Introduction

The data exclusivity regime was introduced in 1998 to protect data which innovator companies submit in support of registration of products in the Australian Register of Therapeutic Goods (ARTG) which contain new “active components”. However, the Federal Court’s interpretation of the statutory provisions relating to data protection and the meaning of the term “active component” may, in some cases, affect whether data exclusivity will apply.

Why do we need data protection?

Prior to introduction of the data exclusivity regime, innovator companies received little protection for the data they generated in relation to new drugs. Patent protection laws provided some level of protection for products that had a new active component, but not all products were subject to a patent. Additionally, patent protection did not protect the company from use of their confidential data by a third party.  

Although confidential data that were submitted to the Therapeutic Goods Administration (TGA) by innovator companies were protected from disclosure, generic companies were still able to “piggyback” on an innovator’s application for registration by relying on an innovator’s data to supplement their own data, thereby circumventing the need to generate their own data. Whilst this saved many millions of research dollars for the generic companies and effectively granted them expedited marketing approval for their products, it disadvantaged the innovator companies, which invested considerable resources to generate the data.

Introduction of a data exclusivity regime

The Therapeutic Goods Legislation Amendment Act 1998 attempted to remedy this situation by inserting a new section 25A into the Therapeutic Goods Act 1989 (Act). Section 25A created a data exclusivity regime for new products containing new ‘active components’ by establishing the principle of “protected information”.

What is “protected information”?

Information is “protected” if it meets the following criteria in Section 25A(2) of the Act:  

  • the information concerns an active component (but not a device) which is contained in an application to register a therapeutic good,  
  • the information is not in the public domain and the sponsor has not given written permission for the Secretary to use the information,  
  • at the time the application was lodged, no goods containing that active ingredient were (or had ever been) included in the ARTG, and  
  • the therapeutic good has been included in the Register for less than 5 years.  

An active component is defined in section 25A(3) as a substance that is, or one of the substances that together are, primarily responsible for the biological or other effect identifying the goods as therapeutic goods.  

How does data protection work?

The data protection scheme works by prohibiting, pursuant to section 25A(1), the Secretary from using “protected” information when evaluating therapeutic goods for registration. The prohibition lasts for 5 years from the date of first registration of the goods and is conditional upon there being no other therapeutic goods containing the same active component in the ARTG, at that time or at any time in the past.  

This means that information submitted by an innovator company in support of registration of a new chemical entity cannot be used by a generic company to ‘bridge’ its own application, if that information is “protected” within the meaning of the Act. Effectively, generic companies would need to submit a full data package (that is, they would need to independently generate their own data) to support registration of a generic product during the 5 year data exclusivity period. This provides a safety net for products containing a new active component that are not protected by a patent.

Case Study - Alphapharm v Lundbeck

What was the case about?

The case of Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559 (Lundbeck case) involved, inter alia, analysis of section 25A of the Act in the context of a purified enantiomer.  

The case concerned the use of information provided by Lundbeck to the TGA for the registration of Lexapro®, an antidepressant, to evaluate an application submitted on 15 June 2005 by Alphapharm for registration of Loxalate®, a generic version of Lexapro. Alphapharm had submitted an abbreviated application and invited the TGA to rely on the data filed by Lundbeck in respect of Lexapro to support registration of its generic product.  

Lexapro contained escitalopram oxalate as the active component, which consisted only of purified S-citalopram, the therapeutically active (+)-enantiomer of the racemate citalopram. Lexapro was registered in the ARTG on 16 September 2003.

Of relevance to this case, Lundbeck had registered Cipramil®, containing the racemate citalopram, on 9 December 1997.

In response to Alphapharm’s application to the TGA, Lundbeck sought a declaration that the information it had provided in relation to its application for registration of Lexapro was protected under section 25A, and an order restraining the Secretary from using the information before 16 September 2008 (i.e. 5 years after registration of Lexapro) to evaluate any other application for registration.  

What did the court decide?

The court refused Lundbeck’s requests for a declaration and restraining order. This was on the basis that the information submitted in support of Lexapro did not meet the criteria of “protected information” as set out in section 25A because there was already another therapeutic good in the ARTG, Cipramil, “consisting of, or containing” the active component escitalopram. Hence, the requirements of section 25(2) were not met. It did not matter that Cipramil contained two possibly active components.  

Therefore, the only product to which data exclusivity could be applied was Cipramil, but because 5 years had elapsed since its inclusion in the ARTG (on 9 December 1997), the period of data exclusivity had expired.  

How did the Court arrive at its decision?

The Lundbeck case hinged on a number of considerations, but the most important was whether Cipramil was a good “consisting of, or containing” (+)-citalopram within the meaning of section 25A(2).  

There was no dispute that (+)-citalopram was the active component of Lexapro. However, both Alphapharm and the Secretary submitted that it was also an active component of Cipramil, ie that Cipramil “consists of or contains” (+)-citalopram as an active component.  

In making its decision, the Court made the following specific findings:  

  • The identity of escitalopram does not change according to whether it forms part of a racemate or not.  
  • Lexapro contains only one active component (escitalopram), whereas Cipramil contains two active components (S-citalopram and R‑citalopram) i.e. escitalopram is the active component of Lexapro and an active component of Cipramil.  
  • It is not required that escitalopram be the active component for section 25A(2)(c)(i) to be enlivened.  
  • The word “containing” must be read in light of definition of “active component” in section 25A(3), which clearly contemplates that therapeutic goods may contain more than one active component.  
  • Therefore, the provisions of section 25A(3) are satisfied if escitalopram is one of two or more active components in Cipramil.  

Lundbeck argued that “active component” as used in section 25A(2) and defined in section 25A(3) was synonymous with “new chemical entity. It drew specific attention to the definition of a “new chemical entity” in Schedule 9 of the Regulations, specifically sections 1(a) and (b):  

  1. a chemical, biological or radiopharmaceutical substance that has not previously been included in the Register, or  
  2. an isomer, mixture of isomers, complex of, derivative of or salt of, a registered chemical substance that, having previously been included in the Register, differs from the registered substance in having different safety or efficacy properties  

Given that Lexapro was registered as a “new chemical entity”, Lundbeck, not unreasonably, expected that the purified enantiomer contained in Lexapro would qualify as a new “active component” and thus be afforded protection. Consistent with Schedule 9 of the Regulations, it was also reasonable that by virtue of its registration by the TGA as a new chemical entity, Lexapro was deemed to be a substance that had “not previously been included in the Register”.

However, the Court did not recognise
the term “new chemical entity” or
consider it to be synonymous with new
“active component”, a position which is
inconsistent with how the industry has
applied these definitions and interpreted
the legislation in practice.


What are the implications for
sponsors of therapeutic goods?

 

The Court’s decision in the Lundbeck
case makes it clear that the protection
afforded by section 25A does not
necessarily apply to all designated “new
chemical entities”, but only those that
have not previously been included in the
ARTG, in any form. This may create a
disincentive for research-based companies
to develop new, purified or improved
versions of active ingredients, given that
applications for new chemical entities
require the generation of significantly
more data and attract higher fees than
generic applications.
 

Whilst the introduction of section 25A
has improved the protection afforded
to innovator companies for intellectual
property relating to their new products,
it is important for sponsors to understand
that there are specific criteria to be met
for data exclusivity to apply.