Pharmaceutical – global perspective
After many years of negotiations and multiple rounds of final negotiations, the final text of the Trans-Pacific Partnership (TPP) agreement was released to the public on 5 November 2015.
In the lead up to the release of the final text, one of the most anticipated topics was the nature and extent to which the TPP would provide protections for pharmaceutical products, and the impact any such protections may have on consumer access to medicines and public health policy in TPP nations.
This article provides a high-level overview of the key provisions of the TPP that may impact upon the pharmaceutical industry in the TPP-region. These provisions largely relate to patent protection and data exclusivity. A more detailed analysis on the impact of these provisions on the pharmaceutical industry in Australia is available here.
The TPP seeks to create greater regional consistency by establishing standards for the subject matter and duration of patents. Relevantly for the pharmaceutical industry in the region, the TPP includes the following provisions relating to patent protection:
- Patents for inventions: signatory states must make patents available for any inventions (both products and processes) which are new, involve an inventive step and are capable of industrial application.
- Exclusions from patentability: signatory states may exclude from patentability inventions the commercial exploitation of which is contrary to ordre public or morality, as well as:
- diagnostic, therapeutic and surgical methods for the treatment of humans or animals, and
- animals and essentially biological processes for the production of plants or animals.
- Secondary use patents: the TPP also requires signatory states to confirm that patents are available for either ‘new uses of a known product, new methods of using a known product, or new processes of using a known product’.
- Patent term extensions on the basis of delays in grant of marketing approval: the TPP requires signatory states to make ‘best efforts’ to process marketing approvals for pharmaceutical products ‘in an efficient and timely manner’. Where the marketing approval process results in an ‘unreasonable curtailment of the effective patent term’, signatory states are to allow adjustments of the patent term to compensate for such curtailment.
The TPP also seeks to create greater regional consistency with respect to data exclusivity, an area of particular interest for the pharmaceutical industry. In particular, the TPP requires signatory states to provide:
- a general data exclusivity period of 5 years from the date marketing approval of a pharmaceutical product is received; and
- in the case of biological pharmaceutical products, either a period of 8 years data exclusivity, or 5 years provided the signatory state also provides effective market protection through ‘other measures’.