White Paper Asserts That Existing Trade Agreements Provide No Data Exclusivity for Biologics

by McDonnell Boehnen Hulbert & Berghoff LLP

Baker, BrookIn a white paper released earlier this month, Professor Brook Baker of the Northeastern University School of Law argues that current trade agreements do not provide data exclusivity for biologics, and therefore, that the twelve countries negotiating the Trans-Pacific Partnership Agreement (TPP) "can and should apply their minds to potential costs of treaty-mandated biologic exclusivity."  In determining that the data exclusivity provisions of existing trade agreements do not apply to biologics, Prof. Baker (at right) reviewed the North American Free Trade Agreement (NAFTA), which applies to the U.S., Mexico, and Canada, the United States-Peru Free Trade Agreement (US-Peru FTA), the Dominican Republic-Central American Free Trade Agreement (DR-CAFTA), the Korea-United States Free Trade Agreement (KORUS), and the United States-Singapore Free Trade Agreement (US-Singapore FTA).  With the exception of the US-Singapore FTA, which Prof. Baker found to be ambiguous with respect to coverage, all of the other treaties contained data exclusivity provisions that applied only to pharmaceuticals involving new chemical entities (traditional small-molecule, chemically synthesized drugs), and not to pharmaceuticals that do not involve new chemical entities (biologics).

According to the white paper, the absence of data exclusivity provisions in these trade agreements (with the possible exception of the US-Singapore FTA) is significant because the Biotechnology Industry Organization (BIO) and United States Trade Representative (USTR) "want to have it both ways."  On the one hand, they:

[A]rgue repeatedly that biologics are different . . . , that they entail different therapeutic risks, that they are not protected by patents to the same extent as small-molecule medicines, that the research, development, registration, and manufacture of biologics all entail greater uncertainties, and thus that the bio-tech industry need different provisions on data/market exclusivity than that provided with respect to chemistry-based pharmaceutical right holders."

On the other hand, however, they argue that TPP negotiators need not worry about the U.S. proposal for a 12-year data exclusivity period for biologics because some of the countries involved in the negotiations "have already indirectly agreed to data exclusivity on biologics in previously trade agreements."  The white paper concludes that such an argument is "without merit."

Notwithstanding the paper's conclusion that current trade agreements do not provide data exclusivity for biologics, and despite acknowledging that "[t]reating biologics differently from traditional small-molecule, chemically synthesized products makes a lot of sense," Prof. Baker contends that the 12-year exclusivity period provided in the Biologics Price Competition and Innovation Act (BPCIA) is "excessive."  In particular, he advises TPP negotiators that they might want to "consider alerting the U.S. and its public to [the] fact that twelve years of data exclusivity for biologics in the TPP would bind the hands of Congress in the future -- it would lock-in an excessive period of data exclusivity through secret, closed-door negotiations, even while the Obama Administration and certain members of Congress are reconsidering wisdom of the existing legislation," adding that "[d]ata exclusivity for biologics, especially extra-long data exclusivity, is a fool's gamble."  The paper notes that the U.S. is intead expected to propose that a 12-year data exclusivity period for biologics be incorporated into the TPP.

For additional information regarding this and other related topics, please see:

• "BIO Reiterates Support for 12-Year Data Exclusivity Period for Biologics," August 20, 2013
• "Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not," May 9, 2013
• "U.S. Negotiators on TPP -- Don't Trade Away the Biopharmaceutical Research Sector," September 30, 2012
• "Senators Support Inclusion of 12-Year Exclusivity Period in Free Trade Agreement," September 12, 2011
• "House Legislators Lobby to Exclude 12-Year Data Exclusivity Period from Free Trade Agreement," August 11, 2011


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Written by:

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.