Patent Law Practice Center

TPP Agreement would reduce data exclusivity for pharma, bio

Trade partners negotiating the Trans-Pacific Partnership trade deal have reached an agreement, although it may be months, or even more than a year, before the Obama Administration submits the deal to Congress for approval. The agreement details have not been officially released, and likely will not be 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).

Article QQ.E.20(1) on biologics reads:

While the term of data exclusivity is not one and the same with 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.

Stay tuned as the official agreement is released and debate in Congress begins.

Point – Counterpoint: The Debate Over Prior User Rights

Written by Gene Quinn, of IPWatchdog and Practice Center Contributor.

Since prior user rights first came up as an issue in the patent reform debate I have been opposed to the idea.  Whether I like prior user rights or not, the reality is that prior user rights are now a part of U.S. patent law.  Nevertheless, the debate goes on about whether prior user rights are a good idea.  In fact, the United States Patent and Trademark Office is tasked through the America Invents Act with conducting a Prior User Rights Study.  To facilitate this study a public hearing on prior user rights was held on October 25 in the Madison Auditorium at its Alexandria, Virginia campus of the USPTO.

With this in mind I thought I would once again revisit prior user rights. One of the arguments I have heard recently supporting prior user rights is that a corporation that is going to invest billions of dollars into a facility should know that their investment is safe and that the plant can’t be shut down by a later filed patent application.  This argument is so specious as to be nearly laughable if you ask me.  This strikes me as just more of corporate America wanting the government to save them from themselves.

Click here for IPWatchdog’s full article.