Prof. Brook K. Baker, Northeastern U. School of Law and Health GAP
Updated and Revised: October 25, 2011
Well before the new leak of the US’s September 2011 Trans-Pacific Partnership Intellectual Property Rights Chapter (Selected Provisions), the US has been touting its alleged Access Window, Trade-Enhancing Access to Medicines or TEAM, which is now revealed as a hoax. Basically the US has created a window within which pharmaceutical companies must apply for a narrow subset of patent term extensions, for data protection, and for patent/registration linkage. But the general rule is that patent-term extensions, data exclusivity, and patent-registration linkage will be automatic. In the optional window where it isn’t automatic (where a country relies, in whole or in part, on the fact of marketing approval/registration in another country in order to register domestically), the patent holder must merely file preliminary information within a yet-to-be defined time period in order to have the benefit of these three TRIPS-plus benefits.
The three TRIPS-plus and “2007 New Trade Policy”-plus provisions set forth in the newly leaked IPR Chapter are: (1) TPP trading partners must now grant cumulative patent term extensions for both delays in granting patents (for delays longer than 4 years post-filing or 2 years post-examination request) AND in granting marketing approval (up to five years), Art. 8-6; (2) TPP trading partners must now grant data exclusivity with respect to both disclosed and undisclosed data, and deny reference to or reliance on such data or the fact of prior registration anywhere in the world, for five years for a new pharmaceutical product and for an additional three years where additional clinical data is filed to support further marketing approvals, Art. 9-2 (it is important to point out that there is no express data-exclusivity, public-health exception mechanism in the TPP text as there is in the 2007 New Trade Policy and in the amended US-Peru and US-Columbia FTAs); and (3) TPP partners must now provide patent-registration linkage mechanisms for patent holders to list their claimed patents, to receive notice when marketing applications are made for the same and “similar” products, to provide automatic stays of marketing approval activity for the follow-on product to allow adjudication of patent validity and/or infringement, to allow for expeditious judicial review along with rights to issue provisional orders, and finally to deny registration for infringing product for the duration of the patent, Art. 9-5. The right of patent term extensions for delays in granting patents is absolute – no exceptions are permitted. TRIPS–plus patent extensions for regulatory delay, data exclusivity, and patent-registration linkage will also be automatic and absolute where countries do not rely in whole or in part on the fact of prior registration in another country in order to grant marketing approval/registration domestically.
It is only where countries do rely on patenting elsewhere that the so-called TEAM Access Window applies. Countries are not required to create the TEAM Access Window, but they “may” do so in a narrow subset of cases – where the party “requires or permits an applicant to obtain approval for marketing a new pharmaceutical product in its territory by relying, in whole or in part, on the prior approval of the pharmaceutical product by the regulatory authority in another county.” Arts. 9.4, 9.6, and 8-6(e) (by reference). Although the term of years for the Access Window is not yet specified, basically a company will get triple-dose TRIPS-plus IP protections if the company files for marketing approval in that country within the Access Window timeframe.
The silver lining for Big Pharma even where the Access Window applies is contained in Article 9-8.(a), which requires the TPP country to allow initiation of marketing registration in that country based on any information available to the applicant, including “evidence of prior approval of the product in another Party [country].” Admittedly, this easy-to–meet standard results in earlier filing for marketing approval, but does little to ensure quicker final approval. More importantly, it comes at the very high price of much stronger monopoly rights.
Article 9-8.(a) may seem innocuous at first glance, but it really is a barn door for Big Pharma. Big Pharma has long chaffed over the lack of harmonization of drug regulatory authorities’ marketing approval requirements, standards, and processes. Big Pharma would like something very like what is provided by the WIPO Patent Cooperation Treaty, an easy-to-use, standarized mechanism that will allow companies to use one unitary application to initiate patent examination and granting under the auspices of WIPO or reliance registration in the instance of national drug regulatory authorities. (Pharma’s intentions and interests in this regard are fully reflected in another leaked text, the US Introduction to Proposed TBT Annexes on Medical Devices, Pharmaceutical Products and Cosmetic Products.) Article 9-8. says:
“Where a party chooses to apply subparagraph 6(e) of Article 8 and paragraphs 4 and 6 of this Article [Article 9], the following provisions shall apply: (a) a Party shall permit an applicant to commence the process of obtaining marketing approval by providing the regulatory authority of the Party information supporting approval of the new pharmaceutical product in the Party that is available to the person at the time the request is made, such as evidence of the prior approval of the product in another Party [most commonly the US or EU]. It is understood, that, while a Party may impose reasonable additional requirements or deadlines as a condition of authorizing the person to market to market the pharmaceutical product in its territory, satisfaction of those additional requirements or deadlines or the granting of approval shall be recognized by the Party as necessarily occurring after the commencement of the marketing approval process within the meaning of subparagraph 6(e) of Article 8 or paragraphs 4 and 6 of this Article.”
This provision requires countries to modify their drug registration laws to rely in whole or in part of the fact of prior registration elsewhere and thereafter to allow pharmaceutical companies to choose the information they want to submit – in other words, they do no have to submit complete dossiers and may not even be required to use required forms to cross the start-line for drug registration. (Note: The US is seeking TPP partners agreement to use the ICD Common Technical Document as the standardized harmonized form to initiate registration requests.) They can potentially drag their heels for years thereafter, as they often do now, in completing and prosecuting their registration application, but based on having satisfied the misnamed Access Window time-frame they will be entitled to multi-year patent term extensions, to successive data exclusivity periods that will run from the time final marketing approval (not from the time of the simplified initiation of the registration request), and patent-registration linkage.
The US has stated that it developed the Access Window to expedite access in TPP partners of the newest medicines. Although the “register early or lose extensions, data exclusivity, and linkage” provisions (subparagraph 6(e) of Article 8 or paragraphs 4 and 6 of Article 9) provide some incentives for earlier product introduction in a subset of cases, the requirements are so minimal – file what you have and you’ve in the door – that the Access Window provisions will be meaningless in practice in expediting access.
However, the problem is not simply making a big deal out of very minor process, the Access Window provisions are also likely to result in pressure from the US and Big Pharma for what is essentially a harmonized global registration system, such as those proposed in the Proposed TBT Chapter Annex on Pharmaceutical Products. We can now see that US is arguing with trade partners that they should vicariously grant registration in their countries based on prior marketing approval by drug regulators in the US, Europe, or Japan. (If countries are hoodwinked into adopting wholesale vicarious or reliance registration, there is a risk that they will have reduced ability to assess medicines in light of the particular patient risks and benefits in their country.) Although reliance registration may have certain advantages for countries with weak regulatory authorities and although lack of procedural harmonization adversely impacts both Big Pharma and generics, countries are being asked to given up far to much TRIPS-plus territory for a quick-registration Access Window that doesn’t require fast completion and prosecution of registration applications and that results in greater and longer monopoly protections that will inevitably lead to higher prices and reduced generic competition.
Big Pharma should be forced to introduce new life saving medicines more quickly in developing country markets. Drug regulatory systems should be made more transparent, efficient, and even harmonized, but only so long as country-specific, high standards for assuring quality, safety, and efficacy are maintained. The desirability of earlier product introduction should have nothing to do with a trade off involving greater IP protections that extend and strengthen drug company patent and data-related monopolies.