[Ip-health] Biologic data exclusivity and the TPP

Biotech. Info. Inst. biotech at biopharma.com
Mon Aug 19 08:11:51 PDT 2013

There is considerable lack of coherence in the definition/scope of 'biologics' (or the other synonyms used) in different countries worldwide.  The U.S. definition, recodifiied/redefined in BPCIA, now corresponds to that of 'biopharmaceuticals,' i.e., essentially pharmaceutical products manufactured by living organisms (using biotechnology), with this including classic biologics, e.g., vaccines and blood/plasma products.  However, other countries have different definitions, such as various EU regulations only include recombinant/genetic engineered products as "biological medicinal products"; and many other countries don't bother to separately define and regulate 'biologics' vs. all pharmaceuticals, treating all pharmaceuticals the same.

Presuming international treaties sooner or later will need to take a stand on the issue of data exclusivity for biologics, what definition of 'biologics' should be used?  Should the U.S. broad definition, which is probably in the minority worldwide, be the one adopted?  Or should there be some jury-rigged definition involving lists and/or characterizing what technologies are included as 'biologics?'   Should only recombinant/genetic engineered products be included, with classic vaccines and blood products of little concern?  Will countries that currently regulate pharmaceuticals with no differentiation of drugs vs. biologics be forced to classify products along the lines of U.S. and other major markets, i.e., treat biologics as separate from drugs and medical devices?

An even more difficult question/issue -- How will specific products be defined?  How do you stop gaming of approvals-based data exclusivity on an international basis?  Will data exclusivity be defined country-by-country or by some rational criteria?  What defines a product deserving or qualifying for data exclusivity?   Specifically, how do you define a new product (presumably to be granted data exclusivity) vs. a modified version of an existing product (presumably not getting new data exclusivity)?  Do you rationally look at the products or the active agents (using what criteria), or do you look at approvals, which are totally uneven worldwide and easily gamed?  For example, in the U.S., biologics approvals are rather meaningless, in the sense that modified versions of existing products that generally receive supplement approvals can also be approved as full BLAs -- All a company has to do to get a full BLA, even for the most trivial or no change (e.g., a simple labeling change), is simply file the full application.  There are no guidelines, much less rules, for when to file a sBLA or full BLA for incrementally modified products.  So, in the U.S., new/full BLAs don't define new products at all (from a science/entity/product perspective).  For example, there are multiple examples of companies receiving their own BLAs for products with trivial (or even no) modifications traditionally handled by supplemental approvals (e.g., Helixate vs. Kogenate, Eylea vs. Zaltrap, Xyntha vs. Refacto).  For example, Helixate is Kogenate manufactured and relabeled by Bayer for U.S. distribution by CSL, with Helixate having its own full BLA (and in the U.S., 12 years of data exclusivity based on that approval date).  

Also, who is going to make decisions and how about which products are the same or different products in different countries?  If a company says its product it distributes country X is different than the version marketed in country Y, e.g., bioprocessing or formulation is slightly different, who's going to be the one to rule whether these are the same (or new or different; thus, presumably receiving data exclusivity) products or not, and on what basis?  

Thank you.

Ronald A. Rader
Biotechnology Information Institute
1700 Rockville Pike, Suite 400
Rockville, MD 20852
Phone:  301-424-0255
E-mail:  biotech at biopharma.com
Web sites:  www.biopharma.com; www.bioinfo.com; 
    www.biosimilars.com; www.biopharmacopeia.com

On Aug 16, 2013, at 12:13 PM, "Baker, Brook" <b.baker at neu.edu> wrote:

> The U.S., acting on behalf of the U.S. biologics industries, will soon be trying to convince parties to the TPP that they should adopt extended data exclusivity for biologics (at least 12 years) as part of the intellectual property chapter.  As part of its marketing strategy, the U.S. is trying to convince parties behind the scenes that biologic data exclusivity is already included in US FTAs and indeed in some of the FTAs already binding certain TPP parties.  Contrary to this assertion, there is no precedent for data protection for biologics at all in existing US FTAs, let alone for for the extended data exclusivity that the US will be seeking.  TPP parties should reject the US data exclusivities as TRIPS-plus, both for chemical entity pharmaceuticals and biologics.
> Paper at:
> http://infojustice.org/wp-content/uploads/2013/08/baker082013.pdf
> Professor Brook K. Baker
> Health GAP (Global Access Project) &
> Northeastern U. School of Law, Program on Human Rights and the Global Economy
> Honorary Research Fellow, Faculty of Law, Univ. of KwaZulu Natal, SA
> 400 Huntington Ave.
> Boston, MA 02115 USA
> (w) 617-373-3217
> (c) 617-259-0760
> (f) 617-373-5056
> b.baker at neu.edu
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