Data exclusivity provisions under the Therapeutic Goods Act 1989
In Australia the Therapeutic Goods Act 1989 (Cth) (“the Act”) sets exclusivity periods for the use of information provided by a sponsor in an application for approval of a therapeutic good by the Therapeutic Goods Administration (“TGA”). Effectively, the sponsor is provided a specific period of protection for such data. The period of “data exclusivity” is separate and distinct from other forms of intellectual property protection, such as patents. There are also similar protections which apply to data submitted in support of agricultural and veterinary (“Agvet”) products under the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (“Agvet Code”). In some circumstances, the data exclusivity period may extend beyond the term of a patent for a pharmaceutical or Agvet product and enhance the market position of the “innovator” company against competing generic companies. This article provides a brief overview of the data exclusivity regime and the circumstances where it may operate to supplement other intellectual property rights.
What data is protected?
The pathway for commercialising pharmaceutical and Agvet products involves obtaining regulatory and marketing approval based on proof of safety, quality and efficacy. The authorities which oversee this process in Australia are the TGA (in the human health area) and the Australian Pesticides and Veterinary Medicines Authority (“APVMA”) (in the agricultural and veterinary field). Sponsors for new products are required to provide specific information in an application for approval of a product under the Act or the Agvet Code.
The “data exclusivity“ provisions provide a defined period of time during which subsequent sponsors for equivalent products may not benefit from or rely upon the confidential data provided by the first sponsor (without their consent). In Australia the period of exclusivity for data is:
- in relation to therapeutic goods, five (5) years for therapeutic goods containing a new active component, where no other therapeutic goods consisting of or containing that active component were included in the Australian Register of Therapeutic Goods (ARTG). An “active component“ is defined as a substance that is, or substances that together are, primarily responsible for the biological or other effect identifying the goods as therapeutic goods. In Australia data exclusivity is not provided for new dosage forms, routes of administration, indications or combinations with other active ingredients.
- in relation to agricultural or veterinary products, up to eleven (11) years in relation to an application to register a new active constituent (i.e. an active constituent that was not a previously endorsed active constituent at the time of registration), or a product containing a new active constituent, where that product has been accepted for evaluation before the active had been approved; five (5) years in relation to the approval to register another agricultural product, or registration variations in relation to an agricultural product, such as labelling; and three (3) years in relation to the approval to register another veterinary chemical product, or registration variations in relation to a veterinary chemical product, such as labelling.
The exclusivity periods apply to confidential information provided under the Act or Agvet Code in support of the application for the registration of a product. The period of data exclusivity commences from the date on which the new product is registered under the Act or Agvet Code. The effect is that generic competitors will be “blocked“ for the period of exclusivity from using an innovator company’s data in support of their own application for approval of an equivalent product. The provisions only cover new products and do not encompass new uses of existing compounds.
The data exclusivity provisions are required as a condition of Australia’s participation in the Trade-Related Aspects of Intellectual Property Rights (“TRIPS“) Agreement. There is discretion for each signatory country to model their protection regime for confidential test data, but in all cases the conditions must be aimed at preventing “unfair commercial use“ of data. The basic requirement is that:
Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.
–TRIPS Agreement Section 7, Article 39(3)
Data exclusivity vs patent protection
Patents and data exclusivity are two distinct forms of intellectual property protection. Whilst in most cases the protection provided by relevant patents will extend beyond the data exclusivity period for an approved product (the minimum term of protection in Australia is twenty (20) years, with an extension of term of up to five (5) years available for pharmaceutical patents), in situations where the time to obtain regulatory approval is drawn-out, the data exclusivity provisions may be effective beyond the patent term. If the patent expires before the data exclusivity period, the separate protection regime can be of strategic relevance for innovator pharmaceutical and Agvet companies. The data exclusivity provisions are also an incentive for innovation in relation to off-patent products.
While the focus for most innovator pharmaceutical and Agvet companies will remain with patent protection for their products, it is useful to be aware of the protection strategies available under the Act and Agvet Code.