Trans-Pacific Partnership – What do IP practitioners need to know?

By Gene Quinn
October 18, 2015

business-world-news-globe-335Trade partners negotiating the Trans-Pacific Partnership trade deal have reached an agreement. The agreement details have not been officially released, and likely will not be submitted to Congress for a mandatory review for at least a month, perhaps longer.

The New York Times, POLITICO and others are reporting that in order to reach an agreement the United States granted a key concession relating to biologics, which are advanced medicines made from living organisms. Presently the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement reportedly knocks that term of protection down to 5 years.

A leaked version of the TPP from WikiLeaks, if indeed an accurate representation of the TPP, confirms that data exclusivity for 5 years was agreed to by the Obama Administration. Specifically, Article QQ.E.16.1(a), which relates to data protection for pharmaceutical test data reads as follows:

If a Party requires, as a condition for granting marketing approval for a new pharmaceutical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product, the Party shall not permit third persons, without the consent of the person who previously submitted such information, to market the same or a similar product on the basis of:

(i) that information; or

(ii) the marketing approval granted to the person who submitted such information

for at least five years from the date of marketing approval of the new pharmaceutical product in the territory of the Party.

(emphasis added).

While the term of data exclusivity is not one in the same with reducing the term of market exclusivity, there is little doubt that more limited data exclusivity would likely lead to significant negative consequences for the bio-pharma industry.

According to POLITICO, some countries viewed 12 years of data protection as prohibitively expensive as they search for ways to offer such treatments to their population. The U.S. government, specifically the Obama Administration, has also long wanted a more limited term for data exclusivity.

Early on in the Obama Administration, Peter Orzag, then the Director of the Office of Management and Budget, sent a letter to Congressman Waxman explaining the President’s position on the appropriate length of exclusive protection for pioneering biologics.  The biotech and pharmaceutical industry had been lobbying for 12 to 14 years of exclusivity. President Obama favored roughly half that time frame, claiming that 7 years “strikes the appropriate balance between innovation and competition by providing for seven years of exclusivity.”  So the battle lines were being drawn. Ultimately, the industry would prevail and Congress would prove 12 years of exclusivity.

Fast forward from 2009 to 2015. Obamacare has passed and the Obama Administration has over the last several years advocated positions at the Supreme Court that have made it extremely difficult for some biotech and pharmaceutical companies. With protection lasting for 12 years being viewed as breaking the bank on rising healthcare costs it is hardly a surprise that President Obama would agree to dramatically reduce the protections afforded to biologics.

The Author

Gene Quinn

Gene Quinn is a Patent Attorney and Editor and President & CEO ofIPWatchdog, Inc.. Gene founded IPWatchdog.com in 1999. Gene is also a principal lecturer in the PLI Patent Bar Review Course and Of Counsel to the law firm of Berenato & White, LLC. Gene’s specialty is in the area of strategic patent consulting, patent application drafting and patent prosecution. He consults with attorneys facing peculiar procedural issues at the Patent Office, advises investors and executives on patent law changes and pending litigation matters, and works with start-up businesses throughout the United States and around the world, primarily dealing with software and computer related innovations. is admitted to practice law in New Hampshire, is a Registered Patent Attorney and is also admitted to practice before the United States Court of Appeals for the Federal Circuit. CLICK HERE to send Gene a message.

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Discuss this

There are currently 4 Comments comments.

  1. Anon October 18, 2015 11:13 pm

    Please clarify that this exclusivity term of years is or is not in addition to the exclusivity of the patent grant.

    Thanks.

  2. Gene Quinn October 19, 2015 11:31 am

    Anon-

    Data exclusivity is different than patent term. There would still be patent term, if patent term can be obtained. Increasingly, however, patents are being denied for new drugs. If KSR ever actually gets enforced in pharma/bio the way it is interpreted elsewhere these types of patents will become quite rare. Pharma/bio use computers to tell them what to investigate, so what a human actually investigates would be at least obvious to try.

    Data exclusivity exists even when no market exclusivity (i.e., patents) exist. Data exclusivity says that the generic can rely on all the information and testing conducted by the innovator but only after X years. If a patent cannot be obtained the FDA will still require all that time and cost. If generics can waltz in and use all that information after 5 years it will mean it is financially impossible to pursue certain paths no matter how promising they may seem.

    -Gene

  3. Anon October 19, 2015 9:44 pm

    The statement “there would still be patent term” leads me to believe that the patent term is used completely first, then this additional term of exclusivity kicks in.

    Is that correct (at least for those things that can obtain patent term)?

  4. Ryan October 23, 2015 9:57 am

    Gene,
    I enjoyed the webinar on Wednesday. Can I get a copy of the slides? Thanks.