, at a minimum, a product that is, or alternatively, contains, a protein produced using biotechnology processes64, for use in human beings for the prevention, treatment, or cure of a disease or condition.

3. Recognizing that international and domestic regulation of new pharmaceutical products that are or contain a biologic is in a formative stage and that market circumstances may evolve over time, the Parties shall consult after 10 years, or as otherwise decided by the TPP Commission, to review the period of exclusivity provided in paragraph 1 and the scope of application provided in paragraph 2, with a view to providing effective incentives for the development of new pharmaceutical products that are or contain a biologic, as well as with a view to facilitating the timely availability of follow-on biosimilars, and to ensuring that the scope of application remains consistent with international developments regarding approval of additional categories of new pharmaceutical products that are or contain a biologic.

[Footnote] 62 Nothing requires a Party to extend the protection of this paragraph to:

(a) any second or subsequent marketing approval of such a pharmaceutical product; or

(b) a pharmaceutical product that is or contains a previously approved biologic.

[Footnote] 63 Each Party may provide that an applicant may request approval of a pharmaceutical product that is a biologic under the procedures set forth in Article QQ.E.16.1(a)-(b) within 5 years of entry into force of this Agreement, provided that other pharmaceutical products in the same class of products have been approved by the Party under the procedures set forth in Article QQ.E.16.1(a)-(b) before entry into force of this Agreement.

[Footnote] 64 Drafters’ note: The Parties understand that Article QQ.A.5 applies to the provisions of this Chapter, including the definition of “biotechnology process” in this paragraph. Accordingly, the Parties understand that each Party may determine the meaning of biotechnology processes in its legal system and practice.

The Pharmaceuticals Research and Manufacturing Association (PhRMA) has already expressed displeasure with the term of data protection for biologics.   PhRMA’s president stated:

“We are disappointed that the Ministers failed to secure 12 years of data protection for biologic medicines, which represent the next wave of innovation in our industry.  This term was not a random number, but the result of a long debate in Congress, which determined that this period of time captured the appropriate balance that stimulated research but gave access to biosimilars in a timely manner.”

See more at: http://phrma.org/media-releases/phrma-statement-on-the-transpacific-partnership-negotiations#sthash.hhnHaxO9.dpuf”

For more information on the Copyright provisions concerning the TPP, see the Electronic Frontier Foundation.  The TPP still must be approved by Congress, and recently Democratic Presidential Candidate Hillary Clinton stated she does not support the agreement—reversing her earlier opinion and putting her at odds with the Obama Administration.  [Hat Tip to Professor Irene Calboli at the Texas A&M University School of Law].